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Tinlarebant is an orally administered medicine from Belite Bio intended to slow disease progression in patients with Stargardt’s disease (STGD1) and geographic atrophy (GA) in complex dry age-related macular degeneration (dry AMD).
Data from a 24-month phase 2 trial in adolescent subjects with STGD1 showed a persistent decrease in the expansion of atrophic lesions in Tinlarebant-treated subjects compared to ProgStar participants with baseline characteristics (age ≤ to 18 years) (p < 0. 001).
In the phase 2 trial, 42% of subjects treated with Tinlarebant (5 out of 12) did not develop atrophic retinal lesions during the 24-month treatment period.
Enrollment in a pivotal Phase 3 trial of Tinlarebant in adolescent subjects STGD1 (“DRAGON”) has been completed with 104 subjects in 11 countries.
Interim data from the “DRAGON” test is expected in the fourth quarter of 2024
First subject treated in a global pivotal phase trial of Tinalrebant in GA subjects (“PHOENIX”) and received approval to initiate the PHOENIX trial in eight countries
As of December 31, 2023, the Company had $88. 2 million in cash.
Conference and webcast on Tuesday, March 12, 2024, at 4:30 p. m. AND
SAN DIEGO, March 11, 2024 (GLOBE NEWSWIRE) — Belite Bio, Inc. (NASDAQ: BLTE) (“Belite Bio” or the “Company”), a clinical-stage biopharmaceutical drug progression company whose goal is to promote novel treatments targeting degenerative diseases. Diseases of the retina. Analyst of Diseases with Significant Unmet Medical Needs, announced its audited monetary effects for the full year 2023 and unaudited and unrevised monetary effects for the quarter ended December 31, 2023, and provided an update on its operations.
“2023 has been a productive year for Belite, from the launch of our Phase III AG trial, the final touch of recruitment for our Phase III Stargardt disease trial, to the exciting 24 months of insight into our Phase III trial. II on Stargardt’s disease”. said Dr. Tom. Lin, president and CEO of Belite Bio. “These milestones continue to highlight Tinlarebant’s cure prospects, not only in Stargardt disease, for which there is still no approved remedy, but also in patients suffering from GA, for whom an oral remedy would be a game-changer. Looking ahead to 2024, we remain focused on our project of creating oral treatments for eye diseases with significant unmet medical desires and are well positioned to execute on our strong balance sheet. We plan to present additional analysis from our Phase 2 Stargardt disease trial in the Association for Research in Vision and Ophthalmology (ARVO) annual meeting in May, and obtain one-year interim data from our Phase 3 DRAGON trial later this year. We also look forward to sharing further updates on recruitment for our PHOENIX trial III phase in Georgia as the year progresses.
2023 Highlights & Milestones:
Clinical Highlights
Tinlarebant (LBS-008) is designed to be a potent once-daily oral retinol-binding protein four (RBPfour) antagonist that decreases RBPfour blood levels and reduces the intake of vitamin A (retinol) in the eye without interrupting the systemic administration of retinol to the eye. Vitamin A is for general vision, but it can accumulate as toxic byproducts in people with STGD1 and GA (the complex form of dry AMD), leading to retinal tissue death and vision loss.
Stargardt’s disease (STGD1): The accumulation of cytotoxic byproducts of vitamin A (bisretinoids) has been implicated in the onset and progression of STGD1. Tinlarebant has been granted Fast Track and Pediatric Rare Disease (RPD) designations through the U. S. Food and Drug Administration. U. S. Food and Drug Administration (FDA) and Orphan Drug Designation (ODD) in the U. S. US, Europe, and Japan for STGD1. Lately, there are no FDA-approved remedies for STGD1.
Trial LBS-008-CT02: Phase 2, open-label, completed 24-month trial in STGD1 adolescent subjects and presentation of knowledge at the end of the trial at the American Ophthalmological Association (AAO) annual meeting in November 2023.
Tinlarebant was well tolerated and treatment was not discontinued due to adverse events.
24-month data showed a decrease and longer-lasting expansion of atrophic lesion in Tinlarebant-treated subjects compared to ProgStar participants with baseline characteristics (age ≤ 18 years) (p <0. 001).
42% of subjects treated with Tinlarebant (5 of 12) expanded atrophic retinal lesions.
Visual acuity stabilized in most trial subjects with an average loss of five letters after 24 months of treatment (a loss of <10 letters is not considered clinically significant).
DRAGON Trial: Ongoing, 24-month, randomized (2:1, active: placebo), double-blind, placebo-controlled, pivotal phase 3, multicenter, pivotal trial in adolescent subjects with STGD1
Enrolment completed with 104 subjects in countries
The number one efficacy endpoint is to decrease the rate of expansion of atrophic lesions; Safety and tolerability will also be assessed.
Expected provisional data for the fourth quarter of 2024
Geographic atrophy (GA): GA, a complex form of dry AMD, is a chronic degenerative disease of the retina that causes blindness in the elderly. The accumulation of poisonous byproducts of vitamin A (bisretinoids) has been implicated in the progression of GA. Lately, there are no FDA-approved oral remedies for GA.
PHOENIX Trial: Ongoing, 24-month, randomized (2:1, active: placebo; n~40 subjects), pivotal pivotal, pivotal, double-blind, placebo-controlled, global, multicenter trial in patients with GA
The number one efficacy endpoint is to decrease the rate of expansion of atrophic lesions; Safety and tolerability will also be assessed.
First patient dosed in the third quarter of 2023
Subjects enrolled
Interim knowledge expected at the halfway point of the trial period.
Company Highlights
Completed a public subscription of the Company’s American Depositary Shares (“ADS”) and warrants (the “Follow-On Offering”) for gross proceeds of $30 million in June 2023.
Launch of another ADS offering program (the “ATM Offering”) with an aggregate offering value of up to $100 million in June 2023.
Raised $22 million through the restructuring of warrants issued in the Follow-On Offering and $29 million through the ATM Offering as of December 31, 2023.
Fiscal 2023 Audited Monetary Effects and Fourth Quarter 2023 Unaudited and Unrevised Monetary Effects:
Cash: As of December 31, 2023, the Company had $88. 2 million in cash, at $42. 1 million as of December 31, 2022.
R Expenses
For the three months ended December 31, 2023, research and development expenses were $4. 9 million, compared to $5. 2 million for the same period in 2022. The reduction is mainly due to higher R&D spending in the fourth quarter of 2022, when the DRAGON trial began. reached certain milestones in a specific district. For the year ended December 31, 2023, study and progression expenses were $24. 8 million, compared to $8. 9 million for the same period in 2022. The accumulation of study and progression expenses is basically due to the construction of upd expenses similar to the conduct of the DRAGON and PHOENIX trials.
General and administrative expenses:
For the three-month period ended December 31, 2023, general and administrative expenses amounted to $2. 1 million, to $1. 5 million for the same period in 2022. The accrual is primarily the result of an accrual of stock-based rebate awarded in 2023. . For the year ended December 31, 2023, general and administrative expenses for 2023 were $6. 8 million, to $4. 0 million for the same time in 2022. The accrual is also primarily the result of an accrual of stock-based reimbursement awarded in 2023 and an increase in fees for professional services.
Net Loss:
For the 3 months ended December 31, 2023, the Company reported a net loss of $7. 0 million, or ($0. 25) consistent with the percentage, to $6. 8 million, or ($0. 27) consistent with the percentage for the same period consistent in 2022. For the year ended December 31, 2023, the Company reported a net loss of $31. 6 million or ($1. 19) consistent with the percentage, to a net loss of $12. 6 million or ($0. 63) consistent with the percentage for the same period consistent in 2022.
Webcast Information
Belite Bio will host a webcast on Tuesday, March 12, 2023 at 4:30 p. m. ET to talk about the company’s currency effects and provide an update on operations. To register for the webcast, visit https://wsw. com/webcast/cc/blte2/1419894. A replay will be available for approximately 90 days after the occasion on the Company’s online investor relations page in https://investors. belitebio. com/presentations-occasions/occasions.
About Belite Bio
Belite Bio is a clinical-stage biopharmaceutical drug progression company that aims to create novel treatments targeting retinal degenerative eye diseases that have significant unmet medical needs, such as (i) age-related atrophic macular degeneration (AMD), known as geographic atrophy. (GA). in complex dry AMD, and (ii) autosomal recessive Stargardt disease type 1, or STGD1, in addition to express metabolic diseases. For more information, follow us on Twitter, Instagram, LinkedIn, Facebook or visit us on www. belitebio. com.
Important Cautionary Statements Regarding Forward-Looking Statements
This press release contains forward-looking information regarding long-term expectations and plans, as well as other information related to matters that are not past facts. These include, but are not limited to, announcements related to the potential implications of clinical knowledge for patients, Belite Bio’s advancement and expected preclinical activities, clinical progression, regulatory milestones and commercialization of its product candidates, as well as any other contains the words “wait”, “hope” and similar expressions. Actual effects would likely differ materially from those indicated in the forward-looking announcements as a result of various vital factors, including, but not limited to, Belite Bio’s ability to demonstrate the protection and efficacy of its drug candidates; the clinical effects of its drug candidates, which may not lead to further progression or regulatory approval; the timeline for completing applicable clinical trials and/or receiving interim/final insights from such clinical trials; the content and timing of decisions made through applicable regulatory governance in connection with the regulatory approval of Belite Bio’s drug candidates; the possible effectiveness of Tinlarebant, as well as the dangers discussed in more detail in the “Risk Factors” segment of Belite Bio’s filings with the United States Securities and Exchange Commission. All forward-looking announcements are based on information recently available to Belite Bio, and Belite Bio undertakes no legal responsibility to publicly update or revise any forward-looking announcements, whether as a result of new data, future events or otherwise, unless as would possibly be necessary. through the law.
BELITE BIO, CONSOLIDATED INCOME STATEMENTS AND COMPREHENSIVE INCOME (Amounts in thousands of U. S. dollars, consistent with consistent percentages and consistent with consistent percentages)
For the year
Completed December 31.
2022
2023
(Verified)
(Verified)
outgoings
Research & Development
8 869
24 844
General Administrative
3 952
6 824
Total Operating Expenses
12 821
31 668
Business Interruption
(12 821
)
(31 668
)
Other Income
Total other income, net
173
45
Loss Before Source of Income Taxes
(12 648
)
(31 623
)
Income from tax expenses
–
9
Net loss
(12 648
)
(31 632
)
Other Income
Foreign currency translation differences, 0 VAT
(196
)
18
Total Total Loss
(12 844
)
(31 614
)
Weighted average number of non-unusual stocks used
Calculation consistent with participation:
– Basic and diluted
19 976 596
26 593 673
Net loss consistent with non-unusual participation
– Basic and diluted
$
(0,63
)
$
(1. 19
)
During the 3 months
Completed December 31.
2022
2023
(Unaudited and unaudited)
(Unaudited and unaudited)
outgoings
Research & Development
5 226
4 862
General Administrative
1 495
2 093
Total Operating Expenses
6 721
6 955
Business Interruption
(6 721
)
(6 955
)
Other Expenses
Total other expenses, net
(62
)
(36
)
Loss Before Source of Income Taxes
(6 783
)
(6 991
)
Income from tax expenses
–
–
Net loss
(6 783
)
(6 991
)
Other Income
Foreign currency translation differences, 0 VAT
127
133
Total Total Loss
(6 656
)
(6 858
)
Weighted average number of non-unusual stocks used
Calculation consistent with participation:
– Basic and diluted
24 889 136
28 316 251
Net loss consistent with non-unusual participation
– Basic and diluted
$
(0,27
)
$
(0,25
)
BELITE BIO, UNCONSOLIDATED BALANCE SHEET (Amounts in thousands of U. S. dollars, equity figures)
December 31
2022
2023
(Verified)
(Verified)
ASSETS
Current assets
Money
$
42 089
$
88 157
Other Income
—
818
Advance invoices and existing assets.
716
947
Other Accounts Receivable to Like Parties
2
18
Total assets
42 807
89 940
Property & Equipment, Net
541
490
Initial invoices and non-current assets
31
3 297
Security repositories
88
104
Assets by operating right of use, net
806
811
TOTAL ASSETS
$
44 273
$
94 642
LIABILITIES AND STOCKHOLDERS’ EQUITY
Current liabilities
Accrued liabilities and accounts payable
1 906
3 325
Operating liabilities – current
198
308
Full Liability
2 104
3 633
Non-current liabilities
Non-current lease liabilities
668
578
TOTAL RESPONSIBILITIES
2 772
4 211
Equity
Common shares, at par of $0. 0001 consistent with the share; 400,000,000 legal actions; 24,898,908 and 29,184,475 shares issued; 24,898,908 and 29,149,444 notable shares as of December 31, 2022 and 2023, respectively
3
3
Premium Sharing
81 761
162 305
Other Cumulative Loss
(392
)
(374
)
Cumulative deficit
(39 871
)
(71 503
)
Total Shareholder Equity
41 501
90 431
TOTAL LIABILITY AND NET WORTH
$
44 273
$
94 642
Media Contact & Investor Relations: Jennifer Wuir@belitebio. com Julie Fallonbelite@argotpartners. com