BELITE BIO, INC (BLTE) SEC Filings & Earnings Calls
EquiReason read 16 BELITE BIO, INC SEC filings in the last 12 months. Latest: 6-K on 2026-10-19 — Belite Bio announced uplisting from Nasdaq Capital Market to Nasdaq Global Select Market, reflecting compliance with stricter financial and liquidity standards and expected to enha.
Source: SEC EDGAR filings · read by EquiReason
- Market cap
- 5.8B
- P/E TTM
- —
- Dividend yield
- —
- 52-week
- —
- Next earnings
- 9 Nov, in 16 days
Every filing, read
last 12 months · SECWhat happened, the numbers inside, guidance and risks. The original is one click away.
8 Sep 20266-KBelite Bio submitted an NDA to Japan's MHLW under Sakigake designation for tinlarebant in Stargardt disease type 1, with FDA also accepting NDA with Priority Review (PDUFA Feb 12, 2027). If approved, would be first-ever treatment for STGD1open
Risks flagged
Regulatory approval not guaranteed; clinical trial failure risk remains for ongoing trials (DRAGON II, PHOENIX).
“Tinlarebant is an investigational therapy; NDA acceptance does not guarantee approval.”
13 Aug 20266-KBelite Bio reports Q2 2026 financial results with FDA acceptance of NDA for tinlarebant with Priority Review, PDUFA date Feb 12, 2027, and strong cash position of $780M.earningsopen
Figures in the filing · each found in the filing text
| Cash and cash equivalents · Q2-2026 | $280M | |
| Investments (U.S. treasury bills and notes) · Q2-2026 | $500M | |
| Research and Development expenses · Q2-2026 | $18M | |
| Selling, General, and Administrative expenses · Q2-2026 | $17M |
11 Aug 20266-KFDA accepted NDA for tinlarebant with Priority Review for Stargardt Disease Type 1; PDUFA date Feb 12, 2027. Phase 3 DRAGON trial met primary endpoint with 35.7% reduction in lesion growth rate.open
Figures in the filing · each found in the filing text
| reduction in growth rate of atrophic retinal lesions (DDAF) | 35.7% |
Risks flagged
Regulatory risk: FDA may not approve by PDUFA date; commercial execution risk post-approval.
“NDA under review; PDUFA date Feb 12, 2027; no guarantee of approval.”
15 Jun 20266-KBelite Bio completed rolling NDA submission to FDA for tinlarebant (STGD1) under Breakthrough Therapy Designation; Phase 3 DRAGON trial met primary endpoint; no approved treatments exist.open
Figures in the filing · each found in the filing text
| STGD1 patient population in U.S. · point_in_time | 53,000 |
Risks flagged
Regulatory approval not guaranteed; FDA 60-day review and potential PDUFA date pending
“The completed application will undergo the 60-day review period with the FDA, and if accepted, a PDUFA target action date will be assigned.” · word for word
20 May 20266-KBelite Bio initiated rolling NDA submission to FDA for tinlarebant in Stargardt disease; Phase 3 DRAGON trial completed; enrollment completed for DRAGON II and PHOENIX trials.open
Figures in the filing · each found in the filing text
| Cash and cash equivalents · Total · Q1-2026 | $276M | |
| U.S. treasury bills and notes · Total · Q1-2026 | $522M | |
| Research & Development Expenses · Total · Q1-2026 | $16M | |
| Selling, General & Administrative Expenses · Total · Q1-2026 | $17M |
21 Apr 20266-KBelite Bio initiated rolling submission of NDA to FDA for tinlarebant (Stargardt disease) under Breakthrough Therapy Designation; expects completion in Q2 2026.open
Risks flagged
Regulatory approval not guaranteed; clinical trial risks remain
“forward-looking statements caution about safety, efficacy, and regulatory decisions”
31 Mar 202620-FBelite Bio reported FY2025 net loss of $77.6M, more than double prior year, with no revenue and increasing R&D and SG&A expenses.earningsopen
Figures in the filing · each found in the filing text
| Net Loss · FY2025 | $78M | +115% y/y |
| Accumulated Deficit · FY2025 | $185M | |
| Research and Development Expenses · FY2025 | $45M | +52% y/y |
| Selling, General and Administrative Expenses · FY2025 | $39M | +284% y/y |
Risks flagged
No revenue, pre-commercial stage
“To date, we have not generated any revenues.” · word for word
Clinical trial failure risk
“Our ability to become and remain profitable depends on our ability to generate product revenue.” · word for word
Funding dependency
“We have financed our operations primarily through the issuance of our ordinary shares... we may require further funding through public or private offerings.” · word for word
2 Mar 20266-KPositive topline results from pivotal Phase 3 DRAGON trial of tinlarebant in Stargardt disease: met primary endpoint with 35.7% reduction in lesion growth rate (p=0.0033). NDA submission on track for Q2 2026.open
Figures in the filing · each found in the filing text
| Cash and cash equivalents · FY2025 | $353M | |
| Investments · FY2025 | $420M | |
| Research and development expenses · Q4-2025 | $15M |
Risks flagged
Clinical trial failure pressure for ongoing PHOENIX trial in GA
“PHOENIX trial in GA is ongoing with interim analysis expected; no data yet.”
27 Jan 20266-KBelite Bio completes enrollment of 60 subjects in Phase 2/3 DRAGON II trial of tinlarebant for Stargardt disease; plans NDA submission in 1H 2026; prior Phase 3 DRAGON trial met primary endpoint with 36% reduction in lesion growth (p=0.0033open
Figures in the filing · each found in the filing text
| Subjects enrolled in DRAGON II · January 2026 | 60 |
Risks flagged
Regulatory and clinical risks remain; NDA submission and approval not guaranteed
“Forward-looking statements caution that actual results may differ materially”
2 Dec 20256-KPriced $350M underwritten public offering of ADSs at $154/ADS; proceeds for commercialization and pipeline.open
Figures in the filing · each found in the filing text
| Gross proceeds | $350M |
Risks flagged
Dilution from offering
“2,272,727 ADSs offered, plus 340,909 option”
1 Dec 20256-KBelite Bio filed unaudited interim financials for nine months ended Sep 30, 2025: net loss widened to $52.3M from $26.0M YoY, R&D and G&A expenses increased significantly. Cash position improved to $157M from $31.7M due to equity offerings.earningsopen
Figures in the filing · each found in the filing text
| Cash and cash equivalents · Q3-2025 | $157M | |
| Net loss · 9M-2025 | $52M | +101% y/y |
| Research and development expenses · 9M-2025 | $31M | +36% y/y |
| General and administrative expenses · 9M-2025 | $25M | +334% y/y |
Risks flagged
Significant operating losses and cash burn rate may require additional financing.
“Net loss of $52.3M for 9 months; operating cash outflow of $26.6M.”
1 Dec 20256-KBelite Bio announced proposed underwritten public offering of ADSs. Proceeds intended for commercialization preparation, pipeline development, and working capital. Dilutive to existing shareholders.open
Risks flagged
Dilution risk from equity offering; no assurance of completion or terms.
“Offering subject to market conditions; no assurance as to whether or when the offering may be completed.”
10 Nov 20256-KCompleted pivotal Phase 3 DRAGON trial in Stargardt disease; final topline data expected Q4 2025. NMPA and MHRA accepted applications based on interim results. Enrollment completed for PHOENIX GA trial.open
Figures in the filing · each found in the filing text
| Cash, liquidity funds, and U.S. treasury bills · Q3-2025 | $276M | |
| Research and development expenses · Q3-2025 | $10M | +52% y/y |
Risks flagged
Clinical trial failure risk remains for ongoing PHOENIX trial and final DRAGON data
“DRAGON final topline data not yet released; PHOENIX interim analysis pending.”
BELITE BIO, INC — questions
- What did BELITE BIO, INC file recently?
- 16 SEC filings in the last 12 months. Latest: 6-K on 2026-10-19 — Belite Bio announced uplisting from Nasdaq Capital Market to Nasdaq Global Select Market, reflecting compliance with stricter financial and liquidity standards and expected to enhance visibility and liquidity.
Every figure on this page comes from BELITE BIO, INC's own SEC filings — see them on SEC EDGAR. Price data is licensed and shown only inside the product.
How these figures are read: methodology · EquiReason.