☒ | QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
☐ | TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
Delaware | 94-3103561 | |
(State or other jurisdiction of incorporation or organization) | (I.R.S. Employer Identification No.) | |
7575 Gateway Blvd, Suite 110 Newark, CA | 94560 | |
(Address of principal executive offices) | (Zip Code) |
Title of each class | Trading symbol(s) | Name of each exchange on which registered | ||
Common stock, $0.0001 par value per share | CBAY | Nasdaq Global Select Market |
Large accelerated filer | ☐ | Accelerated filer | ☐ | |||
Non-accelerated filer | ☒ | Smaller reporting company | ☒ | |||
Emerging growth company | ☐ |
Page | ||||||
PART I | 3 | |||||
Item 1. | 3 | |||||
3 | ||||||
4 | ||||||
5 | ||||||
6 | ||||||
7 | ||||||
Item 2. | ||||||
Item 3. | ||||||
23 | ||||||
Item | 23 | |||||
PART II | 24 | |||||
Item 1. | 24 | |||||
Item 1A. | ||||||
Item 6. | 47 | |||||
48 |
Item 1. | Financial Statements |
June 30, 2021 | December 31, 2020 | |||||||
Assets | ||||||||
Current assets: | ||||||||
Cash and cash equivalents | $ | 32,897 | $ | 28,193 | ||||
Marketable securities | 73,237 | 118,130 | ||||||
Accrued interest receivable | 227 | 277 | ||||||
Prepaid research and development expenses | 6,060 | 2,221 | ||||||
Other prepaid expenses and current assets | 1,392 | 2,764 | ||||||
Total current assets | 113,813 | 151,585 | ||||||
Property and equipment, net | 1,511 | 1,761 | ||||||
Operating lease right-of-use | 270 | 272 | ||||||
Other assets | 1,447 | 207 | ||||||
Total assets | $ | 117,041 | $ | 153,825 | ||||
Liabilities and stockholders’ equity | ||||||||
Current liabilities: | ||||||||
Accounts payable | $ | 1,050 | $ | 231 | ||||
Accrued research and development expenses | 4,126 | 4,698 | ||||||
Other accrued liabilities | 3,783 | 4,928 | ||||||
Total current liabilities | 8,959 | 9,857 | ||||||
Long-term portion of operating lease liability | 988 | 1,262 | ||||||
Total liabilities | 9,947 | 11,119 | ||||||
Commitments and contingencies | 0 | 0 | ||||||
Stockholders’ equity: | ||||||||
Preferred stock, $0.0001 par value: 10,000,000 shares authorized; 0 shares issued and outstanding | 0 | 0 | ||||||
Common stock, $0.0001 par value: 200,000,000 shares authorized; 68,997,938 and 68,946,092 shares issued and outstanding as of J une 30 , 2021 and December 31, 2020, respectively | 7 | 7 | ||||||
Additional paid-in capital | 824,717 | 819,549 | ||||||
Accumulated other comprehensive (loss) income | 1 | 8 | ||||||
Accumulated deficit | (717,631 | ) | (676,858 | ) | ||||
Total stockholders’ equity | 107,094 | 142,706 | ||||||
Total liabilities and stockholders’ equity | $ | 117,041 | $ | 153,825 | ||||
June 30, 2022 | December 31, 2021 | |||||||
Assets | ||||||||
Current assets: | ||||||||
Cash and cash equivalents | $ | 52,753 | $ | 125,806 | ||||
Marketable securities | 111,130 | 60,729 | ||||||
Prepaid research and development expenses | 1,103 | 2,371 | ||||||
Other prepaid expenses and current assets | 1,625 | 2,193 | ||||||
Total current assets | 166,611 | 191,099 | ||||||
Property and equipment, net | 993 | 1,178 | ||||||
Non-current marketable securities | 6,874 | 8,067 | ||||||
Operating lease right-of-use | 220 | 254 | ||||||
Other assets | 3,026 | 1,720 | ||||||
Total assets | $ | 177,724 | $ | 202,318 | ||||
Liabilities and stockholders’ equity | ||||||||
Current liabilities: | ||||||||
Accounts payable | $ | 866 | $ | 2,728 | ||||
Accrued research and development expenses | 7,028 | 9,752 | ||||||
Other accrued liabilities | 4,666 | 5,886 | ||||||
Total current liabilities | 12,560 | 18,366 | ||||||
Development financing liability | 82,333 | 50,320 | ||||||
Long-term portion of operating lease liability | 374 | 695 | ||||||
Total liabilities | 95,267 | 69,381 | ||||||
Commitments and contingencies | 0 | 0 | ||||||
Stockholders’ equity: | ||||||||
Preferred stock, $0.0001 par value: 10,000,000 shares authorized; 0 shares issued and outstanding | 0— | 0— | ||||||
Common stock, $0.0001 par value: 200,000,000 shares authorized; 84,677,939 and 84,677,939 shares issued and outstanding as of June | 8 | 8 | ||||||
Additional paid-in capital | 904,609 | 899,798 | ||||||
Accumulated other comprehensive loss | (441 | ) | (13 | ) | ||||
Accumulated deficit | (821,719 | ) | (766,856 | ) | ||||
Total stockholders’ equity | 82,457 | 132,937 | ||||||
Total liabilities and stockholders’ equity | $ | 177,724 | $ | 202,318 | ||||
Three Months Ended June 30, | Six Months Ended June 30, | |||||||||||||||
2021 | 2020 | 2021 | 2020 | |||||||||||||
Operating expenses: | ||||||||||||||||
Research and development | $ | 16,745 | $ | 7,942 | $ | 29,127 | $ | 17,451 | ||||||||
General and administrative | 6,521 | 3,210 | 11,757 | 7,628 | ||||||||||||
Total operating expenses | 23,266 | 11,152 | 40,884 | 25,079 | ||||||||||||
Loss from operations | (23,266 | ) | (11,152 | ) | (40,884 | ) | (25,079 | ) | ||||||||
Interest income | 44 | 426 | 111 | 1,265 | ||||||||||||
Net loss | $ | (23,222 | ) | $ | (10,726 | ) | $ | (40,773 | ) | $ | (23,814 | ) | ||||
Other comprehensive (loss) income: | ||||||||||||||||
Unrealized (loss) gain on marketable securities | 7 | 316 | (7 | ) | 106 | |||||||||||
Total other comprehensive (loss) income | 7 | 316 | (7 | ) | 106 | |||||||||||
Comprehensive loss | $ | (23,215 | ) | $ | (10,410 | ) | $ | (40,780 | ) | $ | (23,708 | ) | ||||
Basic and diluted net loss per common share | $ | (0.34 | ) | $ | (0.16 | ) | $ | (0.59 | ) | $ | (0.35 | ) | ||||
Weighted average common shares outstanding used to calculate basic and diluted net loss per common share | 68,985,461 | 68,885,108 | 68,965,885 | 68,883,783 | ||||||||||||
Three Months Ended | Six Months Ended | |||||||||||||||
June 30, | June 30, | |||||||||||||||
2022 | 2021 | 2022 | 2021 | |||||||||||||
Operating expenses: | ||||||||||||||||
Research and development | $ | 17,891 | $ | 16,745 | $ | 36,306 | $ | 29,127 | ||||||||
General and administrative | 5,878 | 6,521 | 11,965 | 11,757 | ||||||||||||
Total operating expenses | 23,769 | 23,266 | 48,271 | 40,884 | ||||||||||||
Loss from operations | (23,769 | ) | (23,266 | ) | (48,271 | ) | (40,884 | ) | ||||||||
Other income (expense), net: | ||||||||||||||||
Interest income | 321 | 44 | 419 | 111 | ||||||||||||
Interest expense | (3,648 | ) | 0— | (7,013 | ) | 0— | ||||||||||
Other income | 2 | 0— | 2 | 0— | ||||||||||||
Total other income (expense), net | (3,325 | ) | 44 | (6,592 | ) | 111 | ||||||||||
Net loss | $ | (27,094 | ) | $ | (23,222 | ) | $ | (54,863 | ) | $ | (40,773 | ) | ||||
Other comprehensive loss: | ||||||||||||||||
Unrealized (loss) gain on marketable securities | (222 | ) | 7 | (428 | ) | (7 | ) | |||||||||
Total other comprehensive (loss) gain | (222 | ) | 7 | (428 | ) | (7 | ) | |||||||||
Comprehensive loss | $ | (27,316 | ) | $ | (23,215 | ) | $ | (55,291 | ) | $ | (40,780 | ) | ||||
Basic and diluted net loss per common share | $ | (0.31 | ) | $ | (0.34 | ) | $ | (0.62 | ) | $ | (0.59 | ) | ||||
Weighted average common shares outstanding used to calculate basic and diluted net loss per common share | 87,802,939 | 68,985,461 | 87,802,939 | 68,965,885 |
Six Months Ended June 30, | ||||||||
2021 | 2020 | |||||||
Operating activities | ||||||||
Net loss | $ | (40,773) | $ | (23,814 | ) | |||
Adjustments to reconcile net loss to net cash used in operating activities: | ||||||||
Depreciation and amortization | 339 | 309 | ||||||
Stock-based compensation expense | 5,062 | 2,961 | ||||||
Write-off of deferred financing costs | 312 | — | ||||||
Net accretion and amortization of investments in marketable securities | 426 | (306 | ) | |||||
Changes in assets and liabilities: | ||||||||
Interest receivable and other current assets | 178 | 478 | ||||||
Prepaid research and development expenses and other prepaid assets | (2,793 | ) | 6,510 | |||||
Other assets | (1,240 | ) | 0 | |||||
Accounts payable | 798 | (2,027 | ) | |||||
Accrued liabilities | (2,084 | ) | (6,568 | ) | ||||
Net cash used in operating activities | (39,775 | ) | (22,457 | ) | ||||
Investing activities | ||||||||
Purchases of property and equipment | (87 | ) | 0 | |||||
Purchases of marketable securities | (33,820 | ) | (65,504 | ) | ||||
Proceeds from maturities of marketable securities | 78,280 | 159,136 | ||||||
Net cash provided by investing activities | 44,373 | 93,632 | ||||||
Financing activities | ||||||||
Proceeds from issuance of common stock pursuant to equity award plans | 106 | 7 | ||||||
Cash provided by financing activities | 106 | 7 | ||||||
Net increase in cash and cash equivalents | 4,704 | 71,182 | ||||||
Cash and cash equivalents at beginning of period | 28,193 | 24,869 | ||||||
Cash and cash equivalents at end of period | $ | 32,897 | $ | 96,051 | ||||
Supplemental disclosure | ||||||||
Cash paid for amounts included in the measurement of lease liabilities | $ | 332 | $ | 323 | ||||
Supplemental non-cash investing and financing activities | ||||||||
Accrued financing costs | $ | 93 | $ | 205 | ||||
Accrued financing costs in accounts payable | $ | 21 | $ | — |
Six Months Ended | ||||||||
June 30, | ||||||||
2022 | 2021 | |||||||
Operating activities | ||||||||
Net loss | $ | (54,863 | ) | $ | (40,773 | ) | ||
Adjustments to reconcile net loss to net cash used in operating activities: | ||||||||
Depreciation and amortization | 343 | 339 | ||||||
Stock-based compensation expense | 4,806 | 5,062 | ||||||
Write-off of deferred financing costs | — | 312 | ||||||
Accretion of development financing liability | 7,013 | — | ||||||
Net accretion and amortization of investments in marketable securities | 32 | 426 | ||||||
Changes in assets and liabilities: | ||||||||
Other prepaid expenses and current assets | 1,836 | (2,615 | ) | |||||
Other assets | (1,306 | ) | (1,240 | ) | ||||
Accounts payable | (1,674 | ) | 798 | |||||
Accrued research and development expenses | (2,724 | ) | (665 | ) | ||||
Other accrued liabilities | (1,265 | ) | (1,419 | ) | ||||
Net cash used in operating activities | (47,802 | ) | (39,775 | ) | ||||
Investing activities | ||||||||
Purchases of property and equipment | (124 | ) | (87 | ) | ||||
Purchases of marketable securities | (115,463 | ) | (33,820 | ) | ||||
Proceeds from maturities of marketable securities | 65,795 | 78,280 | ||||||
Net cash (used in) provided by investing activities | (49,792 | ) | 44,373 | |||||
Financing activities | ||||||||
Proceeds from issuance of common stock pursuant to equity award plans | — | 106 | ||||||
Proceeds from development financing | 25,000 | — | ||||||
Issuance costs paid for issuance of common stock | (459 | ) | — | |||||
Net cash provided by financing activities | 24,541 | 106 | ||||||
Net (decrease) increase in cash and cash equivalents | (73,053 | ) | 4,704 | |||||
Cash and cash equivalents at beginning of period | 125,806 | 28,193 | ||||||
Cash and cash equivalents at end of period | $ | 52,753 | $ | 32,897 | ||||
Supplemental disclosure | ||||||||
Cash paid for amounts included in the measurement of lease liabilities | $ | 342 | $ | 332 | ||||
Supplemental non-cash investing and financing activities | ||||||||
Accrued financing costs | $ | — | $ | 93 | ||||
Accrued financing costs in accounts payable | $ | — | $ | 21 |
Three and Six Months Ended June 30, 2021 | ||||||||||||||||||||||||
Accumulated | ||||||||||||||||||||||||
Additional | Other | Total | ||||||||||||||||||||||
Common Stock | Paid-in | Comprehensive | Accumulated | Stockholders’ | ||||||||||||||||||||
Shares | Amount | Capital | Income (Loss) | Deficit | Equity | |||||||||||||||||||
Balances as of December 31, 2020 | 68,946,092 | $ | 7 | $ | 819,549 | $ | 8 | $ | (676,858) | $ | 142,706 | |||||||||||||
Stock-based compensation expense | — | — | 2,505 | — | — | 2,505 | ||||||||||||||||||
Net loss | — | — | — | — | (17,551 | ) | (17,551 | ) | ||||||||||||||||
Net unrealized loss on marketable securities | — | — | — | (14 | ) | — | (14 | ) | ||||||||||||||||
Balances as of March 31, 2021 | 68,946,092 | $ | 7 | $ | 822,054 | $ | (6 | ) | $ | (694,409 | ) | $ | 127,646 | |||||||||||
Issuance of common stock upon exercise of stock options | 51,846 | — | 106 | — | — | 106 | ||||||||||||||||||
Stock-based compensation expense | — | — | 2,557 | — | — | 2,557 | ||||||||||||||||||
Net loss | — | — | — | — | (23,222 | ) | (23,222 | ) | ||||||||||||||||
Net unrealized gain on marketable securities | — | — | — | 7 | — | 7 | ||||||||||||||||||
Balances as of June 30, 2021 | 68,997,938 | $ | 7 | $ | 824,717 | $ | 1 | $ | (717,631 | ) | $ | 107,094 | ||||||||||||
Three and Six Months Ended June 30, 2020 | ||||||||||||||||||||||||
Accumulated | ||||||||||||||||||||||||
Additional | Other | Total | ||||||||||||||||||||||
Common Stock | Paid-in | Comprehensive | Accumulated | Stockholders’ | ||||||||||||||||||||
Shares | Amount | Capital | Income (Loss) | Deficit | Equity | |||||||||||||||||||
Balances as of December 31, 2019 | 68,882,459 | $ | 7 | $ | 812,133 | $ | 80 | $ | (625,872 | ) | $ | 186,348 | ||||||||||||
Stock-based compensation expense | — | — | 1,998 | — | — | 1,998 | ||||||||||||||||||
Net loss | — | — | — | — | (13,088 | ) | (13,088 | ) | ||||||||||||||||
Net unrealized loss on marketable securities | — | — | — | (210 | ) | — | (210 | ) | ||||||||||||||||
Balances as of March 31, 2020 | 68,882,459 | $ | 7 | $ | 814,131 | $ | (130 | ) | $ | (638,960 | ) | $ | 175,048 | |||||||||||
Issuance of common stock upon exercise of stock options | 4,633 | — | 7 | — | — | 7 | ||||||||||||||||||
Stock-based compensation expense | — | — | 963 | — | — | 963 | ||||||||||||||||||
Net loss | — | — | — | — | (10,726 | ) | (10,726 | ) | ||||||||||||||||
Net unrealized gain on marketable securities | — | — | — | 316 | — | 316 | ||||||||||||||||||
Balances as of June 30, 2020 | 68,887,092 | $ | 7 | $ | 815,101 | $ | 186 | $ | (649,686 | ) | $ | 165,608 | ||||||||||||
Accumulated | ||||||||||||||||||||||||
Additional | Other | Total | ||||||||||||||||||||||
Common Stock | Paid-in | Comprehensive | Accumulated | Stockholders’ | ||||||||||||||||||||
Shares | Amount | Capital | Income (Loss) | Deficit | Equity | |||||||||||||||||||
Balances as of December 31, 2021 | 84,677,939 | $ | 8 | $ | 899,798 | $ | (13 | ) | $ | (766,856 | ) | $ | 132,937 | |||||||||||
Issuance costs related to issuance of common stock and pre-funded warrants | — | — | 5 | — | — | 5 | ||||||||||||||||||
Stock-based compensation expense | — | — | 2,414 | — | — | 2,414 | ||||||||||||||||||
Net loss | — | — | — | — | (27,769 | ) | (27,769 | ) | ||||||||||||||||
Net unrealized loss on marketable securities | — | — | — | (206 | ) | — | (206 | ) | ||||||||||||||||
Balances as of March 31, 2022 | 84,677,939 | $ | 8 | $ | 902,217 | $ | (219 | ) | $ | (794,625 | ) | $ | 107,381 | |||||||||||
Issuance of common stock upon exercise of stock options | — | — | — | — | — | �� | ||||||||||||||||||
Stock-based compensation expense | — | — | 2,392 | — | — | 2,392 | ||||||||||||||||||
Net loss | — | — | — | — | (27,094 | ) | (27,094 | ) | ||||||||||||||||
Net unrealized gain on marketable securities | — | — | — | (222 | ) | — | (222 | ) | ||||||||||||||||
Balances as of June 30, 2022 | 84,677,939 | $ | 8 | $ | 904,609 | $ | (441 | ) | $ | (821,719 | ) | $ | 82,457 | |||||||||||
Accumulated | ||||||||||||||||||||||||
Additional | Other | Total | ||||||||||||||||||||||
Common Stock | Paid-in | Comprehensive | Accumulated | Stockholders’ | ||||||||||||||||||||
Shares | Amount | Capital | Income (Loss) | Deficit | Equity | |||||||||||||||||||
Balances as of December 31, 2020 | 68,946,092 | $ | 7 | $ | 819,549 | $ | 8 | $ | (676,858 | ) | $ | 142,706 | ||||||||||||
Stock-based compensation expense | — | — | 2,505 | — | — | 2,505 | ||||||||||||||||||
Net loss | — | — | — | — | (17,551 | ) | (17,551 | ) | ||||||||||||||||
Net unrealized loss on marketable securities | — | — | — | (14 | ) | — | (14 | ) | ||||||||||||||||
Balances as of March 31, 2021 | 68,946,092 | $ | 7 | $ | 822,054 | $ | (6 | ) | $ | (694,409 | ) | $ | 127,646 | |||||||||||
Issuance of common stock upon exercise of stock options | 51,846 | — | 106 | — | — | 106 | ||||||||||||||||||
Stock-based compensation expense | — | — | 2,557 | — | — | 2,557 | ||||||||||||||||||
Net loss | — | — | — | — | (23,222 | ) | (23,222 | ) | ||||||||||||||||
Net unrealized gain on marketable securities | — | — | — | 7 | — | 7 | ||||||||||||||||||
Balances as of June 30, 2021 | 68,997,938 | $ | 7 | $ | 824,717 | $ | 1 | $ | (717,631 | ) | $ | 107,094 | ||||||||||||
As of June 30, 2021 | ||||||||||||||||
Level 1 | Level 2 | Level 3 | Total | |||||||||||||
Cash equivalents: | ||||||||||||||||
Money market funds | $ | 29,429 | $ | — | $ | — | $ | 29,429 | ||||||||
Total cash equivalents | 29,429 | — | — | 29,429 | ||||||||||||
Marketable securities: | ||||||||||||||||
U.S. treasury securities | — | 8,000 | — | 8,000 | ||||||||||||
U.S. and foreign commercial paper | — | 31,972 | — | 31,972 | ||||||||||||
U.S. and foreign corporate debt securities | — | 17,119 | — | 17,119 | ||||||||||||
Asset-backed securities | — | 13,146 | — | 13,146 | ||||||||||||
Supranational debt securities | — | 3,000 | — | 3,000 | ||||||||||||
Total marketable securities | — | 73,237 | — | 73,237 | ||||||||||||
Total assets measured at fair value | $ | 29,429 | $ | 73,237 | $ | — | $ | 102,666 | ||||||||
As of December 31, 2020 | ||||||||||||||||
Level 1 | Level 2 | Level 3 | Total | |||||||||||||
Cash equivalents: | ||||||||||||||||
Money market funds | $ | 22,415 | $ | — | $ | — | $ | 22,415 | ||||||||
U.S. commercial paper | — | — | — | — | ||||||||||||
Total cash equivalents | 22,415 | — | — | 22,415 | ||||||||||||
Marketable securities: | ||||||||||||||||
U.S. treasury securities | — | 15,499 | — | 15,499 | ||||||||||||
U.S. and foreign commercial paper | — | 38,561 | — | 38,561 | ||||||||||||
U.S. and foreign corporate debt securities | — | 29,189 | — | 29,189 | ||||||||||||
U.S. agency securities | — | 23,994 | — | 23,994 | ||||||||||||
Asset-backed securities | — | 7,885 | — | 7,885 | ||||||||||||
Supranational debt securities | — | 3,002 | — | 3,002 | ||||||||||||
Total marketable securities | — | 118,130 | — | 118,130 | ||||||||||||
Total assets measured at fair value | $ | 22,415 | $ | 118,130 | $ | — | $ | 140,545 | ||||||||
As of June 30, 2022 | ||||||||||||||||
Level 1 | Level 2 | Level 3 | Total | |||||||||||||
Assets: | ||||||||||||||||
Cash equivalents: | ||||||||||||||||
Money market funds | $ | 36,269 | $ | — | $ | — | $ | 36,269 | ||||||||
Total cash equivalents | 36,269 | — | — | 36,269 | ||||||||||||
Marketable securities: | ||||||||||||||||
U.S. and foreign commercial paper | — | 34,202 | — | 34,202 | ||||||||||||
U.S. and foreign corporate debt securities | — | 26,602 | — | 26,602 | ||||||||||||
Supranational debt securities | — | 13,405 | — | 13,405 | ||||||||||||
U.S. Agency securities | — | 2,984 | — | 2,984 | ||||||||||||
U.S. treasury securities | — | 40,811 | — | 40,811 | ||||||||||||
Total marketable securities | — | 118,004 | — | 118,004 | ||||||||||||
Total assets measured at fair value | $ | 36,269 | $ | 118,004 | $ | — | $ | 154,273 | ||||||||
As of December 31, 2021 | ||||||||||||||||
Level 1 | Level 2 | Level 3 | Total | |||||||||||||
Cash equivalents: | ||||||||||||||||
Money market funds | $ | 85,638 | $ | — | $ | — | $ | 85,638 | ||||||||
Total cash equivalents | 85,638 | — | — | 85,638 | ||||||||||||
Marketable securities: | ||||||||||||||||
U.S. and foreign commercial paper | — | 28,760 | — | 28,760 | ||||||||||||
U.S. and foreign corporate debt securities | — | 23,535 | — | 23,535 | ||||||||||||
Asset-backed securities | — | 8,522 | — | 8,522 | ||||||||||||
U.S. treasury securities | — | 7,979 | — | 7,979 | ||||||||||||
Total marketable securities | — | 68,796 | — | 68,796 | ||||||||||||
Total assets measured at fair value | $ | 85,638 | $ | 68,796 | $ | — | $ | 154,434 | ||||||||
Amortized Cost | Gross Unrealized Gains | Gross Unrealized Losses | Estimated Fair Value | |||||||||||||
As of June 30, 2022: | ||||||||||||||||
Cash equivalents: | ||||||||||||||||
Money market funds | $ | 36,269 | $ | — | $ | — | $ | 36,269 | ||||||||
Total cash equivalents | 36,269 | — | — | 36,269 | ||||||||||||
Current marketable securities: | ||||||||||||||||
U.S. and foreign commercial paper | 34,202 | — | — | 34,202 | ||||||||||||
U.S. and foreign corporate debt securities | 22,918 | — | (206 | ) | 22,712 | |||||||||||
Supranational debt securities | 13,449 | — | (44 | ) | 13,405 | |||||||||||
U.S. treasury securities | 40,915 | — | (104 | ) | 40,811 | |||||||||||
Total current marketable securities | 111,484 | — | (354 | ) | 111,130 | |||||||||||
Non-current marketable securities: | ||||||||||||||||
U.S. Agency securities | 3,000 | — | (16 | ) | 2,984 | |||||||||||
U.S. corporate debt securities | 3,961 | — | (71 | ) | 3,890 | |||||||||||
Total marketable securities | $ | 154,714 | $ | — | $ | (441 | ) | $ | 154,273 | |||||||
Amortized Cost | Gross Unrealized Gains | Gross Unrealized Losses | Estimated Fair Value | |||||||||||||
As of December 31, 2021: | ||||||||||||||||
Cash equivalents: | ||||||||||||||||
Money market funds | $ | 85,638 | $ | — | $ | — | $ | 85,638 | ||||||||
Total cash equivalents | 85,638 | — | — | 85,638 | ||||||||||||
Current marketable securities: | ||||||||||||||||
U.S. and foreign commercial paper | 28,760 | — | — | 28,760 | ||||||||||||
U.S. and foreign corporate debt securities | 15,476 | — | (8 | ) | 15,468 | |||||||||||
Asset-backed securities | 8,524 | — | (2 | ) | 8,522 | |||||||||||
U.S. treasury securities | 7,982 | — | (3 | ) | 7,979 | |||||||||||
Total current marketable securities | 60,742 | — | (13 | ) | 60,729 | |||||||||||
Non-current marketable securities: | ||||||||||||||||
U.S. corporate debt securities | 8,067 | 2 | (2 | ) | 8,067 | |||||||||||
Total marketable securities | $ | 154,447 | $ | 2 | $ | (15 | ) | $ | 154,434 | |||||||
Due less than 1 year | $ | 111,130 | ||
Due between 1 and 2 years | 6,874 | |||
Total fair value | $ | 118,004 | ||
Three Months Ended June 30, | Six Months Ended June 30, | |||||||||||||||
2021 | 2020 | 2021 | 2020 | |||||||||||||
Numerator: | ||||||||||||||||
Net loss | $ | (23,222 | ) | $ | (10,726 | ) | $ | (40,773 | ) | $ | (23,814 | ) | ||||
Denominator: | ||||||||||||||||
Weighted average number of common stock shares outstanding | 68,985,461 | 68,885,108 | 68,965,885 | 68,883,783 | ||||||||||||
Net loss per share | $ | (0.34 | ) | $ | (0.16 | ) | $ | (0.59 | ) | $ | (0.35 | ) | ||||
Three Months Ended June 30, | Six Months Ended June 30, | |||||||||||||||
2021 | 2020 | 2021 | 2020 | |||||||||||||
Common stock options | 10,869 | 7,654 | 10,869 | 7,654 | ||||||||||||
Incentive awards | 101 | 101 | 101 | 101 | ||||||||||||
Total | 10,970 | 7,755 | 10,970 | 7,755 | ||||||||||||
June 30, 2021 | December 31, 2020 | |||||||
Accrued compensation | $ | 2,271 | $ | 3,769 | ||||
Accrued professional fees and other | 989 | 677 | ||||||
Current portion of operating lease liability | 523 | 482 | ||||||
Total other accrued liabilities | $ | 3,783 | $ | 4,928 | ||||
June 30, 2022 | December 31, 2021 | |||||||
Accrued compensation | $ | 3,011 | $ | 3,986 | ||||
Accrued professional fees and other | 1,041 | 1,333 | ||||||
Current portion of operating lease liability | 614 | 567 | ||||||
Total other accrued liabilities | $ | 4,666 | $ | 5,886 | ||||
Three Months Ended June 30, | Six Months Ended June 30, | |||||||||||||||
2021 | 2020 | 2021 | 2020 | |||||||||||||
Research and development | $ | 1,151 | $ | 664 | $ | 2,228 | $ | 1,108 | ||||||||
General and administrative | 1,406 | 299 | 2,834 | 1,853 | ||||||||||||
Total stock-based compensation expense | $ | 2,557 | $ | 963 | $ | 5,062 | $ | 2,961 | ||||||||
Three Months Ended June 30, | Six Months Ended June 30, | |||||||||||||||
2022 | 2021 | 2022 | 2021 | |||||||||||||
Numerator: | ||||||||||||||||
Net loss | $ | (27,094 | ) | $ | (23,222 | ) | $ | (54,863 | ) | $ | (40,773 | ) | ||||
Denominator: | ||||||||||||||||
Weighted average number of: | ||||||||||||||||
Common stock shares outstanding | 84,677,939 | 68,985,461 | 84,677,939 | 68,965,885 | ||||||||||||
Pre-funded warrants outstanding | 3,125,000 | — | 3,125,000 | — | ||||||||||||
Total | 87,802,939 | 68,985,461 | 87,802,939 | 68,965,885 | ||||||||||||
Net loss per share | $ | (0.31 | ) | $ | (0.34 | ) | $ | (0.62 | ) | $ | (0.59 | ) |
Three Months Ended June 30, | Six Months Ended June 30, | |||||||||||||||
2022 | 2021 | 2022 | 2021 | |||||||||||||
Common stock options | 14,086 | 10,869 | 14,086 | 10,869 | ||||||||||||
Incentive awards | 101 | 101 | 101 | 101 | ||||||||||||
Total | 14,187 | 10,970 | 14,187 | 10,970 | ||||||||||||
Three Months Ended June 30, | Six Months Ended June 30, | |||||||||||||||
2022 | 2021 | 2022 | 2021 | |||||||||||||
Research and development | $ | 1,070 | $ | 1,151 | $ | 2,168 | $ | 2,228 | ||||||||
General and administrative | 1,322 | 1,406 | 2,638 | 2,834 | ||||||||||||
Total stock-based compensation expense | $ | 2,392 | $ | 2,557 | $ | 4,806 | $ | 5,062 | ||||||||
Item 2. | Management’s Discussion and Analysis of Financial Condition and Results of Operations |
Three Months Ended June 30, | Change Q2 | Six Months Ended June 30, | Change Q2 YTD | Three Months Ended June 30, | Change Q2 | Six Months Ended June 30, | Change Q2 YTD | |||||||||||||||||||||||||||||||||||||||||
2021 | 2020 | 2021 vs 2020 | 2021 | 2020 | 2021 vs 2020 | 2022 | 2021 | 2022 vs. 2021 | 2022 | 2021 | 2022 vs 2021 | |||||||||||||||||||||||||||||||||||||
($ in thousands) | ||||||||||||||||||||||||||||||||||||||||||||||||
Operating expenses: | ||||||||||||||||||||||||||||||||||||||||||||||||
Research and development | $ | 16,745 | $ | 7,942 | $ | 8,803 | $ | 29,127 | $ | 17,451 | $ | 11,676 | $ | 17,891 | $ | 16,745 | $ | 1,146 | $ | 36,306 | $ | 29,127 | $ | 7,179 | ||||||||||||||||||||||||
General and administrative | 6,521 | 3,210 | 3,311 | 11,757 | 7,628 | 4,129 | 5,878 | 6,521 | (643 | ) | 11,965 | 11,757 | 208 | |||||||||||||||||||||||||||||||||||
Total operating expenses | 23,266 | 11,152 | 12,114 | 40,884 | 25,079 | 15,805 | 23,769 | 23,266 | 503 | 48,271 | 40,884 | 7,387 | ||||||||||||||||||||||||||||||||||||
Loss from operations | (23,266 | ) | (11,152 | ) | (12,114 | ) | (40,884 | ) | (25,079 | ) | (15,805 | ) | (23,769 | ) | (23,266 | ) | (503 | ) | (48,271 | ) | (40,884 | ) | (7,387 | ) | ||||||||||||||||||||||||
Other income (expense), net: | ||||||||||||||||||||||||||||||||||||||||||||||||
Interest income | 44 | 426 | (382 | ) | 111 | 1,265 | (1,154 | ) | 321 | 44 | 277 | 419 | 111 | 308 | ||||||||||||||||||||||||||||||||||
Interest expense | (3,648 | ) | — | (3,648 | ) | (7,013 | ) | — | (7,013 | ) | ||||||||||||||||||||||||||||||||||||||
Other income | 2 | — | 2 | 2 | — | 2 | ||||||||||||||||||||||||||||||||||||||||||
Total other income (expense), net | (3,325 | ) | 44 | (3,369 | ) | (6,592 | ) | 111 | (6,703 | ) | ||||||||||||||||||||||||||||||||||||||
Net loss | $ | (23,222 | ) | $ | (10,726 | ) | $ | (12,496 | ) | $ | (40,773 | ) | $ | (23,814 | ) | $ | (16,959 | ) | $ | (27,094 | ) | $ | (23,222 | ) | $ | (3,872 | ) | $ | (54,863 | ) | $ | (40,773 | ) | �� | $ | (14,090 | ) | |||||||||||
Three Months Ended June 30, | Change Q2 | Six Months Ended June 30, | Change Q2 YTD | Three Months Ended June 30, | Change Q2 | Six Months Ended June 30, | Change Q2 YTD | |||||||||||||||||||||||||||||||||||||||||
2021 | 2020 | 2021 vs 2020 | 2021 | 2020 | 2021 vs 2020 | 2022 | 2021 | 2022 vs 2021 | 2022 | 2021 | 2022 vs. 2021 | |||||||||||||||||||||||||||||||||||||
Project costs: | ||||||||||||||||||||||||||||||||||||||||||||||||
Seladelpar PBC clinical studies | $ | 8,967 | $ | 3,142 | $ | 5,825 | $ | 14,870 | $ | 8,726 | $ | 6,144 | $ | 9,770 | $ | 8,967 | $ | 803 | $ | 19,043 | $ | 14,870 | $ | 4,173 | ||||||||||||||||||||||||
Seladelpar NASH clinical studies | (9 | ) | 572 | (581 | ) | (19 | ) | 1,469 | (1,488 | ) | ||||||||||||||||||||||||||||||||||||||
Seladelpar PSC clinical studies | — | 2 | (2 | ) | — | 254 | (254 | ) | ||||||||||||||||||||||||||||||||||||||||
Seladelpar drug manufacturing & development | 1,391 | — | 1,391 | 2,145 | — | 2,145 | 1,677 | 1,391 | 286 | 3,933 | 2,145 | 1,788 | ||||||||||||||||||||||||||||||||||||
Seladelpar other studies | 36 | 225 | (189 | ) | 159 | 350 | (191 | ) | ||||||||||||||||||||||||||||||||||||||||
Non-seladelpar studies | 1,286 | 726 | 560 | 2,268 | 1,193 | 1,075 | ||||||||||||||||||||||||||||||||||||||||||
Seladelpar and non-seladelpar other studies | 286 | 1,313 | (1,027 | ) | 386 | 2,408 | (2,022 | ) | ||||||||||||||||||||||||||||||||||||||||
Total project costs | 11,671 | 4,667 | 7,004 | 19,423 | 11,992 | 7,431 | 11,733 | 11,671 | 62 | 23,362 | 19,423 | 3,939 | ||||||||||||||||||||||||||||||||||||
Internal research and development costs | 5,074 | 3,275 | 1,799 | 9,704 | 5,459 | 4,245 | 6,158 | 5,074 | 1,084 | 12,944 | 9,704 | 3,240 | ||||||||||||||||||||||||||||||||||||
Total research and development | $ | 16,745 | $ | 7,942 | $ | 8,803 | $ | 29,127 | $ | 17,451 | $ | 11,676 | $ | 17,891 | $ | 16,745 | $ | 1,146 | $ | 36,306 | $ | 29,127 | $ | 7,179 | ||||||||||||||||||||||||
Six Months Ended June 30, | ||||||||
2021 | 2020 | |||||||
Net cash used in operating activities | $ | (39,775 | ) | $ | (22,457 | ) | ||
Net cash provided by investing activities | 44,373 | 93,632 | ||||||
Cash provided by financing activities | 106 | 7 | ||||||
Net increase in cash and cash equivalents | $ | 4,704 | $ | 71,182 | ||||
Six Months Ended June 30, | ||||||||
2022 | 2021 | |||||||
Net cash used in operating activities | $ | (47,802 | ) | $ | (39,775 | ) | ||
Net cash (used in) provided by investing activities | (49,792 | ) | 44,373 | |||||
Net cash provided by financing activities | 24,541 | 106 | ||||||
Net (decrease) increase in cash and cash equivalents | $ | (73,053 | ) | $ | 4,704 | |||
Item 3. | Quantitative and Qualitative Disclosures About Market Risk |
Item 4. | Controls and Procedures |
Item 1. | Legal Proceedings |
Item 1A. |
Item 6. | Exhibits |
CYMABAY THERAPEUTICS, INC. | ||
By: | /s/ Sujal Shah | |
Sujal Shah | ||
President and Chief Executive Officer | ||
(Principal Executive Officer) | ||
Date: | August | |
By: | /s/ Daniel Menold | |
Daniel Menold | ||
Vice President, Finance | ||
(Principal Financial and Accounting Officer) | ||
Date: | August |