x | QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
o | TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
Cayman Islands | 98-1594670 | ||||
(State or other jurisdiction of incorporation or organization) | (I.R.S. Employer Identification No.) | ||||
103 Carnegie Center Drive, Suite 309 Princeton, NJ | 08540 | ||||
(Address of principal executive offices) | (Zip Code) |
Title of each class | Trading Symbol(s) | Name of each exchange on which registered | ||||||||||||
American Depositary Shares, each representing 1 ordinary share, par value $0.000017100448 per share | LIAN | The Nasdaq Global Market |
Large accelerated filer | o | Accelerated filer | o | |||||||||||
Non-accelerated filer | x | Smaller reporting company | x | |||||||||||
Emerging growth company | x |
Page | ||||||||
PART I. | ||||||||
PART II | ||||||||
ITEM 1A. | ||||||||
ITEM 3. | ||||||||
ITEM 5. | ||||||||
September 30, 2022 | December 31, 2021 | ||||||||||
Assets | |||||||||||
Current assets: | |||||||||||
Cash and cash equivalents | $ | 78,862 | $ | 228,182 | |||||||
Marketable securities | 232,866 | 155,067 | |||||||||
Prepaid expenses and other current assets | 5,117 | 10,354 | |||||||||
Other receivable | 7,393 | 6,044 | |||||||||
Total current assets | 324,238 | 399,647 | |||||||||
Restricted cash, non-current | 20,070 | 20,000 | |||||||||
Property and equipment, net | 3,135 | 1,882 | |||||||||
Operating lease right-of-use assets | 4,362 | 4,763 | |||||||||
Other non-current assets | 37 | 51 | |||||||||
Total assets | $ | 351,842 | $ | 426,343 | |||||||
Liabilities and Shareholders’ Equity | |||||||||||
Current liabilities: | |||||||||||
Accounts payable | $ | 2,019 | $ | 3,231 | |||||||
Accrued expenses | 17,871 | 9,976 | |||||||||
Current portion of operating lease liabilities | 1,750 | 1,125 | |||||||||
Other current liabilities | 387 | 760 | |||||||||
Total current liabilities | 22,027 | 15,092 | |||||||||
Operating lease liabilities | 3,017 | 3,709 | |||||||||
Other liabilities | 200 | 206 | |||||||||
Nonrefundable research deposit | 20,000 | 20,000 | |||||||||
Total liabilities | $ | 45,244 | $ | 39,007 | |||||||
Commitments and contingencies (Note 8) | |||||||||||
Shareholders’ equity (deficit): | |||||||||||
Ordinary shares, $0.000017100448 par value. 2,923,900,005 shares authorized as of September 30, 2022; 108,353,831 shares issued and outstanding as of September 30, 2022; 2,923,900,005 shares authorized as of December 31, 2021; 107,275,458 shares issued and outstanding as of December 31, 2021 | 2 | 2 | |||||||||
Additional paid-in capital | 728,915 | 713,269 | |||||||||
Accumulated other comprehensive (loss) income | (3,844) | 526 | |||||||||
Accumulated deficit | (452,249) | (360,235) | |||||||||
Total LianBio shareholders’ equity | 272,824 | 353,562 | |||||||||
Non-controlling interest | 33,774 | 33,774 | |||||||||
Total shareholders’ equity | 306,598 | 387,336 | |||||||||
Total liabilities and shareholders’ equity | $ | 351,842 | $ | 426,343 |
Three Months Ended September 30, | Nine Months Ended September 30, | ||||||||||||||||||||||
2022 | 2021 | 2022 | 2021 | ||||||||||||||||||||
Operating expenses: | |||||||||||||||||||||||
Research and development | $ | 8,258 | $ | 4,655 | $ | 49,178 | $ | 151,038 | |||||||||||||||
General and administrative | 16,291 | 8,889 | 46,930 | 22,496 | |||||||||||||||||||
Total operating expenses | 24,549 | 13,544 | 96,108 | 173,534 | |||||||||||||||||||
Loss from operations | (24,549) | (13,544) | (96,108) | (173,534) | |||||||||||||||||||
Other income (expense): | |||||||||||||||||||||||
Interest income, net | 1,405 | 32 | 2,238 | 171 | |||||||||||||||||||
Other income (expense), net | 1,253 | 3 | 1,873 | (189) | |||||||||||||||||||
Net loss before income taxes | (21,891) | (13,509) | (91,997) | (173,552) | |||||||||||||||||||
Income taxes (benefit) | 6 | (397) | 17 | 1,553 | |||||||||||||||||||
Net loss | (21,897) | (13,112) | (92,014) | (175,105) | |||||||||||||||||||
Other comprehensive (loss) income: | |||||||||||||||||||||||
Foreign currency translation (loss) income, net of tax | (2,282) | (26) | (3,096) | 104 | |||||||||||||||||||
Unrealized loss on marketable securities, net of tax | (160) | — | (1,274) | — | |||||||||||||||||||
Comprehensive loss | $ | (24,339) | $ | (13,138) | $ | (96,384) | $ | (175,001) | |||||||||||||||
Net loss per share attributable to ordinary shareholders, basic and diluted | $ | (0.20) | $ | (0.63) | $ | (0.85) | $ | (8.52) | |||||||||||||||
Weighted-average shares outstanding used in computing net loss per share attributable to ordinary shareholders, basic and diluted | 108,353,831 | 20,690,908 | 107,854,547 | 20,549,310 |
Redeemable Convertible Preferred Shares | Ordinary Shares | Additional Paid in Capital | Accumulated Other Comprehensive Income (Loss) | Accumulated Deficit | Total LianBio Shareholders’ Equity | Non- Controlling Interest | Total Shareholders’ Equity (Deficit) | |||||||||||||||||||||||||||||||||||||||||||||||||||||||
Shares | Amount | Shares | Amount | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Balance, December 31, 2021 | — | $ | — | 107,275,458 | $ | 2 | $ | 713,269 | $ | 526 | $ | (360,235) | $ | 353,562 | $ | 33,774 | $ | 387,336 | ||||||||||||||||||||||||||||||||||||||||||||
Share-based compensation expense | — | — | — | — | 4,669 | — | — | 4,669 | — | 4,669 | ||||||||||||||||||||||||||||||||||||||||||||||||||||
Receivable from related party | — | — | — | — | 1,710 | — | — | 1,710 | — | 1,710 | ||||||||||||||||||||||||||||||||||||||||||||||||||||
Net Loss | — | — | — | — | — | — | (27,726) | (27,726) | — | (27,726) | ||||||||||||||||||||||||||||||||||||||||||||||||||||
Comprehensive Loss | — | — | — | — | — | (1,216) | — | (1,216) | — | (1,216) | ||||||||||||||||||||||||||||||||||||||||||||||||||||
Balance, March 31, 2022 | — | $ | — | 107,275,458 | $ | 2 | $ | 719,648 | $ | (690) | $ | (387,961) | $ | 330,999 | $ | 33,774 | $ | 364,773 | ||||||||||||||||||||||||||||||||||||||||||||
Share-based compensation expense | — | — | — | — | 4,528 | — | — | 4,528 | — | 4,528 | ||||||||||||||||||||||||||||||||||||||||||||||||||||
Exercise of options | — | — | 1,000,000 | — | — | — | — | — | — | — | ||||||||||||||||||||||||||||||||||||||||||||||||||||
Exercise of warrants | — | — | 78,373 | — | — | — | — | — | — | — | ||||||||||||||||||||||||||||||||||||||||||||||||||||
Net Loss | — | — | — | — | — | — | (42,391) | (42,391) | — | (42,391) | ||||||||||||||||||||||||||||||||||||||||||||||||||||
Comprehensive Loss | — | — | — | — | — | (712) | — | (712) | — | (712) | ||||||||||||||||||||||||||||||||||||||||||||||||||||
Balance, June 30, 2022 | — | $ | — | 108,353,831 | $ | 2 | $ | 724,176 | $ | (1,402) | $ | (430,352) | $ | 292,424 | $ | 33,774 | $ | 326,198 | ||||||||||||||||||||||||||||||||||||||||||||
Share-based compensation expense | — | — | — | — | 4,739 | — | — | 4,739 | — | 4,739 | ||||||||||||||||||||||||||||||||||||||||||||||||||||
Net Loss | — | — | — | — | — | — | (21,897) | (21,897) | — | (21,897) | ||||||||||||||||||||||||||||||||||||||||||||||||||||
Comprehensive Loss | — | — | — | — | — | (2,442) | — | (2,442) | — | (2,442) | ||||||||||||||||||||||||||||||||||||||||||||||||||||
Balance, September 30, 2022 | — | $ | — | 108,353,831 | $ | 2 | $ | 728,915 | $ | (3,844) | $ | (452,249) | $ | 272,824 | $ | 33,774 | $ | 306,598 |
Redeemable Convertible Preferred Shares | Ordinary Shares | Additional Paid in Capital | Accumulated Other Comprehensive (Loss) Income | Accumulated Deficit | Total LianBio Shareholders’ Equity (Deficit) | Non- Controlling Interest | Total Shareholders’ Equity (Deficit) | |||||||||||||||||||||||||||||||||||||||||||||||||||||||
Shares | Amount | Shares | Amount | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Balance, December 31, 2020 | 10,971,231 | $ | 349,789 | 20,477,338 | $ | — | $ | 31,132 | $ | (40) | $ | (163,935) | $ | (132,843) | $ | 34,773 | $ | (98,070) | ||||||||||||||||||||||||||||||||||||||||||||
Share-based compensation expense | — | — | — | — | 1,674 | — | — | 1,674 | — | 1,674 | ||||||||||||||||||||||||||||||||||||||||||||||||||||
Issuance of Series A Preferred Shares at $56.66, net of issuance costs | 52,947 | 2,940 | — | — | — | — | — | — | — | — | ||||||||||||||||||||||||||||||||||||||||||||||||||||
Warrants issued in license agreement | — | — | — | — | — | — | — | — | 9,415 | 9,415 | ||||||||||||||||||||||||||||||||||||||||||||||||||||
Net Loss | — | — | — | — | — | — | (61,565) | (61,565) | — | (61,565) | ||||||||||||||||||||||||||||||||||||||||||||||||||||
Comprehensive Income | — | — | — | — | — | 8 | — | 8 | — | 8 | ||||||||||||||||||||||||||||||||||||||||||||||||||||
Balance, March 31, 2021 | 11,024,178 | $ | 352,729 | 20,477,338 | $ | — | $ | 32,806 | $ | (32) | $ | (225,500) | $ | (192,726) | $ | 44,188 | $ | (148,538) | ||||||||||||||||||||||||||||||||||||||||||||
Share-based compensation expense | — | — | — | — | 1,443 | — | — | 1,443 | — | 1,443 | ||||||||||||||||||||||||||||||||||||||||||||||||||||
Net Loss | — | — | — | — | — | — | (100,428) | (100,428) | — | (100,428) | ||||||||||||||||||||||||||||||||||||||||||||||||||||
Comprehensive Income | — | — | — | — | — | 122 | — | 122 | — | 122 | ||||||||||||||||||||||||||||||||||||||||||||||||||||
Balance, June 30, 2021 | 11,024,178 | $ | 352,729 | 20,477,338 | $ | — | $ | 34,249 | $ | 90 | $ | (325,928) | $ | (291,589) | $ | 44,188 | $ | (247,401) | ||||||||||||||||||||||||||||||||||||||||||||
Share-based compensation expense | — | — | — | — | 2,168 | — | — | 2,168 | — | 2,168 | ||||||||||||||||||||||||||||||||||||||||||||||||||||
Exercise of options | — | — | 1,309,907 | — | 5,309 | — | — | 5,309 | — | 5,309 | ||||||||||||||||||||||||||||||||||||||||||||||||||||
Net Loss | — | — | — | — | — | — | (13,112) | (13,112) | — | (13,112) | ||||||||||||||||||||||||||||||||||||||||||||||||||||
Comprehensive Loss | — | — | — | — | — | (26) | — | (26) | — | (26) | ||||||||||||||||||||||||||||||||||||||||||||||||||||
Balance, September 30, 2021 | 11,024,178 | $ | 352,729 | 21,787,245 | $ | — | $ | 41,726 | $ | 64 | $ | (339,040) | $ | (297,250) | $ | 44,188 | $ | (253,062) |
Nine Months Ended September 30, 2022 | Nine Months Ended September 30, 2021 | ||||||||||
Net loss | $ | (92,014) | $ | (175,105) | |||||||
Adjustments to reconcile net loss to net cash used in operating activities: | |||||||||||
Non-cash share consideration, issued in acquisition of IPR&D | — | 9,415 | |||||||||
Non-cash operating lease expense (benefit) | 354 | (76) | |||||||||
Depreciation expense | 689 | 278 | |||||||||
Share based compensation expense | 13,936 | 5,285 | |||||||||
Amortization of discounts on investments, net | (481) | — | |||||||||
Unrealized foreign currency transaction gain, net | (1,375) | (56) | |||||||||
Changes in operating assets and liabilities: | |||||||||||
Decrease (increase) in prepaid expenses and other current assets | 4,794 | (3,801) | |||||||||
(Increase) decrease in other receivable | (1,244) | 14,216 | |||||||||
Decrease in other non-current assets | 11 | 2 | |||||||||
Decrease in accounts payable | (1,091) | (2,690) | |||||||||
Increase in accrued expenses | 8,197 | 11,568 | |||||||||
(Decrease) increase in other current liabilities | (248) | 1,434 | |||||||||
Increase in withholding tax payable | — | 5,957 | |||||||||
Net cash used in operating activities | (68,472) | (133,573) | |||||||||
Cash flows from investing activities: | |||||||||||
Purchase of property and equipment | (1,610) | (159) | |||||||||
Purchase of marketable securities | (260,367) | — | |||||||||
Sales and redemption of marketable securities | 181,780 | — | |||||||||
Net cash used for investing activities | (80,197) | (159) | |||||||||
Cash flows from financing activities: | |||||||||||
Proceeds from exercise of share options | 1,710 | 5,309 | |||||||||
Proceeds from issuance of redeemable convertible preferred shares | — | 3,000 | |||||||||
Issuance costs related to redeemable convertible preferred shares | — | (60) | |||||||||
Net cash provided by financing activities | 1,710 | 8,249 | |||||||||
Effect of exchange rate changes on cash and cash equivalents | (2,291) | 148 | |||||||||
Net decrease in cash, cash equivalents and restricted cash | $ | (149,250) | $ | (125,335) | |||||||
Cash and cash equivalents, and restricted cash—beginning of period | 248,182 | 254,350 | |||||||||
Cash and cash equivalents, and restricted cash—ending of period | $ | 98,932 | $ | 129,015 | |||||||
Cash and cash equivalents—end of period | $ | 78,862 | $ | 109,015 | |||||||
Restricted cash—end of period | $ | 20,070 | $ | 20,000 | |||||||
Cash and cash equivalents, and restricted cash—ending of period | $ | 98,932 | $ | 129,015 | |||||||
Supplemental disclosure of cash information | |||||||||||
Cash paid for income taxes | $ | 523 | $ | — | |||||||
Supplemental disclosure of non-cash operating activities: | |||||||||||
Right-of-use assets obtained in exchange for lease obligations | $ | 1,233 | $ | 247 | |||||||
Issuance costs in accounts payable and other accrued liabilities | $ | — | $ | 3,310 | |||||||
Purchase of property and equipment in accounts payable | $ | 551 | $ | — |
As of September 30, 2022 (in thousands) | Amortized Cost | Gross Unrealized Gains | Gross Unrealized Losses | Estimated Fair Value | |||||||||||||||||||
Commercial paper | $ | 155,652 | $ | — | $ | (574) | $ | 155,078 | |||||||||||||||
Corporate debt securities | 14,202 | — | (136) | 14,066 | |||||||||||||||||||
Government obligations & agency securities | 64,232 | 1 | (511) | 63,722 | |||||||||||||||||||
Total | $ | 234,086 | $ | 1 | $ | (1,221) | $ | 232,866 |
As of December 31, 2021 (in thousands) | Amortized Cost | Gross Unrealized Gains | Gross Unrealized Losses | Estimated Fair Value | |||||||||||||||||||
Commercial paper | $ | 145,894 | $ | 55 | $ | — | $ | 145,949 | |||||||||||||||
Corporate debt securities | 4,138 | — | — | 4,138 | |||||||||||||||||||
Government obligations | 4,986 | — | (6) | 4,980 | |||||||||||||||||||
Total | $ | 155,018 | $ | 55 | $ | (6) | $ | 155,067 |
As of September 30, 2022 (in thousands) | Securities in an unrealized loss position less than 12 months | Securities in an unrealized loss position greater than 12 months | Total | ||||||||||||||||||||||||||||||||
Unrealized losses | Fair Value | Unrealized losses | Fair Value | Unrealized losses | Fair Value | ||||||||||||||||||||||||||||||
Commercial paper | $ | (574) | $ | 147,581 | $ | — | $ | — | $ | (574) | $ | 147,581 | |||||||||||||||||||||||
Corporate debt securities | (136) | 14,065 | — | — | (136) | 14,065 | |||||||||||||||||||||||||||||
Government obligations & agency securities | (465) | 46,795 | (46) | 14,952 | (511) | 61,747 | |||||||||||||||||||||||||||||
Total | $ | (1,175) | $ | 208,441 | $ | (46) | $ | 14,952 | $ | (1,221) | $ | 223,393 |
As of December 31, 2021 (in thousands) | Securities in an unrealized loss position less than 12 months | Securities in an unrealized loss position greater than 12 months | Total | ||||||||||||||||||||||||||||||||
Unrealized losses | Fair Value | Unrealized losses | Fair Value | Unrealized losses | Fair Value | ||||||||||||||||||||||||||||||
Commercial paper | $ | — | $ | — | $ | — | $ | — | $ | — | $ | — | |||||||||||||||||||||||
Corporate debt securities | — | — | — | — | — | — | |||||||||||||||||||||||||||||
Government obligations | (6) | 4,980 | — | — | (6) | 4,980 | |||||||||||||||||||||||||||||
Total | $ | (6) | $ | 4,980 | $ | — | $ | — | $ | (6) | $ | 4,980 |
September 30, 2022 | |||||||||||
Less than 12 Months | More Than 12 Months | ||||||||||
Commercial paper | $ | 155,078 | $ | — | |||||||
Corporate debt securities | 14,066 | — | |||||||||
Government obligations & agency securities | 46,795 | 16,927 | |||||||||
Total Marketable securities | $ | 215,939 | $ | 16,927 |
December 31, 2021 | |||||||||||
Less than 12 Months | More Than 12 Months | ||||||||||
Commercial paper | $ | 145,949 | $ | — | |||||||
Corporate debt securities | 4,138 | — | |||||||||
Government obligations | — | 4,980 | |||||||||
Total Marketable securities | $ | 150,087 | $ | 4,980 |
As of September 30, 2022 (in thousands) | Level 1 | Level 2 | Level 3 | Total | |||||||||||||||||||
Cash equivalents: | |||||||||||||||||||||||
Money market funds | $ | 53,472 | $ | — | $ | — | $ | 53,472 | |||||||||||||||
Commercial paper | — | 4,988 | — | 4,988 | |||||||||||||||||||
Marketable securities: | |||||||||||||||||||||||
Commercial paper | — | 155,078 | — | 155,078 | |||||||||||||||||||
Corporate debt securities | — | 14,065 | — | 14,065 | |||||||||||||||||||
Government obligations & agency securities | — | 63,723 | — | 63,723 | |||||||||||||||||||
Total | $ | 53,472 | $ | 237,854 | $ | — | $ | 291,326 |
As of December 31, 2021 (in thousands) | Level 1 | Level 2 | Level 3 | Total | |||||||||||||||||||
Cash equivalents: | |||||||||||||||||||||||
Money market funds | $ | 67,289 | $ | — | $ | — | $ | 67,289 | |||||||||||||||
Commercial paper | — | 80,541 | — | 80,541 | |||||||||||||||||||
Corporate debt securities | — | 8,165 | — | 8,165 | |||||||||||||||||||
Marketable securities: | |||||||||||||||||||||||
Commercial paper | — | 145,949 | — | 145,949 | |||||||||||||||||||
Corporate debt securities | — | 4,138 | — | 4,138 | |||||||||||||||||||
Government obligations | — | 4,980 | — | 4,980 | |||||||||||||||||||
Total | $ | 67,289 | $ | 243,773 | $ | — | $ | 311,062 |
September 30, 2022 | December 31, 2021 | ||||||||||
Leasehold improvements | $ | 2,717 | $ | 807 | |||||||
Furniture and fixtures | 113 | 65 | |||||||||
Computer equipment and software | 794 | 471 | |||||||||
Construction in progress | 723 | 1,145 | |||||||||
4,347 | 2,488 | ||||||||||
Accumulated depreciation | (1,212) | (606) | |||||||||
Total property and equipment, net | $ | 3,135 | $ | 1,882 |
September 30, 2022 | December 31, 2021 | ||||||||||
Advance payments to suppliers and rent deposit | $ | 1,592 | $ | 1,499 | |||||||
Prepaid insurance | 907 | 7,378 | |||||||||
Deferred costs | 51 | 3 | |||||||||
VAT receivable | 2,093 | 1,176 | |||||||||
Other prepaid expenses | 474 | 298 | |||||||||
Total prepaid expenses and other current assets | $ | 5,117 | $ | 10,354 |
September 30, 2022 | December 31, 2021 | ||||||||||
Employee compensation and related benefits | $ | 4,801 | $ | 2,309 | |||||||
Professional fees | 4,949 | 3,625 | |||||||||
Consulting and contracted research | 7,968 | 3,925 | |||||||||
Other | 153 | 117 | |||||||||
Total accrued expenses | $ | 17,871 | $ | 9,976 |
Three Months Ended September 30, 2022 | Three Months Ended September 30, 2021 | Nine Months Ended September 30, 2022 | Nine Months Ended September 30, 2021 | ||||||||||||||||||||
Numerator | |||||||||||||||||||||||
Net loss attributable to ordinary shareholders | $ | (21,897) | $ | (13,112) | $ | (92,014) | $ | (175,105) | |||||||||||||||
Denominator | |||||||||||||||||||||||
Weighted-average shares – basic and diluted | 108,353,831 | 20,690,908 | 107,854,547 | 20,549,310 | |||||||||||||||||||
Net loss per ordinary share – basic and diluted | $ | (0.20) | $ | (0.63) | $ | (0.85) | $ | (8.52) |
As of | |||||||||||
September 30, 2022 | September 30, 2021 | ||||||||||
Redeemable Convertible Preferred Shares | — | 11,024,178 | |||||||||
Employee Share Options | 13,163,954 | 9,746,977 | |||||||||
Non-vested restricted share units | 864,050 | — | |||||||||
QED Warrants | — | 100,000 | |||||||||
MyoKardia Warrant | 170,000 | 170,000 | |||||||||
Tarsus Warrants | — | 125,000 | |||||||||
Warrants in LianBio issued to QED and Tarsus | 425,942 | — |
Three Months Ended September 30, 2022 | Three Months Ended September 30, 2021 | Nine Months Ended September 30, 2022 | Nine Months Ended September 30, 2021 | ||||||||||||||||||||
Research and development expenses (in thousands): | |||||||||||||||||||||||
Licensing fees | $ | — | $ | — | $ | 25,000 | $ | 136,915 | |||||||||||||||
Employee related expense | 3,023 | 1,921 | 8,609 | 5,031 | |||||||||||||||||||
CRO costs | 4,417 | 1,952 | 13,463 | 6,521 | |||||||||||||||||||
Other costs | 818 | 782 | 2,106 | 2,571 | |||||||||||||||||||
Total | $ | 8,258 | $ | 4,655 | $ | 49,178 | $ | 151,038 |
Three Months Ended September 30, 2022 | Three Months Ended September 30, 2021 | Nine Months Ended September 30, 2022 | Nine Months Ended September 30, 2021 | ||||||||||||||||||||
Licensing fees: | |||||||||||||||||||||||
Mavacamten | $ | — | $ | — | $ | 5,000 | $ | — | |||||||||||||||
BBP-398 | — | — | — | 8,500 | |||||||||||||||||||
Sisunatovir | — | — | — | 14,000 | |||||||||||||||||||
TP-03 | — | — | 15,000 | 64,415 | |||||||||||||||||||
BT-11 and NX-13 | — | — | — | 18,000 | |||||||||||||||||||
NBTXR3 | — | — | — | 20,000 | |||||||||||||||||||
LYR-210 | — | — | 5,000 | 12,000 | |||||||||||||||||||
Total | $ | — | $ | — | $ | 25,000 | $ | 136,915 |
Three Months Ended September 30, 2022 | Three Months Ended September 30, 2021 | ||||||||||
Operating expenses (in thousands): | |||||||||||
Research and development | $ | 8,258 | $ | 4,655 | |||||||
General and administrative | 16,291 | 8,889 | |||||||||
Total operating expenses | 24,549 | 13,544 | |||||||||
Loss from operations | (24,549) | (13,544) | |||||||||
Other income: | |||||||||||
Interest income, net | 1,405 | 32 | |||||||||
Other income, net | 1,253 | 3 | |||||||||
Net loss before income taxes | (21,891) | (13,509) | |||||||||
Income taxes (benefit) | 6 | (397) | |||||||||
Net loss | $ | (21,897) | $ | (13,112) |
Nine Months Ended September 30, 2022 | Nine Months Ended September 30, 2021 | ||||||||||
Operating expenses (in thousands): | |||||||||||
Research and development | $ | 49,178 | $ | 151,038 | |||||||
General and administrative | 46,930 | 22,496 | |||||||||
Total operating expenses | 96,108 | 173,534 | |||||||||
Loss from operations | (96,108) | (173,534) | |||||||||
Other income (expense): | |||||||||||
Interest income, net | 2,238 | 171 | |||||||||
Other income (expense), net | 1,873 | (189) | |||||||||
Net loss before income taxes | (91,997) | (173,552) | |||||||||
Income taxes | 17 | 1,553 | |||||||||
Net loss | $ | (92,014) | $ | (175,105) |
Nine Months Ended September 30, 2022 | Nine Months Ended September 30, 2021 | ||||||||||
Net cash (used in) provided by (in thousands): | |||||||||||
Operating activities | $ | (68,472) | $ | (133,573) | |||||||
Investing activities | (80,197) | (159) | |||||||||
Financing activities | 1,710 | 8,249 |
Exhibit No. | Description | |||||||
10.1*# | ||||||||
31.1* | ||||||||
31.2* | ||||||||
32.1^ | ||||||||
32.2^ | ||||||||
101.INS | Inline XBRL Instance Document* | |||||||
101.SCH | Inline XBRL Taxonomy Extension Schema Document* | |||||||
101.CAL | Inline XBRL Taxonomy Extension Calculation Linkbase Document* | |||||||
101.LAB | Inline XBRL Taxonomy Extension Label Linkbase Database* | |||||||
101.PRE | Inline XBRL Taxonomy Extension Presentation Linkbase Document* | |||||||
101.DEF | Inline XBRL Taxonomy Extension Definition Linkbase Document* | |||||||
104 | Cover Page Interactive Data File (formatted as Inline XBRL and contained in Exhibit 101) |
* | Filed herewith. | ||||
^ | These certifications are being furnished solely to accompany this quarterly report pursuant to 18 U.S.C. Section 1350, and are not being filed for purposes of Section 18 of the Securities Exchange Act of 1934, as amended, and are not to be incorporated by reference into any filing of the registrant, whether made before or after the date hereof, regardless of any general incorporation language in such filing. | ||||
# | Certain confidential information contained in this exhibit has been omitted because it (i) is not material and (ii) would be competitively harmful if publicly disclosed. |
LianBio | ||||||||
Date: November 10, 2022 | By: | /s/ Yizhe Wang | ||||||
Yizhe Wang | ||||||||
Chief Executive Officer and Director (Principal Executive Officer) | ||||||||
Date: November 10, 2022 | By: | /s/ Yi Larson | ||||||
Yi Larson | ||||||||
Chief Financial Officer (Principal Financial and Accounting Officer) |
Table 6.1(b) (Development Milestone Payments) | |||||
Development Milestone Event | Development Milestone Payment (in Dollars) | ||||
1.[***] | [***] | ||||
1.[***] | [***] | ||||
1.[***] | [***] | ||||
1.[***] | [***] | ||||
Total | [***] |
1. | I have reviewed this Quarterly Report on Form 10-Q of LianBio; |
2. | Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report; |
3. | Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report; |
4. | The registrant’s other certifying officer(s) and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) for the registrant and have: |
(a) | Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this report is being prepared; |
(b) | [Omitted pursuant to Rules 13a-14(a) and 15d-14(a)]; |
(c) | Evaluated the effectiveness of the registrant’s disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and |
(d) | Disclosed in this report any change in the registrant’s internal control over financial reporting that occurred during the registrant’s most recent fiscal quarter (the registrant’s fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect, the registrant’s internal control over financial reporting; and |
5. | The registrant’s other certifying officer(s) and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrant’s auditors and the audit committee of the registrant’s board of directors (or persons performing the equivalent functions): |
(a) | All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the registrant’s ability to record, process, summarize and report financial information; and |
(b) | Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s internal control over financial reporting. |
Date: November 10, 2022 | By: | /s/ Yizhe Wang | |||||||||
Yizhe Wang | |||||||||||
Chief Executive Officer | |||||||||||
(Principal Executive Officer) |
1. | I have reviewed this Quarterly Report on Form 10-Q of LianBio; |
2. | Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report; |
3. | Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report; |
4. | The registrant’s other certifying officer(s) and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) for the registrant and have: |
(a) | Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this report is being prepared; |
(b) | [Omitted pursuant to Rules 13a-14(a) and 15d-14(a)]; |
(c) | Evaluated the effectiveness of the registrant’s disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and |
(d) | Disclosed in this report any change in the registrant’s internal control over financial reporting that occurred during the registrant’s most recent fiscal quarter (the registrant’s fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect, the registrant’s internal control over financial reporting; and |
5. | The registrant’s other certifying officer(s) and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrant’s auditors and the audit committee of the registrant’s board of directors (or persons performing the equivalent functions): |
(a) | All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the registrant’s ability to record, process, summarize and report financial information; and |
(b) | Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s internal control over financial reporting. |
Date: November 10, 2022 | By: | /s/ Yi Larson | |||||||||
Yi Larson | |||||||||||
Chief Financial Officer | |||||||||||
(Principal Financial and Accounting Officer) |
Date: November 10, 2022 | By: | /s/ Yizhe Wang | |||||||||
Yizhe Wang | |||||||||||
Chief Executive Officer | |||||||||||
(Principal Executive Officer) |
Date: November 10, 2022 | By: | /s/ Yi Larson | |||||||||
Yi Larson | |||||||||||
Chief Financial Officer | |||||||||||
(Principal Financial and Accounting Officer) |