STOCK TITAN

Belite Bio Q3 2026 net loss widens to $30.3M

The U.S. review has a February 12, 2027 target action date, alongside applications submitted in Japan, Singapore, the U.K. and Switzerland.

Available on EDGAR Accepted by SEC EDGAR Learn about SEC filing dates
(Moderate)

Sentiment and the balance of points

Rhea-AI Sentiment reads the wording of the document, how positive or negative its language is on a 1 to 5 scale. The balance of points shown with the takes weighs what the document actually discloses, so the two can disagree, for example when a trial that missed its main goal is described in upbeat language.

Form Type
6-K

Rhea-AI Filing Summary

Belite Bio reported a third-quarter 2026 net loss of $30.3 million, compared with $21.7 million in the year-earlier quarter; nine-month net loss was $85.6 million versus $52.3 million. Third-quarter research and development expense was $15.5 million, up from $10.3 million, while selling, general and administrative expense was $21.4 million versus $12.7 million. At September 30, 2026, cash and cash equivalents were $271.3 million, and U.S. Treasury bills and notes were $502.7 million.

Tinlarebant’s U.S. NDA for Stargardt disease type 1 received FDA Priority Review in August 2026, with a February 12, 2027 PDUFA target action date; the FDA said it will not convene an advisory committee meeting to discuss the NDA. Belite submitted a Japanese NDA under Sakigake and marketing authorization applications in Singapore, the United Kingdom and Switzerland through the Access Consortium. Its Phase 3 DRAGON trial in adolescent subjects with STGD1 met its primary endpoint; DRAGON II and PHOENIX are ongoing trials. Belite also uplisted to the Nasdaq Global Select Market.

1 point · 1 major

How this balance works

Rhea-AI gives every point it takes from this document a weight. Minor counts 1, Moderate 3 and Major 9, so one Major point outweighs several Minor ones. The bar adds up the weights on each side, and when neither side holds more than 65% of the total the balance reads Mixed.

It reads the document as published, with the same rules for every company, and it does not look at what the market expected or at how the stock traded, so a point can be objectively good on a day the stock falls.

Rhea-AI Sentiment measures something else, the tone of the wording.

0 major · 1 point

How the balance works

Positive

  • Major pointPhase 3 DRAGON met its primary endpoint in adolescent subjects with STGD1.

Negative

  • Moderate pointQuarterly net loss increased to $30.3 million from $21.7 million in Q3 2025.

Filing Explained

Belite reported 40,614,160 ordinary shares outstanding at September 30, 2026, up from 39,339,960 at December 31, 2025; for an unchanged holding, the larger share base means a smaller ownership fraction.

Cash and cash equivalents $271.3 million As of September 30, 2026
U.S. Treasury bills and notes $502.7 million As of September 30, 2026
Research and development expense $15.5 million; $10.3 million in Q3 2025 Three months ended September 30
Selling, general and administrative expense $21.4 million; $12.7 million in Q3 2025 Three months ended September 30
Net loss $30.3 million; $21.7 million in Q3 2025 Three months ended September 30
Net loss $85.6 million; $52.3 million in 2025 Nine months ended September 30
PDUFA target action date February 12, 2027 Tinlarebant NDA for STGD1
Priority Review regulatory
"NDA for tinlarebant in STGD1 granted priority review"
Priority review is a regulatory fast-track that shortens the time an agency spends evaluating a drug, vaccine or medical device application so a decision comes sooner than normal. For investors, it matters because a faster review is like an express lane to market: it can speed revenue potential and reduce regulatory uncertainty, but it does not guarantee approval and still requires the product to meet safety and effectiveness standards.
PDUFA target action date regulatory
"target action date of February 12, 2027"
The PDUFA target action date is the deadline set by the U.S. Food and Drug Administration (FDA) by which it aims to decide whether to approve or reject a new drug application. This date helps investors gauge when a company’s new medication might reach the market, potentially influencing sales and revenue expectations. It acts as a key milestone signaling progress in the drug approval process.
Sakigake designation regulatory
"under Sakigake designation (J-NDA)"
A sakigake designation is a special regulatory label granted by Japan’s drug and device regulator to medical products deemed highly innovative and likely to address unmet patient needs. It speeds up the review process and gives the product priority access to regulators, similar to getting a fast-track pass through airport security — for investors this can mean earlier sales, lower regulatory uncertainty, and potentially faster returns, though approval is not guaranteed.
Access Consortium pathway regulatory
"via the Access Consortium pathway"
bisretinoids medical
"vitamin A-based toxins (known as bisretinoids)"
serum retinol binding protein 4 (RBP4) medical
"levels of serum retinol binding protein 4 (RBP4)"

FAQ

AI-generated questions and answers. How Rhea-AI works. Not financial advice.

What was BLTE’s net loss in Q3 2026?

Belite Bio reported a $30.3 million net loss for the three months ended September 30, 2026, compared with $21.7 million in the same 2025 period. Non-GAAP net loss, excluding share-based compensation, was $24.3 million, compared with $8.8 million.

How much cash and investments did BLTE report at September 30, 2026?

At September 30, 2026, Belite Bio reported $271.3 million in cash and cash equivalents and $502.7 million in U.S. Treasury bills and notes. The December 31, 2025 comparatives were $352.9 million and $419.7 million, respectively.

How is tinlarebant designed to work?

Belite Bio describes tinlarebant as an oral therapy intended to reduce and maintain serum retinol binding protein 4 (RBP4), the carrier protein for retinol transport from the liver to the eye. By modulating retinol entering the eye, it is intended to reduce bisretinoid formation.

AI-generated analysis. How Rhea-AI works. Not financial advice.

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UNITED STATES 

SECURITIES AND EXCHANGE COMMISSION 

WASHINGTON, D.C. 20549

 

FORM 6-K

 

REPORT OF FOREIGN PRIVATE ISSUER 

PURSUANT TO RULE 13a-16 OR 15b-16 OF 

THE SECURITIES EXCHANGE ACT OF 1934

 

For the month of November 2026

 

Commission File Number: 001-41359

 

Belite Bio, Inc 

(Exact name of registrant as specified in its charter)

 

Not Applicable 

(Translation of Registrant´s name into English)

 

12750 High Bluff Drive Suite 475, 

San Diego, CA 92130 

(Address of principal executive office)

 

Indicate by check mark whether the registrant files or will file annual reports under cover Form 20-F or Form 40-F.

 

Form 20-F x Form 40-F ¨

 

 

 

 

 

On November 12, 2026, Belite Bio, Inc issued a press release entitled “Belite Bio Reports Unaudited Third Quarter 2026 Financial Results and Provides a Corporate Update.” A copy of this press release is attached hereto as Exhibit 99.1 and is incorporated herein by reference.

 

This Report on Form 6-K and the related exhibit shall be deemed to be incorporated by reference into all effective registration statements filed by the registrant under the Securities Act of 1933 and shall be a part thereof from the date on which this report is furnished, to the extent not superseded by documents or reports subsequently filed or furnished.

 

EXHIBIT INDEX

 

Exhibit 99.1 — Press Release

 

 

 

 

SIGNATURE

 

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.

 

  Belite Bio, Inc
   
  By: /s/ Yu-Hsin Lin  
  Name: Yu-Hsin Lin 
  Title: Chief Executive Officer and Chairman

 

Date: November 12, 2026

 

 

 

 

 

Exhibit 99.1 

 

 

  

Belite Bio Reports Unaudited Third Quarter 2026 Financial Results and Provides a Corporate Update

 

· New Drug Application (NDA) for tinlarebant in Stargardt disease type 1 (STGD1) granted priority review by the U.S. Food and Drug Administration (FDA) in August 2026 with Prescription Drug User Fee Act (PDUFA) target action date of February 12, 2027
· Company has been informed by the FDA that it will not convene an advisory committee meeting to discuss the NDA for tinlarebant in STGD1
· Submitted NDA for tinlarebant to Japan’s Ministry of Health, Labour and Welfare under Sakigake designation (J-NDA)
· Submitted Marketing Authorization Applications for tinlarebant in Singapore, the United Kingdom, and Switzerland via the Access Consortium pathway
· Company uplisted to the Nasdaq Global Select Market
· Conference call and webcast on Thursday, November 12, 2026, at 4:30 p.m. ET

 

SAN DIEGO, November 12, 2026 - 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 financial results for the third quarter ended September 30, 2026, and provided a business update.

 

“As we advance toward our PDUFA target action date of February 12, 2027, we remain focused on commercial readiness and are energized by the potential to bring a first-ever treatment to people living with STGD1,” said Dr. Tom Lin, Chairman and Chief Executive Officer of Belite Bio. “The third quarter also marked meaningful progress in our efforts to bring tinlarebant to people living with STGD1 globally. Following the FDA’s acceptance of our NDA with Priority Review, we submitted a J-NDA in Japan under Sakigake designation and filed marketing authorization applications in Singapore, the United Kingdom, and Switzerland through the Access Consortium, as we seek to expand the potential reach of tinlarebant in this rare degenerative retinal disease.”

 

Third Quarter 2026 Business Highlights and Upcoming Milestones:

 

Clinical Highlights

 

Stargardt disease type 1 (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.
o In August 2026, the FDA accepted the NDA for tinlarebant in STGD1 and granted Priority Review, with an assigned PDUFA target action date of February 12, 2027.
o The Company has been informed by the FDA that it will not convene an advisory committee meeting to discuss the NDA for tinlarebant in STGD1. The FDA’s review of the NDA for tinlarebant in STGD1 is still ongoing.
o The Company submitted a J-NDA to the Ministry of Health, Labour and Welfare (MHLW) in Japan for tinlarebant in STGD1 in September 2026. Tinlarebant has been granted Sakigake designation in Japan, which provides for prioritized consultation, pre-application consultation, prioritized review, assignment of a review partner, and an extended re-examination period.

 

 

 

  

 

 

  o The Company also submitted Marketing Authorization Applications for tinlarebant in STGD1 to Singapore’s Health Sciences Authority, the United Kingdom’s Medicines and Healthcare Products Regulatory Agency, and Swissmedic in October 2026 through the Access Consortium framework, a collaborative initiative comprised of multiple regulatory authorities.

  o In July 2026, Belite Bio reported additional, positive secondary endpoint data from the DRAGON trial. Notably, the presentation reported that quantitative autofluorescence (qAF), a marker of toxic bisretinoid accumulation, showed a marked divergence between treatment groups. At month 25, in subjects treated with tinlarebant, qAF values remained stable to slightly decrease from baseline (approximately 2%), whereas placebo-treated subjects showed an approximate 20% increase in qAF from baseline. As previously announced, the Phase 3 DRAGON trial met its primary efficacy endpoint, demonstrating a statistically significant and clinically meaningful 35.7% reduction in the growth rate of retinal lesions, measured as definitely decreased autofluorescence (DDAF) by fundus autofluorescence imaging, compared with placebo. Tinlarebant was well tolerated throughout the trial.

  o Belite Bio also presented encore data at various medical congresses, including at the Schweizerische Ophthalmologische Gesellschaft (SOG) Annual Congress, the 19th Asia-Pacific Vitreo-retina Society (APVRS) Congress, EURETINA 2026, Innovate Retina, and the American Academy of Ophthalmology (AAO) 2026 Annual Meeting.

  · 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.

  o Target enrollment is completed with a total of 73 subjects, including 15 Japanese subjects for the Phase 2/3 trial in STGD1.

  o Trial design and inclusion of Japanese patients are intended to supplement the J-NDA submission in Japan.

  o Primary efficacy endpoint is the growth rate of atrophic lesions; safety and tolerability will also be assessed.

 

Geographic Atrophy (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.
oCompleted enrollment with 530 subjects.
oPrimary efficacy endpoint is the growth rate of atrophic lesions; safety and tolerability will also be assessed.
oThe Company expects to conduct an interim analysis.

 

Corporate Highlights

 

·

Belite Bio hosted a Commercial Day in September 2026 featuring members of management, leading ophthalmology experts and people living with STGD1, which provided an overview of STGD1, the significant unmet need for treatment options and the current treatment landscape, as well as the Company’s prelaunch preparedness strategies and the potential commercial opportunity for tinlarebant in STGD1, if approved by the FDA.

 

 

 

 

 

 

·Belite Bio launched the disease website for STGD1 in October 2026 (https://seestargardtdisease.com/).
·Belite Bio also recently announced the uplisting of the Company’s securities from the Nasdaq Capital Market to the Nasdaq Global Select Market, with trading beginning on October 19, 2026, under the existing ticker symbol “BLTE.”

 

Third Quarter 2026 Financial Results:

 

Cash and Cash Equivalents: As of September 30, 2026, the Company had $271.3 million in cash and cash equivalents, compared with $352.9 million on December 31, 2025.

 

Investments: As of September 30, 2026, the Company had $502.7 million in U.S. treasury bills and U.S. treasury notes, compared to $419.7 million as of December 31, 2025.

 

Research and Development (R&D) Expenses:

 

For the three months ended September 30, 2026, R&D expenses were $15.5 million compared to $10.3 million for the same period in 2025. The increase in R&D expenses in the quarter was primarily attributable to increases in (i) active pharmaceutical ingredient (“API”) manufacturing expense and drug product (“DP”) manufacturing expense, (ii) consultant fees, and (iii) sponsorship funding. For the nine months ended September 30, 2026, R&D expenses were $49.4 million compared to $30.8 million for the same period in 2025. The increase in R&D expenses year-to-date was primarily attributable to (i) a royalty payment for an additional milestone achieved under the license agreement in the second quarter of 2026, (ii) an increase in API and DP manufacturing expenses, and (iii) an increase in consultant fees.

 

On a non-GAAP basis, excluding share-based compensation expenses, non-GAAP R&D expenses for the three months ended September 30, 2026, were $14.7 million compared to $8.0 million for the same period in 2025. For the nine months ended September 30, 2026, non-GAAP R&D expenses were $45.7 million compared to $24.1 million for the same period in 2025.

 

Selling, General, and Administrative (SG&A) Expenses:

 

For the three months ended September 30, 2026, SG&A expenses were $21.4 million compared to $12.7 million for the same period in 2025. The increase in SG&A expenses in the quarter was primarily attributable to an increase in professional service fees. For the nine months ended September 30, 2026, SG&A expenses were $55.1 million compared to $25.4 million for the same period in 2025. The increase in SG&A year-to-date was primarily attributable to increases in (i) professional service fees, and (ii) wages and salaries resulting from our team expansion.

 

On a non-GAAP basis, excluding share-based compensation expenses, non-GAAP SG&A expenses for the three months ended September 30, 2026, were $16.3 million compared to $2.1 million for the same period in 2025. For the nine months ended September 30, 2026, non-GAAP SG&A expenses were $32.9 million compared to $4.9 million for the same period in 2025.

 

 

 

 

 

 

Other Income:

 

For the three months ended September 30, 2026, other income was $6.7 million compared to $1.3 million for the same period in 2025. For the nine months ended September 30, 2026, other income was $18.9 million compared to $3.8 million for the same period in 2025. The increase in other income in the quarter and year-to-date was attributed to interest income from bank deposits, U.S. treasury bills and U.S. treasury notes.

 

Net Loss:

 

For the three months ended September 30, 2026, the Company reported a net loss of $30.3 million, compared to a net loss of $21.7 million for the same period in 2025. For the nine months ended September 30, 2026, net loss was $85.6 million compared to $52.3 million for the same period in 2025. 

 

On a non-GAAP basis, excluding share-based compensation expenses, the Company reported a non-GAAP net loss of $24.3 million for the three months ended September 30, 2026, compared to a non-GAAP net loss of $8.8 million for the same period in 2025. For the nine months ended September 30, 2026, non-GAAP net loss was $59.7 million compared to $25.1 million for the same period in 2025.

 

Webcast Information

 

Belite Bio will host a webcast on Thursday, November 12, 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 click here. A replay of the event will be available on the Investor Relations section of the Company’s website following the event.

 

About Tinlarebant (a/k/a LBS-008)

 

Tinlarebant is a novel oral therapy that is intended to reduce the accumulation of vitamin A-based toxins (known as bisretinoids) that cause retinal disease in Stargardt disease type 1 (STGD1) and also contribute to disease progression in geographic atrophy (GA), or advanced dry age-related macular degeneration (AMD). Bisretinoids are by-products of the visual cycle, which is dependent on the supply of vitamin A (retinol) to the eye. Tinlarebant works by reducing and maintaining levels of serum retinol binding protein 4 (RBP4), the sole carrier protein for retinol transport from the liver to the eye. By modulating the amount of retinol entering the eye, tinlarebant reduces the formation of bisretinoids. Tinlarebant has been granted Breakthrough Therapy Designation, Fast Track Designation, and Rare Pediatric Disease Designation in the U.S., Orphan Drug Designation in the U.S., Europe, Japan, and Switzerland, and Sakigake Designation in Japan for the treatment of STGD1.

 

About Stargardt Disease

 

STGD1 is the most common inherited macular dystrophy in both adults and children. The disease is caused by mutations in a retina-specific gene (ABCA4), which results in progressive accumulation of bisretinoids leading to retinal cell death and progressive loss of central vision. The fluorescent properties of bisretinoids and the development of high-resolution retinal imaging systems have helped ophthalmologists identify and monitor disease progression. Currently, there are no approved treatments for STGD1.

 

About 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.

 

 

 

 

 

 

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 needs, 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 subjects with STGD1, which met its primary endpoint, and the drug is currently being evaluated in a Phase 2/3 trial (DRAGON II) in adolescent subjects with STGD1 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 within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, including statements made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. These forward-looking statements relate to future expectations, plans and prospects, as well as other statements regarding matters that are not historical facts. These statements include but are not limited to statements regarding the potential approval of tinlarebant as the first-ever treatment to patients living with STGD1, the potential implications of clinical data for patients; Belite Bio’s advancement of, and anticipated clinical development, regulatory milestones, and commercialization of its product candidates; the ability or potential 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 potential benefits of any regulatory designations, the potential for and timing of any interim analysis of ongoing clinical trials; the design of clinical trials intended to supplement J-NDA in Japan; the Company’s progress and efforts in commercialization preparation, the Company’s pre-launch preparedness strategies and the potential commercial opportunity for tinlarebant in STGD1, as well as any other statements regarding matters that are not historical facts, and any other statements containing the words “may”, “will”, “expect”, “believe”, “target”, “plan”, “intend”, “continue”, “remain”, “hope”, “potential”, “anticipate”, “estimate”, “look forward”, 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, FDA’s regulatory decisions on the NDA for tinlarebant in STGD1, the outcome and timing of the review of the J-NDA for tinlarebant in STGD1 by the MHLW and of the marketing authorization applications for tinlarebant in STGD1 by the Health Sciences Authority, the Medicines and Healthcare Products Regulatory Agency and Swissmedic; Belite Bio’s ability to demonstrate the safety and efficacy of its drug candidates; the clinical results for its drug candidates, including the results of any interim analysis of the PHOENIX trial, 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; Belite Bio’s ability to successfully commercialize tinlarebant, if approved, including its ability to build out commercial infrastructure, achieve market acceptance, and execute a timely product launch; 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 Nine Months  
    Ended September 30,     Ended September 30,  
    2025     2026     2025     2026  
Expenses                        
Research and development     10,307       15,482       30,753       49,356  
Selling, general and administrative     12,711       21,428       25,378       55,145  
Total operating expenses     23,018       36,910       56,131       104,501  
Loss from operations     (23,018 )     (36,910 )     (56,131 )     (104,501 )
Other income:                                
Total other income, net     1,328       6,650       3,844       18,946  
Loss before income tax     (21,690 )     (30,260 )     (52,287 )     (85,555 )
Income tax expense     -       13       -       68  
Net loss     (21,690 )     (30,273 )     (52,287 )     (85,623 )
Other comprehensive income (loss)                                
Foreign currency translation adjustments, net of nil tax     82       23       228       51  
Total comprehensive loss     (21,608 )     (30,250 )     (52,059 )     (85,572 )
Weighted average number of ordinary shares used in per share calculation:                                
- Basic and Diluted     33,223,232       40,415,114       32,634,966       40,157,365  
Net loss per ordinary share                                
- Basic and Diluted   $ (0.65 )   $ (0.75 )   $ (1.60 )   $ (2.13 )

 

 

 

 

 

 

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 Nine Months 
   Ended September 30,   Ended September 30, 
   2025   2026   2025   2026 
Expenses                
GAAP Research and development   10,307    15,482    30,753    49,356 
Share-based compensation expense   (2,278)   (773)   (6,695)   (3,651)
Non-GAAP research and development   8,029    14,709    24,058    45,705 
GAAP Selling, general and administrative   12,711    21,428    25,378    55,145 
Share-based compensation expense   (10,640)   (5,168)   (20,509)   (22,267)
Non-GAAP selling, general and administrative   2,071    16,260    4,869    32,878 
GAAP Total operating expenses   23,018    36,910    56,131    104,501 
Share-based compensation expense   (12,918)   (5,941)   (27,204)   (25,918)
Non-GAAP Total operating expense   10,100    30,969    28,927    78,583 
GAAP Loss from operations   (23,018)   (36,910)   (56,131)   (104,501)
Share-based compensation expense   12,918    5,941    27,204    25,918 
Non-GAAP Loss from operations   (10,100)   (30,969)   (28,927)   (78,583)
GAAP Net loss   (21,690)   (30,273)   (52,287)   (85,623)
Share-based compensation expense   12,918    5,941    27,204    25,918 
Non-GAAP Net Loss   (8,772)   (24,332)   (25,083)   (59,705)
Weighted average number of ordinary shares used in per share                    
Calculation GAAP and Non-GAAP:                    
- Basic and Diluted   33,223,232    40,415,114    32,634,966    40,157,365 
Net loss per ordinary share                    
- Basic and Diluted GAAP  $(0.65)  $(0.75)  $(1.60)  $(2.13)
- Basic and Diluted Non-GAAP  $(0.26)  $(0.60)  $(0.77)  $(1.49)

 

 

 

  

 

 

BELITE BIO, INC 

UNAUDITED CONDENSED CONSOLIDATED BALANCE SHEETS 

(Amounts in thousands of US Dollars, except share amounts)

 

   December 31,   September 30, 
   2025   2026 
Current assets  $494,272   $498,346 
Other assets   286,284    291,392 
TOTAL ASSETS  $780,556   $789,738 
           
TOTAL LIABILITIES  $10,070   $18,678 
           
TOTAL SHAREHOLDERS’ EQUITY   770,486    771,060 
           
TOTAL LIABILITIES AND SHAREHOLDERS’ EQUITY  $780,556   $789,738 
           
Ordinary shares authorized   400,000,000    400,000,000 
Ordinary shares issued   39,353,365    40,750,271 
Ordinary shares outstanding   39,339,960    40,614,160 

  

Media and Investor Relations Contact:
ir@belitebio.com

 

 

 

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