☒ | 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 | 61-1807780 | |
(State or other jurisdiction of incorporation or organization) | (I.R.S. Employer Identification No.) |
29 Hartwell Avenue Lexington, Massachusetts | 02421 | ||
(Address of principal executive offices) | (Zip Code) |
Title of each class | Trading | Name of each exchange on which registered | ||
Common Stock, $0.001 par value | TBIO | The Nasdaq Global Select Market |
Large accelerated filer | ☐ | Accelerated filer | ||||
☒ | ||||||
Non-accelerated filer | ☐ | Smaller reporting company | ☒ | |||
Emerging growth company | ☒ |
Page | ||||||
PART I. | 1 | |||||
Item 1. | 1 | |||||
1 | ||||||
2 | ||||||
3 | ||||||
4 | ||||||
6 | ||||||
7 | ||||||
Item 2. | 25 | |||||
Item 3. | ||||||
Item 4. | ||||||
PART II. | ||||||
Item 1. | ||||||
Item 1A. | ||||||
Item 5. | 89 | |||||
Item 6. | ||||||
• | the impacts of the COVID-19 pandemic; |
• | the initiation, timing, progress and results of our current and future preclinical studies and clinical trials and our research and development programs; |
• | our estimates regarding expenses, future revenue, capital requirements and need for additional financing; |
• | our expectations regarding our ability to fund our operating expenses and capital expenditure requirements with our cash and cash equivalents and the period in which we expect that such cash and cash equivalents will enable us to fund such operating expenses and capital expenditure requirements; |
• | our plans to develop our product candidates; |
• | the timing of and our ability to submit applications for, obtain and maintain regulatory approvals for our product candidates; |
• | the potential advantages of our product candidates; |
• | the rate and degree of market acceptance and clinical utility of our product candidates; |
• | our estimates regarding the potential market opportunity for our product candidates; |
• | our commercialization, marketing and manufacturing capabilities and strategy; |
• | our expectations regarding our ability to obtain and maintain intellectual property protection for our product candidates; |
• | our ability to identify additional products, product candidates or technologies with significant commercial potential that are consistent with our commercial objectives; |
• | the impact of government laws and regulations; |
• | our competitive position; |
• | developments relating to our competitors and our industry; and |
• | our ability to establish collaborations or obtain additional funding. |
June 30, 2020 | December 31, 2019 | |||||||
Assets | ||||||||
Current assets: | ||||||||
Cash and cash equivalents | $ | 272,193 | $ | 84,580 | ||||
Short-term investments | 20,029 | 104,098 | ||||||
Collaboration receivables | 15,131 | 4,596 | ||||||
Prepaid expenses and other current assets | 7,918 | 9,391 | ||||||
Restricted cash | 950 | 950 | ||||||
Total current assets | 316,221 | 203,615 | ||||||
Property and equipment, net | 15,154 | 12,539 | ||||||
Right-of-use assets, net | 10,130 | 10,400 | ||||||
Goodwill | 21,359 | 21,359 | ||||||
Intangible assets, net | 81,280 | 85,536 | ||||||
Other assets | 10,134 | 2,752 | ||||||
Total assets | $ | 454,278 | $ | 336,201 | ||||
Liabilities and Stockholders’ Equity | ||||||||
Current liabilities: | ||||||||
Accounts payable | $ | 12,912 | $ | 15,968 | ||||
Accrued expenses | 11,126 | 7,072 | ||||||
Current portion of deferred revenue | 27,109 | 18,100 | ||||||
Current portion of operating lease liability | 619 | 530 | ||||||
Total current liabilities | 51,766 | 41,670 | ||||||
Contingent consideration | 109,550 | 103,655 | ||||||
Deferred revenue, net of current portion | 9,818 | 25,256 | ||||||
Operating lease liability, net of current portion | 11,751 | 12,084 | ||||||
Total liabilities | 182,885 | 182,665 | ||||||
Commitments and contingencies (Notes 3, 4 and 12) | ||||||||
Stockholders’ equity: | ||||||||
Preferred stock, $0.001 par value; 10,000,000 shares authorized as of June 30, 2020 and December 31, 2019, respectively; 0 shares issued and outstanding as of June 30, 2020 and December 31, 2019 | — | — | ||||||
Common stock, $0.001 par value; 200,000,000 shares authorized as of June 30, 2020 and December 31, 2019; 69,359,509 shares and 60,022,067 shares issued and outstanding as of June 30, 2020 and December 31, 2019, respectively | 69 | 60 | ||||||
Additional paid-in capital | 680,850 | 512,231 | ||||||
Accumulated deficit | (410,066 | ) | (359,496 | ) | ||||
Accumulated other comprehensive income | 540 | 741 | ||||||
Total stockholders’ equity | 271,393 | 153,536 | ||||||
Total liabilities and stockholders’ equity | $ | 454,278 | $ | 336,201 | ||||
September 30, 2020 | December 31, 2019 | |||||||
Assets | ||||||||
Current assets: | ||||||||
Cash and cash equivalents | $ | 674,050 | $ | 84,580 | ||||
Short-term investments | — | 104,098 | ||||||
Collaboration receivables | 25,139 | 4,596 | ||||||
Prepaid expenses and other current assets | 10,822 | 9,391 | ||||||
Restricted cash | 950 | 950 | ||||||
Total current assets | 710,961 | 203,615 | ||||||
Property and equipment, net | 15,044 | 12,539 | ||||||
Right-of-use | 75,650 | 10,400 | ||||||
Goodwill | 21,359 | 21,359 | ||||||
Intangible assets, net | 81,280 | 85,536 | ||||||
Other assets | 4,334 | 2,752 | ||||||
Total assets | $ | 908,628 | $ | 336,201 | ||||
Liabilities and Stockholders’ Equity | ||||||||
Current liabilities: | ||||||||
Accounts payable | $ | 6,815 | $ | 15,968 | ||||
Accrued expenses | 11,766 | 7,072 | ||||||
Current portion of deferred revenue | 93,164 | 18,100 | ||||||
Current portion of operating lease liability | 12,279 | 530 | ||||||
Total current liabilities | 124,024 | 41,670 | ||||||
Contingent consideration | 123,740 | 103,655 | ||||||
Deferred revenue, net of current portion | 242,047 | 25,256 | ||||||
Operating lease liability, net of current portion | 53,151 | 12,084 | ||||||
Total liabilities | 542,962 | 182,665 | ||||||
Commitments and contingencies (Notes 3 and 12) | ||||||||
Stockholders’ equity: | ||||||||
Preferred stock, $0.001 par value; 10,000,000 shares authorized as of September 30, 2020 and December 31, 2019; 0 shares issued and outstanding as of September 30, 2020 and December 31, 2019 | — | — | ||||||
Common stock, $0.001 par value; 200,000,000 shares authorized as of September 30, 2020 and December 31, 2019; 74,251,559 shares and 60,022,067 shares issued and outstanding as of September 30, 2020 and December 31, 2019, respectively | 74 | 60 | ||||||
Additional paid-in capital | 758,314 | 512,231 | ||||||
Accumulated deficit | (392,722 | ) | (359,496 | ) | ||||
Accumulated other comprehensive income | — | 741 | ||||||
Total stockholders’ equity | 365,666 | 153,536 | ||||||
Total liabilities and stockholders’ equity | $ | 908,628 | $ | 336,201 | ||||
Three Months Ended June 30, | Six Months Ended June 30, | |||||||||||||||
2020 | 2019 | 2020 | 2019 | |||||||||||||
Collaboration revenue | $ | 16,319 | $ | 1,174 | $ | 20,974 | $ | 2,648 | ||||||||
Operating expenses: | ||||||||||||||||
Research and development | 29,002 | 16,625 | 50,442 | 34,048 | ||||||||||||
General and administrative | 8,601 | 7,850 | 16,060 | 14,403 | ||||||||||||
Change in fair value of contingent consideration | 15,347 | 4,889 | 5,895 | 16,591 | ||||||||||||
Total operating expenses | 52,950 | 29,364 | 72,397 | 65,042 | ||||||||||||
Loss from operations | (36,631 | ) | (28,190 | ) | (51,423 | ) | (62,394 | ) | ||||||||
Interest income | 343 | 358 | 853 | 878 | ||||||||||||
Loss before benefit from income taxes | (36,288 | ) | (27,832 | ) | (50,570 | ) | (61,516 | ) | ||||||||
Benefit from income taxes | — | — | — | 486 | ||||||||||||
Net loss | $ | (36,288 | ) | $ | (27,832 | ) | $ | (50,570 | ) | $ | (61,030 | ) | ||||
Net loss per share—basic and diluted | $ | (0.58 | ) | $ | (0.57 | ) | $ | (0.83 | ) | $ | (1.30 | ) | ||||
Weighted average common shares outstanding—basic and diluted | 62,282,291 | 48,749,627 | 61,145,254 | 46,866,842 | ||||||||||||
Three Months Ended September 30, | Nine Months Ended September 30, | |||||||||||||||
2020 | 2019 | 2020 | 2019 | |||||||||||||
Collaboration revenue | $ | 66,446 | $ | 1,266 | $ | 87,420 | $ | 3,914 | ||||||||
Operating expenses: | ||||||||||||||||
Research and development | 26,344 | 17,295 | 76,785 | 51,343 | ||||||||||||
General and administrative | 9,163 | 6,881 | 25,223 | 21,284 | ||||||||||||
Change in fair value of contingent consideration | 14,190 | (19,834 | ) | 20,085 | (3,243 | ) | ||||||||||
Impairment of intangible asset | — | 18,559 | — | 18,559 | ||||||||||||
Total operating expenses | 49,697 | 22,901 | 122,093 | 87,943 | ||||||||||||
Income (loss) from operations | 16,749 | (21,635 | ) | (34,673 | ) | (84,029 | ) | |||||||||
Other income, net | 595 | 408 | 1,447 | 1,286 | ||||||||||||
Income (loss) before benefit from income taxes | 17,344 | (21,227 | ) | (33,226 | ) | (82,743 | ) | |||||||||
Benefit from income taxes | — | — | — | 486 | ||||||||||||
Net income (loss) | $ | 17,344 | $ | (21,227 | ) | $ | (33,226 | ) | $ | (82,257 | ) | |||||
Net income (loss) per share—basic | $ | 0.24 | $ | (0.41 | ) | $ | (0.51 | ) | $ | (1.69 | ) | |||||
Weighted average common shares outstanding—basic | 73,183,923 | 51,891,157 | 65,187,435 | 48,574,275 | ||||||||||||
Net income (loss) per share—diluted | $ | 0.23 | $ | (0.41 | ) | $ | (0.51 | ) | $ | (1.69 | ) | |||||
Weighted average common shares outstanding—diluted | 76,440,293 | 51,891,157 | 65,187,435 | 48,574,275 | ||||||||||||
Three Months Ended June 30, | Six Months Ended June 30, | |||||||||||||||
2020 | 2019 | 2020 | 2019 | |||||||||||||
Net loss | $ | (36,288 | ) | $ | (27,832 | ) | $ | (50,570 | ) | $ | (61,030 | ) | ||||
Other comprehensive income (loss): | ||||||||||||||||
Unrealized gains ( onlosses )available-for-sale securities, net of tax of $0 | (315 | ) | 219 | (201 | ) | 374 | ||||||||||
Comprehensive loss | $ | (36,603 | ) | $ | (27,613 | ) | $ | (50,771 | ) | $ | (60,656 | ) | ||||
Three Months Ended September 30, | Nine Months Ended September 30, | |||||||||||||||
2020 | 2019 | 2020 | 2019 | |||||||||||||
Net income (loss) | $ | 17,344 | $ | (21,227 | ) | $ | (33,226 | ) | $ | (82,257 | ) | |||||
Other comprehensive income (loss): | ||||||||||||||||
Unrealized gains (losses) on available-for-sale | (540 | ) | 109 | (741 | ) | 483 | ||||||||||
Comprehensive income (loss) | $ | 16,804 | $ | (21,118 | ) | $ | (33,967 | ) | $ | (81,774 | ) | |||||
Common Stock | Additional Paid-in | Accumulated | Accumulated Other Comprehensive | Total Stockholders’ | ||||||||||||||||||||
Shares | Amount | Capital | Deficit | Income | Equity | |||||||||||||||||||
Balances at December 31, 2019 | 60,022,067 | $ | 60 | $ | 512,231 | $ | (359,496 | ) | $ | 741 | $ | 153,536 | ||||||||||||
Exercise of stock options | 15,596 | — | 132 | — | — | 132 | ||||||||||||||||||
Stock-based compensation expense | — | — | 3,172 | — | — | 3,172 | ||||||||||||||||||
Unrealized gains on available-for-sale securities | — | — | — | — | 114 | 114 | ||||||||||||||||||
Net loss | — | — | — | (14,282 | ) | — | (14,282 | ) | ||||||||||||||||
Balances at March 31, 2020 | 60,037,663 | 60 | 515,535 | (373,778 | ) | 855 | 142,672 | |||||||||||||||||
Issuance of common stock in connection with public offerings , net of underwriting discounts and commissions and offering costs | 8,544,982 | 9 | 153,602 | — | — | 153,611 | ||||||||||||||||||
Exercise of stock options | 776,864 | — | 5,699 | — | — | 5,699 | ||||||||||||||||||
Stock-based compensation expense | — | — | 6,014 | — | — | 6,014 | ||||||||||||||||||
Unrealized l onosses available-for-sale securities | — | — | — | — | (315 | ) | (315 | ) | ||||||||||||||||
Net loss | — | — | — | (36,288 | ) | — | (36,288 | ) | ||||||||||||||||
Balances at June 30, 2020 | 69,359,509 | $ | 69 | $ | 680,850 | $ | (410,066 | ) | $ | 540 | $ | 271,393 | ||||||||||||
Common Stock | Additional Paid-in | Accumulated | Accumulated Other Comprehensive | Total Stockholders’ | ||||||||||||||||||||
Shares | Amount | Capital | Deficit | Income | Equity | |||||||||||||||||||
Balances at December 31, 2018 | 45,139,955 | $ | 45 | $ | 371,257 | $ | (246,203 | ) | $ | 196 | $ | 125,295 | ||||||||||||
Exercise of stock options | 154,484 | — | 897 | — | — | 897 | ||||||||||||||||||
Stock-based compensation expense | — | — | 1,959 | — | — | 1,959 | ||||||||||||||||||
Unrealized gains on available-for-sale securities | — | — | — | — | 155 | 155 | ||||||||||||||||||
Net loss | — | — | — | (33,198 | ) | — | (33,198 | ) | ||||||||||||||||
Balances at March 31, 2019 | 45,294,439 | 45 | 374,113 | (279,401 | ) | 351 | 95,108 | |||||||||||||||||
Issuance of common stock in connection with private net of placement agent fees and offering costs | 5,582,940 | 6 | 44,128 | — | — | 44,134 | ||||||||||||||||||
Issuance of common stock in connection with a former employee letter agreement | 67,406 | — | 847 | — | — | 847 | ||||||||||||||||||
Forfeited restricted common stock | (1,334 | ) | — | (1 | ) | — | — | (1 | ) | |||||||||||||||
Exercise of stock options | 66,917 | — | 519 | — | — | 519 | ||||||||||||||||||
Stock-based compensation expense | — | — | 2,703 | — | — | 2,703 | ||||||||||||||||||
Unrealized gains on available-for-sale securities | — | — | — | — | 219 | 219 | ||||||||||||||||||
Net loss | — | — | — | (27,832 | ) | — | (27,832 | ) | ||||||||||||||||
Balances at June 30, 2019 | 51,010,368 | $ | 51 | $ | 422,309 | $ | (307,233 | ) | $ | 570 | $ | 115,697 |
Common Stock | Additional Paid-in Capital | Accumulated Deficit | Accumulated Other Comprehensive Income | Total Stockholders’ Equity | ||||||||||||||||||||
Shares | Amount | |||||||||||||||||||||||
Balances at December 31, 2019 | 60,022,067 | $ | 60 | $ | 512,231 | $ | (359,496 | ) | $ | 741 | $ | 153,536 | ||||||||||||
Exercise of stock options | 15,596 | — | 132 | — | — | 132 | ||||||||||||||||||
Stock-based compensation expense | — | — | 3,172 | — | — | 3,172 | ||||||||||||||||||
Unrealized gains on available-for-sale | — | — | — | — | 114 | 114 | ||||||||||||||||||
Net loss | — | — | — | (14,282 | ) | — | (14,282 | ) | ||||||||||||||||
Balances at March 31, 2020 | 60,037,663 | 60 | 515,535 | (373,778 | ) | 855 | 142,672 | |||||||||||||||||
Issuance of common stock in connection with public offerings, net of underwriting discounts and commissions and offering costs | 8,544,982 | 9 | 153,602 | — | — | 153,611 | ||||||||||||||||||
Exercise of stock options | 776,864 | — | 5,699 | — | — | 5,699 | ||||||||||||||||||
Stock-based compensation expense | — | — | 6,014 | — | — | 6,014 | ||||||||||||||||||
Unrealized losses on available-for-sale | — | — | — | — | (315 | ) | (315 | ) | ||||||||||||||||
Net loss | — | — | — | (36,288 | ) | — | (36,288 | ) | ||||||||||||||||
Balances at June 30, 2020 | 69,359,509 | 69 | 680,850 | (410,066 | ) | 540 | 271,393 | |||||||||||||||||
Issuance of common stock in connection with Securities Purchase Agreement | 4,884,434 | 5 | 73,749 | — | — | 73,754 | ||||||||||||||||||
Exercise of stock options | 7,616 | — | 60 | — | — | 60 | ||||||||||||||||||
Stock-based compensation expense | — | — | 3,655 | — | — | 3,655 | ||||||||||||||||||
Unrealized losses on available-for-sale | — | — | — | — | (540 | ) | (540 | ) | ||||||||||||||||
Net income | — | — | — | 17,344 | — | 17,344 | ||||||||||||||||||
Balances at September 30, 2020 | 74,251,559 | $ | 74 | $ | 758,314 | $ | (392,722 | ) | $ | — | $ | 365,666 | ||||||||||||
Six Months Ended June 30, | ||||||||
2020 | 2019 | |||||||
Cash flows from operating activities: | ||||||||
Net loss | $ | (50,570 | ) | $ | (61,030 | ) | ||
Adjustments to reconcile net loss to net cash used in operating activities: | ||||||||
Depreciation and amortization expense | 5,617 | 1,960 | ||||||
Stock-based compensation expense | 9,186 | 5,509 | ||||||
Change in fair value of contingent consideration | 5,895 | 16,591 | ||||||
Deferred income tax benefit | — | (486 | ) | |||||
Changes in operating assets and liabilities: | ||||||||
Collaboration receivables | (10,535 | ) | 177 | |||||
Prepaid expenses and other assets | (5,909 | ) | (1,766 | ) | ||||
Right-of-use assets | 270 | 234 | ||||||
Accounts payable | (2,783 | ) | (1,858 | ) | ||||
Accrued expenses | 4,013 | 600 | ||||||
Lease liability | (244 | ) | (170 | ) | ||||
Deferred revenue | (6,429 | ) | (1,206 | ) | ||||
Net cash used in operating activities | (51,489 | ) | (41,445 | ) | ||||
Cash flows from investing activities: | ||||||||
Purchases of investments | (27,409 | ) | (38,438 | ) | ||||
Sales and maturities of investments | 111,277 | 55,756 | ||||||
Purchases of property and equipment | (4,446 | ) | (1,793 | ) | ||||
Net cash provided by investing activities | 79,422 | 15,525 | ||||||
Cash flows from financing activities: | ||||||||
Proceeds from public offering s , net ofunderwriting discounts and commissions | 154,292 | — | ||||||
Payments of public offering costs | (443 | ) | — | |||||
Proceeds from private placement, net of placement agent fees | — | 44,608 | ||||||
Payments of private placement offering costs | — | (474 | ) | |||||
Proceeds from option exercises | 5,831 | 1,416 | ||||||
Net cash provided by financing activities | 159,680 | 45,550 | ||||||
Net increase in cash, cash equivalents and restricted cash : | 187,613 | 19,630 | ||||||
Cash, cash equivalents and restricted cash at beginning of period | 85,530 | 56,224 | ||||||
Cash, cash equivalents and restricted cash at end of period | $ | 273,143 | $ | 75,854 | ||||
Cash, cash equivalents and restricted cash at end of period: | ||||||||
Cash and cash equivalents | $ | 272,193 | $ | 74,904 | ||||
Restricted cash | 950 | 950 | ||||||
Total cash, cash equivalents and restricted cash at end of period | $ | 273,143 | $ | 75,854 | ||||
Supplemental disclosure of non-cash investing and financing activities: | ||||||||
Purchases of property and equipment included in accounts payable and accrued expenses | $ | 718 | $ | 59 | ||||
Offering costs included in accrued expenses | $ | 238 | $ | — | ||||
Deferred offering costs included in accounts payable and accrued expenses | $ | — | $ | 123 | ||||
Issuance of common stock in connection with a former employee letter agreement | $ | — | $ | 847 |
Common Stock | Additional Paid-in Capital | Accumulated Deficit | Accumulated Other Comprehensive Income | Total Stockholders’ Equity | ||||||||||||||||||||
Shares | Amount | |||||||||||||||||||||||
Balances at December 31, 2018 | 45,139,955 | $ | 45 | $ | 371,257 | $ | (246,203 | ) | $ | 196 | $ | 125,295 | ||||||||||||
Exercise of stock options | 154,484 | — | 897 | — | — | 897 | ||||||||||||||||||
Stock-based compensation expense | — | — | 1,959 | — | — | 1,959 | ||||||||||||||||||
Unrealized gains on available-for-sale | — | — | — | — | 155 | 155 | ||||||||||||||||||
Net loss | — | — | — | (33,198 | ) | — | (33,198 | ) | ||||||||||||||||
Balances at March 31, 2019 | 45,294,439 | 45 | 374,113 | (279,401 | ) | 351 | 95,108 | |||||||||||||||||
Issuance of common stock in connection with private placement, net of placement agent fees and offering costs | 5,582,940 | 6 | 44,128 | — | — | 44,134 | ||||||||||||||||||
Issuance of common stock in connection with a former employee letter agreement | 67,406 | — | 847 | — | — | 847 | ||||||||||||||||||
Forfeited restricted common stock | (1,334 | ) | — | (1 | ) | — | — | (1 | ) | |||||||||||||||
Exercise of stock options | 66,917 | — | 519 | — | — | 519 | ||||||||||||||||||
Stock-based compensation expense | — | — | 2,703 | — | — | 2,703 | ||||||||||||||||||
Unrealized gains on available-for-sale | — | — | — | — | 219 | 219 | ||||||||||||||||||
Net loss | — | — | — | (27,832 | ) | — | (27,832 | ) | ||||||||||||||||
Balances at June 30, 2019 | 51,010,368 | 51 | 422,309 | (307,233 | ) | 570 | 115,697 | |||||||||||||||||
Issuance of common stock in connection with public offering, net of underwriting discounts and commissions and offering costs | 9,000,000 | 9 | 84,002 | — | — | 84,011 | ||||||||||||||||||
Forfeited restricted common stock | (449 | ) | — | — | — | — | — | |||||||||||||||||
Exercise of stock options | 10,806 | — | 84 | — | — | 84 | ||||||||||||||||||
Stock-based compensation expense | — | — | 2,899 | — | — | 2,899 | ||||||||||||||||||
Unrealized gains on available-for-sale | — | — | — | — | 109 | 109 | ||||||||||||||||||
Net loss | — | — | — | (21,227 | ) | — | (21,227 | ) | ||||||||||||||||
Balances at September 30, 2019 | 60,020,725 | $ | 60 | $ | 509,294 | $ | (328,460 | ) | $ | 679 | $ | 181,573 | ||||||||||||
Nine Months Ended September 30, | ||||||||
2020 | 2019 | |||||||
Cash flows from operating activities: | ||||||||
Net loss | $ | (33,226 | ) | $ | (82,257 | ) | ||
Adjustments to reconcile net loss to net cash provided by (used in) operating activities: | ||||||||
Depreciation and amortization expense | 6,374 | 2,951 | ||||||
Stock-based compensation expense | 12,841 | 8,408 | ||||||
Impairment of intangible asset | — | 18,559 | ||||||
Change in fair value of contingent consideration | 20,085 | (3,243 | ) | |||||
Deferred income tax benefit | — | (486 | ) | |||||
Changes in operating assets and liabilities: | ||||||||
Collaboration receivables | (20,543 | ) | 125 | |||||
Prepaid expenses and other assets | (5,766 | ) | (2,293 | ) | ||||
Right-of-use | 1,338 | 357 | ||||||
Long-term prepaid rent | (10,057 | ) | (2,492 | ) | ||||
Accounts payable | (8,560 | ) | (1,740 | ) | ||||
Accrued expenses | 4,913 | 2,244 | ||||||
Lease liability | (962 | ) | (270 | ) | ||||
Deferred revenue | 291,855 | (1,763 | ) | |||||
Net cash provided by (used in) operating activities | 258,292 | (61,900 | ) | |||||
Cash flows from investing activities: | ||||||||
Purchases of investments | (27,409 | ) | (138,156 | ) | ||||
Sales and maturities of investments | 130,765 | 116,311 | ||||||
Purchases of property and equipment | (5,434 | ) | (2,241 | ) | ||||
Net cash provided by (used in) investing activities | 97,922 | (24,086 | ) | |||||
Cash flows from financing activities: | ||||||||
Proceeds from public offerings, net of underwriting discounts and commissions | 154,292 | 84,600 | ||||||
Payments of public offering costs | (681 | ) | (589 | ) | ||||
Proceeds from Securities Purchase Agreement | 73,754 | — | ||||||
Proceeds from private placement, net of placement agent fees | — | 44,608 | ||||||
Payments of private placement offering costs | — | (477 | ) | |||||
Proceeds from option exercises | 5,891 | 1,500 | ||||||
Net cash provided by financing activities | 233,256 | 129,642 | ||||||
Net increase in cash, cash equivalents and restricted cash: | 589,470 | 43,656 | ||||||
Cash, cash equivalents and restricted cash at beginning of period | 85,530 | 56,224 | ||||||
Cash, cash equivalents and restricted cash at end of period | $ | 675,000 | $ | 99,880 | ||||
Cash, cash equivalents and restricted cash at end of period: | ||||||||
Cash and cash equivalents | $ | 674,050 | $ | 98,930 | ||||
Restricted cash | 950 | 950 | ||||||
Total cash, cash equivalents and restricted cash at end of period | $ | 675,000 | $ | 99,880 | ||||
Supplemental disclosure of non-cash investing and financing activities: | ||||||||
Purchases of property and equipment included in accounts payable and accrued expenses | $ | 377 | $ | 2 | ||||
Issuance of common stock in connection with a former employee letter agreement | $ | — | $ | 847 |
Three Months Ended June 30, | Six Months Ended June 30, | |||||||||||||||
2020 | 2019 | 2020 | 2019 | |||||||||||||
Collaboration revenue | $ | 16,319 | $ | 1,174 | $ | 20,974 | $ | 2,648 |
Three Months Ended September 30, | Nine Months Ended September 30, | |||||||||||||||
2020 | 2019 | 2020 | 2019 | |||||||||||||
Collaboration revenue | $ | 66,446 | $ | 1,266 | $ | 87,420 | $ | 3,914 |
June 30, 2020 | December 31, 2019 | |||||||
Contract liabilities | ||||||||
Deferred revenue | $ | 36,927 | $ | 43,356 |
September 30, 2020 | December 31, 2019 | |||||||
Contract liabilities | ||||||||
Deferred revenue | $ | 335,211 | $ | 43,356 |
June 30, 2020 | ||||||||||||||||||||
Estimated Life | Gross Carrying Amount | Accumulated Amortization | Impairment Charge | Net Carrying Amount | ||||||||||||||||
(In thousands) | ||||||||||||||||||||
Definite-lived intangible assets: | ||||||||||||||||||||
MRT | 6 years | $ | 45,992 | $ | (7,003 | ) | $ | — | $ | 38,989 | ||||||||||
Indefinite-lived intangible assets: | ||||||||||||||||||||
IPR&D - CF | Indefinite | 42,291 | — | — | 42,291 | |||||||||||||||
Total intangible assets, net | $ | 88,283 | $ | (7,003 | ) | $ | — | $ | 81,280 | |||||||||||
September 30, 2020 | ||||||||||||||||||||
Estimated Life | Gross Carrying Amount | Accumulated Amortization | Impairment Charge | Net Carrying Amount | ||||||||||||||||
(In thousands) | ||||||||||||||||||||
Definite-lived intangible assets: | ||||||||||||||||||||
MRT | 6 years | $ | 45,992 | $ | (7,003 | ) | $ | 0 | $ | 38,989 | ||||||||||
Indefinite-lived intangible assets: | ||||||||||||||||||||
IPR&D - CF | Indefinite | 42,291 | 0 | 0 | 42,291 | |||||||||||||||
Total intangible assets, net | $ | 88,283 | $ | (7,003 | ) | $ | 0 | $ | 81,280 | |||||||||||
December 31, 2019 | ||||||||||||||||||||
Estimated Life | Gross Carrying Amount | Accumulated Amortization | Impairment Charge | Net Carrying Amount | ||||||||||||||||
(In thousands) | ||||||||||||||||||||
Definite-lived intangible assets: | ||||||||||||||||||||
MRT | 8 years | $ | 45,992 | $ | (2,747 | ) | $ | 0 | $ | 43,245 | ||||||||||
Indefinite-lived intangible assets: | ||||||||||||||||||||
IPR&D - CF | Indefinite | 42,291 | — | — | 42,291 | |||||||||||||||
IPR&D - OTC | Indefinite | 18,559 | — | (18,559 | ) | — | ||||||||||||||
Total intangible assets, net | $ | 106,842 | $ | (2,747 | ) | $ | (18,559 | ) | $ | 85,536 |
December 31, 2019 | ||||||||||||||||||||
Estimated Life | Gross Carrying Amount | Accumulated Amortization | Impairment Charge | Net Carrying Amount | ||||||||||||||||
(In thousands) | ||||||||||||||||||||
Definite-lived intangible assets: | ||||||||||||||||||||
MRT | 8 years | $ | 45,992 | $ | (2,747 | ) | $ | — | $ | 43,245 | ||||||||||
Indefinite-lived intangible assets: | ||||||||||||||||||||
IPR&D - CF | Indefinite | 42,291 | — | — | 42,291 | |||||||||||||||
IPR&D - OTC | Indefinite | 18,559 | — | (18,559 | ) | — | ||||||||||||||
Total intangible assets, net | $ | 106,842 | $ | (2,747 | ) | $ | (18,559 | ) | $ | 85,536 | ||||||||||
Fair Value Measurements as of June 30, 2020 Using: | ||||||||||||||||
Level 1 | Level 2 | Level 3 | Total | |||||||||||||
Assets: | ||||||||||||||||
Money market funds | $ | — | $ | 191,447 | $ | — | $ | 191,447 | ||||||||
U.S. government agency bonds | — | 20,029 | — | 20,029 | ||||||||||||
$ | — | $ | 211,476 | $ | — | $ | 211,476 | |||||||||
Liabilities: | ||||||||||||||||
Contingent consideration | $ | — | $ | — | $ | 109,550 | $ | 109,550 | ||||||||
$ | — | $ | — | $ | 109,550 | $ | 109,550 | |||||||||
Fair Value Measurements as of September 30, 2020 Using: | ||||||||||||||||
Level 1 | Level 2 | Level 3 | Total | |||||||||||||
Assets: | ||||||||||||||||
Money market funds | $ | 0 | $ | 636,615 | $ | 0 | $ | 636,615 | ||||||||
U.S. government agency bonds | 0 | 0 | 0 | 0 | ||||||||||||
$ | 0 | $ | 636,615 | $ | 0 | $ | 636,615 | |||||||||
Liabilities: | ||||||||||||||||
Contingent consideration | $ | 0 | $ | 0 | $ | 123,740 | $ | 123,740 | ||||||||
$ | 0 | $ | 0 | $ | 123,740 | $ | 123,740 | |||||||||
Fair Value Measurements as of December 31, 2019 Using: | ||||||||||||||||
Level 1 | Level 2 | Level 3 | Total | |||||||||||||
Assets: | ||||||||||||||||
Money market funds | $ | — | $ | 56,591 | $ | — | $ | 56,591 | ||||||||
U.S. government agency bonds | — | 104,098 | — | 104,098 | ||||||||||||
$ | — | $ | 160,689 | $ | — | $ | 160,689 | |||||||||
Liabilities: | ||||||||||||||||
Contingent consideration | $ | — | $ | — | $ | 103,655 | $ | 103,655 | ||||||||
$ | — | $ | — | $ | 103,655 | $ | 103,655 | |||||||||
Fair Value Measurements as of December 31, 2019 Using: | ||||||||||||||||
Level 1 | Level 2 | Level 3 | Total | |||||||||||||
Assets: | ||||||||||||||||
Money market funds | $ | — | $ | 56,591 | $ | — | $ | 56,591 | ||||||||
U.S. government agency bonds | — | 104,098 | — | 104,098 | ||||||||||||
$ | — | $ | 160,689 | $ | — | $ | 160,689 | |||||||||
Liabilities: | ||||||||||||||||
Contingent consideration | $ | — | $ | — | $ | 103,655 | $ | 103,655 | ||||||||
$ | — | $ | — | $ | 103,655 | $ | 103,655 | |||||||||
Unobservable Inputs | Fair Value at | |||||||||||
Projected Year of Payment | June 30, 2020 | December 31, 2019 | ||||||||||
Earnout payments | 2026 - 2039 | 101,570 | $ | 96,097 | ||||||||
Milestone payments | 2026 - 2030 | 7,980 | 7,558 | |||||||||
$ | 109,550 | $ | 103,655 | |||||||||
Unobservable | Fair Value at | |||||||||
Projected Year of Payment | September 30, 2020 | December 31, 2019 | ||||||||
Earnout payments | 2026 - 2039 | 115,079 | $ | 96,097 | ||||||
Milestone payments | 2026 - 2032 | 8,661 | 7,558 | |||||||
$ | 123,740 | $ | 103,655 | |||||||
Fair | ||||
Balance as of December 31, 2019 | $ | 103,655 | ||
Increase in fair value of contingent consideration | 5,895 | |||
Balance as of June 30, 2020 | $ | 109,550 | ||
Fair Value | ||||
Balance as of December 31, 2019 | $ | 103,655 | ||
Increase in fair value of contingent consideration | 20,085 | |||
Balance as of September 30, 2020 | $ | 123,740 | ||
June 30, 2020 | December 31, 2019 | |||||||
Laboratory equipment | $ | 10,500 | $ | 9,044 | ||||
Computer equipment | 893 | 779 | ||||||
Office equipment | 883 | 883 | ||||||
Leasehold improvements | 5,635 | 5,635 | ||||||
Construction in progress | 5,865 | 3,460 | ||||||
23,776 | 19,801 | |||||||
Less: Accumulated depreciation and amortization | (8,622 | ) | (7,262 | ) | ||||
$ | 15,154 | $ | 12,539 | |||||
September 30, 2020 | December 31, 2019 | |||||||
Laboratory equipment | $ | 11,763 | $ | 9,044 | ||||
Computer equipment | 892 | 779 | ||||||
Office equipment | 942 | 883 | ||||||
Leasehold improvements | 5,730 | 5,635 | ||||||
Construction in progress | 5,094 | 3,460 | ||||||
24,421 | 19,801 | |||||||
Less: Accumulated depreciation and amortization | (9,377 | ) | (7,262 | ) | ||||
$ | 15,044 | $ | 12,539 | |||||
June 30, 2020 | December 31, 2019 | |||||||
Accrued employee compensation and benefits | $ | 3,244 | $ | 3,547 | ||||
Accrued external research and development expenses | 2,820 | 1,763 | ||||||
Accrued consultant and professional fees | 2,165 | 1,390 | ||||||
Other | 2,897 | 372 | ||||||
$ | 11,126 | $ | 7,072 | |||||
September 30, 2020 | December 31, 2019 | |||||||
Accrued employee compensation and benefits | $ | 4,918 | $ | 3,547 | ||||
Accrued external research and development expenses | 2,058 | 1,763 | ||||||
Accrued consultant and professional fees | 1,358 | 1,390 | ||||||
Other | 3,432 | 372 | ||||||
$ | 11,766 | $ | 7,072 | |||||
Number of Shares | Weighted Average Exercise Price | Weighted Average Remaining Contractual Term | Intrinsic Value | |||||||||||||
(in years) | ||||||||||||||||
Outstanding as of December 31, 2019 | 8,646,378 | $ | 8.06 | 8.42 | $ | 3,687 | ||||||||||
Granted | 2,861,118 | $ | 8.98 | |||||||||||||
Exercised | (792,460 | ) | $ | 7.36 | ||||||||||||
Forfeited | (220,047 | ) | $ | 7.98 | ||||||||||||
Outstanding as of June 30, 2020 | 10,494,989 | $ | 8.37 | 8.21 | $ | 100,634 | ||||||||||
Exercisable as of June 30, 2020 | 4,422,596 | $ | 7.94 | 7.56 | $ | 44,150 | ||||||||||
Vested and expected to vest as of June 30, 2020 | 10,494,989 | $ | 8.37 | 8.21 | $ | 100,634 |
Number of Shares | Weighted Average Exercise Price | Weighted Average Remaining Contractual Term | Intrinsic Value | |||||||||||||
(in years) | ||||||||||||||||
Outstanding as of December 31, 2019 | 8,646,378 | $ | 8.06 | 8.42 | $ | 3,687 | ||||||||||
Granted | 2,992,734 | $ | 9.22 | |||||||||||||
Exercised | (800,076 | ) | $ | 7.36 | ||||||||||||
Forfeited | (529,492 | ) | $ | 8.59 | ||||||||||||
Outstanding as of September 30, 2020 | 10,309,544 | $ | 8.42 | 8.04 | $ | 55,026 | ||||||||||
Exercisable as of September 30, 2020 | 4,915,617 | $ | 7.96 | 7.23 | $ | 27,795 | ||||||||||
Vested and expected to vest as of September 30, 2020 | 10,309,544 | $ | 8.42 | 8.04 | $ | 55,026 |
Six Months Ended June 30, | ||||||||
2020 | 2019 | |||||||
Risk-free interest rate | 0.79 | % | 2.42 | % | ||||
Expected term (in years) | 6.1 | 6.0 | ||||||
Expected volatility | 68.6 | % | 73.3 | % | ||||
Expected dividend yield | 0 | % | 0 | % |
Nine Months Ended September 30, | ||||||||
2020 | 2019 | |||||||
Risk-free interest rate | 0.77 | % | 2.39 | % | ||||
Expected term (in years) | 6.1 | 6.0 | ||||||
Expected volatility | 68.7 | % | 73.1 | % | ||||
Expected dividend yield | 0 | % | 0 | % |
Number of Shares | Weighted Average Grant-Date Fair Value | |||||||
Unvested restricted common stock outstanding as of December 31, 2019 | 34,168 | $ | 1.28 | |||||
Forfeited restricted common stock | — | $ | — | |||||
Vested restricted common stock | (32,477 | ) | $ | 1.28 | ||||
Unvested restricted common stock outstanding as of June 30, 2020 | 1,691 | $ | 1.28 | |||||
Number of Shares | Weighted Average Grant-Date Fair Value | |||||||
Unvested restricted common stock outstanding as of December 31, 2019 | 34,168 | $ | 1.28 | |||||
Forfeited restricted common stock | 0 | $ | 0 | |||||
Vested restricted common stock | (34,168 | ) | $ | 1.28 | ||||
Unvested restricted common stock outstanding as of September 30, 2020 | 0 | $ | 0 | |||||
Three Months Ended June 30, | Six Months Ended June 30, | |||||||||||||||
2020 | 2019 | 2020 | 2019 | |||||||||||||
Research and development expenses | $ | 4,091 | $ | 1,284 | $ | 5,545 | $ | 2,153 | ||||||||
General and administrative expenses | 1,923 | 2,265 | 3,641 | 3,356 | ||||||||||||
$ | 6,014 | $ | 3,549 | $ | 9,186 | $ | 5,509 | |||||||||
Three Months Ended September 30, | Nine Months Ended September 30, | |||||||||||||||
2020 | 2019 | 2020 | 2019 | |||||||||||||
Research and development expenses | $ | 1,578 | $ | 1,301 | $ | 7,123 | $ | 3,454 | ||||||||
General and administrative expenses | 2,077 | 1,598 | 5,718 | 4,954 | ||||||||||||
$ | 3,655 | $ | 2,899 | $ | 12,841 | $ | 8,408 | |||||||||
Three Months Ended | Six Months Ended | |||||||||||||||
2020 | 2019 | 2020 | 2019 | |||||||||||||
Numerator: | ||||||||||||||||
Net loss | $ | (36,288 | ) | $ | (27,832 | ) | $ | (50,570 | ) | $ | (61,030 | ) | ||||
Denominator: | ||||||||||||||||
Weighted average common shares outstanding—basic and diluted | 62,282,291 | 48,749,627 | 61,145,254 | 46,866,842 | ||||||||||||
Net loss per share—basic and diluted | $ | (0.58 | ) | $ | (0.57 | ) | $ | (0.83 | ) | $ | (1.30 | ) | ||||
Three Months Ended September 30, | Nine Months Ended September 30, | |||||||||||||||
2020 | 2019 | 2020 | 2019 | |||||||||||||
Basic net income (loss) per common share: | ||||||||||||||||
Numerator: | ||||||||||||||||
Net income (loss) | $ | 17,344 | $ | (21,227 | ) | $ | (33,226 | ) | $ | (82,257 | ) | |||||
Denominator: | ||||||||||||||||
Weighted average common shares | 73,183,923 | 51,891,157 | 65,187,435 | 48,574,275 | ||||||||||||
Net income (loss) per share—basic | $ | 0.24 | $ | (0.41 | ) | $ | (0.51 | ) | $ | (1.69 | ) | |||||
Diluted net income (loss) per common share: | ||||||||||||||||
Numerator: | ||||||||||||||||
Net income (loss) | $ | 17,344 | $ | (21,227 | ) | $ | (33,226 | ) | $ | (82,257 | ) | |||||
Denominator: | ||||||||||||||||
Weighted average common shares | 76,440,293 | 51,891,157 | 65,187,435 | 48,574,275 | ||||||||||||
Net income (loss) per share—diluted | $ | 0.23 | $ | (0.41 | ) | $ | (0.51 | ) | $ | (1.69 | ) |
June 30, | ||||||||
2020 | 2019 | |||||||
Options to purchase common stock | 10,494,989 | 8,548,660 | ||||||
Unvested restricted common stock | 1,691 | 119,988 | ||||||
10,496,680 | 8,668,648 | |||||||
Three Months Ended September 30, | Nine Months Ended September 30, | |||||||||||||||
2020 | 2019 | 2020 | 2019 | |||||||||||||
Options to purchase common stock | 0 | 8,568,506 | 10,309,544 | 8,568,506 | ||||||||||||
Unvested restricted common stock | 0 | 72,677 | 0 | 72,677 | ||||||||||||
0 | 8,641,183 | 10,309,544 | 8,641,183 | |||||||||||||
Nine Months Ended September 30, | ||||||||
2020 | 2019 | |||||||
Lease cost | ||||||||
Operating lease cost | $ | 3,397 | $ | 2,019 | ||||
Total lease cost | $ | 3,397 | $ | 2,019 | ||||
Other information | ||||||||
Operating cash flows from operating leases | $ | 3,022 | $ | 1,933 | ||||
Operating lease liabilities arising from obtaining right-of-use | $ | 53,778 | — | |||||
Weighted-average remaining lease term | 5 years | 8 years | ||||||
Weighted-average discount rate | 11.9 | % | 17.5 | % |
September 30, | ||||
2020 | $ | 7,784 | ||
2021 | 14,737 | |||
2022 | 15,178 | |||
2023 | 15,591 | |||
2024 | 16,050 | |||
2025 and thereafter | 19,164 | |||
Total future minimum lease payments | 88,504 | |||
Less: imputed interest | (23,074 | ) | ||
Present value of lease liabilities | $ | 65,430 | ||
December 31, | ||||
2020 | $ | 2,659 | ||
2021 | 2,737 | |||
2022 | 2,818 | |||
2023 | 2,860 | |||
2024 | 2,937 | |||
2025 and thereafter | 10,160 | |||
Total future minimum lease payments | 24,171 | |||
Less: imputed interest | (11,557 | ) | ||
Present value of lease liabilities | $ | 12,614 | ||
Three Months Ended June 30, | Six Months Ended June 30, | |||||||||||||||
2020 | 2019 | 2020 | 2019 | |||||||||||||
(in thousands) | ||||||||||||||||
Vaccine program | $ | 9,387 | $ | 288 | $ | 11,976 | $ | 545 | ||||||||
MRT5005 program | 3,350 | 5,263 | 9,444 | 11,884 | ||||||||||||
Discovery program | 2,033 | 1,500 | 5,807 | 3,543 | ||||||||||||
MRT5201 program | — | 2,217 | — | 4,087 | ||||||||||||
Oligonucleotide program | — | 62 | — | 95 | ||||||||||||
Unallocated research and development expenses | 14,232 | 7,295 | 23,215 | 13,894 | ||||||||||||
Total research and development expenses | $ | 29,002 | $ | 16,625 | $ | 50,442 | $ | 34,048 | ||||||||
Three Months Ended September 30, | Nine Months Ended September 30, | |||||||||||||||
2020 | 2019 | 2020 | 2019 | |||||||||||||
(in thousands) | ||||||||||||||||
Vaccine program | $ | 8,437 | $ | 243 | $ | 20,412 | $ | 788 | ||||||||
MRT5005 program | 2,643 | 5,458 | 12,087 | 17,343 | ||||||||||||
Discovery program | 2,923 | 1,873 | 8,730 | 5,416 | ||||||||||||
MRT5201 program | — | 2,155 | — | 6,241 | ||||||||||||
Oligonucleotide program | — | 107 | — | 202 | ||||||||||||
Unallocated research and development expenses | 12,341 | 7,459 | 35,556 | 21,353 | ||||||||||||
Total research and development expenses | $ | 26,344 | $ | 17,295 | $ | 76,785 | $ | 51,343 | ||||||||
Three Months Ended June 30, | ||||||||||||
2020 | 2019 | Change | ||||||||||
(in thousands) | ||||||||||||
Collaboration revenue | $ | 16,319 | $ | 1,174 | $ | 15,145 | ||||||
Operating expenses: | ||||||||||||
Research and development | 29,002 | 16,625 | 12,377 | |||||||||
General and administrative | 8,601 | 7,850 | 751 | |||||||||
Change in fair value of contingent consideration | 15,347 | 4,889 | 10,458 | |||||||||
Total operating expenses | 52,950 | 29,364 | 23,586 | |||||||||
Loss from operations | (36,631 | ) | (28,190 | ) | (8,441 | ) | ||||||
Interest income | 343 | 358 | (15 | ) | ||||||||
Loss before benefit from income taxes | (36,288 | ) | (27,832 | ) | (8,456 | ) | ||||||
Benefit from income taxes | — | — | — | |||||||||
Net loss | $ | (36,288 | ) | $ | (27,832 | ) | $ | (8,456 | ) | |||
Three Months Ended September 30, | ||||||||||||
2020 | 2019 | Change | ||||||||||
(in thousands) | ||||||||||||
Collaboration revenue | $ | 66,446 | $ | 1,266 | $ | 65,180 | ||||||
Operating expenses: | ||||||||||||
Research and development | 26,344 | 17,295 | 9,049 | |||||||||
General and administrative | 9,163 | 6,881 | 2,282 | |||||||||
Change in fair value of contingent consideration | 14,190 | (19,834 | ) | 34,024 | ||||||||
Impairment of intangible asset | — | 18,559 | (18,559 | ) | ||||||||
Total operating expenses | 49,697 | 22,901 | 26,796 | |||||||||
Income (loss) from operations | 16,749 | (21,635 | ) | 38,384 | ||||||||
Other income, net | 595 | 408 | 187 | |||||||||
Income (loss) before benefit from income taxes | 17,344 | (21,227 | ) | 38,571 | ||||||||
Benefit from income taxes | — | — | — | |||||||||
Net income (loss) | $ | 17,344 | $ | (21,227 | ) | $ | 38,571 | |||||
Three Months Ended June 30, | ||||||||||||
2020 | 2019 | Change | ||||||||||
(in thousands) | ||||||||||||
Direct external research and development expenses by program: | ||||||||||||
Vaccine program | $ | 9,387 | $ | 288 | $ | 9,099 | ||||||
MRT5005 program | 3,350 | 5,263 | (1,913 | ) | ||||||||
Discovery program | 2,033 | 1,500 | 533 | |||||||||
MRT5201 program | — | 2,217 | (2,217 | ) | ||||||||
Oligonucleotide program | — | 62 | (62 | ) | ||||||||
Unallocated research and development expenses: | ||||||||||||
Personnel related (including stock-based compensation) | 8,791 | 4,701 | 4,090 | |||||||||
Other | 5,441 | 2,594 | 2,847 | |||||||||
Total research and development expenses | $ | 29,002 | $ | 16,625 | $ | 12,377 | ||||||
Three Months Ended September 30, | ||||||||||||
2020 | 2019 | Change | ||||||||||
(in thousands) | ||||||||||||
Direct external research and development expenses by program: | ||||||||||||
Vaccine program | $ | 8,437 | $ | 243 | $ | 8,194 | ||||||
MRT5005 program | 2,643 | 5,458 | (2,815 | ) | ||||||||
Discovery program | 2,923 | 1,873 | 1,050 | |||||||||
MRT5201 program | — | 2,155 | (2,155 | ) | ||||||||
Oligonucleotide program | — | 107 | (107 | ) | ||||||||
Unallocated research and development expenses: | ||||||||||||
Personnel related (including stock-based compensation) | 6,014 | 4,629 | 1,385 | |||||||||
Other | 6,327 | 2,830 | 3,497 | |||||||||
Total research and development expenses | $ | 26,344 | $ | 17,295 | $ | 9,049 | ||||||
Six Months Ended June 30, | ||||||||||||
2020 | 2019 | Change | ||||||||||
(in thousands) | ||||||||||||
Collaboration revenue | $ | 20,974 | $ | 2,648 | $ | 18,326 | ||||||
Operating expenses: | ||||||||||||
Research and development | 50,442 | 34,048 | 16,394 | |||||||||
General and administrative | 16,060 | 14,403 | 1,657 | |||||||||
Change in fair value of contingent consideration | 5,895 | 16,591 | (10,696 | ) | ||||||||
Total operating expenses | 72,397 | 65,042 | 7,355 | |||||||||
Loss from operations | (51,423 | ) | (62,394 | ) | 10,971 | |||||||
Interest income | 853 | 878 | (25 | ) | ||||||||
Loss before benefit from income taxes | (50,570 | ) | (61,516 | ) | 10,946 | |||||||
Benefit from income taxes | — | 486 | (486 | ) | ||||||||
Net loss | $ | (50,570 | ) | $ | (61,030 | ) | $ | 10,460 | ||||
Nine Months Ended September 30, | ||||||||||||
2020 | 2019 | Change | ||||||||||
(in thousands) | ||||||||||||
Collaboration revenue | $ | 87,420 | $ | 3,914 | $ | 83,506 | ||||||
Operating expenses: | ||||||||||||
Research and development | 76,785 | 51,343 | 25,442 | |||||||||
General and administrative | 25,223 | 21,284 | 3,939 | |||||||||
Change in fair value of contingent consideration | 20,085 | (3,243 | ) | 23,328 | ||||||||
Impairment of intangible asset | — | 18,559 | (18,559 | ) | ||||||||
Total operating expenses | 122,093 | 87,943 | 34,150 | |||||||||
Income (loss) from operations | (34,673 | ) | (84,029 | ) | 49,356 | |||||||
Other income, net | 1,447 | 1,286 | 161 | |||||||||
Income (loss) before benefit from income taxes | (33,226 | ) | (82,743 | ) | 49,517 | |||||||
Benefit from income taxes | — | 486 | (486 | ) | ||||||||
Net loss | $ | (33,226 | ) | $ | (82,257 | ) | $ | 49,031 | ||||
Six Months Ended June 30, | ||||||||||||
2020 | 2019 | Change | ||||||||||
(in thousands) | ||||||||||||
Direct external research and development expenses by program: | ||||||||||||
Vaccine program | $ | 11,976 | $ | 545 | $ | 11,431 | ||||||
MRT5005 program | 9,444 | 11,884 | (2,440 | ) | ||||||||
Discovery program | 5,807 | 3,543 | 2,264 | |||||||||
MRT5201 program | — | 4,087 | (4,087 | ) | ||||||||
Oligonucleotide program | — | 95 | (95 | ) | ||||||||
Unallocated research and development expenses: | ||||||||||||
Personnel related (including stock-based compensation) | 14,777 | 8,986 | 5,791 | |||||||||
Other | 8,438 | 4,908 | 3,530 | |||||||||
Total research and development expenses | $ | 50,442 | $ | 34,048 | $ | 16,394 | ||||||
Nine Months Ended September 30, | ||||||||||||
2020 | 2019 | Change | ||||||||||
(in thousands) | ||||||||||||
Direct external research and development expenses by program: | ||||||||||||
Vaccine program | $ | 20,412 | $ | 788 | $ | 19,624 | ||||||
MRT5005 program | 12,087 | 17,343 | (5,256 | ) | ||||||||
Discovery program | 8,730 | 5,416 | 3,314 | |||||||||
MRT5201 program | — | 6,241 | (6,241 | ) | ||||||||
Oligonucleotide program | — | 202 | (202 | ) | ||||||||
Unallocated research and development expenses: | ||||||||||||
Personnel related (including stock-based compensation) | 20,792 | 13,615 | 7,177 | |||||||||
Other | 14,764 | 7,738 | 7,026 | |||||||||
Total research and development expenses | $ | 76,785 | $ | 51,343 | $ | 25,442 | ||||||
Six Months Ended June 30, | ||||||||
2020 | 2019 | |||||||
(in thousands) | ||||||||
Net cash used in operating activities | $ | (51,489 | ) | $ | (41,445 | ) | ||
Net cash provided by investing activities | 79,422 | 15,525 | ||||||
Net cash provided by financing activities | 159,680 | 45,550 | ||||||
Net increase in cash, cash equivalents and restricted cash | $ | 187,613 | $ | 19,630 | ||||
Nine Months Ended September 30, | ||||||||
2020 | 2019 | |||||||
(in thousands) | ||||||||
Net cash provided by (used in) operating activities | $ | 258,292 | $ | (61,900 | ) | |||
Net cash provided by (used in) investing activities | 97,922 | (24,086 | ) | |||||
Net cash provided by financing activities | 233,256 | 129,642 | ||||||
Net increase in cash, cash equivalents and restricted cash | $ | 589,470 | $ | 43,656 | ||||
* | Filed herewith. |
** | Furnished herewith. |
+ | Portions of this exhibit have been omitted pursuant to Item 601(b)(10)(iv) of Regulation S-K. |
Translate Bio, Inc. | ||||||
Date: | By: | /s/ Ronald C. Renaud, Jr. | ||||
Ronald C. Renaud, Jr. | ||||||
President and Chief Executive Officer | ||||||
Date: | By: | /s/ John R. Schroer | ||||
John R. Schroer | ||||||
Chief Financial Officer and Treasurer |