Document and Entity Information
Document and Entity Information - shares | 9 Months Ended | |
Sep. 30, 2018 | Oct. 30, 2018 | |
Document And Entity Information [Abstract] | ||
Entity Registrant Name | FATE THERAPEUTICS INC | |
Entity Central Index Key | 1,434,316 | |
Document Type | 10-Q | |
Document Period End Date | Sep. 30, 2018 | |
Amendment Flag | false | |
Current Fiscal Year End Date | --12-31 | |
Entity Filer Category | Accelerated Filer | |
Trading Symbol | FATE | |
Entity Common Stock, Shares Outstanding | 64,518,813 | |
Document Fiscal Year Focus | 2,018 | |
Document Fiscal Period Focus | Q3 | |
Entity Small Business | false | |
Entity Emerging Growth Company | true | |
Entity Ex Transition Period | true |
Condensed Consolidated Balance
Condensed Consolidated Balance Sheets - USD ($) $ in Thousands | Sep. 30, 2018 | Dec. 31, 2017 |
Current assets: | ||
Cash and cash equivalents | $ 183,247 | $ 88,952 |
Accounts receivable | 500 | |
Short-term investments and related maturity receivables | 27,945 | 11,997 |
Prepaid expenses and other current assets | 2,237 | 1,647 |
Total current assets | 213,929 | 102,596 |
Property and equipment, net | 3,798 | 2,550 |
Restricted cash | 227 | 122 |
Collaboration contract asset | 2,000 | |
Other assets | 24 | |
Total assets | 219,954 | 105,292 |
Current liabilities: | ||
Accounts payable | 5,236 | 1,678 |
Accrued expenses | 9,638 | 7,254 |
Current portion of CIRM award liability | 1,284 | |
Current portion of deferred rent | 12 | |
Current portion of deferred revenue | 3,250 | 2,105 |
Long-term debt, current portion | 3,264 | |
Total current liabilities | 22,672 | 11,049 |
Deferred rent | 2,441 | 1,347 |
Deferred revenue | 8,000 | 724 |
Accrued expenses | 455 | 175 |
CIRM award liability, net of current portion | 856 | |
Long-term debt, net of current portion | 11,601 | 14,808 |
Commitments and contingencies (Note 6) | ||
Stockholders’ equity: | ||
Preferred stock, $0.001 par value; authorized shares—5,000,000 at September 30, 2018 and December 31, 2017; 2,819,549 Class A Convertible Preferred shares issued and outstanding at September 30, 2018 and December 31, 2017 | 3 | 3 |
Common stock, $0.001 par value; authorized shares—150,000,000 at September 30, 2018 and December 31, 2017; issued and outstanding—64,503,326 at September 30, 2018 and 52,648,601 at December 31, 2017 | 65 | 53 |
Additional paid-in capital | 443,244 | 295,934 |
Accumulated other comprehensive loss | (14) | (3) |
Accumulated deficit | (269,369) | (218,798) |
Total stockholders’ equity | 173,929 | 77,189 |
Total liabilities and stockholders’ equity | $ 219,954 | $ 105,292 |
Condensed Consolidated Balanc_2
Condensed Consolidated Balance Sheets (Parenthetical) - $ / shares | Sep. 30, 2018 | Dec. 31, 2017 |
Preferred stock, par value (in dollars per share) | $ 0.001 | $ 0.001 |
Preferred stock, shares authorized | 5,000,000 | 5,000,000 |
Common stock, par value (in dollars per share) | $ 0.001 | $ 0.001 |
Common stock, authorized shares | 150,000,000 | 150,000,000 |
Common stock issued | 64,503,326 | 52,648,601 |
Common stock, outstanding shares | 64,503,326 | 52,648,601 |
Class A Convertible Preferred Shares | ||
Preferred stock, issued shares | 2,819,549 | 2,819,549 |
Preferred stock, outstanding shares | 2,819,549 | 2,819,549 |
Condensed Consolidated Statemen
Condensed Consolidated Statements of Operations and Comprehensive Loss - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2018 | Sep. 30, 2017 | Sep. 30, 2018 | Sep. 30, 2017 | |
Income Statement [Abstract] | ||||
Collaboration revenue | $ 1,026 | $ 1,026 | $ 3,079 | $ 3,079 |
Type of Revenue [Extensible List] | us-gaap:LicenseMember | us-gaap:LicenseMember | us-gaap:LicenseMember | us-gaap:LicenseMember |
Operating expenses: | ||||
Research and development | $ 13,637 | $ 8,578 | $ 41,929 | $ 24,471 |
General and administrative | 4,081 | 2,788 | 11,501 | 8,489 |
Total operating expenses | 17,718 | 11,366 | 53,430 | 32,960 |
Loss from operations | (16,692) | (10,340) | (50,351) | (29,881) |
Other income (expense): | ||||
Interest income | 339 | 152 | 1,046 | 400 |
Interest expense | (429) | (378) | (1,266) | (856) |
Loss on extinguishment of debt | (118) | (118) | ||
Total other expense, net | (90) | (344) | (220) | (574) |
Net loss | (16,782) | (10,684) | (50,571) | (30,455) |
Other comprehensive income (loss): | ||||
Unrealized gain (loss) on available-for-sale securities, net | 1 | 26 | (11) | (12) |
Comprehensive loss | $ (16,781) | $ (10,658) | $ (50,582) | $ (30,467) |
Net loss per common share, basic and diluted | $ (0.31) | $ (0.26) | $ (0.95) | $ (0.74) |
Weighted-average common shares used to compute basic and diluted net loss per share | 54,185,022 | 41,428,845 | 53,364,823 | 41,407,995 |
Condensed Consolidated Statem_2
Condensed Consolidated Statements of Cash Flows - USD ($) $ in Thousands | 9 Months Ended | |
Sep. 30, 2018 | Sep. 30, 2017 | |
Operating activities | ||
Net loss | $ (50,571) | $ (30,455) |
Adjustments to reconcile net loss to net cash used in operating activities: | ||
Depreciation and amortization | 877 | 681 |
Stock-based compensation | 4,509 | 2,711 |
Amortization of debt discounts and debt issuance costs | 57 | 62 |
Amortization of premiums and discounts on investments, net | (299) | (21) |
Noncash interest expense | 279 | 227 |
Deferred rent | 137 | 816 |
Deferred revenue | 8,421 | (1,579) |
Issuance of common stock for license agreements | 6,100 | |
Cash payments included in loss on extinguishment of debt | 88 | |
Non-cash loss on extinguishment of debt | 30 | |
Changes in operating assets and liabilities: | ||
Accounts receivable | (500) | |
Prepaid expenses and other current assets | (558) | 387 |
Accounts payable and accrued expenses | 3,918 | 957 |
Net cash used in operating activities | (27,630) | (26,096) |
Investing activities | ||
Purchase of property and equipment | (1,186) | (928) |
Purchases of short-term investments | (55,660) | (39,971) |
Maturities of short-term investments | 40,000 | 17,500 |
Net cash used in investing activities | (16,846) | (23,399) |
Financing activities | ||
Issuance of common stock from equity incentive plans, net of issuance costs | 1,914 | 172 |
Proceeds from public offerings of common stock, net of issuance costs | 134,822 | |
Proceeds from CIRM award | 2,140 | |
Proceeds from long-term debt | 15,000 | |
Payments on long-term debt | (10,764) | |
Cash payments included in loss on extinguishment of debt | (88) | |
Payments of debt issuance costs | (10) | |
Net cash provided by financing activities | 138,876 | 4,117 |
Net change in cash, cash equivalents and restricted cash | 94,400 | (45,378) |
Cash, cash equivalents and restricted cash at beginning of the period | 89,074 | 88,731 |
Cash, cash equivalents and restricted cash at end of the period | $ 183,474 | 43,353 |
Common Stock | Private Placement | ||
Financing activities | ||
Issuance costs | (65) | |
Preferred Stock | Private Placement | ||
Financing activities | ||
Issuance costs | $ (128) |
Organization and Summary of Sig
Organization and Summary of Significant Accounting Policies | 9 Months Ended |
Sep. 30, 2018 | |
Organization Consolidation And Presentation Of Financial Statements [Abstract] | |
Organization and Summary of Significant Accounting Policies | 1. Organization and Summary of Significant Accounting Policies Organization Fate Therapeutics, Inc. (the Company) was incorporated in the state of Delaware on April 27, 2007 and has its principal operations in San Diego, California. The Company is a clinical-stage biopharmaceutical company dedicated to the development of programmed cellular immunotherapies for cancer and immune disorders. The Company’s cell therapy pipeline is comprised of NK- and T-cell immuno-oncology programs, including off-the-shelf engineered product candidates derived from clonal master induced pluripotent stem cell (iPSC) lines, and immuno-regulatory programs, including product candidates to prevent life-threatening complications in patients undergoing hematopoietic cell transplantation and to promote immune tolerance in patients with autoimmune disease. Its adoptive cell therapy programs are based on the Company’s novel ex vivo As of September 30, 2018, the Company has devoted substantially all of its efforts to product development, raising capital and building infrastructure and has not generated any revenues from any sales of its therapeutic products. To date, the Company’s revenues have been derived from collaboration agreements and government grants. Public Equity Offerings In September 2018, the Company completed a public offering of common stock in which investors, certain of which are affiliated with the directors of the Company, purchased 10,648,149 shares of its common stock at a price of $13.50 per share under a shelf registration statement. Gross proceeds from the offering were $143.8 million, and, after giving effect to $8.9 million of costs related to the offering (of which $8.7 million was paid during the nine months ended September 30, 2018), net proceeds were $134.9 million. In December 2017, the Company completed a public offering of common stock in which investors purchased 10,953,750 shares of its common stock at a price of $4.20 per share under a shelf registration statement. Gross proceeds from the offering were $46.0 million, and, after giving effect to $3.0 million of costs related to the offering (of which $0.3 million was paid during the nine months ended September 30, 2018), net proceeds were $43.0 million. Use of Estimates The Company’s consolidated financial statements are prepared in accordance with United States generally accepted accounting principles (GAAP). The preparation of the Company’s consolidated financial statements requires it to make estimates and assumptions that impact the reported amounts of assets, liabilities, revenues and expenses and the disclosure of contingent assets and liabilities in the Company’s consolidated financial statements and accompanying notes. The most significant estimates in the Company’s consolidated financial statements relate to accrued expenses. Although these estimates are based on the Company’s knowledge of current events and actions it may undertake in the future, actual results may ultimately materially differ from these estimates and assumptions. Principles of Consolidation The consolidated financial statements include the accounts of the Company and its subsidiaries, Fate Therapeutics Ltd., incorporated in the United Kingdom, and Tfinity Therapeutics, Inc., incorporated in the United States. To date, the aggregate operations of these subsidiaries have not been significant and all intercompany transactions and balances have been eliminated in consolidation. Cash, Cash Equivalents and Restricted Cash Cash and cash equivalents include cash in readily available checking and savings accounts, money market accounts and money market funds. The Company considers all highly liquid investments with an original maturity of three months or less from the date of purchase to be cash equivalents. The following table provides a reconciliation of cash, cash equivalents, and restricted cash reported within the Condensed Consolidated Balance Sheet that sum to the total of the same such amount shown in the Condensed Consolidated Statements of Cash Flows as of September 30, 2018 (in thousands): September 30, 2018 Cash and cash equivalents $ 183,247 Restricted cash 227 Total cash, cash equivalents, and restricted cash shown in the statement of cash flows $ 183,474 Amounts included in restricted cash represent security deposits required to secure the Company’s credit card limit and its facilities lease. Short-Term Investments Available-for-sale securities are carried at fair value, with the unrealized gains and losses reported in comprehensive income. The amortized cost of available-for-sale debt securities is adjusted for amortization of premiums and accretion of discounts to maturity. Such amortization and accretion is included in interest income. Realized gains and losses and declines in value judged to be other-than-temporary, if any, on available-for-sale securities are included in other income or expense. The cost of securities sold is based on the specific identification method. Interest and dividends on securities classified as available-for-sale are included in interest income. Unaudited Interim Financial Information The accompanying interim condensed consolidated financial statements are unaudited. These unaudited interim condensed consolidated financial statements have been prepared in accordance with GAAP and following the requirements of the SEC for interim reporting. As permitted under those rules, certain footnotes or other financial information that are normally required by GAAP can be condensed or omitted. In management’s opinion, the unaudited interim financial statements have been prepared on the same basis as the audited financial statements and include all adjustments, which include only normal recurring adjustments, necessary for the fair presentation of the Company’s financial position and its results of operations and comprehensive loss and its cash flows for the periods presented. These statements do not include all disclosures required by GAAP and should be read in conjunction with the Company’s financial statements and accompanying notes for the fiscal year ended December 31, 2017, contained in the Company’s Annual Report on Form 10-K for the year ended December 31, 2017 filed by the Company with the SEC on March 5, 2018. The results for the three and nine months ended September 30, 2018 are not necessarily indicative of the results expected for the full fiscal year or any other interim period or any future year or period. Revenue Recognition The Company recognizes revenue in a manner that depicts the transfer of control of a product or a service to a customer and reflects the amount of the consideration the Company is entitled to receive in exchange for such product or service. In doing so, the Company follows a five-step approach: (i) identify the contract with a customer, (ii) identify the performance obligations in the contract, (iii) determine the transaction price, (iv) allocate the transaction price to the performance obligations, and (v) recognize revenue when (or as) the customer obtains control of the product or service. A customer is a party that has entered into a contract with the Company, where the purpose of the contract is to obtain a product or a service that is an output of the Company’s ordinary activities in exchange for consideration. To be considered a contract, (i) the contract must be approved (in writing, orally, or in accordance with other customary business practices), (ii) each party’s rights regarding the product product product A performance obligation is defined as a promise to transfer a product The transaction price is the amount of consideration the Company is entitled to receive in exchange for the transfer of control of a product or a service to If a contract has multiple performance obligations, the Company allocates the transaction price to each distinct performance obligation in an amount that reflects the consideration the Company is entitled to receive in exchange for satisfying each distinct performance obligation. For each distinct performance obligation, revenue is recognized when (or as) the Company transfers control of the product or the service applicable to such performance obligation. In those instances where the Company first receives consideration in advance of satisfying its performance obligation, the Company classifies such consideration as deferred revenue until (or as) the Company satisfies such performance obligation. In those instances where the Company first satisfies its performance obligation prior to its receipt of consideration, the consideration is recorded as accounts receivable. The Company expenses incremental costs of obtaining a contract as and when incurred if the expected amortization period of the asset that would be recognized is one year or less, or if the amount of the asset is immaterial. Stock-Based Compensation Stock-based compensation expense represents the cost of the grant date fair value of employee stock option and restricted stock unit grants recognized over the requisite service period of the awards (usually the vesting period) on a straight-line basis, net of estimated forfeitures. For stock option grants for which vesting is subject to performance-based milestones, the expense is recorded over the remaining service period after the point when the achievement of the milestone is probable or the performance condition has been achieved. For stock option grants for which vesting is subject to both performance-based milestones and market conditions, expense is recorded over the derived service period after the point when the achievement of the performance-based milestone is probable or the performance condition has been achieved. The Company estimates the fair value of stock option grants using the Black-Scholes option pricing model, with the exception of option grants for which vesting is subject to both performance-based milestones and market conditions, which are valued using a lattice-based model. The fair value of restricted stock units is based on the closing price of the Company’s common stock as reported on The NASDAQ Global Market on the date of grant. The Company accounts for stock options and restricted stock awards to non-employees using the fair value approach. Stock options and restricted stock awards to non-employees are subject to periodic revaluation over their vesting terms. For stock option grants for which vesting is subject to performance-based milestones, the expense is recorded over the remaining service period after the point when the performance condition is determined to be probable of achievement or when it has been achieved. Convertible Preferred Stock The Company applies the relevant accounting standards to distinguish liabilities from equity when assessing the classification and measurement of preferred stock. Preferred shares subject to mandatory redemptions are considered liabilities and measured at fair value. Conditionally redeemable preferred shares are considered temporary equity. All other preferred shares are considered as stockholders’ equity. The Company applies the relevant accounting standards for derivatives and hedging (in addition to distinguishing liabilities from equity) when accounting for hybrid contracts that contain conversion options. Conversion options must be bifurcated from the host instruments and accounted for as free standing financial instruments according to certain criteria. These criteria include circumstances when (i) the economic characteristics and risks of the embedded derivative instruments are not clearly and closely related to the economic characteristics and risks of the host contract, (ii) the hybrid instrument that embodies both the embedded derivative instrument and the host contract is not re-measured at fair value under otherwise applicable accounting principles with changes in fair value reported in earnings as they occurred, and (iii) a separate instrument with the same terms as the embedded derivative instrument would be considered a derivative instrument. The derivative is subsequently measured at fair value at each reporting date, with the changes in fair value reported in earnings. Comprehensive Loss Comprehensive loss is defined as a change in equity during a period from transactions and other events and circumstances from non‑owner sources. Other comprehensive income includes unrealized gains and losses on available-for-sale securities, which was the only difference between net loss and comprehensive loss for the applicable periods. Net Loss per Common Share Basic net loss per common share is calculated by dividing the net loss by the weighted-average number of shares of common stock outstanding for the period, without consideration for common stock equivalents. Dilutive common stock equivalents for the periods presented include convertible preferred stock, warrants for the purchase of common stock, and common stock options and restricted stock units outstanding under the Company’s stock option and incentive plan. For all periods presented, there is no difference in the number of shares used to calculate basic and diluted shares outstanding due to the Company’s net loss position. For the three and nine months ended September 30, 2018, the Company realized a net loss of $16.8 million and $50.6 million, respectively. Shares of potentially dilutive securities totaled 21.7 million for the three and nine months ended September 30, 2018, including 14.1 million shares associated with a hypothetical conversion of all outstanding shares of the Company’s Class A convertible preferred stock, and an aggregate of 7.5 million shares of common stock issuable upon the exercise of outstanding stock options and the settlement of outstanding restricted stock units. For the three and nine months ended September 30, 2017, the Company realized a net loss of $10.7 million and $30.5 million, respectively. Shares of potentially dilutive securities totaled 20.5 million for the three and nine months ended September 30, 2017, including 14.1 million shares associated with a hypothetical conversion of all outstanding shares of the Company’s Class A convertible preferred stock, and an aggregate of 6.2 million shares of common stock issuable upon the exercise of outstanding stock options and the settlement of outstanding restricted stock units. Going Concern Assessment The Company has assessed its ability to continue as a going concern for a period of one year from the date of the issuance of these financial statements. Substantial doubt about an entity’s ability to continue as a going concern exists when relevant conditions and events, considered in the aggregate, indicate that it is probable that the entity will be unable to meet its obligations as they become due within one year from the financial statement issuance date. The Company determined that there are no conditions or events that raise substantial doubt about its ability to continue as a going concern as of the date of the issuance of these financial statements. Recent Accounting Pronouncements In August 2018, the Financial Accounting Standards Board (FASB) issued Accounting Standards Update (ASU) No. 2018-13 (ASU 2018-13). ASU 2018-13, Fair Value Measurement (Topic 820): Disclosure Framework—Changes to the Disclosure Requirements for Fair Value Measurement , amends the disclosure requirements in 820 by adding, changing, or removing certain disclosures. ASU 2018-13 is effective for fiscal years beginning after December 15, 2019. The Company believes that the adoption of this guidance will not have a material impact on the Company’s Consolidated Financial Statements. In June 2018, the FASB issued ASU 2018-07. ASU 2018-07 expands the scope of ASC 718, Compensation- Stock Compensation, The Company believes that the adoption of this guidance will not have a material impact on the Company’s Consolidated Financial Statements. In March 2018, the FASB issued ASU 2018-05. ASU 2018-05 amends income tax related SEC paragraphs presented pursuant to SEC Staff Accounting Bulletin No. 118 (SAB 118). The SEC issued SAB 118 during December 2017 to address the application of U.S. GAAP in situations when a registrant does not have the necessary information available, prepared or analyzed (including computations) in reasonable detail to complete the accounting for certain income tax effects of the Tax Cuts and Jobs Act of 2017 (the Tax Cuts and Jobs Act), which was enacted in December 2017. Amounts recorded by the Company pursuant to ASU 2018-05 in connection with certain deferred tax assets and liabilities are based on reasonable estimates, and additional work is required to complete the accounting. Any subsequent adjustment to these estimated amounts will be recorded to current tax expense in the period when the accounting is complete. In November 2016, the FASB issued ASU 2016-18, which requires that a statement of cash flows explain the change during the period in the total of cash, cash equivalents, and amounts generally described as restricted cash or restricted cash equivalents. ASU 2016-18 is effective for fiscal years beginning after December 15, 2017. The Company adopted the update retrospectively to each period presented. The adoption of this guidance did not have a material impact on the Company’s Consolidated Financial Statements. In August 2016, the FASB issued ASU 2016-15, which clarifies how entities should classify certain cash receipts and cash payments on the statement of cash flows and how the predominance principle should be applied when cash receipts and cash payments have aspects of more than one class of cash flows. The Company adopted ASU 2016-15 on January 1, 2018. The Company adopted the update retrospectively to each period presented and adjusted the Condensed Consolidated Statements of Cash Flows for the nine months ended September 30, 2017 to reclassify cash payments included in the loss on extinguishment of debt from an operating activity to a financing activity. In February 2016, the FASB issued ASU 2016-02, Leases In May 2014, the FASB issued ASU 2014-09 (Topic 606), which created a single, principle-based revenue recognition model that will supersede and replace nearly all existing U.S. GAAP revenue recognition guidance. Entities will recognize revenue in a manner that depicts the transfer of goods or services to customers and reflects the amount of the consideration which the entity expects to be entitled to receive in exchange for those goods or services. The model provides that entities follow five steps: (i) identify the contract with a customer, (ii) identify the performance obligations in the contract, (iii) determine the transaction price, (iv) allocate the transaction price to the performance obligations, and (v) recognize revenue when (or as) the customer obtains control of the product or service. For public business entities, ASU 2014-09 is effective beginning in the first quarter of 2018 using one of two prescribed transition methods: retrospectively to each prior reporting period presented (full retrospective method), or retrospectively with the cumulative effect of initially applying the guidance recognized at the date of initial application (the cumulative catch-up transition method). The Company adopted ASU 2014-09 in the first quarter of 2018 using the full retrospective method. The Company has evaluated the effect that the updated standard had on its internal processes, financial statements and related disclosures, and has determined that the adoption did not have a material impact on the Company’s historical Consolidated Financial Statements. |
Collaboration and License Agree
Collaboration and License Agreements | 9 Months Ended |
Sep. 30, 2018 | |
Collaboration And License Agreements Disclosure [Abstract] | |
Collaboration and License Agreements | 2. Collaboration and License Agreements Ono Collaboration and Option Agreement On September 14, 2018, the Company entered into a Collaboration and Option Agreement (the Ono Agreement) with Ono Pharmaceutical Co. Ltd. (Ono) for the joint development and commercialization of two off-the-shelf iPSC-derived chimeric antigen receptor (CAR) T-cell product candidates. The first iPSC-derived CAR T-cell candidate (Candidate 1) targets an antigen expressed on certain lymphoblastic leukemias, and the second candidate (Candidate 2) targets a novel antigen identified by Ono expressed on certain solid tumors (each a Candidate and collectively the Candidates). Pursuant to the Ono Agreement, the Company and Ono will jointly conduct research and development activities under a joint development plan, with the goal of advancing each Candidate to a pre-defined preclinical milestone. The Company has granted to Ono an option to obtain an exclusive license under certain intellectual property rights related to its iPSC product platform to develop and commercialize (a) Candidate 1 in Asia, with the Company retaining rights for development and commercialization in all other territories of the world and (b) Candidate 2 in all territories of the world, with the Company retaining the right to co-develop and co-commercialize Candidate 2 in the United States and Europe under a joint arrangement whereby it is eligible to share at least 50% of the profits and losses (each, an Option). The Company has maintained worldwide rights of manufacture for both Candidates. For each Candidate, the Option will expire upon the earliest of: (a) the achievement of the pre-defined preclinical milestone, (b) termination by Ono of research and development activities for the Candidate and (c) the date that is the later of (i) four years after the Effective Date and (ii) completion of all applicable activities contemplated under the joint development plan (the Option Period). Under the terms of the Ono Agreement, Ono paid the Company a non-refundable, non-creditable upfront payment of $10.0 million in connection with entering into the Ono Agreement. Additionally, as consideration for the Company’s conduct of research under a joint development plan, Ono shall pay the Company annual research and development fees set forth in the annual budget included in the joint development plan, which fees are estimated to be $20.0 million in aggregate over the course of the joint development plan. The Company received $5.0 million in October 2018 as a prepayment for the first year of research and development. Further, under the terms of the Ono Agreement, Ono has agreed to pay the Company up to an additional $40.0 million during the Option Period for the preclinical development of Candidate 1 and Candidate 2 in the form of milestone and option exercise fees. Such fees are in addition to the upfront payment and research and development fees. Subject to Ono’s exercise of the Options and to the achievement of certain clinical, regulatory and commercial milestones (Milestones) with respect to each Candidate in specified territories, the Company is entitled to receive an aggregate of up to $285.0 million in milestone payments for Candidate 1 and an aggregate of up to $895.0 million in milestone payments for Candidate 2, with the applicable milestone payments for Candidate 2 for the United States and Europe subject to reduction by 50% if the Company elects to co-develop and co-commercialize Candidate 2 as described above. The Company is also eligible to receive tiered royalties (Royalties) ranging from the mid-single digits to the low-double digits based on annual net sales by Ono of each Candidate in specified territories, with such royalties subject to certain reductions. The Ono Agreement will terminate with respect to a Candidate if Ono does not exercise its Option for a Candidate within the Option Period, or in its entirety if Ono does not exercise any of its Options for the Candidates within their respective Option Periods. In addition, either party may terminate the Ono Agreement in the event of breach, insolvency or patent challenges by the other party; provided, that Ono may terminate the Ono Agreement in its sole discretion (x) on a Candidate-by-Candidate basis at any time after the second anniversary of the effective date of the Ono Agreement or (y) on a Candidate-by-Candidate or country-by-country basis at any time after the expiration of the Option Period, subject to certain limitations. The Ono Agreement will expire on a Candidate-by-Candidate and country-by-country basis upon the expiration of the applicable royalty term, or in its entirety upon the expiration of all applicable payment obligations under the Ono Agreement. The Company applied Accounting Standards Codification (ASC) 808, Collaborative Arrangements Revenue from Contracts with Customers The Company also assessed, in connection with the non-refundable upfront payment of $10.0 million received in September 2018 and the $5.0 million prepayment of the first-year research and development fees in October 2018, whether a significant financing component exists under the Ono Agreement. Such assessment evaluated whether: (i) a substantial amount of the consideration is variable, (ii) the amount, or timing of payment, of the consideration would have varied based on the occurrence or non-occurrence of future events that are not substantially within the control of the Company or Ono, and (iii) the timing of the transfer of the performance obligations is at the discretion of Ono. Based on its assessment, the Company concluded that there was not a significant financing component. The Company also assessed the effects of any variable elements under the Ono Agreement. Such assessment evaluated, among other things, the likelihood of receiving (i) preclinical milestone and option fees, (ii) various clinical, regulatory and commercial milestone payments, and (iii) royalties on net sales of either product Candidate. Based on its assessment, the Company concluded that, based on the likelihood of these variable components occurring, there was not a significant variable element included in the transaction price. In accordance with ASC 606, the Company determined that the initial transaction price under the Ono Agreement equals $30.0 million, consisting of the non-refundable upfront payment of $10.0 million and the aggregate estimated research and development fees of $20.0 million. The non-refundable upfront payment of $10.0 million was recorded as deferred revenue as of September 30, 2018 and will be recognized as revenue over time in conjunction with the Company’s conduct of research services over the estimated four-year period based on costs incurred. The Company recorded the $5.0 million prepayment of the first-year research and development fees as deferred revenue in October 2018, and such fees will be recognized as revenue as the research services are delivered. The Company has not assigned a transaction price to any Milestones given the substantial uncertainty related to their achievement and has not assigned a transaction price to any Royalties. As a direct result of the Company’s entry into the Ono Agreement, the Company incurred an aggregate of $2.0 million in sublicense consideration to existing licensors of the Company. The $2.0 million in sublicense consideration is due during the fourth quarter of 2018, and represents an asset under ASC 340, Other Assets and Deferred Costs. The Company did not recognize any revenue under the Ono Agreement for the three and nine months ended September 30, 2018. As of September 30, 2018, aggregate deferred revenue related to the Ono Agreement was $10.0 million, of which $2.0 million is classified as current. Juno Collaboration and License Agreement On May 4, 2015, the Company entered into a strategic research collaboration and license agreement (the Juno Agreement) with Juno Therapeutics, Inc. (Juno) (acquired by Celgene Corporation) to screen for and identify small molecules that enhance the therapeutic properties of Juno’s genetically-engineered T-cell immunotherapies. Under the Juno Agreement, the Company is primarily responsible for screening and identifying small molecule modulators of immunological cells, while Juno is primarily responsible for the development and commercialization of engineered T-cell immunotherapies incorporating the Company’s modulators. The Company granted Juno an exclusive worldwide license to certain of its intellectual property, including its intellectual property arising under the collaboration, to make, use, sell and otherwise exploit genetically-engineered T-cell immunotherapies using or incorporating small molecule modulators directed against certain designated tumor-associated antigen targets, subject to the selection by Juno of designated tumor-associated antigen targets which selection may be made by Juno on a target-by-target basis. The Company retained exclusive rights to such intellectual property, including its intellectual property arising under the collaboration, for all other purposes, including its use outside of those tumor-associated antigen targets selected by Juno. The Juno Agreement will end on the date that no further payments are due under the Juno Agreement, unless terminated earlier pursuant to the terms of the Juno Agreement. Pursuant to the terms of the Juno Agreement, Juno paid the Company a non-refundable upfront payment of $5.0 million and purchased 1,000,000 shares of the Company’s common stock at a price of $8.00 per share. The Company determined that this common stock purchase represented a premium of $3.40 per share, or $3.4 million in aggregate (Equity Premium), and the remaining $4.6 million was recorded as issuance of common stock in shareholders’ equity. Additionally, Juno agreed to fund all of the Company’s collaboration research activities for an initial four-year research term beginning on the effective date of the Juno Agreement, with minimum annual research payments of $2.0 million to the Company. Juno has the option to extend the exclusive research term for an additional two years beyond the initial four-year term, subject to the payment of an extension fee of $3.0 million and the continued funding of the Company’s activities under the collaboration during the extended term, with minimum annual research payments of $4.0 million to the Company during the two-year extension period. Upon exercise of the research term extension, the Company has the option to require Juno to purchase up to $10.0 million of the Company’s common stock at a premium equal to 120% of the then thirty-day trailing volume weighted average trading price of the Company’s common stock. The Company applied ASC 606 to evaluate the appropriate accounting for the Juno Agreement. In accordance with this guidance, the Company identified its performance obligations, including its grant of an exclusive worldwide license to certain of its intellectual property subject to certain conditions, its conduct of research services and its participation in a joint research committee. The Company determined that its grant of an exclusive worldwide license to certain of its intellectual property subject to certain conditions under the Juno Agreement was not distinct from other performance obligations because such grant is dependent on the conduct and results of the research services. As a result, the exclusive worldwide license is classified as symbolic intellectual property under ASC 606. Additionally, the Company determined that its conduct of research services under the Juno Agreement was not distinct from other performance obligations because such conduct is dependent on the direction of the joint research committee. Accordingly, the Company determined that all performance obligations should be accounted for as one combined performance obligation since no individual performance obligation is distinct, and that the combined performance obligation is transferred ratably over the expected term of conduct of the research services, which is four years. The Company also determined that the transaction price under the Juno Agreement equals $16.4 million, consisting of the non-refundable upfront payment of $5.0 million, the $3.4 million Equity Premium and $8.0 million of estimated payments for the conduct of research services during the initial four-year term. The Company assessed whether, in connection with the non-refundable upfront payment of $5.0 million and the $3.4 million Equity Premium, a significant financing component exists under the Juno Agreement. Such assessment evaluated whether: (i) a substantial amount of the consideration is variable, (ii) the amount, or timing of payment, of the consideration would have varied based on the occurrence or non-occurrence of future events that are not substantially within the control of the Company or Juno, and (iii) the timing of the transfer of the performance obligations is at the discretion of Juno. Based on its assessment, the Company concluded that there was not a significant financing component. The Company assessed the effects of any variable elements under the Juno Agreement. Such assessment evaluated, among other things, the likelihood of receiving (i) various clinical, regulatory and commercial milestone payments and (ii) royalties on net sales of any Juno therapies that use or incorporate the Company’s small molecule modulators. Based on its assessment, the Company concluded that based on the likelihood of these variable components occurring that there was not a significant variable element included in the transaction price. As such, the non-refundable upfront payment of $5.0 million and the $3.4 million Equity Premium were recorded as deferred revenue, and are being recognized as revenue ratably over four years. Under the Juno Agreement, Juno has agreed to pay the Company a selection fee for each tumor-associated antigen target selected by Juno and certain bonus selection fees based on the aggregate number of tumor-associated antigen targets selected by Juno. In accordance with ASC 606, the Company has not assigned a transaction price to any potential selection fees. Additionally, since the selection fees are closely aligned with the previously discussed combined performance obligation, any such future consideration in connection with selection fees will be recognized in conjunction with the combined performance obligation. Under the Juno Agreement, in connection with each Juno therapy that uses or incorporates the Company’s small molecule modulators, Juno has agreed to pay the Company non-refundable, non-creditable milestone payments totaling up to approximately $51.0 million in the aggregate per therapy upon the achievement of various clinical, regulatory and commercial milestones. Additionally, in connection with the third Juno therapy and the fifth Juno therapy that uses or incorporates the Company’s small molecule modulators, Juno has agreed to pay the Company additional non-refundable, non-creditable bonus milestone payments totaling up to approximately $116.0 million and $137.5 million, respectively, in the aggregate, per therapy upon the achievement of various clinical, regulatory, and commercial milestones. In accordance with ASC 606, the Company has not assigned a transaction price to any of these potential milestone payments given the substantial uncertainty related to their achievement. Additionally, since any performance obligation would be complete at the time of milestone achievement, any future consideration in connection with milestone payments will be recognized on the date of achievement. Under the Juno Agreement, beginning on the date of the first commercial sale (in each country) for each Juno therapy that uses or incorporates the Company’s small molecule modulators, and continuing until the later of: (i) the expiration of the last valid patent claim, (ii) ten years after such first commercial sale, or (iii) the expiration of all data and other regulatory exclusivity periods afforded each therapy, Juno has agreed to pay the Company royalties in the low single-digits on net sales of each Juno therapy that uses or incorporates the Company’s small molecule modulators. In accordance with ASC 606, the Company has not assigned a transaction price to any of these potential royalty payments. Additionally, since any performance obligation would be complete at the time of potential sale of each Juno therapy that uses or incorporates the Company’s small molecule modulators, any future consideration in connection with royalty payments will be recognized on the date of sale. Total revenue recognized under the Juno Agreement for the three and nine months ended September 30, 2018 was $1.0 million and $3.1 million, respectively. Total revenue recognized under the Juno Agreement for the three and nine months ended September 30, 2017 was $1.0 million and $3.1 million, respectively. As of September 30, 2018, aggregate deferred revenue related to the Juno Agreement was $1.3 million, all of which is classified as current. As of September 30, 2018, aggregate accounts receivable related to the Juno Agreement were $0.5 million, with such amount received in October 2018. In January 2018, Juno announced its entry into a merger agreement with Celgene Corporation (Celgene), pursuant to which Celgene agreed to acquire all of the outstanding shares of common stock of Juno through a tender offer. On March 6, 2018, Celgene announced that it had completed the acquisition of Juno. This acquisition event did not affect the terms of the Juno Agreement. The Juno Agreement is assignable by Juno to its affiliates or in connection with its acquisition by Celgene. Memorial Sloan Kettering Cancer Center License Agreement On May 15, 2018, the Company entered into an Amended and Restated Exclusive License Agreement (the Amended MSK License) with Memorial Sloan Kettering Cancer Center (MSK). The Amended MSK License amends and restates the Exclusive License Agreement entered into between the Company and MSK on August 19, 2016 (the Original MSK License). Pursuant to the Amended MSK License, MSK granted to the Company additional licenses to certain patents and patent applications relating to new CAR constructs and off-the-shelf CAR T cells, in each case to research, develop, and commercialize licensed products in the field of all human therapeutic uses worldwide. MSK also returned to the Company its entire interest in Tfinity Therapeutics, Inc. (Tfinity), a majority-owned subsidiary of the Company in which MSK owned a minority interest pursuant to the Original MSK License. As a result, Tfinity became a wholly-owned subsidiary of the Company. The Company continues to maintain exclusive licenses to certain patents and patent applications relating to off-the-shelf T-cell immunotherapies, including CAR T cells manufactured from induced pluripotent stem cells, that were granted to the Company by MSK under the Original MSK License. The Company issued 500,000 shares of the Company’s common stock to MSK (the MSK Shares) pursuant to the Amended MSK License. The MSK Shares are being issued pursuant to an exemption from registration under the Securities Act of 1933, as amended (the Securities Act), in reliance on Section 4(a)(2) of the Securities Act regarding transactions by an issuer not involving a public offering. Pursuant to the Amended MSK License, the Company is obligated to register the MSK Shares for resale within 18 months of the effective date of the agreement. Additionally, the Company paid an upfront fee of $0.5 million and is obligated to pay a royalty to MSK on net sales of licensed products and milestone payments upon the achievement of specified clinical and regulatory milestones. The Company is also obligated to pay MSK a percentage of certain sublicense income received by the Company. Under the terms of the Amended MSK License, in the event a licensed product achieves a specified clinical milestone, MSK is then eligible to receive additional milestone payments, where such payments are owed to MSK contingent upon certain increases in the price of the Company’s common stock relative to the price of the common stock as of May 15, 2018, following the date of achievement of such clinical milestone. Given the high degree of uncertainty surrounding the achievement of clinical milestones and the requisite increase in the price of the Company’s common stock, the Company has not recorded a liability for such payments. During the nine months ended September 30, 2018, the Company recognized an aggregate of $5.3 million of research and development expenses, consisting of the $0.5 million upfront cash payment to MSK and the issuance of the MSK Shares, valued at $4.8 million, associated with the Amended MSK License. Gladstone License Agreement On September 11, 2018, the Company entered into an exclusive license agreement (the Gladstone License Agreement) with the J. David Gladstone Institutes (Gladstone). Pursuant to the Gladstone License Agreement, Gladstone granted to the Company exclusive licenses to certain patents and patent applications (the Patent Rights) for the research, development, manufacturing, and commercialization of human therapeutics derived from iPSCs. The Patent Rights cover the use of the clustered regularly interspaced short palindromic repeat (CRISPR) and engineered nuclease-deactivated CRISPR-associated protein-9 (dCas9) system, known as the CRISPR activation (CRISPRa) system, for cellular reprogramming and iPSC generation. In consideration for the rights granted under the Gladstone License Agreement, the Company issued to Gladstone 100,000 shares of the Company’s common stock (the Gladstone Shares). The Gladstone Shares were issued pursuant to an exemption from registration under the Securities Act, in reliance on Section 4(a)(2) of the Securities Act regarding transactions by an issuer not involving a public offering. Additionally, the Company paid Gladstone an upfront fee of $0.1 million and is obligated to pay Gladstone milestone payments upon the achievement of specified clinical and regulatory milestones and a royalty on net sales of licensed products developed using the licensed intellectual property rights. The Company is also obligated to pay Gladstone a percentage of certain income received by the Company in connection with the sublicense of the licensed patent rights. During the three and nine months ended September 30, 2018, the Company recognized an aggregate of $1.4 million of research and development expenses, consisting of the $0.1 million upfront cash payment to Gladstone and the issuance of the Gladstone Shares, valued at $1.3 million, associated with the Gladstone License Agreement. |
California Institute for Regene
California Institute for Regenerative Medicine Award | 9 Months Ended |
Sep. 30, 2018 | |
Award From Regenerative Medicine Institute [Abstract] | |
California Institute for Regenerative Medicine Award | 3. California Institute for Regenerative Medicine Award On April 5, 2018, the Company executed an award agreement with the California Institute for Regenerative Medicine (CIRM) pursuant to which CIRM awarded the Company $4.0 million to advance the Company’s FT516 product candidate into a first-in-human clinical trial (the Award). Pursuant to the terms of the Award, the Company became eligible to receive five disbursements in varying amounts totaling $4.0 million, with one disbursement receivable upon the execution of the Award, and four disbursements receivable upon the completion of certain milestones throughout the project period, which is estimated to be from April 1, 2018, to June 30, 2019 (the Project Period). The Award is subject to certain co-funding requirements by the Company, and the Company is required to provide CIRM progress and financial update reports throughout the Project Period. Following the conclusion of the Project Period, the Company, in its sole discretion, has the option to treat the Award either as a loan or as a grant. In the event the Company elects to treat the Award as a loan, the Company will be obligated to repay i) 60%, ii) 80%, iii) 100% or iv) 100% plus interest at 7% plus LIBOR, of the total Award to CIRM, where such repayment rate is dependent upon the phase of clinical development of FT516 at the time of the Company’s election. If the Company does not elect to treat the Award as a loan within 10 years of the date of the Award, the Award will be considered a grant and the Company will be obligated to pay to CIRM a royalty on commercial sales of FT516 until such royalty payments equal nine times the total amount awarded to the Company under the Award. Since the Company may, at its election, repay some or all of the Award, the Company accounts for the Award as a liability until the time of election. In April 2018, the Company received the first disbursement under the Award in the amount of $1.0 million. In September 2018, the Company received an additional disbursement under the Award in the amount of $1.1 million. The aggregate amount received is recorded as a CIRM Liability on the accompanying consolidated balance sheets and classified as current or non-current based on the potential amount payable within twelve months of the current balance sheet. |
Short-term Investments
Short-term Investments | 9 Months Ended |
Sep. 30, 2018 | |
Short Term Investments [Abstract] | |
Short-term Investments | 4. Short-term Investments The Company invests portions of excess cash in United States treasuries with maturities ranging from three to twelve months from the purchase date. These debt securities are classified as short-term investments in the accompanying consolidated balance sheets and are accounted for as available-for-sale securities. The following table summarizes the Company’s short-term investments accounted for as available-for-sale securities as of September 30, 2018, and December 31, 2017 (in thousands): Maturity (in years) Amortized Cost Unrealized Losses Unrealized Gains Estimated Fair Value September 30, 2018 U.S. Treasury debt securities 1 or less 27,959 (14 ) — 27,945 Total $ 27,959 $ (14 ) $ — $ 27,945 December 31, 2017 U.S. Treasury debt securities 1 or less 12,000 (3 ) — 11,997 Total $ 12,000 $ (3 ) $ — $ 11,997 The Company reviewed its investment holdings as of September 30, 2018 and determined that the unrealized losses were not other-than-temporary unrealized losses because the Company does not intend to sell the underlying securities prior to maturity and it is not more likely than not that the Company will be required to sell these securities before the recovery of their amortized cost basis. During each of the three and nine months ended September 30, 2018 and 2017, the Company did not recognize any impairment or gains or losses on sales of available-for-sale securities. |
Fair Value Measurements
Fair Value Measurements | 9 Months Ended |
Sep. 30, 2018 | |
Fair Value Disclosures [Abstract] | |
Fair Value Measurements | 5. Fair Value Measurements The carrying amounts of accounts payable and accrued liabilities are considered to be representative of their respective fair values because of the short-term nature of those instruments. Based on the borrowing rates available to the Company for loans with similar terms, which is considered a Level 2 input as described below, the Company believes that the fair value of long-term debt approximates its carrying value. The accounting guidance defines fair value, establishes a consistent framework for measuring fair value and expands disclosure for each major asset and liability category measured at fair value on either a recurring or nonrecurring basis. Fair value is defined as an exit price, representing the amount that would be received to sell an asset or paid to transfer a liability in an orderly transaction between market participants. As such, fair value is a market-based measurement that should be determined based on assumptions that market participants would use in pricing an asset or liability. As a basis for considering such assumptions, the accounting guidance establishes a three-tier fair value hierarchy, which prioritizes the inputs used in measuring fair value as follows: Level 1: Observable inputs such as quoted prices in active markets; Level 2: Inputs, other than the quoted prices in active markets, that are observable either directly or indirectly; and Level 3: Unobservable inputs in which there is little or no market data, which require the reporting entity to develop its own assumptions. Financial assets measured at fair value on a recurring basis consist of the Company’s cash equivalents and short-term investments. Cash equivalents consisted of money market funds and short-term investments consisted of U.S. treasuries. The following table presents the Company’s assets which were measured at fair value on a recurring basis as of September 30, 2018 and December 31, 2017 (in thousands): Fair Value Measurements at Reporting Date Using Total Quoted Prices in Active Markets for Identical Assets (Level 1) Significant Other Observable Inputs (Level 2) Significant Unobservable Inputs (Level 3) As of September 30, 2018: Cash equivalents $ 183,247 $ 183,247 $ — $ — U.S. Treasury debt securities 27,945 27,945 — — Total assets $ 211,192 $ 211,192 $ — $ — As of December 31, 2017: Cash equivalents $ 88,952 $ 88,952 $ — $ — U.S. Treasury debt securities 11,997 11,997 — — Total assets $ 100,949 $ 100,949 $ — $ — The Company obtains pricing information from quoted market prices from our investment manager and generally determines the fair value of investment securities using standard observable inputs, including reported trades, broker/dealer quotes, and bids and/or offers. None of the Company’s non-financial assets or liabilities is recorded at fair value on a non-recurring basis. No transfers between levels have occurred during the periods presented. As of September 30, 2018 and December 31, 2017, the Company had no material financial liabilities measured at fair value on a recurring basis. |
Accrued Expenses, Long-Term Deb
Accrued Expenses, Long-Term Debt, Commitments and Contingencies | 9 Months Ended |
Sep. 30, 2018 | |
Accrued Expenses Long Term Debt Commitments And Contingencies Disclosure [Abstract] | |
Accrued Expenses, Long-Term Debt, Commitments and Contingencies | 6. Accrued Expenses, Long-Term Debt, Commitments and Contingencies Accrued Expenses Current accrued expenses consist of the following (in thousands): September 30, 2018 December 31, 2017 Accrued payroll and other employee benefits $ 2,220 $ 1,761 Accrued clinical trial related costs 4,785 3,323 Accrued other 2,633 2,170 Current accrued expenses $ 9,638 $ 7,254 Long-term accrued expenses consist primarily of accruals for the final payment fees associated with our long-term debt. Long-Term Debt Long-term debt and unamortized discount balances are as follows (in thousands): September 30, 2018 December 31, 2017 Long-term debt $ 15,000 $ 15,000 Less debt issuance costs and discount, net of current portion (66 ) (192 ) Long-term debt, net of long-term portion of debt issuance costs and discount 14,934 14,808 Less current portion of long-term debt (3,333 ) — Long-term debt, net $ 11,601 $ 14,808 Current portion of long-term debt $ 3,333 $ — Less current portion of debt issuance costs and discount (69 ) — Current portion of long-term debt, net $ 3,264 $ — SVB Loan Amendment On July 14, 2017 (the First Amendment Effective Date), the Company entered into the First Pursuant to the SVB Loan Amendment, the Bank extended an additional term loan to the Company on July 14, 2017 in the principal amount of $15.0 million (the 2017 Term Loan), a portion of which was applied to repay in full the Company’s existing outstanding debt with the Bank under the Restated LSA, which included outstanding principal, accrued interest, and final payment fees. Following such repayment in full of the Company’s existing outstanding debt with the Bank under the Restated LSA, cash proceeds to the Company from the remaining portion of the 2017 Term Loan were $7.5 million. The 2017 Term Loan matures on January 1, 2022 (the Term Loan Maturity Date) and bears interest at a floating per annum rate equal to the greater of (i) 3.50% above the Prime Rate (as defined in the SVB Loan Amendment) or (ii) 7.25%; provided, however, that in no event shall such interest rate exceed 8.25%. Interest is payable on a monthly basis on the first day of each month . From August 1, 2017 through January 1, 2019 (the Interest-only Period), the Company is required to make monthly payments of interest only. Thereafter, the Company is required to repay the principal, plus monthly payments of accrued interest, in 36 equal monthly installments based on a 36-month amortization schedule. Notwithstanding the foregoing, subject to the achievement of a product development milestone by the Company before the expiration of the above-described Interest-only Period, at the Company’s election (i) the Interest-only Period shall be extended from January 1, 2019 through and including to July 1, 2019 and (ii) the Company shall thereafter repay the principal, plus monthly payments of accrued interest, in 30 equal monthly installments based on a 30-month amortization schedule. The Company’s final payment, due on the Term Loan Maturity Date, shall include all outstanding principal and accrued and unpaid interest under the 2017 Term Loan, plus a 7.5%, or $1.1 million, final payment fee. This final payment fee is accrued as interest expense over the term of the 2017 Term Loan and recorded in accrued expenses. In connection with the SVB Loan Amendment, the Company issued to the Bank on the First Amendment Effective Date a fully exercisable warrant (the 2017 Warrant) to purchase up to an aggregate of 91,463 shares of the Company’s common stock, subject to adjustment, at an exercise price equal to $3.28 per share. The 2017 Warrant would have expired in July 2024. The aggregate fair value of the 2017 Warrant was determined to be $0.2 million using the Black-Scholes option pricing model and was recorded as a debt discount on the 2017 Term Loan. This debt discount is amortized to interest expense over the term of the 2017 Term Loan using the effective interest method. The Company determined the effective interest rate of the 2017 Term Loan to be 10.2% as of the First Amendment Effective Date. During September 2018, the 2017 Warrant was fully exercised in exchange for 67,952 shares of the Company’s common stock in a cashless transaction. The Company determined the repayment of the Restated LSA and issuance of the 2017 Term Loan was a debt extinguishment and accounted for the 2017 Term Loan at fair value as of the First Amendment Effective Date, accordingly. During the third quarter of 2017, the Company recorded a loss on debt extinguishment of $0.1 million, which was primarily related to the unaccrued amount of the final payment fee under the Restated LSA that was paid in connection with the 2017 Term Loan. The Company is required under its loan agreement with the Bank to maintain its deposit and securities accounts with the Bank and to comply with various operating covenants and default clauses. A breach of any of these covenants or clauses could result in a default under the agreement, which would cause all of the outstanding indebtedness under the facility to become immediately due and payable. The Company is in compliance with all such covenants and clauses. For the three and nine months ended September 30, 2018, the Company recorded $0.4 million and $1.3 million, respectively, in aggregate interest expense related to the 2017 Term Loan. For each of the three and nine months ended September 30, 2017, the Company recorded $0.4 million in aggregate interest expense related to the 2017 Term Loan. Restated LSA On July 30, 2014, the Company entered into the Restated LSA with the Bank, collateralized by substantially all of the Company’s assets, excluding certain intellectual property. Pursuant to the Restated LSA, the Bank agreed to make loans to the Company in an aggregate principal amount of up to $20.0 million, comprised of (i) a $10.0 million term loan, funded at the closing date (the Term A Loan) and (ii) subject to the achievement of a specified clinical milestone, additional term loans totaling up to $10.0 million in the aggregate, which were available until December 31, 2014 (each, a Term B Loan). On December 24, 2014, the Company elected to draw on the full $10.0 million under a Term B Loan. The Term A Loan and the Term B Loan were scheduled to mature on January 1, 2018 and June 1, 2018, respectively. The Company was required to make a final payment fee of 7.5%, equaling $0.8 million, of the funded amount for each of the Term A Loan and Term B Loan on the respective maturity dates. These final payment fees were accrued as interest expense over the terms of the loans and recorded in accrued expenses. In connection with the funding of the Term B Loan, the Company issued the Bank and one of its affiliates fully-exercisable warrants to purchase an aggregate of 98,039 shares of the Company’s common stock (the 2014 Warrants) at an exercise price of $4.08 per share. During March 2018, a portion of the 2014 Warrants were exercised in exchange for 34,149 shares of the Company’s common stock in a cashless transaction. As of September 30, 2018, warrants to purchase 49,020 shares of the Company’s common stock remain outstanding subject to the 2014 Warrants. The 2014 Warrants expire in December 2021. For the three and nine months ended September 30, 2017, the Company recorded $0.1 million and $0.5 million, respectively, in aggregate interest expense related to the Term A and Term B Loans. Warrants to purchase 36,074 shares of the Company’s common stock at a weighted average exercise price of $7.21 per share issued in connection with a prior debt agreement between the Company and the Bank in 2009 remain outstanding as of September 30, 2018, with such warrants to purchase 5,305 and 30,769 shares of the Company’s common stock having expiration dates in January 2019 and August 2021, respectively. Facility Leases The Company leases certain office and laboratory space under a non-cancelable operating lease. In May 2018, the Company amended the operating lease, extending the term of the lease through approximately 2028 and agreeing to lease additional space comprising approximately 24,000 square feet in the same building as its existing space for a total occupancy of approximately 72,000 square feet under the lease. With respect to the construction of the additional space, the Company received a $1.9 million tenant improvement allowance from its landlord and accounts for such costs as property and equipment with an offset to deferred rent as incurred. Costs under the tenant improvement allowance will be paid directly by the landlord. As of September 30, 2018, the balance of the tenant improvement allowance remaining is $0.9 million. The lease is subject to additional charges for common area maintenance and other costs. In connection with the lease, the Company has a cash-collateralized irrevocable standby letter of credit in the amount of $0.2 million. As of September 30, 2018, future minimum payments, assuming no early termination, under the operating lease are $40.5 million. The Company maintains the right to terminate the lease on the eighty-second (82 nd In January 2015, the Company entered into a sublease for additional laboratory space. The sublease was accounted for as an operating lease and expired in September 2017. No future payments remain under the sublease. |
Convertible Preferred Stock and
Convertible Preferred Stock and Stockholders' Equity | 9 Months Ended |
Sep. 30, 2018 | |
Convertible Preferred Stock And Stockholders Deficit Disclosure [Abstract] | |
Convertible Preferred Stock and Stockholders' Equity | 7. Convertible Preferred Stock and Stockholders’ Equity Convertible Preferred Stock In November 2016, the Company completed a private placement of stock in which investors, certain of which are affiliated with the directors and officers of the Company, purchased convertible preferred stock and common stock of the Company (the November 2016 Placement). The Company issued 2,819,549 shares of non-voting Class A Convertible Preferred Stock (the Class A Preferred) at $13.30 per share, each of which is convertible into five shares of common stock upon certain conditions defined in the Certificate of Designation of Preferences, Rights and Limitations of the Class A Preferred filed with the Delaware Secretary of State on November 22, 2016 (the CoD). The Class A Preferred were purchased exclusively by entities affiliated with Redmile Group, LLC (collectively, Redmile). The terms of the CoD prohibited Redmile from converting the Class A Preferred into shares of the Company’s common stock if, as a result of conversion, Redmile, together with its affiliates, would own more than 9.99% of the Company’s common stock then issued and outstanding (the Redmile Percentage Limitation), which percentage could change at Redmile’s election upon 61 days’ notice to the Company to (i) any other number less than or equal to 19.99% or (ii) subject to approval of the Company’s stockholders to the extent required in accordance with the NASDAQ Global Market rules, any number in excess of 19.99%. On May 2, 2017, the Company’s stockholders approved the issuance of up to an aggregate of 14,097,745 shares of common stock upon the conversion of the outstanding shares of Class A Preferred. As a result, Redmile has the right to increase the Redmile Percentage Limitation to any percentage in excess of 19.99% at its election. The Company also issued 7,236,837 shares of common stock at $2.66 per share as part of the November 2016 Placement. Gross proceeds from the November 2016 Placement were $56.7 million, and after giving effect to costs related to placement, net proceeds were $54.9 million. The Class A Preferred are non-voting shares and have a stated par value of $0.001 per share and are convertible into five shares of the Company’s common stock at a conversion price of $2.66 per share, which was the fair value of the Company’s common stock on the date of issuance. Holders of the Class A Preferred have the same dividend rights as holders of the Company’s common stock. Additionally, the liquidation preferences of the Class A Preferred are pari passu The Company evaluated the Class A Preferred for liability or equity classification under ASC 480, Distinguishing Liabilities from Equity, The Company also evaluated the Class A Preferred in accordance with the provisions of ASC 815, Derivatives and Hedging, The issuance of convertible preferred stock could generate a beneficial conversion feature (BCF), which arises when a debt or equity security is issued with an embedded conversion option that is beneficial to the investor (or in-the-money) at inception because the conversion option has an effective strike price that is less than the market price of the underlying stock on the commitment date. The Class A Preferred have an effective conversion price of $2.66 per common share, which was equal to the market price of the Company’s stock on the commitment date. Therefore, no BCF was present. The Company also entered into a registration rights agreement (the Registration Rights Agreement) with certain of the purchasers in the November 2016 Placement, excluding those purchasers affiliated with the Company’s directors and officers, requiring the Company to register for the resale of the relevant shares. The Company registered all of the relevant shares issued in the November 2016 Placement for resale on a Form S-3 filed with the SEC, as required under the Registration Rights Agreement, and the registration statement was declared effective in January 2017. Stock Options and Restricted Stock Units Stock option activity under all equity and stock option plans is summarized as follows: Number of Options Weighted- Average Price Balance at December 31, 2017 5,458,043 $ 3.52 Granted 2,964,260 7.55 Canceled (620,489 ) 4.58 Exercised (504,475 ) 3.80 Balance at September 30, 2018 7,297,339 $ 5.05 Restricted stock unit activity under all equity and stock option plans is summarized as follows: Number of Restricted Stock Units Weighted- Average Grant Date Fair Value per Share Balance at December 31, 2017 212,625 $ 4.89 Granted — — Canceled (24,000 ) $ 4.89 Vested — — Balance at September 30, 2018 188,625 $ 4.89 In October 2017, 225,125 shares of common stock underlying restricted stock units vested and were issued to certain employees. The allocation of stock-based compensation for all stock awards is as follows (in thousands): Three Months Ended September 30, Nine Months Ended September 30, 2018 2017 2018 2017 Research and development $ 939 $ 450 $ 2,598 $ 1,599 General and administrative 703 421 1,911 1,112 $ 1,642 $ 871 $ 4,509 $ 2,711 As of September 30, 2018, the outstanding options included 36,800 performance-based options for which the achievement of the performance-based vesting provisions was determined not to be probable. The aggregate grant date fair value of these unvested options at September 30, 2018 was $0.1 million. As of September 30, 2018, the unrecognized compensation cost related to outstanding options (excluding those with performance-based conditions determined not to be probable) was $15.4 million and is expected to be recognized as expense over a weighted average period of approximately 3.1 years. As of September 30, 2018, the unrecognized compensation cost related to restricted stock units was $0.5 million which is expected to be recognized as expense over approximately 1.0 years. The weighted-average assumptions used in the Black-Scholes option pricing model to determine the fair value of the employee stock option grants were as follows: Nine Months Ended September 30, 2018 2017 Risk-free interest rate 2.5 % 2.0 % Expected volatility 79.3 % 90.4 % Expected term (in years) 6.0 5.9 Expected dividend yield 0.0 % 0.0 % The weighted-average assumptions used in the Black-Scholes option pricing model to determine the fair value of the non-employee stock option grants were as follows: Nine Months Ended September 30, 2018 2017 Risk-free interest rate 2.8 % 2.0 % Expected volatility 80.1 % 90.8 % Remaining contractual term (in years) 8.0 8.6 Expected dividend yield 0.0 % 0.0 % Reconciliation of Stockholders’ Equity Accounts The following table summarizes the Company’s changes in Stockholders’ Equity accounts for the nine months ended September 30, 2018 (in thousands): Convertible Preferred Stock Common Stock Additional Paid-in Capital Accumulated Other Comprehensive Loss Accumulated Deficit Total Stockholders' Equity Balance at December 31, 2017 $ 3 $ 53 $ 295,934 $ (3 ) $ (218,798 ) $ 77,189 Exercise of stock options, net of issuance costs — — 606 — — 606 Issuance costs from public offering of common stock — — (37 ) — — (37 ) Stock-based compensation — — 1,382 — — 1,382 Unrealized loss on short-term investments — — — (10 ) — (10 ) Net loss — — — — (14,135 ) (14,135 ) Balance at March 31, 2018 $ 3 $ 53 $ 297,885 $ (13 ) $ (232,933 ) $ 64,995 Exercise of stock options, net of issuance costs — — 175 — — 175 Issuance costs for public offering of common stock — — (19 ) — — (19 ) Stock-based compensation — — 1,485 — — 1,485 Issuance of common stock for license agreement — — 4,845 — — 4,845 Unrealized loss on short-term investments — — — (2 ) — (2 ) Net loss — — — — (19,654 ) (19,654 ) Balance at June 30, 2018 $ 3 $ 53 $ 304,371 $ (15 ) $ (252,587 ) $ 51,825 Exercise of stock options, net of issuance costs — 1 1,132 — — 1,133 Public offering of common stock, net of offering costs — 11 134,844 — — 134,855 Stock-based compensation — — 1,642 — — 1,642 Issuance of common stock for license agreement — — 1,255 — — 1,255 Unrealized gain on short-term investments — — — 1 — 1 Net loss — — — — (16,782 ) (16,782 ) Balance at September 30, 2018 $ 3 $ 65 $ 443,244 $ (14 ) $ (269,369 ) $ 173,929 The following table summarizes the Company’s changes in Stockholders’ Equity accounts for the nine months ended September 30, 2017 (in thousands): Convertible Preferred Stock Common Stock Additional Paid-in Capital Accumulated Other Comprehensive Loss Accumulated Deficit Total Stockholders' Equity Balance at December 31, 2016 $ 3 $ 41 $ 248,957 $ (1 ) $ (175,846 ) $ 73,154 Exercise of stock options, net of issuance costs — — 35 — — 35 Stock-based compensation — — 867 — — 867 Private placement issuance of common stock, net of offering costs — — (13 ) — — (13 ) Private placement issuance of Class A convertible preferred stock, net of offering costs — — (26 ) — — (26 ) Unrealized loss on short-term investments — — — (33 ) — (33 ) Net loss — — — — (10,126 ) (10,126 ) Balance at March 31, 2017 $ 3 $ 41 $ 249,820 $ (34 ) $ (185,972 ) $ 63,858 Exercise of stock options, net of issuance costs — — 32 — — 32 Stock-based compensation — — 973 — — 973 Unrealized loss on short-term investments — — — (5 ) — (5 ) Net loss — — — — (9,645 ) (9,645 ) Balance at June 30, 2017 $ 3 $ 41 $ 250,825 $ (39 ) $ (195,617 ) $ 55,213 Exercise of stock options, net of issuance costs — — 119 — — 119 Issuance costs for public offering of common stock — — (13 ) — — (13 ) Stock-based compensation — — 871 — — 871 Issuance of warrants for common stock — — 217 — — 217 Unrealized gain on short-term investments — — — 26 — 26 Net loss — — — — (10,684 ) (10,684 ) Balance at September 30, 2017 $ 3 $ 41 $ 252,019 $ (13 ) $ (206,301 ) $ 45,749 |
Organization and Summary of S_2
Organization and Summary of Significant Accounting Policies (Policies) | 9 Months Ended |
Sep. 30, 2018 | |
Organization Consolidation And Presentation Of Financial Statements [Abstract] | |
Public Equity Offerings | Public Equity Offerings In September 2018, the Company completed a public offering of common stock in which investors, certain of which are affiliated with the directors of the Company, purchased 10,648,149 shares of its common stock at a price of $13.50 per share under a shelf registration statement. Gross proceeds from the offering were $143.8 million, and, after giving effect to $8.9 million of costs related to the offering (of which $8.7 million was paid during the nine months ended September 30, 2018), net proceeds were $134.9 million. In December 2017, the Company completed a public offering of common stock in which investors purchased 10,953,750 shares of its common stock at a price of $4.20 per share under a shelf registration statement. Gross proceeds from the offering were $46.0 million, and, after giving effect to $3.0 million of costs related to the offering (of which $0.3 million was paid during the nine months ended September 30, 2018), net proceeds were $43.0 million. |
Use of Estimates | Use of Estimates The Company’s consolidated financial statements are prepared in accordance with United States generally accepted accounting principles (GAAP). The preparation of the Company’s consolidated financial statements requires it to make estimates and assumptions that impact the reported amounts of assets, liabilities, revenues and expenses and the disclosure of contingent assets and liabilities in the Company’s consolidated financial statements and accompanying notes. The most significant estimates in the Company’s consolidated financial statements relate to accrued expenses. Although these estimates are based on the Company’s knowledge of current events and actions it may undertake in the future, actual results may ultimately materially differ from these estimates and assumptions. |
Principles of Consolidation | Principles of Consolidation The consolidated financial statements include the accounts of the Company and its subsidiaries, Fate Therapeutics Ltd., incorporated in the United Kingdom, and Tfinity Therapeutics, Inc., incorporated in the United States. To date, the aggregate operations of these subsidiaries have not been significant and all intercompany transactions and balances have been eliminated in consolidation. |
Cash, Cash Equivalents and Restricted Cash | Cash, Cash Equivalents and Restricted Cash Cash and cash equivalents include cash in readily available checking and savings accounts, money market accounts and money market funds. The Company considers all highly liquid investments with an original maturity of three months or less from the date of purchase to be cash equivalents. The following table provides a reconciliation of cash, cash equivalents, and restricted cash reported within the Condensed Consolidated Balance Sheet that sum to the total of the same such amount shown in the Condensed Consolidated Statements of Cash Flows as of September 30, 2018 (in thousands): September 30, 2018 Cash and cash equivalents $ 183,247 Restricted cash 227 Total cash, cash equivalents, and restricted cash shown in the statement of cash flows $ 183,474 Amounts included in restricted cash represent security deposits required to secure the Company’s credit card limit and its facilities lease. |
Short-Term Investments | Short-Term Investments Available-for-sale securities are carried at fair value, with the unrealized gains and losses reported in comprehensive income. The amortized cost of available-for-sale debt securities is adjusted for amortization of premiums and accretion of discounts to maturity. Such amortization and accretion is included in interest income. Realized gains and losses and declines in value judged to be other-than-temporary, if any, on available-for-sale securities are included in other income or expense. The cost of securities sold is based on the specific identification method. Interest and dividends on securities classified as available-for-sale are included in interest income. |
Unaudited Interim Financial Information | Unaudited Interim Financial Information The accompanying interim condensed consolidated financial statements are unaudited. These unaudited interim condensed consolidated financial statements have been prepared in accordance with GAAP and following the requirements of the SEC for interim reporting. As permitted under those rules, certain footnotes or other financial information that are normally required by GAAP can be condensed or omitted. In management’s opinion, the unaudited interim financial statements have been prepared on the same basis as the audited financial statements and include all adjustments, which include only normal recurring adjustments, necessary for the fair presentation of the Company’s financial position and its results of operations and comprehensive loss and its cash flows for the periods presented. These statements do not include all disclosures required by GAAP and should be read in conjunction with the Company’s financial statements and accompanying notes for the fiscal year ended December 31, 2017, contained in the Company’s Annual Report on Form 10-K for the year ended December 31, 2017 filed by the Company with the SEC on March 5, 2018. The results for the three and nine months ended September 30, 2018 are not necessarily indicative of the results expected for the full fiscal year or any other interim period or any future year or period. |
Revenue Recognition | Revenue Recognition The Company recognizes revenue in a manner that depicts the transfer of control of a product or a service to a customer and reflects the amount of the consideration the Company is entitled to receive in exchange for such product or service. In doing so, the Company follows a five-step approach: (i) identify the contract with a customer, (ii) identify the performance obligations in the contract, (iii) determine the transaction price, (iv) allocate the transaction price to the performance obligations, and (v) recognize revenue when (or as) the customer obtains control of the product or service. A customer is a party that has entered into a contract with the Company, where the purpose of the contract is to obtain a product or a service that is an output of the Company’s ordinary activities in exchange for consideration. To be considered a contract, (i) the contract must be approved (in writing, orally, or in accordance with other customary business practices), (ii) each party’s rights regarding the product product product A performance obligation is defined as a promise to transfer a product The transaction price is the amount of consideration the Company is entitled to receive in exchange for the transfer of control of a product or a service to If a contract has multiple performance obligations, the Company allocates the transaction price to each distinct performance obligation in an amount that reflects the consideration the Company is entitled to receive in exchange for satisfying each distinct performance obligation. For each distinct performance obligation, revenue is recognized when (or as) the Company transfers control of the product or the service applicable to such performance obligation. In those instances where the Company first receives consideration in advance of satisfying its performance obligation, the Company classifies such consideration as deferred revenue until (or as) the Company satisfies such performance obligation. In those instances where the Company first satisfies its performance obligation prior to its receipt of consideration, the consideration is recorded as accounts receivable. The Company expenses incremental costs of obtaining a contract as and when incurred if the expected amortization period of the asset that would be recognized is one year or less, or if the amount of the asset is immaterial. |
Stock-Based Compensation | Stock-Based Compensation Stock-based compensation expense represents the cost of the grant date fair value of employee stock option and restricted stock unit grants recognized over the requisite service period of the awards (usually the vesting period) on a straight-line basis, net of estimated forfeitures. For stock option grants for which vesting is subject to performance-based milestones, the expense is recorded over the remaining service period after the point when the achievement of the milestone is probable or the performance condition has been achieved. For stock option grants for which vesting is subject to both performance-based milestones and market conditions, expense is recorded over the derived service period after the point when the achievement of the performance-based milestone is probable or the performance condition has been achieved. The Company estimates the fair value of stock option grants using the Black-Scholes option pricing model, with the exception of option grants for which vesting is subject to both performance-based milestones and market conditions, which are valued using a lattice-based model. The fair value of restricted stock units is based on the closing price of the Company’s common stock as reported on The NASDAQ Global Market on the date of grant. The Company accounts for stock options and restricted stock awards to non-employees using the fair value approach. Stock options and restricted stock awards to non-employees are subject to periodic revaluation over their vesting terms. For stock option grants for which vesting is subject to performance-based milestones, the expense is recorded over the remaining service period after the point when the performance condition is determined to be probable of achievement or when it has been achieved. |
Convertible Preferred Stock | Convertible Preferred Stock The Company applies the relevant accounting standards to distinguish liabilities from equity when assessing the classification and measurement of preferred stock. Preferred shares subject to mandatory redemptions are considered liabilities and measured at fair value. Conditionally redeemable preferred shares are considered temporary equity. All other preferred shares are considered as stockholders’ equity. The Company applies the relevant accounting standards for derivatives and hedging (in addition to distinguishing liabilities from equity) when accounting for hybrid contracts that contain conversion options. Conversion options must be bifurcated from the host instruments and accounted for as free standing financial instruments according to certain criteria. These criteria include circumstances when (i) the economic characteristics and risks of the embedded derivative instruments are not clearly and closely related to the economic characteristics and risks of the host contract, (ii) the hybrid instrument that embodies both the embedded derivative instrument and the host contract is not re-measured at fair value under otherwise applicable accounting principles with changes in fair value reported in earnings as they occurred, and (iii) a separate instrument with the same terms as the embedded derivative instrument would be considered a derivative instrument. The derivative is subsequently measured at fair value at each reporting date, with the changes in fair value reported in earnings. |
Comprehensive Loss | Comprehensive Loss Comprehensive loss is defined as a change in equity during a period from transactions and other events and circumstances from non‑owner sources. Other comprehensive income includes unrealized gains and losses on available-for-sale securities, which was the only difference between net loss and comprehensive loss for the applicable periods. |
Net Loss per Common Share | Net Loss per Common Share Basic net loss per common share is calculated by dividing the net loss by the weighted-average number of shares of common stock outstanding for the period, without consideration for common stock equivalents. Dilutive common stock equivalents for the periods presented include convertible preferred stock, warrants for the purchase of common stock, and common stock options and restricted stock units outstanding under the Company’s stock option and incentive plan. For all periods presented, there is no difference in the number of shares used to calculate basic and diluted shares outstanding due to the Company’s net loss position. For the three and nine months ended September 30, 2018, the Company realized a net loss of $16.8 million and $50.6 million, respectively. Shares of potentially dilutive securities totaled 21.7 million for the three and nine months ended September 30, 2018, including 14.1 million shares associated with a hypothetical conversion of all outstanding shares of the Company’s Class A convertible preferred stock, and an aggregate of 7.5 million shares of common stock issuable upon the exercise of outstanding stock options and the settlement of outstanding restricted stock units. For the three and nine months ended September 30, 2017, the Company realized a net loss of $10.7 million and $30.5 million, respectively. Shares of potentially dilutive securities totaled 20.5 million for the three and nine months ended September 30, 2017, including 14.1 million shares associated with a hypothetical conversion of all outstanding shares of the Company’s Class A convertible preferred stock, and an aggregate of 6.2 million shares of common stock issuable upon the exercise of outstanding stock options and the settlement of outstanding restricted stock units. |
Going Concern Assessment | Going Concern Assessment The Company has assessed its ability to continue as a going concern for a period of one year from the date of the issuance of these financial statements. Substantial doubt about an entity’s ability to continue as a going concern exists when relevant conditions and events, considered in the aggregate, indicate that it is probable that the entity will be unable to meet its obligations as they become due within one year from the financial statement issuance date. The Company determined that there are no conditions or events that raise substantial doubt about its ability to continue as a going concern as of the date of the issuance of these financial statements. |
Recent Accounting Pronouncements | Recent Accounting Pronouncements In August 2018, the Financial Accounting Standards Board (FASB) issued Accounting Standards Update (ASU) No. 2018-13 (ASU 2018-13). ASU 2018-13, Fair Value Measurement (Topic 820): Disclosure Framework—Changes to the Disclosure Requirements for Fair Value Measurement , amends the disclosure requirements in 820 by adding, changing, or removing certain disclosures. ASU 2018-13 is effective for fiscal years beginning after December 15, 2019. The Company believes that the adoption of this guidance will not have a material impact on the Company’s Consolidated Financial Statements. In June 2018, the FASB issued ASU 2018-07. ASU 2018-07 expands the scope of ASC 718, Compensation- Stock Compensation, The Company believes that the adoption of this guidance will not have a material impact on the Company’s Consolidated Financial Statements. In March 2018, the FASB issued ASU 2018-05. ASU 2018-05 amends income tax related SEC paragraphs presented pursuant to SEC Staff Accounting Bulletin No. 118 (SAB 118). The SEC issued SAB 118 during December 2017 to address the application of U.S. GAAP in situations when a registrant does not have the necessary information available, prepared or analyzed (including computations) in reasonable detail to complete the accounting for certain income tax effects of the Tax Cuts and Jobs Act of 2017 (the Tax Cuts and Jobs Act), which was enacted in December 2017. Amounts recorded by the Company pursuant to ASU 2018-05 in connection with certain deferred tax assets and liabilities are based on reasonable estimates, and additional work is required to complete the accounting. Any subsequent adjustment to these estimated amounts will be recorded to current tax expense in the period when the accounting is complete. In November 2016, the FASB issued ASU 2016-18, which requires that a statement of cash flows explain the change during the period in the total of cash, cash equivalents, and amounts generally described as restricted cash or restricted cash equivalents. ASU 2016-18 is effective for fiscal years beginning after December 15, 2017. The Company adopted the update retrospectively to each period presented. The adoption of this guidance did not have a material impact on the Company’s Consolidated Financial Statements. In August 2016, the FASB issued ASU 2016-15, which clarifies how entities should classify certain cash receipts and cash payments on the statement of cash flows and how the predominance principle should be applied when cash receipts and cash payments have aspects of more than one class of cash flows. The Company adopted ASU 2016-15 on January 1, 2018. The Company adopted the update retrospectively to each period presented and adjusted the Condensed Consolidated Statements of Cash Flows for the nine months ended September 30, 2017 to reclassify cash payments included in the loss on extinguishment of debt from an operating activity to a financing activity. In February 2016, the FASB issued ASU 2016-02, Leases In May 2014, the FASB issued ASU 2014-09 (Topic 606), which created a single, principle-based revenue recognition model that will supersede and replace nearly all existing U.S. GAAP revenue recognition guidance. Entities will recognize revenue in a manner that depicts the transfer of goods or services to customers and reflects the amount of the consideration which the entity expects to be entitled to receive in exchange for those goods or services. The model provides that entities follow five steps: (i) identify the contract with a customer, (ii) identify the performance obligations in the contract, (iii) determine the transaction price, (iv) allocate the transaction price to the performance obligations, and (v) recognize revenue when (or as) the customer obtains control of the product or service. For public business entities, ASU 2014-09 is effective beginning in the first quarter of 2018 using one of two prescribed transition methods: retrospectively to each prior reporting period presented (full retrospective method), or retrospectively with the cumulative effect of initially applying the guidance recognized at the date of initial application (the cumulative catch-up transition method). The Company adopted ASU 2014-09 in the first quarter of 2018 using the full retrospective method. The Company has evaluated the effect that the updated standard had on its internal processes, financial statements and related disclosures, and has determined that the adoption did not have a material impact on the Company’s historical Consolidated Financial Statements. |
Organization and Summary of S_3
Organization and Summary of Significant Accounting Policies (Tables) | 9 Months Ended |
Sep. 30, 2018 | |
Organization Consolidation And Presentation Of Financial Statements [Abstract] | |
Reconciliation of Cash, Cash Equivalents, and Restricted Cash | The following table provides a reconciliation of cash, cash equivalents, and restricted cash reported within the Condensed Consolidated Balance Sheet that sum to the total of the same such amount shown in the Condensed Consolidated Statements of Cash Flows as of September 30, 2018 (in thousands): September 30, 2018 Cash and cash equivalents $ 183,247 Restricted cash 227 Total cash, cash equivalents, and restricted cash shown in the statement of cash flows $ 183,474 |
Short-term Investments (Tables)
Short-term Investments (Tables) | 9 Months Ended |
Sep. 30, 2018 | |
Short Term Investments [Abstract] | |
Summary of Short-term Investments | The following table summarizes the Company’s short-term investments accounted for as available-for-sale securities as of September 30, 2018, and December 31, 2017 (in thousands): Maturity (in years) Amortized Cost Unrealized Losses Unrealized Gains Estimated Fair Value September 30, 2018 U.S. Treasury debt securities 1 or less 27,959 (14 ) — 27,945 Total $ 27,959 $ (14 ) $ — $ 27,945 December 31, 2017 U.S. Treasury debt securities 1 or less 12,000 (3 ) — 11,997 Total $ 12,000 $ (3 ) $ — $ 11,997 |
Fair Value Measurements (Tables
Fair Value Measurements (Tables) | 9 Months Ended |
Sep. 30, 2018 | |
Fair Value Disclosures [Abstract] | |
Schedule of Assets Measured at Fair Value on Recurring Basis | The following table presents the Company’s assets which were measured at fair value on a recurring basis as of September 30, 2018 and December 31, 2017 (in thousands): Fair Value Measurements at Reporting Date Using Total Quoted Prices in Active Markets for Identical Assets (Level 1) Significant Other Observable Inputs (Level 2) Significant Unobservable Inputs (Level 3) As of September 30, 2018: Cash equivalents $ 183,247 $ 183,247 $ — $ — U.S. Treasury debt securities 27,945 27,945 — — Total assets $ 211,192 $ 211,192 $ — $ — As of December 31, 2017: Cash equivalents $ 88,952 $ 88,952 $ — $ — U.S. Treasury debt securities 11,997 11,997 — — Total assets $ 100,949 $ 100,949 $ — $ — |
Accrued Expenses, Long-Term D_2
Accrued Expenses, Long-Term Debt, Commitments and Contingencies (Tables) | 9 Months Ended |
Sep. 30, 2018 | |
Accrued Expenses Long Term Debt Commitments And Contingencies Disclosure [Abstract] | |
Schedule of accrued expenses | Current accrued expenses consist of the following (in thousands): September 30, 2018 December 31, 2017 Accrued payroll and other employee benefits $ 2,220 $ 1,761 Accrued clinical trial related costs 4,785 3,323 Accrued other 2,633 2,170 Current accrued expenses $ 9,638 $ 7,254 |
Schedule of long-term debt and unamortized discount balances | Long-term debt and unamortized discount balances are as follows (in thousands): September 30, 2018 December 31, 2017 Long-term debt $ 15,000 $ 15,000 Less debt issuance costs and discount, net of current portion (66 ) (192 ) Long-term debt, net of long-term portion of debt issuance costs and discount 14,934 14,808 Less current portion of long-term debt (3,333 ) — Long-term debt, net $ 11,601 $ 14,808 Current portion of long-term debt $ 3,333 $ — Less current portion of debt issuance costs and discount (69 ) — Current portion of long-term debt, net $ 3,264 $ — |
Convertible Preferred Stock a_2
Convertible Preferred Stock and Stockholders' Equity (Tables) | 9 Months Ended |
Sep. 30, 2018 | |
Stockholders' Equity | |
Summary of stock option activity under the Plan | Stock option activity under all equity and stock option plans is summarized as follows: Number of Options Weighted- Average Price Balance at December 31, 2017 5,458,043 $ 3.52 Granted 2,964,260 7.55 Canceled (620,489 ) 4.58 Exercised (504,475 ) 3.80 Balance at September 30, 2018 7,297,339 $ 5.05 |
Summary of restricted stock unit activity under the Plan | Restricted stock unit activity under all equity and stock option plans is summarized as follows: Number of Restricted Stock Units Weighted- Average Grant Date Fair Value per Share Balance at December 31, 2017 212,625 $ 4.89 Granted — — Canceled (24,000 ) $ 4.89 Vested — — Balance at September 30, 2018 188,625 $ 4.89 |
Schedule of allocation of stock-based compensation for all stock awards | The allocation of stock-based compensation for all stock awards is as follows (in thousands): Three Months Ended September 30, Nine Months Ended September 30, 2018 2017 2018 2017 Research and development $ 939 $ 450 $ 2,598 $ 1,599 General and administrative 703 421 1,911 1,112 $ 1,642 $ 871 $ 4,509 $ 2,711 |
Summary of changes in Stockholders' equity | The following table summarizes the Company’s changes in Stockholders’ Equity accounts for the nine months ended September 30, 2018 (in thousands): Convertible Preferred Stock Common Stock Additional Paid-in Capital Accumulated Other Comprehensive Loss Accumulated Deficit Total Stockholders' Equity Balance at December 31, 2017 $ 3 $ 53 $ 295,934 $ (3 ) $ (218,798 ) $ 77,189 Exercise of stock options, net of issuance costs — — 606 — — 606 Issuance costs from public offering of common stock — — (37 ) — — (37 ) Stock-based compensation — — 1,382 — — 1,382 Unrealized loss on short-term investments — — — (10 ) — (10 ) Net loss — — — — (14,135 ) (14,135 ) Balance at March 31, 2018 $ 3 $ 53 $ 297,885 $ (13 ) $ (232,933 ) $ 64,995 Exercise of stock options, net of issuance costs — — 175 — — 175 Issuance costs for public offering of common stock — — (19 ) — — (19 ) Stock-based compensation — — 1,485 — — 1,485 Issuance of common stock for license agreement — — 4,845 — — 4,845 Unrealized loss on short-term investments — — — (2 ) — (2 ) Net loss — — — — (19,654 ) (19,654 ) Balance at June 30, 2018 $ 3 $ 53 $ 304,371 $ (15 ) $ (252,587 ) $ 51,825 Exercise of stock options, net of issuance costs — 1 1,132 — — 1,133 Public offering of common stock, net of offering costs — 11 134,844 — — 134,855 Stock-based compensation — — 1,642 — — 1,642 Issuance of common stock for license agreement — — 1,255 — — 1,255 Unrealized gain on short-term investments — — — 1 — 1 Net loss — — — — (16,782 ) (16,782 ) Balance at September 30, 2018 $ 3 $ 65 $ 443,244 $ (14 ) $ (269,369 ) $ 173,929 The following table summarizes the Company’s changes in Stockholders’ Equity accounts for the nine months ended September 30, 2017 (in thousands): Convertible Preferred Stock Common Stock Additional Paid-in Capital Accumulated Other Comprehensive Loss Accumulated Deficit Total Stockholders' Equity Balance at December 31, 2016 $ 3 $ 41 $ 248,957 $ (1 ) $ (175,846 ) $ 73,154 Exercise of stock options, net of issuance costs — — 35 — — 35 Stock-based compensation — — 867 — — 867 Private placement issuance of common stock, net of offering costs — — (13 ) — — (13 ) Private placement issuance of Class A convertible preferred stock, net of offering costs — — (26 ) — — (26 ) Unrealized loss on short-term investments — — — (33 ) — (33 ) Net loss — — — — (10,126 ) (10,126 ) Balance at March 31, 2017 $ 3 $ 41 $ 249,820 $ (34 ) $ (185,972 ) $ 63,858 Exercise of stock options, net of issuance costs — — 32 — — 32 Stock-based compensation — — 973 — — 973 Unrealized loss on short-term investments — — — (5 ) — (5 ) Net loss — — — — (9,645 ) (9,645 ) Balance at June 30, 2017 $ 3 $ 41 $ 250,825 $ (39 ) $ (195,617 ) $ 55,213 Exercise of stock options, net of issuance costs — — 119 — — 119 Issuance costs for public offering of common stock — — (13 ) — — (13 ) Stock-based compensation — — 871 — — 871 Issuance of warrants for common stock — — 217 — — 217 Unrealized gain on short-term investments — — — 26 — 26 Net loss — — — — (10,684 ) (10,684 ) Balance at September 30, 2017 $ 3 $ 41 $ 252,019 $ (13 ) $ (206,301 ) $ 45,749 |
Employee Stock Option | |
Stockholders' Equity | |
Schedule of weighted-average assumptions used to determine the fair value of stock option grants | The weighted-average assumptions used in the Black-Scholes option pricing model to determine the fair value of the employee stock option grants were as follows: Nine Months Ended September 30, 2018 2017 Risk-free interest rate 2.5 % 2.0 % Expected volatility 79.3 % 90.4 % Expected term (in years) 6.0 5.9 Expected dividend yield 0.0 % 0.0 % |
Non Employee Stock Option | |
Stockholders' Equity | |
Schedule of weighted-average assumptions used to determine the fair value of stock option grants | The weighted-average assumptions used in the Black-Scholes option pricing model to determine the fair value of the non-employee stock option grants were as follows: Nine Months Ended September 30, 2018 2017 Risk-free interest rate 2.8 % 2.0 % Expected volatility 80.1 % 90.8 % Remaining contractual term (in years) 8.0 8.6 Expected dividend yield 0.0 % 0.0 % |
Organization and Summary of S_4
Organization and Summary of Significant Accounting Policies (Details) - USD ($) $ / shares in Units, $ in Thousands | 1 Months Ended | 9 Months Ended | ||
Sep. 30, 2018 | Dec. 31, 2017 | Sep. 30, 2018 | Sep. 30, 2017 | |
Equity transactions | ||||
Net proceeds from issuance of shares after related cash costs | $ 1,914 | $ 172 | ||
September 2018 Public Equity Offering | Investors Affiliated with Directors | ||||
Equity transactions | ||||
Shares sold | 10,648,149 | |||
Share issue price (in dollars per share) | $ 13.50 | $ 13.50 | ||
Gross proceeds from issuance of shares | $ 143,800 | |||
Net proceeds from issuance of shares after related cash costs | 134,900 | |||
Costs related to equity offering | 8,900 | |||
Costs related to equity offering paid | 8,700 | $ 8,700 | ||
December 2017 Public Equity Offering | ||||
Equity transactions | ||||
Shares sold | 10,953,750 | |||
Share issue price (in dollars per share) | $ 4.20 | |||
Gross proceeds from issuance of shares | $ 46,000 | |||
Net proceeds from issuance of shares after related cash costs | 43,000 | |||
Costs related to equity offering | $ 3,000 | |||
Costs related to equity offering paid | $ 300 | $ 300 |
Organization and Summary of S_5
Organization and Summary of Significant Accounting Policies (Details 2) - USD ($) $ in Thousands | Sep. 30, 2018 | Dec. 31, 2017 | Sep. 30, 2017 | Dec. 31, 2016 |
Organization Consolidation And Presentation Of Financial Statements [Abstract] | ||||
Cash and cash equivalents | $ 183,247 | $ 88,952 | ||
Restricted cash | 227 | |||
Total cash, cash equivalents, and restricted cash shown in the statement of cash flows | $ 183,474 | $ 89,074 | $ 43,353 | $ 88,731 |
Organization and Summary of S_6
Organization and Summary of Significant Accounting Policies (Details 3) - USD ($) $ in Thousands, shares in Millions | 3 Months Ended | 9 Months Ended | ||||||
Sep. 30, 2018 | Jun. 30, 2018 | Mar. 31, 2018 | Sep. 30, 2017 | Jun. 30, 2017 | Mar. 31, 2017 | Sep. 30, 2018 | Sep. 30, 2017 | |
Revenue Recognition [Abstract] | ||||||||
Net loss | $ (16,782) | $ (19,654) | $ (14,135) | $ (10,684) | $ (9,645) | $ (10,126) | $ (50,571) | $ (30,455) |
Potentially dilutive securities (in shares) | 21.7 | 20.5 | 21.7 | 20.5 | ||||
Common stock issuable upon the exercise of outstanding options | 7.5 | 6.2 | 7.5 | 6.2 | ||||
Class A Convertible Preferred Stock | ||||||||
Revenue Recognition [Abstract] | ||||||||
Shares associated with a hypothetical conversion of convertible preferred stock | 14.1 | 14.1 | 14.1 | 14.1 |
Collaboration and License Agr_2
Collaboration and License Agreements (Details) - USD ($) | Sep. 14, 2018 | Sep. 11, 2018 | May 15, 2018 | May 04, 2015 | Oct. 31, 2018 | Sep. 30, 2018 | Jun. 30, 2018 | Sep. 30, 2017 | Sep. 30, 2018 | Sep. 30, 2017 | Dec. 31, 2017 |
Collaboration agreement | |||||||||||
Research and development | $ 13,637,000 | $ 8,578,000 | $ 41,929,000 | $ 24,471,000 | |||||||
Revenue recognized | 1,026,000 | 1,026,000 | 3,079,000 | 3,079,000 | |||||||
Aggregate deferred revenue, current | $ 3,250,000 | $ 3,250,000 | $ 2,105,000 | ||||||||
Common stock issued | 64,503,326 | 64,503,326 | 52,648,601 | ||||||||
Value of shares issued | $ 1,255,000 | $ 4,845,000 | |||||||||
Ono Pharmaceutical Co. Ltd | |||||||||||
Collaboration agreement | |||||||||||
Aggregate research and development fees payments receivable | $ 20,000,000 | ||||||||||
Collaborative arrangement potential additional milestones | $ 40,000,000 | ||||||||||
Non-refundable upfront payments recorded as deferred revenue | $ 10,000,000 | ||||||||||
Recognition period of deferred revenue | 4 years | ||||||||||
Ono Pharmaceutical Co. Ltd | Candidate 2 | |||||||||||
Collaboration agreement | |||||||||||
Percentage of reduction on milestone payments | 50.00% | ||||||||||
Ono Pharmaceutical Co. Ltd | Subsequent Event | |||||||||||
Collaboration agreement | |||||||||||
Payments for research and development fees | $ 5,000,000 | ||||||||||
Collaborative arrangement annual payments receivable recorded as deferred revenue | $ 5,000,000 | ||||||||||
Ono Pharmaceutical Co. Ltd | Maximum | Candidate 1 | |||||||||||
Collaboration agreement | |||||||||||
Aggregate milestone payments | $ 285,000,000 | ||||||||||
Ono Pharmaceutical Co. Ltd | Maximum | Candidate 2 | |||||||||||
Collaboration agreement | |||||||||||
Aggregate milestone payments | 895,000,000 | ||||||||||
Ono Pharmaceutical Co. Ltd | Collaborative Arrangement | |||||||||||
Collaboration agreement | |||||||||||
Non-refundable, non-creditable upfront payment receivable | $ 10,000,000 | ||||||||||
Transaction price of the agreement | $ 30,000,000 | ||||||||||
Research and development | 20,000,000 | ||||||||||
Sub license consideration payable | 2,000,000 | 2,000,000 | |||||||||
Asset corresponding to sub license consideration | 2,000,000 | 2,000,000 | |||||||||
Revenue recognized | 0 | 0 | |||||||||
Aggregate deferred revenue | 10,000,000 | 10,000,000 | |||||||||
Aggregate deferred revenue, current | 2,000,000 | 2,000,000 | |||||||||
Ono Pharmaceutical Co. Ltd | Collaborative Arrangement | Minimum | |||||||||||
Collaboration agreement | |||||||||||
Profits and losses sharing percentage | 50.00% | ||||||||||
Juno Therapeutics, Inc | |||||||||||
Collaboration agreement | |||||||||||
Non-refundable upfront payments recorded as deferred revenue | $ 5,000,000 | ||||||||||
Recognition period of deferred revenue | 4 years | ||||||||||
Common stock issued | 1,000,000 | ||||||||||
Issuance of common stock | $ 4,600,000 | ||||||||||
Research term | 4 years | ||||||||||
Minimum annual research payments receivable | $ 2,000,000 | ||||||||||
Extended term of research | 2 years | ||||||||||
Extension fee | $ 3,000,000 | ||||||||||
Minimum annual payments receivable for extended term of research | $ 4,000,000 | ||||||||||
Common stock premium percentage on trading price upon exercise of extension | 120.00% | ||||||||||
Trailing trading period considered for premium | 30 days | ||||||||||
Aggregate equity premium on shares issued recorded as deferred revenue | $ 3,400,000 | ||||||||||
Term of royalties payable after first commercial sale | 10 years | ||||||||||
Juno Therapeutics, Inc | Maximum | |||||||||||
Collaboration agreement | |||||||||||
Aggregate milestone payments | $ 51,000,000 | ||||||||||
Common stock issued upon exercise of extension | 10,000,000 | ||||||||||
Juno Therapeutics, Inc | Maximum | Third Juno Product | |||||||||||
Collaboration agreement | |||||||||||
Additional aggregate milestone payments | 116,000,000 | ||||||||||
Juno Therapeutics, Inc | Maximum | Fifth Juno Product | |||||||||||
Collaboration agreement | |||||||||||
Additional aggregate milestone payments | 137,500,000 | ||||||||||
Juno Therapeutics, Inc | Collaborative Arrangement | |||||||||||
Collaboration agreement | |||||||||||
Transaction price of the agreement | 16,400,000 | ||||||||||
Revenue recognized | 1,000,000 | $ 1,000,000 | 3,100,000 | $ 3,100,000 | |||||||
Aggregate deferred revenue, current | 1,300,000 | 1,300,000 | |||||||||
Proceeds from non refundable upfront fee | $ 5,000,000 | ||||||||||
Share Price | $ 8 | ||||||||||
Equity premium on share price (in dollars per share) | $ 3.40 | ||||||||||
Aggregate equity premium on shares issued under agreement | $ 3,400,000 | ||||||||||
Estimated research payments received under agreement | $ 8,000,000 | ||||||||||
Combined performance obligation occurrence period | 4 years | ||||||||||
Revenue recognize from previous deferred revenue | 500,000 | ||||||||||
MSK | Amended MSK License | |||||||||||
Collaboration agreement | |||||||||||
Research and development | 5,300,000 | $ 5,300,000 | |||||||||
Common stock issued | 500,000 | ||||||||||
Obligation to register resale of shares | within 18 months of the effective date of the agreement | ||||||||||
Upfront cash payment | $ 500,000 | 500,000 | $ 500,000 | ||||||||
Value of shares issued | 4,800,000 | 4,800,000 | |||||||||
Gladstone | Gladstone License Agreement | |||||||||||
Collaboration agreement | |||||||||||
Research and development | 1,400,000 | 1,400,000 | |||||||||
Common stock issued | 100,000 | ||||||||||
Upfront cash payment | $ 100,000 | 100,000 | 100,000 | ||||||||
Value of shares issued | $ 1,300,000 | $ 1,300,000 |
California Institute For Rege_2
California Institute For Regenerative Medicine Award (Details) $ in Millions | Apr. 05, 2018USD ($)Disbursement | Jun. 30, 2019 | Sep. 30, 2018USD ($) | Apr. 30, 2018USD ($) | Sep. 30, 2018 |
Award from regenerative medicine institute | |||||
Period to treat award as grant, if award not treated as loan | 10 years | ||||
California Institute for Regenerative Medicine | |||||
Award from regenerative medicine institute | |||||
Receipt of first disbursement under the Award | $ | $ 1 | ||||
Receipt of additional disbursement under the Award | $ | $ 1.1 | ||||
California Institute for Regenerative Medicine | LIBOR | Scenario, Forecast | |||||
Award from regenerative medicine institute | |||||
Award considered as a loan, interest rate | 7.00% | ||||
California Institute for Regenerative Medicine | Loan Repayment Period One | Scenario, Forecast | |||||
Award from regenerative medicine institute | |||||
Repayment percentage of award amount | 60.00% | ||||
California Institute for Regenerative Medicine | Loan Repayment Period Two | Scenario, Forecast | |||||
Award from regenerative medicine institute | |||||
Repayment percentage of award amount | 80.00% | ||||
California Institute for Regenerative Medicine | Loan Repayment Period Three | Scenario, Forecast | |||||
Award from regenerative medicine institute | |||||
Repayment percentage of award amount | 100.00% | ||||
California Institute for Regenerative Medicine | Loan Repayment Period Four | Scenario, Forecast | |||||
Award from regenerative medicine institute | |||||
Repayment percentage of award amount | 100.00% | ||||
California Institute for Regenerative Medicine | FT516 | |||||
Award from regenerative medicine institute | |||||
Award agreement executed date | Apr. 5, 2018 | ||||
Award for first-in-human clinical trial | $ | $ 4 | ||||
Number of disbursements | Disbursement | 5 | ||||
Number of disbursement receivable upon the execution of the award | Disbursement | 1 | ||||
Number of disbursements receivable based on completion of certain operating milestones | Disbursement | 4 | ||||
Estimated project start date | Apr. 1, 2018 | ||||
Estimated project end date | Jun. 30, 2019 |
Short-term Investments (Details
Short-term Investments (Details) - USD ($) | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2018 | Sep. 30, 2017 | Sep. 30, 2018 | Sep. 30, 2017 | |
Schedule Of Available For Sale Securities [Line Items] | ||||
Available-for-sale securities, impairment | $ 0 | $ 0 | $ 0 | $ 0 |
Available-for-sale securities, gains (losses) on sales | $ 0 | $ 0 | $ 0 | $ 0 |
U.S. Treasury debt securities | ||||
Schedule Of Available For Sale Securities [Line Items] | ||||
Short term investments, maturity start range | 3 months | |||
Short term investments, maturity end range | 12 months |
Short-term Investments (Detai_2
Short-term Investments (Details 2) - USD ($) $ in Thousands | 9 Months Ended | 12 Months Ended |
Sep. 30, 2018 | Dec. 31, 2017 | |
Schedule Of Available For Sale Securities [Line Items] | ||
Amortized Cost | $ 27,959 | $ 12,000 |
Unrealized Losses | (14) | (3) |
Estimated Fair Value | $ 27,945 | $ 11,997 |
U.S. Treasury debt securities | ||
Schedule Of Available For Sale Securities [Line Items] | ||
Maturity (in years) | 1 or less | 1 or less |
Amortized Cost | $ 27,959 | $ 12,000 |
Unrealized Losses | (14) | (3) |
Estimated Fair Value | $ 27,945 | $ 11,997 |
Fair Value Measurements (Detail
Fair Value Measurements (Details) - USD ($) $ in Thousands | Sep. 30, 2018 | Dec. 31, 2017 |
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
U.S. Treasury debt securities | $ 27,945 | $ 11,997 |
Fair Value Measurements Recurring | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Cash equivalents | 183,247 | 88,952 |
Total assets | 211,192 | 100,949 |
Fair Value Measurements Recurring | U.S. Treasury debt securities | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
U.S. Treasury debt securities | 27,945 | 11,997 |
Fair Value Measurements Recurring | Quoted prices in Active Market for Identical Assets (Level 1) | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Cash equivalents | 183,247 | 88,952 |
Total assets | 211,192 | 100,949 |
Fair Value Measurements Recurring | Quoted prices in Active Market for Identical Assets (Level 1) | U.S. Treasury debt securities | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
U.S. Treasury debt securities | $ 27,945 | $ 11,997 |
Fair Value Measurements (Deta_2
Fair Value Measurements (Details 2) - USD ($) | Sep. 30, 2018 | Dec. 31, 2017 |
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Transfer of assets from level 1 to level 2 | $ 0 | |
Transfer of assets from level 2 to level 1 | 0 | |
Transfer of liabilities from level 1 to level 2 | 0 | |
Transfer of liabilities from level 2 to level 1 | 0 | |
Fair Value Measurements Nonrecurring | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Non-financial assets | 0 | |
Non-financial liabilities | 0 | |
Fair Value Measurements Recurring | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Non-financial assets | 211,192,000 | $ 100,949,000 |
Liabilities measured at fair value | $ 0 | $ 0 |
Accrued Expenses, Long-Term D_3
Accrued Expenses, Long-Term Debt, Commitments and Contingencies (Details) - USD ($) $ in Thousands | Sep. 30, 2018 | Dec. 31, 2017 |
Current accrued expenses | ||
Accrued payroll and other employee benefits | $ 2,220 | $ 1,761 |
Accrued clinical trial related costs | 4,785 | 3,323 |
Accrued other | 2,633 | 2,170 |
Current accrued expenses | $ 9,638 | $ 7,254 |
Accrued Expenses, Long-Term D_4
Accrued Expenses, Long-Term Debt, Commitments and Contingencies (Details 2) - USD ($) $ in Thousands | Sep. 30, 2018 | Dec. 31, 2017 |
Debt Disclosure [Abstract] | ||
Long-term debt | $ 15,000 | $ 15,000 |
Less debt issuance costs and discount, net of current portion | (66) | (192) |
Long-term debt, net of long-term portion of debt issuance costs and discount | 14,934 | 14,808 |
Less current portion of long-term debt | (3,333) | |
Long-term debt, net | 11,601 | $ 14,808 |
Current portion of long-term debt | 3,333 | |
Less current portion of debt issuance costs and discount | (69) | |
Current portion of long-term debt, net | $ 3,264 |
Accrued Expenses, Long-Term D_5
Accrued Expenses, Long-Term Debt, Commitments and Contingencies (Details 3) | Jul. 14, 2017USD ($)$ / sharesshares | Sep. 30, 2018USD ($)$ / sharesshares | May 31, 2018USD ($)ft² | Mar. 31, 2018shares | Sep. 30, 2018USD ($)$ / shares | Sep. 30, 2017USD ($) | Sep. 30, 2018USD ($)$ / sharesshares | Sep. 30, 2017USD ($) | Dec. 24, 2014USD ($) | Jul. 30, 2014USD ($) |
Current accrued expenses | ||||||||||
Loss on extinguishment of debt | $ (118,000) | $ (118,000) | ||||||||
Principal payment on long-term debt | 10,764,000 | |||||||||
Cash-collateralized irrevocable standby letter of credit | $ 200,000 | |||||||||
Non-Cancelable Operating Lease | ||||||||||
Current accrued expenses | ||||||||||
Lease extended term | 2,028 | |||||||||
Additional leased space | ft² | 24,000 | |||||||||
Leased space of office and laboratory | ft² | 72,000 | |||||||||
Payment for early termination of lease | $ 2,500,000 | $ 2,500,000 | $ 2,500,000 | |||||||
Future minimum payments | 40,500,000 | 40,500,000 | 40,500,000 | |||||||
Tenant improvement allowance | 900,000 | $ 1,900,000 | 900,000 | 900,000 | ||||||
Sublease Lease | ||||||||||
Current accrued expenses | ||||||||||
Future minimum payments | $ 0 | $ 0 | $ 0 | |||||||
Sublease expiration date | 2017-09 | |||||||||
SVB Loan Amendment | ||||||||||
Current accrued expenses | ||||||||||
First amendment effective date | Jul. 14, 2017 | |||||||||
SVB Loan Amendment | 2017 Term Loan | ||||||||||
Current accrued expenses | ||||||||||
Principal amount | $ 15,000,000 | |||||||||
Cash proceeds from remaining portion of debt | $ 7,500,000 | |||||||||
Debt instrument, maturity date | Jan. 1, 2022 | |||||||||
Debt instrument, variable rate description | The 2017 Term Loan matures on January 1, 2022 (the Term Loan Maturity Date) and bears interest at a floating per annum rate equal to the greater of (i) 3.50% above the Prime Rate (as defined in the SVB Loan Amendment) or (ii) 7.25%; provided, however, that in no event shall such interest rate exceed 8.25%. | |||||||||
Debt instrument, interest payment terms | Interest is payable on a monthly basis on the first day of each month. | |||||||||
Debt instrument, frequency of periodic payment | monthly | |||||||||
Interest rate (as a percent) | 8.25% | 8.25% | 8.25% | |||||||
Debt instrument interest only payment period | August 1, 2017 through January 1, 2019 | |||||||||
Number of equal monthly installments to repay principal and accrued interest | 36 months | |||||||||
Debt instrument extended interest only payment period | January 1, 2019 through and including to July 1, 2019 | |||||||||
Final payment fee | 7.50% | |||||||||
Final payment fee (amounts in dollars) | $ 1,100,000 | |||||||||
Effective interest rate | 10.20% | |||||||||
Loss on extinguishment of debt | (100,000) | |||||||||
Aggregate interest expense | $ 400,000 | 400,000 | $ 1,300,000 | 400,000 | ||||||
SVB Loan Amendment | 2017 Term Loan | 2017 Warrant | ||||||||||
Current accrued expenses | ||||||||||
Exercise price (in dollars per share) | $ / shares | $ 3.28 | |||||||||
Warrants expiration date | 2024-07 | |||||||||
Fair values of warrants issued | $ 200,000 | |||||||||
Warrants issued to cashless exercised in exchange | shares | 67,952 | |||||||||
SVB Loan Amendment | 2017 Term Loan | Product Development Milestone Achievement | ||||||||||
Current accrued expenses | ||||||||||
Number of equal monthly installments to repay principal and accrued interest | 30 months | |||||||||
SVB Loan Amendment | 2017 Term Loan | Minimum | ||||||||||
Current accrued expenses | ||||||||||
Debt instrument, floating rate | 7.25% | |||||||||
SVB Loan Amendment | 2017 Term Loan | Minimum | Prime Rate | ||||||||||
Current accrued expenses | ||||||||||
Debt instrument, floating rate | 3.50% | |||||||||
SVB Loan Amendment | 2017 Term Loan | Maximum | ||||||||||
Current accrued expenses | ||||||||||
Debt instrument, floating rate | 8.25% | |||||||||
SVB Loan Amendment | 2017 Term Loan | Maximum | 2017 Warrant | ||||||||||
Current accrued expenses | ||||||||||
Warrants to purchase shares of common stock issued on conversion | shares | 91,463 | |||||||||
Amended And Restated Loan And Security Agreement | ||||||||||
Current accrued expenses | ||||||||||
Aggregate interest expense | $ 100,000 | $ 500,000 | ||||||||
Amended And Restated Loan And Security Agreement | Warrants Expiration Period January 2019 | ||||||||||
Current accrued expenses | ||||||||||
Warrants to purchase shares of common stock issued on conversion | shares | 5,305 | |||||||||
Warrants expiration date | 2019-01 | |||||||||
Amended And Restated Loan And Security Agreement | Warrants Expiration Period August 2021 | ||||||||||
Current accrued expenses | ||||||||||
Warrants to purchase shares of common stock issued on conversion | shares | 30,769 | |||||||||
Warrants expiration date | 2021-08 | |||||||||
Amended And Restated Loan And Security Agreement | Warrant | ||||||||||
Current accrued expenses | ||||||||||
Warrants to purchase shares of common stock issued on conversion | shares | 36,074 | |||||||||
Exercise price (in dollars per share) | $ / shares | $ 7.21 | $ 7.21 | $ 7.21 | |||||||
Amended And Restated Loan And Security Agreement | Maximum | ||||||||||
Current accrued expenses | ||||||||||
Principal amount | $ 20,000,000 | |||||||||
Amended And Restated Loan And Security Agreement | Term A Loan | ||||||||||
Current accrued expenses | ||||||||||
Principal amount | 10,000,000 | |||||||||
Debt instrument, maturity date | Jan. 1, 2018 | |||||||||
Final payment fee | 7.50% | |||||||||
Final payment fee (amounts in dollars) | $ 800,000 | |||||||||
Amended And Restated Loan And Security Agreement | Term B Loan | ||||||||||
Current accrued expenses | ||||||||||
Debt instrument, maturity date | Jun. 1, 2018 | |||||||||
Final payment fee | 7.50% | |||||||||
Final payment fee (amounts in dollars) | $ 800,000 | |||||||||
Amended And Restated Loan And Security Agreement | Term B Loan | 2014 Warrants | ||||||||||
Current accrued expenses | ||||||||||
Warrants to purchase shares of common stock issued on conversion | shares | 98,039 | |||||||||
Exercise price (in dollars per share) | $ / shares | $ 4.08 | $ 4.08 | $ 4.08 | |||||||
Warrants expiration date | 2021-12 | |||||||||
Warrants issued to cashless exercised in exchange | shares | 34,149 | |||||||||
Amended And Restated Loan And Security Agreement | Term B Loan | 2014 Warrants | Warrants Expiration Period December 2021 | ||||||||||
Current accrued expenses | ||||||||||
Warrants to purchase shares of common stock issued on conversion | shares | 49,020 | |||||||||
Amended And Restated Loan And Security Agreement | Term B Loan | Maximum | ||||||||||
Current accrued expenses | ||||||||||
Principal amount | $ 10,000,000 | |||||||||
Amended And Restated Loan And Security Agreement | Term B Loan Tranche 1 | Minimum | ||||||||||
Current accrued expenses | ||||||||||
Principal amount | $ 10,000,000 |
Convertible Preferred Stock a_3
Convertible Preferred Stock and Stockholders' Equity (Details) - USD ($) $ / shares in Units, $ in Thousands | 1 Months Ended | 9 Months Ended | ||||
Oct. 31, 2017 | Nov. 30, 2016 | Sep. 30, 2018 | Sep. 30, 2017 | Dec. 31, 2017 | May 02, 2017 | |
Convertible preferred stock | ||||||
Net proceeds from issuance of shares after related cash costs | $ 1,914 | $ 172 | ||||
Preferred stock, par value (in dollars per share) | $ 0.001 | $ 0.001 | ||||
Restricted Stock Units (RSUs) | ||||||
Convertible preferred stock | ||||||
Expected recognition weighted average period of unrecognized compensation cost | 1 year | |||||
Unrecognized compensation cost related to unvested restricted shares | $ 500 | |||||
Restricted Stock Units (RSUs) | Certain Employees | ||||||
Convertible preferred stock | ||||||
Restricted stock units, vested | 225,125 | |||||
Restricted stock units, issued | 225,125 | |||||
Employee And Non Employee Stock Option | ||||||
Convertible preferred stock | ||||||
Outstanding options | 7,297,339 | 5,458,043 | ||||
Unrecognized compensation cost related to outstanding options | $ 15,400 | |||||
Expected recognition weighted average period of unrecognized compensation cost | 3 years 1 month 6 days | |||||
Employee And Non Employee Stock Option | Vesting Based On Performance | ||||||
Convertible preferred stock | ||||||
Outstanding options | 36,800 | |||||
Aggregate grant date fair value | $ 100 | |||||
Non-Voting Class A Preferred Stock | ||||||
Convertible preferred stock | ||||||
Preferred stock, par value (in dollars per share) | $ 0.001 | |||||
Conversion price | $ 2.66 | |||||
Non-Voting Class A Preferred Stock | Redmile Group, LLC and Affiliates | ||||||
Convertible preferred stock | ||||||
Terms of conversion | The Class A Preferred were purchased exclusively by entities affiliated with Redmile Group, LLC (collectively, Redmile). The terms of the CoD prohibited Redmile from converting the Class A Preferred into shares of the Company’s common stock if, as a result of conversion, Redmile, together with its affiliates, would own more than 9.99% of the Company’s common stock then issued and outstanding (the Redmile Percentage Limitation), which percentage could change at Redmile’s election upon 61 days’ notice to the Company to (i) any other number less than or equal to 19.99% or (ii) subject to approval of the Company’s stockholders to the extent required in accordance with the NASDAQ Global Market rules, any number in excess of 19.99%. On May 2, 2017, the Company’s stockholders approved the issuance of up to an aggregate of 14,097,745 shares of common stock upon the conversion of the outstanding shares of Class A Preferred. As a result, Redmile has the right to increase the Redmile Percentage Limitation to any percentage in excess of 19.99% at its election. | |||||
Non-Voting Class A Preferred Stock | Maximum | ||||||
Convertible preferred stock | ||||||
Number of shares to be issued upon conversion | 14,097,745 | |||||
Non-Voting Class A Preferred Stock | Maximum | Redmile Group, LLC and Affiliates | ||||||
Convertible preferred stock | ||||||
Percentage of common stock ownership upon preferred stock conversion | 9.99% | |||||
Preferred shares converted into common stock percentage of ownership change upon notice | 19.99% | |||||
Private Placement | Common Stock | ||||||
Convertible preferred stock | ||||||
Share issue price (in dollars per share) | $ 2.66 | |||||
Common stock issued | 7,236,837 | |||||
Net proceeds from issuance of shares after related cash costs | $ 54,900 | |||||
Gross proceeds from issuance of shares | $ 56,700 | |||||
Private Placement | Non-Voting Class A Preferred Stock | ||||||
Convertible preferred stock | ||||||
Preferred stock, issued shares | 2,819,549 | |||||
Share issue price (in dollars per share) | $ 13.30 | |||||
Number of shares to be issued upon conversion | 5 |
Convertible Preferred Stock a_4
Convertible Preferred Stock and Stockholders' Equity (Details 2) - Employee And Non Employee Stock Option | 9 Months Ended |
Sep. 30, 2018$ / sharesshares | |
Number of Options | |
Balance at the beginning of the period | shares | 5,458,043 |
Granted | shares | 2,964,260 |
Canceled | shares | (620,489) |
Exercised | shares | (504,475) |
Balance at the end of the period | shares | 7,297,339 |
Weighted-Average Price | |
Balance at the beginning of the period | $ / shares | $ 3.52 |
Granted | $ / shares | 7.55 |
Canceled | $ / shares | 4.58 |
Exercised | $ / shares | 3.80 |
Balance at the end of the period | $ / shares | $ 5.05 |
Convertible Preferred Stock a_5
Convertible Preferred Stock and Stockholders' Equity (Details 3) - Restricted Stock Units (RSUs) | 9 Months Ended |
Sep. 30, 2018$ / sharesshares | |
Number of Restricted Stock Units | |
Balance at the beginning of the period | shares | 212,625 |
Canceled | shares | (24,000) |
Balance at the end of the period | shares | 188,625 |
Weighted-Average Grant Date Fair Value per Share | |
Balance at the beginning of the period | $ / shares | $ 4.89 |
Canceled | $ / shares | 4.89 |
Balance at the end of the period | $ / shares | $ 4.89 |
Convertible Preferred Stock a_6
Convertible Preferred Stock and Stockholders' Equity (Details 4) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2018 | Sep. 30, 2017 | Sep. 30, 2018 | Sep. 30, 2017 | |
Convertible preferred stock | ||||
Total stock-based compensation expense | $ 1,642 | $ 871 | $ 4,509 | $ 2,711 |
Research And Development | ||||
Convertible preferred stock | ||||
Total stock-based compensation expense | 939 | 450 | 2,598 | 1,599 |
General And Administrative | ||||
Convertible preferred stock | ||||
Total stock-based compensation expense | $ 703 | $ 421 | $ 1,911 | $ 1,112 |
Convertible Preferred Stock a_7
Convertible Preferred Stock and Stockholders' Equity (Details 5) | 9 Months Ended | |
Sep. 30, 2018 | Sep. 30, 2017 | |
Employee Stock Option | ||
Weighted-average assumptions to determine fair value of stock options | ||
Risk-free interest rate | 2.50% | 2.00% |
Expected volatility | 79.30% | 90.40% |
Expected term (in years) | 6 years | 5 years 10 months 24 days |
Expected dividend yield | 0.00% | 0.00% |
Non Employee Stock Option | ||
Weighted-average assumptions to determine fair value of stock options | ||
Risk-free interest rate | 2.80% | 2.00% |
Expected volatility | 80.10% | 90.80% |
Remaining contractual term (in years) | 8 years | 8 years 7 months 6 days |
Expected dividend yield | 0.00% | 0.00% |
Convertible Preferred Stock a_8
Convertible Preferred Stock and Stockholders' Equity (Details 6) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | ||||||
Sep. 30, 2018 | Jun. 30, 2018 | Mar. 31, 2018 | Sep. 30, 2017 | Jun. 30, 2017 | Mar. 31, 2017 | Sep. 30, 2018 | Sep. 30, 2017 | |
Class Of Stock [Line Items] | ||||||||
Beginning balance | $ 51,825 | $ 64,995 | $ 77,189 | $ 55,213 | $ 63,858 | $ 73,154 | $ 77,189 | $ 73,154 |
Exercise of stock options, net of issuance costs | 1,133 | 175 | 606 | 119 | 32 | 35 | ||
Issuance costs from public offering of common stock | (19) | (37) | (13) | |||||
Public offering of common stock, net of offering costs | 134,855 | |||||||
Stock-based compensation | 1,642 | 1,485 | 1,382 | 871 | 973 | 867 | ||
Issuance of warrants for common stock | 217 | |||||||
Issuance of common stock for license agreement | 1,255 | 4,845 | ||||||
Private placement issuance of common stock, net of offering costs | (13) | |||||||
Private placement issuance of Class A convertible preferred stock, net of offering costs | (26) | |||||||
Unrealized gain (loss) on short-term investments | 1 | (2) | (10) | 26 | (5) | (33) | ||
Net loss | (16,782) | (19,654) | (14,135) | (10,684) | (9,645) | (10,126) | (50,571) | (30,455) |
Ending balance | 173,929 | 51,825 | 64,995 | 45,749 | 55,213 | 63,858 | 173,929 | 45,749 |
Class A Convertible Preferred Shares | ||||||||
Class Of Stock [Line Items] | ||||||||
Beginning balance | 3 | 3 | 3 | 3 | 3 | 3 | 3 | 3 |
Ending balance | 3 | 3 | 3 | 3 | 3 | 3 | 3 | 3 |
Common Stock | ||||||||
Class Of Stock [Line Items] | ||||||||
Beginning balance | 53 | 53 | 53 | 41 | 41 | 41 | 53 | 41 |
Exercise of stock options, net of issuance costs | 1 | |||||||
Public offering of common stock, net of offering costs | 11 | |||||||
Ending balance | 65 | 53 | 53 | 41 | 41 | 41 | 65 | 41 |
Additional Paid In Capital | ||||||||
Class Of Stock [Line Items] | ||||||||
Beginning balance | 304,371 | 297,885 | 295,934 | 250,825 | 249,820 | 248,957 | 295,934 | 248,957 |
Exercise of stock options, net of issuance costs | 1,132 | 175 | 606 | 119 | 32 | 35 | ||
Issuance costs from public offering of common stock | (19) | (37) | (13) | |||||
Public offering of common stock, net of offering costs | 134,844 | |||||||
Stock-based compensation | 1,642 | 1,485 | 1,382 | 871 | 973 | 867 | ||
Issuance of warrants for common stock | 217 | |||||||
Issuance of common stock for license agreement | 1,255 | 4,845 | ||||||
Private placement issuance of common stock, net of offering costs | (13) | |||||||
Private placement issuance of Class A convertible preferred stock, net of offering costs | (26) | |||||||
Ending balance | 443,244 | 304,371 | 297,885 | 252,019 | 250,825 | 249,820 | 443,244 | 252,019 |
Accumulated Other Comprehensive Loss | ||||||||
Class Of Stock [Line Items] | ||||||||
Beginning balance | (15) | (13) | (3) | (39) | (34) | (1) | (3) | (1) |
Unrealized gain (loss) on short-term investments | 1 | (2) | (10) | 26 | (5) | (33) | ||
Ending balance | (14) | (15) | (13) | (13) | (39) | (34) | (14) | (13) |
Accumulated Deficit | ||||||||
Class Of Stock [Line Items] | ||||||||
Beginning balance | (252,587) | (232,933) | (218,798) | (195,617) | (185,972) | (175,846) | (218,798) | (175,846) |
Net loss | (16,782) | (19,654) | (14,135) | (10,684) | (9,645) | (10,126) | ||
Ending balance | $ (269,369) | $ (252,587) | $ (232,933) | $ (206,301) | $ (195,617) | $ (185,972) | $ (269,369) | $ (206,301) |