Belite Bio Reports Fourth Quarter and Full Year 2024 Financial Results and Provides Corporate Update
Rhea-AI Summary
Belite Bio (NASDAQ: BLTE) has reported its Q4 and full-year 2024 financial results. The company's Phase 3 DRAGON trial for Stargardt 1 (STGD1) treatment received DSMB recommendation to proceed without modifications, with completion expected in Q4 2025. The PHOENIX trial for geographic atrophy has enrolled 406 subjects.
Key financial highlights: Cash position of $31.7 million as of December 31, 2024, with additional $113.5 million in investments. The company raised $15 million through a registered direct offering in February 2025. Full-year 2024 results showed R&D expenses of $29.9 million (up from $24.8M in 2023) and G&A expenses of $10.1 million (up from $6.8M in 2023). Net loss for 2024 was $36.1 million or ($1.18) per share.
Tinlarebant, their lead drug candidate, is advancing in multiple trials including the DRAGON trial for STGD1 and PHOENIX trial for geographic atrophy. The drug has received Fast Track, Rare Pediatric Disease, and Orphan Drug Designations in various regions.
Positive
- DSMB recommended DRAGON Phase 3 trial continuation without modifications
- Strong cash position with $145.2M total ($31.7M cash + $113.5M investments)
- Successfully raised $15M in February 2025 offering
- Increased other income to $3.9M from investments
Negative
- Net loss increased to $36.1M in 2024 from $31.6M in 2023
- R&D expenses increased 20.6% to $29.9M
- G&A expenses rose 48.5% to $10.1M
- Cash decreased from $88.2M to $31.7M year-over-year
News Market Reaction
On the day this news was published, BLTE gained 0.54%, reflecting a mild positive market reaction.
Data tracked by StockTitan Argus on the day of publication.
- Following a pre-specified interim analysis, the Data Safety Monitoring Board (DSMB) recommended the DRAGON trial, a pivotal Phase 3 trial in adolescent Stargardt 1 (STGD1) subjects, proceed without any modification; trial completion expected Q4 2025 (including a three-month follow-up period)
- Pivotal global Phase 3 PHOENIX trial of Tinlarebant in geographic atrophy (GA) subjects is ongoing with 406 subjects enrolled
- Raised
$15 million in gross proceeds in a registered direct offering on February 5, 2025 - Conference call and webcast on Monday, March 17, 2025, at 4:30 p.m. ET
SAN DIEGO, March 17, 2025 (GLOBE NEWSWIRE) -- Belite Bio, Inc (NASDAQ: BLTE), a clinical-stage biopharmaceutical 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 fourth quarter and full-year ended December 31, 2024, and provided a business update.
“We made exciting progress in our clinical development efforts over the past year, and the recent completion of the interim analysis of the Phase 3 DRAGON trial was an important milestone that brought us one step closer to realizing Tinlarebant’s potential to slow progression of STGD1,” said Dr. Tom Lin, Chairman and CEO of Belite. “We are very excited with the DSMB’s recommendation and the safety profile of Tinlarebant, and we remain on track to complete the trial by the fourth quarter of 2025. With the continued execution in our Phase 3 trials and the close of our recent
Full Year 2024 Business Highlights and Upcoming Milestones:
Clinical Highlights
Tinlarebant (LBS-008) 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 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) has been implicated in the onset and progression of STGD1, for which there are no approved treatments. Tinlarebant has been granted 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: Ongoing, 24-month, randomized (2:1, active: placebo), double-masked, placebo-controlled, global, multi-center, pivotal Phase 3 trial in adolescent STGD1 subjects
- Following a pre-specified interim analysis, an independent DSMB recommended trial continuation without modifications, maintaining a sample size of 104 subjects
- In addition, the DSMB recommended to submit the data for further regulatory review for drug approval
- Primary efficacy endpoint is the growth rate of atrophic lesions; safety and tolerability will also be assessed
- Trial completion expected by Q4 2025 (including a three-month follow-up period)
- DRAGON II Trial: Combination of a Phase 1b open-label trial to evaluate the pharmacokinetics and pharmacodynamics of Tinlarebant in Japanese adolescent STGD1 subjects and a Phase 2/3, 24-month, randomized (1:1, active: placebo), double-masked, placebo-controlled, multicenter trial in adolescent STGD1 subjects
- Completed the Phase 1b portion of the trial with six subjects evaluated in Japan in Q3 of 2024
- Enrolled 11 subjects in the Phase 2/3 trial, with a target enrollment of approximately 60 subjects, aged 12 to 20 years old, including approximately 10 Japanese subjects; data from the Japanese subjects is intended to facilitate a future new drug application in Japan
- Primary efficacy endpoint is the growth rate of atrophic lesions; safety and tolerability will also be assessed
- DRAGON Trial: Ongoing, 24-month, randomized (2:1, active: placebo), double-masked, placebo-controlled, global, multi-center, pivotal Phase 3 trial in adolescent STGD1 subjects
- Geographic Atrophy (GA): GA, is a chronic degenerative disease of the retina that leads to blindness in the elderly. Accumulation of toxic vitamin A byproducts (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 subjects
- Sample size increased from approximately 430 subjects to 500 subjects. 406 subjects have been enrolled
- Primary efficacy endpoint is the growth rate of atrophic lesions; safety and tolerability will also be assessed
- Company expects to conduct an interim analysis
- PHOENIX Trial: Ongoing, 24-month, randomized (2:1, active: placebo), double-masked, placebo-controlled, global, multi-center, pivotal Phase 3 trial in GA subjects
Corporate Highlights
- In February 2025, the Company completed a registered direct offering priced at the market, raising gross proceeds of
$15 million , with the potential for additional proceeds of approximately$15 million from the exercise of five-year warrants issued in the offering.
Audited Full Year 2024 and Reviewed Fourth Quarter 2024 Financial Results:
Cash: As of December 31, 2024, the Company had
Investments: As of December 31, 2024, the Company had
R&D Expenses:
For the three months ended December 31, 2024, research and development expenses were
For the year ended December 31, 2024, research and development expenses were
G&A Expenses:
For the three months ended December 31, 2024, general and administration expenses were
Other Income (expense):
For the three months ended December 31, 2024, other income was
Net Loss:
For the three months ended December 31, 2024, the Company reported a net loss of
Webcast Information
Belite Bio will host a webcast on Monday, March 17, 2025, 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/481614529. A replay will be available for approximately 90 days following the event at the Company’s Investor Relations website at https://investors.belitebio.com/presentations-events/events.
About Belite Bio
Belite Bio is a clinical-stage biopharmaceutical 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’s lead candidate, Tinlarebant, an oral therapy intended to reduce the accumulation of toxins in the eye, is currently being evaluated in a Phase 3 study (DRAGON) and a Phase 2/3 study (DRAGON II) in adolescent STGD1 subjects and a Phase 3 study (PHOENIX) in subjects with GA. For more information, follow us on Twitter, Instagram, LinkedIn, Facebook or visit us at www.belitebio.com.
Important Cautions Regarding Forward Looking Statements
This press release contains forward-looking statements about future expectations and plans, 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, and any other statements containing the words “expect”, “hope” and similar expressions. Actual results may differ materially from those indicated in the forward-looking statements as a result of various important factors, 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; the timing to complete relevant clinical trials and/or to receive the interim/final data of such clinical trials; the content and timing of decisions made by the relevant regulatory authorities regarding regulatory approval of Belite Bio’s drug candidates; the potential efficacy of Tinlarebant, 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.
| BELITE BIO, INC CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS (Amounts in thousands of US Dollars, except share and per share amounts) | |||||||
| For the Year | |||||||
| Ended December 31, | |||||||
| 2023 | 2024 | ||||||
| Expenses | |||||||
| Research and development | 24,844 | 29,939 | |||||
| General and administrative | 6,824 | 10,057 | |||||
| Total operating expenses | 31,668 | 39,996 | |||||
| Loss from operations | (31,668 | ) | (39,996 | ) | |||
| Other income | |||||||
| Total other income, net | 45 | 3,858 | |||||
| Loss before income tax | (31,623 | ) | (36,138 | ) | |||
| Income tax expense | 9 | 6 | |||||
| Net loss | (31,632 | ) | (36,144 | ) | |||
| Other comprehensive income (loss) | |||||||
| Foreign currency translation adjustments, net of nil tax | 18 | (286 | ) | ||||
| Total comprehensive loss | (31,614 | ) | (36,430 | ) | |||
| Weighted average number of ordinary shares used in per share calculation: | |||||||
| - Basic and Diluted | 26,593,673 | 30,538,378 | |||||
| Net loss per ordinary share | |||||||
| - Basic and Diluted | $ | (1.19 | ) | $ | (1.18 | ) | |
| For the Three Months | |||||||
| Ended December 31, | |||||||
| 2023 | 2024 | ||||||
| (Unaudited and Unreviewed) | (Unaudited) | ||||||
| Expenses | |||||||
| Research and development | 4,862 | 7,254 | |||||
| General and administrative | 2,093 | 4,203 | |||||
| Total operating expenses | 6,955 | 11,457 | |||||
| Loss from operations | (6,955 | ) | (11,457 | ) | |||
| Other expense | |||||||
| Total other income (expense), net | (36 | ) | 1,357 | ||||
| Loss before income tax | (6,991 | ) | (10,100 | ) | |||
| Income tax expense | - | - | |||||
| Net loss | (6,991 | ) | (10,100 | ) | |||
| Other comprehensive income (loss) | |||||||
| Foreign currency translation adjustments, net of nil tax | 133 | (259 | ) | ||||
| Total comprehensive loss | (6,858 | ) | (10,359 | ) | |||
| Weighted average number of ordinary shares used in per share calculation: | |||||||
| - Basic and Diluted | 28,316,251 | 31,453,211 | |||||
| Net loss per ordinary share | |||||||
| - Basic and Diluted | $ | (0.25 | ) | $ | (0.32 | ) | |
| BELITE BIO, INC CONSOLIDATED BALANCE SHEETS (Amounts in thousands of US Dollars, except share amounts) | |||||||
| December 31 | |||||||
| 2023 | 2024 | ||||||
| ASSETS | |||||||
| Current Assets | |||||||
| Cash | $ | 88,157 | $ | 31,677 | |||
| Investments | - | 113,472 | |||||
| Other receivables | 818 | 575 | |||||
| Prepayments and other current assets | 947 | 1,349 | |||||
| Other receivables due from related parties | 18 | - | |||||
| Total current assets | 89,940 | 147,073 | |||||
| Property and equipment, net | 490 | 444 | |||||
| Intangible assets | - | 31 | |||||
| Prepayments and other non-current assets | 3,297 | 3,960 | |||||
| Security deposits | 104 | 103 | |||||
| Operating lease right-of-use asset, net | 811 | 521 | |||||
| TOTAL ASSETS | $ | 94,642 | $ | 152,132 | |||
| LIABILITIES AND SHAREHOLDERS’ EQUITY | |||||||
| Current liabilities | |||||||
| Accrued expenses and other liabilities | 3,325 | 5,761 | |||||
| Other payables to related parties | - | 13 | |||||
| Operating lease liabilities – current | 308 | 276 | |||||
| Total current liabilities | 3,633 | 6,050 | |||||
| Non-current liabilities | |||||||
| Operating lease liabilities –non – current | 578 | 261 | |||||
| TOTAL LIABILITIES | 4,211 | 6,311 | |||||
| Shareholders’ equity | |||||||
| Ordinary shares, par value of US | 3 | 3 | |||||
| Additional paid-in capital | 162,305 | 254,125 | |||||
| Accumulated other comprehensive loss | (374 | ) | (660 | ) | |||
| Accumulated deficit | (71,503 | ) | (107,647 | ) | |||
| Total shareholders’ equity | 90,431 | 145,821 | |||||
| TOTAL LIABILITIES AND SHAREHOLDERS’ EQUITY | $ | 94,642 | $ | 152,132 | |||
Media and Investor Relations Contact:
Jennifer Wu
ir@belitebio.com
Julie Fallon
belite@argotpartners.com
FAQ
What were Belite Bio's (BLTE) key financial results for full-year 2024?
When is Belite Bio's DRAGON Phase 3 trial expected to complete?
How many subjects are enrolled in BLTE's PHOENIX trial for geographic atrophy?
What regulatory designations has Tinlarebant received for STGD1 treatment?
How much capital did BLTE raise in their February 2025 offering?
