☒ | 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 |
Symbol(s) on which registered
Large accelerated filer | ☐ | Accelerated filer | ☒ | |||
Non-accelerated filer | ☐ | Smaller reporting company | ☒ | |||
Emerging growth company | ☒ |
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PART I. | 1 | |||||
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Item 2. | 25 | |||||
Item 3. | 40 | |||||
Item 4. | 40 | |||||
PART II. | 41 | |||||
Item 1. | 41 | |||||
Item 1A. | 41 | |||||
Item 5. | 89 | |||||
Item 6. | 90 | |||||
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the impacts of theCOVID-19 pandemic;
• | 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;
• | 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 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, cash equivalents and short-term investments and the period in which we expect that such cash, cash equivalents and short-term investments will enable us to fund such operating expenses and capital expenditure requirements;
• | 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 ability to continue as a going concern;
• | our plans to develop our product candidates; |
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 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 potential advantages of our product candidates;
• | the rate and degree of market acceptance and clinical utility 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 estimates regarding the potential market opportunity for our product candidates;
• | our commercialization, marketing and manufacturing capabilities and strategy; |
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 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; |
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; |
the impact of government laws and regulations;
• | our competitive position; |
our competitive position;
• | developments relating to our competitors and our industry; and |
developments relating to our competitors and our industry;
• | our ability to establish collaborations or obtain additional funding. |
our ability to establish collaborations or obtain additional funding; and
our expectations regarding the time during which we will be an emerging growth company under the JOBS Act.
ii
We may not actually achieve the plans, intentions or expectations disclosed in our forward-looking statements, and you should not place undue reliance on our forward-looking statements. Actual results or events could differ materially from the plans, intentions and expectations disclosed in the forward-looking statements we make. We have included important factors in the cautionary statements included in this Quarterly Report on
Assets Current assets: Cash and cash equivalents Short-term investments Collaboration receivables Prepaid expenses and other current assets Restricted cash Total current assets Property and equipment, net Right-of-use assets, net Goodwill Intangible assets, net Other assets Total assets Liabilities and Stockholders’ Equity Current liabilities: Accounts payable Accrued expenses Current portion of deferred revenue Current portion of operating lease liability Total current liabilities Contingent consideration Deferred revenue, net of current portion Operating lease liability, net of current portion Total liabilities Commitments and contingencies (Notes 3, 4 and 12) Stockholders’ equity: Preferred stock, $0.001 par value; 10,000,000 shares authorized as of March 31, 2020 and December 31, 2019, respectively; no shares issued and outstanding as of March 31, 2020 and December 31, 2019 Common stock, $0.001 par value; 200,000,000 shares authorized as of March 31, 2020 and December 31, 2019; 60,037,663 shares and 60,022,067 shares issued and outstanding as of March 31, 2020 and December 31, 2019, respectively Additionalpaid-in capital Accumulated deficit Accumulated other comprehensive income Total stockholders’ equity Total liabilities and stockholders’ equity March 31,
2020 December 31,
2019 $ 97,468 $ 84,580 57,627 104,098 6,228 4,596 6,921 9,391 950 950 169,194 203,615 13,781 12,539 10,268 10,400 21,359 21,359 84,844 85,536 5,796 2,752 $ 305,242 $ 336,201 �� $ 6,297 $ 15,968 7,478 7,072 26,760 18,100 573 530 41,108 41,670 94,203 103,655 15,328 25,256 11,931 12,084 162,570 182,665 — — 60 60 515,535 512,231 (373,778 ) (359,496 ) 855 741 142,672 153,536 $ 305,242 $ 336,201
2020 $ 674,050 $ 84,580 — 104,098 25,139 4,596 10,822 9,391 950 950 710,961 203,615 15,044 12,539 75,650 10,400 21,359 21,359 81,280 85,536 4,334 2,752 $ 908,628 $ 336,201 $ 6,815 $ 15,968 11,766 7,072 93,164 18,100 12,279 530 124,024 41,670 123,740 103,655 242,047 25,256 53,151 12,084 542,962 182,665 — — 74 60 758,314 512,231 (392,722 ) (359,496 ) — 741 365,666 153,536 $ 908,628 $ 336,201
Three Months Ended March 31, | ||||||||
2020 | 2019 | |||||||
Collaboration revenue | $ | 4,654 | $ | 1,474 | ||||
Operating expenses: | ||||||||
Research and development | 21,439 | 17,423 | ||||||
General and administrative | 7,458 | 6,554 | ||||||
Change in fair value of contingent consideration | (9,452 | ) | 11,702 | |||||
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Total operating expenses | 19,445 | 35,679 | ||||||
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Loss from operations | (14,791 | ) | (34,205 | ) | ||||
Interest income, net | 509 | 521 | ||||||
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Loss before benefit from income taxes | (14,282 | ) | (33,684 | ) | ||||
Benefit from income taxes | — | 486 | ||||||
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Net loss | $ | (14,282 | ) | $ | (33,198 | ) | ||
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Net loss per share—basic and diluted | $ | (0.24 | ) | $ | (0.74 | ) | ||
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Weighted average common shares outstanding—basic and diluted | 60,008,217 | 45,004,521 | ||||||
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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 March 31, | ||||||||
2020 | 2019 | |||||||
Net loss | $ | (14,282 | ) | $ | (33,198 | ) | ||
Other comprehensive income (loss): | ||||||||
Unrealized gains onavailable-for-sale securities, net of tax of $0 | 114 | 155 | ||||||
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Comprehensive loss | $ | (14,168 | ) | $ | (33,043 | ) | ||
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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 onavailable-for-sale securities | — | — | — | — | 114 | 114 | ||||||||||||||||||
Net loss | — | — | — | (14,282 | ) | — | (14,282 | ) | ||||||||||||||||
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Balances at March 31, 2020 | 60,037,663 | $ | 60 | $ | 515,535 | $ | (373,778 | ) | $ | 855 | $ | 142,672 | ||||||||||||
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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 onavailable-for-sale securities | — | — | — | — | 155 | 155 | ||||||||||||||||||
Net loss | — | — | — | (33,198 | ) | — | (33,198 | ) | ||||||||||||||||
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Balances at March 31, 2019 | 45,294,439 | $ | 45 | $ | 374,113 | $ | (279,401 | ) | $ | 351 | $ | 95,108 | ||||||||||||
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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 | ||||||||||||
Three Months Ended March 31, | ||||||||
2020 | 2019 | |||||||
Cash flows from operating activities: | ||||||||
Net loss | $ | (14,282 | ) | $ | (33,198 | ) | ||
Adjustments to reconcile net loss to net cash used in operating activities: | ||||||||
Depreciation and amortization expense | 1,351 | 1,025 | ||||||
Stock-based compensation expense | 3,172 | 1,959 | ||||||
Change in fair value of contingent consideration | (9,452 | ) | 11,702 | |||||
Deferred income tax benefit | — | (486 | ) | |||||
Changes in operating assets and liabilities: | ||||||||
Collaboration receivables | (1,633 | ) | (482 | ) | ||||
Prepaid expenses and other assets | (397 | ) | (285 | ) | ||||
Right-of-use assets | 132 | 115 | ||||||
Accounts payable | (9,545 | ) | (1,048 | ) | ||||
Accrued expenses | 584 | (71 | ) | |||||
Lease liability | (110 | ) | (74 | ) | ||||
Deferred revenue | (1,267 | ) | (688 | ) | ||||
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Net cash used in operating activities | (31,447 | ) | (21,531 | ) | ||||
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Cash flows from investing activities: | ||||||||
Purchases of investments | (27,409 | ) | — | |||||
Sales and maturities of investments | 73,994 | 28,905 | ||||||
Purchases of property and equipment | (2,325 | ) | (1,039 | ) | ||||
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Net cash provided by investing activities | 44,260 | 27,866 | ||||||
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Cash flows from financing activities: | ||||||||
Payments of public offering costs | (57 | ) | — | |||||
Proceeds from option exercises | 132 | 897 | ||||||
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Net cash provided by financing activities | 75 | 897 | ||||||
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Net increase in cash, cash equivalents and restricted cash | 12,888 | 7,232 | ||||||
Cash, cash equivalents and restricted cash at beginning of period | 85,530 | 56,224 | ||||||
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Cash, cash equivalents and restricted cash at end of period | $ | 98,418 | $ | 63,456 | ||||
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Cash, cash equivalents and restricted cash at end of period: | ||||||||
Cash and cash equivalents | $ | 97,468 | $ | 62,431 | ||||
Restricted cash | 950 | 1,025 | ||||||
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Total cash, cash equivalents and restricted cash at end of period | $ | 98,418 | $ | 63,456 | ||||
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Supplemental disclosure ofnon-cash investing and financing activities: | ||||||||
Purchases of property and equipment included in accounts payable and accrued expenses | $ | 764 | $ | 95 | ||||
Deferred offering costs included in accounts payable and accrued expenses | $ | 120 | $ | — |
thousands, except share amounts)
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 |
diseases under a collaboration with Sanofi Pasteur Inc. (“Sanofi”), the vaccines global business unit of Sanofi S.A.
possible effects on its financial condition, liquidity, operations, suppliers, industry and workforce.
data.
In September 2019, the Company announced its decisiona clinical proof of technology trial anticipated to discontinue the developmentbegin mid-year 2021.
In July 2019, the Company filed a universal shelf registration statement on FormS-3 with the SEC (the “2019 Shelf”) to register for sale from time to time up to $250.0 million of common stock, preferred stock, debt securities, warrants and/or units in one or more offerings, which became effective on July 19, 2019 (FileNo. 333-232543).
In July 2019, the Company entered into an Open Market Sale AgreementSM (the “Sales Agreement”) with Jefferies LLC (“Jefferies”) under which the Company may issue and sell shares of its common stock, from time to time, having an aggregate offering price of up to $50.0 million. The offer and sales of shares under the Sales Agreement were also registered under the Securities Act of 1933, as amended (the “Securities Act”), pursuant to the 2019 Shelf. Between April 1, 2020 and May 5, 2020, the Company settled transactions that occurred pursuant to the Sales Agreement, whereby the Company issued and sold an aggregate of 2,863,163 shares of its common stock between March 30, 2020 and May 1, 2020, resulting in gross proceeds of $37.9 million, before deducting commissions of $1.1 million and other offering expenses of $0.2 million (see Note 14). Sales of common stock through Jefferies may be made by any method that is deemed an “at the market” offering as defined in Rule 415 promulgated under the Securities Act. Jefferies has agreed to use its commercially reasonable efforts consistent with its normal trading and sales practices to sell the common stock based upon the Company’s instructions. The Company is not obligated to make any sales of its common stock under the Sales Agreement.
On March 13, 2020, the Company entered into Amendment No. 1 to thean Open Market Sale Agreement increased the aggregate dollar amount of shares of common stock that the Company may issue and sell shares of its common stock, from time to time, having an aggregate offering price of up to $100.0 million.
Registration Statement. The price to the public was $22.00 per share, resulting in gross proceeds to the Company of $125.0 million, before deducting underwriting discounts and commissions of $7.5 million and other offering expenses of $0.5 million. The Company did not receive any proceeds from the sale of shares of common stock by the stockholder.
Going Concern
July 20, 2020 (see Note 3).
Based on its recurring losses and cash outflows from operations since inception, expectation of continuing operating losses and cash outflows from operations for the foreseeable future and the need to raise additional capital to finance its future operations, the Company concluded that there is substantial doubt about its ability to continue as a going concern.
result in a
Pursuant to the Amended Sanofi Agreement,6.
Pursuant to the Amended Sanofi Agreement, the Company and Sanofi have agreed to a governance structure, including committees and working groups, to manage the activities under the collaboration. If the Company and Sanofi do not mutually agree on certain decisions, Sanofi would be able to break a deadlock without the Company’s consent. The collaboration includes an estimated budget. Sanofi is responsible for paying reimbursable development costs, including the Company’s employee costs,out-of-pocket costs paid to third parties and manufacturing costs, up to a specified amount for the Licensed Field other thanSARS-CoV-2, for which each party pays its own employee costs and share equally in the collective out of pocket costs.
Sanofi.
amount for each Licensed Field.
an additional
regulatory, manufacturing and commercialization milestones.milestones, inclusive of the fee to exercise the option to extend the Collaboration Term. In particular, the Company is entitled to receive development, and regulatory milestone payments of up to $63.0 million per Licensed Field and sales milestone payments of up to $85.0$148.0 million perfor each Licensed Field.Field, other than the
Notwithstanding
Pursuant to the Amended Sanofi Agreement, Sanofi has also agreed to pay the Company a tiered royaltyroyalties on worldwide net sales of all mRNA vaccines within each in the
Under the Sanofi Amendment,Agreement, except where such vaccines are provided as a donation or transferred to a third party without any profit margin, in which case the Company and Sanofi agreedwill be paid royalties sufficient to negotiate in good faith an additional amendment related to activities directed to clinical development or commercializationcover its royalty obligations.
Moreover,
Accountingsingle performance obligation in accordance with ASC 606.
The Company accounts for the Sanofi Amendment entered into on March 26, 2020, with the exception of the Licensed Field forSARS-CoV-2, under ASC 606. In determining the appropriate amount of revenue to be recognized under ASC 606, the Company performed the following steps: (i) identified the promised goods or services in the contract; (ii) determined whether the promised goods or services are performance obligations including whether they are distinct in the context of the contract; (iii) measurement of the transaction price, including the constraint on variable consideration; (iv) allocation of the transaction price to the performance obligations; and (v) recognition of revenue when (or as) the Company satisfies each performance obligation.
containing mRNA until the Company transfers such manufacturing capabilities to Sanofi; and (vi) the technology and process transfer. The Company assessed whether each of these promised goods or services are distinct performance obligations on their own or if they need to be combined with other promises to create a bundle that is a distinct performance obligation. The Company determined that the promised goods and services do not have standalone value and are highly interrelated. Accordingly, the promised goods and
Under ASC 606, at the end of each reporting period, the Companyre-evaluates the probability that the consideration associated with each milestone or reimbursement will not be subject to a significant reversal in the cumulative amount of revenue recognized, and, if necessary, adjusts the estimate of the overall transaction price. The estimated collaboration budget is consistentlyre-evaluated and changes to the budget, if any, require approval by the Joint Steering Committee. If an approved change occurs, the Company willre-evaluate the transaction price which could potentially affect the cumulative amount of revenue recognized. In March 2020, the joint steering committee agreed to a revised budget and collaboration plan. As a result, during the three months ended March 31, 2020, the Company increased the overall transaction price by $30.5 million. The transaction price includes the upfront,non-refundable payment of $45.0 million for the transfer of the combined license, supply and development obligations under the Original Sanofi Agreement, an estimated $34.3 million in reimbursable employee costs, an estimated $88.3 million in reimbursable development costs includingout-of-pocket costs paid to third parties and manufacturing costs and an estimated $14.0 million in milestone payments.
obligation.
The Company has estimated the completion of manufacturing activities to be in 2024.
Three Months Ended March 31, | ||||||||
2020 | 2019 | |||||||
Collaboration revenue | $ | 4,654 | $ | 1,474 |
Three Months Ended September 30, | Nine Months Ended September 30, | |||||||||||||||
2020 | 2019 | 2020 | 2019 | |||||||||||||
Collaboration revenue | $ | 66,446 | $ | 1,266 | $ | 87,420 | $ | 3,914 |
March 31, 2020 | December 31, 2019 | |||||||
Contract liabilities | ||||||||
Deferred revenue | $ | 42,088 | $ | 43,356 |
The Company considers
September 30, 2020 | December 31, 2019 | |||||||
Contract liabilities | ||||||||
Deferred revenue | $ | 335,211 | $ | 43,356 |
The Company evaluated the Sanofi Amendment, with respect to the Licensed Field for SARS-COV-2, under the ASC 606 contract modification guidance and determined that the Sanofi Amendment, with respect to the Licensed Field for SARS-COV-2, should be accounted for as a separate contract as it added additional distinct goods and services at a stand-alone price. The Original Sanofi Agreement will continue to be accounted for under ASC 606. The Company determined the Sanofi Amendment, with respect to the Licensed Field for SARS-COV-2, will be accounted for under ASC 808 as both parties are active participants and each party pays its own employee costs and share equally in the collective out
March 31, 2020 | ||||||||||||||||||||
Estimated Life | Gross Carrying Amount | Accumulated Amortization | Impairment Charge | Net Carrying Amount | ||||||||||||||||
(In thousands) | ||||||||||||||||||||
Definite-lived intangible assets: | ||||||||||||||||||||
MRT | 6 years | $ | 45,992 | $ | (3,439 | ) | $ | — | $ | 42,553 | ||||||||||
|
|
|
|
|
|
|
| |||||||||||||
Indefinite-lived intangible assets: | ||||||||||||||||||||
IPR&D—CF | Indefinite | 42,291 | — | — | 42,291 | |||||||||||||||
|
|
|
|
|
|
|
| |||||||||||||
Total intangible assets, net | $ | 88,283 | $ | (3,439 | ) | $ | — | $ | 84,844 | |||||||||||
|
|
|
|
|
|
|
|
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 | ||||||||||
|
|
|
|
|
|
|
|
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 |
program.
Fair Value Measurements as of March 31, 2020 Using: | ||||||||||||||||
Level 1 | Level 2 | Level 3 | Total | |||||||||||||
Assets: | ||||||||||||||||
Money market funds | $ | — | $ | 53,850 | $ | — | $ | 53,850 | ||||||||
U.S. government agency bonds | — | 57,627 | — | 57,627 | ||||||||||||
|
|
|
|
|
|
|
| |||||||||
$ | — | $ | 111,477 | $ | — | $ | 111,477 | |||||||||
|
|
|
|
|
|
|
| |||||||||
Liabilities: | ||||||||||||||||
Contingent consideration | $ | — | $ | — | $ | 94,203 | $ | 94,203 | ||||||||
|
|
|
|
|
|
|
| |||||||||
$ | — | $ | — | $ | 94,203 | $ | 94,203 | |||||||||
|
|
|
|
|
|
|
|
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 | |||||||||
Unobservable Inputs | Fair Value at | |||||||||||
Projected Year of Payment | March 31, 2020 | December 31, 2019 | ||||||||||
Earnout payments | 2026 - 2039 | 87,054 | $ | 96,097 | ||||||||
Milestone payments | 2026 - 2030 | 7,149 | 7,558 | |||||||||
|
|
|
| |||||||||
$ | 94,203 | $ | 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 Value | ||||
Balance as of December 31, 2019 | $ | 103,655 | ||
Decrease in fair value of contingent consideration | (9,452 | ) | ||
|
| |||
Balance as of March 31, 2020 | $ | 94,203 | ||
|
|
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 | ||
March 31, 2020 | December 31, 2019 | |||||||
Laboratory equipment | $ | 9,700 | $ | 9,044 | ||||
Computer equipment | 893 | 779 | ||||||
Office equipment | 883 | 883 | ||||||
Leasehold improvements | 5,635 | 5,635 | ||||||
Construction in progress | 4,590 | 3,460 | ||||||
|
|
|
| |||||
21,701 | 19,801 | |||||||
Less: Accumulated depreciation and amortization | (7,920 | ) | (7,262 | ) | ||||
|
|
|
| |||||
$ | 13,781 | $ | 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 | |||||
March 31, 2020 | December 31, 2019 | |||||||
Accrued external research and development expenses | $ | 3,879 | $ | 1,763 | ||||
Accrued employee compensation and benefits | 2,298 | 3,547 | ||||||
Accrued consultant and professional fees | 1,174 | 1,390 | ||||||
Other | 127 | 372 | ||||||
|
|
|
| |||||
$ | 7,478 | $ | 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 | |||||
plan.
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 | 2,369,168 | $ | 7.66 | |||||||||||||
Exercised | (15,596 | ) | $ | 8.49 | ||||||||||||
Forfeited | (16,723 | ) | $ | 9.16 | ||||||||||||
|
| |||||||||||||||
Outstanding as of March 31, 2020 | 10,983,227 | $ | 7.97 | 8.56 | $ | 22,260 | ||||||||||
|
| |||||||||||||||
Exercisable as of March 31, 2020 | 4,287,057 | $ | 7.72 | 7.88 | $ | 9,685 | ||||||||||
Vested and expected to vest as of March 31, 2020 | 10,983,227 | $ | 7.97 | 8.56 | $ | 22,260 |
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 |
Three Months Ended March 31, | ||||||||
2020 | 2019 | |||||||
Risk-free interest rate | 0.86 | % | 2.47 | % | ||||
Expected term (in years) | 6.1 | 6.0 | ||||||
Expected volatility | 68.0 | % | 73.9 | % | ||||
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 | (27,405 | ) | $ | 1.28 | ||||
|
| |||||||
Unvested restricted common stock outstanding as of March 31, 2020 | 6,763 | $ | 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 March 31, | ||||||||
2020 | 2019 | |||||||
Research and development expenses | $ | 1,454 | $ | 869 | ||||
General and administrative expenses | 1,718 | 1,090 | ||||||
|
|
|
| |||||
$ | 3,172 | $ | 1,959 | |||||
|
|
|
|
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 | |||||||||
10. Net Loss per Share
Net Loss per Share
Three Months Ended March 31, | ||||||||
2020 | 2019 | |||||||
Numerator: | ||||||||
Net loss | $ | (14,282 | ) | $ | (33,198 | ) | ||
Denominator: | ||||||||
Weighted average common shares outstanding—basic and diluted | 60,008,217 | 45,004,521 | ||||||
|
|
|
| |||||
Net loss per share—basic and diluted | $ | (0.24 | ) | $ | (0.74 | ) | ||
|
|
|
|
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 | ) |
The Company’s potentially dilutive securities, which include stock options and As of September 30, 2020, there are 0 unvested shares of restricted common stock, have been excluded from the computation of diluted net loss per share attributable to common stockholders as the effect would be to reduce the net loss per share. Therefore, the weighted average number of shares of common stock outstanding used to calculate both basic and diluted net loss per share attributable to common stockholders is the same.
stock.
Three Months Ended March 31, | ||||||||
2020 | 2019 | |||||||
Options to purchase common stock | 10,983,227 | 8,012,029 | ||||||
Unvested restricted common stock | 6,763 | 168,758 | ||||||
|
|
|
| |||||
10,989,990 | 8,180,787 | |||||||
|
|
|
|
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 | ||
leases do not provide an implicit rate, the Company uses its incremental borrowing rate, which are the rates incurred to borrow on a collateralized basis over a term equal to the lease payments in a similar economic environment, in determining the present value of lease payments. The Company used the incremental borrowing rate on January 1, 2019 for operating leases that commenced prior to that date and for all subsequent leases the Company used an appropriate borrowing rate upon commencement date.
Agreement
In November 2016, the Company entered into a research agreement with MIT pursuant to which the Company was obligated to reimburse MIT in an amount up to $3.1 million for specified direct and indirect costs incurred through October 2019 in specified research activities conducted for the Company (the “2016 MIT Agreement”). Research and development expenses related to this agreement totaled $0 million and $0.2 million during the three months ended March 31, 2020 and 2019, respectively. As amended, the 2016 MIT Agreement expired in October 2019 and as of March 31, 2020, the Company had paid MIT the total committed amount.
Research and development expenses
respectively.
Offerings
Between April 1,Event
Business Impact of theCOVID-19 Pandemic
The outbreak of a novel strain of virus namedSARS-CoV-2 (severe acute respiratory syndrome 2), which causes coronavirus disease, orCOVID-19, has presented a substantial public health and economic challenge around the world and is affecting our employees, patients, communities and business operations, as well as the U.S. economy and financial markets. In April 2020, we announced that enrollment and dosing have been paused in our ongoing Phase 1/2 clinical trial in patients with cystic fibrosis, or CF, as a consequence of the response to theCOVID-19 pandemic. We are uncertain when such enrollment and dosing will resume, which may impact our timing to report data from this trial. The full extent to which theCOVID-19 pandemic will directly or indirectly impact our business, results of operations and financial condition will depend on future developments that are highly uncertain and cannot be accurately predicted, including new information that may emerge concerningCOVID-19, the actions taken in an effort to contain it or to potentially treat or vaccinate againstCOVID-19 and the economic impact on local, regional, national and international markets. Management is actively monitoring this situation and the possible effects on our financial condition, liquidity, operations, suppliers, industry, and workforce. For additional information on risks posed by theCOVID-19 pandemic, please see Part II, Item 1A – “Risk Factors – Risks Related toCOVID-19,” included elsewhere in this Quarterly Report on Form10-Q.
translation and expression of fully functional CFTR protein, thereby restoring this essential ion channel, which we believe will address the pathology of CF directly. Currently approved CFTR modulating therapies are limited to patients with specific genetic mutations; therefore, there remains a significant unmet medical need for patients with CF who have genetic mutations
data.
hypertension.
protein for destruction within the cell may have advantages over other protein degradation approaches, including the ability to reach previously undruggable therapeutic targets and increased target selectivity. We have early discovery efforts ongoing in this area.
On March 26, 2020, we amended our collaboration with Sanofi to include Two of the target pathogens under development are a novel strain of an mRNA vaccine forcoronavirus named as an additional infectious disease pathogen. Multiple are being evaluatedto supportMRT5500 was selected as the lead candidate selection with the goalfor a vaccine againstinitiatingassociated with afirst-in-human2020. Assuming an accelerated development pathway2020, and is now expected to begin in the first quarter of 2021 due to a delay in theCOVID-19 pandemic and successful completion manufacturing of clinical studies demonstrating safety and efficacy, earliest approval of a vaccine from this program could occur in the second half of 2021.trial material. For information on risks related to our successful development of a vaccine againstCOVID-19, please see Part II, Item 1A – “Risk Factors – Risks Related to the COVID-19 Pandemic,” included elsewhere in this Quarterly Report on Form10-Q.
For the influenza vaccine program, lead lipid nanoparticles/mRNA formulation is being evaluated in preclinical studies to support clinical proof of technology trial anticipated to begin mid-year 2021. Preclinical studies are ongoing for targets against additional viral and bacterial pothogens.
In September 2019, we announced our decision to discontinue the development of MRT5201, a liver targeted treatment for ornithine transcarbamylase, or OTC, deficiency. Our decision to discontinue the development of MRT5201 for OTC deficiency was based on data from preclinical studies completed in 2019, the results of which did not support the desired pharmacokinetic and safety profile for advancement of the program. These data are related to the first-generation liver lipid nanoparticle, or LNP, designed to be delivered to the liver via intravenous administration from the program. As such, this LNP is different from that used in our CF and other pulmonary development programs which are designed to deliver theLNP-encapsulated mRNA through nebulization.
In 2018, we entered into a collaboration and license agreement with Sanofi, or the Original Sanofi Agreement, to develop mRNA vaccines for up to five infectious disease pathogens, or the Licensed Fields. On March 26, 2020, we and Sanofi amended the Original Sanofi Agreement, or the Sanofi Amendment, to include vaccines againstSARS-CoV-2 as an additional Licensed Field, increasing the number of infectious disease pathogens to up to six. The Original Sanofi Agreement, as amended by the Sanofi Amendment, is referred to as the Amended Sanofi Agreement.
Under the Amended Sanofi Agreement, we and Sanofi are jointly conducting research and development activities to advance mRNA vaccines and mRNA vaccine platform development during a three-year research term, which may be extended by mutual agreement. We are eligible to receive up to $805.0 million in payments, including an upfront payment of $45.0 million, which we received in 2018; certain development, regulatory and sales-related milestones across several vaccine targets, and option exercise fees if Sanofi exercises its option related to development of vaccines for additional pathogens. Sanofi did not pay an upfront fee to us with respect to the addition ofSARS-CoV-2 as a Licensed Field. We are also eligible to receive reimbursable development costs and tiered royalty payments associated with worldwide sales of certain developed vaccines, if any.
We and Sanofi also agreed that certain provisions of the Original Sanofi Agreement, including provisions related to milestone payments, royalties and royalty reductions, shall not apply to vaccine products for the prevention, treatment or cure ofSARS-CoV-2 that are purchased by a governmental authority whileSARS-CoV-2 is a declared pandemic. We and Sanofi agreed to negotiate in good faith the royalty terms applicable to such products, which terms shall reflect the economic conditions applicable to commercializing such products and shall not exceed the royalty terms for the existing Licensed Fields.
Through March 31,September 30, 2020, we have funded our operations primarily with net cashthrough sales of equity securities and research and collaboration agreements and we have received proceeds of $189.2 millionapproximately $1.1 billion from the sale of redeemable convertible preferred stock and the sale of bridge units, which ultimately converted into shares of our common stock, net cash proceeds of $113.2 million from our initial public offering of our common stock, or the IPO, $45.0 million from the upfront payment received under the Original Sanofi Agreement, net cash proceeds of $44.1 million from a private placement of our common stock and net cash proceeds of $84.0 million from a public offering of our common stock.
such transactions.
licensing arrangements with third parties or grants from organizations and foundations. We may be unable to raise additional funds or enter into such other agreements or arrangements when needed on favorable terms, or at all. If we fail to raise capital or enter into such agreements as, and when, needed, we may have to significantly delay, scale back or discontinue the development and commercialization of one or more of our product candidates or delay our pursuit of potential
There is no assurance that wecondition will be successful in obtaining additional financingdepend on terms acceptable to us, if at all, nor is it considered probable under the accounting standards. As such, under the requirements of ASC205-40, management may not consider the potential for future capital raises or management plans to reduce costsdevelopments that are not considered probablehighly uncertain and cannot be accurately predicted, including new information that may emerge concerning
included elsewhere in this Quarterly Report on Form
In 2018, we entered into
Under revenue recognition guidance, we account for: (i) the license we conveyed to Sanofi with respect to the Licensed Fields, (ii) the licensed
We recognize adjustments in revenue under the cumulative
Three Months Ended March 31, | ||||||||
2020 | 2019 | |||||||
(in thousands) | ||||||||
MRT5005 program | $ | 6,094 | $ | 6,622 | ||||
Discovery program | 3,775 | 2,042 | ||||||
Vaccine program | 2,589 | 257 | ||||||
MRT5201 program | — | 1,869 | ||||||
Oligonucleotide program | — | 34 | ||||||
Unallocated research and development expenses | 8,981 | 6,599 | ||||||
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Total research and development expenses | $ | 21,439 | $ | 17,423 | ||||
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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 | ||||||||
In September 2019, we announced our decision to discontinue the development
the success of our collaboration with Sanofi;
Interest Income
Interestnet
Other
Other income (expense), net consists of miscellaneous income and expense unrelated to our core operations.
Income Taxes
development tax credit carryforwards of $6.5 million and $2.7 million, respectively, which will, if not utilized, begin to expire in 2032 and 2028, respectively, and orphan drug tax credit carryforwards of $13.0 million, which begin to expire in 2037. We also have state investment tax credit carryforwards of $0.3 million, which will, if not utilized, begin to expire in 2020. As of December 31, 2019, we recorded a full valuation allowance against our deferred tax assets, except for the deferred tax asset associated with our alternative minimum tax credit carryforwards, which will be fully refundable.
Three Months Ended March 31, | ||||||||||||
2020 | 2019 | Change | ||||||||||
(in thousands) | ||||||||||||
Collaboration revenue | $ | 4,654 | $ | 1,474 | $ | 3,180 | ||||||
Operating expenses: | ||||||||||||
Research and development | 21,439 | 17,423 | 4,016 | |||||||||
General and administrative | 7,458 | 6,554 | 904 | |||||||||
Change in fair value of contingent consideration | (9,452 | ) | 11,702 | (21,154 | ) | |||||||
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Total operating expenses | 19,445 | 35,679 | (16,234 | ) | ||||||||
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Loss from operations | (14,791 | ) | (34,205 | ) | 19,414 | |||||||
Interest income, net | 509 | 521 | (12 | ) | ||||||||
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Loss before benefit from income taxes | (14,282 | ) | (33,684 | ) | 19,402 | |||||||
Benefit from income taxes | — | 486 | (486 | ) | ||||||||
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Net loss | $ | (14,282 | ) | $ | (33,198 | ) | $ | 18,916 | ||||
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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 | |||||
September 30, 2020. See “—Components of Our Results of Operations – Collaboration Revenue” above.
Three Months Ended March 31, | ||||||||||||
2020 | 2019 | Change | ||||||||||
(in thousands) | ||||||||||||
Direct external research and development expenses by program: |
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MRT5005 program | $ | 6,094 | $ | 6,622 | $ | (528 | ) | |||||
Discovery program | 3,775 | 2,042 | 1,733 | |||||||||
Vaccine program | 2,589 | 257 | 2,332 | |||||||||
MRT5201 program | — | 1,869 | (1,869 | ) | ||||||||
Oligonucleotide program | — | 34 | (34 | ) | ||||||||
Unallocated research and development expenses: | ||||||||||||
Personnel related (including stock-based compensation) | 5,985 | 4,285 | 1,700 | |||||||||
Other | 2,996 | 2,314 | 682 | |||||||||
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Total research and development expenses | $ | 21,439 | $ | 17,423 | $ | 4,016 | ||||||
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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 | ||||||
programs.
Direct external expenses of our vaccine program increased by $2.3 million during the three months ended March 31, 2020 compared to the three months ended March 31, 2019 primarily due to increased costs related to the advancement of the development programs associated with the Sanofi collaboration.
diseases.
General and Administrative Expenses
General and administrative expenses were $7.5 million for the three months ended March 31, 2020, compared to $6.6 million for the three months ended March 31, 2019. The increase of $0.9 million was due to an increase of $0.8 million in personnel-related costs primarily due to an increase in stock-based compensation expense.
Benefit from Income Taxes
Duringtime and a decrease in the discount rate.
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 | ||||
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 | ||||||
liquidity.
In July 2019,
In July 2019, we entered intoMay 4, 2020.
On March 13, 2020, we filed a universal shelf registration statement on FormS-3 with the SEC, or the 2020 Shelf, to register for sale from time to time up to $350.0 million of our common stock, preferred stock, debt securities, warrants and/or units in one of more offerings (FileNo. 333-237159). This registration statement was declared effective on May 4, 2020. Upon the effectiveness of the 2020 Shelf, we deregistered the 2019 Shelf and no more sales may be made pursuant to the 2019 Shelf. On March 13, 2020, we entered into Amendment No. 1 to the Open Market Sale AgreementSM with Jefferies, which increased the aggregate dollar amount of shares of common stock that we may issue and sell pursuant to the Sales Agreement from $50.0 million to $100.0 million, which became effective when the 2020 Shelf was declared effective. As of May 1, 2020, we had issued and sold $37.9 million under the Sales Agreement. In the future, $62.1 million of shares of common stock remain available to be sold pursuant to the Sales Agreement, which sales, if any, would be made under the 2020 Shelf. Any
Registration Statement. The price to the public was $22.00 per share, resulting in gross proceeds to us of $125.0 million, before deducting underwriting discounts and commissions of $7.5 million and other offering expenses of $0.5 million. We did not receive any proceeds from the sales of shares of common stock by the stockholder.
Three Months Ended March 31, | ||||||||
2020 | 2019 | |||||||
(in thousands) | ||||||||
Net cash used in operating activities | $ | (31,447 | ) | $ | (21,531 | ) | ||
Net cash provided by investing activities | 44,260 | 27,866 | ||||||
Net cash provided by financing activities | 75 | 897 | ||||||
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Net increase in cash, cash equivalents and restricted cash | $ | 12,888 | $ | 7,232 | ||||
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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 | ||||
During the three months ended March 31, 2019, operating activities used $21.5 million of cash, resulting from our net loss of $33.2 million and net cash used in changes in our operating assets and liabilities of $2.5 million, partially offset by netnon-cash charges of $14.2 million. Netnon-cash charges for the three months ended March 31, 2019 primarily consisted of an $11.7 million increase in the change in the fair value of contingent consideration which was primarily due to the continued progress of MRT5005, the time value of money due to the passage of time and a decrease in the discount rate.
investments.
our ability to continue as a going concern.
On June 22, 2020, we and Sanofi entered into the Second Sanofi Amendment, which further amends the Original Sanofi Agreement to expand the scope of the collaboration and licenses granted to Sanofi, which became effective on July 20, 2020.
if the
Moreover, if
development, and, in that case,
the success of our collaboration with Sanofi;
our ability to continue as a going concern.
We have identified conditions and events that raise substantial doubt about our ability to continue as a going concern.
As of March 31, 2020, we had $155.1 million in existing cash, cash equivalents and short-term investments. We expect these available cash resources, together with the net proceeds of approximately $36.6 million from the issuances and sales of our common stock pursuant to the Sales Agreement between March 30, 2020 and May 1, 2020, which transactions were settled between April 1, 2020 and May 5, 2020, to fund our operating expenses and capital expenditure requirements into the third quarter of 2021. As of December 31, 2019, management concluded that there was substantial doubt under Accounting Standards UpdateNo. 2014-15, Disclosure of Uncertainties about an Entity’s Ability to Continue as a Going Concern (Subtopic 205-40). The report from our independent registered public accounting firm for the year ended December 31, 2019 includes an explanatory paragraph stating that our recurring losses and cash outflows from operations since inception, expectation of continuing operating losses and cash outflows from operations for the foreseeable future and the need to raise additional capital to finance our future
operations raise substantial doubt about our ability to continue as a going concern. Based on our available cash resources, we do not have sufficient cash on hand to support current operations for at least the next twelve months from the date of filing this Quarterly Report on Form10-Q. If we are unable to obtain sufficient funding, we may be forced to delay or reduce the scope of our development programs, our business, prospects, financial condition and results of operations will be materially and adversely affected, and we may be unable to continue as a going concern. If we are unable to continue as a going concern, we may have to liquidate our assets and may receive less than the value at which those assets are carried on our audited financial statements, and it is likely that investors will lose all or a part of their investment. Future reports from our independent registered public accounting firm may also contain statements expressing substantial doubt about our ability to continue as a going concern. If we seek additional financing to fund our business activities in the future and there remains substantial doubt about our ability to continue as a going concern, investors or other financing sources may be unwilling to provide funding to us on commercially reasonable terms, if at all.
condition.condition
In the near term, we are dependent on the success of MRT5005.
successful initiation of clinical trials;
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In April 2020, we announced that enrollment and dosing havehad been paused in our ongoing Phase 1/2 clinical trial in patients with CF as a consequence of the response to thewhenthough we were able to resume enrollment and dosing of patients in this trial resume,as announced in September 2020, we may encounter slower than expected enrollment or dosing delays due to the CF patient population, or CF advocacy groups may provide additional guidance for the safety of the CF population, which may delay the trial. WeAt this time we are uncertain when suchunable to predict the rate of enrollment and dosing will resume.timing for reporting data. We expect that thetrialstrial of MRT5005 as described above in “Risks Related to the
As part of our strategy, we intend to seek to enter into collaborations with third parties for one or more of our programs or product candidates. For example, in June 2018, we entered into
Any collaborations we enter into, including ourSanofi.
Collaborators may have
Collaborators
Collaborators
Collaborators may delay
Collaborators
Product
A collaborator with marketing and distribution rights to one or more of our product candidates that achieve regulatory approval
Collaborators
Collaborators
Collaborations
If our collaborations doSanofi does not result in the successful development and commercialization of products,vaccines, or if one of any future collaboratorsSanofi terminates its agreement with us, we may not receive any future research funding or milestone or royalty payments under the collaboration. If we do not receive the funding we expect under these agreements,our agreement with Sanofi, our development of productvaccine candidates could be delayed and we may need additional resources to develop our productvaccine candidates.
IfSanofi’s activities.
Under Even if we are able to successfully enter into collaborations with third parties for one or more of our programs or product candidates, such collaborations may be subject to risks similar to those described above under the Shire Agreement, priorrisk factor captioned “We have an existing collaboration with Sanofi and we are highly dependent on the efforts of Sanofi to advance our vaccine development program, including the first dosing of a patientvaccine against
business could be adversely affected
We do not currently have any agreements with third-party manufacturers for the long-term commercial supply of any of our product candidates.
We expect that the
Further, as set forth above in the risk factor captioned “We and Sanofi may not be successful in our joint efforts to successfully develop in an expedited timeframe an mRNA vaccine against
On August 3, 2017, Congress passed the FDA Reauthorization Act of 2017, or FDARA. FDARA, among other things, codified the FDA’s
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countries outside the European Union, including the United States, and, as a result, increases the scrutiny that clinical trial sites located in the EEA should apply to transfers of personal data from such sites to countries that are considered to lack an adequate level of data protection, such as the United States. The GDPR also permits data protection authorities to require destruction of improperly gathered or used personal information and or impose substantial fines for violations of the GDPR, which can be up to four percent of global revenues or 20 million Euros, whichever is greater and it also confers a private right of action on data subjects and consumer associations to lodge complaints with supervisory authorities, seek judicial remedies, and obtain compensation for damages resulting from violations of the GDPR. In addition, the GDPR provides that European Union member states may make their own further laws and regulations limiting the processing of personal data, including genetic, biometric or health data.
An active trading market for our common stock may not be sustained.
Our shares of common stock began trading on the Nasdaq Global Select Market on June 28, 2018. Given the limited trading history of our common stock, there is a risk that an active trading market for our shares will not be sustained, which could put downward pressure on the market price for our common stock and thereby affect the ability of our stockholders to sell their shares. An inactive trading market may also impair our ability to raise capital to continue to fund operations by selling shares and may impair our ability to acquire other companies or technologies by using our shares as consideration.
We are an “emerging growth company” and a “smaller reporting company,” and the reduced disclosure requirements applicable to emerging growth companies and smaller reporting companies may make our common stock less attractive to investors.
We are an “emerging growth company,” or EGC, as defined in the Jumpstart Our Business Startups Act of 2012, or the JOBS Act. We will remain an EGC until the earlier of: (i) the last day of the fiscal year in which we have total annual gross revenue of $1.07 billion or more; (ii) the last day of the fiscal year following the fifth anniversary of the date of our initial public offering; (iii) the date on which we have issued more than $1 billion in nonconvertible debt during the previous three years; or (iv) the date on which we are deemed to be a large accelerated filer under the rules of the SEC, which means the last day of the first fiscal year in which the market value of our common stock that is held bynon-affiliates exceeds $700 million as of June 30. For so long as we remain an EGC, we are permitted and intend to rely on exemptions from certain disclosure requirements that are applicable to other public companies that are not EGCs. These exemptions include:
not being required to comply with the auditor attestation requirements in the assessment of our internal control over financial reporting;
reduced disclosure obligations regarding executive compensation;
exemptions from the requirements of holding a nonbinding advisory vote on executive compensation and stockholder approval of any golden parachute payments not previously approved; and
an exemption from compliance with the requirement of the Public Company Accounting Oversight Board regarding the communication of critical audit matters in the auditor’s report on the financial statements.
In addition, the JOBS Act provides that an EGC may take advantage of an extended transition period for complying with new or revised accounting standards. This allows an EGC to delay the adoption of certain accounting standards until those standards would otherwise apply to private companies. We have irrevocably elected not to avail ourselves of this exemption from new or revised accounting standards and, therefore, we will be subject to the same new or revised accounting standards as other public companies that are not EGCs.
We are also a smaller reporting company, and we will remain a smaller reporting company until the fiscal year following the determination that our voting andnon-voting common shares held bynon-affiliates is more than $250 million measured on the last business day of our second fiscal quarter, or our annual revenues are less than $100 million during the most recently completed fiscal year and our voting andnon-voting common shares held bynon-affiliates is more than $700 million measured on the last business day of our second fiscal quarter. Similar to emerging growth companies, smaller reporting companies have reduced disclosure obligations, such as an exemption from providing selected financial data and an ability to provide simplified executive compensation information and only two years of audited financial statements.
We have elected to take advantage of certain of the reduced reporting obligations. Investors may find our common stock less attractive as a result of our reliance on these exemptions. If some investors find our common stock less attractive as a result, there may be a less active trading market for our common stock and our stock price may be more volatile.
We will incur increased costs as a result of operating as a public company, and our management will be required to devote substantial time to new compliance initiatives and requirements.
Salesthe Premises, including our share of Unregistered Securities
None.
UseProceeds from Initial Public Offering$190.00 per square foot of Common StockOn July 2, 2018,the Premises. The TI Allowance can be used for payment of design, permits, and construction costs in connection with the construction of such tenant improvements. The TI Allowance shall be paid by the Landlord as a reimbursement so long as we closed our IPOhave satisfied the specified requisition conditions, including the completion of 9,350,000 sharesthe tenant improvements.
Aggregate net proceeds from the offering, inclusivePremises.
* | 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 |
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