Cover Page
Cover Page - shares | 9 Months Ended | |
Sep. 30, 2022 | Nov. 09, 2022 | |
Cover [Abstract] | ||
Document Type | 10-Q | |
Amendment Flag | false | |
Document Period End Date | Sep. 30, 2022 | |
Document Fiscal Year Focus | 2022 | |
Document Fiscal Period Focus | Q3 | |
Document Quarterly Report | true | |
Document Transition Report | false | |
Entity Registrant Name | Alaunos Therapeutics, Inc. | |
Entity Central Index Key | 0001107421 | |
Current Fiscal Year End Date | --12-31 | |
Entity Filer Category | Non-accelerated Filer | |
Trading Symbol | TCRT | |
Entity Emerging Growth Company | false | |
Entity Small Business | true | |
Entity Common Stock, Shares Outstanding | 216,182,042 | |
Entity Interactive Data Current | Yes | |
Title of 12(b) Security | Common Stock | |
Security Exchange Name | NASDAQ | |
Entity Current Reporting Status | Yes | |
Entity Shell Company | false | |
Entity File Number | 001-33038 | |
Entity Incorporation, State or Country Code | DE | |
Entity Tax Identification Number | 84-1475642 | |
Entity Address, Address Line One | 8030 El Rio Street | |
Entity Address, City or Town | Houston | |
Entity Address, State or Province | TX | |
Entity Address, Postal Zip Code | 77054 | |
City Area Code | 346 | |
Local Phone Number | 355-4099 |
BALANCE SHEETS
BALANCE SHEETS - USD ($) $ in Thousands | Sep. 30, 2022 | Dec. 31, 2021 |
Current assets: | ||
Cash and cash equivalents | $ 37,807 | $ 76,054 |
Restricted cash | 13,938 | 0 |
Receivables | 2,911 | 1,111 |
Prepaid expenses and other current assets | 849 | 1,666 |
Total current assets | 55,505 | 78,831 |
Property and equipment, net | 9,050 | 10,941 |
Right of use asset | 2,247 | 4,420 |
Deposits | 42 | 42 |
Other non-current assets | 500 | 631 |
Total assets | 67,344 | 94,865 |
Current liabilities: | ||
Accounts payable | 1,984 | 1,368 |
Current portion of long-term debt | 22,668 | 7,868 |
Accrued expenses | 7,675 | 6,076 |
Lease liability, current | 542 | 729 |
Total current liabilities | 32,869 | 16,041 |
Long-term debt | 0 | 16,250 |
Lease liability, non-current | 2,334 | 4,518 |
Other non-current liabilities | 28 | 0 |
Total liabilities | 35,231 | 36,809 |
Commitments and contingencies (Note 9) | ||
Stockholders' equity | ||
Common stock $0.001 par value; 420,000,000 shares authorized, 216,182,042 shares issued and outstanding at September 30, 2022 and 350,000,000 shares authorized, 216,127,443 shares issued and outstanding at December 31, 2021 | 216 | 216 |
Additional paid-in capital | 903,365 | 900,693 |
Accumulated deficit | (871,468) | (842,852) |
Total stockholders' equity | 32,113 | 58,057 |
Total liabilities and stockholders' equity | $ 67,344 | $ 94,865 |
BALANCE SHEETS (Parenthetical)
BALANCE SHEETS (Parenthetical) - $ / shares | Sep. 30, 2022 | Dec. 31, 2021 |
Statement of Financial Position [Abstract] | ||
Common stock, par value | $ 0.001 | $ 0.001 |
Common stock, shares authorized | 420,000,000 | 350,000,000 |
Common stock, shares issued | 216,182,042 | 216,127,443 |
Common stock, shares outstanding | 216,182,042 | 216,127,443 |
STATEMENTS OF OPERATIONS
STATEMENTS OF OPERATIONS - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2022 | Sep. 30, 2021 | Sep. 30, 2022 | Sep. 30, 2021 | |
Income Statement [Abstract] | ||||
Collaboration revenue | $ 2,911 | $ 398 | $ 2,911 | $ 398 |
Operating expenses: | ||||
Research and development | 7,893 | 14,521 | 19,411 | 41,427 |
General and administrative | 3,282 | 8,173 | 10,217 | 25,469 |
Gain on lease modification | 0 | 0 | (133) | 0 |
Total operating expenses | 11,175 | 22,694 | 29,495 | 66,896 |
Loss from operations | (8,264) | (22,296) | (26,584) | (66,498) |
Other income (expense): | ||||
Interest Expense | (841) | (444) | (2,266) | (444) |
Other income (expense), net | 254 | 7 | 279 | (15) |
Other income (expense), net | (587) | (437) | (1,987) | (459) |
Net loss | $ (8,851) | $ (22,733) | $ (28,571) | $ (66,957) |
Earnings per share, Basic | $ (0.04) | $ (0.11) | $ (0.13) | $ (0.31) |
Earnings per share, Diluted | $ (0.04) | $ (0.11) | $ (0.13) | $ (0.31) |
Weighted Average Number Of Shares Outstanding Basic | 215,098,995 | 214,542,465 | 215,015,377 | 214,310,349 |
Weighted Average Number Of Diluted Shares Outstanding | 215,098,995 | 214,542,465 | 215,015,377 | 214,310,349 |
STATEMENTS OF CHANGES IN STOCKH
STATEMENTS OF CHANGES IN STOCKHOLDERS' EQUITY - USD ($) $ in Thousands | Total | Common Stock | Additional Paid In Capital | Accumulated Deficit |
Balance at Dec. 31, 2020 | $ 123,982 | $ 215 | $ 887,868 | $ (764,101) |
Balance (in shares) at Dec. 31, 2020 | 214,591,906 | |||
Stock-based compensation | 9,857 | 9,857 | ||
Exercise of employee stock options | 1,037 | 1,037 | ||
Exercise of employee stock options (in shares) | 363,109 | |||
Restricted stock awards | $ 1 | (1) | ||
Restricted stock awards (in shares) | 1,601,224 | |||
Cancelled restricted common stock (in shares) | (410,435) | |||
Issuance of warrants | 788 | 788 | ||
Net loss | (66,957) | (66,957) | ||
Balance at Sep. 30, 2021 | 68,707 | $ 216 | 899,549 | (831,058) |
Balance (in shares) at Sep. 30, 2021 | 216,145,804 | |||
Balance at Jun. 30, 2021 | 88,281 | $ 216 | 896,390 | (808,325) |
Balance (in shares) at Jun. 30, 2021 | 215,559,148 | |||
Stock-based compensation | 2,371 | 2,371 | ||
Restricted stock awards (in shares) | 875,000 | |||
Cancelled restricted common stock (in shares) | (288,344) | |||
Issuance of warrants | 788 | 788 | ||
Net loss | (22,733) | (22,733) | ||
Balance at Sep. 30, 2021 | 68,707 | $ 216 | 899,549 | (831,058) |
Balance (in shares) at Sep. 30, 2021 | 216,145,804 | |||
Balance at Dec. 31, 2021 | 58,057 | $ 216 | 900,693 | (842,852) |
Balance (in shares) at Dec. 31, 2021 | 216,127,443 | |||
Stock-based compensation | 2,651 | 2,651 | ||
Exercise of employee stock options | $ 21 | 21 | ||
Exercise of employee stock options (in shares) | 26,250 | 26,250 | ||
Repurchase of common stock | $ (45) | (45) | ||
Repurchase of common stock (in Shares) | (18,750) | |||
Restricted stock awards (in shares) | 280,000 | |||
Cancelled restricted common stock (in shares) | (232,901) | |||
Net loss | (28,571) | (28,571) | ||
Balance at Sep. 30, 2022 | 32,113 | $ 216 | 903,365 | (871,468) |
Balance (in shares) at Sep. 30, 2022 | 216,182,042 | |||
Balance at Jun. 30, 2022 | 40,180 | $ 216 | 902,536 | (862,572) |
Balance (in shares) at Jun. 30, 2022 | 216,174,542 | |||
Stock-based compensation | 808 | 808 | ||
Exercise of employee stock options | 21 | 21 | ||
Exercise of employee stock options (in shares) | 26,250 | |||
Repurchase of common stock | (45) | (45) | ||
Repurchase of common stock (in Shares) | (18,750) | |||
Net loss | (8,851) | (8,851) | ||
Balance at Sep. 30, 2022 | $ 32,113 | $ 216 | $ 903,365 | $ (871,468) |
Balance (in shares) at Sep. 30, 2022 | 216,182,042 |
STATEMENTS OF CASH FLOWS
STATEMENTS OF CASH FLOWS - USD ($) $ in Thousands | 9 Months Ended | |
Sep. 30, 2022 | Sep. 30, 2021 | |
Cash flows from operating activities: | ||
Net loss | $ (28,571) | $ (66,957) |
Adjustments to reconcile net loss to net cash used in operating activities: | ||
Depreciation | 2,065 | 1,892 |
Amortization of financing costs | 634 | 148 |
Stock-based compensation | 2,651 | 9,857 |
Decrease (increase) in the carrying amount of right-of-use assets | 2,306 | (529) |
Gain on lease modification | (133) | 0 |
(Increase) decrease in: | ||
Receivables | (1,800) | 3,155 |
Prepaid expenses and other current assets | 817 | 7,646 |
Other non-current assets | 131 | 508 |
Increase (decrease) in: | ||
Accounts payable | 616 | 503 |
Accrued expenses | 1,525 | (3,169) |
Lease liabilities | (2,371) | 604 |
Other non-current liabilities | 28 | 0 |
Net cash used in operating activities | (22,102) | (46,342) |
Cash flows from investing activities: | ||
Purchases of property and equipment | (100) | (2,964) |
Net cash used in investing activities | (100) | (2,964) |
Cash flows from financing activities: | ||
Proceeds from long-term debt borrowing | 0 | 25,000 |
Debt issuance costs | 0 | (75) |
Proceeds from the exercise of stock options | 21 | 1,037 |
Repurchase of common stock | (45) | 0 |
Repayment of long-term debt | (2,083) | 0 |
Net cash provided by (used in) financing activities | (2,107) | 25,962 |
Net decrease in cash, cash equivalents and restricted cash | (24,309) | (23,344) |
Cash, cash equivalents and restricted cash, beginning of period | 76,054 | 115,069 |
Cash, cash equivalents and restricted cash, end of period | 51,745 | 91,725 |
Supplementary disclosure of cash flow information: | ||
Cash paid for interest | 1,603 | 136 |
Amounts included in accrued expenses and accounts payable related to property and equipment | $ 74 | $ 348 |
Organization
Organization | 9 Months Ended |
Sep. 30, 2022 | |
Accounting Policies [Abstract] | |
Organization | 1. Organization Overview Alaunos Therapeutics, Inc., which is referred to herein as “Alaunos,” or the “Company,” is a clinical-stage oncology-focused cell therapy company developing adoptive TCR-T cell therapies, designed to treat multiple solid tumor types in large cancer patient populations with unmet clinical needs. On January 25, 2022, the Company changed its corporate name from ZIOPHARM Oncology, Inc. to Alaunos Therapeutics, Inc. The Company is leveraging its proprietary, non-viral Sleeping Beauty gene transfer platform and its cancer hotspot mutation TCR library to design and manufacture autologous cell therapies that target neoantigens arising from shared tumor-specific mutations in key oncogenic genes, including KRAS, TP53 and EGFR. The Company’s operations to date have consisted primarily of conducting research and development and raising capital to fund those efforts. In May 2021, the Company announced that it will be winding down its existing Controlled IL-12 clinical program. The Company continues to seek a partner for this program. The accompanying financial statements have been prepared on a going concern basis, which contemplates the realization of assets and satisfaction of liabilities and commitments in the normal course of business. The Company follows the guidance of Accounting Standards Codification ("ASC") Topic 205-40, Presentation of Financial Statements - Going Concern, in order to determine whether there is substantial doubt about its ability to continue as a going concern for one year after the date its financial statements are issued. The Company has operated at a loss since its inception in 2003 and has no recurring revenue from operations. The Company anticipates that losses will continue for the foreseeable future. As of September 30, 2022, the Company had approximately $ 37.8 million of cash and cash equivalents and $ 13.9 million of restricted cash related to the Company's debt agreement (see Note 4). The Company’s accumulated deficit at September 30, 2022 was approximately $ 871.5 million. Given its current development plans and cash management efforts, the Company anticipates cash resources will be sufficient to fund operations into the second quarter of 2023. The Company’s ability to continue operations after its current cash resources are exhausted depends on its ability to obtain additional financing, 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, management may need to curtail its development efforts and planned operations to conserve cash. Based on the current cash forecast, management has determined that the Company's present capital resources will not be sufficient to fund its planned operations for at least one year from the issuance date of the financial statements, which raises substantial doubt as to the Company's ability to continue as a going concern. This forecast of cash resources is forward-looking information that involves risks and uncertainties, and the actual amount of expenses could vary materially and adversely as a result of a number of factors. As of September 30, 2022, there were 216,182,042 shares of common stock outstanding and an additional 33,545,557 shares of common stock reserved for issuance pursuant to outstanding stock options and warrants. 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, or GAAP, 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 presentation of the financial position of the Company and its results of operations and cash flows for the periods presented. 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, 2021, included in the Company’s Annual Report on Form 10-K for the fiscal year ended December 31, 2021 filed with the SEC on March 30, 2022, or the Annual Report. The results disclosed in the statements of operations for the three and nine months ended September 30, 2022 are not necessarily indicative of the results to be expected for the full fiscal year 2022. Use of Estimates The preparation of financial statements in conformity with GAAP 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. |
Financings
Financings | 9 Months Ended |
Sep. 30, 2022 | |
Text Block [Abstract] | |
Financings | 2. Financings 2021 Loan and Security Agreement On August 6, 2021, the Company entered into a Loan and Security Agreement (the "Loan and Security Agreement") with Silicon Valley Bank and affiliates of Silicon Valley Bank (collectively, "SVB"). The Loan and Security Agreement provided for an initial term loan of $ 25.0 million funded at the closing (the "Term A Tranche"), with an additional tranche of $ 25.0 million available if certain funding and clinical milestones were met by August 31, 2022 (the "Term B Tranche"). Effective December 28, 2021, the Company, entered into a First Amendment (the “Amendment”) to the Loan and Security Agreement (as so amended, the "Amended Loan and Security Agreement"). The Amended Loan and Security Agreement extended the interest-only period through August 31, 2022. The Amended Milestones (as defined below) were not met by the Company on or prior to August 31, 2022, and therefore, the interest-only period was not extended beyond August 31, 2022. The Amendment also eliminated the Term B Tranche, which remained unfunded, leaving only the Term A Tranche (the "SVB Facility"). Under the Amended Loan and Security Agreement, the SVB Facility will mature on August 1, 2023. Please refer to Note 4 - Debt, for further discussion of the Loan and Security Agreement and the Amended Loan and Security Agreement. 2022 Equity Distribution Agreement On August 12, 2022, the Company entered into an Equity Distribution Agreement (the "Equity Distribution Agreement") with Piper Sandler & Co. ("Piper Sandler"), pursuant to which the Company can offer and sell, from time to time at its sole discretion, shares of its common stock having an aggregate offering price of up to $ 50.0 million through Piper Sandler as its sales agent in an "at the market offering." Piper Sandler will receive a commission of 3.0 % of the gross proceeds of any common stock sold under the Equity Distribution Agreement. During the three and nine months ended September 30, 2022, there have been no sales of the Company's common stock under the Equity Distribution Agreement. |
Summary of Significant Accounti
Summary of Significant Accounting Policies | 9 Months Ended |
Sep. 30, 2022 | |
Accounting Policies [Abstract] | |
Summary of Significant Accounting Policies | 3. Summary of Significant Accounting Policies The Company’s significant accounting policies were identified in the Company’s Annual Report. There have been no material changes in those policies since the filing of its Annual Report. |
Debt
Debt | 9 Months Ended |
Sep. 30, 2022 | |
Debt Disclosure [Abstract] | |
Debt | 4. Debt The carrying values of the Company's debt obligation were as follows: September 30, December 31, ($ in thousands) 2022 2021 Loan and Security Agreement $ 23,461 $ 25,209 Unamortized discount on Loan and Security Agreement ( 793 ) ( 1,091 ) Total debt $ 22,668 $ 24,118 As of September 30, 2022, the SVB Facility was fully drawn in the amount of $ 25.0 million. The SVB Facility bears interest at a floating rate per annum on outstanding loans, payable monthly, at the greater of (a) 7.75 % and (b) the current published U.S. prime rate, plus a margin of 4.5 % . As of September 30, 2022, interest on the outstanding loans was 10.75 %. The Amended Loan and Security Agreement provided for an interest-only period through August 31, 2022. On or prior to August 31, 2022, the Company had not (i) received at least $ 50.0 million in net cash proceeds from the sale of the Company’s equity securities after the date of the Amended Loan and Security Agreement, on terms acceptable to SVB, nor (ii) achieved positive data in the first cohort of the Library TCR-T Trial endorsed by an independent safety monitoring committee as a safe dose to proceed (together, the “Amended Milestones”), and, therefore, the interest-only period was not extended beyond August 31, 2022. Commencing on September 1, 2022, aggregate outstanding borrowings are payable in twelve consecutive, equal monthly installments of principal plus accrued interest. All outstanding obligations under the Amended Loan and Security Agreement are due and payable on August 1, 2023 . The Company will also owe SVB 5.75 % of the original principal amounts borrowed as a final payment (the "Final Payment"). The Company is permitted to make up to two prepayments, subject to a prepayment premium of the amount being prepaid, ranging from 1.00 % to 2.00 %, of the SVB Facility, each such prepayment to be at least $ 5.0 million plus all accrued and unpaid interest on the portion being prepaid. As a result of not achieving the Amended Milestones on or prior to August 31, 2022, the Amended Loan and Security Agreement required the Company to cash collateralize half of the sum of the then-outstanding principal amount of the SVB Facility, plus an amount equal to 5.75 % of the original principal amount of the SVB Facility. As of September 30, 2022, the Company has collateralized $ 13.9 million, which is classified as restricted cash on the balance sheet. So long as no event of default has occurred and subject to certain other terms related to the remaining outstanding balance under the SVB Facility being satisfied, $ 2.5 million will be released from the collateral account following the eighth scheduled payment of principal and interest, and a further $ 4.0 million will be released following the tenth scheduled payment of principal and interest. The SVB Facility and related obligations under the Amended Loan and Security Agreement are secured by substantially all of the Company’s properties, rights and assets, except for its intellectual property (which is subject to a negative pledge under the Amended Loan and Security Agreement). In addition, the Amended Loan and Security Agreement contains customary representations, warranties, events of default and covenants. In connection with its entry into the Loan and Security Agreement, the Company issued to SVB warrants to purchase (i) up to 432,844 shares of the Company’s common stock, in the aggregate, and (ii) up to an additional 432,842 shares of common stock, in the aggregate, in the event the Company achieved certain clinical milestones, in each case at an exercise price per share of $ 2.22 . In connection with its entry into the Amendment, the Company amended and restated the warrants issued to SVB. As amended and restated, the warrants are for up to 649,615 shares of the Company's common stock, in the aggregate, at an exercise price per share of $ 1.16 , or the SVB Warrants. The SVB Warrants expire on August 6, 2031 . The issuance costs for the Loan and Security Agreement, including the Amended Loan and Security Agreement, were approximately $ 1.2 million and primarily related to the SVB Warrants, which will be amortized into interest expense over the period to August 1, 2023 . Interest expense was $ 0.8 million for the three months ended September 30, 2022 and was $ 2.3 million for the nine months ended September 30, 2022, compared to $ 0.4 million for the three and nine months ended September 30, 2021. The fair value of the Amended Loan and Security Agreement as of September 30, 2022 approximates its face value. |
Fair Value Measurements
Fair Value Measurements | 9 Months Ended |
Sep. 30, 2022 | |
Fair Value Disclosures [Abstract] | |
Fair Value Measurements | 5. Fair Value Measurements The Company has certain financial assets and liabilities recorded at fair value which have been classified as Level 1, 2 or 3 within the fair value hierarchy as described in the accounting standards for fair value measurements. • 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 and nonrecurring basis as of September 30, 2022 and December 31, 2021 are as follows: ($ in thousands) Fair Value Measurements at Reporting Date Using Description Balance as of Quoted Prices in Significant Significant Cash equivalents $ 36,807 $ 36,807 $ — $ — ($ in thousands) Fair Value Measurements at Reporting Date Using Description Balance as of Quoted Prices in Significant Significant Cash equivalents $ 75,222 $ 75,222 $ — $ — The cash equivalents represent demand deposit accounts and deposits in a short-term United States treasury money market mutual fund quoted in an active market and classified as a Level 1 asset. There have been no changes to the valuation methods during the nine months ended September 30, 2022. We had no financial assets or liabilities that were classified as Level 2 or Level 3 during the nine months ended September 30, 2022. |
Net Loss per Share
Net Loss per Share | 9 Months Ended |
Sep. 30, 2022 | |
Earnings Per Share [Abstract] | |
Net Loss per Share | 6. 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, inducement stock options, unvested restricted stock and warrants, 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 consisted of the following as of September 30, 2022 and 2021, respectively: September 30, 2022 2021 Common stock options 10,623,215 11,072,894 Inducement stock options - 97,500 Unvested restricted stock 940,000 1,510,655 Warrants 22,922,342 22,705,571 34,485,557 35,386,620 |
Related Party Transactions
Related Party Transactions | 9 Months Ended |
Sep. 30, 2022 | |
Related Party Transactions [Abstract] | |
Related Party Transactions | 7. Related Party Transactions Collaboration with Vineti Inc. On July 9, 2020, the Company entered into a master service agreement and statement of work with Vineti, Inc. ("Vineti"). Pursuant to the agreement, Vineti has been developing a software platform to coordinate and orchestrate the order, cell collection and manufacturing process for the Company’s T-cell therapy, or TCR-T, clinical programs. Heidi Hagen, who became a director of the Company in June 2019 and resigned November 2, 2021 and the Company's Interim Chief Executive Officer on February 25, 2021 and resigned on August 30, 2021, is a co-founder and former officer of Vineti. During the three and nine months ended September 30, 2022, the Company recorded no expenses for Vineti, compared to $ 0.1 million of expenses for the three months ended September 30, 2021 and $ 0.4 million for the nine months ended September 30, 2021. WaterMill Settlement Agreement On February 4, 2021, the Company entered into an agreement, or the Settlement Agreement, with WaterMill Asset Management Corp. and Robert W. Postma (collectively, the "WaterMill Parties"). Pursuant to the Settlement Agreement, the Company increased the size of its board of directors from eight to nine directors and appointed Mr. Postma to fill the newly created directorship. In accordance with the Settlement Agreement, the Company agreed to reimburse the WaterMill Parties for up to $ 0.4 million of their reasonable out-of-pocket expenses out of a total of approximately $ 0.7 million in fees and expenses actually incurred by the WaterMill Parties in connection with (i) the WaterMill Parties' solicitation of written consents from the Company's stockholders to vote in favor of certain proposals, as set forth in the definitive consent statement filed by the WaterMill Parties on October 30, 2020, and (ii) the negotiation, execution, and effectuation of the Settlement Agreement. As of February 19, 2021, the Company has fully reimbursed the WaterMill Parties an aggregate amount of $ 0.4 million. Joint Venture with TriArm Therapeutics/Eden BioCell On December 18, 2018, the Company and TriArm Therapeutics, Ltd. (“TriArm”) launched Eden BioCell, Ltd. (“Eden BioCell”) as a joint venture to lead commercialization of the Company’s Sleeping Beauty -generated CAR-T therapies in the People’s Republic of China (including Macau and Hong Kong), Taiwan and Korea. The Company licensed to Eden BioCell the rights in Greater China for its third-generation Sleeping Beauty -generated CAR-T therapies targeting the CD19 antigen. Eden BioCell is owned equally by the Company and TriArm and the parties share decision-making authority. TriArm has contributed $ 10.0 million to Eden BioCell and has committed up to an additional $ 25.0 million to this joint venture. TriArm also manages all clinical development in the territory pursuant to a master services agreement between TriArm and Eden BioCell. James Huang was the founder and serves as managing partner of Panacea Venture, which is an investor in TriArm. Mr. Huang is the Chair of the Company's board of directors and has been a director since July 2020. He also serves as a member of Eden BioCell’s board of directors. For the three and nine months ended September 30, 2022, Eden BioCell incurred a net loss and the Company continues to have no commitment to fund its operations. In September 2021, TriArm and Alaunos mutually agreed to dissolve the Eden BioCell joint venture. Refer to Note 12 - Joint Venture , for further details. |
Commitments and Contingencies
Commitments and Contingencies | 9 Months Ended |
Sep. 30, 2022 | |
Commitments and Contingencies Disclosure [Abstract] | |
Commitments and Contingencies | 9. Commitments and Contingencies License Agreements Exclusive License Agreement with PGEN Therapeutics On October 5, 2018, the Company entered into an exclusive license agreement, or License Agreement, with PGEN Therapeutics, or PGEN, a wholly owned subsidiary of Precigen Inc., or Precigen, which was formerly known as Intrexon Corporation. Pursuant to the terms of the License Agreement, the Company has exclusive, worldwide rights to research, develop and commercialize (i) TCR products designed for neoantigens for the treatment of cancer, (ii) products utilizing Precigen’s RheoSwitch® gene switch, or RTS, for the treatment of cancer, referred to as IL-12 Products and (iii) CAR products directed to (A) CD19 for the treatment of cancer, referred to as CD19 Products, and (B) BCMA for the treatment of cancer, subject to certain obligations to pursue such target under the Ares Trading Agreement. Under the License Agreement, the Company also has exclusive, worldwide rights 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 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, as defined in the License Agreement, to develop and commercialize IL-12 products, CD19 products, BCMA products and TCR Products. In consideration of the licenses and other rights granted by PGEN, the Company will pay PGEN an annual license fee of $ 0.1 million and the Company has agreed to reimburse PGEN for certain historical costs of the licensed programs up to $ 1.0 million, which was fully paid during the year ended December 31, 2019. 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 PGEN tiered royalties ranging from low-single digits to high-single digits on the net sales derived from the sale of any approved IL-12 products and CAR products. The Company will also pay PGEN royalties ranging from low-single digits to mid-single digits on the net sales derived from the sale of any approved TCR products, up to a maximum royalty amount of $ 100.0 million in the aggregate. The Company will also pay PGEN twenty percent of any sublicensing income received by us relating to the licensed products. The Company is responsible for all development costs associated with each of the licensed products. PGEN will pay the Company royalties ranging from low-single digits to mid-single digits on the net sales derived from the sale of PGEN’s CAR products, up to a maximum royalty amount of $ 100.0 million. In October 2020, the Company entered into an amendment to the License Agreement relating to the transfer of certain materials and PGEN’s obligations to provide transition assistance relating to the IL-12 products. License Agreement and 2015 Research and Development Agreement —The University of Texas MD Anderson Cancer Center On January 13, 2015 , the Company, together with Precigen, entered into the MD Anderson License with MD Anderson (which Precigen subsequently assigned to PGEN). Pursuant to the MD Anderson License, the Company, together with PGEN, 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 served as the Company’s Chief Executive Officer from May 2015 until February 2021 and was formerly a tenured professor of pediatrics at MD Anderson. On August 17, 2015, the Company, Precigen and MD Anderson entered into the 2015 R&D 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. The rights and obligations of Precigen under the 2015 R&D Agreement were assigned to the Company pursuant to the Fourth Amendment to 2015 R&D Agreement which was entered into on September 19, 2019 (the “Fourth Amendment”) with an effective date of October 5, 2018. The activities under the 2015 R&D Agreement are directed by a joint steering committee comprised of two members from the Company and one member from MD Anderson. As provided under the MD Anderson License, the Company provided funding for research and development activities in support of the research programs under the 2015 R&D 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 2015 R&D Agreement, extending its term until April 15, 2021. In connection with the execution of the 2019 R&D Agreement described below, on October 22, 2019, the Company amended the 2015 R&D Agreement to extend the term of the 2015 R&D Agreement until December 31, 2026 and to allow cash resources on hand at MD Anderson under the 2015 R&D Agreement to be used for development costs under the 2019 R&D Agreement. 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-day cure period, MD Anderson will have the right to convert the MD Anderson License into a non-exclusive license if the Company and Precigen are not using commercially reasonable efforts to commercialize the licensed intellectual property on a case-by-case basis. After five years from the date of the MD Anderson License and subject to a 180-day cure period, MD Anderson will have the right to terminate the MD Anderson License with respect to specific technology(ies) funded by the government or subject to a third-party contract if the Company and Precigen are not meeting the diligence requirements in such funding agreement or contract, as applicable. MD Anderson may also terminate the agreement with written notice upon material breach by the Company and Precigen, if such breach has not been cured within 60 days of receiving such notice. In addition, the MD Anderson License will terminate upon the occurrence of certain insolvency events for both the Company and Precigen and may be terminated by the mutual written agreement of the Company, PGEN, and MD Anderson. 2019 Research and Development Agreement—The University of Texas MD Anderson Cancer Center On October 22, 2019, the Company entered into the 2019 Research and Development Agreement, or the 2019 R&D Agreement, with MD Anderson, pursuant to which the parties agreed to collaborate with respect to the TCR program. Under the 2019 R&D Agreement, the parties will, among other things, collaborate on programs to expand the Company's TCR library and conduct clinical trials. The activities under the 2019 R&D Agreement are directed by a joint steering committee comprised of two members from the Company and one member from MD Anderson. The Company will own all inventions and intellectual property developed under the 2019 R&D Agreement and the Company will retain all rights to intellectual property for oncology products manufactured using non-viral gene transfer technologies under the 2019 R&D Agreement, including the Company's Sleeping Beauty technology. The Company has granted MD Anderson an exclusive license for such intellectual property outside the field of oncology and to develop and commercialize TCR products manufactured using viral gene transfer technologies limited to autologous products if used for cancer treatment or prevention, and a non-exclusive license for allogenic anti-tumor TCR products manufactured using viral-based technologies. Under the 2019 R&D Agreement, the Company agreed, beginning on January 1, 2021, to reimburse MD Anderson up to a total of $ 20.0 million for development costs under the 2019 R&D Agreement, after the funds from the 2015 R&D Agreement are exhausted. In addition, the Company will pay MD Anderson royalties on net sales of its TCR products. The Company is required to make performance-based payments upon the successful completion of clinical and regulatory benchmarks relating to its TCR products. The aggregate potential benchmark payments are $ 36.5 million, of which only $ 3.0 million will be due prior to the first marketing approval of the Company's TCR products. The royalty rates and benchmark payments owed to MD Anderson may be reduced upon the occurrence of certain events. The Company also agreed to sell its TCR products to MD Anderson at preferential prices and will sell the Company's TCR products in Texas exclusively to MD Anderson for a limited period of time following the first commercial sale of the Company's TCR products. For the three months ended September 30, 2022, the Company incurred clinical expenses of $ 0.3 million from MD Anderson related to this agreement compared to $ 0 for the three months ended September 30, 2021. For the nine months ended September 30, 2022, the Company incurred clinical expenses of $ 0.7 million from MD Anderson related to this agreement compared to $ 0 for the nine months ended September 30, 2021. The 2019 R&D Agreement will terminate on December 31, 2026 and either party may terminate the 2019 R&D Agreement following written notice of a material breach. The 2019 R&D Agreement also contains customary provisions related to indemnification obligations, confidentiality and other matters. In connection with the execution of the 2019 R&D Agreement, on October 22, 2019, the Company issued MD Anderson a warrant to purchase 3,333,333 shares of the Company's common stock, which is referred to as the MD Anderson Warrant. Please refer to Note 11 - Warrants , for further discussion of the MD Anderson Warrant. The MD Anderson Warrant has an initial exercise price of $ 0.001 per share, expires on December 31, 2026 , and vests upon the occurrence of certain clinical milestones. As of September 30, 2022, the milestones have not been met. License Agreement with the NCI On May 28, 2019, the Company entered into a patent license agreement, or the Patent License, with the National Cancer Institute, or the NCI. Pursuant to the Patent License, the Company holds an exclusive, worldwide license to certain intellectual property to develop and commercialize patient-derived (autologous), peripheral blood T-cell therapy products engineered by transposon-mediated gene transfer to express TCRs reactive to mutated KRAS, TP53 and EGFR neoantigens. In addition, pursuant to the Patent License, the Company holds an exclusive, worldwide license to certain intellectual property for manufacturing technologies to develop and commercialize autologous, peripheral blood T-cell therapy products engineered by non-viral gene transfer to express TCRs, as well as a non-exclusive, worldwide license to certain additional manufacturing technologies. On May 29, 2019, January 8, 2020, September 28, 2020, April 16, 2021, May 4, 2021, and August 13, 2021 the Company amended the Patent License to expand its TCR library to include additional TCRs reactive to mutated KRAS and TP53 neoantigens licensed from the NCI. The terms of the Patent License require the Company to pay the NCI minimum annual royalties in the amount of $ 0.3 million, which amount will be reduced to $ 0.1 million once the aggregate minimum annual royalties paid by the Company equals $ 1.5 million. The Company is also required to make performance-based payments upon successful completion of clinical and regulatory benchmarks relating to the licensed products. Of such payments, the aggregate potential benchmark payments are $ 4.3 million, of which aggregate payments of $ 3.0 million are due only after marketing approval in the United States or in Europe, Japan, Australia, China or India. The first benchmark payment of $ 0.1 million was due upon the initiation of the Company's first sponsored Phase 1 clinical trial of a licensed product or licensed process in the field of use licensed under the Patent License. The Company paid the first benchmark payment during the nine months ended September 30, 2022. In addition, the Company is required to pay the NCI one-time benchmark payments following aggregate net sales of licensed products at certain aggregate net sales ranging from $ 250.0 million to $ 1.0 billion. The aggregate potential amount of these benchmark payments is $ 12.0 million. The Company must also pay the NCI royalties on net sales of products covered by the Patent License at rates in the low to mid-single digits depending upon the technology included in a licensed product. To the extent the Company enters into a sublicensing agreement relating to a licensed product, the Company is required to pay the NCI a percentage of all consideration received from a sublicensee, which percentage will decrease based on the stage of development of the licensed product at the time of the sublicense. The Patent License will expire upon expiration of the last patent contained in the licensed patent rights, unless terminated earlier. The NCI may terminate or modify the Patent License in the event of a material breach, including if the Company does not meet certain milestones by certain dates, or upon certain insolvency events that remain uncured following the date that is 90 days following written notice of such breach or insolvency event. The Company may terminate the Patent License, or any portion thereof, in the Company's sole discretion at any time upon 60 days’ written notice to the NCI. In addition, the NCI has the right to: (i) require the Company to sublicense the rights to the product candidates covered by the Patent License upon certain conditions, including if the Company is not reasonably satisfying required health and safety needs and (ii) terminate or modify the Patent License, including if the Company is not satisfying requirements for public use as specified by federal regulations. For the three months ended September 30, 2022, the Company recognized $ 0.1 million in license payments to the NCI under this agreement, compared to $ 0.3 million for the three months ended September 30, 2021. For the nine months ended September 30, 2022, the Company recognized $ 0.5 million in license payments to the NCI under this agreement, compared to $ 0.6 million for the nine months ended September 30, 2021. Cooperative Research and Development Agreement (CRADA) with the NCI On January 9, 2017, the Company entered into a Cooperative Research and Development Agreement (the “CRADA”) with the NCI. The purpose of this collaboration was to advance a personalized TCR-T approach for the treatment of solid tumors. Using the Company's Sleeping Beauty technology, the NCI would analyze a patient’s own cancer cells, identify their unique neoantigens and TCRs reactive against those neoantigens and then use the Company's Sleeping Beauty technology to transpose one or more TCRs into T cells for re-infusion. Research conducted under the CRADA will be at the direction of Steven A. Rosenberg, M.D., Ph.D., Chief of the Surgery Branch at the NCI, in collaboration with the Company's researchers. The Company is responsible for providing the NCI with the test materials necessary for them to conduct their studies, and eventually, clinical trials pursuant to the CRADA. Inventions, data and materials discovered or produced in connection with performance of the research plan under the CRADA will remain the sole property of the party who produced the discovery. The parties will jointly own all inventions jointly discovered under the research plan. The owner of any invention under the CRADA will make the decision to file a patent covering the invention, or in the case of a jointly owned invention, the Company will have the first opportunity to file a patent covering the invention. If the Company fails to provide timely notice of its decision to the NCI or decide not to file a patent covering the joint invention, the NCI has the right to make the filing. For any invention solely owned by the NCI or jointly made by the NCI and the Company for which a patent application was filed, the U.S. Public Health service grants the Company an exclusive option to elect an exclusive or non-exclusive commercialization license. For inventions owned solely by the NCI or jointly owned by the NCI and the Company, which are licensed according to the terms described above, the Company agreed to grant to the U.S. government a non-exclusive, non-transferable, irrevocable and paid up license to practice the invention or have the invention practiced on its behalf throughout the world. The Company is also required to grant the U.S. government a non-exclusive, non-transferable, irrevocable and paid up license to practice the invention or have the invention practiced on its behalf throughout the world for any of the Company's solely owned inventions. The agreement may be terminated by any of the parties upon 60 days prior written consent. The NCI has a cleared Investigational New Drug Application, or IND, that would permit them to begin this trial. To the Company's knowledge, the trial has not yet enrolled due to matters internal to the NCI and unrelated to the Company's technology. The progress and timeline for this trial, including the timeline for dosing patients, are under control of the NCI. In February 2019, the Company extended the CRADA with the NCI until January 9, 2022, committing an additional $ 5.0 million to this program. In March 2022, the Company entered into an amendment to the CRADA that is retroactive, effective January 9, 2022 to extend the term of the CRADA until January 9, 2023. In June 2022, the Company entered into the Fourth Amendment to the CRADA (the "CRADA Fourth Amendment") which, among other things, extended the term of the CRADA until January 9, 2025. In connection with the CRADA Fourth Amendment, the Company agreed to contribute $ 1.0 million per year, payable on a quarterly basis, beginning in the first quarter of 2023. The Company did no t record expenses under the CRADA for the three and nine months ended September 30, 2022, as compared to $ 0 for the three months ended September 30, 2021 and $ 1.3 million for the nine months ended September 30, 2021. Patent and Technology License Agreement—The University of Texas MD Anderson Cancer Center and the Texas A&M University System On August 24, 2004, 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. Under the terms of the agreement, the Company may be required to make additional payments to the Licensors upon achievement of certain milestones in varying amounts which, on a cumulative basis could total up to an additional $ 4.5 million. In addition, the Licensors are entitled to receive royalty payments on sales from a licensed product and will also be entitled to receive a portion of any fees that the Company may receive from a possible sublicense under certain circumstances. During the three and nine months ended September 30, 2022, $ 2.5 million was expensed as a one-time milestone payment under the terms of the agreement, compared to $ 0.1 million for the three and nine months ended September 30, 2021. During the three and nine months ended September 30, 2022 and 2021, the Company did no t incur royalty expenses on sales under this agreement. Collaboration Agreement with Solasia Pharma K.K. On March 7, 2011, the Company entered into a License and Collaboration Agreement with Solasia Pharma K. K. ("Solasia"), which was amended on July 31, 2014 to include an exclusive worldwide license and amended on October 14, 2021 to revise certain payment schedule details (as so amended, the "Solasia License and Collaboration Agreement"). Pursuant to the Solasia 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. As consideration for the license, the Company is 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 revenue 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 Solasia License and Collaboration Agreement, will receive a portion of all milestone and royalty payments made by Solasia to the Company in accordance with the terms of the Solasia License and Collaboration Agreement with the licensors, as described above. In June 2022, Solasia announced that darinaparsin had been approved from relapsed or refractory Peripheral T-Cell Lymphoma by the Ministry of Health, Labor and Welfare in Japan. During the three and nine months ended September 30, 2022, the Company recorded $2.9 million of collaboration revenue under the Solasia License and Collaboration Agreement primarily related to Solasia's achievement of certain sales-based milestones in Japan. During the three and nine months ended September 30, 2021, the Company recorded $ 0.4 million of collaboration revenue under the Solasia License and Collaboration Agreement. During the three and nine months ended September 30, 2022 and 2021, the Company did no t record royalty revenues on net sales of darinaparsin under this agreement. |
Leases
Leases | 9 Months Ended |
Sep. 30, 2022 | |
Leases, Operating [Abstract] | |
Leases | 8. Leases In April 2022, the Company modified its real estate lease agreement executed on December 15, 2020 with MD Anderson for office space in Houston, which reduced the Company's leased space from 18,111 square feet to 3,228 square feet. As a result, the associated lease liability and right-of-use asset were remeasured to $ 0.4 million based on revised lease payments. A gain of $ 0.1 million was recorded on the lease modification during the nine months ended September 30, 2022. In June 2022, the Company executed an agreement to sub-sublease 4,772 square feet of subleased office space in Boston. The term of the sub-sublease is from July 1, 2022 to June 30, 2025 and provides the sub-subtenant with an option to extend through to July 31, 2026 . For the three and nine months ended September 30, 2022, the Company recognized $ 44 thousand in lease income, which is classified within other income (expense), net in the statement of operations. |
Stock-Based Compensation
Stock-Based Compensation | 9 Months Ended |
Sep. 30, 2022 | |
Text Block [Abstract] | |
Stock-Based Compensation | 10. Stock-Based Compensation The Company recognized stock-based compensation expense on all employee and non-employee awards as follows: For the Three Months Ended September 30, For the Nine Months Ended September 30, (in thousands) 2022 2021 2022 2021 Research and development 145 535 673 2,115 General and administrative 663 1,836 1,978 7,742 Stock-based compensation expense $ 808 $ 2,371 $ 2,651 $ 9,857 The Company granted an aggregate of 1,275,000 stock options during the three months ended September 30, 2022, with a weighted-average grant date fair value of $ 1.52 per share, and granted an aggregate of 4,667,500 stock options during the nine months ended September 30, 2022, with a weighted-average grant date fair value of $ 0.67 per share. The Company granted an aggregate of 2,755,000 stock options during the three months ended September 30, 2021, with a weighted-average grant date fair value of $ 1.08 per share, and granted an aggregate of 7,150,438 stock options during the nine months ended September 30, 2021, with a weighted-average grant date fair value of $ 1.91 per share. For the three and nine months ended September 30, 2022 and 2021, 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 September 30, For the Nine Months Ended September 30, 2022 2021 2022 2021 Risk-free interest rate 2.94 – 3.62 % 0.89 – 0.96 % 1.63 – 3.62 % 0.50 – 1.15 % Expected life in years 6.23 - 6.25 6.00 - 6.25 5.27 - 6.25 5.50 - 6.25 Expected volatility 82.43 - 85.89 % 72.53 - 72.84 % 74.49 - 85.89 % 72.53 - 74.80 % Expected dividend yield — % — % — % — % 2. Stock option activity under the Company’s stock option plans for the nine months ended September 30, 2022 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, 2021 10,665,869 $ 2.87 Granted 4,667,500 1.08 Exercised ( 26,250 ) 0.80 Cancelled ( 4,683,904 ) 3.40 Outstanding, September 30, 2022 10,623,215 $ 1.85 8.27 $ 3,572 Options exercisable, September 30, 2022 3,211,631 $ 2.69 7.01 $ 510 Options exercisable, December 31, 2021 4,410,312 $ 3.85 7.53 $ — Options available for future grant, September 30, 2022 15,245,494 At September 30, 2022, total unrecognized compensation costs related to unvested stock options outstanding amounted to $ 7.1 million. The cost is expected to be recognized over a weighted-average period of 2.01 years. A summary of the status of unvested restricted stock for the nine months ended September 30, 2022 is as follows: Number of Shares Weighted-Average Grant Date Fair Value Unvested, December 31, 2021 1,198,580 $ 2.10 Granted 280,000 0.82 Vested ( 305,679 ) 2.28 Cancelled ( 232,901 ) 3.15 Unvested, September 30, 2022 940,000 $ 1.41 At September 30, 2022, total unrecognized compensation costs related to unvested restricted stock outstanding amounted to $ 1.2 million. The cost is expected to be recognized over a weighted-average period of 1.83 years. |
Warrants
Warrants | 9 Months Ended |
Sep. 30, 2022 | |
Warrants Disclosure [Abstract] | |
Warrant | 11. Warrants In connection with the Company’s November 2018 private placement that provided net proceeds of approximately $ 47.1 million, the Company issued warrants to purchase an aggregate of 18,939,394 shares of common stock, which became exercisable six months after the closing of the private placement (the "November 2018 Warrants"). The November 2018 Warrants had an exercise price of $ 3.01 per share and have a five-year term. The fair value of the November 2018 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. On July 26, 2019 and September 12, 2019, the Company entered into agreements with existing investors whereby the investors exercised the November 2018 Warrants for an aggregate of 17,803,031 shares of common stock, at an exercise price of $ 3.01 per share. Proceeds from the warrant exercise after deducting placement agent fees and other related expenses of $ 1.1 million were approximately $ 52.5 million. The Company issued participating investors new warrants to purchase up to 17,803,031 additional shares of common stock (the "2019 Warrants") as consideration for the warrant holders to exercise their November 2018 Warrants. The 2019 Warrants will expire on the fifth anniversary of the initial exercise date and have an exercise price of $ 7.00 . The 2019 Warrants were valued using a Black-Scholes valuation model and resulted in a $ 60.8 million non-cash charge in the Company’s statement of operations in 2019. On October 22, 2019, the Company entered into the 2019 R&D Agreement with MD Anderson. In connection with the execution of the 2019 R&D Agreement, the Company issued the MD Anderson Warrant to purchase 3,333,333 shares of common stock. The MD Anderson Warrant has an initial exercise price of $ 0.001 per share and grant date fair value of $ 14.5 million. The MD Anderson Warrant expires on December 31, 2026 and vests upon the occurrence of certain clinical milestones. The Company will recognize expense on the MD Anderson Warrant in the same manner as if the Company paid cash for services to be rendered. For the three and nine months ended September 30, 2022 and September 30, 2021, the Company did not recognize any expense related to the MD Anderson Warrant as the clinical milestones had not been achieved. On August 6, 2021, the Company entered into the Loan and Security Agreement with SVB. Refer to Note 4 - Debt . In connection with the Loan and Security Agreement, the Company issued SVB warrants to purchase 432,844 shares of common stock with an exercise price of $2.22 per share. The warrants have a ten-year life and were fully vested upon issuance. The fair value of the warrants was estimated at $ 0.8 million using a Black-Scholes model with the following assumptions: expected volatility of 79 %, risk free interest rate of 1.31 %, expected life of ten years and no dividends. On December 28, 2021, the Company entered into the Amendment, as described in Note 4 - Debt, in connection with which, the original warrants issued to SVB were amended and restated. As amended and restated, the SVB Warrants are for up to 649,615 shares of common stock, in the aggregate, at an exercise price per share of $1.16 . The SVB Warrants expire on August 6, 2031 and were fully vested upon issuance. Using a Black-Scholes model with an expected volatility of 81 %, risk free interest rate of 1.49 %, expected life of 10 years and no dividends, the Company recorded a $ 0.2 million increase in the fair value of the SVB Warrants due to the modification of the SVB Warrants. The Company assessed whether the SVB Warrants require accounting as derivatives. The Company determined that the SVB Warrants were (1) indexed to the Company’s own stock and (2) classified in stockholders’ equity in accordance with FASB Accounting Standards Codification (“ASC”) Topic 815, Derivatives and Hedging . As such, the Company has concluded the SVB Warrants meet the scope exception for determining whether the instruments require accounting as derivatives and should be classified in stockholders’ equity. |
Joint Venture
Joint Venture | 9 Months Ended |
Sep. 30, 2022 | |
Equity Method Investments and Joint Ventures [Abstract] | |
Joint Venture | 12. Joint Venture On December 18, 2018, the Company entered into a Framework Agreement with TriArm whereby the parties agreed to launch Eden BioCell, to lead clinical development and commercialization of certain Sleeping Beauty -generated CAR-T therapies as set forth in a separate license agreement. On January 3, 2019, Eden BioCell was incorporated in Hong Kong as a private company. Eden BioCell, the Company and TriArm entered into a Share Subscription Agreement on January 23, 2019, where the Company and TriArm agreed to contribute certain intellectual property, services and cash (only with respect to TriArm) to Eden BioCell to subscribe for a certain number of newly issued ordinary shares in the share capital of Eden BioCell. The closing of the transaction occurred on July 5, 2019. The Framework Agreement and Share Subscription Agreements were each respectively amended to be effective as of this date. Upon consummation of the joint venture, Eden BioCell and the Company also entered into a license agreement, pursuant to which the Company licensed the rights to Eden BioCell for third generation Sleeping Beauty -generated CAR-T therapies targeting the CD19 antigen for the territory of China (including Macau and Hong Kong), Taiwan and Korea. TriArm and the Company each received a 50 % equity interest in the joint venture in exchange for their contributions to Eden BioCell. The Company determined that Eden BioCell was considered a variable interest entity, or VIE, and concluded that it is not the primary beneficiary of the VIE as it did not have the power to direct the activities of the VIE. As a result, the Company accounts for the equity interest in Eden BioCell under the equity method of accounting as it has the ability to exercise significant influence. In March 2021, Eden BioCell began treating patients in a clinical trial with the Company’s investigational CD19 RPM CAR-T cell therapy, under the IND cleared by the Taiwan FDA in December 2020. In the first half of 2021, two patients were treated in this trial. The lead investigator at National Taiwan University in Taipei, has reported no serious adverse safety events in either of these patients. Laboratory results continue to support, as previously published, that non-viral Sleeping Beauty gene transfer is effective in genetically modifying autologous T-cells. Patients were infused two days after gene transfer, thus shortening the turnaround time and demonstrating an advantage over viral methods. Based on laboratory data from the first two patients generated between March and May 2021, the TriArm/Eden team concluded, in concert with the investigator and the Company, that further process development work is required. In September 2021, TriArm and the Company mutually agreed to dissolve the joint venture. For the three and nine months ended September 30, 2022 and September 30, 2021, Eden BioCell incurred a net loss. The Company continues to have no commitment to fund its operations. |
Subsequent Events
Subsequent Events | 9 Months Ended |
Sep. 30, 2022 | |
Subsequent Events [Abstract] | |
Subsequent Events | 13. Subsequent Events The Company has evaluated subsequent events from the balance sheet date through the date on which these financial statements were issued. The Company did not have any material subsequent events that impacted its financial statements or disclosures. |
Summary of Significant Accoun_2
Summary of Significant Accounting Policies (Policies) | 9 Months Ended |
Sep. 30, 2022 | |
Accounting Policies [Abstract] | |
Basis of Presentation | 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, or GAAP, 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 presentation of the financial position of the Company and its results of operations and cash flows for the periods presented. 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, 2021, included in the Company’s Annual Report on Form 10-K for the fiscal year ended December 31, 2021 filed with the SEC on March 30, 2022, or the Annual Report. The results disclosed in the statements of operations for the three and nine months ended September 30, 2022 are not necessarily indicative of the results to be expected for the full fiscal year 2022. |
Use of Estimates | Use of Estimates The preparation of financial statements in conformity with GAAP 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. |
Debt (Tables)
Debt (Tables) | 9 Months Ended |
Sep. 30, 2022 | |
Debt Disclosure [Abstract] | |
Schedule of Debt | The carrying values of the Company's debt obligation were as follows: September 30, December 31, ($ in thousands) 2022 2021 Loan and Security Agreement $ 23,461 $ 25,209 Unamortized discount on Loan and Security Agreement ( 793 ) ( 1,091 ) Total debt $ 22,668 $ 24,118 |
Fair Value Measurements (Tables
Fair Value Measurements (Tables) | 9 Months Ended |
Sep. 30, 2022 | |
Fair Value Disclosures [Abstract] | |
Assets and Liabilities Measured at Fair Value on Recurring Basis | Assets and liabilities measured at fair value on a recurring and nonrecurring basis as of September 30, 2022 and December 31, 2021 are as follows: ($ in thousands) Fair Value Measurements at Reporting Date Using Description Balance as of Quoted Prices in Significant Significant Cash equivalents $ 36,807 $ 36,807 $ — $ — ($ in thousands) Fair Value Measurements at Reporting Date Using Description Balance as of Quoted Prices in Significant Significant Cash equivalents $ 75,222 $ 75,222 $ — $ — |
Net Loss per Share (Tables)
Net Loss per Share (Tables) | 9 Months Ended |
Sep. 30, 2022 | |
Earnings Per Share [Abstract] | |
Potential Dilutive Shares Excluded from Computation of Diluted Net Loss Per Share | Such potentially dilutive shares of common stock consisted of the following as of September 30, 2022 and 2021, respectively: September 30, 2022 2021 Common stock options 10,623,215 11,072,894 Inducement stock options - 97,500 Unvested restricted stock 940,000 1,510,655 Warrants 22,922,342 22,705,571 34,485,557 35,386,620 |
Stock-Based Compensation (Table
Stock-Based Compensation (Tables) | 9 Months Ended |
Sep. 30, 2022 | |
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 September 30, For the Nine Months Ended September 30, (in thousands) 2022 2021 2022 2021 Research and development 145 535 673 2,115 General and administrative 663 1,836 1,978 7,742 Stock-based compensation expense $ 808 $ 2,371 $ 2,651 $ 9,857 |
Fair Value of Stock Options Assumptions Using Black-Scholes Option Valuation Model | For the three and nine months ended September 30, 2022 and 2021, 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 September 30, For the Nine Months Ended September 30, 2022 2021 2022 2021 Risk-free interest rate 2.94 – 3.62 % 0.89 – 0.96 % 1.63 – 3.62 % 0.50 – 1.15 % Expected life in years 6.23 - 6.25 6.00 - 6.25 5.27 - 6.25 5.50 - 6.25 Expected volatility 82.43 - 85.89 % 72.53 - 72.84 % 74.49 - 85.89 % 72.53 - 74.80 % Expected dividend yield — % — % — % — % |
Stock Option Activity under Stock Option Plan | Stock option activity under the Company’s stock option plans for the nine months ended September 30, 2022 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, 2021 10,665,869 $ 2.87 Granted 4,667,500 1.08 Exercised ( 26,250 ) 0.80 Cancelled ( 4,683,904 ) 3.40 Outstanding, September 30, 2022 10,623,215 $ 1.85 8.27 $ 3,572 Options exercisable, September 30, 2022 3,211,631 $ 2.69 7.01 $ 510 Options exercisable, December 31, 2021 4,410,312 $ 3.85 7.53 $ — Options available for future grant, September 30, 2022 15,245,494 |
Summary of Unvested Restricted Stock | A summary of the status of unvested restricted stock for the nine months ended September 30, 2022 is as follows: Number of Shares Weighted-Average Grant Date Fair Value Unvested, December 31, 2021 1,198,580 $ 2.10 Granted 280,000 0.82 Vested ( 305,679 ) 2.28 Cancelled ( 232,901 ) 3.15 Unvested, September 30, 2022 940,000 $ 1.41 At September 30, 2022, total unrecognized compensation costs related to unvested restricted stock outstanding amounted to $ 1.2 million. The cost is expected to be recognized over a weighted-average period of 1.83 years. |
Organization - Additional Infor
Organization - Additional Information (Details) - USD ($) $ in Thousands | Sep. 30, 2022 | Dec. 31, 2021 |
Cash and cash equivalents | $ 37,807 | $ 76,054 |
Restricted cash related to the Company's debt agreement | 13,900 | |
Accumulated deficit | $ 871,468 | $ 842,852 |
Common stock, shares authorized | 420,000,000 | 350,000,000 |
Common stock, shares outstanding | 216,182,042 | 216,127,443 |
Common Stock [Member] | ||
Common stock, shares outstanding | 216,182,042 | |
Common stock reserved for future issuance | 33,545,557 |
Financings - Additional Informa
Financings - Additional Information (Details) - USD ($) $ in Millions | 3 Months Ended | 9 Months Ended | ||
Aug. 12, 2022 | Sep. 30, 2022 | Sep. 30, 2022 | Aug. 06, 2021 | |
Share-Based Payment Arrangement, Tranche One [Member] | Silicon Valley Bank [Member] | ||||
Class of Stock [Line Items] | ||||
Initial term loan | $ 25 | |||
Share-Based Payment Arrangement, Tranche Two [Member] | Silicon Valley Bank [Member] | ||||
Class of Stock [Line Items] | ||||
Additonal tranche facility | $ 25 | |||
Equity Distribution Agreement | ||||
Class of Stock [Line Items] | ||||
Sale of stock during period | 0 | |||
Stock Issued During Period, Shares, New Issues | 0 | |||
Aggregate offering price | $ 50 | |||
Percentage Of Commission On Gross Proceeds From Sale Of Common Stock | 3% |
Debt - Schedule of Debt (Detail
Debt - Schedule of Debt (Details) - USD ($) $ in Thousands | Sep. 30, 2022 | Dec. 31, 2021 |
Debt Instrument [Line Items] | ||
Total debt | $ 22,668 | $ 24,118 |
Less: current portion of long-term debt | (22,668) | (7,868) |
Long-term debt | 0 | 16,250 |
Silicon Valley Bank Loan [Member] | ||
Debt Instrument [Line Items] | ||
Debt instrument, face amount | 23,461 | 25,209 |
Unamortized discount on Term Loan Agreement | $ (793) | $ (1,091) |
Debt - Additional Information (
Debt - Additional Information (Details) - USD ($) $ / shares in Units, $ in Millions | 3 Months Ended | 9 Months Ended | ||||
Dec. 28, 2021 | Aug. 06, 2021 | Sep. 30, 2022 | Sep. 30, 2021 | Sep. 30, 2022 | Sep. 30, 2021 | |
Debt Instrument [Line Items] | ||||||
Line of credit facility, interest rate | 4.50% | |||||
Interest expense amortized date | Aug. 01, 2023 | |||||
Interest expense | $ 0.8 | $ 0.4 | $ 2.3 | $ 0.4 | ||
Restricted cash related to the Company's debt agreement | 13.9 | $ 13.9 | ||||
Term Loan [Member] | ||||||
Debt Instrument [Line Items] | ||||||
Interest rate | 10.75% | |||||
Percentage of original principal due as a final payment | 5.75% | |||||
Line of credit facility, interest rate | 7.75% | |||||
Cash proceeds from sale of equity | $ 50 | |||||
Silicon Valley Bank Loan [Member] | ||||||
Debt Instrument [Line Items] | ||||||
Warrants issued | 649,615 | |||||
Warrants expiration date | Aug. 06, 2031 | |||||
Description of payment terms | The Company will also owe SVB 5.75% of the original principal amounts borrowed as a final payment (the "Final Payment"). The Company is permitted to make up to two prepayments, subject to a prepayment premium of the amount being prepaid, ranging from 1.00% to 2.00%, of the SVB Facility, each such prepayment to be at least $5.0 million plus all accrued and unpaid interest on the portion being prepaid. | |||||
Debt instrument description of variable rate basis | The SVB Facility bears interest at a floating rate per annum on outstanding loans, payable monthly, at the greater of (a) 7.75% and (b) the current published U.S. prime rate, plus a margin of 4.5% | |||||
Prepayment premium | $ 5 | |||||
Number of warrants issued | 432,844 | |||||
Warrant exercise per share | $ 1.16 | $ 2.22 | ||||
Additional number warrants issued | 432,842 | |||||
Debt instrument, initial maturity date | Aug. 01, 2023 | |||||
Silicon Valley Bank Loan [Member] | Debt Instrument Redemption Period One | Maximum | ||||||
Debt Instrument [Line Items] | ||||||
Percentage of prepayments premium | 2% | |||||
Silicon Valley Bank Loan [Member] | Debt Instrument Redemption Period One | Minimum | ||||||
Debt Instrument [Line Items] | ||||||
Percentage of prepayments premium | 1% | |||||
Silicon Valley Bank Loan [Member] | Term Loan [Member] | ||||||
Debt Instrument [Line Items] | ||||||
Fully drawn amount | $ 25 | |||||
Restricted cash related to the Company's debt agreement | $ 13.9 | $ 13.9 | ||||
Silicon Valley Bank Loan [Member] | Term Loan [Member] | Tenth Scheduled Payment Member | ||||||
Debt Instrument [Line Items] | ||||||
Proceeds from collateral account | $ 4 | |||||
Silicon Valley Bank Loan [Member] | Term Loan [Member] | Eighth Scheduled Payment | ||||||
Debt Instrument [Line Items] | ||||||
Proceeds from collateral account | 2.5 | |||||
Silicon Valley Bank Loan [Member] | Warrants | ||||||
Debt Instrument [Line Items] | ||||||
Issuance costs | $ 1.2 |
Fair Value Measurements - Asset
Fair Value Measurements - Assets and Liabilities Measured at Fair Value on Recurring Basis (Details) - Fair Value, Measurements, Recurring - USD ($) $ in Thousands | Sep. 30, 2022 | Dec. 31, 2021 |
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Cash equivalents | $ 36,807 | $ 75,222 |
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 | $ 36,807 | $ 75,222 |
Fair Value Measurements (Detail
Fair Value Measurements (Details) $ in Thousands | Sep. 30, 2022 USD ($) |
Fair Value, Inputs, Level 2, and Level 3 Member | |
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | |
Assets, Fair Value Disclosure | $ 0 |
Net Loss Per Share - Potential
Net Loss Per Share - Potential Dilutive Shares Excluded from Computation of Diluted Net Loss Per Share (Details) - shares | 9 Months Ended | |
Sep. 30, 2022 | Sep. 30, 2021 | |
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Antidilutive securities excluded from computation of earnings per share, amount | 34,485,557 | 35,386,620 |
Warrants | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Antidilutive securities excluded from computation of earnings per share, amount | 22,922,342 | 22,705,571 |
Common Stock Options | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Antidilutive securities excluded from computation of earnings per share, amount | 10,623,215 | 11,072,894 |
Inducement Stock Options | Two Thousand Twelve Stock Option Plan [Member] | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Antidilutive securities excluded from computation of earnings per share, amount | 0 | 97,500 |
Unvested Restricted Stock | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Antidilutive securities excluded from computation of earnings per share, amount | 940,000 | 1,510,655 |
Related Party Transactions - Ad
Related Party Transactions - Additional Information (Details) - USD ($) $ in Millions | 3 Months Ended | 9 Months Ended | |||||
Feb. 19, 2021 | Feb. 04, 2021 | Dec. 18, 2018 | Sep. 30, 2022 | Sep. 30, 2021 | Sep. 30, 2022 | Sep. 30, 2021 | |
Vineti Inc [Member] | Collaborative Arrangement [Member] | |||||||
Related Party Transaction [Line Items] | |||||||
Related Party Transaction Expenses From Transactions With Related Party Advisory Fees | $ 0 | $ 0.1 | $ 0 | $ 0.4 | |||
Eden Biocell [Member] | |||||||
Related Party Transaction [Line Items] | |||||||
Payments to Fund Long-term Loans to Related Parties | $ 10 | ||||||
Additional Loans Committed | $ 25 | ||||||
WatermillAndRobertWPostmaMember | |||||||
Related Party Transaction [Line Items] | |||||||
Pocket expenses | $ 0.4 | ||||||
Fees and Expenses, Related Party | $ 0.7 | ||||||
Related party transaction, reimbursed amount | $ 0.4 |
Commitments and Contingencies -
Commitments and Contingencies - Additional Information (Details) - USD ($) | 1 Months Ended | 3 Months Ended | 9 Months Ended | 12 Months Ended | |||||||||
May 28, 2019 | Aug. 17, 2015 | Jan. 13, 2015 | Mar. 31, 2023 | Sep. 30, 2022 | Sep. 30, 2021 | Sep. 30, 2022 | Sep. 30, 2021 | Dec. 31, 2019 | Oct. 22, 2019 | Feb. 19, 2019 | Oct. 05, 2018 | Aug. 24, 2004 | |
Accrued Payments | |||||||||||||
Research and development expense | $ 7,893,000 | $ 14,521,000 | $ 19,411,000 | $ 41,427,000 | |||||||||
Collaboration revenue | 2,911,000 | 398,000 | 2,911,000 | 398,000 | |||||||||
MD Anderson Warrant [Member] | |||||||||||||
Accrued Payments | |||||||||||||
Number of Warrants | 3,333,333 | ||||||||||||
Warrant exercise per share | $ 0.001 | ||||||||||||
Warrant Expiry date | Dec. 31, 2026 | ||||||||||||
MD Anderson Agreement and Worldwide License [Member] | |||||||||||||
Accrued Payments | |||||||||||||
License agreement commencing date | Jan. 13, 2015 | ||||||||||||
MD Anderson License and the Research and Development Agreement [Member] | |||||||||||||
Accrued Payments | |||||||||||||
Reimbursement of historical costs | $ 20,000,000 | ||||||||||||
Quarterly expense incurred | 300,000 | 0 | 700,000 | 0 | |||||||||
Aggregate potential benchmark payments | 36,500,000 | ||||||||||||
Payments due prior to the first marketing approval | $ 3,000,000 | ||||||||||||
CRADA Agreement [Member] | |||||||||||||
Accrued Payments | |||||||||||||
Quarterly expense incurred | 0 | 0 | 0 | 1,300,000 | |||||||||
Contribution payable on per annum basis | $ 1,000,000 | ||||||||||||
Obligations due under contract | $ 5,000,000 | ||||||||||||
CAR Products [Member] | |||||||||||||
Accrued Payments | |||||||||||||
Maximum Royalty Amount | $ 100,000,000 | ||||||||||||
The University of Texas MD Anderson Cancer Center and The Texas A & M University System | |||||||||||||
Accrued Payments | |||||||||||||
Milestone maximum payment | $ 4,500,000 | ||||||||||||
Payment under license agreement | 100,000 | 100,000 | |||||||||||
One time milestone payment | 2,500,000 | 2,500,000 | |||||||||||
The University of Texas MD Anderson Cancer Center and The Texas A & M University System | Royalty [Member] | |||||||||||||
Accrued Payments | |||||||||||||
Payment under license agreement | 0 | 0 | 0 | 0 | |||||||||
License Agreement with the National Cancer Institute [Member] | |||||||||||||
Accrued Payments | |||||||||||||
License Expense | 100,000 | 300,000 | 500,000 | 600,000 | |||||||||
License Agreement with the National Cancer Institute [Member] | One Time Benchmark Payments [Member] | |||||||||||||
Accrued Payments | |||||||||||||
First benchmark payment | $ 100,000 | ||||||||||||
Ziop License Agreement With The National Cancer Institute [Member] | |||||||||||||
Accrued Payments | |||||||||||||
Minimum royalties amount payable | 300,000 | ||||||||||||
Royalties amount payable thereafter | 100,000 | ||||||||||||
Aggregate minimum annual royalties paid | $ 1,500,000 | ||||||||||||
Description Of First Benchmark Payable | The first benchmark payment of $0.1 million was due upon the initiation of the Company's first sponsored Phase 1 clinical trial of a licensed product or licensed process in the field of use licensed under the Patent License. The Company paid the first benchmark payment during the nine months ended September 30, 2022. | ||||||||||||
Description Of option To terminate Agreement | The NCI may terminate or modify the Patent License in the event of a material breach, including if the Company does not meet certain milestones by certain dates, or upon certain insolvency events that remain uncured following the date that is 90 days following written notice of such breach or insolvency event. | ||||||||||||
Agreement termination, notice period | 60 days | ||||||||||||
Ziop License Agreement With The National Cancer Institute [Member] | Performance Based Payments Member [Member] | |||||||||||||
Accrued Payments | |||||||||||||
Aggregate Benchmark Payments Payable | $ 4,300,000 | ||||||||||||
Ziop License Agreement With The National Cancer Institute [Member] | One Time Benchmark Payments [Member] | |||||||||||||
Accrued Payments | |||||||||||||
Potential Benchmark Payments Payable | 12,000,000 | ||||||||||||
Ziop License Agreement With The National Cancer Institute [Member] | Post Marketing Approval [Member] | Performance Based Payments Member [Member] | |||||||||||||
Accrued Payments | |||||||||||||
Aggregate Benchmark Payments Payable | 3,000,000 | ||||||||||||
Ziop License Agreement With The National Cancer Institute [Member] | licensed products [Member] | One Time Benchmark Payments [Member] | |||||||||||||
Accrued Payments | |||||||||||||
Maximum Sales Revenue On Which Benchmark Payments Payable | 1,000,000,000 | ||||||||||||
Minimum sales revenue on which benchmark payments payable | $ 250,000,000 | ||||||||||||
Collaboration Agreement With Solasia Pharma KK [Member] | |||||||||||||
Accrued Payments | |||||||||||||
Collaboration revenue | 400,000 | 400,000 | |||||||||||
Collaboration Agreement With Solasia Pharma KK [Member] | Royalty [Member] | |||||||||||||
Accrued Payments | |||||||||||||
Collaboration revenue | $ 0 | $ 0 | $ 0 | $ 0 | |||||||||
Intrexon Corporation | |||||||||||||
Accrued Payments | |||||||||||||
Annual License Fees | 100,000 | ||||||||||||
Expected additional milestones payable | 52,500,000 | ||||||||||||
Payment for historical costs of the licensed programs | $ 1,000,000 | ||||||||||||
Intrexon Corporation | T-cell receptor | |||||||||||||
Accrued Payments | |||||||||||||
Maximum royalty amount | $ 100,000,000 | ||||||||||||
Portion of income payable to related party | 20% | ||||||||||||
Minimum | MD Anderson License and the Research and Development Agreement [Member] | |||||||||||||
Accrued Payments | |||||||||||||
Research and development expense | $ 15,000,000 | ||||||||||||
Maximum | MD Anderson License and the Research and Development Agreement [Member] | |||||||||||||
Accrued Payments | |||||||||||||
Research and development expense | $ 20,000,000 |
Leases - Additional Information
Leases - Additional Information (Details) $ in Thousands | 3 Months Ended | 9 Months Ended | |
Sep. 30, 2022 USD ($) ft² | Sep. 30, 2022 USD ($) ft² | Dec. 31, 2021 USD ($) | |
Right of use asset | $ 2,247 | $ 2,247 | $ 4,420 |
Gain (Loss) On Modification Of Lease | $ 100 | ||
SubleaseArea | ft² | 4,772 | 4,772 | |
Lease term, description | The term of the sub-sublease is from July 1, 2022 to June 30, 2025 and provides the sub-subtenant with an option to extend through to July 31, 2026 | ||
Other Income Expense [Member] | |||
Lease income | $ 44 | $ 44 | |
Houston, TX | |||
Operating Lease Area | ft² | 3,228 | 3,228 | |
Right of use asset | $ 400 | $ 400 | |
Previously Reported | Houston, TX | |||
Operating Lease Area | ft² | 18,111 | 18,111 |
Stock-Based Compensation Expens
Stock-Based Compensation Expense Included in Statement of Operations (Details) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2022 | Sep. 30, 2021 | Sep. 30, 2022 | Sep. 30, 2021 | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Stock-based compensation | $ 808 | $ 2,371 | $ 2,651 | $ 9,857 |
Research and Development Expense | ||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Stock-based compensation | 145 | 535 | 673 | 2,115 |
General and Administrative Expense | ||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Stock-based compensation | $ 663 | $ 1,836 | $ 1,978 | $ 7,742 |
Stock-Based Compensation - Addi
Stock-Based Compensation - Additional Information (Details) - USD ($) $ / shares in Units, $ in Millions | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2022 | Sep. 30, 2021 | Sep. 30, 2022 | Sep. 30, 2021 | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Stock options, granted | 1,275,000 | 2,755,000 | 4,667,500 | 7,150,438 |
Weighted-average grant date fair value | $ 1.52 | $ 1.08 | $ 0.67 | $ 1.91 |
Unvested Stock | ||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Unrecognized compensation costs related to unvested restricted stock outstanding | $ 7.1 | $ 7.1 | ||
Expected recognition period | 2 years 3 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 | $ 1.2 | $ 1.2 | ||
Expected recognition period | 1 year 9 months 29 days |
Stock-Based Compensation - Fair
Stock-Based Compensation - Fair Value of Stock Options Assumptions Using Black-Scholes Option Valuation Model (Details) | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2022 | Sep. 30, 2021 | Sep. 30, 2022 | Sep. 30, 2021 | |
Risk-free interest rate, Minimum | 2.94% | 0.89% | 1.63% | 0.50% |
Risk-free interest rate, Maximum | 3.62% | 0.96% | 3.62% | 1.15% |
Expected volatility, Minimum | 82.43% | 72.53% | 74.49% | 72.53% |
Expected volatility, Maximum | 85.89% | 72.84% | 85.89% | 74.80% |
Expected dividend yield | 0% | 0% | 0% | 0% |
Maximum [Member] | ||||
Expected life in years | 6 years 3 months | 6 years 3 months | 6 years 3 months | 6 years 3 months |
Minimum [Member] | ||||
Expected life in years | 6 years 2 months 23 days | 6 years | 5 years 3 months 7 days | 5 years 6 months |
Stock-Based Compensation - Stoc
Stock-Based Compensation - Stock Option Activity Under Stock Option Plan (Details) - USD ($) $ / shares in Units, $ in Thousands | 3 Months Ended | 9 Months Ended | 12 Months Ended | ||
Sep. 30, 2022 | Sep. 30, 2021 | Sep. 30, 2022 | Sep. 30, 2021 | Dec. 31, 2021 | |
Number of Shares | |||||
Beginning Balance | 10,665,869 | ||||
Granted | 1,275,000 | 2,755,000 | 4,667,500 | 7,150,438 | |
Exercised | (26,250) | ||||
Cancelled | (4,683,904) | ||||
Ending Balance | 10,623,215 | 10,623,215 | 10,665,869 | ||
Options exercisable, at end of period | 3,211,631 | 3,211,631 | 4,410,312 | ||
Options available for future grant | 15,245,494 | 15,245,494 | |||
Weighted Average Exercise Price | |||||
Beginning Balance | $ 2.87 | ||||
Granted | 1.08 | ||||
Exercised | 0.80 | ||||
Cancelled | 3.40 | ||||
Ending Balance | $ 1.85 | 1.85 | $ 2.87 | ||
Options exercisable, at end of period | $ 2.69 | $ 2.69 | $ 3.85 | ||
Weighted Average Contractual Term (Years) | |||||
Outstanding, at end of period | 8 years 3 months 7 days | ||||
Options exercisable, at end of period | 7 years 3 days | 7 years 6 months 10 days | |||
Aggregate Intrinsic Value | |||||
Outstanding, at end of period | $ 3,572 | $ 3,572 | |||
Options exercisable, at end of period | $ 510 | $ 510 | $ 0 |
Stock-Based Compensation - Summ
Stock-Based Compensation - Summary of Non-Vested Restricted Stock (Details) - Non Vested Restricted Stock [Member] | 9 Months Ended |
Sep. 30, 2022 $ / shares shares | |
Number of Shares | |
Beginning Balance | shares | 1,198,580 |
Granted | shares | 280,000 |
Vested | shares | (305,679) |
Cancelled | shares | (232,901) |
Ending Balance | shares | 940,000 |
Weighted Average Grant Date Fair Value | |
Beginning Balance | $ / shares | $ 2.10 |
Granted | $ / shares | 0.82 |
Vested | $ / shares | 2.28 |
Cancelled | $ / shares | 3.15 |
Ending Balance | $ / shares | $ 1.41 |
Warrants - Additional Informati
Warrants - Additional Information (Details) - USD ($) $ / shares in Units, $ in Thousands | 3 Months Ended | 9 Months Ended | |||||||
Dec. 28, 2021 | Aug. 06, 2021 | Oct. 22, 2019 | Sep. 12, 2019 | Nov. 11, 2018 | Sep. 30, 2022 | Sep. 30, 2021 | Sep. 30, 2022 | Sep. 30, 2021 | |
Fair Value Assumptions Expected volatility Rate Maximum | 85.89% | 72.84% | 85.89% | 74.80% | |||||
Fair Value Assumptions Risk Free Interest Rate Maximum | 3.62% | 0.96% | 3.62% | 1.15% | |||||
Proceeds from private placement | $ 52,500 | ||||||||
Silicon Valley Bank Loan [Member] | |||||||||
Warrant exercise per share | $ 1.16 | $ 2.22 | |||||||
Number of warrants issued | 432,844 | ||||||||
MD Anderson Warrant [Member] | |||||||||
Number of securities into which the class of warrant converted | 3,333,333 | ||||||||
Warrant exercise per share | $ 0.001 | ||||||||
Fair value of warrants | $ 14,500 | ||||||||
Warrant Expiry date | Dec. 31, 2026 | ||||||||
SVB Warrants [Member] | |||||||||
Common stock | 432,844 | ||||||||
Exercise price | $2.22 | ||||||||
Warrants fully vested upon issuance | 10 years | ||||||||
Black-Scholes Model [Member] | Silicon Valley Bank Loan [Member] | |||||||||
Fair Value Assumptions Expected Term1 | 10 years | ||||||||
Exercise price | $1.16 | ||||||||
Expected volatility | 81% | ||||||||
Risk-free interest rate | 1.49% | ||||||||
Number of warrants issued | 649,615 | ||||||||
Dividends | $ 0 | ||||||||
Change in fair value | $ 200 | ||||||||
Black-Scholes Model [Member] | SVB Warrants [Member] | |||||||||
Fair value of warrants | $ 800 | ||||||||
Fair Value Assumptions Expected Term1 | 10 years | ||||||||
Expected volatility | 79% | ||||||||
Risk-free interest rate | 1.31% | ||||||||
Dividends | $ 0 | ||||||||
Securities Purchase Agreement [Member] | |||||||||
Aggregate offering price | $ 47,100 | ||||||||
Private Placement [Member] | |||||||||
Number of securities into which the class of warrant converted | 17,803,031 | 18,939,394 | |||||||
Warrant exercise per share | $ 3.01 | $ 3.01 | |||||||
Fair value of warrants | $ 18,400 | ||||||||
Fair Value Assumptions Expected volatility Rate Maximum | 71% | ||||||||
Fair Value Assumptions Risk Free Interest Rate Maximum | 2.99% | ||||||||
Fair Value Assumptions Expected Term1 | 5 years | ||||||||
Placement agent fees and other expenses | $ 1,100 | ||||||||
Dividends | $ 0 | ||||||||
Private Placement [Member] | New Warrants [Member] | |||||||||
Number of securities into which the class of warrant converted | 17,803,031 | ||||||||
Warrant exercise per share | $ 7 | ||||||||
Non-cash inducement warrant expense | $ 60,800 |
Joint Venture - Additional Info
Joint Venture - Additional Information (Details) | Jul. 05, 2019 |
Ziopharm [Member] | Eden Bio Cell [Member] | |
Subsidiary or Equity Method Investee [Line Items] | |
Equity interest in affilated entity | 50% |