Full Press Release Details
CONDENSED CONSOLIDATED BALANCE SHEETS
(Amounts in thousands of US Dollars, except
share and per share amounts)
| December 31, 2024 | September 30, 2025 | |||||||
| ASSETS | ||||||||
| Current Assets | ||||||||
| Cash and cash equivalents | $ | 31,677 | $ | 157,034 | ||||
| Available-for-sale investments | 4,549 | - | ||||||
| Held-to-maturity investments | 108,923 | 118,580 | ||||||
| Other receivables | 575 | 6 | ||||||
| Prepayments and other current assets | 1,349 | 1,593 | ||||||
| Total current assets | 147,073 | 277,213 | ||||||
| Property and equipment, net | 444 | 317 | ||||||
| Intangible assets | 31 | 24 | ||||||
| Prepayments and other non-current assets | 3,960 | 4,229 | ||||||
| Security deposits | 103 | 101 | ||||||
| Operating lease right-of-use asset, net | 521 | 509 | ||||||
| TOTAL ASSETS | $ | 152,132 | $ | 282,393 | ||||
| LIABILITIES AND SHAREHOLDERS' EQUITY | ||||||||
| Current liabilities | ||||||||
| Accrued expenses and other liabilities | 5,761 | 7,793 | ||||||
| Other payables to related parties | 13 | 8 | ||||||
| Operating lease liabilities - current | 276 | 265 | ||||||
| Total current liabilities | 6,050 | 8,066 | ||||||
| Non-current liabilities | ||||||||
| Operating lease liabilities - non-current | 261 | 245 | ||||||
| TOTAL LIABILITIES | 6,311 | 8,311 | ||||||
| Shareholders' equity | ||||||||
| Ordinary shares, par value of US$0.0001 per share; 400,000,000 shares authorized. 31,857,802 and 34,903,104 shares issued; 31,826,549 and 34,890,991 shares outstanding as of December 31, 2024 and September 30, 2025, respectively | 3 | 3 | ||||||
| Additional paid-in capital | 254,125 | 434,445 | ||||||
| Accumulated other comprehensive loss | (660 | ) | (432 | ) | ||||
| Accumulated deficit | (107,647 | ) | (159,934 | ) | ||||
| Total shareholders' equity | 145,821 | 274,082 | ||||||
| TOTAL LIABILITIES AND SHAREHOLDERS' EQUITY | $ | 152,132 | $ | 282,393 |
The accompanying notes are an integral part of
the consolidated financial statements.
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
AND COMPREHENSIVE LOSS
(Amounts in thousands of US Dollars, except
share and per share amounts)
| Nine Months Ended September 30, | ||||||||
| 2024 | 2025 | |||||||
| Expenses | ||||||||
| Research and development | $ | 22,685 | $ | 30,753 | ||||
| General and administrative | 5,854 | 25,378 | ||||||
| Total operating expenses | 28,539 | 56,131 | ||||||
| Loss from operations | (28,539 | ) | (56,131 | ) | ||||
| Other income: | ||||||||
| Interest income, net | 2,496 | 3,468 | ||||||
| Other income | 5 | 376 | ||||||
| Total other income, net | 2,501 | 3,844 | ||||||
| Loss before income tax | ||||||||
| Income tax expense | 6 | - | ||||||
| Net loss | (26,044 | ) | (52,287 | ) | ||||
| Other comprehensive income (loss) | ||||||||
| Foreign currency translation adjustments, net of nil tax | (27 | ) | 228 | |||||
| Total comprehensive loss | $ | (26,071 | ) | $ | (52,059 | ) | ||
| Weighted average number of ordinary shares used in per share calculation: | ||||||||
| - Basic and Diluted | 30,231,207 | 32,634,966 | ||||||
| Net loss per ordinary share | ||||||||
| - Basic and Diluted | $ | (0.86 | ) | $ | (1.60 | ) |
The accompanying notes are an integral part of
the consolidated financial statements.
CONDENSED CONSOLIDATED STATEMENTS OF SHAREHOLDERS'
(Amounts in thousands of US Dollars, except
| Accumulated | |||||||||||||||||||||||||
| Additional | other | Total | |||||||||||||||||||||||
| Ordinary Shares | Paid - in | Comprehensive | Accumulated | Shareholders' | |||||||||||||||||||||
| Shares | Amount | Capital | loss | deficit | Equity | ||||||||||||||||||||
| Balance as of December 31, 2023 | 29,149,444 | $ | 3 | $ | 162,305 | $ | (374 | ) | $ | (71,503 | ) | $ | 90,431 | ||||||||||||
| Issuance of shares upon registered direct offering, net | 651,380 | - | 24,811 | - | - | 24,811 | |||||||||||||||||||
| Issuance of shares upon At-the-Market ("ATM"), net | 134,875 | - | 5,960 | - | - | 5,960 | |||||||||||||||||||
| Non-cash exercise of Representative's Warrants | 9,976 | - | - | - | - | - | |||||||||||||||||||
| Exercise of warrants | 668,957 | - | 10,208 | - | - | 10,208 | |||||||||||||||||||
| Exercise of share options | 264,700 | - | 2,079 | - | - | 2,079 | |||||||||||||||||||
| Share-based compensation expense | - | - | 4,782 | - | - | 4,782 | |||||||||||||||||||
| Net loss | - | - | - | - | (26,044 | ) | (26,044 | ) | |||||||||||||||||
| Foreign currency translation adjustment | - | - | - | (27 | ) | - | (27 | ) | |||||||||||||||||
| Balances as of September 30, 2024 | 30,879,332 | 3 | 210,145 | (401 | ) | (97,547 | ) | 112,200 | |||||||||||||||||
| Balances as of December 31, 2024 | 31,826,549 | 3 | 254,125 | (660 | ) | (107,647 | ) | 145,821 | |||||||||||||||||
| Issuance of shares upon registered direct offering, net | 489,079 | - | 27,746 | - | - | 27,746 | |||||||||||||||||||
| Issuance of shares upon PIPE, net | 1,953,124 | - | 118,552 | - | - | 118,552 | |||||||||||||||||||
| Exercise of warrants | 19,866 | - | 357 | - | - | 357 | |||||||||||||||||||
| Exercise of share options | 502,373 | - | 6,460 | - | - | 6,460 | |||||||||||||||||||
| Share-based compensation | - | - | 20,755 | - | - | 20,755 | |||||||||||||||||||
| Share-based compensation-RSU | 100,000 | - | 6,450 | - | - | 6,450 | |||||||||||||||||||
| Net loss | - | - | - | - | (52,287 | ) | (52,287 | ) | |||||||||||||||||
| Foreign currency translation | - | - | - | 228 | - | 228 | |||||||||||||||||||
| Balances as of September 30, 2025 | 34,890,991 | 3 | 434,445 | (432 | ) | (159,934 | ) | 274,082 |
The accompanying notes are an integral part of
the consolidated financial statements.
CONSOLIDATED STATEMENTS OF CASH FLOWS
(Amounts in thousands of US Dollars)
| Nine Months Ended September 30, | ||||||||
| 2024 | 2025 | |||||||
| Cash flows from operating activities | ||||||||
| Net loss | $ | (26,044 | ) | $ | (52,287 | ) | ||
| Adjustments to reconcile net loss to net cash used in operating activities: | ||||||||
| Depreciation | 121 | 127 | ||||||
| Amortization of operating lease right-of-use asset | 210 | 211 | ||||||
| Amortization of intangible assets | - | 9 | ||||||
| Share-based compensation expense | 4,782 | 27,205 | ||||||
| Interest income from investments | (2,412 | ) | (3,159 | ) | ||||
| Losses on operating lease modification | - | 1 | ||||||
| Changes in operating assets and liabilities: | ||||||||
| Other receivables | 56 | (6 | ) | |||||
| Other receivables due from related parties | 18 | - | ||||||
| Prepayments | (711 | ) | (481 | ) | ||||
| Other payables due to related parties | 21 | (5 | ) | |||||
| Accrued expenses and other liabilities | (446 | ) | 2,005 | |||||
| Security deposits | - | 4 | ||||||
| Operating lease liabilities | (228 | ) | (227 | ) | ||||
| Net cash used in operating activities | (24,633 | ) | (26,603 | ) | ||||
| Cash flows from investing activities | ||||||||
| Acquisition of property and equipment | (116 | ) | - | |||||
| Acquisition of intangible assets | (29 | ) | - | |||||
| Acquisition of available-for-sale investments | (4,500 | ) | - | |||||
| Proceeds from maturities of available-for-sale investments | - | 4,549 | ||||||
| Acquisition of held-to-maturity investments | (120,813 | ) | (95,761 | ) | ||||
| Proceeds from maturities of held-to-maturity investments | 40,900 | 89,839 | ||||||
| Net cash used in investing activities | (84,558 | ) | (1,373 | ) | ||||
| Cash flows from financing activities | ||||||||
| Payments of PIPE offering costs | - | (6,448 | ) | |||||
| Proceeds from PIPE offering, net | - | 125,000 | ||||||
| Payments of ATM offering costs | (30 | ) | - | |||||
| Proceeds from ATM offering, net of commissions | 6,752 | - | ||||||
| Payments of registered direct offering costs | (189 | ) | (304 | ) | ||||
| Proceeds from registered direct offering | 25,000 | 28,050 | ||||||
| Proceeds from exercise of warrants, net | 10,208 | 357 | ||||||
| Proceeds from exercise of share options | 2,079 | 6,460 | ||||||
| Net cash provided by financing activities | 43,820 | 153,115 | ||||||
| Effects of exchange rate on cash | 8 | 218 | ||||||
| NET (DECREASE) INCREASE IN CASH AND CASH EQUIVALENTS | (65,363 | ) | 125,357 | |||||
| CASH AND CASH EQUIVALENTS AT BEGINNING OF THE PERIOD | 88,157 | 31,677 | ||||||
| CASH AND CASH EQUIVALENTS AT END OF THE PERIOD | $ | 22,794 | $ | 157,034 | ||||
| SUPPLEMENTAL DISCLOSURE OF CASH FLOW INFORMATION | ||||||||
| Cash paid for income tax | 6 | - | ||||||
| SUPPLEMENTAL DISCLOSURE OF NON-CASH INVESTING AND FINANCING ACTIVITIES | ||||||||
| ATM offering sales commissions reclassed to additional paid-in-capital | 185 | - | ||||||
| Non-cash exercise of Representative's Warrants | - | * | - | |||||
| Right-of-use assets obtained in exchange of lease liabilities | 14 | 534 | ||||||
| Right-of-use assets in exchange of lease liabilities from an operating lease modification | - | 361 |
issued 9,976 shares of ordinary shares in a non-cash exercise of 12,500 shares of Representative's Warrants.
The accompanying notes are an integral part of
the consolidated financial statements.
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
(Amounts in thousands of US$ except for number
of shares and per share data, unless otherwise noted)
AND BASIS OF PRESENTATION
Belite Bio, Inc ("Belite" or
the "Company") was incorporated under the laws of the Cayman Islands on March 27, 2018. The Company and its subsidiaries
are engaged in the research and development of novel therapeutics targeting significant unmet needs.
In June 2016, the Company's ultimate
controlling shareholder (i.e., the sole shareholder of Belite's principal shareholder, Lin Bioscience International Ltd.),
Lin BioScience, Inc., a public company in Taiwan (stock code: 6696.TW), established Belite Bio Holdings Corp. (formerly known as
Lin BioScience Holdings Corporation) and Belite Bio, LLC (formerly known as Lin BioScience, LLC), in Delaware. Belite Bio Holdings Corp.
is established as an intermediate holding company and owns 100% equity interests in Belite Bio, LLC, which is mainly engaged in research
and development of Tinlarebant (a/k/a LBS-008) and LBS-009.
In March 2018, Lin BioScience, Inc.,
established the Company in the Cayman Islands, as a subsidiary to its wholly-owned subsidiary Lin Bioscience International Ltd.,
for reorganization purposes.
In June 2018, as part of the reorganization,
the Company's principal shareholder, Lin Bioscience International Ltd., acquired the entire equity interest in Belite Bio Holdings
Corp. from Lin BioScience, Inc. and then contributed the entire equity interest in Belite Bio Holdings Corp. to the Company in July 2018,
together with other considerations in exchange for the Company's ordinary shares. Lin Bioscience International Ltd. transferred
1) cash of $900, 2) assignment of Lin BioScience, Inc.'s rights, title, interests and obligations under the exclusive license
agreement by and between Lin BioScience, Inc. and Columbia University and 3) 1,600 shares of Belite Bio Holdings Corp. to the Company
in exchange for its 5,340,221 ordinary shares. After above transaction, Belite Bio Holdings Corp. became Belite's wholly-owned subsidiary,
which in turn owns 100% equity interests in Belite Bio, LLC.
Before and after the reorganization, the Company,
together with its subsidiaries, is effectively controlled by the same shareholders, and therefore the reorganization is considered a recapitalization
of entities under common control in accordance with Accounting Standards Codification ("ASC") 805-50-25. The consolidation
of the Company and its subsidiaries have been accounted for at historical cost in the accompanying consolidated financial statements in
accordance with ASC 805-50-45-5.
In August 2018, Belite Bio Holdings Corp.
established RBP4 Pty Ltd in Australia as its wholly-owned subsidiary for carrying out clinical trials in Australia and tax refund purposes.
In January and February 2020, the Company
closed two rounds of Series A Preferred Share financing and the relevant investors became shareholders of the Company. In December 2020,
the Company closed a round of Series B Preferred Share financing, and the relevant investors became shareholders of the Company.
After the private placements, Lin Bioscience International Ltd. hold 80.10% of the Company's equity.
In June 2021, the Company established Belite
Bio (HK) Limited in Hong Kong as a wholly - owned subsidiary which further established Belite Bio (Shanghai) Limited in Shanghai, China
in August 2021 for the purpose of carrying out clinical trials in China.
On April 28, 2022, the Company consummated
its initial public offering ("IPO") of 6,000,000 American Depository Shares ("ADSs") at a public offering price
per ADS of $6. Each ADS represents one ordinary share of Belite. The gross proceeds from IPO, before deducting the underwriting discounts
and commissions and offering expenses were $36,000 with net proceeds of $33,705. On May 20, 2022, the underwriter exercised in full
its over-allotment option to purchase 772,091 ADS, resulting in additional net proceeds of $4,285.
Upon closing of the IPO offering in April 2022,
the Company issued to Benchmark Company, LLC ("Benchmark") the representative of the underwriters warrants to purchase a number
of ADSs equal to 169,302 ADSs (the "Representative's Warrants"). The Representative's Warrants have an exercise
price equal to US$7.50 per ADS and are exercisable until the date on April 28, 2027, after the date of commencement on November 3,
2022. The Representative's Warrants are also exercisable on a cashless basis.
On June 2, 2023, the Company completed its
follow-on offering of (i) 2,000,000 of ADSs, representing 2,000,000 of the Company ordinary shares, par value US$0.0001 per share;
and (ii) warrants to purchase an aggregate of 2,000,000 of the Company ordinary shares represented by ADSs with an exercise price
of $18.00 per warrants. The ADSs and accompanying warrants are immediately separable and will be issued separately but were sold together
at a public offering price of $15.00. The gross proceeds from this offering, before deducting the underwriting discounts and commissions
and offering expenses were $30,000 with net proceeds of $27,317.
On June 16, 2023, the Company entered into
a sales agreement (the "Sales Agreement"), with SVB Securities LLC ("SVB Securities") and Cantor Fitzgerald &
Co. ("Cantor"), acting as the Company's sales agents, under which may, from time to time, offer and sell ADSs through
an At-the-Market ("ATM") offering program, having an aggregate offering price of up to $100,000. Each ADS represents one of
the Company ordinary shares, par value $0.0001 per share. The Company has raised $28,608 and $16,984 in gross proceeds after deducting
sales commissions and other fees and expenses with the net proceeds $27,403 and $16,295, by issuing 731,843 ADSs, and 284,719 ADSs for
the years ended December 31, 2023, and 2024, respectively.
On April 25, 2024, the Company announced
that it entered into a securities purchase agreement with an institutional investor, for the purchase and sale of up to an aggregate of
651,380 ADSs, each ADS representing one ordinary share of the Company at a purchase price of $38.38 per ADS, and the warrants ("Existing
Warrants") to purchase up to an aggregate of 651,380 ADSs, which have an exercise price equal to $44.14 per ADS and immediately
exercisable and expiring on the five-year anniversary of the issuance, in a registered direct offering. The gross proceeds to the Company
from the offering were approximately $25,000 (before any warrant exercise), before deducting the expenses payable by the Company and net
proceeds of $24,811.
On November 3, 2024, the Company entered
into an inducement offer letter agreement for the immediate exercise of Existing Warrants to purchase up to an aggregate of 651,380 ordinary
shares of the Company originally issued in April 2024, at an exercise price of $44.14 per share. The gross proceeds to the Company
from the exercise of Existing Warrants were $28,752. In consideration for the immediate exercise of Existing Warrants for cash, the Company
issued new warrants ("November Warrants") to purchase up to 651,380 ordinary shares. The November Warrants have
an exercise price of $70.00 per share, exercisable immediately upon issuance and will expire five years from the date of issuance. If
the investor were to exercise the November Warrants in full, the gross proceeds from such new warrants would be approximately $45,597.
In December 2024, Belite Bio (HK) Limited