☒ | 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 f each exchangeon 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. | ||||||
Item 4. | ||||||
PART II | ||||||
Item 1. | ||||||
Item 1A. | ||||||
Item 6. | 50 | |||||
Item 1. Financial Statements |
March 31, 2021 | December 31, 2020 | |||||||
Assets | ||||||||
Current assets: | ||||||||
Cash and cash equivalents | $ | 43,326 | $ | 28,193 | ||||
Marketable securities | 82,132 | 118,130 | ||||||
Accrued interest receivable | 265 | 277 | ||||||
Prepaid research and development expenses | 5,631 | 2,221 | ||||||
Other prepaid expenses and current assets | 1,919 | 2,764 | ||||||
Total current assets | 133,273 | 151,585 | ||||||
Property and equipment, net | 1,690 | 1,761 | ||||||
Operating lease right-of-use | 273 | 272 | ||||||
Other assets | 1,446 | 207 | ||||||
Total assets | $ | 136,682 | $ | 153,825 | ||||
Liabilities and stockholders’ equity | ||||||||
Current liabilities: | ||||||||
Accounts payable | $ | 1,606 | $ | 231 | ||||
Accrued research and development expenses | 3,294 | 4,698 | ||||||
Other accrued liabilities | 3,009 | 4,928 | ||||||
Total current liabilities | 7,909 | 9,857 | ||||||
Long-term portion of operating lease liability | 1,127 | 1,262 | ||||||
Total liabilities | 9,036 | 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; 68,946,092 and 68,946,092 shares issued and outstanding as of March 31, 2021 and December 31, 2020, respectively | 7 | 7 | ||||||
Additional paid-in capital | 822,054 | 819,549 | ||||||
Accumulated other comprehensive (loss) income | (6 | ) | 8 | |||||
Accumulated deficit | (694,409 | ) | (676,858 | ) | ||||
Total stockholders’ equity | 127,646 | 142,706 | ||||||
Total liabilities and stockholders’ equity | $ | 136,682 | $ | 153,825 | ||||
September 30, | December 31, | |||||||
2021 | 2020 | |||||||
Assets | ||||||||
Current assets: | ||||||||
Cash and cash equivalents | $ | 68,963 | $ | 28,193 | ||||
Marketable securities | 44,825 | 118,130 | ||||||
Accrued interest receivable | 69 | 277 | ||||||
Prepaid research and development expenses | 5,071 | 2,221 | ||||||
Other prepaid expenses and current assets | 648 | 2,764 | ||||||
Total current assets | 119,576 | 151,585 | ||||||
Property and equipment, net | 1,341 | 1,761 | ||||||
Operating lease right-of-use | 264 | 272 | ||||||
Other assets | 1,721 | 207 | ||||||
Total assets | $ | 122,902 | $ | 153,825 | ||||
Liabilities and stockholders’ equity | ||||||||
Current liabilities: | ||||||||
Accounts payable | $ | 764 | $ | 231 | ||||
Accrued research and development expenses | 6,451 | 4,698 | ||||||
Other accrued liabilities | 4,526 | 4,928 | ||||||
Total current liabilities | 11,741 | 9,857 | ||||||
Development financing liability | 23,259 | 0 | ||||||
Long-term portion of operating lease liability | 844 | 1,262 | ||||||
Total liabilities | 35,844 | 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; 69,043,969 and 68,946,092 shares issued and outstanding as of September 30, 2021 and December 31, 2020, respectively | 7 | 7 | ||||||
Additional paid-in capital | 827,365 | 819,549 | ||||||
Accumulated other comprehensive (loss) income | (1 | ) | 8 | |||||
Accumulated deficit | (740,313 | ) | (676,858 | ) | ||||
Total stockholders’ equity | 87,058 | 142,706 | ||||||
Total liabilities and stockholders’ equity | $ | 122,902 | $ | 153,825 | ||||
Three Months Ended | Nine Months Ended | |||||||||||||||||||||||
Three Months Ended March 31, | September 30, | September 30, | ||||||||||||||||||||||
2021 | 2020 | 2021 | 2020 | 2021 | 2020 | |||||||||||||||||||
Operating expenses: | ||||||||||||||||||||||||
Research and development | $ | 12,382 | $ | 9,509 | $ | 17,010 | $ | 7,743 | $ | 46,137 | $ | 25,194 | ||||||||||||
General and administrative | 5,236 | 4,418 | 5,179 | 3,907 | 16,936 | 11,535 | ||||||||||||||||||
Total operating expenses | 17,618 | 13,927 | 22,189 | 11,650 | 63,073 | 36,729 | ||||||||||||||||||
Loss from operations | (17,618 | ) | (13,927 | ) | (22,189 | ) | (11,650 | ) | (63,073 | ) | (36,729 | ) | ||||||||||||
Other income (expense), net: | ||||||||||||||||||||||||
Interest income | 67 | 839 | 29 | 229 | 140 | 1,494 | ||||||||||||||||||
Interest expense | (522 | ) | 0 | (522 | ) | 0 | ||||||||||||||||||
Total other income (expense), net | (493 | ) | 229 | (382 | ) | 1,494 | ||||||||||||||||||
Net loss | $ | (17,551 | ) | $ | (13,088 | ) | $ | (22,682 | ) | $ | (11,421 | ) | $ | (63,455 | ) | $ | (35,235 | ) | ||||||
Other comprehensive loss: | ||||||||||||||||||||||||
Unrealized loss on marketable securities | (14 | ) | (210 | ) | ||||||||||||||||||||
Other comprehensive (loss) income: | ||||||||||||||||||||||||
Unrealized (loss) gain on marketable securities | (2 | ) | (104 | ) | (9 | ) | 2 | |||||||||||||||||
Total other comprehensive loss | (14 | ) | (210 | ) | ||||||||||||||||||||
Total other comprehensive (loss) income | (2 | ) | (104 | ) | (9 | ) | 2 | |||||||||||||||||
Comprehensive loss | $ | (17,565 | ) | $ | (13,298 | ) | $ | (22,684 | ) | $ | (11,525 | ) | $ | (63,464 | ) | $ | (35,233 | ) | ||||||
Basic and diluted net loss per common share | $ | (0.25 | ) | $ | (0.19 | ) | $ | (0.33 | ) | $ | (0.17 | ) | $ | (0.92 | ) | $ | (0.51 | ) | ||||||
Weighted average common shares outstanding used to calculate basic and diluted net loss per common share | 68,946,092 | 68,882,459 | 69,022,937 | 68,887,092 | 68,985,112 | 68,884,894 |
Nine Months Ended | ||||||||
September 30, | ||||||||
2021 | 2020 | |||||||
Operating activities | ||||||||
Net loss | $ | (63,455 | ) | $ | (35,235 | ) | ||
Adjustments to reconcile net loss to net cash used in operating activities: | ||||||||
Depreciation and amortization | 515 | 468 | ||||||
Stock-based compensation expense | 7,611 | 5,513 | ||||||
Accretion of development financing liability | 522 | — | ||||||
Write-off of deferred financing costs | 312 | 0 | ||||||
Net accretion and amortization of investments in marketable securities | 543 | (240 | ) | |||||
Changes in assets and liabilities: | ||||||||
Interest receivable and other current assets | 765 | 42 | ||||||
Prepaid expenses | (1,490 | ) | 7,071 | |||||
Other assets | (1,514 | ) | 0 | |||||
Accounts payable | 512 | (1,556 | ) | |||||
Accrued liabilities | 491 | (5,972 | ) | |||||
Net cash used in operating activities | (55,188 | ) | (29,909 | ) | ||||
Investing activities | ||||||||
Purchases of property and equipment | (87 | ) | (21 | ) | ||||
Purchases of marketable securities | (44,607 | ) | (153,951 | ) | ||||
Proceeds from maturities of marketable securities | 117,360 | 206,278 | ||||||
Net cash provided by investing activities | 72,666 | 52,306 | ||||||
Financing activities | ||||||||
Proceeds from issuance of common stock pursuant to equity award plans | 205 | 7 | ||||||
Proceeds from development financing, net of transaction costs | 23,087 | 0 | ||||||
Net cash provided by financing activities | 23,292 | 7 | ||||||
Net increase in cash and cash equivalents | 40,770 | 22,404 | ||||||
Cash and cash equivalents at beginning of period | 28,193 | 24,869 | ||||||
Cash and cash equivalents at end of period | $ | 68,963 | $ | 47,273 | ||||
Supplemental disclosure | ||||||||
Cash paid for amounts included in the measurement of lease liabilities | $ | 498 | $ | 484 | ||||
Supplemental non-cash investing and financing activities | ||||||||
Accrued financing costs | $ | 350 | $ | 0 |
Three Months Ended March 31, | ||||||||
2021 | 2020 | |||||||
Operating activities | ||||||||
Net loss | $ | (17,551 | ) | $ | (13,088 | ) | ||
Adjustments to reconcile net loss to net cash used in operating activities: | ||||||||
Depreciation and amortization | 164 | 153 | ||||||
Stock-based compensation expense | 2,505 | 1,998 | ||||||
Net accretion and amortization of investments in marketable securities | 196 | (205 | ) | |||||
Changes in assets and liabilities: | ||||||||
Interest receivable and other current assets | 299 | 310 | ||||||
Prepaid research and development expenses and other prepaid assets | (2,852 | ) | 1,951 | |||||
Other assets | (1,239 | ) | 0 | |||||
Accounts payable | 1,375 | (1,290 | ) | |||||
Accrued liabilities | (3,458 | ) | (4,537 | ) | ||||
Net cash used in operating activities | (20,561 | ) | (14,708 | ) | ||||
Investing activities | ||||||||
Purchases of property and equipment | (94 | ) | 0 | |||||
Purchases of marketable securities | (18,212 | ) | (65,503 | ) | ||||
Proceeds from maturities of marketable securities | 54,000 | 112,136 | ||||||
Net cash provided by investing activities | 35,694 | 46,633 | ||||||
Financing activities | ||||||||
Cash provided by financing activities | 0 | 0 | ||||||
Net increase in cash and cash equivalents | 15,133 | 31,925 | ||||||
Cash and cash equivalents at beginning of period | 28,193 | 24,869 | ||||||
Cash and cash equivalents at end of period | $ | 43,326 | $ | 56,794 | ||||
Supplemental disclosure | ||||||||
Cash paid for amounts included in the measurement of lease liabilities | $ | 166 | $ | 161 |
Three Months Ended March 31, 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 | |||||||||||
Three and Nine Months Ended September 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 | ||||||||||||
Issuance of common stock upon exercise of stock options | 46,031 | — | 99 | — | — | 99 | ||||||||||||||||||
Stock-based compensation expense | — | — | 2,549 | — | — | 2,549 | ||||||||||||||||||
Net loss | — | — | — | — | (22,682 | ) | (22,682 | ) | ||||||||||||||||
Net unrealized loss on marketable securities | — | — | — | (2 | ) | — | (2 | ) | ||||||||||||||||
Balances as of September 30, 2021 | 69,043,969 | $ | 7 | $ | 827,365 | $ | (1 | ) | $ | (740,313 | ) | $ | 87,058 | |||||||||||
Three and Nine Months Ended September 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 | ||||||||||||
Stock-based compensation expense | — | — | 2,552 | — | — | 2,552 | ||||||||||||||||||
Net loss | — | — | — | — | (11,421 | ) | (11,421 | ) | ||||||||||||||||
Net unrealized loss on marketable securities | — | — | — | (104 | ) | — | (104 | ) | ||||||||||||||||
Balances as of September 30, 2020 | 68,887,092 | $ | 7 | $ | 817,653 | $ | 82 | $ | (661,107 | ) | $ | 156,635 | ||||||||||||
Three Months Ended March 31, 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 | |||||||||||
As of March 31, 2021 | ||||||||||||||||
Level 1 | Level 2 | Level 3 | Total | |||||||||||||
Cash equivalents: | ||||||||||||||||
Money market funds | $ | 38,460 | $ | — | $ | — | $ | 38,460 | ||||||||
Total cash equivalents | 38,460 | — | — | 38,460 | ||||||||||||
Marketable securities: | ||||||||||||||||
U.S. treasury securities | — | 8,000 | — | 8,000 | ||||||||||||
U.S. and foreign commercial paper | — | 33,475 | — | 33,475 | ||||||||||||
U.S. and foreign corporate debt securities | — | 23,677 | — | 23,677 | ||||||||||||
Asset-backed securities | — | 13,978 | — | 13,978 | ||||||||||||
Supranational debt securities | — | 3,002 | — | 3,002 | ||||||||||||
Total marketable securities | — | 82,132 | — | 82,132 | ||||||||||||
Total assets measured at fair value | $ | 38,460 | $ | 82,132 | $ | — | $ | 120,592 | ||||||||
As of September 30, 2021 | ||||||||||||||||||||||||||||||||
Level 1 | Level 2 | Level 3 | Total | |||||||||||||||||||||||||||||
Assets: | ||||||||||||||||||||||||||||||||
Cash equivalents: | ||||||||||||||||||||||||||||||||
Money market funds | $ | 39,716 | $ | — | $ | — | $ | 39,716 | ||||||||||||||||||||||||
Total cash equivalents | 39,716 | — | — | 39,716 | ||||||||||||||||||||||||||||
Marketable securities: | ||||||||||||||||||||||||||||||||
U.S. and foreign co m mercial paper | — | 29,676 | — | 29,676 | ||||||||||||||||||||||||||||
U.S. and foreign corporate debt securities | — | 6,566 | — | 6,566 | ||||||||||||||||||||||||||||
Asset-backed securities | — | 8,583 | — | 8,583 | ||||||||||||||||||||||||||||
Total marketable securities | — | 44,825 | — | 44,825 | ||||||||||||||||||||||||||||
Total assets measured at fair value | $ | 39,716 | $ | 44,825 | $ | — | $ | 84,541 | ||||||||||||||||||||||||
As of December 31, 2020 | As of December 31, 2020 | |||||||||||||||||||||||||||||||
Level 1 | Level 2 | Level 3 | Total | Level 1 | Level 2 | Level 3 | Total | |||||||||||||||||||||||||
Cash equivalents: | ||||||||||||||||||||||||||||||||
Money market funds | $ | 22,415 | $ | — | $ | — | $ | 22,415 | $ | 22,415 | $ | — | $ | — | $ | 22,415 | ||||||||||||||||
U.S. commercial paper | — | — | — | — | ||||||||||||||||||||||||||||
Total cash equivalents | 22,415 | — | — | 22,415 | 22,415 | — | — | 22,415 | ||||||||||||||||||||||||
Marketable securities: | ||||||||||||||||||||||||||||||||
U.S. treasury securities | — | 15,499 | — | 15,499 | — | 15,499 | — | 15,499 | ||||||||||||||||||||||||
U.S. and foreign commercial paper | — | 38,561 | — | 38,561 | — | 38,561 | — | 38,561 | ||||||||||||||||||||||||
U.S. and foreign corporate debt securities | — | 29,189 | — | 29,189 | — | 29,189 | — | 29,189 | ||||||||||||||||||||||||
U.S. agency securities | — | 23,994 | — | 23,994 | — | 23,994 | — | 23,994 | ||||||||||||||||||||||||
Asset-backed securities | — | 7,885 | — | 7,885 | — | 7,885 | — | 7,885 | ||||||||||||||||||||||||
Supranational debt securities | — | 3,002 | — | 3,002 | — | 3,002 | — | 3,002 | ||||||||||||||||||||||||
Total marketable securities | — | 118,130 | — | 118,130 | — | 118,130 | — | 118,130 | ||||||||||||||||||||||||
Total assets measured at fair value | $ | 22,415 | $ | 118,130 | $ | — | $ | 140,545 | $ | 22,415 | $ | 118,130 | $ | — | $ | 140,545 | ||||||||||||||||
Three Months Ended March 31, | ||||||||
2021 | 2020 | |||||||
Numerator: | ||||||||
Net loss | $ | (17,551 | ) | $ | (13,088 | ) | ||
Denominator: | ||||||||
Weighted average number of common stock shares outstanding | 68,946,092 | 68,882,459 | ||||||
Net loss per share | $ | (0.25 | ) | $ | (0.19 | ) |
Three Months Ended | Nine Months Ended | |||||||||||||||
September 30, | September 30, | |||||||||||||||
2021 | 2020 | 2021 | 2020 | |||||||||||||
Numerator: | ||||||||||||||||
Net loss | $ | (22,682 | ) | $ | (11,421 | ) | $ | (63,455 | ) | $ | (35,235 | ) | ||||
Denominator: | ||||||||||||||||
Weighted average number of common stock shares outstanding | 69,022,937 | 68,887,092 | 68,985,112 | 68,884,894 | ||||||||||||
Net loss per share | $ | (0.33 | ) | $ | (0.17 | ) | $ | (0.92 | ) | $ | (0.51 | ) |
Three Months Ended March 31, | ||||||||
2021 | 2020 | |||||||
Common stock options | 10,052 | 6,117 | ||||||
Incentive awards | 101 | 101 | ||||||
Total | 10,153 | 6,218 | ||||||
Three Months Ended | Nine Months Ended | |||||||||||||||
September 30, | September 30, | |||||||||||||||
2021 | 2020 | 2021 | 2020 | |||||||||||||
Common stock options | 10,704 | 8,126 | 10,704 | 8,126 | ||||||||||||
Incentive awards | 101 | 101 | 101 | 101 | ||||||||||||
Total | 10,805 | 8,227 | 10,805 | 8,227 | ||||||||||||
September 30, | December 31, | |||||||||||||||
2021 | 2020 | |||||||||||||||
March 31, 2021 | December 31, 2020 | |||||||||||||||
Accrued compensation | $ | 1,504 | $ | 3,769 | $ | 2,710 | $ | 3,769 | ||||||||
Accrued professional fees and other | 1,003 | 677 | 1,271 | 677 | ||||||||||||
Current portion of operating lease liability | 502 | 482 | 545 | 482 | ||||||||||||
Total other accrued liabilities | $ | 3,009 | $ | 4,928 | $ | 4,526 | $ | 4,928 | ||||||||
Three Months Ended | Nine Months Ended | |||||||||||||||
September 30, | September 30, | |||||||||||||||
2021 | 2020 | 2021 | 2020 | |||||||||||||
Research and development | $ | 1,115 | $ | 1,055 | $ | 3,343 | $ | 2,163 | ||||||||
General and administrative | 1,434 | 1,497 | 4,268 | 3,350 | ||||||||||||
Total stock-based compensation expense | $ | 2,549 | $ | 2,552 | $ | 7,611 | $ | 5,513 | ||||||||
Three Months Ended March 31, | ||||||||
2021 | 2020 | |||||||
Research and development | $ | 1,077 | $ | 444 | ||||
General and administrative | 1,428 | 1,554 | ||||||
Total stock-based compensation expense | $ | 2,505 | $ | 1,998 | ||||
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations |
Three Months Ended March 31, | Change Q1 | |||||||||||||||||||||||||||||||||||
2021 | 2020 | 2021 vs 2020 | Three Months Ended September 30, | Change Q3 | Nine Months Ended September 30, | Change Q3 YTD | ||||||||||||||||||||||||||||||
($ in thousands) | 2021 | 2020 | 2021 vs 2020 | 2021 | 2020 | 2021 vs 2020 | ||||||||||||||||||||||||||||||
Operating expenses: | ||||||||||||||||||||||||||||||||||||
Research and development | $ | 12,382 | $ | 9,509 | $ | 2,873 | $ | 17,010 | $ | 7,743 | $ | 9,267 | $ | 46,137 | $ | 25,194 | $ | 20,943 | ||||||||||||||||||
General and administrative | 5,236 | 4,418 | 818 | 5,179 | 3,907 | 1,272 | 16,936 | 11,535 | 5,401 | |||||||||||||||||||||||||||
Total operating expenses | 17,618 | 13,927 | 3,691 | 22,189 | 11,650 | 10,539 | 63,073 | 36,729 | 26,344 | |||||||||||||||||||||||||||
Loss from operations | (17,618 | ) | (13,927 | ) | (3,691 | ) | (22,189 | ) | (11,650 | ) | (10,539 | ) | (63,073 | ) | (36,729 | ) | (26,344 | ) | ||||||||||||||||||
Other income (expense), net: | ||||||||||||||||||||||||||||||||||||
Interest income | 67 | 839 | (772 | ) | 29 | 229 | (200 | ) | 140 | 1,494 | (1,354 | ) | ||||||||||||||||||||||||
Interest expense | (522 | ) | — | (522 | ) | (522 | ) | — | (522 | ) | ||||||||||||||||||||||||||
Total other income (expense), net | (493 | ) | 229 | (722 | ) | (382 | ) | 1,494 | (1,876 | ) | ||||||||||||||||||||||||||
Net loss | $ | (17,551 | ) | $ | (13,088 | ) | $ | (4,463 | ) | $ | (22,682 | ) | $ | (11,421 | ) | $ | (11,261 | ) | $ | (63,455 | ) | $ | (35,235 | ) | $ | (28,220 | ) | |||||||||
Three Months Ended March 31, | Change Q1 | Three Months Ended September 30, | Change Q3 | Nine Months Ended September 30, | Change Q3 YTD | |||||||||||||||||||||||||||||||
2021 | 2020 | 2021 vs 2020 | 2021 | 2020 | 2021 vs 2020 | 2021 | 2020 | 2021 vs 2020 | ||||||||||||||||||||||||||||
Project costs: | ||||||||||||||||||||||||||||||||||||
Seladelpar PBC clinical studies | $ | 5,903 | $ | 5,584 | $ | 319 | $ | 10,180 | $ | 2,279 | $ | 7,901 | $ | 25,050 | $ | 11,005 | $ | 14,045 | ||||||||||||||||||
Seladelpar NASH clinical studies | (10 | ) | 897 | (907 | ) | (52 | ) | 138 | (190 | ) | (71 | ) | 1,607 | (1,678 | ) | |||||||||||||||||||||
Seladelpar PSC clinical studies | — | 252 | (252 | ) | — | (36 | ) | 36 | — | 218 | (218 | ) | ||||||||||||||||||||||||
Seladelpar drug manufacturing & development | 754 | 237 | 517 | 1,530 | 630 | 900 | 3,675 | 1,010 | 2,665 | |||||||||||||||||||||||||||
Seladelpar other studies | 123 | 125 | (2 | ) | 144 | 170 | (26 | ) | 303 | 520 | (217 | ) | ||||||||||||||||||||||||
Non-seladelpar studies | 982 | 230 | 752 | 279 | 854 | (575 | ) | 2,547 | 1,667 | 880 | ||||||||||||||||||||||||||
Total project costs | 7,752 | 7,325 | 427 | 12,081 | 4,035 | 8,046 | 31,504 | 16,027 | 15,477 | |||||||||||||||||||||||||||
Internal research and development costs | 4,630 | 2,184 | 2,446 | 4,929 | 3,708 | 1,221 | 14,633 | 9,167 | 5,466 | |||||||||||||||||||||||||||
Total research and development | $ | 12,382 | $ | 9,509 | $ | 2,873 | $ | 17,010 | $ | 7,743 | $ | 9,267 | $ | 46,137 | $ | 25,194 | $ | 20,943 | ||||||||||||||||||
Three Months Ended March 31, | Nine Months Ended September 30, | |||||||||||||||
2021 | 2020 | 2021 | 2020 | |||||||||||||
Net cash used in operating activities | $ | (20,561 | ) | $ | (14,708 | ) | $ | (55,188 | ) | $ | (29,909 | ) | ||||
Net cash provided by investing activities | 35,694 | 46,633 | 72,666 | 52,306 | ||||||||||||
Net cash provided by financing activities | 23,292 | 7 | ||||||||||||||
Net increase in cash and cash equivalents | $ | 15,133 | $ | 31,925 | $ | 40,770 | $ | 22,404 | ||||||||
Item 3. Quantitative and Qualitative Disclosures About Market Risk |
Item 4. Controls and Procedures |
Item 1. | Legal Proceedings |
Item 6. | Exhibits |
CYMABAY THERAPEUTICS, INC. | ||||
By: | /s/ Sujal Shah | |||
Sujal Shah | ||||
President and Chief Executive Officer | ||||
Date: | ||||
By: | /s/ Daniel Menold | |||
Daniel Menold | ||||
Vice President, Finance | ||||
(Principal Financial and Accounting Officer) | ||||
Date: |