Belite Bio Reports Preliminary, Unaudited Fourth Quarter and Full Year 2025 Financial Results and Provides a Corporate Update
Rhea-AI Summary
Belite Bio (NASDAQ: BLTE) reported positive pivotal Phase 3 DRAGON topline results showing a 35.7% reduction in macular lesion growth versus placebo and remains on track to submit an NDA to the FDA in Q2 2026. The company completed a $402 million public offering and entered 2026 with $352.9M cash and $419.7M investments.
Other updates: DRAGON II reached targeted enrollment (72 subjects as of Feb 27, 2026), PHOENIX completed enrollment with 530 subjects, and GAAP net loss for 2025 was $77.6M.
Positive
- DRAGON Phase 3 met primary endpoint: 35.7% lesion-growth reduction
- On track to submit an NDA in Q2 2026
- Completed a $402 million underwritten public offering
- Cash position of $352.9 million at Dec 31, 2025
- Investments of $419.7 million in U.S. treasury securities
Negative
- R&D expenses rose to $45.4M for 2025 (from $29.9M)
- Selling, general & admin increased to $38.8M for 2025 (from $10.1M)
- GAAP net loss widened to $77.6M for 2025
Key Figures
Market Reality Check
Peers on Argus
BLTE gained 0.93% with elevated volume, while peers showed mixed, mostly modest moves: DNLI +0.21%, TVTX +2.44%, APGE +2.59%, OCUL -5.89%, TARS -0.30%. The pattern points to stock-specific drivers rather than a broad biotech move.
Previous Earnings Reports
| Date | Event | Sentiment | Move | Catalyst |
|---|---|---|---|---|
| Feb 23 | Earnings webcast preview | Positive | +4.6% | Announcement of webcast to discuss preliminary 2025 results and business update. |
| Nov 10 | Q3 2025 earnings | Positive | +3.7% | Reported Q3 results, PHOENIX enrollment completion, DRAGON progress, and sizable financings. |
| Aug 11 | Q2 2025 earnings | Positive | -0.5% | Q2 results with Breakthrough Therapy designation and PHOENIX enrollment milestones. |
| May 13 | Q1 2025 earnings | Positive | +1.2% | Q1 results plus DRAGON DSMB support and PHOENIX enrollment progress, alongside new funding. |
| Mar 17 | FY 2024 earnings | Positive | +0.5% | Full-year 2024 results with advancing DRAGON and PHOENIX programs and growing expenses. |
Earnings-related communications have typically produced mild positive reactions, with one small negative move despite generally constructive clinical and funding updates.
Across recent earnings and preview events, Belite Bio has consistently paired financial updates with clinical and regulatory milestones for tinlarebant, including PHOENIX enrollment completion, DRAGON progress, and multiple expedited designations. Cash and equivalents previously ranged from $31.7M at YE 2024 to $275.6M by Q3 2025, alongside widening net losses. Today’s preliminary 2025 results and corporate update extend that trajectory, adding Phase 3 efficacy detail, larger cash balances, and confirmation of the NDA timeline.
Historical Comparison
In the past year, BLTE’s earnings-related updates moved the stock an average of 1.89%. Today’s pre-announcement gain of 0.93% fit comfortably within this typical reaction range.
Earnings releases have tracked tinlarebant’s path from ongoing Phase 3 DRAGON and PHOENIX enrollment to Phase 3 completion, expanding cash resources via financings while net losses increased alongside R&D and G&A investment.
Market Pulse Summary
This announcement combines pivotal Phase 3 DRAGON efficacy data, completion of PHOENIX enrollment in GA, and a strengthened cash position of $352.9M plus $419.7M in investments with widening 2025 net loss of $77.6M. Investors may track the planned NDA submission in Q2 2026, interim PHOENIX analysis, and trends in R&D and G&A spending to gauge how Belite balances late-stage development progress against ongoing operating and commercialization preparation costs.
Key Terms
new drug application (nda) regulatory
u.s. food and drug administration (fda) regulatory
breakthrough therapy regulatory
fast track regulatory
orphan drug designation regulatory
p-value medical
AI-generated analysis. Not financial advice.
- Following positive topline results from the pivotal, global Phase 3 DRAGON trial of tinlarebant in adolescents with Stargardt disease type 1 (STGD1), the Company is on track to submit a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) in Q2 2026
- Completed enrollment in the Phase 2/3 DRAGON II trial in STGD1
- Completed a
$402 million underwritten public offering of American Depositary Shares - Conference call and webcast on Monday, March 2, 2026, at 4:30 p.m. ET
SAN DIEGO, March 02, 2026 (GLOBE NEWSWIRE) -- Belite Bio, Inc (NASDAQ: BLTE) (“Belite Bio” or the “Company”), a clinical-stage drug development company focused on advancing novel therapeutics targeting degenerative retinal diseases that have significant unmet medical needs, today announced its preliminary, unaudited financial results for the fourth quarter and full-year ended December 31, 2025, and provided a business update.
“2025 marked a defining year for Belite, highlighted by positive topline results from our pivotal Phase 3 DRAGON trial, establishing tinlarebant as a potential first-in-class therapy for Stargardt disease,” said Dr. Tom Lin, Chairman and CEO of Belite Bio. “Combined with the completion of our
Full Year 2025 Business Highlights and Upcoming Milestones
Clinical Highlights
Tinlarebant is an oral, potent, once-daily, retinol binding protein 4 (RBP4) antagonist that decreases RBP4 levels in the blood and reduces vitamin A (retinol) delivery to the eye without disrupting systemic retinol delivery to other tissues. Vitamin A is critical for normal vision but can accumulate as toxic byproducts in individuals affected with STGD1 and geographic atrophy (GA), the advanced form of dry age-related macular degeneration (AMD), leading to retinal cell death and loss of vision.
Stargardt disease (STGD1): Accumulation of cytotoxic vitamin A byproducts (bisretinoids) compounds has been implicated in the onset and progression of STGD1, for which there is no approved treatment. Tinlarebant has been granted Breakthrough Therapy, Fast Track, and Rare Pediatric Disease Designations in the U.S.; Orphan Drug Designation in the U.S., Europe, and Japan; and Sakigake (Pioneer Drug) Designation in Japan for the treatment of STGD1.
- DRAGON Trial: Completed, 24-month, 104 subjects, aged 12 to 20 years old, randomized (2:1, active: placebo), double-masked, placebo-controlled, global, multi-center, pivotal Phase 3 trial in adolescent STGD1 patients
- Met its primary efficacy endpoint, demonstrating a statistically significant and clinically meaningful
35.7% reduction in the growth rate of macular lesions, measured as definitely decreased autofluorescence (DDAF) by fundus autofluorescence imaging, compared with placebo. - Achieved statistical significance when applying the pre-specified analysis (p-value = 0.0033).
- Demonstrated in a post-hoc analysis that the treatment effect remained (
35.4% ) consistent with a p-value < 0.0001 when considering the progressive nature typically seen in STGD1. - On track to submit an NDA to the FDA in the second quarter of 2026.
- Met its primary efficacy endpoint, demonstrating a statistically significant and clinically meaningful
- DRAGON II Trial: Combination of a Phase 1b open-label trial to evaluate the pharmacokinetics and pharmacodynamics of tinlarebant in adolescent Japanese STGD1 patients and a Phase 2/3, 24-month, randomized (1:1, active: placebo), double-masked, placebo-controlled, multi-center trial in adolescent STGD1 patients aged 12 to 20 years old across Japan, the U.S., and the United Kingdom.
- Targeted enrollment of 60 subjects was reached in January 2026.
- Subjects who passed screening before enrollment cut off are allowed to be enrolled in the trial through early March. 72 subjects were enrolled as of February 27, 2026.
- Trial design and inclusion of Japanese patients are intended to facilitate a future NDA in Japan.
- Primary efficacy endpoint is the growth rate of atrophic lesions; safety and tolerability will also be assessed.
Geographic Atrophy (GA): GA is a chronic degenerative disease of the retina that leads to blindness in the elderly. Accumulation of bisretinoids has been implicated in the progression of GA. There are currently no FDA-approved, orally administered treatments for GA.
- PHOENIX Trial: Ongoing, 24-month, randomized (2:1, active: placebo), double-masked, placebo-controlled, global, multi-center, pivotal Phase 3 trial in GA patients
- Completed enrollment with 530 subjects.
- Primary efficacy endpoint is the growth rate of atrophic lesions; safety and tolerability will also be assessed.
- The Company expects to conduct an interim analysis.
Corporate Highlights
- Completed a
$402 million underwritten public offering of American Depositary Shares with overallotment fully exercised by the underwriters, with net proceeds intended to support commercialization preparation, development and expansion of pipelines, and general corporate purposes.
Preliminary and Unaudited Fourth Quarter and Full Year 2025 Financial Results
Cash and Cash Equivalents: As of December 31, 2025, the Company had
Investments: As of December 31, 2025, the Company had
R&D Expenses:
For the three months ended December 31, 2025, research and development expenses were
On a non-GAAP basis, excluding share-based compensation expenses, non-GAAP research and development expenses for the three months and year ended December 31, 2025, were
Selling, G&A Expenses:
For the three months ended December 31, 2025, selling, general and administrative expenses were
On a non-GAAP basis, excluding share-based compensation expenses, non-GAAP selling, general and administrative expenses for the three months ended December 31, 2025, were
Other Income:
For the three months ended December 31, 2025, other income was
Net Loss:
For the three months ended December 31, 2025, the Company reported a GAAP net loss of
On a non-GAAP basis, excluding share-based compensation expenses, the Company reported a non-GAAP net loss of
Webcast Information
Belite Bio will host a webcast on Monday, March 2, 2026, at 4:30 p.m. Eastern Time to discuss the Company’s financial results and provide a business update. To join the webcast, please visit https://events.q4inc.com/attendee/547616305. A replay will be available for approximately 90 days following the event.
About Belite Bio
Belite Bio is a clinical-stage drug development company focused on advancing novel therapeutics targeting degenerative retinal diseases that have significant unmet medical need, such as Stargardt disease type 1 (STGD1) and geographic atrophy (GA) in advanced dry age-related macular degeneration (AMD), in addition to specific metabolic diseases. Belite Bio’s lead candidate, tinlarebant, is an oral therapy intended to reduce the accumulation of bisretinoid toxins in the eye. The Company has completed a Phase 3 trial (DRAGON) in adolescent STGD1 subjects and is currently being evaluated in a Phase 2/3 trial (DRAGON II) in adolescent STGD1 subjects and a Phase 3 trial (PHOENIX) in subjects with GA. For more information, follow us on X, Instagram, LinkedIn, and Facebook, or visit us at www.belitebio.com.
Important Cautions Regarding Forward Looking Statements
This press release contains forward-looking statements regarding future expectations, plans and prospectus, as well as other statements regarding matters that are not historical facts. These statements include but are not limited to statements regarding the potential implications of clinical data for patients, and Belite Bio’s advancement of, and anticipated preclinical activities, clinical development, regulatory milestones, and commercialization of its product candidates, the ability of tinlarebant to treat STGD1 and GA, the timing to complete relevant clinical trials and/or to receive the interim/final data of such clinical trials; the timing to submit trial data to regulatory authorities for drug approval, as well as any other statements regarding matters that are not historical facts, and any other statements containing the words “expect”, “believe”, “target”, “plan”, “hope” “potential” and other similar expressions. Actual results may differ materially from those indicated in the forward-looking statements as a result of various important factors related to Belite Bio’s business, including but not limited to Belite Bio’s ability to demonstrate the safety and efficacy of its drug candidates; the clinical results for its drug candidates, which may not support further development or regulatory approval; expectations for the timing of initiation, enrollment and completion of, and data relating to, its clinical trials; the timing to complete any ancillary clinical trials and/or to receive the interim/final data of such clinical trials; the timing to communicate with and submit trial data to regulatory authorities for drug approval in various jurisdictions; the content and timing of decisions made by the relevant regulatory authorities regarding regulatory approval of Belite Bio’s drug candidates; timing for Belite Bio to share additional data at upcoming medical meetings; the potential efficacy of tinlarebant to set a new benchmark for future research in inherited retinal disorders, as well as those risks more fully discussed in the “Risk Factors” section in Belite Bio’s filings with the U.S. Securities and Exchange Commission. All forward-looking statements are based on information currently available to Belite Bio, and Belite Bio undertakes no obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events or otherwise, except as may be required by law.
Discussion of Non-GAAP Financial Measures
To supplement the Company’s unaudited condensed consolidated financial results prepared in accordance with GAAP, the Company discloses certain non-GAAP financial measures that exclude share-based compensation, including research and development (non-GAAP), selling, general and administrative (non-GAAP), total operating expenses (non-GAAP), loss from operations (non-GAAP), net loss (non-GAAP), weighted average number of ordinary shares used in per share (non-GAAP) and net loss per ordinary share basic and diluted (non-GAAP).
The Company believes that these non-GAAP measures provide supplemental information that may be helpful in understanding period-to-period trends in operating expenses and results when considered together with, and not as a substitute for, the corresponding GAAP financial measures. These measures are intended to increase transparency into expense items that may vary from period to period for reasons such as the timing, structure, and valuation of equity awards. These measures are not intended to replace GAAP financial information and are not considered by management to be superior to GAAP measures.
At the Company’s current stage of development as a clinical-stage biotechnology company, the primary expenditures relate to the execution of clinical trials, regulatory activities (including preparation for potential NDA submissions), and the management of ongoing operations. In this context, management believes that the supplemental presentation of operating expenses excluding certain non-cash charges, such as share-based compensation, may assist users in understanding the nature and scale of cash-based operating activities by reducing period-to-period volatility from non-cash items. However, these non-GAAP measures are not intended to represent, and should not be viewed as, measures of liquidity, cash burn rate, or cash flows.
Non-GAAP measures have inherent limitations and may differ from similarly titled measures used by other companies. Accordingly, these measures should be viewed as supplemental and evaluated together with the Company’s GAAP results and the reconciliations to the most directly comparable GAAP measures presented in this release.
Explanation of Adjustment – Share-based compensation:
Share-based compensation expense consists of non-cash charges related to the fair value of equity awards awarded to employees and other non-employees. The amount recognized in any period may vary based on factors such as grant timing, award structure, and valuation assumptions, which may not be directly correlated with the timing or magnitude of cash payments related to the Company’s clinical, regulatory, and operational activities. The exclusion of share-based compensation in the Company’s non-GAAP measures is intended to supplementally illustrate operating expense trends and facilitate period-to-period comparisons of cash-based expenditures. The Company recognizes that share-based compensation is an important component of total compensation, and does not view non-GAAP measures as a replacement for GAAP results, which include the full impact of share-based compensation.
| BELITE BIO, INC UNAUDITED CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS (Amounts in thousands of US Dollars, except share and per share amounts) | ||||||||||||||||
| For the Three Months | For the Year | |||||||||||||||
| Ended December 31, | Ended December 31, | |||||||||||||||
| 2024 | 2025 | 2024 | 2025 | |||||||||||||
| Expenses | ||||||||||||||||
| Research and development | 7,254 | 14,624 | 29,939 | 45,377 | ||||||||||||
| Selling, general and administrative | 4,203 | 13,453 | 10,057 | 38,831 | ||||||||||||
| Total operating expenses | 11,457 | 28,077 | 39,996 | 84,208 | ||||||||||||
| Loss from operations | (11,457 | ) | (28,077 | ) | (39,996 | ) | (84,208 | ) | ||||||||
| Other income: | ||||||||||||||||
| Total other income, net | 1,357 | 2,753 | 3,858 | 6,597 | ||||||||||||
| Loss before income tax | (10,100 | ) | (25,324 | ) | (36,138 | ) | (77,611 | ) | ||||||||
| Income tax expense | — | — | 6 | — | ||||||||||||
| Net loss | (10,100 | ) | (25,324 | ) | (36,144 | ) | (77,611 | ) | ||||||||
| Other comprehensive income (loss) | ||||||||||||||||
| Foreign currency translation adjustments, net of nil tax | (259 | ) | (104 | ) | (286 | ) | 124 | |||||||||
| Total comprehensive loss | (10,359 | ) | (25,428 | ) | (36,430 | ) | (77,487 | ) | ||||||||
| Weighted average number of ordinary shares used in per share | ||||||||||||||||
| calculation: | ||||||||||||||||
| - Basic and Diluted | 31,453,211 | 36,218,289 | 30,538,378 | 33,538,160 | ||||||||||||
| Net loss per ordinary share | ||||||||||||||||
| - Basic and Diluted | $ | (0.32 | ) | $ | (0.70 | ) | $ | (1.18 | ) | $ | (2.31 | ) | ||||
| BELITE BIO, INC RECONCILIATION OF GAAP TO NON-GAAP UNAUDITED OPERATING RESULTS (Amounts in thousands of US Dollars, except share and per share amounts) | ||||||||||||||||
| For the Three Months | For the Year | |||||||||||||||
| Ended December 31, | Ended December 31, | |||||||||||||||
| 2024 | 2025 | 2024 | 2025 | |||||||||||||
| Expenses | ||||||||||||||||
| GAAP Research and development | 7,254 | 14,624 | 29,939 | 45,377 | ||||||||||||
| Share-based compensation expense | (1,510 | ) | (2,452 | ) | (3,775 | ) | (9,147 | ) | ||||||||
| Non-GAAP research and development | 5,744 | 12,172 | 26,164 | 36,230 | ||||||||||||
| GAAP Selling, general and administrative | 4,203 | 13,453 | 10,057 | 38,831 | ||||||||||||
| Share-based compensation expense | (2,696 | ) | (9,263 | ) | (5,212 | ) | (29,772 | ) | ||||||||
| Non-GAAP selling, general and administrative | 1,507 | 4,190 | 4,845 | 9,059 | ||||||||||||
| GAAP Total operating expenses | 11,457 | 28,077 | 39,996 | 84,208 | ||||||||||||
| Share-based compensation expense | (4,206 | ) | (11,715 | ) | (8,987 | ) | (38,919 | ) | ||||||||
| Non-GAAP Total operating expense | 7,251 | 16,362 | 31,009 | 45,289 | ||||||||||||
| GAAP Loss from operations | (11,457 | ) | (28,077 | ) | (39,996 | ) | (84,208 | ) | ||||||||
| Share-based compensation expense | 4,206 | 11,715 | 8,987 | 38,919 | ||||||||||||
| Non-GAAP Loss from operations | (7,251 | ) | (16,362 | ) | (31,009 | ) | (45,289 | ) | ||||||||
| GAAP Net loss | (10,100 | ) | (25,324 | ) | (36,144 | ) | (77,611 | ) | ||||||||
| Share-based compensation expense | 4,206 | 11,715 | 8,987 | 38,919 | ||||||||||||
| Non-GAAP Net Loss | (5,894 | ) | (13,609 | ) | (27,157 | ) | (38,692 | ) | ||||||||
| Weighted average number of ordinary shares used in per share | ||||||||||||||||
| Calculation GAAP and Non-GAAP: | ||||||||||||||||
| - Basic and Diluted | 31,453,211 | 36,218,289 | 30,538,378 | 33,538,160 | ||||||||||||
| Net loss per ordinary share | ||||||||||||||||
| - Basic and Diluted GAAP | $ | (0.32 | ) | $ | (0.70 | ) | $ | (1.18 | ) | $ | (2.31 | ) | ||||
| - Basic and Diluted Non-GAAP | $ | (0.19 | ) | $ | (0.38 | ) | $ | (0.89 | ) | $ | (1.15 | ) | ||||
| BELITE BIO, INC UNAUDITED CONDENSED CONSOLIDATED BALANCE SHEETS (Amounts in thousands of US Dollars, except share amounts) | ||||||
| December 31, | December 31, | |||||
| 2024 | 2025 | |||||
| Current assets | $ | 147,073 | $ | 494,272 | ||
| Other assets | 5,059 | 286,284 | ||||
| TOTAL ASSETS | $ | 152,132 | $ | 780,556 | ||
| TOTAL LIABILITIES | $ | 6,311 | $ | 10,070 | ||
| TOTAL SHAREHOLDERS’ EQUITY | 145,821 | 770,486 | ||||
| TOTAL LIABILITIES AND SHAREHOLDERS’ EQUITY | $ | 152,132 | $ | 780,556 | ||
| Ordinary shares authorized | 400,000,000 | 400,000,000 | ||||
| Ordinary shares issued | 31,857,802 | 39,353,365 | ||||
| Ordinary shares outstanding | 31,826,549 | 39,339,960 | ||||
Media and Investor Relations Contact:
Jennifer Wu
ir@belitebio.com
Julie Fallon
belite@argotpartners.com
FAQ
When will Belite Bio (BLTE) submit its NDA to the FDA for tinlarebant?
What were the key DRAGON Phase 3 results announced by Belite Bio (BLTE) in March 2026?
How much capital did Belite Bio (BLTE) raise in its recent public offering and what is the use?
What is Belite Bio's reported cash and investments position at year-end 2025 (BLTE)?
What enrollment status did Belite Bio report for DRAGON II and PHOENIX trials (BLTE)?
How did Belite Bio's 2025 expenses and net loss change compared to 2024 (BLTE)?
