☒ | 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 | 26-1622110 | |
(State or Other Jurisdiction of Incorporation or Organization) | (I.R.S. Employer Identification No.) | |
480 Arsenal Way | ||
Watertown, MA | 02472 | |
(Address Of Principal Executive Offices) | (Zip Code) |
Large accelerated filer ☐ | Accelerated filer ☐ | |
Non-accelerated filer ☒ | Smaller reporting company ☐ |
Page | ||
- | our ability to enroll patients in clinical trials, timely and successfully complete those trials and receive necessary regulatory approvals; |
- | our ability to establish our own manufacturing facilities and to receive or manufacture sufficient quantities of our product candidates; |
September 30, | December 31, | ||||||
2016 | 2015 | ||||||
(unaudited) | |||||||
Assets | |||||||
Current assets: | |||||||
Cash and cash equivalents | $ | 59,488 | $ | 32,337 | |||
Short term deposits and investments | 19,788 | 4,125 | |||||
Restricted cash | 335 | 133 | |||||
Accounts receivable | 483 | 824 | |||||
Prepaid expenses and other current assets | 3,303 | 1,494 | |||||
Total current assets | 83,397 | 38,913 | |||||
Property and equipment, net | 2,066 | 2,029 | |||||
Restricted cash and other deposits | 316 | 316 | |||||
Other assets | — | 1,566 | |||||
Total assets | $ | 85,779 | $ | 42,824 | |||
Liabilities, redeemable convertible preferred stock, and stockholders’ equity (deficit) | |||||||
Current liabilities: | |||||||
Accounts payable | $ | 1,040 | $ | 2,179 | |||
Accrued expenses | 2,434 | 3,378 | |||||
Loans payable, current portion | 2,913 | — | |||||
Deferred revenue, current portion | 1,041 | 1,313 | |||||
Contingently repayable grant funding | 262 | 420 | |||||
Total current liabilities | 7,690 | 7,290 | |||||
Non‑current liabilities: | |||||||
Deferred rent and lease incentive | 234 | 105 | |||||
Loans payable, net of current portion | 9,064 | 11,855 | |||||
Deferred revenue, net of current portion | 3,348 | 2,295 | |||||
Other long‑term liabilities | — | 290 | |||||
Total liabilities | 20,336 | 21,835 | |||||
Commitments and contingencies (Notes 8 and 13) | |||||||
Redeemable Convertible Preferred Stock: | |||||||
Series A redeemable convertible preferred stock, $0.0001 par value; 0 and 2,589,868 shares authorized; 0 and 2,589,868 shares issued and outstanding; as of September 30, 2016 and December 31, 2015 respectively. | — | 3,644 | |||||
Series B redeemable convertible preferred stock, $0.0001 par value; 0 and 7,437,325 shares authorized; 0 and 7,437,325 shares issued and outstanding; as of September 30, 2016 and December 31, 2015 respectively. | — | 21,448 | |||||
Series C redeemable convertible preferred stock, $0.0001 par value; 0 and 5,000,002 shares authorized; 0 and 5,000,002 shares issued and outstanding; as of September 30, 2016 and December 31, 2015 respectively. | — | 20,178 | |||||
Series D redeemable convertible preferred stock, $0.0001 par value; 0 and 8,166,662 shares authorized; 0 and 8,099,994 shares issued and outstanding; as of September 30, 2016 and December 31, 2015 respectively. | — | 42,902 | |||||
Series SRN redeemable convertible preferred stock, $0.0001 par value; 0 and 5,611,112 shares authorized; 0 and 2,111,109 shares issued and outstanding; as of September 30, 2016 and December 31, 2015 respectively. | — | 12,082 | |||||
Series E redeemable convertible preferred stock, $0.0001 par value; 0 and 9,030,654 shares authorized; 0 and 8,888,888 shares issued and outstanding; as of September 30, 2016 and December 31, 2015 respectively. | — | 37,228 | |||||
Total redeemable convertible preferred stock | — | 137,482 | |||||
Stockholders’ equity (deficit): | |||||||
Preferred stock, $0.0001 par value; 10,000,000 and 0 shares authorized; 0 shares issued and outstanding at September 30, 2016 and December 31, 2015, respectively. | — | — | |||||
Common stock, $0.0001 par value; 200,000,000 and 62,164,377 shares authorized at September 30, 2016 and December 31, 2015 respectively; 18,190,180 and 2,180,976 shares issued, 18,188,313 and 2,173,399 shares outstanding as of September 30, 2016 and December 31, 2015, respectively. | 1 | — | |||||
Additional paid-in capital | 207,489 | 1 | |||||
Accumulated deficit | (137,493 | ) | (111,508 | ) | |||
Accumulated other comprehensive loss | (4,554 | ) | (4,986 | ) | |||
Total stockholders’ equity (deficit) | 65,443 | (116,493 | ) | ||||
Total liabilities, redeemable convertible preferred stock and stockholders’ equity | $ | 85,779 | $ | 42,824 |
Three Months Ended September 30, | Nine Months Ended September 30, | ||||||||||||||
2016 | 2015 | 2016 | 2015 | ||||||||||||
Grant and collaboration revenue | $ | 1,048 | $ | 1,607 | $ | 5,153 | $ | 3,877 | |||||||
Operating expenses: | |||||||||||||||
Research and development | 6,021 | 5,483 | 18,669 | 15,769 | |||||||||||
General and administrative | 2,495 | 2,195 | 7,294 | 6,305 | |||||||||||
Total operating expenses | 8,516 | 7,678 | 25,963 | 22,074 | |||||||||||
Loss from operations | (7,468 | ) | (6,071 | ) | (20,810 | ) | (18,197 | ) | |||||||
Investment income | 98 | 25 | 121 | 149 | |||||||||||
Foreign currency transaction gain (loss), net | (51 | ) | 668 | (429 | ) | 616 | |||||||||
Interest expense | (311 | ) | (334 | ) | (931 | ) | (843 | ) | |||||||
Other expense, net | 4 | (13 | ) | (78 | ) | (50 | ) | ||||||||
Net loss | (7,728 | ) | (5,725 | ) | (22,127 | ) | (18,325 | ) | |||||||
Other comprehensive loss: | |||||||||||||||
Foreign currency translation adjustment | 15 | (800 | ) | 416 | (763 | ) | |||||||||
Unrealized gain (loss) on securities | 16 | — | 16 | — | |||||||||||
Comprehensive loss | $ | (7,697 | ) | $ | (6,525 | ) | $ | (21,695 | ) | $ | (19,088 | ) | |||
Net loss | (7,728 | ) | (5,725 | ) | (22,127 | ) | (18,325 | ) | |||||||
Accretion of redeemable convertible preferred stock | — | (1,836 | ) | (4,566 | ) | (4,959 | ) | ||||||||
Net loss attributable to common stockholders | $ | (7,728 | ) | $ | (7,561 | ) | $ | (26,693 | ) | $ | (23,284 | ) | |||
Net loss per share attributable to common stockholders | |||||||||||||||
Basic and diluted | $ | (0.43 | ) | $ | (3.50 | ) | $ | (3.39 | ) | $ | (10.86 | ) | |||
Weighted average common shares outstanding | |||||||||||||||
Basic and diluted | 18,108,014 | 2,159,658 | 7,881,625 | 2,144,731 |
Series A | Series B | Series C | Series D | Series SRN | Series E | ||||||||||||||||||||||||||||||||||||||||||||||||||||
redeemable | redeemable | redeemable | redeemable | redeemable | redeemable | Accumulated | |||||||||||||||||||||||||||||||||||||||||||||||||||
convertible | convertible | convertible | convertible | convertible | convertible | Additional | other | ||||||||||||||||||||||||||||||||||||||||||||||||||
preferred stock | preferred stock | preferred stock | preferred stock | preferred stock | preferred stock | Common stock | paid‑In | Accumulated | comprehensive | Stockholders’ | |||||||||||||||||||||||||||||||||||||||||||||||
Shares | Amount | Shares | Amount | Shares | Amount | Shares | Amount | Shares | Amount | Shares | Amount | Shares | Amount | Capital | deficit | loss | Equity (Deficit) | ||||||||||||||||||||||||||||||||||||||||
Balance at December 31, 2015 | 2,589,868 | $ | 3,644 | 7,437,325 | $ | 21,448 | 5,000,002 | $ | 20,178 | 8,099,994 | $ | 42,902 | 2,111,109 | $ | 12,082 | 8,888,888 | $ | 37,228 | 2,173,399 | $ | — | $ | 1 | $ | (111,508 | ) | $ | (4,986 | ) | $ | (116,493 | ) | |||||||||||||||||||||||||
Vesting of restricted common stock | — | — | — | — | — | — | — | — | — | — | — | — | 6,647 | — | 16 | — | — | 16 | |||||||||||||||||||||||||||||||||||||||
Issuance of common stock upon exercise of options | — | — | — | — | — | — | — | — | — | — | — | — | 25,210 | — | 48 | — | — | 48 | |||||||||||||||||||||||||||||||||||||||
Stock‑based compensation expense | — | — | — | — | — | — | — | — | — | — | — | — | — | — | 1,281 | — | — | 1,281 | |||||||||||||||||||||||||||||||||||||||
Accretion of preferred stock to redemption value | — | 75 | — | 449 | — | 446 | — | 1,131 | — | 913 | — | 1,552 | — | — | (708 | ) | (3,858 | ) | — | (4,566 | ) | ||||||||||||||||||||||||||||||||||||
Exercise of common warrants | — | — | — | — | — | — | — | — | — | — | — | — | 567,306 | — | — | — | — | — | |||||||||||||||||||||||||||||||||||||||
Conversion of convertible stock upon listing | (2,589,868 | ) | (3,719 | ) | (7,437,325 | ) | (21,897 | ) | (5,000,002 | ) | (20,624 | ) | (8,099,994 | ) | (44,033 | ) | (2,111,109 | ) | (12,995 | ) | (8,888,888 | ) | (38,780 | ) | 10,126,118 | 1 | 142,047 | — | — | 142,048 | |||||||||||||||||||||||||||
Issuance of common stock, Initial public offering net of issuance costs | — | — | — | — | — | — | — | — | — | — | — | — | 5,289,633 | — | 64,501 | — | — | 64,501 | |||||||||||||||||||||||||||||||||||||||
Conversion of series D preferred stock warrants into warrants for the purchase of common stock | — | — | — | — | — | — | — | — | — | — | — | — | — | — | 189 | — | — | 189 | |||||||||||||||||||||||||||||||||||||||
Conversion of series E preferred stock warrants into warrants for the purchase of common stock | — | — | — | — | — | — | — | — | — | — | — | — | — | — | 114 | — | — | 114 | |||||||||||||||||||||||||||||||||||||||
Currency translation adjustment | — | — | — | — | — | — | — | — | — | — | — | — | — | — | — | — | 416 | 416 | |||||||||||||||||||||||||||||||||||||||
Unrealized gains (losses) on securities | — | — | — | — | — | — | — | — | — | — | — | — | — | — | — | — | 16 | 16 | |||||||||||||||||||||||||||||||||||||||
Net loss | — | — | — | — | — | — | — | — | — | — | — | — | — | — | — | (22,127 | ) | — | (22,127 | ) | |||||||||||||||||||||||||||||||||||||
Balance at September 30, 2016 (unaudited) | — | $ | — | — | $ | — | — | $ | — | — | $ | — | — | $ | — | — | $ | — | 18,188,313 | $ | 1 | $ | 207,489 | $ | (137,493 | ) | $ | (4,554 | ) | $ | 65,443 |
Nine Months Ended | |||||||
September 30, | |||||||
2016 | 2015 | ||||||
Operating activities | |||||||
Net loss | $ | (22,127 | ) | $ | (18,325 | ) | |
Adjustments to reconcile net loss to net cash used in operating activities: | |||||||
Depreciation | 545 | 866 | |||||
Amortization of premiums and accretion of discounts on investments | 113 | — | |||||
Stock‑based compensation expense | 1,281 | 869 | |||||
Non‑cash interest expense | 176 | 139 | |||||
Change in fair value of redeemable convertible preferred stock warrant | 12 | (17 | ) | ||||
Changes in operating assets and liabilities: | |||||||
Accounts receivable | 341 | 112 | |||||
Prepaid expenses and other assets | (1,668 | ) | (608 | ) | |||
Restricted cash and other deposits | 507 | 1,388 | |||||
Accounts payable | (35 | ) | 363 | ||||
Deferred revenue | 586 | (34 | ) | ||||
Contingently repayable grant funding | (207 | ) | (446 | ) | |||
Accrued expenses and other liabilities | (763 | ) | 870 | ||||
Net cash used in operating activities | (21,239 | ) | (14,823 | ) | |||
Investing activities | |||||||
Maturities of short term government obligations | 6,900 | — | |||||
Purchase of short term investments | (23,318 | ) | (739 | ) | |||
Purchases of property and equipment | (478 | ) | (1,031 | ) | |||
Net cash used in investing activities | (16,896 | ) | (1,770 | ) | |||
Financing activities | |||||||
Net proceeds from issuance of preferred stock and warrants | — | 32,669 | |||||
Vesting of restricted stock | 16 | — | |||||
Principle payments on loan payable | — | (1,619 | ) | ||||
Deferred IPO costs paid | (4,068 | ) | — | ||||
Issuance of convertible note | — | 7,092 | |||||
Proceeds from Initial Public Offering, net of underwriters' discounts and commissions | 68,871 | — | |||||
Exercise of stock options | 48 | 78 | |||||
Net cash provided by financing activities | 64,867 | 38,220 | |||||
Effect of exchange rate changes on cash | 419 | (705 | ) | ||||
Net increase in cash and cash equivalents | 27,151 | 20,922 | |||||
Cash and cash equivalents at beginning of period | 32,337 | 16,592 | |||||
Cash and cash equivalents at end of period | $ | 59,488 | $ | 37,514 | |||
Cash paid during the year for: | |||||||
Interest | $ | 729 | $ | 418 | |||
Supplemental noncash investing and financing activities: | |||||||
Purchase of property and equipment not yet paid | $ | 31 | $ | 11 | |||
Reclassification of deferred IPO costs from non-current assets to additional paid-in capital | 4,369 | — | |||||
Accrued dividends and accretion of preferred stock to redemption value | 4,566 | 4,959 | |||||
Conversion of bridge loans into Series E preferred | — | 7,288 | |||||
Unrealized gain on marketable securities | $ | 16 | $ | — |
September 30, 2016 | |||||||||||||||
Amortized Cost | Gross Unrealized Gains | Gross Unrealized Losses | Estimated Fair Value | ||||||||||||
U.S. Treasury securities | $ | — | $ | — | $ | — | $ | — | |||||||
Corporate bonds | 19,804 | 6 | (23 | ) | 19,788 | ||||||||||
Total available-for-sale marketable securities | $ | 19,804 | $ | 6 | $ | (23 | ) | $ | 19,788 | ||||||
December 31, 2015 | |||||||||||||||
Amortized Cost | Gross Unrealized Gains | Gross Unrealized Losses | Estimated Fair Value | ||||||||||||
U.S. Treasury securities | $ | 3,516 | $ | — | $ | — | $ | 3,516 | |||||||
Corporate bonds | — | — | — | — | |||||||||||
Total available-for-sale marketable securities | $ | 3,516 | $ | — | $ | — | $ | 3,516 | |||||||
September 30, 2016 | December 31, 2015 | ||||||||||||||
Fair Value | Amortized Cost | Fair Value | Amortized Cost | ||||||||||||
Less than one year | $ | 19,788 | $ | 19,804 | $ | 3,516 | $ | 3,516 | |||||||
Three Months Ended September 30, | Nine Months Ended September 30, | ||||||||||||||
2016 | 2015 | 2016 | 2015 | ||||||||||||
(unaudited) | (unaudited) | ||||||||||||||
Numerator: | |||||||||||||||
Net (loss) | $ | (7,728 | ) | $ | (5,725 | ) | $ | (22,127 | ) | $ | (18,325 | ) | |||
Less: accretion on preferred stock | — | (1,836 | ) | (4,566 | ) | (4,959 | ) | ||||||||
Net loss attributable to common stockholders | $ | (7,728 | ) | $ | (7,561 | ) | $ | (26,693 | ) | $ | (23,284 | ) | |||
Denominator: | |||||||||||||||
Weighted‑average common shares outstanding—basic and diluted | 18,108,014 | 2,159,658 | 7,881,625 | 2,144,731 | |||||||||||
Net loss per share attributable to common stockholders—basic and diluted | $ | (0.43 | ) | $ | (3.50 | ) | $ | (3.39 | ) | $ | (10.86 | ) |
September 30, | |||||
2016 | 2015 | ||||
(unaudited) | |||||
Redeemable convertible preferred stock | — | 6,872,090 | |||
Stock options to purchase common stock | 2,140,295 | 2,165,187 | |||
Stock warrants to purchase common stock | 113,795 | 17,888 | |||
Total | 2,254,090 | 9,055,165 |
September 30, 2016 | |||||||||||||||
(level 1) | (level 2) | (level 3) | Total | ||||||||||||
Money market funds, included in cash equivalents | $ | 67 | $ | — | $ | — | $ | 67 | |||||||
Tri-party repurchase agreements, included in cash equivalents | $ | — | $ | 32,000 | $ | — | $ | 32,000 | |||||||
US Treasury obligations, included in investments | $ | — | $ | — | $ | — | $ | — | |||||||
Corporate bonds, included in investments | $ | 19,788 | $ | — | $ | — | $ | 19,788 | |||||||
Warrants to purchase redeemable convertible preferred stock, included in other long term liabilities | $ | — | $ | — | $ | — | $ | — |
December 31, 2015 | |||||||||||||||
(level 1) | (level 2) | (level 3) | Total | ||||||||||||
US Treasury obligations, included in cash equivalents | $ | 14,486 | $ | — | $ | — | $ | 14,486 | |||||||
US Treasury obligations, included in investments | $ | 3,516 | $ | — | $ | — | $ | 3,516 | |||||||
Corporate bonds, included in investments | $ | — | $ | — | $ | — | $ | — | |||||||
Warrants to purchase redeemable convertible preferred stock, included in other long term liabilities | $ | — | $ | — | $ | 290 | $ | 290 |
September 30, | December 31, | ||||||
2016 | 2015 | ||||||
(unaudited) | |||||||
Laboratory equipment | $ | 4,617 | $ | 4,028 | |||
Computer equipment and software | 501 | 409 | |||||
Leasehold improvements | 165 | 91 | |||||
Furniture and fixtures | 225 | 222 | |||||
Office equipment | 62 | 62 | |||||
P,P&E—Construction in process | — | 144 | |||||
Total property and equipment | 5,570 | 4,956 | |||||
Less accumulated depreciation | (3,504 | ) | (2,927 | ) | |||
Property and equipment, net | $ | 2,066 | $ | 2,029 |
September 30, | December 31, | ||||||
2016 | 2015 | ||||||
(unaudited) | |||||||
Payroll | $ | 297 | $ | — | |||
Legal | 59 | 213 | |||||
Bonus | 519 | 669 | |||||
Current portion of deferred rent and lease incentive | 12 | 405 | |||||
Accrued patent fees | 184 | 219 | |||||
Accrued external research and development costs | 662 | 1,649 | |||||
Other | 701 | 223 | |||||
Accrued expenses | $ | 2,434 | $ | 3,378 |
Year ended December 31, | |||
2016 | $ | 1,176 | |
2017 | 1,244 | ||
2018 | 1,291 | ||
2019 | 1,330 | ||
2020 | 335 | ||
Total minimum lease payments | $ | 5,376 |
Year ended December 31, | |||
2016 | $ | 972 | |
2017 | 5,319 | ||
2018 | 5,318 | ||
2019 | 3,379 | ||
Total debt payments | 14,988 | ||
Less: Amount representing interest | (2,268 | ) | |
Less: Debt discount and deferred charges | (919 | ) | |
Less: Current portion of issuance costs | 54 | ||
Loans payable, net of current portion | $ | 11,855 |
Periods ending | |||||
September 30, 2016 | December 31, 2015 | ||||
(unaudited) | |||||
Conversion of Series A Preferred | — | 664,068 | |||
Conversion of Series B Preferred | — | 1,907,006 | |||
Conversion of Series C Preferred | — | 1,282,051 | |||
Conversion of Series D Preferred | — | 2,191,412 | |||
Conversion of Series SRN Preferred | — | 1,798,433 | |||
Conversion of Series E Preferred | — | 2,662,885 | |||
Exercise of common warrants | 113,795 | 651,618 | |||
Shares available for future stock incentive awards | 783,494 | 100,034 | |||
Exercise of outstanding common stock options | 2,140,295 | 1,569,379 | |||
Total | 3,037,584 | 12,826,886 |
Nine Months Ended | |||||||
September 30, | |||||||
2016 | 2015 | ||||||
Risk-free interest rate | 1.39 | % | 1.71 | % | |||
Expected dividend yield | — | — | |||||
Expected life | 6.05 | 6.00 | |||||
Expected volatility | 95.62 | % | 84.60 | % | |||
Weighted-average fair value of common stock | $ | 9.79 | $ | 1.41 |
Nine Months Ended | |||||
September 30, | |||||
2016 | 2015 | ||||
Risk‑free interest rate | 1.58 | % | 1.82 | % | |
Expected dividend yield | — | — | |||
Expected life (in years) | 9.41 | 6.36 | |||
Expected volatility | 87.75 | % | 96.75 | % |
Weighted‑average | ||||||||||||
Weighted‑average | remaining | Aggregate | ||||||||||
Number of | exercise | contractual term | intrinsic value | |||||||||
options | price | (in years) | (in thousands) | |||||||||
Employee | ||||||||||||
Outstanding at December 31, 2015 | 1,247,160 | $ | 5.05 | 7.41 | $ | 3,130 | ||||||
Granted | 511,039 | $ | 12.60 | |||||||||
Exercised | (21,088 | ) | $ | 2.16 | ||||||||
Forfeited | (9,124 | ) | $ | 7.74 | ||||||||
Outstanding at September 30, 2016 | 1,727,987 | $ | 7.30 | 7.57 | $ | 12,004 | ||||||
Vested at September 30, 2016 | 805,229 | $ | 3.70 | 5.62 | $ | 8,493 | ||||||
Vested and expected to vest at September 30, 2016 | 1,315,411 | $ | 5.23 | 7.41 | $ | 11,582 | ||||||
Non‑Employee | ||||||||||||
Outstanding at December 31, 2015 | 322,220 | $ | 2.93 | 5.50 | $ | 1,288 | ||||||
Granted | 98,718 | $ | 7.70 | |||||||||
Exercised | (5,085 | ) | $ | 0.47 | ||||||||
Forfeited | (3,546 | ) | $ | 0.47 | ||||||||
Outstanding at September 30, 2016 | 412,307 | $ | 4.12 | 5.94 | $ | 4,176 | ||||||
Vested at September 30, 2016 | 325,519 | $ | 3.12 | 5.03 | $ | 3,622 | ||||||
Vested and expected to vest at September 30, 2016 | 412,097 | $ | 4.12 | 5.93 | $ | 4,176 |
Weighted‑ | ||||||
average | ||||||
exercise | ||||||
Shares | price | |||||
Unvested as of December 31, 2015 | 7,574 | $ | 2.77 | |||
Issued | 940 | 9.36 | ||||
Vested | (6,647 | ) | 3.72 | |||
Unvested as of September 30, 2016 | 1,867 | $ | 2.77 |
Three Months Ended | Nine Months Ended | ||||||||||||||
September 30, | September 30, | ||||||||||||||
2016 | 2015 | 2016 | 2015 | ||||||||||||
Research and development | $ | 353 | $ | 40 | $ | 747 | $ | 321 | |||||||
General and administrative | 280 | 212 | 534 | 548 | |||||||||||
Total | $ | 633 | $ | 252 | $ | 1,281 | $ | 869 |
- | potentially establish a sales, marketing and distribution infrastructure and scale‑up external manufacturing capabilities to commercialize any products for which we may obtain regulatory approval; |
- | add personnel and clinical, scientific, operational, financial and management information systems to support our product development and potential future commercialization efforts, and to enable us to operate as a public company. |
Three Months Ended | Nine Months Ended | ||||||||||||||||||||||||||||
September 30, | Increase | September 30, | Increase | ||||||||||||||||||||||||||
2016 | 2015 | (decrease) | 2016 | 2015 | (decrease) | ||||||||||||||||||||||||
External research and development expenses: | (unaudited) | (unaudited) | |||||||||||||||||||||||||||
SEL-212 | $ | 1,265 | $ | 1,984 | $ | (719 | ) | (36 | )% | $ | 4,919 | $ | 6,319 | $ | (1,400 | ) | (22 | )% | |||||||||||
Discovery and preclinical stage product programs, collectively | 497 | 84 | 413 | 492 | % | 2,447 | 471 | 1,976 | 420 | % | |||||||||||||||||||
Internal research and development expenses | 4,259 | 3,415 | 844 | 25 | % | 11,303 | 8,979 | 2,324 | 26 | % | |||||||||||||||||||
Total research and development expenses | $ | 6,021 | $ | 5,483 | $ | 538 | 10 | % | $ | 18,669 | $ | 15,769 | $ | 2,900 | 18 | % |
Three Months Ended | ||||||||||||||
September 30, | Increase | |||||||||||||
2016 | 2015 | (decrease) | ||||||||||||
(unaudited) | ||||||||||||||
Grant revenue | $ | 891 | $ | 759 | $ | 132 | 17 | % | ||||||
Collaboration revenue | $ | 157 | $ | 848 | (691 | ) | (81 | )% | ||||||
Total revenue | $ | 1,048 | $ | 1,607 | $ | (559 | ) | (35 | )% |
Three Months Ended | ||||||||||||||
September 30, | Increase | |||||||||||||
2016 | 2015 | (decrease) | ||||||||||||
(unaudited) | ||||||||||||||
Research and development | $ | 6,021 | $ | 5,483 | $ | 538 | 10 | % |
Three Months Ended | ||||||||||||||
September 30, | Increase | |||||||||||||
2016 | 2015 | (decrease) | ||||||||||||
(unaudited) | ||||||||||||||
General and administrative | $ | 2,495 | $ | 2,195 | $ | 300 | 14 | % |
Nine Months Ended | ||||||||||||||
September 30, | Increase | |||||||||||||
2016 | 2015 | (decrease) | ||||||||||||
(unaudited) | ||||||||||||||
Grant revenue | $ | 4,492 | $ | 1,987 | $ | 2,505 | 126 | % | ||||||
Collaboration revenue | 661 | 1,890 | (1,229 | ) | (65 | )% | ||||||||
Total revenue | $ | 5,153 | $ | 3,877 | $ | 1,276 | 33 | % |
Nine Months Ended | ||||||||||||||
September 30, | Increase | |||||||||||||
2016 | 2015 | (decrease) | ||||||||||||
(unaudited) | ||||||||||||||
Research and development | $ | 18,669 | $ | 15,769 | $ | 2,900 | 18 | % |
Nine Months Ended | ||||||||||||||
September 30, | Increase | |||||||||||||
2016 | 2015 | (decrease) | ||||||||||||
(unaudited) | ||||||||||||||
General and administrative | $ | 7,294 | $ | 6,305 | $ | 989 | 16 | % |
- | our collaboration agreements remaining in effect, our ability to enter into additional collaboration agreements and our ability to achieve milestones under these agreements; |
- | the scope, progress, results and costs of preclinical development, laboratory testing and clinical trials for our other product candidates; |
- | the costs and timing of future commercialization activities, including manufacturing, marketing, sales and distribution, for any of our product candidates for which we receive marketing approval; |
- | the costs and timing of preparing, filing and prosecuting patent applications, maintaining and enforcing our intellectual property rights and defending any intellectual property-related claims; and |
Nine Months Ended | |||||||
September 30, | |||||||
2016 | 2015 | ||||||
(unaudited) | (unaudited) | ||||||
Beginning of the period | $ | 32,337 | $ | 16,592 | |||
Net cash used in operating activities | (21,239 | ) | (14,823 | ) | |||
Net cash used in investing activities | (16,896 | ) | (1,770 | ) | |||
Net cash provided by financing activities | 64,867 | 38,220 | |||||
Effect of exchange rate changes on cash | 419 | (705 | ) | ||||
End of the period | $ | 59,488 | $ | 37,514 |
Less than | More than | ||||||||||||||||||
Contractual Obligations | Total | 1 year | 1 to 3 years | 3 to 5 years | 5 years | ||||||||||||||
Operating leases(1) | $ | 5,375 | $ | 1,176 | $ | 2,535 | $ | 1,664 | $ | — | |||||||||
Research and development contract obligations(2) | 240 | 60 | 120 | 60 | — | ||||||||||||||
Long term debt(3) | 14,988 | 972 | 10,637 | 3,379 | — | ||||||||||||||
Total obligations | $ | 20,603 | $ | 2,208 | $ | 13,292 | $ | 5,103 | $ | — |
- | continue the research and development of our other product candidates; |
- | potentially establish a sales, marketing and distribution infrastructure; |
- | scale up external manufacturing capabilities to commercialize any products for which we may obtain regulatory approval; |
- | add clinical, scientific, operational, financial and management information systems and personnel, including personnel to support our product development and potential future commercialization efforts and to support our transition to a public company; and |
- | experience any delays or encounter any issues with any of the above, including, but not limited to, failed studies, complex results, safety issues or other regulatory challenges. |
- | our collaboration agreements remaining in effect, our entering into additional collaboration agreements and our ability to achieve milestones under these agreements; |
- | the scope, progress, results and costs of preclinical development, laboratory testing and clinical trials for our other product candidates; |
- | the costs and timing of future commercialization activities, including manufacturing, marketing, sales and distribution, for any of our product candidates for which we receive marketing approval; |
- | the costs and timing of preparing, filing and prosecuting patent applications, maintaining and enforcing our intellectual property rights and defending any intellectual property‑related claims; |
- | the extent to which we acquire or invest in businesses, products and technologies, including entering into licensing or collaboration arrangements for product candidates. |
- | making arrangements with third party manufacturers for, or establishing, commercial manufacturing capabilities, or --establishing such capabilities ourselves; |
- | our existing collaboration agreements remaining in effect and our entering into new collaborations throughout the development process as appropriate, from preclinical studies through to commercialization; |
- | obtaining and maintaining coverage and adequate reimbursement by third‑party payors, including government payors, for our products, if approved; |
- | maintaining and growing an organization of scientists and business people who can develop and commercialize our product candidates and technology. |
- | due to the unproven nature of our SVP therapeutics, they may have different efficacy and safety rates in various indications; |
- | the FDA or other regulatory agencies may lack experience in evaluating the efficacy and safety of products based on SVP or a biologic sourced from China or other jurisdictions, which could result in a longer‑than‑expected regulatory review process, increase our expected development costs or delay or prevent commercialization of our product candidates; and |
- | in the event of a biologics license application for SEL‑212 or another product and a pre‑approval inspection by the FDA of the facilities of 3SBio or any other manufacturer of biologics we may use, the FDA may not approve the facility for production or may make observations that will take significant time for 3SBio or such other provider to address. |
- | clinical trials of our product candidates may produce unfavorable, incomplete or inconclusive results; |
- | regulators or institutional review boards may not authorize us or our investigators to commence a clinical trial or conduct a clinical trial at a prospective trial site; |
- | we may experience delays in reaching, or fail to reach, agreement on acceptable terms with contract research organizations, or CROs, or clinical trial sites; |
- | we may be unable to recruit suitable patients to participate in a clinical trial, the number of patients required for clinical trials of our product candidates may be larger than we expect, enrollment in these clinical trials may be slower than we expect or participants may drop out of these clinical trials at a higher rate than we expect; |
- | the number of clinical trial sites required for clinical trials of our product candidates may be larger than we expect; |
- | our third‑party contractors may fail to comply with regulatory requirements or meet their contractual obligations to us in a timely manner, or at all; |
- | we may have to suspend or terminate clinical trials of our product candidates for various reasons, including a finding that the participants are being exposed to unacceptable health risks; |
- | investigators, regulators, data safety monitoring boards or institutional review boards may require that we or our investigators suspend or terminate clinical research, or we may decide to do so ourselves, for various reasons including noncompliance with regulatory requirements, inspection of the clinical trial operations or trial site by the FDA or other regulatory authorities resulting in the imposition of a clinical hold, unforeseen safety issues such as a finding that the participants are being exposed to unacceptable health risks, undesirable side effects or other unexpected characteristics, failure to demonstrate a benefit from using a drug, changes in governmental regulations or administrative actions; |
- | investigators may deviate from the trial protocol, fail to conduct the trial in accordance with regulatory requirements or misreport study data; |
- | the cost of clinical trials of our product candidates may be greater than we expect; |
- | the supply or quality of raw materials or manufactured product candidates (whether provided by us or third parties) or other materials necessary to conduct clinical trials of our product candidates may be insufficient, inadequate or not available at an acceptable cost, or we may experience interruptions in supply; |
- | regulators may revise the requirements for approving our product candidates, or such requirements may not be as we expect; |
- | the FDA or comparable foreign regulatory authorities may disagree with our clinical trial design or our interpretation of data from preclinical studies and clinical trials, or may change the requirements for approval even after it has reviewed and commented on the design of our clinical trials; and |
- | regarding trials managed by our existing or any future collaborators, our collaborators may face any of the above issues, and may conduct clinical trials in ways they view as advantageous to them but potentially suboptimal for us. |
- | be delayed in obtaining marketing approval for our product candidates, if at all; |
- | lose the support of collaborators, requiring us to bear more of the burden of research and development; |
- | not obtain marketing approval at all; |
- | obtain marketing approval in some countries and not in others; |
- | obtain approval for indications or patient populations that are not as broad as intended or desired; |
- | obtain approval with labeling that includes significant use or distribution restrictions or safety warnings; |
- | be subject to additional post‑marketing testing requirements; or |
- | have a product removed from the market after obtaining marketing approval. |
- | the severity of the disease under investigation; |
- | the patient eligibility criteria for the study in question; |
- | the perceived risks and benefits of the product candidate under study; |
- | the availability of other treatments for the disease under investigation; |
- | the existence of competing clinical trials; |
- | our efforts to facilitate timely enrollment in clinical trials; |
- | investigators engagement with, or enthusiasm about, the trial; |
- | the patient referral practices of physicians; |
- | the design of the trial; |
- | the ability to monitor patients adequately during and after treatment; and |
- | the proximity and availability of clinical trial sites for prospective patients. |
- | regulatory authorities may withdraw approvals of such product; |
- | regulatory authorities may require the addition of labeling statements, such as a “black box” warning or a contraindication; |
- | regulatory authorities may impose additional restrictions on the marketing of, or the manufacturing processes for, the particular product; |
- | we may be required to create a medication guide outlining the risks of such side effects for distribution to patients; |
- | we could be sued and held liable for harm caused to patients, or become subject to fines, injunctions or the imposition of civil or criminal penalties; and |
- | our reputation may suffer. |
- | inability, failure or unwillingness of third‑party manufacturers to comply with regulatory requirements, maintain quality assurance, meet our needs, specifications or schedules or continue to supply products to us; |
- | reduced control we have over product development, including with respect to our lead product candidate, due to our reliance on such third‑party manufacturers, |
- | breach of manufacturing agreements by the third‑party manufacturers; |
- | misappropriation or disclosure of our proprietary information, including our trade secrets and know‑how; |
- | relationships that the third party manufacturer may have with others, some of which may be our competitors, and, if it does not successfully carry out its contractual duties, does not meet expectations, experiences work stoppages, or |
- | needs to be replaced, we may need to enter into alternative arrangements, which may not be available, desirable or cost‑effective; and |
- | termination or nonrenewal of agreements by third‑party manufacturers at times that are costly or inconvenient for us. |
- | collaborators have significant discretion in determining the efforts and resources that they will apply to these -collaborations; |
- | collaborators may not perform their obligations as expected; |
- | collaborators may not pursue development and commercialization of any product candidates that achieve regulatory approval or may elect not to continue or renew development or commercialization programs based on preclinical or clinical trial results, changes in the collaborators’ strategic focus or available funding, or external factors, such as an acquisition, that divert resources or create competing priorities; |
- | collaborators may delay clinical trials, provide insufficient funding for a clinical trial program, stop a clinical trial or abandon a product candidate, repeat or conduct new clinical trials or require a new formulation of a product candidate for clinical testing; |
- | collaborators could independently develop, or develop with third parties, products that compete directly or indirectly with our product candidates if the collaborators believe that competitive products are more likely to be successfully developed or can be commercialized under terms that are more economically attractive than ours, which may cause collaborators to cease to devote resources to the commercialization of our product candidates; |
- | a collaborator with marketing and distribution rights to one or more of our product candidates that achieve regulatory approval may not commit sufficient resources to the marketing and distribution of such product or products; |
- | disagreements with collaborators, including disagreements over proprietary rights, contract interpretation or the preferred course of development, might cause delays or termination of the research, development or commercialization of product candidates, might lead to additional responsibilities for us with respect to product candidates, or might result in litigation or arbitration, any of which would be time‑consuming and expensive; |
- | collaborators may not properly maintain or defend our intellectual property rights or may use our proprietary information in such a way as to invite litigation that could jeopardize or invalidate our intellectual property or proprietary information or expose us to potential litigation; |
- | collaborators may infringe the intellectual property rights of third parties, which may expose us to litigation and potential liability; |
- | collaborations may be terminated for the convenience of the collaborator and, if terminated, we would potentially lose the right to pursue further development or commercialization of the applicable product candidates; |
- | collaborators may learn about our technology and use this knowledge to compete with us in the future; |
- | there may be conflicts between different collaborators that could negatively affect those collaborations and potentially others; |
- | the number and type of our collaborations could adversely affect our attractiveness to future collaborators or acquirers; and |
- | we currently have, and in the future may have, a limited number of collaborations and the loss of, or a disruption in our relationship with, any one or more of such collaborators may could harm our business. |
- | their efficacy, safety and other potential advantages compared to alternative treatments; |
- | the clinical indications for which our product candidates are approved; |
- | our ability to offer them for sale at competitive prices; |
- | their convenience and ease of administration compared to alternative treatments; |
- | the willingness of the target patient population to try new therapies and of physicians to prescribe these therapies; |
- | the strength of marketing and distribution support; |
- | the availability of third‑party coverage and adequate reimbursement for our product candidates; |
- | the prevalence and severity of their side effects and their overall safety profiles; |
- | any restrictions on the use of our product candidates together with other medications; |
- | interactions of our product candidates with other medicines patients are taking; |
- | our ability to create awareness with patients and physicians about the harmful effects of uric acid deposits; |
- | the timing of market introduction of any approved product candidates as well as competitive products and other therapies; |
- | inability of certain types of patients to take our product candidates; |
- | their ability to remain attractive in the event of changing treatment guidelines; |
- | adverse publicity about the product or favorable publicity about competitive products; and |
- | potential product liability claims. |
- | our inability to recruit, train and retain adequate numbers of effective sales and marketing personnel; |
- | the inability of sales personnel to obtain access to or educate physicians on the benefits of our products; |
- | the lack of complementary products to be offered by sales personnel, which may put us at a competitive disadvantage relative to companies with more extensive product lines; |
- | unforeseen costs and expenses associated with creating an independent sales and marketing organization; and |
- | inability to obtain sufficient coverage and reimbursement from third‑party payors and governmental agencies for our product candidates. |
- | regulatory investigations, product recalls or withdrawals, or labeling, marketing or promotional restrictions; |
- | decreased demand for any product candidates or products that we may develop; |
- | injury to our reputation and significant negative media attention; |
- | loss of clinical trial participants or increased difficulty in enrolling future participants; |
- | significant costs to defend the related litigation or to reach a settlement; |
- | substantial payments to trial participants or patients; |
- | loss of revenue; |
- | reduced resources of our management to pursue our business strategy; and |
- | the inability to commercialize any products that we may develop. |
- | the federal Anti‑Kickback Statute, which prohibits, among other things, persons and entities from knowingly and willfully soliciting, offering, receiving or providing remuneration, directly or indirectly, in cash or in kind, to induce or reward, or in return for, either the referral of an individual for, or the purchase, order or recommendation of, any good or service for which payment may be made under a federal healthcare program such as Medicare and Medicaid. A person or entity does not need to have actual knowledge of the federal Anti‑Kickback Statute or specific intent to violate it to have committed a violation; in addition, the government may assert that a claim including items or services resulting from a violation of the federal Anti‑Kickback Statute constitutes a false or fraudulent claim for purposes of the False Claims Act); |
- | the federal false claims and civil monetary penalties laws, including the civil False Claims Act, which impose criminal and civil penalties, through civil whistleblower or qui tam actions, against individuals or entities for knowingly presenting, or causing to be presented, to the federal government claims for payment that are false or fraudulent or making a false statement to avoid, decrease or conceal an obligation to pay money to the federal government; |
- | the federal Health Insurance Portability and Accountability Act of 1996, or HIPAA, which imposes criminal and civil liability for, among other things, executing or attempting to execute a scheme to defraud any healthcare benefit program or making false statements relating to healthcare matters. Similar to the federal Anti‑Kickback Statute, a person or entity does not need to have actual knowledge of the statute or specific intent to violate it to have committed a violation; |
- | HIPAA, as amended by the Health Information Technology for Economic and Clinical Health Act, or HITECH, and its implementing regulations, which also imposes obligations, including mandatory contractual terms, on certain types of people and entities with respect to safeguarding the privacy, security and transmission of individually identifiable health information; |
- | the federal Physician Payments Sunshine Act, which requires manufacturers of drugs, devices, biologics and medical supplies for which payment is available under Medicare, Medicaid or the Children’s Health Insurance Program (with certain exceptions) to report annually to the government information related to certain payments or other “transfers of value” made to physicians (defined to include doctors, dentists, optometrists, podiatrists and chiropractors) and teaching hospitals, and requires applicable manufacturers to report annually to the government ownership and investment interests held by the physicians described above and their immediate family members and payments or other “transfers of value” to such physician owners; and |
- | analogous state and foreign laws and regulations, such as state anti‑kickback and false claims laws, which may apply to sales or marketing arrangements and claims involving healthcare items or services reimbursed by third‑party payors, including private insurers; state laws that require pharmaceutical companies to comply with the pharmaceutical industry’s voluntary compliance guidelines and the relevant compliance guidance promulgated by the federal government; state laws that require drug manufacturers to report information related to payments and other transfers of value to physicians and other healthcare providers or marketing expenditures; and state and foreign laws governing the privacy and security of health information in some circumstances, many of which differ from each other in significant ways and often are not preempted by HIPAA, thus complicating compliance efforts. |
- | an annual, nondeductible fee payable by any entity that manufactures or imports specified branded prescription drugs and biologic agents; |
- | an increase in the statutory minimum rebates a manufacturer must pay under the Medicaid Drug Rebate Program; |
- | a new methodology by which rebates owed by manufacturers under the Medicaid Drug Rebate Program are calculated for drugs that are inhaled, infused, instilled, implanted or injected; |
- | a new Medicare Part D coverage gap discount program, in which manufacturers must agree to offer 50% point‑of‑sale discounts off negotiated prices of applicable brand drugs to eligible beneficiaries under their coverage gap period, as a condition for the manufacturer’s outpatient drugs to be covered under Medicare Part D; |
- | extension of manufacturers’ Medicaid rebate liability to individuals enrolled in Medicaid managed care organizations; |
- | expansion of eligibility criteria for Medicaid programs; |
- | expansion of the entities eligible for discounts under the Public Health Service pharmaceutical pricing program; |
- | a new requirement to annually report drug samples that manufacturers and distributors provide to physicians; and |
- | a new Patient‑Centered Outcomes Research Institute to oversee, identify priorities in, and conduct comparative clinical effectiveness research, along with funding for such research. |
- | litigation involving patients taking our products |
- | restrictions on such products, manufacturers or manufacturing processes; |
- | restrictions on the labeling or marketing of a product; |
- | restrictions on product distribution or use; |
- | requirements to conduct post‑marketing studies or clinical trials; |
- | warning letters; |
- | withdrawal of products from the market; |
- | suspension or termination of ongoing clinical trials; |
- | refusal to approve pending applications or supplements to approved applications that we submit; |
- | recall of products; |
- | fines, restitution or disgorgement of profits or revenues; |
- | suspension or withdrawal of marketing approvals; |
- | damage to relationships with existing and potential collaborators; |
- | unfavorable press coverage and damage to our reputation; |
- | refusal to permit the import or export of our products; |
- | product seizure or detention; |
- | injunctions; or |
- | imposition of civil or criminal penalties. |
- | others may be able to make compounds that are the same as or similar to our current or future product candidates but that are not covered by the claims of the patents that we own or have exclusively licensed; |
- | we or any of our licensors or collaborators might not have been the first to make the inventions covered by the patents or pending patent applications that we own or have exclusively licensed; |
- | we or any of our licensors or collaborators might not have been the first to file patent applications covering certain of our inventions; |
- | others may independently develop similar or alternative technologies or duplicate any of our technologies without infringing our intellectual property rights; |
- | the prosecution of our pending patent applications may not result in granted patents; |
- | granted patents that we own or have licensed may not cover our products or may be held not infringed, invalid or unenforceable, as a result of legal challenges by our competitors; |
- | with respect to granted patents that we own or have licensed, especially patents that we either acquire or in‑license, if certain information was withheld from or misrepresented to the patent examiner, such patents might be held to be unenforceable; |
- | patent protection on our product candidates may expire before we are able to develop and commercialize the product, or before we are able to recover our investment in the product candidates; |
- | our competitors might conduct research and development activities in the United States and other countries that provide a safe harbor from patent infringement claims for such activities, as well as in countries in which we do not have patent rights, and may then use the information learned from such activities to develop competitive products for sale in markets where we intend to market our product candidates; |
- | we may not develop additional proprietary technologies that are patentable; |
- | the patents of others may have an adverse effect on our business; and |
- | we may choose not to file a patent application for certain technologies, trade secrets or know‑how, and a third party may subsequently file a patent covering such intellectual property. |
- | cease developing, selling or otherwise commercializing our product candidates; |
- | pay substantial damages for past use of the asserted intellectual property; |
- | obtain a license from the holder of the asserted intellectual property, which license may not be available on reasonable terms, if at all; and |
- | in the case of trademark claims, redesign or rename some or all of our product candidates, or other brands to avoid infringing the intellectual property rights of third parties, which may not be possible and, even if possible, could be costly and time‑consuming. |
- | multiple, conflicting and changing laws and regulations, such as privacy regulations, tax laws, export and import restrictions, employment laws, regulatory requirements and other governmental approvals, permits and licenses; |
- | failure by us to obtain and maintain regulatory approvals for the use of our product candidates in various countries; |
- | additional potentially relevant third‑party patent rights; |
- | complexities and difficulties in obtaining protection of and enforcing our intellectual property rights; |
- | difficulties in staffing and managing foreign operations; |
- | complexities associated with managing multiple‑payor reimbursement regimes, government payors or patient self‑pay systems; |
- | limits on our ability to penetrate international markets; |
- | financial risks, such as longer payment cycles, difficulty collecting accounts receivable, the impact of local and regional financial crises on demand and payment for our product candidates and exposure to foreign currency exchange rate fluctuations, which could result in increased operating expenses and reduced revenues; |
- | natural disasters, political and economic instability, including wars, events of terrorism and political unrest, outbreak of disease, boycotts, curtailment of trade and other business restrictions and economic weakness, including inflation; |
- | changes in diplomatic and trade relationships; |
- | challenges in enforcing our contractual and intellectual property rights, especially in those foreign countries that do not respect and protect intellectual property rights to the same extent as the United States; |
- | certain expenses including, among others, expenses for travel, translation and insurance; |
- | legal risks, including use of the legal system by the government to benefit itself or affiliated entities at our expense, including expropriation of property; and |
- | regulatory and compliance risks that relate to maintaining accurate information and control over sales and activities that may fall within the purview of the FCPA its books and records provisions, or its anti‑bribery provisions. |
- | disruption in our relationships with future customers or with current or future distributors or suppliers as a result of such a transaction; |
- | unexpected liabilities related to acquired companies; |
- | difficulties integrating acquired personnel, technologies and operations into our existing business; |
- | diversion of management time and focus from operating our business to acquisition integration challenges; |
- | increases in our expenses and reductions in our cash available for operations and other uses; |
- | possible write‑offs or impairment charges relating to acquired businesses; and |
- | inability to develop a sales force for any additional product candidates. |
- | the success of competitive products or technologies; |
- | results of clinical trials of our product candidates or those of our competitors; |
- | failure or discontinuation of any of our development programs; |
- | commencement of, termination of, or any development related to any collaboration or licensing arrangement; |
- | regulatory or legal developments in the United States and other countries; |
- | development of new product candidates that may address our markets and make our product candidates less attractive; |
- | changes in physician, hospital or healthcare provider practices that may make our product candidates less useful; |
- | announcements by us, our partners or our competitors of significant acquisitions, strategic partnerships, joint ventures, collaborations or capital commitments; |
- | announcement or market expectation of additional financing efforts; |
- | developments or disputes concerning patent applications, issued patents or other proprietary rights; |
- | the recruitment or departure of key personnel; |
- | the level of expenses related to any of our product candidates or clinical development programs; |
- | failure to meet or exceed financial estimates, projections or development timelines of the investment community or that we provide to the public; |
- | the results of our efforts to discover, develop, acquire or in‑license additional product candidates or products; |
- | actual or expected changes in estimates as to financial results, development timelines or recommendations by securities analysts; |
- | variations in our financial results or those of companies that are perceived to be similar to us; |
- | changes in the structure of healthcare payment systems; |
- | sale of common stock by us or our stockholders in the future as well as the overall trading volume of our common stock; |
- | market conditions in the pharmaceutical and biotechnology sectors; |
- | general economic, industry and market conditions; and |
- | the other factors described in this “Risk factors” section. |
- | being permitted to provide only two years of audited financial statements, in addition to any required unaudited interim financial statements, with correspondingly reduced “Management’s discussion and analysis of financial condition and results of operations”; |
- | not being required to comply with the auditor attestation requirements in the assessment of our internal control over financial reporting; |
- | not being required to comply with any requirement that may be adopted by the Public Company Accounting Oversight Board regarding mandatory audit firm rotation or a supplement to the auditor’s report providing additional information about the audit and the financial statements; |
- | reduced disclosure obligations regarding executive compensation; and |
- | exemptions from the requirements of holding a nonbinding advisory vote on executive compensation and shareholder approval of any golden parachute payments not previously approved. |
• | a classified board of directors with three‑year staggered terms, which may delay the ability of stockholders to change the membership of a majority of our board of directors; |
• | no cumulative voting in the election of directors, which limits the ability of minority stockholders to elect director candidates; |
• | the exclusive right of our board of directors to elect a director to fill a vacancy created by the expansion of the board of directors or the resignation, death or removal of a director, which prevents stockholders from filling vacancies on our board of directors; |
• | the ability of our board of directors to authorize the issuance of shares of preferred stock and to determine the terms of those shares, including preferences and voting rights, without stockholder approval, which could be used to significantly dilute the ownership of a hostile acquirer; |
• | the ability of our board of directors to alter our bylaws without obtaining stockholder approval; |
• | the required approval of the holders of at least two‑thirds of the shares entitled to vote at an election of directors to adopt, amend or repeal our bylaws or repeal the provisions of our restated certificate of incorporation regarding the election and removal of directors; |
• | a prohibition on stockholder action by written consent, which forces stockholder action to be taken at an annual or special meeting of our stockholders; |
• | the requirement that a special meeting of stockholders may be called only by the chairman of the board of directors, the chief executive officer, the president or the board of directors, which may delay the ability of our stockholders to force consideration of a proposal or to take action, including the removal of directors; and |
• | advance notice procedures that stockholders must comply with in order to nominate candidates to our board of directors or to propose matters to be acted upon at a stockholders’ meeting, which may discourage or deter a potential acquirer from conducting a solicitation of proxies to elect the acquirer’s own slate of directors or otherwise attempting to obtain control of us. |
SELECTA BIOSCIENCES, INC. | ||
Date: November 10, 2016 | /s/ Werner Cautreels, Ph.D. | |
Werner Cautreels, Ph.D. | ||
President and Chief Executive Officer | ||
(Principal Executive Officer) | ||
Date: November 10, 2016 | /s/ David Siewers | |
David Siewers | ||
Chief Financial Officer | ||
(Principal Financial and Accounting Officer) |
Incorporated by Reference | ||||||||||||
Exhibit Number | Exhibit Description | Form | File No. | Exhibit | Filing Date | Filed Herewith | ||||||
3.1 | Restated Certificate of Incorporation of Selecta Biosciences, Inc. | 8-K | 001-37798 | 3.1 | 6/29/2016 | |||||||
3.2 | Amended and Restated By-laws of Selecta Biosciences, Inc. | 8-K | 001-37798 | 3.2 | 6/29/2016 | |||||||
10.1 | Fourth Amendment to Lease, dated August 21, 2016, by and between ARE-480 Arsenal Street LLC and Selecta Biosciences, Inc. | 8-K | 001-37798 | 10.1 | 9/14/2016 | |||||||
31.1 | Rule 13a-14(a) / 15d-14(a) Certification of Chief Executive Officer | * | ||||||||||
31.2 | Rule 13a-14(a) / 15d-14(a) Certification of Chief Financial Officer | * | ||||||||||
32.1 | Section 1350 Certification of Chief Executive Officer | ** | ||||||||||
32.2 | Section 1350 Certification of Chief Financial Officer | ** | ||||||||||
101.INS | XBRL Instance Document | * | ||||||||||
101.SCH | XBRL Taxonomy Extension Schema Document | * | ||||||||||
101.CAL | XBRL Taxonomy Extension Calculation Linkbase Document | * | ||||||||||
101.DEF | XBRL Taxonomy Extension Definition Linkbase Document | * | ||||||||||
101.LAB | XBRL Taxonomy Extension Label Linkbase Document | * | ||||||||||
101.PRE | XBRL Taxonomy Extension Presentation Linkbase Document | * | ||||||||||
1. | I have reviewed this Quarterly Report on Form 10-Q of Selecta Biosciences, Inc.; |
2. | Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report; |
3. | Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report; |
4. | The registrant’s other certifying officer(s) and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) for the registrant and have: |
a.) | Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this report is being prepared; |
b.) | [omitted]; |
c.) | Evaluated the effectiveness of the registrant’s disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and |
d.) | Disclosed in this report any change in the registrant’s internal control over financial reporting that occurred during the registrant’s most recent fiscal quarter (the registrant’s fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect, the registrant’s internal control over financial reporting; and |
5. | The registrant’s other certifying officer(s) and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrant’s auditors and the audit committee of the registrant’s board of directors (or persons performing the equivalent functions): |
a.) | All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the registrant’s ability to record, process, summarize and report financial information; and |
b.) | Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s internal control over financial reporting. |
November 10, 2016 | /s/ Werner Cautreels, Ph.D. | |
Werner Cautreels, Ph.D. | ||
President and Chief Executive Officer |
1. | I have reviewed this Quarterly Report on Form 10-Q of Selecta Biosciences, Inc.; |
2. | Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report; |
3. | Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report; |
4. | The registrant’s other certifying officer(s) and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) for the registrant and have: |
a.) | Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this report is being prepared; |
b.) | [omitted]; |
c.) | Evaluated the effectiveness of the registrant’s disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and |
d.) | Disclosed in this report any change in the registrant’s internal control over financial reporting that occurred during the registrant’s most recent fiscal quarter (the registrant’s fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect, the registrant’s internal control over financial reporting; and |
5. | The registrant’s other certifying officer(s) and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrant’s auditors and the audit committee of the registrant’s board of directors (or persons performing the equivalent functions): |
a.) | All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the registrant’s ability to record, process, summarize and report financial information; and |
b.) | Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s internal control over financial reporting. |
November 10, 2016 | /s/ David Siewers | |
David Siewers | ||
Chief Financial Officer |
1. | The Quarterly Report on Form 10-Q of the Company for the period ended September 30, 2016 (the “Report”) fully complies with the requirements of Section 13(a) or 15(d) of the Securities Exchange Act of 1934, as amended; and |
2. | The information contained in the Report fairly presents, in all material respects, the financial condition and results of operations of the Company. |
November 10, 2016 | /s/ Werner Cautreels, Ph.D. | |
Werner Cautreels, Ph.D. | ||
President and Chief Executive Officer |
1. | The Quarterly Report on Form 10-Q of the Company for the period ended September 30, 2016 (the “Report”) fully complies with the requirements of Section 13(a) or 15(d) of the Securities Exchange Act of 1934, as amended; and |
2. | The information contained in the Report fairly presents, in all material respects, the financial condition and results of operations of the Company. |
November 10, 2016 | /s/ David Siewers | |
David Siewers | ||
Chief Financial Officer |
Document and Entity Information - shares |
9 Months Ended | |
---|---|---|
Sep. 30, 2016 |
Nov. 10, 2016 |
|
Document and Entity Information | ||
Document Type | 10-Q | |
Amendment Flag | false | |
Document and Period End Date | Sep. 30, 2016 | |
Document Fiscal Year Focus | 2016 | |
Document Fiscal Period Focus | Q3 | |
Entity Registrant Name | SELECTA BIOSCIENCES INC | |
Entity Central Index Key | 0001453687 | |
Current Fiscal Year End Date | --12-31 | |
Entity Filer Category | Non-accelerated Filer | |
Entity Common Stock, Shares Outstanding | 18,190,180 |
Consolidated Statements of Operations and Comprehensive Loss - USD ($) $ in Thousands |
3 Months Ended | 9 Months Ended | ||
---|---|---|---|---|
Sep. 30, 2016 |
Sep. 30, 2015 |
Sep. 30, 2016 |
Sep. 30, 2015 |
|
Statement of Comprehensive Income [Abstract] | ||||
Grant and collaboration revenue | $ 1,048 | $ 1,607 | $ 5,153 | $ 3,877 |
Operating expenses: | ||||
Research and development | 6,021 | 5,483 | 18,669 | 15,769 |
General and administrative | 2,495 | 2,195 | 7,294 | 6,305 |
Total operating expenses | 8,516 | 7,678 | 25,963 | 22,074 |
Loss from operations | (7,468) | (6,071) | (20,810) | (18,197) |
Investment income | 98 | 25 | 121 | 149 |
Foreign currency transaction gain (loss), net | (51) | 668 | (429) | 616 |
Interest expense | (311) | (334) | (931) | (843) |
Other expense, net | 4 | (13) | (78) | (50) |
Net loss | (7,728) | (5,725) | (22,127) | (18,325) |
Other comprehensive loss: | ||||
Foreign currency translation adjustment | 15 | (800) | 416 | (763) |
Unrealized gain (loss) on securities | 16 | 0 | 16 | 0 |
Comprehensive loss | (7,697) | (6,525) | (21,695) | (19,088) |
Net loss | (7,728) | (5,725) | (22,127) | (18,325) |
Accretion of redeemable convertible preferred stock | 0 | (1,836) | (4,566) | (4,959) |
Net loss attributable to common stockholders | $ (7,728) | $ (7,561) | $ (26,693) | $ (23,284) |
Net loss per share attributable to common stockholders | ||||
Basic and diluted (in dollars per share) | $ (0.43) | $ (3.50) | $ (3.39) | $ (10.86) |
Weighted average common shares outstanding | ||||
Basic and diluted (in shares) | 18,108,014 | 2,159,658 | 7,881,625 | 2,144,731 |
Consolidated Statements of Redeemable Convertible Preferred Stock and Stockholders' Equity (Deficit) - 9 months ended Sep. 30, 2016 - USD ($) |
Total |
Common stock |
Additional paid-In Capital |
Accumulated deficit |
Accumulated other comprehensive loss |
Series A redeemable convertible preferred stock |
Series B redeemable convertible preferred stock |
Series C redeemable convertible preferred stock |
Series D redeemable convertible preferred stock |
Series D redeemable convertible preferred stock
Additional paid-In Capital
|
Series SRN redeemable convertible preferred stock |
Series E redeemable convertible preferred stock |
Series E redeemable convertible preferred stock
Additional paid-In Capital
|
---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Beginning balance (in shares) at Dec. 31, 2015 | 2,589,868 | 7,437,325 | 5,000,002 | 8,099,994 | 2,111,109 | 8,888,888 | |||||||
Beginning balance at Dec. 31, 2015 | $ 137,482,000 | $ 3,644,000 | $ 21,448,000 | $ 20,178,000 | $ 42,902,000 | $ 12,082,000 | $ 37,228,000 | ||||||
Increase (Decrease) in Temporary Equity [Roll Forward] | |||||||||||||
Accretion of preferred stock to redemption value | 4,566,000 | $ 75,000 | $ 449,000 | $ 446,000 | $ 1,131,000 | $ 913,000 | $ 1,552,000 | ||||||
Conversion of convertible stock upon listing (in shares) | (2,589,868) | (7,437,325) | (5,000,002) | (8,099,994) | (2,111,109) | (8,888,888) | |||||||
Conversion of convertible stock upon listing | $ (3,719,000) | $ (21,897,000) | $ (20,624,000) | $ (44,033,000) | $ (12,995,000) | $ (38,780,000) | |||||||
Ending balance (in shares) at Sep. 30, 2016 | 0 | 0 | 0 | 0 | 0 | 0 | |||||||
Ending balance at Sep. 30, 2016 | $ 0 | $ 0 | $ 0 | $ 0 | $ 0 | $ 0 | $ 0 | ||||||
Beginning balance (in shares) at Dec. 31, 2015 | 2,173,399 | 2,173,399 | |||||||||||
Beginning balance at Dec. 31, 2015 | $ (116,493,000) | $ 0 | $ 1,000 | $ (111,508,000) | $ (4,986,000) | ||||||||
Increase (Decrease) in Stockholders' Equity [Roll Forward] | |||||||||||||
Vesting of restricted common stock (in shares) | 6,647 | ||||||||||||
Vesting of restricted common stock | 16,000 | 16,000 | |||||||||||
Issuance of common stock upon exercise of options (in shares) | 25,210 | ||||||||||||
Issuance of common stock upon exercise of options | 48,000 | 48,000 | |||||||||||
Stock‑based compensation expense | 1,281,000 | 1,281,000 | |||||||||||
Accretion of preferred stock to redemption value | (4,566,000) | (708,000) | (3,858,000) | ||||||||||
Exercise of common warrants (in shares) | 567,306 | ||||||||||||
Exercise of common warrants | 0 | ||||||||||||
Conversion of convertible stock upon listing (in shares) | 10,126,118 | ||||||||||||
Conversion of convertible stock upon listing | 142,048,000 | $ 1,000 | 142,047,000 | ||||||||||
Issuance of common stock, Initial public offering net of issuance costs | 64,501,000 | $ 5,289,633 | 64,501,000 | ||||||||||
Conversion of preferred stock warrants into warrants for the purchase of common stock | $ 189,000 | $ 189,000 | $ 114,000 | $ 114,000 | |||||||||
Currency translation adjustment | 416,000 | 416,000 | |||||||||||
Unrealized gains (losses) on securities | 16,000 | 16,000 | |||||||||||
Net loss | $ (22,127,000) | (22,127,000) | |||||||||||
Ending balance (in shares) at Sep. 30, 2016 | 18,188,313 | 18,188,313 | |||||||||||
Ending balance at Sep. 30, 2016 | $ 65,443,000 | $ 1,000 | $ 207,489,000 | $ (137,493,000) | $ (4,554,000) |
Nature of the Business and Basis of Presentation |
9 Months Ended |
---|---|
Sep. 30, 2016 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
Nature of the Business and Basis of Presentation | Nature of the Business and Basis of Presentation Selecta Biosciences, Inc. (the “Company”) was incorporated in Delaware on December 10, 2007, and is based in Watertown, Massachusetts. The Company is a biopharmaceutical company dedicated to developing the first generation of nanoparticle immunomodulatory drugs for the treatment and prevention of human diseases. Since inception, the Company has devoted its efforts principally to research and development of its technology and product candidates, recruiting management and technical staff, acquiring operating assets, and raising capital. The Company is subject to risks common to companies in the biotechnology industry including, but not limited to, new technological innovations, protection of proprietary technology, dependence on key personnel, compliance with government regulations and the need to obtain additional financing. Product candidates currently under development will require significant additional research and development efforts, including extensive pre-clinical and clinical testing and regulatory approval, prior to commercialization. These efforts require significant amounts of additional capital, adequate personnel infrastructure and extensive compliance-reporting capabilities. The Company’s product candidates are in development. There can be no assurance that the Company’s research and development will be successfully completed, that adequate protection for the Company’s intellectual property will be obtained, that any products developed will obtain necessary government regulatory approval or that any approved products will be commercially viable. Even if the Company’s product development efforts are successful, it is uncertain when, if ever, the Company will generate significant revenue from product sales. The Company operates in an environment of rapid change in technology and substantial competition from pharmaceutical and biotechnology companies. In addition, the Company is dependent upon the services of its employees and consultants. In connection with the initial public offering (“IPO”), the Company’s Board of Directors and stockholders approved a one-for-3.9 reverse stock split of the Company’s common stock. The reverse stock split became effective June 7, 2016. All share and per share amounts in these condensed interim financial statements and notes thereto have been retroactively adjusted for all periods presented to give effect to this reverse stock split, including reclassifying an amount equal to the reduction in par value of common stock to additional paid-in capital. On June 21, 2016 the Company completed an IPO of its common stock and issued and sold 5,000,000 shares of common stock at a price to the public of $14.00 per share for net proceeds of $60.8 million after deducting underwriting discounts and commissions and offering expenses. On July 25, 2016, 289,633 additional shares of the Company’s common stock were sold to the underwriters pursuant to the exercise of their option to purchase additional shares of common stock at a price to the public of $14.00 per share resulting in additional net proceeds of approximately $3.7 million after deducting underwriting discounts, commissions and offering expenses, bringing the total IPO net proceeds to $64.5 million. Upon the closing of the IPO on June 27, 2016, all outstanding shares of the Company’s convertible preferred stock automatically converted into 10,126,118 shares of the Company’s common stock. In addition, at this time, the warrants to purchase shares of the Company’s Series D and Series E convertible preferred stock were converted into warrants to purchase shares of the Company’s common stock. Unaudited Interim Financial Information The accompanying unaudited consolidated financial statements for the three and nine months ended September 30, 2016 and 2015 have been prepared by the Company, pursuant to the rules and regulations of the Securities and Exchange Commission (the “SEC”) for interim financial statements. Certain information and footnote disclosures normally included in financial statements prepared in accordance with accounting principles generally accepted in the United States of America (“GAAP”) have been condensed or omitted pursuant to such rules and regulations. However, the Company believes that the disclosures are adequate to make the information presented not misleading. These consolidated financial statements should be read in conjunction with the Company’s audited consolidated financial statements and the notes thereto for the year ended December 31, 2015 included in the Company’s final prospectus filed under the Securities Act of 1933, as amended, with the SEC pursuant to Rule 424(b)(4) on June 23, 2016. The unaudited interim financial statements have been prepared on the same basis as the audited consolidated financial statements. In the opinion of management, the accompanying unaudited interim consolidated financial statements contain all adjustments that are necessary for a fair statement of the Company’s financial statements for the three and nine months ended September 30, 2016 and 2015 and its cash flows for the nine months ended September 30, 2016 and 2015. Such adjustments are of a normal and recurring nature. The results of operations for the three and nine months ended September 30, 2016 are not necessarily indicative of the results of operations that may be expected for the year ending December 31, 2016. Liquidity The Company has incurred losses since inception and negative cash flows from operating activities. As of September 30, 2016 and December 31, 2015, the Company had an accumulated deficit of $137.5 million and $111.5 million, respectively. The Company’s cash and cash equivalents as of September 30, 2016 and December 31, 2015, includes $2.8 million and $3.0 million of unrestricted cash held by its Russian subsidiary. The future success of the Company is dependent upon its ability to obtain additional capital through issuances of equity and debt securities and from collaboration and grant agreements in order to further the development of its technology and product candidates, and ultimately upon its ability to attain profitable operations. There can be no assurance that the Company will be able to obtain the necessary financing to successfully develop and market its product candidates or attain profitability. Guarantees and Indemnifications As permitted under Delaware law, the Company indemnifies its officers, directors, consultants and employees for certain events or occurrences that happen by reason of the relationship with, or position held at, the Company. Through September 30, 2016, the Company had not experienced any losses related to these indemnification obligations, and no claims were outstanding. The Company does not expect significant claims related to these indemnification obligations and, consequently, concluded that the fair value of these obligations is negligible, and no related reserves were established. |
Summary of Significant Accounting Policies |
9 Months Ended |
---|---|
Sep. 30, 2016 | |
Accounting Policies [Abstract] | |
Summary of Significant Accounting Policies | Summary of Significant Accounting Policies Principles of Consolidation The consolidated financial statements include the accounts of the Company and its wholly owned subsidiaries, Selecta RUS, LLC (“Selecta (RUS)”), a Russian limited liability corporation, and Selecta Biosciences Security Corporation, a Massachusetts Security Corporation. All significant intercompany accounts and transactions have been eliminated. Foreign Currency The functional currency of Selecta (RUS) is the ruble. Assets and liabilities of Selecta (RUS) are translated at period-end exchange rates, while revenues and expenses are translated at average exchange rates for the period. Translation gains and losses are reflected in accumulated other comprehensive loss within stockholders’ deficit. Foreign currency transaction gains or losses are reflected in the consolidated statements of operations and comprehensive loss. Use of Estimates The preparation of consolidated financial statements in conformity with U.S. GAAP requires the Company’s management to make estimates and assumptions that affect the reported amounts of assets and liabilities, the disclosure of contingent assets and liabilities at the date of the consolidated financial statements and the reported amounts of revenues and expenses during the reporting period. The Company’s management considers many factors in selecting appropriate financial accounting policies and controls, and bases its estimates on historical experience and other market-specific or other relevant assumptions that it believes to be reasonable under the circumstances. In preparing these consolidated financial statements, management used significant estimates in the following areas, among others: revenue recognition, the fair value of common stock and other equity instruments, accounting for stock-based compensation, income taxes, collectability of accounts receivable, useful lives of long-lived assets, accrued expenses, and accounting for project development. The Company assesses the above estimates on an ongoing basis; however, actual results could materially differ from those estimates. The Company’s management made significant estimates and assumptions in determining the fair value of its common stock for those periods reported prior to the completion of the IPO. The Company utilized various valuation methodologies in accordance with the framework of the 2004 American Institute of Certified Public Accountants’ Technical Practice Aid, Valuation of Privately-Held Company Equity Securities Issued as Compensation, to estimate the fair value of its common stock. Each valuation methodology included estimates and assumptions that require the Company’s judgment. These estimates and assumptions included a number of objective and subjective factors, including external market conditions affecting the biotechnology industry sector, the prices at which the Company sold shares of preferred stock, the superior rights and preferences of securities senior to the Company’s common stock at the time and the likelihood of achieving a liquidity event, such as an initial public offering or sale. Significant changes to the key assumptions used in the valuations could result in different fair values of common stock at each valuation date. Segment Information Operating segments are identified as components of an enterprise about which separate discrete financial information is available for evaluation by the chief operating decision maker, the Company’s Chief Executive Officer, in making decisions regarding resource allocation and assessing performance. The Company views its operations and manages its business in one operating segment, the research and development of nanoparticle immunomodulatory drugs for the treatment and prevention of human diseases. Cash Equivalents and Short Term Investments Cash equivalents include all highly liquid investments maturing within 90 days from the date of purchase. Investments consist of securities with remaining maturities greater than 90 days when purchased. The Company classifies these investments as available‑for‑sale and records them at fair value in the accompanying consolidated balance sheets. Unrealized gains or losses are included in accumulated other comprehensive income (loss). Premiums or discounts from par value are amortized to investment income over the life of the underlying investment. The Company, as part of its cash management strategy, may invest in reverse repurchase agreements. All reverse repurchase agreements are tri-party and have maturities of three months or less at the time of investment. These agreements are collateralized by U.S. treasury securities for an amount no less than 102% of their value. Although available to be sold to meet operating needs or otherwise, securities are generally held through maturity. The cost of securities sold is determined based on the specific identification method for purposes of recording realized gains and losses. During the reporting periods, there were no realized gains or losses on sales of investments, and no investments were adjusted for other than temporary declines in fair value. Concentrations of Credit Risk and Off‑Balance Sheet Risk Financial instruments that potentially subject the Company to concentration of credit risk consist primarily of cash, cash equivalents, and accounts receivable. Cash and cash equivalents are deposited with federally insured financial institutions in the United States and may, at times, exceed federally insured limits. Management believes that the financial institutions that hold the Company’s deposits are financially credit worthy and, accordingly, minimal risk exists with respect to those balances. Generally, these deposits may be redeemed upon demand and therefore bear minimal interest rate risk. As an integral part of operating its Russian subsidiary, the Company also maintains cash in Russian bank accounts in denominations of both rubles and U.S. dollars. As of September 30, 2016, the Company maintained approximately $3.1 million in Russian bank accounts, of which $2.8 million was held in U.S. dollars. The Company has minimal credit risk as the majority of accounts receivable relates to amounts due under a government sponsored grant, collaboration with large pharmaceutical companies or grants from well‑known and supported non‑profit organizations. The Company did not have any off balance sheet arrangements as of September 30, 2016 and December 31, 2015. Fair Value of Financial Instruments The Company’s financial instruments consist mainly of cash equivalents, short‑term investments, restricted cash, accounts receivable, accounts payable, loans payable, common stock warrants, and redeemable convertible preferred stock warrants. The carrying amounts of cash equivalents, short term investments, restricted cash, accounts receivable, and accounts payable approximate their estimated fair value due to their short term maturities. The carrying amount of loans payable approximates their estimated fair value. Accounting standards define fair value as the price that would be received to sell an asset or paid to transfer a liability in an orderly transaction between market participants at the measurement date. A three‑level hierarchy is used to prioritize the inputs to valuation techniques used to measure fair value. The hierarchy gives the highest priority to unadjusted quoted prices in active markets for identical assets or liabilities (Level 1 measurements), and the lowest priority to unobservable inputs (Level 3 measurements). The three levels of the fair value hierarchy are described below: Level 1—Level 1 inputs are quoted prices in active markets for identical assets or liabilities that the reporting entity has the ability to access at the measurement date. Level 2—Level 2 inputs are inputs other than quoted prices included within Level 1 that are observable for the asset or liability, either directly or indirectly. If the asset or liability has a specified (contractual) term, a Level 2 input must be observable for substantially the full term of the asset or liability. Level 3—Level 3 inputs are unobservable inputs for the asset or liability in which there is little, if any, market activity for the asset or liability at the measurement date. To the extent that a valuation is based on models or inputs that are less observable or unobservable in the market, the determination of fair value requires more judgment. Accordingly, the degree of judgment exercised by the Company in determining fair value is greatest for instruments categorized in Level 3. A financial instrument’s level within the fair value hierarchy is based on the lowest level of any input that is significant to the fair value measurement. Fair value is a market‑based measure considered from the perspective of a market participant rather than an entity‑specific measure. Therefore, even when market assumptions are not readily available, the Company’s own assumptions are set to reflect those that market participants would use in pricing the asset or liability at the measurement date. The Company uses prices and inputs that are current as of the measurement date, including during periods of market dislocation. In periods of market dislocation, the observability of prices and inputs may change for many instruments. This condition could cause an instrument to be reclassified within levels in the fair value hierarchy. There were no transfers within the fair value hierarchy during the nine months ended September 30, 2016 or the year ended December 31, 2015. Property and Equipment Property and equipment are recorded at cost and depreciated using the straight‑line method over the estimated useful lives of the respective assets, generally seven years for furniture, five years for equipment and three years for computer and office equipment. Leasehold improvements are amortized over their useful life or the life of the lease, whichever is shorter. Major additions and betterments are capitalized. Maintenance and repairs, which do not improve or extend the life of the respective assets, are charged to operations as incurred. Costs incurred for construction in progress are recorded as assets and are not amortized until the construction is substantially complete and the assets are ready for their intended use. Impairment of Long‑Lived Assets The Company periodically evaluates its long‑lived assets for potential impairment. Impairment is assessed when there is evidence that events or changes in circumstances indicate that the carrying amount of an asset may not be recovered. Recoverability of these assets is assessed based on undiscounted expected future cash flows from the assets, considering a number of factors, including past operating results, budgets and economic projections, market trends, and product development cycles. Impairment in the carrying value of each asset is assessed when the undiscounted expected future cash flows derived from the asset are less than their carrying value. The Company did not recognize any impairment charges through September 30, 2016. Debt Issuance Costs Debt issuance costs and fees paid to lenders are recorded as a direct deduction from the face amount of the related debt. Debt issuance costs are accounted for as additional debt discount and are amortized over the term of the related debt using the interest method and recorded as interest expense. Costs and fees paid to third parties are expensed as incurred. Revenue Recognition The Company’s revenue is primarily generated from research grants in both the United States and Russia, and, prior to its termination, a license and research collaboration agreement with Sanofi. The Company recognizes revenue in accordance with ASC Topic 605, Revenue Recognition. Accordingly, revenue is recognized when all of the following criteria are met: - Persuasive evidence of an arrangement exists; - Delivery has occurred or services have been rendered; - The seller’s price to the buyer is fixed or determinable; and - Collectability is reasonably assured. Amounts received prior to satisfying the revenue recognition criteria are recognized as deferred revenue in the Company’s consolidated balance sheets. Amounts expected to be recognized as revenue within the 12 months following the balance sheet date are classified as deferred revenue, current portion. Amounts not expected to be recognized as revenue within the 12 months following the balance sheet date are classified as deferred revenue, net of current portion. Collaboration Revenue When evaluating multiple element arrangements such as the agreement with Sanofi discussed in Note 13, the Company considers whether the deliverables under the arrangement represent separate units of accounting. This evaluation requires subjective determinations and requires management to make judgments about the individual deliverables and whether such deliverables are separable from the other aspects of the contractual relationship. In determining the units of accounting, management evaluates certain criteria, including whether the deliverables have standalone value, based on the consideration of the relevant facts and circumstances for each arrangement. The consideration received is allocated among the separate units of accounting using the relative selling price method, and the applicable revenue recognition criteria are applied to each of the separate units. The Company determines the estimated selling price for deliverables within each agreement using vendor‑specific objective evidence (“VSOE”) of selling price, if available, third‑party evidence (“TPE”) of selling price if VSOE is not available, or best estimate of selling price if neither VSOE nor TPE is available. Determining the best estimate of selling price for a deliverable requires significant judgment. The Company has used its best estimate of selling price to estimate the selling price for licenses to the Company’s proprietary technology, since the Company does not have VSOE or TPE of selling price for these deliverables. In those circumstances, the Company considers market conditions as well as entity‑specific factors, including those factors contemplated in negotiating the agreements, estimated development costs, probability of success and the time needed to commercialize a product candidate pursuant to the license. In validating the Company’s best estimate of selling price, the Company evaluates whether changes in the key assumptions used to determine the best estimate of selling price will have a significant effect on the allocation of arrangement consideration between multiple deliverables. The Company may receive upfront payments when licensing its intellectual property in conjunction with a research and development agreement. When management believes the license to its intellectual property does not have stand‑alone value from the other deliverables to be provided in the arrangement, the Company generally recognizes revenue attributed to the license over the Company’s contractual or estimated performance period. When management believes the license to its intellectual property has stand‑alone value, the Company generally recognizes revenue attributed to the license upon delivery. The periods over which revenue should be recognized are subject to estimates by management and may change over the course of the research and development agreement. Such a change could have a material impact on the amount of revenue the Company records in future periods. Payments or reimbursements resulting from the Company’s research and development efforts are recognized as the services are performed. At the inception of each agreement that includes milestone payments, the Company evaluates whether each milestone is substantive and at risk to both parties on the basis of the contingent nature of the milestone, specifically reviewing factors such as the scientific and other risks that must be overcome to achieve the milestone, as well as the level of effort and investment required. Revenues from milestones, if they are nonrefundable and deemed substantive, are recognized upon successful accomplishment of the milestones. Milestones that are not considered substantive are accounted for as license payments and recognized over the remaining period of performance. Grant Agreements Grant revenue is generally recognized as the related research and development work is performed. Grant arrangements frequently include payment milestones which the Company has judged to be non‑substantive milestones as they are typically entitled to receive payment regardless of the outcome of the research work. Revenue under such arrangements is recognized using a proportional performance method, but not in excess of cash actually received. Amounts received prior to satisfying the above revenue recognition criteria are recorded as deferred revenue in the accompanying consolidated balance sheets. Research and Development Costs Costs incurred in the research and development of the Company’s products are expensed as incurred. Research and development expenses include costs incurred in performing research and development activities, including salaries and benefits, facilities cost, overhead costs, contract services, supplies and other outside costs. Nonrefundable advance payments for goods and services that will be used in future research and development activities are expensed when the activity has been performed or when the goods have been received rather than when the payment is made. Clinical Trial Costs Clinical trial costs are a component of research and development expenses. The Company accrues and expenses clinical trial activities performed by third parties based on an evaluation of the progress to completion of specific tasks using data such as patient enrollment, clinical site activation, and other information provided to the Company by its vendors. Income Taxes The Company provides deferred tax assets and liabilities for the expected future tax consequences of temporary differences between the Company’s financial statement carrying amounts and the tax bases of assets and liabilities using enacted tax rates expected to be in effect in the years in which the differences are expected to reverse. A valuation allowance is provided to reduce the deferred tax assets to the amount that will more‑likely‑than‑not be realized. The Company determines whether it is more likely than not that a tax position will be sustained upon examination. If it is not more likely than not that a position will be sustained, none of the benefit attributable to the position is recognized. The tax benefit to be recognized for any tax position that meets the more‑likely‑than‑not recognition threshold is calculated as the largest amount that is more than 50% likely of being realized upon resolution of the contingency. The Company accounts for interest and penalties related to uncertain tax positions as part of its provision for income taxes. To date, the Company has not incurred interest and penalties related to uncertain tax positions. Should such costs be incurred, they would be classified as a component of income tax expense. Warrants The Company has issued common stock warrants and redeemable convertible preferred stock warrants to investors and lenders. Common stock warrants are classified as a component of permanent equity because they are freestanding financial instruments that are legally detachable and separately exercisable from other debt and equity instruments, are contingently exercisable, do not embody an obligation for the Company to repurchase its own shares, and permit the holders to receive a fixed number of common shares upon exercise. In addition, such warrants require physical settlement and do not provide any guarantee of value or return. Common stock warrants are initially recorded at their issuance date fair value and are not subsequently re‑measured. These warrants are valued using the Black‑Scholes option pricing model (“Black‑Scholes”). In connection with the automatic conversion of the Company’s convertible preferred stock, which occurred upon the closing of the IPO on June 27, 2016, the preferred stock warrants became warrants to purchase common stock. The Company performed the final mark to market adjustment on the preferred stock warrant using the fair value of the underlying common shares of $14.00 per share on June 27, 2016 and recorded the change in fair value in other income (expense), net in the consolidated statement of operations and comprehensive loss. The preferred stock warrant liability was then reclassified to additional paid-in-capital as the preferred stock warrants became warrants to purchase common stock. Stock‑Based Compensation The Company accounts for all stock‑based compensation granted to employees and non‑employees using a fair value method. Stock‑based compensation awarded to employees is measured at the grant date fair value of stock option grants and is recognized over the requisite service period of the awards, usually the vesting period, on a straight‑line basis, net of estimated forfeitures. Stock‑based compensation awarded to non‑employees are subject to revaluation over their vesting terms. The Company reduces recorded stock‑based compensation for estimated forfeitures. To the extent that actual forfeitures differ from the Company’s estimates, the differences are recorded as a cumulative adjustment in the period the estimates were adjusted. Stock‑based compensation expense recognized in the financial statements is based on awards that are ultimately expected to vest. Comprehensive Loss Comprehensive loss is defined as the change in the equity of a business entity during a period from transactions and other events and circumstances from non‑owner sources. It includes all changes in equity during a period except those resulting from investments by owners and distributions to owners. Comprehensive loss consists of both: (i) all components of net loss and (ii) all components of comprehensive loss other than net loss, referred to as other comprehensive loss. For all periods presented, other comprehensive loss is comprised solely of foreign currency translation adjustments. Net Loss Per Share The Company has reported losses since inception and has computed basic net loss per share attributable to common stockholders by dividing net loss attributable to common stockholders by the weighted average number of common shares outstanding for the period. The Company has computed diluted net loss per common share after giving consideration to all potentially dilutive common shares, including stock options, convertible preferred stock, and warrants outstanding during the period except where the effect of including such securities would be antidilutive. Because the Company has reported net losses since inception, these potential common shares have been anti‑dilutive and basic and diluted loss per share have been the same. Deferred Rent Rent expense and lease incentives from operating leases are recognized on a straight‑line basis over the lease term. The difference between rent expense recognized and rental payments is recorded as deferred rent in the accompanying consolidated balance sheets. Contingent Liabilities The Company accounts for its contingent liabilities in accordance with ASC No. 450, Contingencies. A provision is recorded when it is both probable that a liability has been incurred and the amount of the loss can be reasonably estimated. With respect to legal matters, provisions are reviewed and adjusted to reflect the impact of negotiations, estimated settlements, legal rulings, advice of legal counsel and other information and events pertaining to a particular matter. As of September 30, 2016 and December 31, 2015, the Company was not a party to any litigation that could have a material adverse effect on the Company’s business, financial position, results of operations or cash flows. Recent Accounting Pronouncements In May 2014, the FASB issued ASU No. 2014‑9, Revenue from Contracts with Customers (“ASU 2014‑9”), which amends the guidance for revenue recognition to replace numerous industry‑ specific requirements. ASU 2014‑9 implements a five‑step process for customer contract revenue recognition that focuses on transfer of control, as opposed to transfer of risk and rewards. ASU 2014‑9 also requires enhanced disclosures regarding the nature, amount, timing, and uncertainty of revenues and cash flows from contracts with customers. Other major provisions include ensuring the time value of money is considered in the transaction price, and allowing estimates of variable consideration to be recognized before contingencies are resolved in certain circumstances. The amendments in ASU 2014‑9 are effective for reporting periods beginning after December 15, 2017. Early adoption is permitted, but not before December 15, 2016. Entities can transition to the standard either retrospectively or as a cumulative‑effect adjustment as of the date of adoption. The Company is currently in the process of evaluating the effect the adoption of ASU 2014‑9 may have on its financial statements. In August 2014, the FASB issued ASU 2014-15, Presentation of Financial Statements—Going Concern. ASU 2014-15 requires management of all entities to evaluate whether there are conditions and events that raise substantial doubt about the entity’s ability to continue as a going concern within one year after the financial statements are issued, and to make certain disclosures if it concludes that substantial doubt exists or when its plans alleviate substantial doubt about the entity’s ability to continue as a going concern. ASU 2014-15 is effective for the Company for annual reporting periods beginning in 2016 and for interim reporting periods starting in the first quarter of 2017. The Company is currently evaluating the impact that the standard will have on the financial statements, and has not yet determined what effect, if any, the impact of adoption will be. In February 2016, FASB issued ASU No.2016‑2, Leases (“ASU 2016‑2”). ASU 2016‑2 requires a lessee to separate the lease components from the non‑lease components in a contract and recognize in the statement of financial position a liability to make lease payments (the lease liability) and a right‑of‑use asset representing its right to use the underlying asset for the lease term. It also aligns lease accounting for lessors with the revenue recognition guidance in ASU 2014‑9. ASU 2016‑2 is effective for fiscal years beginning after December 15, 2018, including interim periods within those fiscal years, and is to be applied at the beginning of the earliest period presented using a modified retrospective approach. In March 2016, the FASB issued ASU 2016-9, Improvements to Employee Share-Based Payment Accounting, which simplifies several aspects of accounting for share-based payment transactions including the income tax consequences, classification of awards as either equity or liabilities, and classification on the statement of cash flows. The new standard is effective for fiscal years beginning after December 15, 2016 and interim periods within those fiscal years with early adoption permitted. The Company is evaluating the impact that the adoption of this standard will have on its financial statements. |
Available-for-Sale Marketable Securities |
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Investments, Debt and Equity Securities [Abstract] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Available-for-Sale Marketable Securities | Available-for-Sale Marketable Securities As of September 30, 2016 and December 31, 2015, the Company’s available-for-sale marketable securities consisted of debt securities issued by the U.S. government and corporate debt securities. The following tables summarize the Company’s available-for-sale marketable securities by major type of security as of September 30, 2016 and December 31, 2015 (in thousands):
All available-for-sale marketable securities are classified in the Company’s Condensed Balance Sheets as Short term deposits and investments. The Company classifies its marketable debt securities based on their contractual maturity dates. As of September 30, 2016, the Company’s marketable debt securities mature at various dates through August 2017. The fair values and amortized cost of marketable debt securities by contractual maturity were as follows (in thousands):
As of September 30, 2016 the Company held a total of 11 out of 13 positions that were in an unrealized loss position, none of which had been in an unrealized loss position for 12 months or greater. Based on the Company’s review of these securities, the Company believes that the cost basis of its available-for-sale marketable securities is recoverable and that, therefore, it had no other-than-temporary impairments on these securities as of September 30, 2016. The Company does not intend to sell these debt securities and the Company believes it is not more likely than not that it will be required to sell these securities before the recovery of their amortized cost basis, which may be maturity. |
Net Loss Per Share |
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Earnings Per Share [Abstract] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Net Loss Per Share | Net Loss Per Share Because the Company has reported a net loss attributable to common stockholders for all periods presented, basic and diluted net loss per share attributable to common stockholders are the same for those periods. The following table sets forth the computation of basic and diluted net loss per share (in thousands, except share and per‑share data):
Potential common shares issuable upon conversion of warrants to purchase common stock and stock options that are excluded from the computation of diluted weighted average shares outstanding are as follows:
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Fair Value Measurements |
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Fair Value Measurements | Fair Value Measurements The tables below present information about the Company’s financial assets and liabilities that are measured and carried at fair value as of September 30, 2016 and December 31, 2015 and indicate the level within the fair value hierarchy where each measurement is classified. Below is a summary of assets measured at fair value on a recurring basis (in thousands):
At September 30, 2016, all cash and cash equivalent investments where held in money market funds and tri-party repurchase agreements which are collateralized by government securities for an amount not less than 102% of their value. All reverse repurchase agreements are tri-party and have maturities of three months or less at the time of investment. At December 31, 2015 the average maturity for the US Treasury obligations was 106 days. Fair value of US Treasury obligations approximates amortized value. In July 2015, the Company issued warrants for the purchase of 80,813 shares of common stock at an exercise price of $17.55 in connection with the issuance of convertible notes. These warrants expire three years from date of issuance. Common stock warrants are classified as permanent equity which are initially recorded at issuance date fair value and are not subsequently re‑measured. In August 2013 and July 2014, in conjunction with the execution of a loan and security agreement (Note 9), the Company issued warrants to the lenders for the purchase of up to 66,668 shares of the Company’s Series D redeemable convertible preferred stock (“Series D Preferred”) at an exercise price of $4.50 per share. At the IPO, these warrants were converted to warrants to purchase 17,888 of common stock at an exercise price of $16.77. These warrants are classified as permanent equity in the accompanying consolidated balance sheets and will expire four years from the date of issuance. In December 2015, in conjunction with the execution of a loan and security agreement (Note 9), the Company issued warrants to the lenders for the purchase of up to 37,978 shares of the Company’s Series E Preferred at an exercise price of $4.50 per share. At the IPO, these warrants were converted to warrants to purchase 15,094 of common stock at an exercise price of $11.32. These warrants are classified as permanent equity in the accompanying consolidated balance sheets and will expire four years from the date of issuance. |
Property and Equipment |
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Property and Equipment | Property and Equipment Property and equipment consists of the following (in thousands):
Depreciation expense for the three months ended September 30, 2016 and 2015 was $0.1 million and $0.2 million respectively and for the nine months ended September 30, 2016 and 2015, was $0.5 million and $0.9 million, respectively. |
Accrued Expenses |
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Accrued Expenses | Accrued Expenses Accrued expenses consist of the following (in thousands):
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Commitments and Contingencies |
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Commitments and Contingencies Disclosure [Abstract] | |||||||||||||||||||||||||||||||||||||
Commitments and Contingencies | Commitments and Contingencies Operating Leases The Company has a non‑cancellable operating lease for its laboratory and office space located in Watertown, Massachusetts. As part of the lease agreement, the landlord provided the Company a tenant improvement allowance of up to $0.7 million, which the Company fully utilized during 2012. The tenant improvement allowance is accounted for as a lease incentive obligation and is being amortized as a reduction to rent expense over the lease term. The leasehold improvements are capitalized as a component of property and equipment. In connection with the lease, the Company secured a letter of credit for $0.3 million which renews automatically each year and is classified in restricted cash and other deposits in the accompanying consolidated balance sheets. In April 2015, the Company amended the lease agreement to exchange 13,711 square feet of space for another 15,174 square feet of space within the same building. Rental payments on the prior space ceased as of March 31, 2015 and rental payments on the new space began on October 1, 2015. The Company subleased a portion of its facility to a tenant with a term that would have expired in March 2017. In March 2015, the tenant terminated the sublease and vacated the space. The sublease amount from the tenant was recorded as a reduction of lease expense and totaled $0.2 million for the year ended December 31, 2015. In August 2016, the Company signed an amendment to the operating lease, which extends the lease term of the Company's laboratory and office space through March 31, 2020. The lease agreement includes a rent escalation clause, and accordingly, rent expense is being recognized on a straight-line basis over the lease term. Deferred rent and lease incentive liability totaled $0.2 million and $0.5 million as of September 30, 2016 and December 31, 2015, respectively. Included in that amount, the current portion of deferred rent and lease incentive liability is classified as accrued expenses and was less than $0.1 million at September 30, 2016 and $0.4 million at December 31, 2015, respectively. The Company has a month‑to‑month facility agreement for its Moscow, Russia facility. Rent expense is recognized as incurred. Rent expense, net of sublease payments, for the three months ended September 30, 2016 and September 30, 2015 was $0.4 million, and $0.5 million respectively, and for the nine months ended September 30, 2016 and September 30, 2015 was $1.1 million and $1.0 million, respectively. As of December 31, 2015, the future minimum lease payments under the lease, as amended by the lease amendment are as follows (in thousands):
Other As permitted under Delaware law, the Company indemnifies its directors for certain events or occurrences while the director is, or was, serving at the Company’s request in such capacity. The term of the indemnification is for the director’s lifetime. The maximum potential amount of future payments the Company could be required to make is unlimited; however, the Company has directors’ insurance coverage that limits its exposure and enables it to recover a portion of any future amounts paid. The Company also has indemnification arrangements under certain of its facility leases that require it to indemnify the landlord against certain costs, expenses, fines, suits, claims, demands, liabilities, and actions directly resulting from certain breaches, violations, or non‑performance of any covenant or condition of the Company’s lease. The term of the indemnification is for the term of the related lease agreement. The maximum potential amount of future payments the Company could be required to make under these indemnification agreements is unlimited. To date, the Company had not experienced any material losses related to any of its indemnification obligations, and no material claims with respect thereto were outstanding. The Company does not expect significant claims related to these indemnification obligations and, accordingly, has concluded that the fair value of these obligations is negligible, and no related reserves have been established. The Company is a party in various other contractual disputes and potential claims arising in the ordinary course of business. The Company does not believe that the resolution of these matters will have a material adverse effect on its financial position or results of operations. |
Debt |
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Debt Disclosure [Abstract] | |||||||||||||||||||||||||||||||||||||||||||||||||
Debt | Debt Term Loans On August 9, 2013, the Company entered into a loan and security agreement with two lenders to borrow up to $7.5 million. The Company initially borrowed $3.0 million in August 2013 and subsequently borrowed an additional $4.5 million in July 2014. The amounts borrowed are collectively referred to as “Term Loans.” In December 2015, the Company refinanced its existing debt facility that was originally entered into on August 9, 2013, as amended with Oxford Finance LLC (“Oxford”) and Square 1Bank (“Square 1”), to increase the amount of the borrowing to $12.0 million and to extend the repayment term. The lenders for the refinanced debt facility are Oxford and Pacific Western Bank (“Pacific Western”). Pacific Western had acquired Square 1 since the time of the original loan. Such a change in lender does not constitute third party financing on its own, and does not require extinguishment accounting. As a result of the refinancing, the stated interest rate was also adjusted to reflect the current market borrowing rate. As of September 30, 2016 and December 31, 2015, the outstanding principal balance under the Term Loans was $12.0 million. According to ASC 470‑50‑40, the refinancing and modification of the prior debt in a non‑troubled debt situation must be treated as either an extinguishment or a modification based on whether the present value of the cash flows under the terms of the new debt instrument is different by greater than, or less than, 10% from the present value of the remaining cash flows under the terms of the original instrument. For cash flow changes greater than 10%, the debt modification is accounted for as a debt extinguishment, whereby the original debt is derecognized and the new debt is initially recorded at fair value, with the difference recognized as an extinguishment gain or loss. For cash flow changes of less than 10%, the new loan is considered a modification and no gain or loss is recognized. In considering all cash flow changes, the Company concluded that the refinancing of the debt as of December 31, 2015 is a modification of the debt and not a debt extinguishment, and as a result the debt is initially recorded at its amortizable value net of discounts and deferred costs. The Term Loans are collateralized by the assets of the Company and bear interest at 8.1% per annum. The monthly payments for the Term Loans are initially interest only through January 2017. Principal repayments for the Term Loans are due over 30 monthly installments beginning on February 1, 2017. The Term Loans may be prepaid at the Company’s option at any time prior to maturity subject to a prepayment fee of 3% if prepaid prior to the first anniversary of the borrowing date, 2% if prepaid after the first anniversary but before the second anniversaries, and 1% if prepaid after the second anniversary. The Term Loans do not include any financial covenants. The Term Loans require a final payment fee of 6.0% on the aggregate principal amounts borrowed upon repayment at maturity, on a prepayment date, or upon default. The final payment fee totaling $0.7 million is recorded as a loan discount. In addition, the Term Loans contain a subjective acceleration clause whereby in an event of default, an immediate acceleration of repayment occurs if there is a material impairment of the lenders’ lien or the value of the collateral, a material adverse change in the business condition or operations, or a material uncertainty exists that any portion of the loan may not be repaid. To date, there have been no such events and the lender has not exercised its right under this clause. As a result, the Company concluded that a material adverse change has not occurred and is unlikely to occur, therefore, no liability has been recorded in connection with the clause. In connection with the Term Loans, the Company granted the lenders warrants in August 2013 to purchase up to 26,668 shares of the Company’s Series D Preferred and additional warrants in July 2014 to purchase up to 40,000 shares of the Company’s Series D Preferred. As of the IPO, the warrants to purchase up to 66,668 shares of the Company’s Series D Preferred were converted to warrants to purchase 17,888 shares of the Company’s common stock. Additionally, with the refinancing of the Term Loans at December 31, 2015, the Company granted the lenders 37,978 shares of the Company’s Series E Preferred which also was converted at the IPO to warrants to purchase 15,094 shares of Company’s common stock. The initial grant date fair value of the warrants of $0.1 million, $0.1 million and $0.1 million for each issuance respectively, was recorded as a loan discount. Term Loan discounts are amortized as additional interest expense over the term of the loans. Interest expense for the three months ended September 30, 2016 and 2015 totaled $0.3 million and $0.1 million, respectively, and for the nine months ended September 30, 2016 and 2015 was $0.9 million and $0.5 million, respectively. Future minimum payments on the Term Loans as of December 31, 2015 are as follows (in thousands):
Convertible Notes In April 2015, the Company issued convertible notes as a bridge loan to be automatically converted into the Company’s capital stock upon the consummation of a private placement of the Company’s Preferred Stock. The convertible notes bore interest at 8% per annum, compounding monthly. In the event the Company was unable to consummate the private placement by July 15, 2015, the Company would be required to issue warrants to purchase shares of the Company’s common stock equal to 20% of the convertible note principal divided by $17.55. On July 24, 2015, the Company issued warrants to the convertible note holders to purchase up to 80,813 shares of the Company’s common stock at an exercise price of $17.55 per share for a term of three years. The carrying value and accrued interest of the outstanding convertible notes were automatically converted into 1,619,550 shares of Series E Preferred. As part of the Series E Preferred issuance, the convertible note holders also received warrants to purchase up to 103,817 shares of the Company’s common stock (Note 10). The difference between the carrying value and accrued interest of the convertible notes that were converted and the combined fair value of the Series E Preferred shares and common stock warrants issued were negligible. There was no interest expense related to the convertible notes for the three and nine months ended September 30, 2016, and $0.1 million and $0.3 million for the three and nine months ended September 30, 2015, respectively. |
Preferred Stock |
9 Months Ended |
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Sep. 30, 2016 | |
Temporary Equity Disclosure [Abstract] | |
Preferred Stock | Preferred Stock The Company issued Preferred Stock with a $0.0001 par value to investors for cash or as settlement for outstanding debt under convertible notes. The Company had issued Preferred Stock of (i) 2,589,868 shares of Series A redeemable convertible preferred stock (“Series A Preferred”), (ii) 7,437,325 shares of Series B redeemable convertible preferred stock (“Series B Preferred”), (iii) 5,000,002 shares of Series C redeemable convertible preferred stock (“Series C Preferred”), (iv) 8,099,994 shares of Series D Preferred, (v) 2,111,109 shares of Series SRN Redeemable Convertible Preferred Stock (“Series SRN Preferred”) and (vi) 8,888,888 shares of Series E Preferred. In April 2014 and August 2014, the Company issued an additional 3,211,105 shares of Series D Preferred at $4.50 per share for total net proceeds of $14,349,239. In July 2014, the Company issued an additional 1,333,332 shares of Series SRN Preferred at $4.50 per share for total net proceeds of $5.8 million. In connection with the issuance of the additional shares of Series SRN Preferred, the Series SRN Preferred terms were amended. Significant terms that were amended included a change of the Series SRN Preferred optional and mandatory conversion price (other than a special conversion event, as defined in the certificate of incorporation) to $16.77 per share, the elimination of a time‑based tranche investment requirement, and the removal of a call option for the Company to repurchase the Series SRN Preferred shares. Based upon the qualitative characteristics of the amendments, the Company determined that the changes significantly modified the terms of Series SRN Preferred resulting in an extinguishment of the then outstanding SRN Preferred shares. As a result, the carrying value of Series SRN Preferred of $5.0 million at the date of the amendment was derecognized, and the amended Series SRN Preferred shares were recorded at their fair value of $4.50 per share. The difference of $1.5 million was recorded as additional paid in capital. In August 2015 and September 2015, the Company issued an aggregate of 7,269,338 shares of Series E Preferred at $4.50 per share for total gross proceeds of $32.7 million with issuance costs totaling $0.2 million. In addition, the Company issued 1,619,550 shares of Series E Preferred in connection with the conversion of convertible notes (Note 9). In connection with the Series E Preferred issuances, each Series E Preferred stockholder also received warrants to purchase a number of shares of the Company’s common stock that equal to 25% of the number of Series E Preferred shares issued. The fair value of the issued common stock warrants is accounted for as an issuance discount on the Series E Preferred. The common stock warrants are classified as permanent equity and were recorded as additional paid‑in capital. All outstanding shares of the Company’s convertible preferred stock automatically converted into 10,126,118 shares of the Company’s common stock upon the closing of the IPO on June 27, 2016. |
Common Stock |
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Stockholders' Equity Note [Abstract] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Common Stock | Common Stock The voting, dividend and liquidation rights of the common stockholders are subject to and qualified by the rights, powers and preferences of the Preferred Stock. The common stock has the following characteristics: Voting The common stockholders are entitled to one vote for each share of common stock held with respect to all matters voted on by the stockholders of the Company. Common stock voting rights on certain matters are subject to the powers, preferences, and rights of the Senior Preferred. Dividends The common stockholders are entitled to receive dividends, if and when declared by the Board of Directors. The Company may not declare or pay any cash dividends to the common stockholders unless dividends are first declared and paid to the holders of Preferred Stock in accordance with their respective terms. Through September 30, 2016, no dividends have been declared or paid on common stock. Liquidation After holders of Preferred Stock are satisfied of their liquidation preferences upon any voluntary or involuntary liquidation, dissolution or winding up of the affairs of the Company, the common stockholders are then entitled to receive that portion of the remaining funds to be distributed to all holders of the Company’s stock on an as‑converted basis. Reserved Shares The Company has authorized shares of common stock for future issuance as follows:
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Stock Incentive Plans |
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Disclosure of Compensation Related Costs, Share-based Payments [Abstract] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Stock Incentive Plans | Stock Incentive Plans The Company maintained the 2008 Stock Incentive Plan (the “2008 Plan”) for employees, consultants, advisors, and directors. The 2008 Plan provided for the granting of incentive and non‑qualified stock option and restricted stock awards as determined by the Board. As of September 30, 2016, a total of 2,213,412 shares of common stock are authorized for grants under the 2008 Plan with 10,163 shares available for future grant. All stock options granted under the 2008 Plan may be exercised into restricted stock subject to forfeiture provisions upon termination. The 2008 Plan provided that the exercise price of incentive stock options cannot be less than 100% of the fair market value of the common stock on the grant date for participants who own less than 10% of the total combined voting power of the Company, and not less than 110% for participants who own more than 10% of the Company’s voting power. Options and restricted stock granted under the 2008 Plan vest over periods as determined by the Board, which are generally four years and with terms that generally expire ten years from the grant date. The fair value of each option award was estimated on the grant date using Black‑Scholes. Expected volatilities were based on historical volatilities from guideline companies, since there was no active market for the Company’s common stock. The Company used the “simplified” method to estimate the expected life of options granted and are expected to be outstanding. The risk‑free interest rate used is the rate for a U.S. Treasury zero coupon issue with a remaining life consistent with the options expected life on the grant date. The Company has not paid, and does not expect to pay, any cash dividends in the foreseeable future. Forfeitures were estimated at the time of grant and were adjusted, if necessary, in subsequent periods if actual forfeitures differed from those estimates. The Company had estimated a forfeitures rate of 10% based on historical attrition trends. The Company records stock‑based compensation expense only on the awards that are expected to vest. As of the S-1 registration date of May 24, 2016, the Company ceased granting awards under the 2008 Plan; however, awards issued under the 2008 Plan remain subject to the terms of the applicable 2008 Plan agreement. On June 7, 2016, the Company’s stockholders approved the 2016 Incentive Award Plan (the “2016 Plan”), which became effective June 21, 2016. The 2016 Plan provides for the granting of incentive and non‑qualified stock option and restricted stock awards as determined by the Board. As of September 30, 2016, a total of 1,210,256 shares of common stock are authorized for grants under the 2016 Plan with 783,494 shares available for future grant. The 2016 Plan provides that the exercise price of incentive stock options cannot be less than 100% of the fair market value of the common stock on the grant date for participants who own less than 10% of the total combined voting power of the Company, and not less than 110% for participants who own more than 10% of the Company’s voting power. Options and restricted stock granted under the 2016 Plan vest over periods as determined by the Board, which are generally four years and with terms that generally expire ten years from the grant date. On June 7, 2016, the Company’s stockholders approved the 2016 Employee Stock Purchase Plan (the “ESPP”), which became effective June 21, 2016. A total of 173,076 shares of common stock were reserved for issuance under the ESPP. In addition, the number of shares of common stock that may be issued under the ESPP will automatically increase on the first day of each calendar year, beginning in 2017 and ending in and including 2026, by an amount equal to (i) 1% of the number of shares of the Company’s common stock outstanding on the last day of the applicable preceding calendar year and (ii) such smaller number of shares as is determined by the Company’s Board of Directors. The weighted average assumptions used for employee stock option grants issued for the nine month period ended September 30, 2016 and in 2015:
The resulting weighted average grant date fair value of stock options granted to employees during the nine months ended September 30, 2016 and year ended December 31, 2015 was $9.79 and $5.03, respectively. The aggregate intrinsic value of stock options exercised during the nine months ended September 30, 2016 and year ended December 31, 2015 was $0.1 million and $0.3 million, respectively. As of September 30, 2016 and December 31, 2015, total unrecognized compensation expense related to unvested employee stock options was $5.5 million and $2.3 million, respectively, which is expected to be recognized over a weighted average period of 3.2 years and 3.1 years, respectively. The weighted average assumptions used for unvested non‑employee stock options are as follows:
The unvested options held by non‑employees are revalued using the Company’s estimate of fair value on each vesting and reporting date through the remaining vesting period. Non‑employee stock‑based compensation expense of $0.2 million and $0.4 million was recorded during the nine months ended September 30, 2016 and for the year ended December 31, 2015, respectively. As of September 30, 2016 and December 31, 2015, total unrecognized compensation expense related to unvested non‑employee stock options was $1.0 million and $0.1 million, respectively. The following table summarizes the activity under the Plan and the 2016 Plan since December 31, 2015:
Restricted Stock During the year ended December 31, 2013, the Company issued 30,317 shares of restricted common stock to employees upon the early exercise of stock options. During the year ended December 31, 2014, the Company issued 2,564 shares of restricted common stock to employees. Under the terms of each agreement, the Company has a repurchase provision whereby the Company has the right to repurchase any unvested shares when/if the shareholders terminate their business relationship with the Company, at a price equal to the original exercise price. Accordingly, the Company recorded the cumulative payments received of $0.1 million for the purchase of the restricted shares as a liability. The Company records payment received from the granting of restricted stock as a liability which is amortized over the vesting period. As of September 30, 2016 and December 31, 2015, the remaining liability was less than $0.1 million. Total fair value of restricted shares that vested during the nine month period ended September 30, 2016 was less than $0.1 million. The following table summarizes the restricted stock award activity of the 2008 Plan and the 2016 Plan since December 31, 2015:
As of September 30, 2016 and December 31, 2015, total unrecognized compensation expense related to restricted stock awards was less than $0.1 million, which the Company expects to recognize over a weighted average period of approximately 0.25 years and 1.0 years, respectively. The Company recorded stock-based compensation expense related to stock options and restricted common stock in the following expense categories of its consolidated statements of operations and comprehensive loss (in thousands):
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Revenue Arrangements |
9 Months Ended |
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Sep. 30, 2016 | |
Revenue Recognition [Abstract] | |
Revenue Arrangements | Revenue Arrangements Sanofi Collaboration Agreement On November 27, 2012, the Company and Sanofi entered into a license and research collaboration agreement focused on the identification and development of vaccines against food allergies (the “Sanofi Agreement”). Under the arrangement, the Company agreed to perform research to identify an initial vaccine candidate for development and commercialization by Sanofi under an exclusive license. Pursuant to the Sanofi Agreement, the Company received an upfront payment of $2.0 million for the initial indication in November 2012 and an additional payment of $3.0 million in August 2013. In November 2014, Sanofi exercised the option to include celiac disease as an additional indication, and in May 2015, the Sanofi Agreement was amended to add terms specific to the celiac disease indication and to terminate Sanofi's right to exercise its option for any additional indications. Sanofi paid the Company an additional $2.0 million upon the exercise of the option in May 2015 and an additional $1.0 million in July 2016 upon attaining the first milestone for the celiac disease indication. To date, Sanofi has paid the Company $8.0 million in the aggregate under the Sanofi Agreement. Except as authorized by Sanofi or permitted under the Sanofi Agreement, during the term of the Sanofi Agreement, exclusivity obligations prevent the Company from researching, developing, or commercializing products in these indications or granting third party licenses under the intellectual property rights and technologies licensed to Sanofi for use in these indications. As per the agreement, the research term expired for the first indication on the third anniversary (November 27, 2015) of the agreement. The Company completed its research obligations within the initial three year period and is not obligated to perform any further research on the specific indication under the agreement. A vaccine candidate for development and commercialization was not selected by Sanofi by the end of the research plan, and therefore no further milestone payments have been received. The Company identified the deliverables under the arrangement as the license, the research necessary to identify the development candidate, and participation of the Joint Research Committee ("JRC"). The Company determined that the exclusive license granted to Sanofi did not have standalone value from the research to be performed to identify the vaccine development candidate. As a result, each upfront and milestone consideration was allocated to the combined unit of account comprising the license and research services, and is being recognized over the estimated development period using a proportional performance method. The consideration allocated to participation on the JRC was not material. The Company recognized revenue in the amount of $0.2 million and $0.5 million for the three months ended September 30, 2016 and 2015, respectively, and $0.6 million and $1.5 million for the nine months ended September 30, 2016 and 2015, respectively. Termination of the Sanofi Collaboration Agreement On November 9, 2016, the Company received written notice from Sanofi that Sanofi has elected to terminate in its entirety the Sanofi Agreement. The termination of the Sanofi Agreement will be effective on May 8, 2017, or the Termination Date, which is six months from the date of the notice. As discussed above, Sanofi has paid the Company $8.0 million in the aggregate under the Sanofi Agreement to date. The Company would have been eligible to receive additional development-based, regulatory-based and sales-based milestone payments and tiered royalties on net sales of any approved product generated by the collaboration had the Sanofi Agreement not been terminated. As of September 30, 2016, the Company had $2.2 million of deferred revenue associated with the Sanofi Agreement, which is expected to be recognized within the termination period. Upon timely exercise by the Company, all rights granted to Sanofi will terminate and revert to the Company effective on the Termination Date, and Sanofi is required to grant to the Company a royalty bearing, exclusive license, with the right to grant sublicenses, under certain Sanofi intellectual property solely to the extent necessary to research, develop, make, have made, use, offer for sale, import, export and otherwise commercialize the vaccine candidates developed under the Sanofi Agreement. The exclusivity obligations discussed above will also expire on the Termination Date. The Company intends to exercise its right to acquire the development programs under the Sanofi Agreement. The Company will be solely responsible for performing and funding any development and clinical trial activities relating to further development of vaccine candidates that it chooses to undertake after the Termination Date. Other Research and Collaboration Agreements The Company has entered into other research and collaboration agreements in 2016 and 2015 for which the Company recognized revenue of zero and $0.3 million for the three months ended September 30, 2016 and 2015, respectively, and $0.1 million and $0.4 million for the nine months ended September 30, 2016 and 2015, respectively. Grant Agreements The Company receives funding in the form of grants from the National Institutes of Health (“NIH”), the Juvenile Diabetes Research Foundation (“JDRF”), the Bill and Melinda Gates Foundation, the Russian Ministry of Industry and Trade (“Minpromtorg”), and the Russia based Development Fund of New Technologies Development and Commercialization Center (“Skolkovo”). NIH The Company has two grants through the NIH. The first grant, for an aggregate amount of $8.1 million, was awarded in May 2014 to support research in the development of a next generation vaccine for smoking cessation and relapse prevention. The Company recognized revenue in the amount of $0.7 million and $0.5 million for the three months ended September 30, 2016 and 2015, respectively, and $3.7 million and $1.5 million for the nine months ended September 30, 2016 and 2015, respectively under the arrangement. The second grant is for an aggregate amount of $0.2 million, which was awarded in September 2015 for the development of nanoparticles for immune tolerance to factor VIII. The Company recognized revenue in an amount less than $0.1 million for the three and nine months ended September 30, 2016 related to this grant. JDRF The JDRF grant is a joint grant with Sanofi entered into in September 2014 for $0.4 million to conduct Type 1 Diabetes research. The Company recognized revenue in the amount of less than $0.1 million and zero for the three months ended September 30, 2016 and 2015, respectively, and $0.1 million and $0.2 million for the nine months ended September 30, 2016 and 2015, respectively, related to this grant. Bill and Melinda Gates Foundation The Company received a grant in 2013 from the Bill and Melinda Gates Foundation for $1.2 million to fund the Company’s immunology research on malaria antigens. During 2014, the grant amount was increased to a total of $1.6 million and the term was extended to a three-year research term. Revenue is recognized on a proportional performance basis as it relates to employee time expended on the research, along with reimbursement for external costs directly related to, and approved, by the grant terms. The Company recognized revenue in the amount of $0.1 million and $0.3 million for the three months ended September 30, 2016 and 2015, respectively, and $0.4 million and $0.3 million for the nine months ended September 30, 2016 and 2015, respectively, related to this grant. Minpromtorg The Company had a contract awarded from Minpromtorg for approximately $4.6 million to fund the Company’s nicotine cessation vaccine clinical trial to be conducted in Russia. The grant covered a term from July 9, 2013 through December 31, 2015, and provided for reimbursement of expenses incurred by the Company from the clinical trial. Under the agreement term, the Company was subject to a penalty in the event that the clinical trial was delayed or terminated prior to completion. As a result of the penalty provision, the Company concluded the amounts received under the agreement were not fixed or determinable. In 2014, the Company terminated its plan to conduct the clinical trial in Russia subjecting the Company to the penalty obligation. In February 2015, the Company received an executed final settlement agreement from Minpromtorg that included the repayment of funds previously received by the Company totaling $0.2 million, and a penalty fee that equaled to 10% of the contract value, or $0.2 million. The Company paid the settlement payment in March 2015 and all mutual claims under the contract were terminated. According to the terms of the agreement, Minpromtorg has the right to audit the expenditure incurred under the agreement for a period up to three years from each research milestone date. All grant funding received in excess of the penalty settlement will remain as a liability on the balance sheet until such time the audit period has expired and at which time, the amount will be recognized as revenue. Through September 30, 2016, the Company received payments totaling approximately $1.4 million. The first audit period expired on December 31, 2015, and as a result $0.4 million of revenue was recognized for the year ended December 31, 2015. The second audit expired during the nine months ended September 30, 2016, and as a result $0.2 million of revenue was recognized for the nine months ended September 30, 2016. Skolkovo On November 28, 2014, the Company executed a grant awarded by Skolkovo for the development of a therapeutic vaccine using nanoparticles to treat chronic infection caused by HPV and diseases associated with this infection. The grant covers a period from August 1, 2014 through July 21, 2017. The grant provides for up to $2.7 million that covers 48.5% of the estimated total cost of the research plan with the remaining 51.5% of estimated costs to be contributed by the Company. The Company has received from Skolkovo $1.8 million through the nine months ended September 30, 2016. At any time during the term of the grant agreement, but not more than once per quarter, Skolkovo has the right to request information related to the project and to conduct an audit of the expenses incurred by the Company. In the event the project or the expenses do not meet predefined requirements, the Company may be required to reimburse the funds received up to three years after the completion of the project. As a result, the Company has determined that the grant funding is not fixed or determinable and all amounts received to date are recorded as deferred revenue in the consolidated balance sheet until the completion of Skolkovo’s audit or the expiration of the audit term. |
Related-Party Transactions |
9 Months Ended |
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Sep. 30, 2016 | |
Related Party Transactions [Abstract] | |
Related-Party Transactions | Related‑Party Transactions As part of the Series B Preferred and Series D Preferred financings (as described in Note 10), the Company’s landlord (the “Landlord”) purchased 49,254 shares of Series B Preferred at $2.0303 per share for total proceeds of $0.1 million and 488,888 shares of Series D Preferred at $4.50 per share for total proceeds of $2.2 million. Additionally, in April 2015, the Landlord participated in the Company’s bridge loan in the amount of $0.2 million, which converted into Series E Preferred (see Note 10). The Landlord paid the same price as the price paid by other investors in each of these Preferred Stock purchases. At the IPO, all preferred stock was converted to common stock. The Company incurred expenses for consulting services provided by its founders totaling $0.1 million during each of the three months ended September 30, 2016 and 2015, and $0.2 million for each of the nine months ended September 30, 2016 and 2015. |
Technology License Agreements |
9 Months Ended |
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Sep. 30, 2016 | |
Goodwill and Intangible Assets Disclosure [Abstract] | |
Technology License Agreements | Technology License Agreements MIT On November 25, 2008, the Company entered into an Exclusive Patent License agreement with the Massachusetts Institute of Technology (“MIT”). The Company received an exclusive royalty‑bearing license to utilize patents held by MIT in exchange for upfront consideration and annual license maintenance fees. Such fees are expensed as incurred and have not been material to any period presented. In the event the Company sublicenses the MIT patents to a third party, it will be required to remit to MIT a percentage (ranging from 10% to 30%) of sublicense income. In addition, the Company is obligated to pay MIT a certain amount upon the achievement of defined clinical milestones, up to a total of $1.5 million. On December 18, 2008, the Company entered into a patent‑cross‑license agreement with BIND Therapeutics, Inc. whereby each party receives a license for the use of the other patents in their respective fields of use. In exchange for this license, the Company paid a one‑time expense in 2008. Shenyang Sunshine Pharmaceutical Co., Ltd In May 2014, the Company entered into a license agreement with Shenyang Sunshine Pharmaceutical Co., Ltd., (“3SBio”) which is referred to as the 3SBio License. Pursuant to the 3SBio License, the Company was granted an exclusive license to certain pegsiticase‑related patents and related “know‑how” owned or in‑licensed by 3SBio for the worldwide (except for Greater China and Japan) development and commercialization of products based thereupon for human therapeutic, diagnostic and prophylactic use. The Company was also granted a worldwide (except for Greater China) exclusive license to develop, commercialize and manufacture or have manufactured products combining the Company’s proprietary SVP technology with pegsiticase or related compounds supplied by 3SBio (or otherwise supplied if the Company’s rights to manufacture are in effect) for human therapeutic, diagnostic and prophylactic use. The Company was also granted a co‑exclusive license to manufacture and have manufactured pegsiticase and related compounds for preclinical and clinical use or, if the 3SBio License is terminated for 3SBio’s material breach, for any use under the 3SBio License. Otherwise, the Company is obligated to obtain all of its supply of such compounds for Phase 3 clinical trials and commercial use from 3SBio under the terms of supply agreements to be negotiated. Pursuant to the 3SBio License, the Company is required to use commercially reasonable efforts to develop and commercialize a product containing pegsiticase or a related compound. If the Company does not commercialize any such product in a particular country in Asia, Africa or South America within 48 months after approval of any such product in the U.S. or a major European country, then 3SBio will have the right to do so, but only until the Company commercializes a product combining the Company’s SVP technology with any such compound in such country. The Company has paid to 3SBio an aggregate of $1.0 million in upfront and milestone‑based payments under the 3SBio License. The Company is required to make future payments to 3SBio contingent upon the occurrence of events related to the achievement of clinical and regulatory approval milestones of up to an aggregate of $21.0 million for products containing the Company’s SVP technology, and up to an aggregate of $41.5 million for products without the Company’s SVP technology. The Company is also required to pay 3SBio tiered royalties on annual worldwide net sales (on a country‑by‑country and product‑by‑product basis) related to the pegsiticase component of products at percentages ranging from the low‑to‑mid single digits for products containing the Company’s SVP technology, and a range of no more than ten percent points from the mid‑single digits to low double‑digits for products without the Company’s SVP technology. The Company will pay these royalties to 3SBio, subject to specified reductions, on a country‑by‑country and product‑by‑product basis until the later of (i) the date that all of the patent rights for that product have expired in that country, or (ii) a specified number of years from the first commercial sale of such product in such country. The 3SBio License expires on the date of expiration of all of the Company’s royalty payment obligations unless earlier terminated by either party for an uncured material default or for the other party’s bankruptcy. Any such termination by 3SBio for material default may be on a country‑by‑country or product‑by‑product basis in certain circumstances. The Company may also terminate the 3SBio License on a country‑by‑country or product‑by‑product basis for any reason effective upon 60 days’ prior written notice to 3SBio or, with respect to a given product, immediately upon written notice to 3SBio if the Company identifies a safety or efficacy concern related to such product. Massachusetts Eye and Ear Infirmary and The Schepens Eye Research Institute, Inc. In May 2016, the Company entered into a license agreement with the Massachusetts Eye and Ear Infirmary and The Schepens Eye Research Institute, Inc., (collectively, “MEE”) referred to as the MEE License. Under the MEE License, the Company was granted an exclusive commercial worldwide license, with the right to grant sublicenses through multiple tiers, to make, have made, use, offer to sell, sell and import certain products and to practice certain processes, the sale, use or practice of which are covered by patents and proprietary know‑how owned or controlled by MEE, for use of Anc80 gene therapy vectors for gene augmentation therapies expressing certain target sequences. MEE also granted the Company exclusive options to exclusively license certain of their intellectual property rights relating to several additional target sequences and variations thereof each linked to a specified disease. During a defined option period, the Company may exercise this right for up to a designated number of target sequences. If the Company exercises its options, under certain circumstances, the Company may substitute alternative target sequences for previously selected target sequences. The Company agreed to use commercially reasonable efforts to develop and commercialize licensed products pursuant to a development plan, and to market and sell at least one product for each target sequence for which the Company exercised its option as soon as reasonably practicable. Subject to certain exceptions, following commercial launch, the Company must use commercially reasonable efforts to market, sell, and maintain public availability of licensed products in a certain number of specified major markets. Pursuant to the MEE Agreement, the Company agreed to pay MEE a license fee in the low six figures, annual license maintenance fees ranging from the mid‑twenty thousands to mid‑seventy thousands and an option maintenance fee in the low five figures for each exercisable option. The Company also agreed to reimburse MEE for a specified percentage of the past patent expenses for the patents licensed to the Company. The Company also agreed to pay development milestones on a licensed product‑by‑licensed product basis, totaling up to an aggregate of between $4,175,000 to $37,025,000 and sales milestones on a licensed product‑by‑licensed product basis, totaling up to an aggregate of between $50,000,000 to $70,000,000; tiered royalties on a licensed product‑by‑licensed product and country‑by‑country basis equal to a percentage of net sales ranging from mid‑single digits to mid‑teens, subject to the prevalence of the targeted disease and certain reductions; and a percentage, in a range expected to be in the mid‑teens depending on timing, of any sublicense income the Company receives from sublicensing its rights granted thereunder, subject to certain reductions and exclusions. Upon exercise of each option, the Company agreed to pay MEE an option exercise fee ranging from low‑six figures to mid‑six figures, depending on the prevalence of the targeted disease. The MEE License will continue until the expiration of the last to expire of the patent rights licensed thereunder. The Company may terminate the MEE License in whole or in part upon prior written notice. MEE may terminate the MEE License on a target sequence‑by‑target sequence basis if the Company fails to make any scheduled payments in respect of such target sequence or if the Company materially breaches a diligence obligation in respect of such target sequence, in each case if the Company fails to cure within a specified time period. MEE may terminate the MEE License in its entirety if the Company materially breaches certain of its obligations related to diligence, representations and warranties, and maintenance of insurance; if the Company challenges the validity or enforceability of any patents licensed thereunder; if any of the Company’s executive officers are convicted of a felony relating to manufacture, use, sale or importation of licensed products; or upon the Company’s insolvency or bankruptcy. |
Income Taxes |
9 Months Ended |
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Sep. 30, 2016 | |
Income Tax Disclosure [Abstract] | |
Income Taxes | Income Taxes The Company did not provide for any income taxes in any of the three or nine month periods ended September 30, 2016 or 2015. The Company has evaluated the positive and negative evidence bearing upon the realizability of its U.S. net deferred tax assets. As required by the provisions of ASC 740, Income Taxes, management has determined that it is more-likely-than-not that the Company will not utilize the benefits of federal and state U.S. net deferred tax assets for financial reporting purposes. Accordingly, the net deferred tax assets are subject to a valuation allowance at September 30, 2016 and December 31, 2015. |
401(k) Savings Plan |
9 Months Ended |
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Sep. 30, 2016 | |
Compensation and Retirement Disclosure [Abstract] | |
401(k) Savings Plan | 401(k) Savings Plan The Company maintains a defined‑contribution savings plan under Section 401(k) of the Internal Revenue Code (the “401(k) Plan”). The 401(k) Plan covers all employees who meet defined minimum age and service requirements, and allows participants to defer a portion of their annual compensation on a pretax basis. The 401 (k) Plan provides for matching contributions on a portion of participant contributions pursuant to the 401(k) Plan’s matching formula. All matching contributions vest ratably over 4 years and participant contributions vest immediately. Contributions by the Company totaling less than $0.1 million for the three months ended September 30, 2016 and 2015, and $0.1 million for each of the nine months ended September 30, 2016 and 2015, have been recorded in the consolidated statements of operations and comprehensive loss. |
Subsequent Events |
9 Months Ended |
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Sep. 30, 2016 | |
Subsequent Events [Abstract] | |
Subsequent Events | Subsequent Events As previously disclosed in our Current Report on Form 8-K, filed with the SEC on November 10, 2016, and as discussed in Note 13, on November 9, 2016, we received written notice from Sanofi that Sanofi has elected to terminate in its entirety the Sanofi Agreement. The termination of the Sanofi Agreement will be effective on May 8, 2017, which is six months from the date of the notice. |
Summary of Significant Accounting Policies (Policies) |
9 Months Ended |
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Sep. 30, 2016 | |
Accounting Policies [Abstract] | |
Principles of Consolidation | Principles of Consolidation The consolidated financial statements include the accounts of the Company and its wholly owned subsidiaries, Selecta RUS, LLC (“Selecta (RUS)”), a Russian limited liability corporation, and Selecta Biosciences Security Corporation, a Massachusetts Security Corporation. All significant intercompany accounts and transactions have been eliminated. |
Foreign Currency | Foreign Currency The functional currency of Selecta (RUS) is the ruble. Assets and liabilities of Selecta (RUS) are translated at period-end exchange rates, while revenues and expenses are translated at average exchange rates for the period. Translation gains and losses are reflected in accumulated other comprehensive loss within stockholders’ deficit. Foreign currency transaction gains or losses are reflected in the consolidated statements of operations and comprehensive loss. |
Use of Estimates | Use of Estimates The preparation of consolidated financial statements in conformity with U.S. GAAP requires the Company’s management to make estimates and assumptions that affect the reported amounts of assets and liabilities, the disclosure of contingent assets and liabilities at the date of the consolidated financial statements and the reported amounts of revenues and expenses during the reporting period. The Company’s management considers many factors in selecting appropriate financial accounting policies and controls, and bases its estimates on historical experience and other market-specific or other relevant assumptions that it believes to be reasonable under the circumstances. In preparing these consolidated financial statements, management used significant estimates in the following areas, among others: revenue recognition, the fair value of common stock and other equity instruments, accounting for stock-based compensation, income taxes, collectability of accounts receivable, useful lives of long-lived assets, accrued expenses, and accounting for project development. The Company assesses the above estimates on an ongoing basis; however, actual results could materially differ from those estimates. The Company’s management made significant estimates and assumptions in determining the fair value of its common stock for those periods reported prior to the completion of the IPO. The Company utilized various valuation methodologies in accordance with the framework of the 2004 American Institute of Certified Public Accountants’ Technical Practice Aid, Valuation of Privately-Held Company Equity Securities Issued as Compensation, to estimate the fair value of its common stock. Each valuation methodology included estimates and assumptions that require the Company’s judgment. These estimates and assumptions included a number of objective and subjective factors, including external market conditions affecting the biotechnology industry sector, the prices at which the Company sold shares of preferred stock, the superior rights and preferences of securities senior to the Company’s common stock at the time and the likelihood of achieving a liquidity event, such as an initial public offering or sale. Significant changes to the key assumptions used in the valuations could result in different fair values of common stock at each valuation date. |
Segment Information | Segment Information Operating segments are identified as components of an enterprise about which separate discrete financial information is available for evaluation by the chief operating decision maker, the Company’s Chief Executive Officer, in making decisions regarding resource allocation and assessing performance. The Company views its operations and manages its business in one operating segment, the research and development of nanoparticle immunomodulatory drugs for the treatment and prevention of human diseases. |
Cash Equivalents and Short Term Investments | Cash Equivalents and Short Term Investments Cash equivalents include all highly liquid investments maturing within 90 days from the date of purchase. Investments consist of securities with remaining maturities greater than 90 days when purchased. The Company classifies these investments as available‑for‑sale and records them at fair value in the accompanying consolidated balance sheets. Unrealized gains or losses are included in accumulated other comprehensive income (loss). Premiums or discounts from par value are amortized to investment income over the life of the underlying investment. The Company, as part of its cash management strategy, may invest in reverse repurchase agreements. All reverse repurchase agreements are tri-party and have maturities of three months or less at the time of investment. These agreements are collateralized by U.S. treasury securities for an amount no less than 102% of their value. Although available to be sold to meet operating needs or otherwise, securities are generally held through maturity. The cost of securities sold is determined based on the specific identification method for purposes of recording realized gains and losses. |
Concentrations of Credit Risk and Off-Balance Sheet Risk | Concentrations of Credit Risk and Off‑Balance Sheet Risk Financial instruments that potentially subject the Company to concentration of credit risk consist primarily of cash, cash equivalents, and accounts receivable. Cash and cash equivalents are deposited with federally insured financial institutions in the United States and may, at times, exceed federally insured limits. Management believes that the financial institutions that hold the Company’s deposits are financially credit worthy and, accordingly, minimal risk exists with respect to those balances. Generally, these deposits may be redeemed upon demand and therefore bear minimal interest rate risk. As an integral part of operating its Russian subsidiary, the Company also maintains cash in Russian bank accounts in denominations of both rubles and U.S. dollars. |
Fair Value of Financial Instruments | Fair Value of Financial Instruments The Company’s financial instruments consist mainly of cash equivalents, short‑term investments, restricted cash, accounts receivable, accounts payable, loans payable, common stock warrants, and redeemable convertible preferred stock warrants. The carrying amounts of cash equivalents, short term investments, restricted cash, accounts receivable, and accounts payable approximate their estimated fair value due to their short term maturities. The carrying amount of loans payable approximates their estimated fair value. Accounting standards define fair value as the price that would be received to sell an asset or paid to transfer a liability in an orderly transaction between market participants at the measurement date. A three‑level hierarchy is used to prioritize the inputs to valuation techniques used to measure fair value. The hierarchy gives the highest priority to unadjusted quoted prices in active markets for identical assets or liabilities (Level 1 measurements), and the lowest priority to unobservable inputs (Level 3 measurements). The three levels of the fair value hierarchy are described below: Level 1—Level 1 inputs are quoted prices in active markets for identical assets or liabilities that the reporting entity has the ability to access at the measurement date. Level 2—Level 2 inputs are inputs other than quoted prices included within Level 1 that are observable for the asset or liability, either directly or indirectly. If the asset or liability has a specified (contractual) term, a Level 2 input must be observable for substantially the full term of the asset or liability. Level 3—Level 3 inputs are unobservable inputs for the asset or liability in which there is little, if any, market activity for the asset or liability at the measurement date. To the extent that a valuation is based on models or inputs that are less observable or unobservable in the market, the determination of fair value requires more judgment. Accordingly, the degree of judgment exercised by the Company in determining fair value is greatest for instruments categorized in Level 3. A financial instrument’s level within the fair value hierarchy is based on the lowest level of any input that is significant to the fair value measurement. Fair value is a market‑based measure considered from the perspective of a market participant rather than an entity‑specific measure. Therefore, even when market assumptions are not readily available, the Company’s own assumptions are set to reflect those that market participants would use in pricing the asset or liability at the measurement date. The Company uses prices and inputs that are current as of the measurement date, including during periods of market dislocation. In periods of market dislocation, the observability of prices and inputs may change for many instruments. This condition could cause an instrument to be reclassified within levels in the fair value hierarchy. |
Property and Equipment | Property and Equipment Property and equipment are recorded at cost and depreciated using the straight‑line method over the estimated useful lives of the respective assets, generally seven years for furniture, five years for equipment and three years for computer and office equipment. Leasehold improvements are amortized over their useful life or the life of the lease, whichever is shorter. Major additions and betterments are capitalized. Maintenance and repairs, which do not improve or extend the life of the respective assets, are charged to operations as incurred. Costs incurred for construction in progress are recorded as assets and are not amortized until the construction is substantially complete and the assets are ready for their intended use. |
Impairment of Long-Lived Assets | Impairment of Long‑Lived Assets The Company periodically evaluates its long‑lived assets for potential impairment. Impairment is assessed when there is evidence that events or changes in circumstances indicate that the carrying amount of an asset may not be recovered. Recoverability of these assets is assessed based on undiscounted expected future cash flows from the assets, considering a number of factors, including past operating results, budgets and economic projections, market trends, and product development cycles. Impairment in the carrying value of each asset is assessed when the undiscounted expected future cash flows derived from the asset are less than their carrying value. |
Debt Issuance Costs | Debt Issuance Costs Debt issuance costs and fees paid to lenders are recorded as a direct deduction from the face amount of the related debt. Debt issuance costs are accounted for as additional debt discount and are amortized over the term of the related debt using the interest method and recorded as interest expense. Costs and fees paid to third parties are expensed as incurred. |
Revenue Recognition | Revenue Recognition The Company’s revenue is primarily generated from research grants in both the United States and Russia, and, prior to its termination, a license and research collaboration agreement with Sanofi. The Company recognizes revenue in accordance with ASC Topic 605, Revenue Recognition. Accordingly, revenue is recognized when all of the following criteria are met: - Persuasive evidence of an arrangement exists; - Delivery has occurred or services have been rendered; - The seller’s price to the buyer is fixed or determinable; and - Collectability is reasonably assured. Amounts received prior to satisfying the revenue recognition criteria are recognized as deferred revenue in the Company’s consolidated balance sheets. Amounts expected to be recognized as revenue within the 12 months following the balance sheet date are classified as deferred revenue, current portion. Amounts not expected to be recognized as revenue within the 12 months following the balance sheet date are classified as deferred revenue, net of current portion. |
Collaborative Revenue | Collaboration Revenue When evaluating multiple element arrangements such as the agreement with Sanofi discussed in Note 13, the Company considers whether the deliverables under the arrangement represent separate units of accounting. This evaluation requires subjective determinations and requires management to make judgments about the individual deliverables and whether such deliverables are separable from the other aspects of the contractual relationship. In determining the units of accounting, management evaluates certain criteria, including whether the deliverables have standalone value, based on the consideration of the relevant facts and circumstances for each arrangement. The consideration received is allocated among the separate units of accounting using the relative selling price method, and the applicable revenue recognition criteria are applied to each of the separate units. The Company determines the estimated selling price for deliverables within each agreement using vendor‑specific objective evidence (“VSOE”) of selling price, if available, third‑party evidence (“TPE”) of selling price if VSOE is not available, or best estimate of selling price if neither VSOE nor TPE is available. Determining the best estimate of selling price for a deliverable requires significant judgment. The Company has used its best estimate of selling price to estimate the selling price for licenses to the Company’s proprietary technology, since the Company does not have VSOE or TPE of selling price for these deliverables. In those circumstances, the Company considers market conditions as well as entity‑specific factors, including those factors contemplated in negotiating the agreements, estimated development costs, probability of success and the time needed to commercialize a product candidate pursuant to the license. In validating the Company’s best estimate of selling price, the Company evaluates whether changes in the key assumptions used to determine the best estimate of selling price will have a significant effect on the allocation of arrangement consideration between multiple deliverables. The Company may receive upfront payments when licensing its intellectual property in conjunction with a research and development agreement. When management believes the license to its intellectual property does not have stand‑alone value from the other deliverables to be provided in the arrangement, the Company generally recognizes revenue attributed to the license over the Company’s contractual or estimated performance period. When management believes the license to its intellectual property has stand‑alone value, the Company generally recognizes revenue attributed to the license upon delivery. The periods over which revenue should be recognized are subject to estimates by management and may change over the course of the research and development agreement. Such a change could have a material impact on the amount of revenue the Company records in future periods. Payments or reimbursements resulting from the Company’s research and development efforts are recognized as the services are performed. At the inception of each agreement that includes milestone payments, the Company evaluates whether each milestone is substantive and at risk to both parties on the basis of the contingent nature of the milestone, specifically reviewing factors such as the scientific and other risks that must be overcome to achieve the milestone, as well as the level of effort and investment required. Revenues from milestones, if they are nonrefundable and deemed substantive, are recognized upon successful accomplishment of the milestones. Milestones that are not considered substantive are accounted for as license payments and recognized over the remaining period of performance. |
Grant Agreements | Grant Agreements Grant revenue is generally recognized as the related research and development work is performed. Grant arrangements frequently include payment milestones which the Company has judged to be non‑substantive milestones as they are typically entitled to receive payment regardless of the outcome of the research work. Revenue under such arrangements is recognized using a proportional performance method, but not in excess of cash actually received. Amounts received prior to satisfying the above revenue recognition criteria are recorded as deferred revenue in the accompanying consolidated balance sheets. |
Research and Development Costs | Research and Development Costs Costs incurred in the research and development of the Company’s products are expensed as incurred. Research and development expenses include costs incurred in performing research and development activities, including salaries and benefits, facilities cost, overhead costs, contract services, supplies and other outside costs. Nonrefundable advance payments for goods and services that will be used in future research and development activities are expensed when the activity has been performed or when the goods have been received rather than when the payment is made. |
Clinical Trial Costs | Clinical Trial Costs Clinical trial costs are a component of research and development expenses. The Company accrues and expenses clinical trial activities performed by third parties based on an evaluation of the progress to completion of specific tasks using data such as patient enrollment, clinical site activation, and other information provided to the Company by its vendors. |
Income Taxes | Income Taxes The Company provides deferred tax assets and liabilities for the expected future tax consequences of temporary differences between the Company’s financial statement carrying amounts and the tax bases of assets and liabilities using enacted tax rates expected to be in effect in the years in which the differences are expected to reverse. A valuation allowance is provided to reduce the deferred tax assets to the amount that will more‑likely‑than‑not be realized. The Company determines whether it is more likely than not that a tax position will be sustained upon examination. If it is not more likely than not that a position will be sustained, none of the benefit attributable to the position is recognized. The tax benefit to be recognized for any tax position that meets the more‑likely‑than‑not recognition threshold is calculated as the largest amount that is more than 50% likely of being realized upon resolution of the contingency. The Company accounts for interest and penalties related to uncertain tax positions as part of its provision for income taxes. To date, the Company has not incurred interest and penalties related to uncertain tax positions. Should such costs be incurred, they would be classified as a component of income tax expense. |
Warrants | Warrants The Company has issued common stock warrants and redeemable convertible preferred stock warrants to investors and lenders. Common stock warrants are classified as a component of permanent equity because they are freestanding financial instruments that are legally detachable and separately exercisable from other debt and equity instruments, are contingently exercisable, do not embody an obligation for the Company to repurchase its own shares, and permit the holders to receive a fixed number of common shares upon exercise. In addition, such warrants require physical settlement and do not provide any guarantee of value or return. Common stock warrants are initially recorded at their issuance date fair value and are not subsequently re‑measured. These warrants are valued using the Black‑Scholes option pricing model (“Black‑Scholes”). |
Stock-Based Compensation | Stock‑Based Compensation The Company accounts for all stock‑based compensation granted to employees and non‑employees using a fair value method. Stock‑based compensation awarded to employees is measured at the grant date fair value of stock option grants and is recognized over the requisite service period of the awards, usually the vesting period, on a straight‑line basis, net of estimated forfeitures. Stock‑based compensation awarded to non‑employees are subject to revaluation over their vesting terms. The Company reduces recorded stock‑based compensation for estimated forfeitures. To the extent that actual forfeitures differ from the Company’s estimates, the differences are recorded as a cumulative adjustment in the period the estimates were adjusted. Stock‑based compensation expense recognized in the financial statements is based on awards that are ultimately expected to vest. |
Comprehensive Loss | Comprehensive Loss Comprehensive loss is defined as the change in the equity of a business entity during a period from transactions and other events and circumstances from non‑owner sources. It includes all changes in equity during a period except those resulting from investments by owners and distributions to owners. Comprehensive loss consists of both: (i) all components of net loss and (ii) all components of comprehensive loss other than net loss, referred to as other comprehensive loss. |
Net Loss Per Share | Net Loss Per Share The Company has reported losses since inception and has computed basic net loss per share attributable to common stockholders by dividing net loss attributable to common stockholders by the weighted average number of common shares outstanding for the period. The Company has computed diluted net loss per common share after giving consideration to all potentially dilutive common shares, including stock options, convertible preferred stock, and warrants outstanding during the period except where the effect of including such securities would be antidilutive. Because the Company has reported net losses since inception, these potential common shares have been anti‑dilutive and basic and diluted loss per share have been the same. |
Deferred Rent | Deferred Rent Rent expense and lease incentives from operating leases are recognized on a straight‑line basis over the lease term. The difference between rent expense recognized and rental payments is recorded as deferred rent in the accompanying consolidated balance sheets. |
Contingent Liabilities | Contingent Liabilities The Company accounts for its contingent liabilities in accordance with ASC No. 450, Contingencies. A provision is recorded when it is both probable that a liability has been incurred and the amount of the loss can be reasonably estimated. With respect to legal matters, provisions are reviewed and adjusted to reflect the impact of negotiations, estimated settlements, legal rulings, advice of legal counsel and other information and events pertaining to a particular matter. |
Recent Accounting Pronouncements | Recent Accounting Pronouncements In May 2014, the FASB issued ASU No. 2014‑9, Revenue from Contracts with Customers (“ASU 2014‑9”), which amends the guidance for revenue recognition to replace numerous industry‑ specific requirements. ASU 2014‑9 implements a five‑step process for customer contract revenue recognition that focuses on transfer of control, as opposed to transfer of risk and rewards. ASU 2014‑9 also requires enhanced disclosures regarding the nature, amount, timing, and uncertainty of revenues and cash flows from contracts with customers. Other major provisions include ensuring the time value of money is considered in the transaction price, and allowing estimates of variable consideration to be recognized before contingencies are resolved in certain circumstances. The amendments in ASU 2014‑9 are effective for reporting periods beginning after December 15, 2017. Early adoption is permitted, but not before December 15, 2016. Entities can transition to the standard either retrospectively or as a cumulative‑effect adjustment as of the date of adoption. The Company is currently in the process of evaluating the effect the adoption of ASU 2014‑9 may have on its financial statements. In August 2014, the FASB issued ASU 2014-15, Presentation of Financial Statements—Going Concern. ASU 2014-15 requires management of all entities to evaluate whether there are conditions and events that raise substantial doubt about the entity’s ability to continue as a going concern within one year after the financial statements are issued, and to make certain disclosures if it concludes that substantial doubt exists or when its plans alleviate substantial doubt about the entity’s ability to continue as a going concern. ASU 2014-15 is effective for the Company for annual reporting periods beginning in 2016 and for interim reporting periods starting in the first quarter of 2017. The Company is currently evaluating the impact that the standard will have on the financial statements, and has not yet determined what effect, if any, the impact of adoption will be. In February 2016, FASB issued ASU No.2016‑2, Leases (“ASU 2016‑2”). ASU 2016‑2 requires a lessee to separate the lease components from the non‑lease components in a contract and recognize in the statement of financial position a liability to make lease payments (the lease liability) and a right‑of‑use asset representing its right to use the underlying asset for the lease term. It also aligns lease accounting for lessors with the revenue recognition guidance in ASU 2014‑9. ASU 2016‑2 is effective for fiscal years beginning after December 15, 2018, including interim periods within those fiscal years, and is to be applied at the beginning of the earliest period presented using a modified retrospective approach. In March 2016, the FASB issued ASU 2016-9, Improvements to Employee Share-Based Payment Accounting, which simplifies several aspects of accounting for share-based payment transactions including the income tax consequences, classification of awards as either equity or liabilities, and classification on the statement of cash flows. The new standard is effective for fiscal years beginning after December 15, 2016 and interim periods within those fiscal years with early adoption permitted. The Company is evaluating the impact that the adoption of this standard will have on its financial statements. |
Available-for-Sale Marketable Securities (Tables) |
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Investments, Debt and Equity Securities [Abstract] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Summary of Available-for-Sale Marketable Securities | The following tables summarize the Company’s available-for-sale marketable securities by major type of security as of September 30, 2016 and December 31, 2015 (in thousands):
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Schedule of Fair Values and Amortized Cost of Marketable Debt Securities by Contractual Maturity | The fair values and amortized cost of marketable debt securities by contractual maturity were as follows (in thousands):
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Net Loss Per Share (Tables) |
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Sep. 30, 2016 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Earnings Per Share [Abstract] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Computation of Basic and Diluted Net Loss Per Share | The following table sets forth the computation of basic and diluted net loss per share (in thousands, except share and per‑share data):
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Potential Common Shares Issuable Upon Conversion of Warrants to Purchase Common Stock and Stock Options Excluded from Computation of Diluted Weighted Average Shares Outstanding | Potential common shares issuable upon conversion of warrants to purchase common stock and stock options that are excluded from the computation of diluted weighted average shares outstanding are as follows:
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Fair Value Measurements (Tables) |
9 Months Ended | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Sep. 30, 2016 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Fair Value Disclosures [Abstract] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Financial Assets and Liabilities Measured and Carried at Fair Value | The tables below present information about the Company’s financial assets and liabilities that are measured and carried at fair value as of September 30, 2016 and December 31, 2015 and indicate the level within the fair value hierarchy where each measurement is classified. Below is a summary of assets measured at fair value on a recurring basis (in thousands):
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Property and Equipment (Tables) |
9 Months Ended | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Sep. 30, 2016 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Property, Plant and Equipment [Abstract] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Schedule of Property and Equipment | Property and equipment consists of the following (in thousands):
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Accrued Expenses (Tables) |
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Sep. 30, 2016 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Payables and Accruals [Abstract] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Summary of Accrued Expenses | Accrued expenses consist of the following (in thousands):
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Commitments and Contingencies (Tables) |
9 Months Ended | ||||||||||||||||||||||||||||||||||||
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Sep. 30, 2016 | |||||||||||||||||||||||||||||||||||||
Commitments and Contingencies Disclosure [Abstract] | |||||||||||||||||||||||||||||||||||||
Schedule of Future Minimum Lease Payments as Amended by Lease Amendment | As of December 31, 2015, the future minimum lease payments under the lease, as amended by the lease amendment are as follows (in thousands):
|
Debt (Tables) |
9 Months Ended | ||||||||||||||||||||||||||||||||||||||||||||||||
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Sep. 30, 2016 | |||||||||||||||||||||||||||||||||||||||||||||||||
Debt Disclosure [Abstract] | |||||||||||||||||||||||||||||||||||||||||||||||||
Future Minimum Payments on the Term Loans | Future minimum payments on the Term Loans as of December 31, 2015 are as follows (in thousands):
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Common Stock (Tables) |
9 Months Ended | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Sep. 30, 2016 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Stockholders' Equity Note [Abstract] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Schedule of authorized shares of common stock reserved for future issuance | The Company has authorized shares of common stock for future issuance as follows:
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Stock Incentive Plans (Tables) |
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Sep. 30, 2016 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Disclosure of Compensation Related Costs, Share-based Payments [Abstract] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Schedule of Weighted Average Assumptions Used for Stock Option Grants | The weighted average assumptions used for employee stock option grants issued for the nine month period ended September 30, 2016 and in 2015:
The weighted average assumptions used for unvested non‑employee stock options are as follows:
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Summary of Activity | The following table summarizes the activity under the Plan and the 2016 Plan since December 31, 2015:
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Summary of Restricted Stock Award Activity | The following table summarizes the restricted stock award activity of the 2008 Plan and the 2016 Plan since December 31, 2015:
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Stock-Based Compensation Expense Related to Stock Options and Restricted Common Stock | The Company recorded stock-based compensation expense related to stock options and restricted common stock in the following expense categories of its consolidated statements of operations and comprehensive loss (in thousands):
|
Nature of the Business and Basis of Presentation - Liquidity (Details) - USD ($) $ in Thousands |
Sep. 30, 2016 |
Dec. 31, 2015 |
---|---|---|
Organization, Consolidation and Presentation of Financial Statements [Abstract] | ||
Accumulated deficit | $ 137,493 | $ 111,508 |
Russian subsidiary | ||
Cash and Cash Equivalents [Line Items] | ||
Unrestricted cash held by subsidiary | $ 2,800 | $ 3,000 |
Summary of Significant Accounting Policies - Segment Information (Details) |
9 Months Ended |
---|---|
Sep. 30, 2016
segment
| |
Accounting Policies [Abstract] | |
Number of operating segments | 1 |
Summary of Significant Accounting Policies - Cash Equivalents and Short Term Investments (Details) - USD ($) |
3 Months Ended | 9 Months Ended | ||
---|---|---|---|---|
Sep. 30, 2016 |
Sep. 30, 2015 |
Sep. 30, 2016 |
Sep. 30, 2015 |
|
Cash and Cash Equivalents [Line Items] | ||||
Realized gains or losses on sale of investments | $ 0 | $ 0 | $ 0 | $ 0 |
Minimum | ||||
Cash and Cash Equivalents [Line Items] | ||||
Cash and cash equivalents collateralized by government securities (as a percent) | 102.00% | 102.00% |
Summary of Significant Accounting Policies - Concentrations of Credit Risk and Off-Balance Sheet Risk (Details) $ in Millions |
Sep. 30, 2016
USD ($)
|
---|---|
Rubles | |
Concentration Risk [Line Items] | |
Cash maintained in Russian bank accounts | $ 3.1 |
U S dollars | |
Concentration Risk [Line Items] | |
Cash maintained in Russian bank accounts | $ 2.8 |
Summary of Significant Accounting Policies - Property and Equipment (Details) |
9 Months Ended |
---|---|
Sep. 30, 2016 | |
Furniture | |
Property, Plant and Equipment [Line Items] | |
Estimated useful life | 7 years |
Equipment | |
Property, Plant and Equipment [Line Items] | |
Estimated useful life | 5 years |
Computer and office equipment | |
Property, Plant and Equipment [Line Items] | |
Estimated useful life | 3 years |
Summary of Significant Accounting Policies - Warrants (Details) |
Jun. 27, 2016
$ / shares
|
---|---|
Accounting Policies [Abstract] | |
Convertible preferred stock underlying share fair value price (in dollars per share) | $ 14.00 |
Available-for-Sale Marketable Securities - Summary of Available-for-Sale Marketable Securities (Details) - USD ($) $ in Thousands |
Sep. 30, 2016 |
Dec. 31, 2015 |
---|---|---|
Schedule of Available-for-sale Securities [Line Items] | ||
Amortized Cost | $ 19,804 | $ 3,516 |
Gross Unrealized Gains | 6 | 0 |
Gross Unrealized Losses | (23) | 0 |
Estimated Fair Value | 19,788 | 3,516 |
U.S. Treasury securities | ||
Schedule of Available-for-sale Securities [Line Items] | ||
Amortized Cost | 0 | 3,516 |
Gross Unrealized Gains | 0 | 0 |
Gross Unrealized Losses | 0 | 0 |
Estimated Fair Value | 0 | 3,516 |
Corporate bonds | ||
Schedule of Available-for-sale Securities [Line Items] | ||
Amortized Cost | 19,804 | 0 |
Gross Unrealized Gains | 6 | 0 |
Gross Unrealized Losses | (23) | 0 |
Estimated Fair Value | $ 19,788 | $ 0 |
Available-for-Sale Marketable Securities - Schedule of Fair Values and Amortized Cost of Marketable Debt Securities by Contractual Maturity (Details) - USD ($) $ in Thousands |
Sep. 30, 2016 |
Dec. 31, 2015 |
---|---|---|
Fair Value | ||
Less than one year | $ 19,788 | $ 3,516 |
Amortized Cost | ||
Less than one year | $ 19,804 | $ 3,516 |
Available-for-Sale Marketable Securities - Narrative (Details) |
9 Months Ended |
---|---|
Sep. 30, 2016
USD ($)
position
| |
Investments, Debt and Equity Securities [Abstract] | |
Number of positions in an unrealized loss position, less than 12 months | 11 |
Number of investment positions | 13 |
Other-than-temporary impairments | $ | $ 0 |
Net Loss Per Share - Computation of Basic and Diluted Net Loss Per Share (Details) - USD ($) $ / shares in Units, $ in Thousands |
3 Months Ended | 9 Months Ended | ||
---|---|---|---|---|
Sep. 30, 2016 |
Sep. 30, 2015 |
Sep. 30, 2016 |
Sep. 30, 2015 |
|
Numerator: | ||||
Net (loss) | $ (7,728) | $ (5,725) | $ (22,127) | $ (18,325) |
Less: accretion on preferred stock | 0 | (1,836) | (4,566) | (4,959) |
Net loss attributable to common stockholders | $ (7,728) | $ (7,561) | $ (26,693) | $ (23,284) |
Denominator: | ||||
Weighted‑average common shares outstanding—basic and diluted (in shares) | 18,108,014 | 2,159,658 | 7,881,625 | 2,144,731 |
Net loss per share attributable to common stockholders—basic and diluted (in dollars per share) | $ (0.43) | $ (3.50) | $ (3.39) | $ (10.86) |
Net Loss Per Share - Potential Common Shares Issuable Upon Conversion of Warrants to Purchase Common Stock and Stock Options Excluded from Computation of Diluted Weighted Average Shares Outstanding (Details) - shares |
9 Months Ended | |
---|---|---|
Sep. 30, 2016 |
Sep. 30, 2015 |
|
Potential common shares | ||
Total (in shares) | 2,254,090 | 9,055,165 |
Redeemable convertible preferred stock | ||
Potential common shares | ||
Total (in shares) | 0 | 6,872,090 |
Stock options to purchase common stock | ||
Potential common shares | ||
Total (in shares) | 2,140,295 | 2,165,187 |
Stock warrants to purchase common stock | ||
Potential common shares | ||
Total (in shares) | 113,795 | 17,888 |
Property and Equipment - Schedule of Property and Equipment (Details) - USD ($) $ in Thousands |
Sep. 30, 2016 |
Dec. 31, 2015 |
---|---|---|
Property, Plant and Equipment [Line Items] | ||
Total property and equipment | $ 5,570 | $ 4,956 |
Less accumulated depreciation | (3,504) | (2,927) |
Property and equipment, net | 2,066 | 2,029 |
Laboratory equipment | ||
Property, Plant and Equipment [Line Items] | ||
Total property and equipment | 4,617 | 4,028 |
Computer equipment and software | ||
Property, Plant and Equipment [Line Items] | ||
Total property and equipment | 501 | 409 |
Leasehold improvements | ||
Property, Plant and Equipment [Line Items] | ||
Total property and equipment | 165 | 91 |
Furniture and fixtures | ||
Property, Plant and Equipment [Line Items] | ||
Total property and equipment | 225 | 222 |
Office equipment | ||
Property, Plant and Equipment [Line Items] | ||
Total property and equipment | 62 | 62 |
P,P&E—Construction in process | ||
Property, Plant and Equipment [Line Items] | ||
Total property and equipment | $ 0 | $ 144 |
Property and Equipment - Narrative (Details) - USD ($) $ in Thousands |
3 Months Ended | 9 Months Ended | ||
---|---|---|---|---|
Sep. 30, 2016 |
Sep. 30, 2015 |
Sep. 30, 2016 |
Sep. 30, 2015 |
|
Property, Plant and Equipment [Abstract] | ||||
Depreciation expense | $ 100 | $ 200 | $ 545 | $ 866 |
Accrued Expenses (Details) - USD ($) $ in Thousands |
Sep. 30, 2016 |
Dec. 31, 2015 |
---|---|---|
Payables and Accruals [Abstract] | ||
Payroll | $ 297 | $ 0 |
Legal | 59 | 213 |
Bonus | 519 | 669 |
Current portion of deferred rent and lease incentive | 12 | 405 |
Accrued patent fees | 184 | 219 |
Accrued external research and development costs | 662 | 1,649 |
Other | 701 | 223 |
Accrued expenses | $ 2,434 | $ 3,378 |
Commitments and Contingencies - Narrative (Details) |
3 Months Ended | 9 Months Ended | 12 Months Ended | ||||
---|---|---|---|---|---|---|---|
Sep. 30, 2016
USD ($)
|
Sep. 30, 2015
USD ($)
|
Sep. 30, 2016
USD ($)
|
Sep. 30, 2015
USD ($)
|
Dec. 31, 2015
USD ($)
|
Dec. 31, 2012
USD ($)
|
Apr. 30, 2015
ft²
|
|
Sublease income recorded as a reduction of lease expense | $ 200,000 | ||||||
Deferred rent and lease incentive liability | $ 200,000 | $ 200,000 | 500,000 | ||||
Current portion of deferred rent and lease incentive | 12,000 | 12,000 | 405,000 | ||||
Rent expense, net of sublease payments | 400,000 | $ 500,000 | 1,100,000 | $ 1,000,000 | |||
Restricted cash and other deposits | Letter of Credit | |||||||
Letter of credit | 300,000.0 | 300,000.0 | |||||
Accrued expenses | |||||||
Current portion of deferred rent and lease incentive | $ 100,000 | $ 100,000 | $ 400,000 | ||||
Laboratory and office space | |||||||
Area exchanged (in square feet) | ft² | 13,711 | ||||||
Laboratory And Office Space Agreement Amendment April 2015 | |||||||
Area exchanged (in square feet) | ft² | 15,174 | ||||||
Maximum | Laboratory and office space | |||||||
Tenant improvement allowance | $ 700,000.0 |
Commitments and Contingencies - Schedule of Future Minimum Lease Payments as Amended by Lease Amendment (Details) $ in Thousands |
Dec. 31, 2015
USD ($)
|
---|---|
Year ended December 31, | |
2016 | $ 1,176 |
2017 | 1,244 |
2018 | 1,291 |
2019 | 1,330 |
2020 | 335 |
Total minimum lease payments | $ 5,376 |
Debt - Future Minimum Payments on the Term Loans (Details) - Term Loan $ in Thousands |
Dec. 31, 2015
USD ($)
|
---|---|
Year ended December 31, | |
2016 | $ 972 |
2017 | 5,319 |
2018 | 5,318 |
2019 | 3,379 |
Total debt payments | 14,988 |
Less: Amount representing interest | (2,268) |
Less: Debt discount and deferred charges | (919) |
Less: Current portion of issuance costs | 54 |
Loans payable, net of current portion | $ 11,855 |
Stock Incentive Plans - Schedule of Weighted Average Assumptions for Employee Stock Option Grants (Details) - 2008 Plan - Shares available for future stock incentive awards - $ / shares |
9 Months Ended | |
---|---|---|
Sep. 30, 2016 |
Sep. 30, 2015 |
|
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Risk-free interest rate | 1.39% | 1.71% |
Expected dividend yield | 0.00% | 0.00% |
Expected life | 6 years 18 days | 6 years |
Expected volatility | 95.62% | 84.60% |
Weighted-average fair value of common stock (in dollars per share) | $ 9.79 | $ 1.41 |
Stock Incentive Plans - Schedule of Weighted Average Assumptions for Unvested Non Employee Stock Options (Details) - Non-employee stock options |
9 Months Ended | |
---|---|---|
Sep. 30, 2016 |
Sep. 30, 2015 |
|
Share-based Goods and Nonemployee Services Transaction [Line Items] | ||
Risk‑free interest rate | 1.58% | 1.82% |
Expected dividend yield | 0.00% | 0.00% |
Expected life (in years) | 9 years 4 months 28 days | 6 years 4 months 10 days |
Expected volatility | 87.75% | 96.75% |
Stock Incentive Plans - Restricted Stock (Narrative) (Details) - Restricted Stock Units (RSUs) - USD ($) $ in Millions |
9 Months Ended | 12 Months Ended | 24 Months Ended | ||
---|---|---|---|---|---|
Sep. 30, 2016 |
Dec. 31, 2015 |
Dec. 31, 2014 |
Dec. 31, 2013 |
Dec. 31, 2014 |
|
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||
Number of shares issued upon the early exercise of stock options | 30,317 | ||||
Number of shares issued | 2,564 | ||||
Payments received for the purchase of restricted shares | $ 0.1 | ||||
Outstanding liability (less than) | $ 0.1 | $ 0.1 | |||
Total fair value of restricted shares (less than) | 0.1 | ||||
Unrecognized compensation expense related to unvested employee stock options (less than) | $ 0.1 | $ 0.1 | |||
Weighted average period for recognizing, unrecognized compensation expense | 3 months | 1 year |
Stock Incentive Plans - Summary of Restricted Stock Award Activity (Details) - The 2008 Plan and the 2016 Plan - Restricted Stock Units (RSUs) |
9 Months Ended |
---|---|
Sep. 30, 2016
$ / shares
shares
| |
Shares | |
Beginning balance (in shares) | shares | 7,574 |
Issued (in shares) | shares | 940 |
Vested (in shares) | shares | (6,647) |
Ending balance (in shares) | shares | 1,867 |
Weighted-average exercise price | |
Beginning balance (in dollars per share) | $ / shares | $ 2.77 |
Issued (in dollars per share) | $ / shares | 9.36 |
Vested (in dollars per share) | $ / shares | 3.72 |
Ending balance (in dollars per share) | $ / shares | $ 2.77 |
Stock Incentive Plans - Stock-Based Compensation Expense Related to Stock Options and Restricted Common Stock (Details) - USD ($) $ in Thousands |
3 Months Ended | 9 Months Ended | ||
---|---|---|---|---|
Sep. 30, 2016 |
Sep. 30, 2015 |
Sep. 30, 2016 |
Sep. 30, 2015 |
|
Share-based Compensation Arrangement by Share-based Payment Award, Compensation Cost [Line Items] | ||||
Total | $ 633 | $ 252 | $ 1,281 | $ 869 |
Research and development | ||||
Share-based Compensation Arrangement by Share-based Payment Award, Compensation Cost [Line Items] | ||||
Total | 353 | 40 | 747 | 321 |
General and administrative | ||||
Share-based Compensation Arrangement by Share-based Payment Award, Compensation Cost [Line Items] | ||||
Total | $ 280 | $ 212 | $ 534 | $ 548 |
Revenue Arrangements - Sanofi Collaboration Agreement (Narrative) (Details) - USD ($) $ in Thousands |
1 Months Ended | 3 Months Ended | 9 Months Ended | 47 Months Ended | ||||||
---|---|---|---|---|---|---|---|---|---|---|
Nov. 27, 2012 |
Jul. 31, 2016 |
May 31, 2016 |
Aug. 31, 2013 |
Nov. 30, 2012 |
Sep. 30, 2016 |
Sep. 30, 2015 |
Sep. 30, 2016 |
Sep. 30, 2015 |
Sep. 30, 2016 |
|
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | ||||||||||
Grant and collaboration revenue | $ 1,048 | $ 1,607 | $ 5,153 | $ 3,877 | ||||||
Sanofi | ||||||||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | ||||||||||
Initial payment for first indication | $ 2,000 | $ 2,000 | ||||||||
Additional payment for preclinical research for each indication | $ 3,000 | |||||||||
Additional payment upon attaining first milestone for celiac disease indication | $ 1,000 | |||||||||
Aggregate payments under Sanofi Agreement | $ 8,000 | |||||||||
Initial period to complete research obligations | 3 years | |||||||||
Grant and collaboration revenue | $ 200 | $ 500 | $ 600 | $ 1,500 |
Revenue Arrangements - Termination of the Sanofi Collaboration Agreement (Narrative) (Details) - Sanofi $ in Millions |
47 Months Ended |
---|---|
Sep. 30, 2016
USD ($)
| |
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | |
Aggregate payments under Sanofi Agreement | $ 8.0 |
Deferred revenue expected to be recognized within the termination period | $ 2.2 |
Revenue Arrangements - Other Research and Collaboration Agreements (Narrative) (Details) - USD ($) |
3 Months Ended | 9 Months Ended | ||
---|---|---|---|---|
Sep. 30, 2016 |
Sep. 30, 2015 |
Sep. 30, 2016 |
Sep. 30, 2015 |
|
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | ||||
Grant and collaboration revenue | $ 1,048,000 | $ 1,607,000 | $ 5,153,000 | $ 3,877,000 |
Other Research And Collaboration Agreements | ||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | ||||
Grant and collaboration revenue | $ 0 | $ 300,000 | $ 100,000 | $ 400,000 |
Revenue Arrangements - NIH (Narrative) (Details) - NIH $ in Millions |
1 Months Ended | 3 Months Ended | 9 Months Ended | |||
---|---|---|---|---|---|---|
Sep. 30, 2015
USD ($)
|
May 31, 2014
USD ($)
|
Sep. 30, 2016
USD ($)
grant
|
Sep. 30, 2015
USD ($)
|
Sep. 30, 2016
USD ($)
grant
|
Sep. 30, 2015
USD ($)
|
|
Research and Development Arrangement, Contract to Perform for Others [Line Items] | ||||||
Number of grants | grant | 2 | 2 | ||||
First Grant | ||||||
Research and Development Arrangement, Contract to Perform for Others [Line Items] | ||||||
Aggregate amount of grant | $ 8.1 | |||||
Revenue recognized | $ 0.7 | $ 0.5 | $ 3.7 | $ 1.5 | ||
Second Grant | ||||||
Research and Development Arrangement, Contract to Perform for Others [Line Items] | ||||||
Aggregate amount of grant | $ 0.2 | |||||
Revenue recognized | $ 0.1 | $ 0.1 |
Revenue Arrangements - JDRF (Narrative) (Details) - JDRF - USD ($) |
1 Months Ended | 3 Months Ended | 9 Months Ended | ||
---|---|---|---|---|---|
Sep. 30, 2014 |
Sep. 30, 2016 |
Sep. 30, 2015 |
Sep. 30, 2016 |
Sep. 30, 2015 |
|
Research and Development Arrangement, Contract to Perform for Others [Line Items] | |||||
Aggregate amount of grant | $ 400,000 | ||||
Revenue recognized | $ 100,000 | $ 0 | $ 100,000 | $ 200,000 |
Revenue Arrangements - Bill and Melinda Gates Foundation (Narrative) (Details) - Bill and Melinda Gates Foundation - USD ($) $ in Millions |
3 Months Ended | 9 Months Ended | 12 Months Ended | |||
---|---|---|---|---|---|---|
Sep. 30, 2016 |
Sep. 30, 2015 |
Sep. 30, 2016 |
Sep. 30, 2015 |
Dec. 31, 2014 |
Dec. 31, 2013 |
|
Research and Development Arrangement, Contract to Perform for Others [Line Items] | ||||||
Aggregate amount of grant | $ 1.6 | $ 1.2 | ||||
Extended research term | 3 years | |||||
Revenue recognized | $ 0.1 | $ 0.3 | $ 0.4 | $ 0.3 |
Revenue Arrangements - Minpromtorg (Narrative) (Details) - USD ($) $ in Thousands |
1 Months Ended | 9 Months Ended | 12 Months Ended | 20 Months Ended | 30 Months Ended | |
---|---|---|---|---|---|---|
Feb. 28, 2015 |
Sep. 30, 2016 |
Sep. 30, 2015 |
Dec. 31, 2015 |
Sep. 30, 2016 |
Dec. 31, 2015 |
|
Research and Development Arrangement, Contract to Perform for Others [Line Items] | ||||||
Contingently repayable grant funding | $ (207) | $ (446) | ||||
Minpromtorg | ||||||
Research and Development Arrangement, Contract to Perform for Others [Line Items] | ||||||
Aggregate amount of grant | $ 4,600 | |||||
Repayment of funds | $ 200 | |||||
Penalty fee, as percent of contract value | 10.00% | |||||
Penalty fee | $ 200 | |||||
Period to audit expenditure incurred | 3 years | |||||
Contingently repayable grant funding | $ 1,400 | |||||
Revenue recognized | $ 200 | $ 400 |
Revenue Arrangements - Skolkovo (Narrative) (Details) - USD ($) |
9 Months Ended | 22 Months Ended | ||
---|---|---|---|---|
Nov. 28, 2014 |
Sep. 30, 2016 |
Sep. 30, 2015 |
Sep. 30, 2016 |
|
Research and Development Arrangement, Contract to Perform for Others [Line Items] | ||||
Contingently repayable grant funding | $ (207,000) | $ (446,000) | ||
Skolkovao | ||||
Research and Development Arrangement, Contract to Perform for Others [Line Items] | ||||
Aggregate amount of grant | $ 2,700,000.0 | |||
Percentage of estimated cost of research plan | 48.50% | |||
Remaining percentage contributed by the entity | 51.50% | |||
Contingently repayable grant funding | $ 1,800,000 | |||
Period to audit expenditure incurred | 3 years |
Technology License Agreements - MIT (Narrative) (Details) - MIT |
Nov. 25, 2008
USD ($)
|
---|---|
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | |
Payment amount upon achievement of defined clinical milestones | $ 1,500,000.0 |
Minimum | |
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | |
Percentage of sublicense income | 10.00% |
Maximum | |
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | |
Percentage of sublicense income | 30.00% |
Technology License Agreements - Shenyang Sunshine Pharmaceutical Co., Ltd (Narrative) (Details) - 3SBio License - USD ($) $ in Millions |
1 Months Ended | 9 Months Ended |
---|---|---|
May 31, 2014 |
Sep. 30, 2016 |
|
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | ||
Period for commercialization of product | 48 months | |
Aggregate amount of upfront and milestone based payments | $ 1.0 | |
Aggregate amount for future payments upon achievement of clinical and regulatory approval milestones for products containing SVP technology | $ 21.0 | |
Aggregate amount for future payments upon achievement of clinical and regulatory approval milestones for products without SVP technology | $ 41.5 | |
Period for prior written notice to terminate license | 60 days |
Technology License Agreements - Massachusetts Eye and Ear Infirmary and The Schepens Eye Research Institute, Inc. (Narrative) (Details) - MEE |
1 Months Ended |
---|---|
May 31, 2016
USD ($)
product
| |
Minimum | |
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | |
Minimum number of products marketed and sold | product | 1 |
Payment under development milestone method | $ 4,175,000 |
Payment under sales milestone method | 50,000,000 |
Maximum | |
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | |
Payment under development milestone method | 37,025,000 |
Payment under sales milestone method | $ 70,000,000 |
401(k) Savings Plan (Details) - 401(k) Plan - USD ($) $ in Millions |
3 Months Ended | 9 Months Ended | ||
---|---|---|---|---|
Sep. 30, 2016 |
Sep. 30, 2015 |
Sep. 30, 2016 |
Sep. 30, 2015 |
|
Defined Contribution Plan Disclosure [Line Items] | ||||
Vesting period | 4 years | |||
Employer contribution made | $ 0.1 | $ 0.1 | $ 0.1 | $ 0.1 |
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