Document and Entity Information
Document and Entity Information - shares | 3 Months Ended | |
Mar. 31, 2019 | Apr. 30, 2019 | |
Document and Entity Information [Abstract] | ||
Document Type | 10-Q | |
Amendment Flag | false | |
Document Period End Date | Mar. 31, 2019 | |
Document Fiscal Year Focus | 2019 | |
Document Fiscal Period Focus | Q1 | |
Entity Registrant Name | ZIOPHARM ONCOLOGY INC | |
Entity Central Index Key | 0001107421 | |
Current Fiscal Year End Date | --12-31 | |
Entity Filer Category | Accelerated Filer | |
Trading Symbol | ZIOP | |
Entity Emerging Growth Company | false | |
Entity Small Business | true | |
Entity Common Stock, Shares Outstanding | 162,394,494 |
BALANCE SHEETS
BALANCE SHEETS - USD ($) $ in Thousands | Mar. 31, 2019 | Dec. 31, 2018 |
Current assets: | ||
Cash and cash equivalents | $ 51,487 | $ 61,729 |
Receivables | 854 | 1,864 |
Prepaid expenses and other current assets | 21,752 | 20,692 |
Total current assets | 74,093 | 84,285 |
Property and equipment, net | 967 | 1,097 |
Operating lease right of use assets | 1,589 | |
Deposits | 130 | 128 |
Other non-current assets | 6,724 | 9,541 |
Total assets | 83,503 | 95,051 |
Current liabilities: | ||
Accounts payable | 859 | 707 |
Accrued expenses | 6,836 | 8,763 |
Lease liability - current portion | 644 | |
Deferred rent - current portion | 13 | |
Total current liabilities | 8,339 | 9,483 |
Lease liability - noncurrent portion | 948 | |
Deferred rent - noncurrent portion | 4 | |
Total liabilities | 9,287 | 9,487 |
Commitments and contingencies (Note 6) | ||
Stockholders' deficit: | ||
Common stock, $0.001 par value; 250,000,000 shares authorized; 162,287,161 and 161,066,136 shares issued and outstanding at March 31, 2019 and December 31, 2018, respectively | 162 | 161 |
Additional paid-in capital | 653,817 | 651,732 |
Accumulated deficit | (579,763) | (566,329) |
Total stockholders' equity | 74,216 | 85,564 |
Total liabilities and stockholders' equity | $ 83,503 | $ 95,051 |
BALANCE SHEETS (Parenthetical)
BALANCE SHEETS (Parenthetical) - $ / shares | Mar. 31, 2019 | Dec. 31, 2018 |
Common stock, par value | $ 0.001 | $ 0.001 |
Common stock, shares authorized | 250,000,000 | 250,000,000 |
Common stock, shares issued | 162,287,161 | 161,066,136 |
Common stock, shares outstanding | 162,287,161 | 161,066,136 |
STATEMENTS OF OPERATIONS
STATEMENTS OF OPERATIONS - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2019 | Mar. 31, 2018 | |
Income Statement [Abstract] | ||
Collaboration revenue | $ 146 | |
Operating expenses: | ||
Research and development | $ 9,476 | 10,183 |
General and administrative | 4,145 | 6,159 |
Total operating expenses | 13,621 | 16,342 |
Loss from operations | (13,621) | (16,196) |
Other income, net | 187 | 148 |
Change in fair value of derivative liabilities | 28 | |
Net loss | (13,434) | (16,020) |
Preferred stock dividends | (5,120) | |
Net loss applicable to common stockholders | $ (13,434) | $ (21,140) |
Basic and diluted net loss per share | $ (0.08) | $ (0.15) |
Weighted average common shares outstanding used to compute basic and diluted net loss per share | 160,640,859 | 140,853,120 |
STATEMENTS OF CHANGES IN PREFER
STATEMENTS OF CHANGES IN PREFERRED STOCK AND STOCKHOLDERS' Equity (DEFICIT) - USD ($) $ in Thousands | Total | Common Stock | Additional Paid In Capital Common Stock | Accumulated Deficit | Series 1 Preferred Stock - Mezzanine |
Balance at Dec. 31, 2017 | $ (96,806) | $ 143 | $ 615,493 | $ (712,442) | $ 143,992 |
Balance (in shares) at Dec. 31, 2017 | 142,658,037 | 119,644 | |||
Adjustment for implementation of ASU No. 2014-09, Revenue from Contracts with Customers | (8,131) | (8,131) | |||
Stock-based compensation | 3,659 | 3,659 | |||
Cancelled restricted common stock (in shares) | (70,867) | ||||
Repurchase of restricted common stock | (731) | $ (1) | (730) | ||
Repurchase of restricted common stock (Shares) | (188,234) | ||||
Preferred stock dividends | $ 5,047 | ||||
Preferred stock dividends | (5,120) | (5,120) | |||
Preferred stock dividends (in shares) | 3,624 | ||||
Net loss | (16,020) | (16,020) | |||
Balance at Mar. 31, 2018 | (123,149) | $ 142 | 613,302 | (736,593) | $ 149,039 |
Balance (in shares) at Mar. 31, 2018 | 142,398,936 | 123,268 | |||
Balance at Dec. 31, 2018 | 85,564 | $ 161 | 651,732 | (566,329) | |
Balance (in shares) at Dec. 31, 2018 | 161,066,136 | ||||
Stock-based compensation | 1,456 | 1,456 | |||
Issuance of restricted common stock | 1,000 | $ 1 | 999 | ||
Issuance of restricted common stock (in shares) | 1,393,536 | ||||
Cancelled restricted common stock (in shares) | (7,333) | ||||
Repurchase of restricted common stock | (370) | (370) | |||
Repurchase of restricted common stock (Shares) | (165,178) | ||||
Net loss | (13,434) | (13,434) | |||
Balance at Mar. 31, 2019 | $ 74,216 | $ 162 | $ 653,817 | $ (579,763) | |
Balance (in shares) at Mar. 31, 2019 | 162,287,161 |
STATEMENTS OF CASH FLOWS
STATEMENTS OF CASH FLOWS - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2019 | Mar. 31, 2018 | |
Cash flows from operating activities: | ||
Net loss | $ (13,434) | $ (16,020) |
Adjustments to reconcile net loss to net cash used in operating activities: | ||
Depreciation | 140 | 117 |
Stock-based compensation | 1,456 | 3,659 |
Bonus paid in common stock, net | 630 | |
Change in fair value of derivative liabilities | (28) | |
(Increase) decrease in: | ||
Receivables | 1,009 | 1 |
Prepaid expenses and other current assets | (1,058) | (1,172) |
Other noncurrent assets | 2,817 | (490) |
Deposits | (2) | |
Increase (decrease) in: | ||
Accounts payable | 152 | (3,811) |
Accrued expenses | (1,929) | (1,030) |
Deferred revenue | (146) | |
Deferred rent | 17 | (37) |
Other liabilities | (30) | |
Net cash used in operating activities | (10,232) | (18,957) |
Cash flows from investing activities: | ||
Purchases of property and equipment | (10) | (150) |
Net cash used in investing activities | (10) | (150) |
Cash flows from financing activities: | ||
Repurchase of common stock | (731) | |
Net cash provided by (used in) financing activities | 0 | (731) |
Net decrease in cash and cash equivalents, and restricted cash | (10,242) | (19,838) |
Cash and cash equivalents, and restricted cash, beginning of period | 61,729 | 71,335 |
Cash and cash equivalents, and restricted cash, end of period | 51,487 | 51,497 |
Supplementary disclosure of cash flow information: | ||
Bonus paid in common stock, gross | $ 1,000 | |
Series 1 Preferred Stock | ||
Supplementary disclosure of noncash investing and financing activities: | ||
Payment of dividends in preferred stock | $ 5,120 |
Business
Business | 3 Months Ended |
Mar. 31, 2019 | |
Accounting Policies [Abstract] | |
Business | 1. Business Overview ZIOPHARM Oncology, Inc., which is referred to herein as “ZIOPHARM,” or the “Company,” is a biopharmaceutical company seeking to develop, acquire, and commercialize, on its own or with partners, a diverse portfolio of immuno-oncology therapies. The Company’s operations to date have consisted primarily of raising capital and conducting research and development. The Company’s fiscal year ends on December 31. The Company has operated at a loss since its inception in 2003 and has no recurring revenues from operations. The Company anticipates that losses will continue for the foreseeable future. As of March 31, 2019, the Company had approximately $51.5 million of cash and cash equivalents and the Company’s accumulated deficit was approximately $579.8 million. Given its current development plans, the Company anticipates cash resources will be sufficient to fund operations into the second quarter of 2020. The Company’s ability to continue operations after its current cash resources are exhausted depends on its ability to obtain additional financing or to achieve profitable operations, as to which no assurances can be given. Cash requirements may vary materially from those now planned because of changes in the Company’s focus and direction of its research and development programs, competitive and technical advances, patent developments, regulatory changes or other developments. If adequate additional funds are not available when required, or if the Company is unsuccessful in entering into partnership agreements for further development of its product candidates, management may need to curtail its development efforts and planned operations to conserve cash. Basis of Presentation The accompanying unaudited interim financial statements have been prepared in accordance with the instructions to Form 10-Q pursuant to the rules and regulations of the Securities and Exchange Commission, or the SEC. Certain information and note disclosures required by generally accepted accounting principles in the United States have been condensed or omitted pursuant to such rules and regulations. It is management’s opinion that the accompanying unaudited interim financial statements reflect all adjustments (which are normal and recurring) that are necessary for a fair statement of the results for the interim periods. The unaudited interim financial statements should be read in conjunction with the audited financial statements and the notes thereto for the year ended December 31, 2018, included in the Company’s Annual Report on Form 10-K for the fiscal year ended December 31, 2018 filed with the SEC on March 5, 2019, or the Form 10-K. The year-end balance sheet data was derived from the audited financial statements but does not include all disclosures required by generally accepted accounting principles in the United States. The results disclosed in the statements of operations for the three months ended March 31, 2019 are not necessarily indicative of the results to be expected for the full fiscal year. Use of Estimates The preparation of financial statements in conformity with accounting principles generally accepted in the United States requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and the disclosure of contingent assets and liabilities at the date of the financial statements and the reported amounts of revenues and expenses during the reporting period. Although the Company regularly assesses these estimates, actual results could differ from those estimates. Changes in estimates are recorded in the period in which they become known. The Company’s most significant estimates and judgments used in the preparation of its financial statements are: • Clinical trial expenses; • Collaboration agreements and revenue recognition; • Fair value measurements of stock based compensation and Series 1 preferred stock; and • Income taxes Subsequent Events The Company evaluated all events and transactions that occurred after the balance sheet date through the date of this filing. Except as disclosed below, the Company did not have any material subsequent events that impacted its financial statements or disclosures. On December 18, 2018, Ziopharm and TriArm Therapeutics, Ltd. (“TriArm”) announced that the companies plan to launch Eden BioCell, Ltd. (“Eden BioCell”) to lead clinical development and commercialization of Sleeping Beauty -generated CAR-T therapies in the People’s Republic of China (including Macau and Hong Kong), Taiwan and Korea. TriArm is a cell therapy company with operations in Germany, China and the United States. For the territory of China, Taiwan and Korea, Ziopharm will license the rights to Eden BioCell for third-generation Sleeping Beauty -generated CAR-T therapies targeting the CD19 antigen. Eden BioCell will be jointly-owned by Ziopharm and TriArm. TriArm has committed up to $35.0 million to this joint venture. Under the terms of the agreement, Eden BioCell has rights in the region to CAR-T cells very rapidly manufactured in two days or less using the Sleeping Beauty platform to express a CD19-specific CAR and membrane-bound interleukin 15, or mbIL15, along with a kill switch. Each party will share decision-making authority. TriArm will manage all clinical development to execute trials in China for Eden BioCell. On January 3, 2019 Eden BioCell was incorporated in Hong Kong. The definitive agreements are expected to be executed in the first half of 2019. |
Summary of Significant Accounti
Summary of Significant Accounting Policies | 3 Months Ended |
Mar. 31, 2019 | |
Accounting Policies [Abstract] | |
Summary of Significant Accounting Policies | 2. Summary of Significant Accounting Policies The Company’s significant accounting policies were identified in the Company’s Form 10-K. There have been no material changes in those policies since the filing of its Form 10-K except as noted below with respect to the Company’s revenue recognition. Leases In February 2016, the FASB issued ASU 2016-02, Leases (Topic 842), to increase transparency and comparability among organizations by requiring the recognition of a right-of-use assets and lease liabilities for most lease arrangements on the balance sheet. Under the standard, disclosures are required to meet the objective of enabling users of financial statements to assess the amount, timing, and uncertainty of cash flows arising from leases. The new standard is effective for fiscal years beginning after December 15, 2018, and the Company adopted the standard on January 1, 2019. The standard permits two transition methods, (1) to apply the new lease requirements at the beginning of the earliest period presented, or (2) to apply the new lease requirements at the effective date. Under both transition methods there is a cumulative effect adjustment. The Company adopted Topic 842 as of January 1, 2019 using the effective date method, in which it did not restate prior periods. Upon adoption, the Company elected the package of practical expedients permitted under the transition guidance within Topic 842 which, among other things, allowed it to carry forward the historical lease classification. The adoption of Topic 842 resulted in recognition of approximately $1.6 $1.6 million of lease liabilities on the Company’s balance sheets. The adoption did not have a material impact on the Company’s statements of operations or accumulated deficit. The Company has implemented changes to related processes, controls and disclosures in connection with the adoption of Topic 842 (Note 8). New Accounting Pronouncements In November 2016, the FASB issued ASU 2016-18, Statement of Cash Flows: Restricted Cash or ASU 2016-18. The amendments in this update require that amounts generally described as restricted cash and restricted cash equivalents be included within cash and cash equivalents when reconciling the beginning-of-period and end-of-period total amounts shown on the statement of cash flows. ASU 2016-18 was effective January 1, 2018. As a result of adopting ASU 2016-18, the Company includes its restricted cash balance in the cash and cash equivalents reconciliation of operating, investing and financing activities. The following table provides a reconciliation of cash, cash equivalents, and restricted cash within the statement of financial position that sum to the total of the same such amounts shown in the statement of cash flows. March 31, 2019 2018 (in thousands) Cash and cash equivalents $ 51,487 $ 51,108 Restricted cash included in prepaid expenses and other current assets — 389 Total cash, cash equivalents, and restricted cash shown in the statement of cash flows $ 51,487 $ 51,497 In August 2018, the FASB issued ASU No. 2018-13, Fair Value Measurement (Topic 820): Disclosure Framework—Changes to the Disclosure Requirements for Fair Value Measurement , or ASU 2018-03. The guidance in this ASU modify the disclosure requirements on fair value measurements in Topic 820, Fair Value Measurement. Under the new guidance, transfers between asset classes and the valuation related to level 3 assets is modified. The new standard is effective for annual reporting periods beginning after December 15, 2019, including interim reporting periods within each annual reporting period. The Company is currently evaluating the impact of the adoption of this ASU on the financial statements. In June 2018, the FASB issued ASU No. 2018-07, Compensation—Stock Compensation (Topic 718): Improvements to Nonemployee Share-Based Payment Accounting , or ASU 2018-07. The guidance in this ASU expand the scope of Topic 718 to include share-based payment transactions for acquiring goods and services from nonemployees. The new standard is effective for annual reporting periods beginning after December 15, 2019, including interim reporting periods within each annual reporting period. The Company is currently evaluating the impact of the adoption of this ASU on the financial statements. |
Fair Value Measurements
Fair Value Measurements | 3 Months Ended |
Mar. 31, 2019 | |
Fair Value Disclosures [Abstract] | |
Fair Value Measurements | 3. Fair Value Measurements The Company accounts for its financial assets and liabilities using fair value measurements. The authoritative accounting guidance defines fair value, establishes a framework for measuring fair value under generally accepted accounting principles and enhances disclosures about fair value measurements. Fair value is defined as the exchange price that would be received for an asset or paid to transfer a liability (an exit price) in the principal or most advantageous market for the asset or liability in an orderly transaction between market participants on the measurement date. Valuation techniques used to measure fair value must maximize the use of observable inputs and minimize the use of unobservable inputs. The fair value hierarchy is based on three levels of inputs, of which the first two are considered observable and the last unobservable, that may be used to measure fair value as follows: • Level 1—Quoted prices in active markets for identical assets or liabilities. • Level 2—Inputs other than Level 1 that are observable, either directly or indirectly, such as quoted prices for similar assets or liabilities; quoted prices in markets that are not active; or other inputs that are observable or can be corroborated by observable market data for substantially the full term of the assets or liabilities. • Level 3—Unobservable inputs that are supported by little or no market activity and that are significant to the fair value of the assets or liabilities. Assets and liabilities measured at fair value on a recurring basis as of March 31, 2019 and December 31, 2018 were as follows: ($ in thousands) Fair Value Measurements at Reporting Date Using Description Balance as of March 31, 2019 Quoted Prices in Active Markets for Identical Assets/Liabilities (Level 1) Significant Other Observable Inputs (Level 2) Significant Unobservable Inputs (Level 3) Assets: Cash equivalents $ 24,568 $ 24,568 $ — $ — ($ in thousands) Fair Value Measurements at Reporting Date Using Description Balance as of December 31, 2018 Quoted Prices in Active Markets for Identical Assets/Liabilities (Level 1) Significant Other Observable Inputs (Level 2) Significant Unobservable Inputs (Level 3) Cash equivalents $ 24,437 $ 24,437 $ — $ — The cash equivalents represent deposits in a short-term United States treasury money market mutual fund quoted in an active market and classified as a Level 1 asset. |
Net Loss per Share
Net Loss per Share | 3 Months Ended |
Mar. 31, 2019 | |
Earnings Per Share [Abstract] | |
Net Loss per Share | 4. Net Loss per Share Basic net loss per share is computed by dividing net loss by the weighted average number of shares of common stock outstanding for the period. The Company’s potentially dilutive shares, which include outstanding common stock options, unvested restricted stock and preferred stock, have not been included in the computation of diluted net loss per share for any of the periods presented as the result would be anti-dilutive. Such potentially dilutive shares of common stock at March 31, 2019 and 2018 consisted of the following: March 31, 2019 2018 Stock options 5,416,085 3,822,968 Unvested restricted stock 1,621,845 1,532,201 Warrants 18,939,394 — Preferred stock — 35,152,089 25,977,324 40,507,258 During the year ended December 31, 2018, the Company and Precigen, Inc., or Precigen, a wholly owned subsidiary of Intrexon Corporation, or Intrexon, entered into a License Agreement to replace all existing agreements between the companies that will provide the Company with certain exclusive and non-exclusive rights to technology controlled by Precigen. The License Agreement was dated October 5, 2018. In consideration of the Company entering into the License Agreement, Intrexon agreed to forfeit and return to the Company all shares of the Company’s Series 1 Preferred Stock held by or payable to Intrexon as of the date of the License Agreement (Note 6). |
Revenue Recognition
Revenue Recognition | 3 Months Ended |
Mar. 31, 2019 | |
Revenue from Contract with Customer [Abstract] | |
Revenue Recognition | 5. Revenue Recognition The Company adopted Accounting Standards Codification, or ASC Topic 606, Revenue from Contracts with Customers, 6), which was the Company’s sole open revenue contract outstanding at January 1, 2018. The Company primarily generates revenue through collaboration arrangements with strategic partners for the development and commercialization of product candidates. Commencing January 1, 2018, the Company recognized revenue in accordance with ASC 606 which replaced ASC 605, Multiple Element Arrangements , as used in historical years. The core principle of ASC 606 is that an entity should recognize revenue to depict the transfer of promised goods and/or services to customers in an amount that reflects the consideration to which the entity expects to be entitled in exchange for those goods and/or services. To determine the appropriate amount of revenue to be recognized for arrangements that the Company determines are within the scope of ASC 606, the Company performs the following steps: (i) identify the contract(s) with the customer, (ii) identify the performance obligations in the contract, (iii) determine the transaction price, (iv) allocate the transaction price to the performance obligations in the contract and (v) recognize revenue when (or as) each performance obligation is satisfied. The Company recognizes collaboration revenue under certain of the Company’s license or collaboration agreements that are within the scope of ASC 606. The Company’s contracts with customers typically include promises related to licenses to intellectual property, research and development services and options to purchase additional goods and/or services. If the license to the Company’s intellectual property is determined to be distinct from the other performance obligations identified in the arrangement, the Company recognizes revenue from non-refundable, up-front fees allocated to the license when the license is transferred to the licensee and the licensee is able to use and benefit from the license. For licenses that are bundled with other promises, the Company utilizes judgement to assess the nature of the combined performance obligation to determine whether the combined performance obligation is satisfied over time or at a point in time and, if over time, the appropriate method of measuring progress for purposes of recognizing revenue from non-refundable, up-front fees. Contracts that include an option to acquire additional goods and/or services are evaluated to determine if such option provides a material right to the customer that it would not have received without entering into the contract. If so, the option is accounted for as a separate performance obligation. If not, the option is considered a marketing offer which would be accounted for as a separate contract upon the customer’s election. The terms of the Company’s arrangements with customers typically include the payment of one or more of the following: (i) non-refundable, up-front payment, (ii) development, regulatory and commercial milestone payments, (iii) future options and (iv) royalties on net sales of licensed products. Accordingly, the transaction price is generally comprised of a fixed fee due at contract inception and variable consideration in the form of milestone payments due upon the achievement of specified events and tiered royalties earned when customers recognize net sales of licensed products. The Company measures the transaction price based on the amount of consideration to which it expects to be entitled in exchange for transferring the promised goods and/or services to the customer. The Company utilizes the most likely amount method to estimate the amount of variable consideration, to predict the amount of consideration to which it will be entitled for its one open contract. Amounts of variable consideration are included in the transaction price to the extent that it is probable that a significant reversal in the amount of cumulative revenue recognized will not occur when the uncertainty associated with the variable consideration is subsequently resolved. At the inception of each arrangement that includes development and regulatory milestone payments, the Company evaluates whether the associated event is considered probable of achievement and estimates the amount to be included in the transaction price using the most likely amount method. Milestone payments that are not within the control of the Company or the licensee, such as those dependent upon receipt of regulatory approval, are not considered to be probable of achievement until the triggering event occurs. At the end of each reporting period, the Company reevaluates the probability of achievement of each milestone and any related constraint, and if necessary, adjusts its estimate of the overall transaction price. Any such adjustments are recorded on a cumulative catch-up basis, which would affect revenue and net loss in the period of adjustment. For arrangements that include sales-based royalties, including milestone payments based upon the achievement of a certain level of product sales, the Company recognizes revenue upon the later of: (i) when the related sales occur or (ii) when the performance obligation to which some or all of the payment has been allocated has been satisfied (or partially satisfied). To date, the Company has not recognized any development, regulatory or commercial milestones or royalty revenue resulting from any of its collaboration arrangements. Consideration that would be received for optional goods and/or services is excluded from the transaction price at contract inception. The Company allocates the transaction price to each performance obligation identified in the contract on a relative standalone selling price basis. However, certain components of variable consideration are allocated specifically to one or more particular performance obligations in a contact to the extent both of the following criteria are met: (i) the terms of the payment relate specifically to the efforts to satisfy the performance obligation or transfer the distinct good or service and (ii) allocating the variable amount of consideration entirely to the performance obligation or the distinct good or service is consistent with the allocation objective of the standard whereby the amount allocated depicts the amount of consideration to which the entity expects to be entitled in exchange for transferring the promised goods or services. The Company develops assumptions that require judgment to determine the standalone selling price for each performance obligation identified in each contract. The key assumptions utilized in determining the standalone selling price for each performance obligation may include forecasted revenues, development timelines, estimated research and development costs, discount rates, likelihood of exercise and probabilities of technical and regulatory success. Revenue is recognized based on the amount of the transaction price that is allocated to each respective performance obligation when or as the performance obligation is satisfied by transferring a promised good and/or service to the customer. For performance obligations that are satisfied over time, the Company recognizes revenue by measuring the progress toward complete satisfaction of the performance obligation using a single method of measuring progress which depicts the performance in transferring control of the associated goods and/or services to the customer. The Company uses input methods to measure the progress toward the complete satisfaction of performance obligations satisfied over time. The Company evaluates the measure of progress each reporting period and, if necessary, adjusts the measure of performance and related revenue recognition. Any such adjustments are recorded on a cumulative catch-up basis, which would affect revenue and net loss in the period of adjustment. As it relates to the Ares Trading Agreement (Note 6), the Company recognized the upfront payment associated with its one open contract as a contract liability upon receipt of payment as it requires deferral of revenue recognition to a future period until the Company performs its obligations under the arrangement. Amounts expected to be recognized as revenue within the twelve months following the balance sheet date are classified in current liabilities. Amounts not expected to be recognized as revenue within the twelve months following the balance sheet date are classified as contract liabilities, net of current portion. The Company determined that there were three performance obligations; the first performance obligation consists of the license and research development services and the other two performance obligations are material rights as it relates to potential future targets that have not yet been identified. As described above, the transaction price of $57.5 million was allocated to the performance obligations based on their relative standalone selling There are multiple distinct performance obligations, including material rights; thus, the Company allocates the transaction price to each distinct performance obligation based on its relative standalone selling price. The standalone selling price is generally determined based on the prices charged to customers or using expected cost-plus margin. Revenue is recognized by measuring the progress toward complete satisfaction of the performance obligations using an input measure. Furthermore, the Company has not capitalized any contract costs under the guidance in ASC 340-40, Other Assets and Deferred Costs: Contracts with Customers . The Company does not believe that any variable consideration should be included in the transaction price at the date of adoption of ASC 606 on January 1, 2018. Such assessment considered the application of the constraint to ensure that estimates of variable consideration would be included in the transaction price only to the extent the Company had a high degree of confidence that revenue would not be reversed in a subsequent reporting period. The Company will re-evaluate the transaction price, including the estimated variable consideration included in the transaction price and all constrained amounts, in each reporting period and as other changes in circumstances occur. On October 5, 2018, the Company entered into the license agreement with Precigen. As between the Company and Precigen, the terms of the License Agreement replace the terms of: (a) the Channel Agreement previously entered into with Intrexon Corporation (the “Channel Agreement”), including all amendments to the Channel Agreement; (b) certain rights and obligations pursuant to the Ares Trading Agreement; (c) the MD Anderson License (Note 6); and (d) that certain Research and Development Agreement between the Company, Intrexon and The University of Texas MD Anderson Cancer Center, or MD Anderson, with an effective date of August 17, 2015 or the Research and Development Agreement, and any amendments or statements of work thereto. In partial consideration of the Company entering into the License Agreement, Precigen is required to use diligent good faith efforts to transfer the Company’s rights and obligations under the Ares Trading Agreement to Intrexon (or it’s affiliate). As a result, the Company has very limited obligations under the Ares Trading Agreeme nt. |
Commitments and Contingencies
Commitments and Contingencies | 3 Months Ended |
Mar. 31, 2019 | |
Commitments and Contingencies Disclosure [Abstract] | |
Commitments and Contingencies | 6. Commitments and Contingencies License Agreements Exclusive License Agreement with Precigen, Inc. On October 5, 2018, the Company entered into an exclusive license agreement, or the License Agreement, with Precigen. As between the Company and Precigen, the terms of the License Agreement replace and supersede the terms of: (a) that certain Exclusive Channel Partner Agreement by and between the Company and Intrexon, dated January 6, 2011, as amended by the First Amendment to Exclusive Channel Partner Agreement effective September 13, 2011, the Second Amendment to the Exclusive Channel Partner Agreement effective March 27, 2015, and the Third Amendment to Exclusive Channel Partner Agreement effective June 29, 2016, which was subsequently assigned by Intrexon to Precigen; (b) certain rights and obligations pursuant to that certain License and Collaboration Agreement effective March 27, 2015 between , Intrexon and ARES TRADING S.A., or Ares Trading, a subsidiary of Merck KGaA, or Merck, as assigned by Intrexon to Precigen, or the Ares Trading Agreement; (c) that certain License Agreement between the Company, Intrexon, and MD Anderson, with an effective date of January 13, 2015, or the MD Anderson License, which was subsequently assigned by Intrexon and assumed by Precigen effective as of January 1, 2018; and (d) that certain Research and Development Agreement between the Company, Intrexon and MD Anderson with an effective date of August 17, 2015, or the Research and Development Agreement, and any amendments or statements of work thereto. Pursuant to the terms of the License Agreement, Precigen has granted the Company an exclusive, worldwide, royalty-bearing, sub-licensable license to research, develop and commercialize (i) products utilizing Precigen’s RheoSwitch® gene switch, or RTS, for the treatment of cancer, referred to as IL-12 Products, (ii) CAR products directed to (A) CD19 for the treatment of cancer, referred to as CD19 Products, and (B) a second target, subject to the rights of Merck to pursue such target under the Ares Trading Agreement, and (iii) TCR products designed for neoantigens for the treatment of cancer. Precigen has also granted the Company an exclusive, worldwide, royalty-bearing, sub-licensable license for certain patents relating to the Sleeping Beauty technology to research, develop and commercialize TCR products for both neoantigens and shared antigens for the treatment of cancer, referred to as TCR Products. The Company will be solely responsible for all aspects of the research, development and commercialization of the exclusively licensed products for the treatment of cancer. The Company is required to use commercially reasonable efforts to develop and commercialize IL-12 products and CD19 products and after a two-year period, the TCR Products. Precigen has also granted the Company an exclusive, worldwide, royalty-bearing, sub-licensable license to research, develop and commercialize products utilizing an additional construct that expresses RTS IL-12 for the treatment of cancer, referred to as Gorilla IL-12 Products. In consideration of the licenses and other rights granted by Precigen, the Company will pay Precigen an annual license fee of $0.1 million and has agreed to reimburse Precigen for certain historical costs of the licensed programs up to $1.0 million, payable quarterly. The Company will make milestone payments totaling up to an additional $52.5 million for each exclusively licensed program upon the initiation of later stage clinical trials and upon the approval of exclusively licensed products in various jurisdictions. In addition, the Company will pay Precigen tiered royalties ranging from low-single digit to high-single digit on the net sales derived from the sales of any approved IL-12 products and CAR products. The Company will also pay Precigen royalties ranging from low-single digit to mid-single digit on the net sales derived from the sales of any approved TCR Products, up to a maximum royalty amount of $ 100 20 The Company is responsible for all development costs associated with each of the licensed products, other than Gorilla IL-12 products. The Company and Precigen will share the development costs and operating profits for Gorilla IL-12 products, with the Company responsible for 80% of the development costs and receiving 80% of the operating profits, and Precigen responsible for the remaining 20% of the development costs and receiving 20% of the operating profits. Precigen will pay the Company royalties ranging from low-single digits to mid-single digits on the net sales derived from the sale of Precigen’s CAR products, up to $50.0 million. In consideration of entering into the License Agreement, Intrexon has forfeited and returned to the Company all shares of Series 1 preferred stock held by or payable to Intrexon as of the date of the License Agreement (Note 7). License Agreement—The University of Texas MD Anderson Cancer Center On January 13, 2015, the Company, together with Intrexon, entered into the MD Anderson License with MD Anderson (which Intrexon subsequently assigned to Precigen). Pursuant to the MD Anderson License, the Company, together with Precigen, holds an exclusive, worldwide license to certain technologies owned and licensed by MD Anderson including technologies relating to novel CAR T-cell therapies, non-viral gene transfer systems, genetic modification and/or propagation of immune cells and other cellular therapy approaches, Natural Killer, or NK Cells, and TCRs, arising from the laboratory of Laurence Cooper, M.D., Ph.D., who became the Company’s Chief Executive Officer in May 2015 On August 17, 2015, the Company, Precigen and MD Anderson entered into the Research and Development Agreement, to formalize the scope and process for the transfer by MD Anderson, pursuant to the terms of the MD Anderson License, of certain existing research programs and related technology rights, as well as the terms and conditions for future collaborative research and development of new and ongoing research programs. Pursuant to the Research and Development Agreement, the Company, Precigen and MD Anderson formed a joint steering committee to oversee and manage the new and ongoing research programs. Under the License Agreement with Precigen, the Company and Precigen agreed that Precigen would no longer participate on the joint steering committee after the date of the License Agreement. As provided under the MD Anderson License, the Company provided funding for research and development activities in support of the research programs under the Research and Development Agreement for a period of three years and in an amount of no less than $15.0 million and no greater than $20.0 million per year. On November 14, 2017, the Company entered into an amendment to the Research and Development Agreement extending its term until April 15, 2021. During the three months ended March 31, 2019, the Company expensed approximately $1.4 million for its research programs being conducted in Houston. The net balance of cash resources on hand at MD Anderson available to offset expenses and future costs is $ 26.4 The term of the MD Anderson License expires on the last to occur of (a) the expiration of all patents licensed thereunder, or (b) the twentieth anniversary of the date of the MD Anderson License; provided, however, that following the expiration of the term of the MD Anderson License, the Company, together with Precigen, shall then have a fully-paid up, royalty free, perpetual, irrevocable and sublicensable license to use the licensed intellectual property thereunder. After ten years from the date of the MD Anderson License and subject to a 90- Cooperative Research and Development Agreement (CRADA) with the National Cancer Institute On January 10, 2017, the Company announced the signing of a Cooperative Research and Development Agreement, or CRADA, with the National Cancer Institute, or NCI for the development of adoptive cell transfer, or ACT,-based immunotherapies genetically modified using the Sleeping Beauty Sleeping Beauty In February 2019, the Company extended the CRADA with the NCI for two years, committing an additional $5.0 million to this remaining obligation, as of March 31, 2019, to the $6.9 million over the next two years, payable in $625 thousand payments on a quarterly basis. The Company made one payment of $625 thousand, during the three months ended March 31, 2019 and 2018, respectively. Exclusive Channel Partner Agreement with Precigen for the Cancer Programs From 2011 to 2018, the Company was party to various arrangements with Intrexon (now Precigen) in which the Company used Precigen’s technology to research and develop cancer treatments in return for various future profit sharing and royalty arrangements. These agreements were modified or terminated by the License Agreement described in Note 7. Ares Trading License and Collaboration Agreement On March 27, 2015, Precigen was entitled to receive $5.0 million, from Ares Trading, payable in equal quarterly installments over two years for each identified product candidate, which will be used to fund discovery work. The Company was responsible for costs exceeding the quarterly installments and all other costs of the preclinical research and development. For the three months ended March 31, 2018, the Company expensed $1.6 million under the Ares Trading Agreement. The Company did not incur any costs under the agreement for the three months ended March 31, 2019 as there are no continuing obligations to reimburse Ares Trading paid a non-refundable upfront fee of $115.0 50% of the upfront fee, or $57.5 million, which was received from Intrexon in July 2015. Under the License Agreement, Precigen agreed to perform all future obligations of the Company under the Ares Trading Agreement other than certain payment obligations. Accordingly, the Company recognized the remaining deferred revenue as part of the settlement of related party relationships as described in Note 7. Patent and Technology License Agreement—The University of Texas MD Anderson Cancer Center and the Texas A&M University System On August 24, 200 4, the Company entered into a patent and technology license agreement with MD Anderson and the Texas A&M University System, which the Company refers to, collectively, as the Licensors. Under this agreement, the Company was granted an exclusive, worldwide license to rights (including rights to U.S. and foreign patent and patent applications and related improvements and know-how) for the manufacture and commercialization of two classes of organic arsenicals (water- and lipid-based) for human and animal use. The class of water-based organic arsenicals includes darinaparsin. The Company issued options to purchase 50,222 shares outside of its stock option $87 i.e. $1.0 $1.0 $4.5 Collaboration Agreement with Solasia Pharma K.K. On March 7, 2011, the Company entered into a License and Collaboration Agreement with Solasia. Pursuant to the License and Collaboration Agreement, the Company granted Solasia an exclusive license to develop and commercialize darinaparsin in both intravenous and oral forms and related organic arsenic molecules, in all indications for human use in a pan-Asian/Pacific territory comprising Japan, China, Hong Kong, Macau, Republic of Korea, Taiwan, Singapore, Australia, New Zealand, Malaysia, Indonesia, Philippines and Thailand. As consideration for the license, the Company received an upfront payment of $5.0 million to be used exclusively for further clinical development of darinaparsin outside of the pan-Asian/Pacific territory and will be entitled to receive additional payments of up to $32.5 million in development-based milestones and up to $53.5 million in sales-based milestones. The Company will also be entitled to receive double digit royalty payments from Solasia based upon net sales of licensed products in the applicable territories, once commercialized, and a percentage of sublicense revenues generated by Solasia. The $5.0 million upfront payment received in March 2011 was amortized over the period of the research and development effort, which was completed in March 2016. On July 31, 2014, the Company entered into an amendment and restatement of the License and Collaboration Agreement granting Solasia an exclusive worldwide license to develop and commercialize darinaparsin, and related organoarsenic molecules, in both intravenous and oral forms in all indications for human use. In exchange, the Company will be eligible to receive from Solasia development- and sales-based milestones, a royalty on net sales of darinaparsin, once commercialized, and a percentage of any sublicense revenues generated by Solasia. Solasia will be responsible for all costs related to the development, manufacturing and commercialization of darinaparsin. The Company’s Licensors, as defined in the agreement, will receive a portion of all milestone and royalty payments made by Solasia to the Company in accordance with the terms of the license agreement with the Licensors. On March 28, 2016, Solasia initiated a multi-center pivotal clinical trial intended to provide substantial evidence of efficacy necessary to support the filing of an application for an NDA for darinaparsin in certain of the territories assigned to Solasia. The initiation of the trial on March 28, 2016 triggered a $1.0 million milestone payment from Solasia to the Company which was received in May 2016. The Company subsequently made an equivalent payment to MD Anderson as the ultimate licensor of darinaparsin (see above). |
Related Party Transactions
Related Party Transactions | 3 Months Ended |
Mar. 31, 2019 | |
Related Party Transactions [Abstract] | |
Related Party Transactions | 7. Related Party Transactions Collaborations with Intrexon/ Precigen During the three months ended March 31, 2018, the Company issued an aggregate of 3,624 5.1 During the three months ended March 31, 2019, and 2018, the Company expensed $1.2 million and $2.8 million, respectively, for services performed by Precigen. As of March 31, 2019, and 2018, the Company recorded $0.9 million and $2.8 million, respectively, in current liabilities on its balance sheet for amounts due to Precigen. As discussed further in Note 1, on October 5, 2018, the Company entered into the License Agreement, the terms of which replaced the terms of the Channel Agreement. Collaboration with Precigen and MD Anderson On January 13, 2015, the Company, together with Intrexon, entered into the MD Anderson License with MD Anderson (which Intrexon subsequently assigned to Precigen). Pursuant to the MD Anderson License, the Company, together with Precigen, hold an exclusive, worldwide license to certain technologies owned and licensed by MD Anderson including technologies relating to novel CAR T-cell therapies, non-viral gene transfer systems, genetic modification and/or propagation of immune cells and other cellular therapy approaches, Natural Killer, or NK Cells, and TCRs, arising from the laboratory of Laurence Cooper, M.D., Ph.D., who became the Company’s Chief Executive Officer in May 2015 and was formerly a tenured professor of pediatrics at MD Anderson and is now currently a visiting scientist under that institution’s policies. In partial consideration for entering into the MD Anderson License, the Company issued MD Anderson an aggregate of 11,722,163 $67.3 The Company has determined that the rights acquired in the MD Anderson License represent in-process research and development with no alternative future use. During the three months ending March 31, 2018, the Company made one quarterly payment totaling $2.7 $41.9 Settlement of a Related Party Relationship Exclusive License Agreement with Precigen On October 5, 2018, the Company entered into the license agreement with Precigen. As between the Company and Precigen, the terms of the License Agreement replace the terms of: (a) the Channel Agreement, including all amendments to the Channel Agreement; (b) certain rights and obligations pursuant to the Ares Trading Agreement; (c) the MD Anderson License; and (d) the Research and Development Agreement, and any amendments or statements of work thereto. Pursuant to the terms of the License Agreement, Precigen has granted the Company an exclusive, worldwide, royalty-bearing, sub-licensable license to research, develop and commercialize (i) products utilizing Precigen’s RheoSwitch ® Sleeping Beauty The Company is solely responsible for all aspects of the research, development and commercialization of the exclusively licensed products for the treatment of cancer. The Company is required to use commercially reasonable efforts to develop and commercialize IL-12 Products and CD19 Products and after a two-year period, the TCR Products. Precigen has also granted the Company an exclusive, worldwide, royalty-bearing, sub-licensable license to research, develop and commercialize Gorilla IL-12 Products. Ziopharm agreed to reimburse Precigen for certain historical costs of the licensed programs up to $1.0 million, payable quarterly. The Company determined that the fair value of this program was $1.0 million and this was expensed in accordance with ASC 730, Research and Development during the year ended December 31, 2018 and it has been included in accrued expense on the balance sheet. The agreement also calls for an annual license fee of $100 thousand as long as the agreement is effective. The Company will also make milestone payments totaling up to an additional $52.5 million for each exclusively licensed program upon the initiation of later stage clinical trials and upon the approval of exclusively licensed products in various jurisdictions. In addition, the Company will pay Precigen tiered royalties ranging from low-single digit to high-single digit on the net sales derived from the sales of any approved IL-12 Products and CAR Products. The Company will also pay Precigen royalties ranging from low-single digit to mid-single digit on the net sales derived from the sales of any approved TCR Products, up to a maximum royalty amount of $100.0 million in the aggregate. The Company will also pay Precigen 20% of any sublicensing income received by the Company relating to the licensed products. The Company is responsible for all development costs associated with each of the licensed products, other than Gorilla IL-12 Products. The Company and Precigen will share the development costs and operating profits for Gorilla IL-12 Products, with the Company responsible for 80% of the development costs and receiving 80% of the operating profits, and Precigen responsible for the remaining 20% of the development costs and receiving 20% of the operating profits. Precigen will pay the Company royalties ranging from low-single digits to mid-single digits on the net sales derived from the sale of Precigen’s CAR products, up to $50.0 million. In consideration of the Company entering into the License Agreement, Intrexon forfeited and returned to the Company all shares of the Company’s Series 1 preferred stock held by or payable to Intrexon as of the date of the License Agreement. In addition, Precigen is required to transfer all of Ziopharm’s rights and obligations under the Ares Trading Agreement to Intrexon (or its affiliate). As a result, Ziopharm shall not be responsible for any remaining obligations under the Ares Trading Agreement. The Company determined that this transaction represented a capital transaction between related parties. The Company calculated the fair value of the preferred stock and the derivative liability on the date of the transaction, noting a total fair value of $163.3 million. The relinquishment of the Company’s obligation under the Ares Trading Agreement was also considered part of the overall capital transaction. The Company recognized an additional credit to accumulated deficit of $49.5 million as a result of the relief of the obligation under the Ares Trading Agreement (Note 8). The total amount of the settlement was $212.8 million. The Company incurred approximately $7.4 million of transaction advisory costs with third-party vendors, of which $5.4 million was considered a direct cost associated with the Series 1 preferred stock extinguishment and is also included as part of the consideration transferred. The remaining $2.0 million of transaction costs were recognized as an expense during the year ended December 31, 2018. The Company recognized a net credit to accumulated deficit of $207.3 million, calculated as the difference in the carrying value of the Series 1 preferred stock, derivative liability, and contract liability, and the consideration transferred of $5.4 million, in connection with the transaction. This amount is included in net income available to common shareholders in the calculation of earnings per share (Note 3). |
Leases
Leases | 3 Months Ended |
Mar. 31, 2019 | |
Leases, Operating [Abstract] | |
Leases | 8. Leases The Company adopted Topic 842 on January 1, 2019 using the effective date method, in which it did not restate prior periods. Upon adoption, the Company elected the package of practical expedients permitted under the transition guidance within Topic 842 which, among other things, allowed it to carry forward the historical lease classification. The Company does not allocate consideration in its leases to lease and non-lease components and does not record leases on its balance sheets with terms of 12 months or less. The Company uses its estimated incremental borrowing rate, which is derived from information available at the lease commencement date, in determining the present value of lease payments. The Company’s incremental borrowing rate represents the rate of interest that it would have to pay to borrow over a similar term an amount equal to the lease payments in a similar economic environment. The Company considers publicly available data for instruments with similar terms and characteristics when determining its incremental borrowing rates. The adoption of Topic 842 resulted in recognition of approximately $1.6 million of right-of-use assets and $1.6 million of lease liabilities on the Company’s balance sheets. The adoption did not have a material impact on the Company’s statements of operations or accumulated deficit. The Company has implemented changes to related processes, controls and disclosures in connection with the adoption of Topic 842. The Company will review the classification of newly entered leases as either an operating or a finance lease and recognize a related right-of-use asset and lease liabilities on its balance sheets upon commencement. In June 2012, the Company entered into a master lease for the Company’s corporate headquarters in Boston office, which was originally set to expire in August 2016. On December 21, 2015 and April 15, 2016, the Company renewed the sublease for the Company’s corporate headquarters, through August 31, 2021. As of March 31, 2019 and 2018, a total security deposit of $128 thousand is included in deposits on the balance sheet. On January 30, 2018, the Company entered into a lease agreement for office space in Houston at MD Anderson. Under the terms of the Houston lease agreement, the Company leases approximately two hundred and ten square feet and are required to make rental payments at an average monthly rate of approximately $1 thousand through April 2021. All future rent expense incurred in Houston, will be deducted from the Company’s prepayments at MD Anderson. On March 12, 2019, the Company entered into a lease agreement for office space in Houston. Under the terms of the Houston lease agreement, the Company leases approximately one thousand and thirty-eight square feet and is required to make rental payments at an average monthly rate of approximately $2 thousand through April 2021. As of March 31, 2019, a total security deposit of $2 thousand is included in deposits on the balance sheet. The components of lease expense were as follows: (in thousands) Three Months Ended Operating lease cost $ 178 Total lease cost $ 178 Weighted-average remaining lease term (years) 2.40 Weighted-average discount rate 8.00 % Cash paid for amounts included in the measurement of the lease liabilities were $178 thousand for the quarter ended March 31, 2019. As of March 31, 2019, the maturities of the Company’s operating lease liabilities were as follows (in thousands): Maturity of Lease Liabilities Operating Leases 2019 (excluding the three months ended March 31, 2019) 557 2020 755 2021 491 Total lease payments 1,803 Less: Imputed Interest 211 Present value of lease payments $ 1,592 Disclosures related to periods prior to adoption of the New Lease Standard Prior to the adoption of ASC 842, the Company recorded rent expense on a straight-line basis over the term of the lease under ASC 840. Total rent expense for the three months ended March 31, 2018 was approximately $178 thousand. For comparative purposes, the Company’s aggregate future minimum non-cancellable commitments under operating leases as of December 31, 2018 were as follows: 2019 723 2020 736 2021 488 Future minimum lease payments, net $ 1,947 |
Stock-Based Compensation
Stock-Based Compensation | 3 Months Ended |
Mar. 31, 2019 | |
Text Block [Abstract] | |
Stock-Based Compensation | 9. Stock-Based Compensation The Company recognized stock-based compensation expense on all employee and non-employee awards as follows: For the three months ended March 31, (in thousands) 2019 2018 Research and development $ 433 $ 603 General and administrative 1,023 3,056 Stock-based compensation expense $ 1,456 $ 3,659 The Company granted an aggregate of 1,496,333 stock options during the three months ended March 31, 2019 with a weighted-average grant date fair value of $1.62 per share. The Company granted an aggregate of 7,500 stock options during the three months ended March 31, 2018 with a weighted-average grant date fair value of $3.00 per share. The Company recognizes as they occur. For the three months ended March 31, 2019 and 2018, the fair value of stock options was estimated on the date of grant using a Black-Scholes option valuation model with the following assumptions: For the three months ended March 31, 2019 2018 Risk-free interest rate 2.28 - 2.53% 2.56 - 2.74% Expected life in years 6 - 6.25 6 Expected volatility 78.87 - 85.00% 80.75 - 81.10% Expected dividend yield 0 0 Stock option activity under the Company’s stock option plan for the three months ended March 31, 2019 is as follows: (in thousands, except share and per share data) Number of Shares Weighted- Average Exercise Price Weighted- Average Contractual Term (Years) Aggregate Intrinsic Value Outstanding, December 31, 2018 5,277,085 $ 4.24 Granted 1,496,333 2.24 Exercised — — Cancelled (1,357,333 ) 4.33 Outstanding, March 31, 2019 5,416,085 $ 3.66 7.82 $ 5,494 Options exercisable, March 31, 2019 2,213,008 $ 5.14 5.33 $ 1,025 Options exercisable, December 31, 2018 3,099,935 $ 5.15 4.93 $ 88 Options available for future grant 3,996,638 At March 31, 2019, total unrecognized compensation costs related to unvested stock options outstanding amounted to $6.2 million. The cost is expected to be recognized over a weighted-average period of 1.61 years. A summary of the status of unvested restricted stock for the three months ended March 31, 2019 is as follows: Number of Shares Weighted-Average Grant Date Fair Value Non-vested, December 31, 2018 682,070 $ 3.47 Granted 1,393,536 2.24 Vested (446,428 ) 2.24 Cancelled (7,333 ) 4.14 Non-vested, March 31, 2019 1,621,845 $ 2.92 At March 31, 2019, total unrecognized compensation costs related to unvested restricted stock outstanding amounted to $4.1 million. The cost is expected to be recognized over a weighted-average period of 1.59 years. |
Preferred Stock
Preferred Stock | 3 Months Ended |
Mar. 31, 2019 | |
Equity [Abstract] | |
Preferred Stock | 10. Preferred Stock The Company’s Board of Directors is authorized to designate any series of Preferred Stock, to fix and determine the variations in relative rights, preferences, privileges and restrictions as between and among such series. On June 29, 2016, 100,000 shares of its newly designated Series 1 preferred stock. Each share of the Company’s Series 1 preferred stock had a stated value of $1,200, subject to appropriate adjustment in the event of any stock dividend, stock split, combination or other recapitalization. The Series 1 preferred stock had certain rights, preferences, privileges and obligations, including dividend rights, conversion rights, consent rights with respect to certain Company actions, and rights to preferential payments in the event of any voluntary or involuntary liquidation, dissolution or winding up of the Company or a change of control or sale, lease, transfer or exclusive license of all or substantially all of the Company’s assets prior to the conversion of the Series 1 preferred stock. On October 5, 2018, the Company and Precigen entered into the License Agreement to replace all existing agreements between the companies, which provides the Company with certain exclusive and non-exclusive rights to technology controlled by Precigen. In consideration of the Company entering into the License Agreement, Intrexon forfeited and returned to the Company all shares of the Company’s Series 1 preferred stock held by or payable to Intrexon as of the date of the License Agreement (Notes 6 and 7). |
Derivative Financial Instrument
Derivative Financial Instruments | 3 Months Ended |
Mar. 31, 2019 | |
Derivative Instruments and Hedging Activities Disclosure [Abstract] | |
Derivative Financial Instruments | 11. Derivative Financial Instruments The Company determined that certain embedded features related to the Series 1 preferred stock were derivative financial instruments. The company values the embedded derivative financial instruments related to the Series 1 preferred stock as Level 3 financial liabilities (Note 3). On October 5, 2018, the Company entered into the License Agreement with Precigen. In partial consideration for the termination of the former agreements, the companies agreed that Intrexon would forfeit all outstanding shares of the Series 1 preferred stock held by Intrexon, including any accrued dividends (Note 10). |
Warrants
Warrants | 3 Months Ended |
Mar. 31, 2019 | |
Warrants Disclosure [Abstract] | |
Warrant | 12. Warrants The Company assesses whether an equity classified financial instrument is indexed to an entity’s own stock for purposes of determining whether a financial instrument should be treated as a derivative. In connection with the Company’s November 2018 private placement, the Company issued warrants to purchase an aggregate of 18,939,394 of $3.01 per share and have a five-year term. The relative fair value of the warrants was estimated at $18.4 million using a Black-Scholes model with the following assumptions: expected volatility of 71%, risk free interest rate of 2.99%, expected life of five years and no dividends. The Company assessed whether the warrants require accounting as derivatives. The Company determined that the warrants were (1) indexed to the Company’s own stock and (2) classified in stockholders’ equity in accordance with Financial Accounting Standards Board (FASB”) Accounting Standards Codification (“ASC”) Topic 815, Derivatives and Hedging . As such, the Company has concluded the warrants meet the scope exception for determining whether the instruments require accounting as derivatives and should be classified in stockholders’ equity. |
Summary of Significant Accoun_2
Summary of Significant Accounting Policies (Policies) | 3 Months Ended |
Mar. 31, 2019 | |
Accounting Policies [Abstract] | |
Leases | Leases In February 2016, the FASB issued ASU 2016-02, Leases (Topic 842), to increase transparency and comparability among organizations by requiring the recognition of a right-of-use assets and lease liabilities for most lease arrangements on the balance sheet. Under the standard, disclosures are required to meet the objective of enabling users of financial statements to assess the amount, timing, and uncertainty of cash flows arising from leases. The new standard is effective for fiscal years beginning after December 15, 2018, and the Company adopted the standard on January 1, 2019. The standard permits two transition methods, (1) to apply the new lease requirements at the beginning of the earliest period presented, or (2) to apply the new lease requirements at the effective date. Under both transition methods there is a cumulative effect adjustment. The Company adopted Topic 842 as of January 1, 2019 using the effective date method, in which it did not restate prior periods. Upon adoption, the Company elected the package of practical expedients permitted under the transition guidance within Topic 842 which, among other things, allowed it to carry forward the historical lease classification. The adoption of Topic 842 resulted in recognition of approximately $1.6 $1.6 million of lease liabilities on the Company’s balance sheets. The adoption did not have a material impact on the Company’s statements of operations or accumulated deficit. The Company has implemented changes to related processes, controls and disclosures in connection with the adoption of Topic 842 (Note 8). |
New Accounting Pronouncements | New Accounting Pronouncements In November 2016, the FASB issued ASU 2016-18, Statement of Cash Flows: Restricted Cash or ASU 2016-18. The amendments in this update require that amounts generally described as restricted cash and restricted cash equivalents be included within cash and cash equivalents when reconciling the beginning-of-period and end-of-period total amounts shown on the statement of cash flows. ASU 2016-18 was effective January 1, 2018. As a result of adopting ASU 2016-18, the Company includes its restricted cash balance in the cash and cash equivalents reconciliation of operating, investing and financing activities. The following table provides a reconciliation of cash, cash equivalents, and restricted cash within the statement of financial position that sum to the total of the same such amounts shown in the statement of cash flows. March 31, 2019 2018 (in thousands) Cash and cash equivalents $ 51,487 $ 51,108 Restricted cash included in prepaid expenses and other current assets — 389 Total cash, cash equivalents, and restricted cash shown in the statement of cash flows $ 51,487 $ 51,497 In August 2018, the FASB issued ASU No. 2018-13, Fair Value Measurement (Topic 820): Disclosure Framework—Changes to the Disclosure Requirements for Fair Value Measurement , or ASU 2018-03. The guidance in this ASU modify the disclosure requirements on fair value measurements in Topic 820, Fair Value Measurement. Under the new guidance, transfers between asset classes and the valuation related to level 3 assets is modified. The new standard is effective for annual reporting periods beginning after December 15, 2019, including interim reporting periods within each annual reporting period. The Company is currently evaluating the impact of the adoption of this ASU on the financial statements. In June 2018, the FASB issued ASU No. 2018-07, Compensation—Stock Compensation (Topic 718): Improvements to Nonemployee Share-Based Payment Accounting , or ASU 2018-07. The guidance in this ASU expand the scope of Topic 718 to include share-based payment transactions for acquiring goods and services from nonemployees. The new standard is effective for annual reporting periods beginning after December 15, 2019, including interim reporting periods within each annual reporting period. The Company is currently evaluating the impact of the adoption of this ASU on the financial statements. |
Summary of Significant Accoun_3
Summary of Significant Accounting Policies (Tables) | 3 Months Ended |
Mar. 31, 2019 | |
Accounting Policies [Abstract] | |
Schedule of Reconciliation of Cash, Cash Equivalents, and Restricted Cash | The following table provides a reconciliation of cash, cash equivalents, and restricted cash within the statement of financial position that sum to the total of the same such amounts shown in the statement of cash flows. March 31, 2019 2018 (in thousands) Cash and cash equivalents $ 51,487 $ 51,108 Restricted cash included in prepaid expenses and other current assets — 389 Total cash, cash equivalents, and restricted cash shown in the statement of cash flows $ 51,487 $ 51,497 |
Fair Value Measurements (Tables
Fair Value Measurements (Tables) | 3 Months Ended |
Mar. 31, 2019 | |
Fair Value Disclosures [Abstract] | |
Assets and Liabilities Measured at Fair Value on Recurring Basis | Assets and liabilities measured at fair value on a recurring basis as of March 31, 2019 and December 31, 2018 were as follows: ($ in thousands) Fair Value Measurements at Reporting Date Using Description Balance as of March 31, 2019 Quoted Prices in Active Markets for Identical Assets/Liabilities (Level 1) Significant Other Observable Inputs (Level 2) Significant Unobservable Inputs (Level 3) Assets: Cash equivalents $ 24,568 $ 24,568 $ — $ — ($ in thousands) Fair Value Measurements at Reporting Date Using Description Balance as of December 31, 2018 Quoted Prices in Active Markets for Identical Assets/Liabilities (Level 1) Significant Other Observable Inputs (Level 2) Significant Unobservable Inputs (Level 3) Cash equivalents $ 24,437 $ 24,437 $ — $ — |
Net Loss per Share (Tables)
Net Loss per Share (Tables) | 3 Months Ended |
Mar. 31, 2019 | |
Earnings Per Share [Abstract] | |
Potential Dilutive Shares Excluded from Computation of Diluted Net Loss Per Share | Such potentially dilutive shares of common stock at March 31, 2019 and 2018 consisted of the following: March 31, 2019 2018 Stock options 5,416,085 3,822,968 Unvested restricted stock 1,621,845 1,532,201 Warrants 18,939,394 — Preferred stock — 35,152,089 25,977,324 40,507,258 |
Leases (Tables)
Leases (Tables) | 3 Months Ended |
Mar. 31, 2019 | |
Leases, Operating [Abstract] | |
Components of Lease Expense | The components of lease expense were as follows: (in thousands) Three Months Ended Operating lease cost $ 178 Total lease cost $ 178 Weighted-average remaining lease term (years) 2.40 Weighted-average discount rate 8.00 % |
Lessee, Operating Lease, Liability, Maturity | As of March 31, 2019, the maturities of the Company’s operating lease liabilities were as follows (in thousands): Maturity of Lease Liabilities Operating Leases 2019 (excluding the three months ended March 31, 2019) 557 2020 755 2021 491 Total lease payments 1,803 Less: Imputed Interest 211 Present value of lease payments $ 1,592 |
Future Net Minimum Lease Payments under Operating Leases | For comparative purposes, the Company’s aggregate future minimum non-cancellable commitments under operating leases as of December 31, 2018 were as follows: 2019 723 2020 736 2021 488 Future minimum lease payments, net $ 1,947 |
Stock-Based Compensation (Table
Stock-Based Compensation (Tables) | 3 Months Ended |
Mar. 31, 2019 | |
Text Block [Abstract] | |
Stock-Based Compensation Expense on All Employee and Non-Employee Awards | The Company recognized stock-based compensation expense on all employee and non-employee awards as follows: For the three months ended March 31, (in thousands) 2019 2018 Research and development $ 433 $ 603 General and administrative 1,023 3,056 Stock-based compensation expense $ 1,456 $ 3,659 |
Fair Value of Stock Options Assumptions Using Black-Scholes Option Valuation Model | For the three months ended March 31, 2019 and 2018, the fair value of stock options was estimated on the date of grant using a Black-Scholes option valuation model with the following assumptions: For the three months ended March 31, 2019 2018 Risk-free interest rate 2.28 - 2.53% 2.56 - 2.74% Expected life in years 6 - 6.25 6 Expected volatility 78.87 - 85.00% 80.75 - 81.10% Expected dividend yield 0 0 |
Stock Option Activity under Stock Option Plan | Stock option activity under the Company’s stock option plan for the three months ended March 31, 2019 is as follows: (in thousands, except share and per share data) Number of Shares Weighted- Average Exercise Price Weighted- Average Contractual Term (Years) Aggregate Intrinsic Value Outstanding, December 31, 2018 5,277,085 $ 4.24 Granted 1,496,333 2.24 Exercised — — Cancelled (1,357,333 ) 4.33 Outstanding, March 31, 2019 5,416,085 $ 3.66 7.82 $ 5,494 Options exercisable, March 31, 2019 2,213,008 $ 5.14 5.33 $ 1,025 Options exercisable, December 31, 2018 3,099,935 $ 5.15 4.93 $ 88 Options available for future grant 3,996,638 |
Summary of Unvested Restricted Stock | A summary of the status of unvested restricted stock for the three months ended March 31, 2019 is as follows: Number of Shares Weighted-Average Grant Date Fair Value Non-vested, December 31, 2018 682,070 $ 3.47 Granted 1,393,536 2.24 Vested (446,428 ) 2.24 Cancelled (7,333 ) 4.14 Non-vested, March 31, 2019 1,621,845 $ 2.92 |
Business - Additional Informati
Business - Additional Information (Detail) - USD ($) $ in Thousands | 3 Months Ended | ||
Mar. 31, 2019 | Dec. 31, 2018 | Mar. 31, 2018 | |
Accounting Policies [Abstract] | |||
Cash and cash equivalents | $ 51,487 | $ 61,729 | $ 51,108 |
Accumulated deficit | (579,763) | $ (566,329) | |
Research and development expense related to joint venture | $ 35,000 |
Summary of Significant Accoun_4
Summary of Significant Accounting Policies - Additional Information (Detail) $ in Thousands | Mar. 31, 2019USD ($) |
Summary Of Significant Accounting Policies [Line Items] | |
Total operating lease liabilities | $ 1,592 |
Operating Lease, Right-of-Use Asset | $ 1,589 |
Lessee, Operating Lease, Term of Contract | 12 months |
ASU 2016-02 | |
Summary Of Significant Accounting Policies [Line Items] | |
Total operating lease liabilities | $ 1,600 |
Operating Lease, Right-of-Use Asset | $ 1,600 |
Reconciliation of Cash, Cash Eq
Reconciliation of Cash, Cash Equivalents, and Restricted Cash (Detail) - USD ($) $ in Thousands | Mar. 31, 2019 | Dec. 31, 2018 | Mar. 31, 2018 | Dec. 31, 2017 |
Cash and Cash Equivalents [Line Items] | ||||
Cash and cash equivalents | $ 51,487 | $ 61,729 | $ 51,108 | |
Restricted cash included in prepaid expenses and other current assets | 389 | |||
Total cash, cash equivalents, and restricted cash shown in the statement of cash flows | $ 51,487 | $ 61,729 | $ 51,497 | $ 71,335 |
Assets and Liabilities Measured
Assets and Liabilities Measured at Fair Value on Recurring Basis (Detail) - Fair Value, Measurements, Recurring - USD ($) $ in Thousands | Mar. 31, 2019 | Dec. 31, 2018 |
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Cash equivalents | $ 24,568 | $ 24,437 |
Quoted Prices in Active Markets for Identical Assets/Liabilities (Level 1) | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Cash equivalents | $ 24,568 | $ 24,437 |
Potential Dilutive Shares Exclu
Potential Dilutive Shares Excluded from Computation of Diluted Net Loss Per Share (Detail) - shares | 3 Months Ended | |
Mar. 31, 2019 | Mar. 31, 2018 | |
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Antidilutive securities excluded from computation of earnings per share, amount | 25,977,324 | 40,507,258 |
Warrants | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Antidilutive securities excluded from computation of earnings per share, amount | 18,939,394 | |
Stock Options | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Antidilutive securities excluded from computation of earnings per share, amount | 5,416,085 | 3,822,968 |
Unvested Restricted Stock | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Antidilutive securities excluded from computation of earnings per share, amount | 1,621,845 | 1,532,201 |
Series 1 Preferred Stock | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Antidilutive securities excluded from computation of earnings per share, amount | 35,152,089 |
Revenue Recognition - Additiona
Revenue Recognition - Additional Information (Detail) - USD ($) $ in Thousands | Mar. 31, 2019 | Dec. 31, 2018 | Jan. 01, 2018 | May 31, 2015 |
Revenue, Initial Application Period Cumulative Effect Transition [Line Items] | ||||
Accumulated deficit | $ (579,763) | $ (566,329) | ||
Difference between Revenue Guidance in Effect before and after Topic 606 | ASU 2014-09 | ||||
Revenue, Initial Application Period Cumulative Effect Transition [Line Items] | ||||
Accumulated deficit | $ (8,100) | |||
ARES Trading License | ||||
Revenue, Initial Application Period Cumulative Effect Transition [Line Items] | ||||
Deferred revenue, upfront payment | $ 57,500 |
Commitments and Contingencies -
Commitments and Contingencies - Additional Information (Detail) $ in Thousands | Oct. 05, 2018USD ($) | Jan. 13, 2015USD ($) | May 07, 2011USD ($) | Mar. 07, 2011USD ($) | Jul. 31, 2015USD ($) | Aug. 24, 2004Patent | Mar. 31, 2019USD ($)shares | Mar. 31, 2018USD ($) | Dec. 31, 2018USD ($) | Dec. 31, 2017 | Feb. 19, 2019USD ($) | Jan. 30, 2018ft² | Mar. 31, 2016USD ($) | Dec. 31, 2014USD ($) |
Commitments and Contingencies Disclosure [Line Items] | ||||||||||||||
Research and development expense | $ 9,476 | $ 10,183 | $ 1,000 | |||||||||||
Research and development arrangement Terms | Pursuant to the Research and Development Agreement, the Company, Precigen and MD Anderson have agreed to form a joint steering committee that will oversee and manage the new and ongoing research programs. Under the License Agreement with Precigen, the Company and Precigen agreed that Precigen would no longer participate on the joint steering committee after the date of the License Agreement. As provided under the MD Anderson License, the Company provided funding for research and development activities in support of the research programs under the Research and Development Agreement for a period of three years and in an amount of no less than $15.0 million and no greater than $20.0 million per year. | |||||||||||||
Cash balance | 51,487 | 51,108 | $ 61,729 | |||||||||||
Agreement commencement date | 2015-05 | |||||||||||||
Reimbursement of historical costs | $ 1,000 | |||||||||||||
MD Anderson License and the Research and Development Agreement Member [Member] | ||||||||||||||
Commitments and Contingencies Disclosure [Line Items] | ||||||||||||||
Research and development service agreement aggregate quarterly payments | 1,400 | |||||||||||||
Cash resources on hand | 26,400 | |||||||||||||
CRADA Agreement [Member] | ||||||||||||||
Commitments and Contingencies Disclosure [Line Items] | ||||||||||||||
Obligations due under contract | $ 5,000 | |||||||||||||
Remaining contractual obligation | $ 6,900 | |||||||||||||
Quarterly payments under contract | $ 625 | 625 | ||||||||||||
Gorilla IL12 Products [Member] | Parent [Member] | ||||||||||||||
Commitments and Contingencies Disclosure [Line Items] | ||||||||||||||
Percentage of development costs | 80.00% | |||||||||||||
Percentage of operating profits | 80.00% | |||||||||||||
CAR Products [Member] | ||||||||||||||
Commitments and Contingencies Disclosure [Line Items] | ||||||||||||||
Amount of royalties receivable | $ 50,000 | |||||||||||||
The University of Texas MD Anderson Cancer Center and The Texas A & M University System | ||||||||||||||
Commitments and Contingencies Disclosure [Line Items] | ||||||||||||||
Milestone maximum payment | $ 4,500 | |||||||||||||
Number of products | Patent | 2 | |||||||||||||
Options to purchase common stock | shares | 50,222 | |||||||||||||
The University of Texas MD Anderson Cancer Center and The Texas A & M University System | Research and Development Expense | ||||||||||||||
Commitments and Contingencies Disclosure [Line Items] | ||||||||||||||
Issuance of common stock in a license agreement | $ 87 | |||||||||||||
Solasia | ||||||||||||||
Commitments and Contingencies Disclosure [Line Items] | ||||||||||||||
Upfront payment received | $ 5,000 | $ 5,000 | ||||||||||||
Milestone payment received | $ 1,000 | |||||||||||||
Milestone Payments Payable | $ 1,000 | |||||||||||||
Solasia | Development-based milestones | ||||||||||||||
Commitments and Contingencies Disclosure [Line Items] | ||||||||||||||
Expected Additional milestone payments to be received | 32,500 | |||||||||||||
Solasia | Sales-based milestones | ||||||||||||||
Commitments and Contingencies Disclosure [Line Items] | ||||||||||||||
Expected Additional milestone payments to be received | $ 53,500 | |||||||||||||
ARES Trading License | ||||||||||||||
Commitments and Contingencies Disclosure [Line Items] | ||||||||||||||
Research and development expense | $ 1,600 | |||||||||||||
Agreement termination, notice period | 90 days | |||||||||||||
Prepaid Expenses and Other Current Assets | MD Anderson License | ||||||||||||||
Commitments and Contingencies Disclosure [Line Items] | ||||||||||||||
Cash balance | $ 19,800 | |||||||||||||
Other Noncurrent Assets | MD Anderson License and the Research and Development Agreement Member [Member] | ||||||||||||||
Commitments and Contingencies Disclosure [Line Items] | ||||||||||||||
Cash resources on hand | 6,600 | |||||||||||||
Other Noncurrent Assets | MD Anderson License | ||||||||||||||
Commitments and Contingencies Disclosure [Line Items] | ||||||||||||||
Cash balance | $ 6,600 | |||||||||||||
Intrexon Corporation | ||||||||||||||
Commitments and Contingencies Disclosure [Line Items] | ||||||||||||||
Licensing fee | $ 115,000 | |||||||||||||
Milestone payment receivable period | 2 years | |||||||||||||
Upfront payment received | $ 57,500 | |||||||||||||
Percentage of upfront fee Payable | 50.00% | |||||||||||||
Annual Licensing fee | 100 | |||||||||||||
Reimbursement of historical costs | 1,000 | |||||||||||||
Expected additional milestones payable | $ 52,500 | |||||||||||||
Intrexon Corporation | Gorilla IL12 Products [Member] | ||||||||||||||
Commitments and Contingencies Disclosure [Line Items] | ||||||||||||||
Percentage of development costs | 20.00% | |||||||||||||
Percentage of operating profits | 20.00% | |||||||||||||
Intrexon Corporation | T-cell receptor | ||||||||||||||
Commitments and Contingencies Disclosure [Line Items] | ||||||||||||||
Maximum royalty amount | $ 100,000 | |||||||||||||
Portion of income payable to related party | 20.00% | |||||||||||||
Minimum | MD Anderson License and the Research and Development Agreement Member [Member] | ||||||||||||||
Commitments and Contingencies Disclosure [Line Items] | ||||||||||||||
Research and development expense | $ 15,000 | |||||||||||||
Maximum | MD Anderson License and the Research and Development Agreement Member [Member] | ||||||||||||||
Commitments and Contingencies Disclosure [Line Items] | ||||||||||||||
Research and development expense | $ 20,000 | |||||||||||||
Houston, TX | ||||||||||||||
Commitments and Contingencies Disclosure [Line Items] | ||||||||||||||
Operating lease area | ft² | 210 |
Related Party Transactions - Ad
Related Party Transactions - Additional Information (Detail) - USD ($) | Oct. 05, 2018 | Jun. 29, 2016 | Mar. 31, 2019 | Mar. 31, 2018 | Dec. 31, 2018 | Dec. 31, 2015 |
Related Party Transaction [Line Items] | ||||||
Change in fair value of derivative liability | $ 28,000 | |||||
Amounts expensed for services incurred | $ 13,621,000 | 16,342,000 | ||||
Research and development expense | 9,476,000 | 10,183,000 | $ 1,000,000 | |||
Aggregate Amount Potentially Reimburseable Amount | $ 1,000,000 | |||||
Related Party Transaction Expenses From Transactions With Related Party Advisory Fees | $ 2,000,000 | |||||
MD Anderson License and the Research and Development Agreement Member [Member] | ||||||
Related Party Transaction [Line Items] | ||||||
Research and development service agreement aggregate quarterly payments | 1,400,000 | |||||
Cash resources on hand | 26,400,000 | |||||
MD Anderson License and the Research and Development Agreement Member [Member] | Other Current Assets [Member] | ||||||
Related Party Transaction [Line Items] | ||||||
Cash resources on hand | 19,800,000 | |||||
MD Anderson License and the Research and Development Agreement Member [Member] | Other Noncurrent Assets [Member] | ||||||
Related Party Transaction [Line Items] | ||||||
Cash resources on hand | 6,600,000 | |||||
Gorilla IL-12 Products | ||||||
Related Party Transaction [Line Items] | ||||||
Percentage of development cost shared by other party | 80.00% | |||||
Percentage of operating profit shared by other party | 80.00% | |||||
Series 1 Preferred Stock | ||||||
Related Party Transaction [Line Items] | ||||||
Temporary equity, fair value | 5,100,000 | |||||
Change in fair value of derivative liability | (165,000) | 28,000 | ||||
Related Party Transaction Expenses From Transactions With Related Party Advisory Fees | $ 5,400,000 | |||||
License Agreement | M.D. Anderson Cancer Center | ||||||
Related Party Transaction [Line Items] | ||||||
Issuance of common stock in licensing agreement (in shares) | 11,722,163 | |||||
Research and development expense | $ 67,300,000 | |||||
Cooperative Research and Development Agreement | M.D. Anderson Cancer Center | ||||||
Related Party Transaction [Line Items] | ||||||
Research and development service agreement aggregate quarterly payments | 2,700,000 | |||||
Research and development service agreement aggregate payments | 41,900,000 | |||||
Intrexon Corporation/Precigen | ||||||
Related Party Transaction [Line Items] | ||||||
Amounts expensed for services incurred | 1,200,000 | 2,800,000 | ||||
Amount due to related party, current | $ 900,000 | $ 2,800,000 | ||||
Aggregate Amount Potentially Reimburseable Amount | 1,000,000 | |||||
Annual License Fees | 100,000 | |||||
Additional Milestone Payment Payable For Licensed Program | 52,500,000 | |||||
Maximum Royalty payable | $ 100,000,000 | |||||
Percentage Of Sublicensing Income | 20.00% | |||||
Maximum Royalty Receivables | $ 50,000,000 | |||||
Preferred Stock Contract Liability Derivative Liability | 163,300,000 | |||||
Increase in Accumulated Deficit | 49,500,000 | |||||
Related Party Transaction, Amounts of Transaction | $ 212,800,000 | |||||
Intrexon Corporation/Precigen | Gorilla IL-12 Products | ||||||
Related Party Transaction [Line Items] | ||||||
Percentage of development cost shared by other party | 20.00% | |||||
Percentage of operating profit shared by other party | 20.00% | |||||
Intrexon Corporation/Precigen | Series 1 Preferred Stock | ||||||
Related Party Transaction [Line Items] | ||||||
Issuance of common stock in licensing agreement (in shares) | 100,000 | 3,624 | ||||
Consideration Transferred in License Agreement | $ 207,300,000 | |||||
Preferred Stock Redemption Discount | 5,400,000 | |||||
Third Party Vendor [Member] | ||||||
Related Party Transaction [Line Items] | ||||||
Related Party Transaction Expenses From Transactions With Related Party Advisory Fees | $ 7,400,000 |
Lease expense (Detail)
Lease expense (Detail) $ in Thousands | 3 Months Ended |
Mar. 31, 2019USD ($) | |
Operating lease cost | $ 178 |
Total lease cost | $ 178 |
Weighted-average remaining lease term (years) | 2 years 4 months 24 days |
Weighted-average discount rate | 8.00% |
Operating lease liabilities (De
Operating lease liabilities (Detail) $ in Thousands | Mar. 31, 2019USD ($) |
2019 (excluding the three months ended March 31, 2019) | $ 557 |
2020 | 755 |
2021 | 491 |
Total lease payments | 1,803 |
Less: Imputed Interest | 211 |
Present value of lease payments | $ 1,592 |
Future minimum current and non-
Future minimum current and non-current lease liabilities (Detail) $ in Thousands | Dec. 31, 2018USD ($) |
2019 | $ 723 |
2020 | 736 |
2021 | 488 |
Future minimum lease payments, net | $ 1,947 |
Leases - Additional Information
Leases - Additional Information (Details) $ in Thousands | Mar. 12, 2019USD ($)ft² | Mar. 31, 2019USD ($) | Mar. 31, 2018USD ($) | Jan. 01, 2019USD ($) | Jan. 30, 2018USD ($)ft² |
Land Subject to Ground Leases | ft² | 1,038 | ||||
Lessee Operating Lease Monthly Average Rental Payment | $ 2 | ||||
Operating Lease, Payments | $ 178 | ||||
Operating Leases, Rent Expense, Net | $ 178 | ||||
Security Deposit | 2 | ||||
Operating Lease, Right-of-Use Asset | 1,589 | ||||
Operating Lease, Liability | 1,592 | ||||
Boston, MA | |||||
Security Deposit | $ 128 | $ 128 | |||
Sublease term amendment | Aug. 31, 2021 | ||||
Operating lease expiration month and year | 2016-08 | ||||
Houston, TX | |||||
Operating Lease Area | ft² | 210 | ||||
Operating Leases Future Minimum Monthly Payment Due Through Year 2021 | $ 1 | ||||
Adjustments for New Accounting Pronouncement [Member] | |||||
Operating Lease, Right-of-Use Asset | $ 1,600 | ||||
Operating Lease, Liability | $ 1,600 |
Stock-Based Compensation Expens
Stock-Based Compensation Expense Included in Statement of Operations (Detail) - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2019 | Mar. 31, 2018 | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Stock-based compensation | $ 1,456 | $ 3,659 |
Research and Development Expense | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Stock-based compensation | 433 | 603 |
General and Administrative Expense | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Stock-based compensation | $ 1,023 | $ 3,056 |
Stock-Based Compensation - Addi
Stock-Based Compensation - Additional Information (Detail) - USD ($) | 3 Months Ended | |
Mar. 31, 2019 | Mar. 31, 2018 | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Stock options, granted | 1,496,333 | 7,500 |
Weighted-average grant date fair value | $ 1.62 | $ 3 |
Unvested Stock | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Unrecognized compensation costs related to unvested restricted stock outstanding | $ 6,200,000 | |
Expected recognition period | 1 year 7 months 9 days | |
Unvested Restricted Common Stock | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Unrecognized compensation costs related to unvested restricted stock outstanding | $ 4,100,000 | |
Expected recognition period | 1 year 7 months 2 days |
Fair Value of Stock Options Ass
Fair Value of Stock Options Assumptions Using Black-Scholes Option Valuation Model (Detail) | 3 Months Ended | |
Mar. 31, 2019 | Mar. 31, 2018 | |
Risk-free interest rate, Minimum | 2.28% | 2.56% |
Risk-free interest rate, Maximum | 2.53% | 2.74% |
Expected life in years | 6 years | |
Expected volatility, Minimum | 78.87% | 80.75% |
Expected volatility, Maximum | 85.00% | 81.10% |
Expected dividend yield | 0.00% | 0.00% |
Maximum [Member] | ||
Expected life in years | 6 years 3 months | |
Minimum [Member] | ||
Expected life in years | 6 years |
Stock Option Activity Under Sto
Stock Option Activity Under Stock Option Plan (Detail) - USD ($) $ / shares in Units, $ in Thousands | 3 Months Ended | 12 Months Ended | |
Mar. 31, 2019 | Mar. 31, 2018 | Dec. 31, 2018 | |
Number of Shares | |||
Beginning Balance | 5,277,085 | ||
Granted | 1,496,333 | 7,500 | |
Cancelled | (1,357,333) | ||
Ending Balance | 5,416,085 | 5,277,085 | |
Options exercisable, at end of period | 2,213,008 | 3,099,935 | |
Options available for future grant | 3,996,638 | ||
Weighted Average Exercise Price | |||
Beginning Balance | $ 4.24 | ||
Granted | 2.24 | ||
Cancelled | 4.33 | ||
Ending Balance | 3.66 | $ 4.24 | |
Options exercisable, at end of period | $ 5.14 | $ 5.15 | |
Weighted Average Contractual Term (Years) | |||
Outstanding, at end of period | 7 years 9 months 25 days | ||
Options exercisable, at end of period | 5 years 3 months 29 days | 4 years 11 months 4 days | |
Aggregate Intrinsic Value | |||
Outstanding, at end of period | $ 5,494 | ||
Options exercisable, at end of period | $ 1,025 | $ 88 |
Summary of Non-Vested Restricte
Summary of Non-Vested Restricted Stock (Detail) - Unvested Restricted Common Stock | 3 Months Ended |
Mar. 31, 2019$ / sharesshares | |
Number of Shares | |
Beginning Balance | shares | 682,070 |
Granted | shares | 1,393,536 |
Vested | shares | (446,428) |
Cancelled | shares | (7,333) |
Ending Balance | shares | 1,621,845 |
Weighted Average Grant Date Fair Value | |
Beginning Balance | $ / shares | $ 3.47 |
Granted | $ / shares | 2.24 |
Vested | $ / shares | 2.24 |
Cancelled | $ / shares | 4.14 |
Ending Balance | $ / shares | $ 2.92 |
Preferred Stock - Additional In
Preferred Stock - Additional Information (Detail) - Intrexon Corporation/Precigen - Series 1 Preferred Stock - $ / shares | Jun. 29, 2016 | Mar. 31, 2018 |
Equity [Line Items] | ||
Issuance of common stock in licensing agreement (in shares) | 100,000 | 3,624 |
Preferred stock, stated value | $ 1,200 |
Warrants - Additional Informati
Warrants - Additional Information (Detail) - USD ($) $ / shares in Units, $ in Millions | 3 Months Ended | |
Mar. 31, 2019 | Mar. 31, 2018 | |
Fair Value Assumptions Expected volatility Rate Maximum | 85.00% | 81.10% |
Fair Value Assumptions Risk Free Interest Rate Maximum | 2.53% | 2.74% |
Fair Value Assumptions Expected Term1 | 6 years | |
Fair Value Assumptions Expected Dividend Rate | 0.00% | 0.00% |
Private Placement [Member] | ||
Number of securities into which the class of warrant converted | 18,939,394 | |
Warrant Exercise Per share | $ 3.01 | |
fair value of adjustment of warrants | $ 18.4 | |
Fair Value Assumptions Expected volatility Rate Maximum | 71.00% | |
Fair Value Assumptions Risk Free Interest Rate Maximum | 2.99% | |
Fair Value Assumptions Expected Term1 | 5 years | |
Fair Value Assumptions Expected Dividend Rate | 0.00% |