Cover Page
Cover Page - USD ($) | 12 Months Ended | ||
Dec. 31, 2022 | Mar. 24, 2023 | Jun. 30, 2022 | |
Cover [Abstract] | |||
Document Type | 10-K | ||
Document Annual Report | true | ||
Document Period End Date | Dec. 31, 2022 | ||
Current Fiscal Year End Date | --12-31 | ||
Document Transition Report | false | ||
Entity File Number | 001-36783 | ||
Entity Registrant Name | Bellicum Pharmaceuticals, Inc. | ||
Entity Incorporation, State or Country Code | DE | ||
Entity Tax Identification Number | 20-1450200 | ||
Entity Address, Address Line One | 3730 Kirby Drive, Suite 1200 | ||
Entity Address, City or Town | Houston | ||
Entity Address, State or Province | TX | ||
Entity Address, Postal Zip Code | 77098 | ||
City Area Code | 281 | ||
Local Phone Number | 454-3424 | ||
Title of 12(b) Security | Common Stock, par value $0.01 per share | ||
Trading Symbol | BLCM | ||
Security Exchange Name | NASDAQ | ||
Entity Well-known Seasoned Issuer | No | ||
Entity Voluntary Filers | No | ||
Entity Current Reporting Status | Yes | ||
Entity Interactive Data Current | Yes | ||
Entity Filer Category | Non-accelerated Filer | ||
Entity Small Business | true | ||
Entity Emerging Growth Company | false | ||
ICFR Auditor Attestation Flag | false | ||
Entity Shell Company | false | ||
Entity Public Float | $ 9,205,453 | ||
Entity Common Stock, Shares Outstanding | 9,046,298 | ||
Documents Incorporated by Reference | Portions of the registrant’s Definitive Proxy Statement relating t o its 2023 Annual Meeting of Stockholders are incorporated by reference into Part III of this Annual Report on Form 10-K. Such Proxy Statement will be filed with the U.S. Securities and Exchange Commission within 120 days following the end of the registrant’s fiscal year ended December 31, 2022. | ||
Entity Central Index Key | 0001358403 | ||
Document Fiscal Year Focus | 2022 | ||
Document Fiscal Period Focus | FY | ||
Amendment Flag | false |
Audit Information
Audit Information | 12 Months Ended |
Dec. 31, 2022 | |
Auditor Information [Abstract] | |
Auditor Firm ID | 42 |
Auditor Name | Ernst & Young LLP |
Auditor Location | Houston, Texas |
Consolidated Balance Sheets
Consolidated Balance Sheets - USD ($) $ in Thousands | Dec. 31, 2022 | Dec. 31, 2021 |
Current assets: | ||
Cash and cash equivalents | $ 21,837 | $ 46,156 |
Restricted cash | 0 | 1,501 |
Accounts receivable, interest and other receivables | 0 | 205 |
Prepaid expenses and other current assets | 1,964 | 1,269 |
Total current assets | 23,801 | 49,131 |
Property and equipment, net | 22 | 12 |
Total assets | 23,823 | 49,143 |
Current liabilities: | ||
Accounts payable | 486 | 90 |
Accrued expenses and other current liabilities | 2,477 | 3,849 |
Warrant derivative liability | 809 | 2,773 |
Total current liabilities | 3,772 | 6,712 |
Total liabilities | 3,772 | 6,712 |
Commitments and contingencies | ||
Redeemable Preferred stock: $0.01 par value; 10,000,000 shares authorized, Series 1 redeemable convertible preferred stock, $0.01 par value, 1,517,500 shares authorized at December 31, 2022 and December 31, 2021, 452,000 shares issued and outstanding at December 31, 2022 and December 31, 2021 | 18,036 | 18,036 |
Stockholders’ equity: | ||
Common stock, $0.01 par value; 160,000,000 shares authorized at December 31, 2022 and 80,000,000 shares authorized at December 31, 2021; 8,682,447 shares issued and 8,614,701 shares outstanding at December 31, 2022; 8,497,025 shares issued and 8,429,279 shares outstanding at December 31, 2021 | 87 | 85 |
Treasury stock: 67,746 shares held at December 31, 2022 and December 31, 2021 | (5,056) | (5,056) |
Additional paid-in capital | 582,763 | 580,156 |
Accumulated other comprehensive loss | (354) | (338) |
Accumulated deficit | (575,425) | (550,452) |
Total stockholders’ equity | 2,015 | 24,395 |
Total liabilities, redeemable preferred stock and stockholders’ equity | $ 23,823 | $ 49,143 |
Consolidated Balance Sheets (Pa
Consolidated Balance Sheets (Parenthetical) - $ / shares | Dec. 31, 2022 | Dec. 31, 2021 |
Preferred stock, par value (in dollars per share) | $ 0.01 | $ 0.01 |
Preferred stock, authorized (in shares) | 10,000,000 | 10,000,000 |
Common stock, par value (in dollars per share) | $ 0.01 | $ 0.01 |
Common stock, authorized (in shares) | 160,000,000 | 80,000,000 |
Common stock, issued (in shares) | 8,682,447 | 8,497,025 |
Common stock, outstanding (in shares) | 8,614,701 | 8,429,279 |
Treasury stock, shares (in shares) | 67,746 | 67,746 |
Convertible Preferred Stock | ||
Preferred stock, par value (in dollars per share) | $ 0.01 | $ 0.01 |
Preferred stock, authorized (in shares) | 1,517,500 | 1,517,500 |
Preferred stock, issued (in shares) | 452,000 | 452,000 |
Preferred stock, outstanding (in shares) | 452,000 | 452,000 |
Consolidated Statements of Oper
Consolidated Statements of Operations and Comprehensive Loss - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2022 | Dec. 31, 2021 | |
Revenues | ||
Revenues | $ 1,500 | $ 6,200 |
Operating expenses | ||
Research and development | 22,764 | 23,578 |
General and administrative | 5,717 | 7,010 |
Total operating expenses | 28,481 | 30,588 |
Other operating expense | ||
Loss on dispositions, net | 0 | (478) |
Total other operating expense | 0 | (478) |
Loss from operations | (26,981) | (24,866) |
Other income (expense): | ||
Interest income, net of interest expense | 46 | 28 |
Change in fair value of warrant and private placement option liabilities | 1,964 | 15,126 |
Other income | 0 | 7 |
Total other income | 2,010 | 15,161 |
Loss before tax | (24,971) | (9,705) |
Income tax expense | (2) | 0 |
Net loss | $ (24,973) | $ (9,705) |
Net loss per common share attributable to common shareholders, basic (in dollars per share) | $ (0.81) | $ (0.84) |
Net loss per common share attributable to common shareholders, diluted (in dollars per share) | $ (0.81) | $ (0.84) |
Weighted-average shares outstanding-basic (in shares) | 30,828,247 | 11,504,294 |
Weighted-average shares outstanding- diluted (in shares) | 30,828,247 | 11,504,294 |
Net loss | $ (24,973) | $ (9,705) |
Other comprehensive income (loss): | ||
Foreign currency translation adjustment | (16) | 1 |
Comprehensive loss | (24,989) | (9,704) |
Supply agreement | ||
Revenues | ||
Revenues | 0 | 700 |
License revenue | ||
Revenues | ||
Revenues | $ 1,500 | $ 5,500 |
Consolidated Statements of Rede
Consolidated Statements of Redeemable Convertible Preferred Stock and Stockholders’ Equity (Deficit) - USD ($) $ in Thousands | Total | Common Stock | Treasury Stock | Additional Paid-In Capital | Accumulated Deficit | Accumulated Other Comprehensive Loss | Series 1 Preferred Preferred Stock |
Preferred stock, beginning balance (in shares) at Dec. 31, 2020 | 452,000 | ||||||
Preferred stock, beginning balance at Dec. 31, 2020 | $ 18,036 | ||||||
Preferred stock, ending balance (in shares) at Dec. 31, 2021 | 452,000 | ||||||
Preferred stock, ending balance at Dec. 31, 2021 | $ 18,036 | $ 18,036 | |||||
Balance, beginning of period (in shares) at Dec. 31, 2020 | 8,385,650 | 67,746 | |||||
Balance, beginning of period at Dec. 31, 2020 | (2,497) | $ 84 | $ (5,056) | $ 543,561 | $ (540,747) | $ (339) | |
Increase (Decrease) in Stockholders' Equity | |||||||
Share-based compensation | 3,439 | 3,439 | |||||
Issuance of common stock upon vesting of restricted stock units (in shares) | 111,375 | ||||||
Issuance of common stock upon vesting of restricted stock units | 0 | $ 1 | (1) | ||||
Issuance of common stock and pre-funded warrants exercise, net of issuance costs (in shares) | 0 | ||||||
Issuance of common stock and pre-funded warrants exercise, net of issuance costs | 32,908 | 32,908 | |||||
Extinguishment of private option liability | 249 | 249 | |||||
Comprehensive loss | $ (9,704) | (9,705) | 1 | ||||
Balance, end of period (in shares) at Dec. 31, 2021 | 8,429,279 | 8,497,025 | 67,746 | ||||
Balance, end of period at Dec. 31, 2021 | $ 24,395 | $ 85 | $ (5,056) | 580,156 | (550,452) | (338) | |
Preferred stock, ending balance (in shares) at Dec. 31, 2022 | 452,000 | ||||||
Preferred stock, ending balance at Dec. 31, 2022 | 18,036 | $ 18,036 | |||||
Increase (Decrease) in Stockholders' Equity | |||||||
Share-based compensation | 2,609 | 2,609 | |||||
Issuance of common stock upon vesting of restricted stock units (in shares) | 128,472 | ||||||
Issuance of common stock upon vesting of restricted stock units | 0 | $ 1 | (1) | ||||
Issuance of common stock and pre-funded warrants exercise, net of issuance costs (in shares) | 56,950 | ||||||
Issuance of common stock and pre-funded warrants exercise, net of issuance costs | 0 | $ 1 | (1) | ||||
Comprehensive loss | $ (24,989) | (24,973) | (16) | ||||
Balance, end of period (in shares) at Dec. 31, 2022 | 8,614,701 | 8,682,447 | 67,746 | ||||
Balance, end of period at Dec. 31, 2022 | $ 2,015 | $ 87 | $ (5,056) | $ 582,763 | $ (575,425) | $ (354) |
Consolidated Statements of Cash
Consolidated Statements of Cash Flows - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2022 | Dec. 31, 2021 | |
Cash flows from operating activities: | ||
Net loss | $ (24,973) | $ (9,705) |
Adjustments to reconcile net loss to net cash used in operating activities: | ||
Share-based compensation | 2,609 | 3,439 |
Depreciation and amortization expense | 11 | 105 |
Change in fair value of warrant and private placement derivative liabilities | (1,964) | (15,126) |
Loss on dispositions, net | 0 | 478 |
Amortization of right-of-use assets | 0 | 33 |
Accretion of lease liability | 0 | 23 |
Changes in operating assets and liabilities: | ||
Accounts receivable, interest and other receivables | 205 | 170 |
Prepaid expenses and other assets | (695) | (462) |
Accounts payable | 396 | (801) |
Accrued liabilities and other | (1,372) | (1,260) |
Net cash used in operating activities | (25,783) | (23,106) |
Cash flows from investing activities: | ||
Proceeds from sale of property and equipment | 0 | 900 |
Purchases of property and equipment | (21) | (7) |
Net cash provided by (used in) investing activities | (21) | 893 |
Cash flows from financing activities: | ||
Proceeds from issuance of pre-funded warrants, net | 0 | 32,908 |
Payment on financing lease obligations | 0 | (35) |
Net cash provided by financing activities | 0 | 32,873 |
Effect of exchange rate changes on cash | (16) | 1 |
Net change in cash, cash equivalents and restricted cash | (25,820) | 10,661 |
Cash, cash equivalents and restricted cash at beginning of period | 47,657 | 36,996 |
Cash, cash equivalents and restricted cash at end of period | $ 21,837 | $ 47,657 |
ORGANIZATION, BASIS OF PRESENTA
ORGANIZATION, BASIS OF PRESENTATION, AND SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES | 12 Months Ended |
Dec. 31, 2022 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
ORGANIZATION, BASIS OF PRESENTATION, AND SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES | ORGANIZATION, BASIS OF PRESENTATION, AND SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES Organization Bellicum Pharmaceuticals, Inc. (“Bellicum”) is a biopharmaceutical company that has developed novel cellular immunotherapies for various forms of cancer. Bellicum has two wholly-owned subsidiaries, Bellicum Pharma Limited, a private limited company organized under the laws of the United Kingdom, and Bellicum Pharma GmbH, a private limited liability company organized under German law. Both were formed for the purpose of developing product candidates in Europe. Bellicum, Bellicum Pharma Limited and Bellicum Pharma GmbH are collectively referred to herein as the “Company.” All intercompany balances and transactions among the consolidated entities have been eliminated in consolidation. Operating segments are identified as components of an enterprise about which separate discrete financial information is available for evaluation by the chief operating decision-maker. The Company has determined that it has one operating and reporting segment as it allocates resources and assesses financial performance on a consolidated basis. The Company’s chief operating decision maker is its Chief Executive Officer who manages operations and reviews the financial information as a single operating segment for purposes of allocating resources and evaluating its financial performance. Basis of Presentation The accompanying financial statements have been prepared in conformity with the authoritative U.S. generally accepted accounting principles (“GAAP”). The Company has experienced net losses since its inception and as of December 31, 2022, the Company has an accumulated deficit of $575.4 million. The Company believes that there is substantial doubt that its current capital resources, which consist of cash and cash equivalents, are sufficient to fund operations through at least the next twelve months from the date the accompanying financial statements are issued. The accompanying financial statements have been prepared on a basis that assumes that the Company will continue as a going concern, and do not include any adjustments that may result from the outcome of this uncertainty. This basis of accounting contemplates the recovery of the Company’s assets and the satisfaction of the Company’s liabilities and commitments in the normal course of business and does not include any adjustments to reflect the possible future effects of the recoverability and classification of recorded asset amounts or amounts and classification of liabilities that might be necessary should the Company be unable to continue as a going concern. In March 2023, the Company announced its decision to discontinue its ongoing Phase 1/2 clinical trials evaluating the safety and preliminary efficacy of its GoCAR-T cell product candidates in combination with rimiducid in heavily pre-treated cancer patients. The trials for BPX-601 and BPX-603 are being discontinued following the Company’s assessment of the risk/benefit profile of BPX-601 in combination with rimiducid. The Company is communicating with clinical trial sites and regulatory agencies regarding its decision to discontinue its trials, and an evaluation of the Company’s strategic alternatives is underway. The strategic alternatives include, but are not limited to, a merger, sale, or other business combination, a strategic partnership with one or more parties, or the licensing, sale, or divestiture of our programs. Despite undertaking this process, the Company may not be successful in completing a transaction, and even if a strategic transaction is completed, it ultimately may not deliver the anticipated benefits. If the Company does not successfully consummate a strategic alternative, its board of directors may decide to pursue a dissolution and liquidation of the Company. Use of Estimates The preparation of the financial statements in accordance with GAAP requires management to make certain estimates and judgments that affect the reported amounts of assets, liabilities, revenue recognition, and expenses. Actual results could differ materially from those estimates. Revenue Recognition The Company’s only source of revenue in 2022 was from its option and license agreement with University of Texas M.D. Anderson Cancer Center (“M.D. Anderson”). The Company has generated revenue from its licensing agreements since 2019. Prior to 2019, the Company’s only source of revenue was from grants. The Company’s sources of revenue in 2021 were from its option and license agreements with M.D. Anderson and a supply agreement with Takeda. Takeda Supply Agreement On May 4, 2021, the Company entered a multi-year supply agreement with Takeda. The Company will supply Takeda with rimiducid for potential use in clinical trials of TAK-007 (CD19 CAR-NK cell therapy). The Company generated revenue of $0.7 million in the second quarter of 2021, with the possibility of additional revenue from future sales. The promised product in the supply agreement with Takeda consists of rimiducid including any components, drug substance, raw materials and/or excipients to be supplied by the Company. Revenue is generally recognized upon the transfer of control of promised goods to customers in an amount that reflects the consideration to which the entity expects to be entitled in exchange for those goods. M.D. Anderson License Agreements On January 22, 2019, the Company entered into a licensing and commercialization agreement with M.D. Anderson (the “2019 M.D. Anderson License Agreement”). Under the 2019 M.D. Anderson License Agreement, the Company granted M.D. Anderson non-exclusive rights in certain Caspase-9 and related technologies and use of a small molecule known as rimiducid in a certain cell therapy program. During the fourth quarter of 2019, and under the terms of the 2019 M.D. Anderson License Agreement, M.D. Anderson exercised an option to grant a non-exclusive sublicense of the rights licensed by the Company to M.D. Anderson. M.D. Anderson, as a result of this exercise, granted a sublicense that entitled the Company to receive as consideration an upfront license fee as well as additional future annual maintenance fees, milestone payments related to the achievement of pre-specified development, regulatory, and commercialization events, and royalties on net sales of licensed products. During the year ended December 31, 2022, the Company earned an annual license maintenance fee of $0.5 million. On August 31, 2021, the Company entered into a second licensing and commercialization agreement with M.D. Anderson (the “2021 M.D. Anderson Option and License Agreement”). Under the 2021 M.D. Anderson Option and License Agreement, M.D. Anderson has certain rights to the use of CaspaCIDe and rimiducid in product candidates nominated under the agreement, and receives an option to a non-exclusive license to the technology in these candidates. Upon exercise of an option and sublicense of a product candidate to a third party, the Company is entitled to a sublicense execution fee, a percentage of certain consideration received by M.D. Anderson for the sublicense, an annual maintenance fee, and a percentage royalty on net sales of licensed products. During the year ended December 31, 2022, the Company earned an annual license maintenance fee of $1.0 million for two nominated programs. Licenses of Intellectual Property Revenue is recognized from the satisfaction of performance obligations when such obligations have been fulfilled. If a license to the Company’s intellectual property is determined to be distinct from the other performance obligations identified in the arrangement, revenue is recognized from non-refundable, up-front fees allocated to the license when the license is transferred to the customer and the customer is able to use and benefit from the license. For licenses that are bundled with other promises, the Company uses judgment to assess the nature of the combined performance obligation to determine whether the combined performance obligation is satisfied over a period of time or at a point in time. If over a period of time, the Company evaluates the measure of progress each reporting period and, if necessary, adjusts the measure of performance and related revenue recognition. Milestone Payments At the inception of each arrangement that includes developmental, regulatory or commercial milestone payments, the Company evaluates whether achieving the milestones is considered probable and estimates the amount to be included in the transaction price using the most likely amount method. If it is probable that a significant revenue reversal would not occur, the value of the associated milestone is included in the transaction price. Milestone payments that are not within the Company’s control, such as approvals from regulators or where attainment of the specified event is dependent on the development activities of a third party, are not considered probable of being achieved until those approvals are received or the specified event occurs. Royalty Revenues For arrangements that include sales-based royalties, including milestone payments based on the level of sales, and the license is deemed to be the predominant item to which the royalties relate, the Company recognizes revenue at the later of (i) when the related sales occur, or (ii) when the performance obligation to which some or all of the royalty has been allocated has been satisfied (or partially satisfied). To date, no royalties have been received. Cash, Cash Equivalents, and Restricted Cash The Company considers all short-term, highly liquid investments with a maturity of three months or less from the date of purchase and that can be liquidated without prior notice or penalty, to be cash equivalents. The following table provides a reconciliation of cash, cash equivalents and restricted cash reported within the balance sheets that sum to the total of the same such amounts shown in the statements of cash flows. (in thousands) December 31, 2022 December 31, 2021 Cash and cash equivalents $ 21,837 $ 46,156 Restricted cash — 1,501 Total cash, cash equivalents and restricted cash shown in the statements of cash flows $ 21,837 $ 47,657 In April 2020, the Company sold its U.S. manufacturing facility to The University of Texas M.D. Anderson Cancer Center (“M.D. Anderson”). Pursuant to the Company’s asset purchase agreement with M.D. Anderson, $1.5 million of the cash proceeds received were subject to certain escrow provisions and recorded as restricted cash. The claims against the escrow have been resolved and the funds were released and transferred to the Company in July 2022. Disposition of Assets and Liabilities Held for Sale and Held for Use In the fourth quarter of 2020, in connection with the Company’s restructuring plan, management elected to seek an exit to its leased R&D facility in Houston, Texas. The lease termination and disposal of the assets and liabilities associated with the facility was completed on February 26, 2021. Under the terms of the agreement, a third party assumed the lease for the facility. In addition, the third party paid $1.1 million to the Company for substantially all of the property, and equipment associated with the location. The consideration included $0.9 million in cash and an unsecured promissory note for $0.2 million. The principal amount of the promissory note together with accrued interest of 4% per annum was paid in July 2022. On March 15, 2021, the Company entered an agreement to terminate its sub-lease of the South San Francisco office space contingent upon consent of the prime lessor. Under the terms of the agreement, the company agreed to pay a lease termination fee of $0.9 million while the security deposit of $0.2 million was returned to the Company in June 2021. The decision to exit this lease reflects the ability of the Company to carry on its administrative function remotely. On March 26, 2021, the Company met all of the conditions of the agreement and disposed of substantially all of the assets and liabilities associated with the lease including the right-of-use asset of $0.6 million, leased equipment with a net book value less than $0.1 million, and the related lease liability of $1.0 million. The Company recognized a loss on termination of $0.5 million during the first quarter of 2021. Property and Equipment Furniture, equipment and software are recorded at cost and are depreciated using the straight-line method over the estimated useful lives of the related assets, which range from 3 to 5 years. Property and equipment consisted of the following: (in thousands, except useful lives) Estimated Useful Lives December 31, 2022 December 31, 2021 Lab equipment 5 Years 0 530 Manufacturing equipment 5 Years 0 138 Computer and office equipment 3 to 5 Years 510 841 Software 3 Years 82 94 Total 592 1,603 Less: accumulated depreciation (570) (1,591) Property and equipment, net $ 22 $ 12 During the years ended December 31, 2022 and 2021, the Company recorded $0.01 million and $0.11 million of depreciation expense, respectively. Accrued Expenses and Other Current Liabilities Accrued expenses and other liabilities consist of the following: December 31, 2022 December 31, 2021 Accrued payroll 264 $ 320 Accrued patient treatment costs 675 2,086 Accrued clinical research costs 841 479 Accrued manufacturing costs 434 328 Accrued professional services 207 305 Accrued other 56 331 Total accrued expenses and other current liabilities $ 2,477 $ 3,849 Warrant Derivatives In an underwritten public offering (the “2019 Offering”), the Company issued Series 1 Redeemable Convertible Non-Voting Preferred Stock (the “Series 1 Preferred Stock”) and warrants (the “2019 Public Warrants”) to purchase its common stock. These 2019 Public Warrants are classified as liabilities in the accompanying consolidated balance sheets because the public warrants embody a conditional or unconditional obligation to repurchase the Company’s shares. The Company accounted for these warrants at fair value on the date of issuance and they are subject to re-measurement to fair value at each balance sheet date. Any change in fair value is recognized as a component of other income (expense) on the accompanying consolidated statements of operations and comprehensive loss. The Company estimates the fair value of these liabilities using the Black-Scholes valuation technique, which utilizes assumptions including (i) the fair value of the underlying stock at the valuation measurement date, (ii) volatility of the price of the underlying stock, (iii) the expected term, and (iv) risk-free interest rates. The Company will continue to adjust the liability for changes in fair value until the earlier of the exercise or expiration of the warrants or a change in control, as defined. The warrants are freely exercisable at any time from the issuance date until the expiration date, provided exercise does not cause a warrant holder to exceed a pre-determined beneficial ownership limit. See Note 4 - Public Offering and Private Placement for discussions of the 2019 Public Warrants. In November 2020 and December 2021, the Company issued prefunded warrants and accompanying warrants (the “2020 Pre-funded Warrants” and “2020 Common Warrants”, the “2021 Pre-funded Warrants” and “2021 Common Warrants”, respectively). These pre-funded warrants and common warrants are classified as equity. The pre-funded warrants and common warrants neither embody a conditional or unconditional obligation, nor are they indexed to an obligation, to repurchase the Company’s shares by transferring assets. Furthermore, the monetary value of the pre-funded warrants and accompanying warrants, at inception, is not solely or predominately based on (a) a fixed monetary amount, (b) variations in something other than the fair value of the Company’s shares, or (c) variations inversely related to the fair value of the Company’s own shares. Therefore, the pre-funded warrants and common warrants do not meet the criteria requiring liability classification. See Note 4 - Public Offering and Private Placement for discussions of the 2020 Pre-funded and Common Warrants and 2021 Pre-funded and Common Warrants. Private Placement Option Besides the 2019 Offering, the Company completed a private placement and entered into the 2019 Securities Purchase Agreement that contained a call option on preferred shares that are puttable outside the control of the Company. Prior to the fourth quarter of 2021, the Company recorded the option as a liability and measured the option at fair value. The Company re-measured the option to fair value at each balance sheet date and recorded changes in fair value in other income (expense) in the accompanying consolidated statement of operations and comprehensive loss at each reporting period. Offering expenses arising from the issuance of the private placement option were expensed as incurred. The Company estimated the fair value of these liabilities using a binomial lattice model, which utilized assumptions including (i) the fair value of the underlying stock at the valuation measurement date, (ii) volatility of the price of the underlying stock, (iii) the expected term, and (iv) risk-free interest rates. In 2021, the Company entered into the 2021 Securities Purchase Agreement, pursuant to which certain of the purchasers irrevocably waived the right to cause the Company to conduct the “First Closing” and “Second Closing” under the private placement option contained in the 2019 Securities Purchase Agreement (each term as defined in the 2019 Securities Purchase Agreement), which releases the Company of potential obligations. The Company has therefore derecognized the option liability at its balance sheet date ended on December 31, 2021. Preferred Stock Preferred shares issued by the Company that are subject to mandatory redemption are classified as liability instruments in the accompanying consolidated balance sheets and are measured at fair value at the date of issuance. Conditionally redeemable preferred shares (including preferred shares that feature redemption rights that are either within the control of the holder or subject to redemption upon the occurrence of uncertain events not solely within the Company’s control) are classified within mezzanine equity in the accompanying consolidated balance sheets. At all other times, preferred shares are classified within stockholders’ equity. Operating Leases At the inception of a contractual arrangement, the Company determines whether the contract contains a lease by assessing whether there is an identified asset and whether the contract conveys the right to control the use of the identified asset in exchange for consideration over a period of time. If both criteria are met, upon lease commencement, the Company records a lease liability which represents the Company’s obligation to make lease payments arising from the lease, and a corresponding right-of-use (“ROU”) asset which represents the Company’s right to use an underlying asset during the lease term. Operating leases are recognized as ROU assets and operating lease liabilities on the balance sheet at the commencement date based on the present value of the future minimum lease payments over the lease term calculated using the Company’s incremental borrowing rate applicable to the underlying asset unless the implicit rate is readily determinable. Any lease incentives received are deferred and recorded as a reduction of the ROU asset and amortized over the term of the lease. Rent expense, comprised of amortization of the ROU asset and the implicit interest accreted on the operating lease liability, is recognized on a straight-line basis over the lease term. The Company determines the lease term as the noncancellable period of the lease and may include options to extend or terminate the lease when it is reasonably certain that the Company will exercise such options. Leases with a term of 12 months or less are not recognized on the balance sheets. Fair Value of Financial Instruments Fair value is defined as an exit price, representing the amount that would be received to sell an asset or paid to transfer a liability in an orderly transaction between market participants. As such, fair value is a market-based measurement that should be determined based on assumptions that market participants would use in pricing an asset or liability. As a basis for considering such assumptions, a fair value hierarchy has been established that prioritizes the inputs used to measure fair value. The hierarchy gives the highest priority to unadjusted quoted prices in active markets for identical assets or liabilities (Level 1 measurement) and the lowest priority to unobservable inputs (Level 3 measurement). These inputs are classified into the following hierarchy: Level 1 Inputs - quoted prices (unadjusted) in active markets for identical assets that the reporting entity has the ability to access at the measurement date; Level 2 Inputs - inputs other than quoted prices included within Level 1 that are observable for the asset, either directly or indirectly; and Level 3 Inputs - unobservable inputs for the assets. The categorization of a financial instrument within the valuation hierarchy is based upon the lowest level of input that is significant to the fair value measurement. The Company believes the recorded values of its financial instruments, including cash and cash equivalents, accounts payable, accrued liabilities, and debt approximate their fair values due to the short-term nature of these instruments. Financial Instruments and Credit Risks Financial instruments that potentially subject the Company to credit risk include cash and cash equivalents and accounts receivable. Cash is deposited in demand accounts in federally insured domestic institutions to minimize risk. Insurance is provided through the Federal Deposit Insurance Corporation and Security Investor Protection Corporation. Although the balances in these accounts exceed the federally insured limit from time to time, the Company has not incurred losses related to these deposits. Equity Issuance Costs Equity issuance costs represent costs paid to third parties in order to obtain equity financing. These costs have been netted against the proceeds of the equity issuances. Licenses and Patents Licenses and patent costs for technologies that are utilized in research and development and have no alternative future use are expensed as incurred. Costs related to the license of patents from third parties and internally developed patents are classified as research and development expenses. Legal costs related to patent applications and maintenance are classified as general and administrative expenses in the accompanying consolidated statements of operations and comprehensive loss. Research and Development Research and development expenses consist of expenses incurred in performing research and development activities, including compensation and benefits for research and development employees and consultants, facilities expenses, overhead expenses, cost of laboratory supplies, manufacturing expenses, fees paid to third parties and other outside expenses. Research and development costs are expensed as incurred. Clinical trial and other development costs incurred by third parties are expensed as the contracted work is performed. The Company accrues for costs incurred as the services are being provided by monitoring the status of the clinical trial or project and the invoices received from its external service providers. The Company ’ s estimates depend on the timeliness and accuracy of the data provided by the vendors regarding the status of each project and total project spending. The Company adjusts its accrual as actual costs become known. Collaboration Agreements The Company enters into collaboration agreements that include varying arrangements regarding which parties perform and bear the costs of research and development activities. The Company may share the costs of research and development activities with a collaborator, or the Company may be reimbursed for all or a significant portion of the costs of the Company ’ s research and development activities. The Company records its internal and third-party development costs associated with these collaborations as research and development expenses. When the Company is entitled to reimbursement of all or a portion of the research and development expenses that it incurs under a collaboration, the Company records those reimbursable amounts as a deduction to the research and development expenses. If the collaboration is a cost-sharing arrangement in which both the Company and its collaborator perform development work and share costs, the Company also recognizes, as research and development expenses in the period when its collaborator incurs development expenses, the portion of the collaborator’s development expenses that the Company is obligated to reimburse. Contract Manufacturing Services Contract manufacturing services are expensed as incurred. Prepaid expenses are capitalized and amortized as services are performed. Share-Based Compensation The Company accounts for share-based compensation based on the measurement and recognition of compensation expense for all share-based payment awards made to employees, directors and consultants to be recognized in the financial statements, based on their fair value. The Company calculates the fair value of stock options on the date of grant using the Black-Scholes pricing model, which requires a number of estimates, including the expected life of awards, interest rates, stock volatility and other assumptions. Restricted stock is measured based on the fair market value of the underlying stock on the date of grant. If the awards are classified as liability awards, the fair value is remeasured at each reporting date and the compensation expense is adjusted accordingly. Additionally, the Company applies a forfeiture rate to estimate the number of grants that will ultimately vest, as applicable, and adjusts the expense as these awards vest. All of the Company’s current equity awards are service based awards and the share-based compensation cost is being recognized over the requisite service period of the awards on a straight-line basis. Income Taxes Income taxes are accounted for under the asset and liability method. Deferred tax assets and liabilities are recognized for the future tax consequences attributable to differences between the financial statement carrying amounts of existing assets and liabilities and their respective tax bases. This method also requires the recognition of future tax benefits such as net operating loss and tax credit carry forwards, to the extent that realization of such benefits is more likely than not. A valuation allowance is recorded when the realization of future tax benefits is uncertain. The Company records a valuation allowance for the full amount of deferred tax assets, which would otherwise be recorded for tax benefits relating to the operating loss and tax credit carryforwards, as realization of such deferred tax assets cannot be determined to be more likely than not. Deferred tax assets and liabilities are measured using enacted tax rates expected to apply to taxable income in the years in which those temporary differences are expected to be recovered or settled. The effect on deferred tax assets and liabilities of a change in tax rates is recognized in the statement of operations in the period that includes the enactment date. As of December 31, 2022, the Company had recorded a full valuation allowance on its net U.S. and foreign deferred tax assets because the Company expects that it is more likely than not that its deferred tax assets will not be realized in the foreseeable future. Should the actual amounts differ from our estimates, the amount of the valuation allowance could be materially impacted. The Company accounts for uncertain tax positions in accordance with the provisions of the Accounting Standards Codification (ASC) 740 , Income Taxes . When uncertain tax positions exist, the Company recognizes the tax benefit of tax positions to the extent that the benefit will more likely than not be realized. The determination as to whether the tax benefit will more likely than not be realized is based upon the technical merits of the tax position as well as consideration of the available facts and circumstances. As of December 31, 2022 and 2021, the Company had no uncertain tax positions and no interest or penalties have been charged for the years ended December 31, 2022 and 2021. The Company is subject to routine audits by taxing jurisdictions; however, there are currently no audits for any tax periods in progress. The tax years 2005 through 2022 remain open to examination by the U.S. Internal Revenue Service. Comprehensive Loss Comprehensive loss is defined as the change in equity of a business enterprise during a period, from transactions, and other events and circumstances from non-owner sources. Components of other comprehensive loss includes, among other items, unrealized gains and losses on the changes in fair value of investments and unrealized gains and losses on the change in foreign currency exchange rates. These components are added, net of their related tax effect, to the reported net loss to arrive at comprehensive loss. Net Loss and Net Loss per Share of Common Stock Attributable to Common Stockholders Basic net loss per share attributable to common stockholders is calculated by dividing the net loss attributable to common stockholders by the weighted-average number of shares of common stock outstanding during the period without consideration for common stock equivalents. Diluted earnings per share is based on the more dilutive method between the two-class method and the treasury stock method and includes the effect from potential issuance of ordinary shares, such as shares issuable pursuant to the conversion of preferred stock to common stock, exercise of warrants to purchase common stock, exercise of stock options, and vesting of restricted stock units. For periods of net loss, diluted net loss per share is calculated similarly to basic net loss per share. The following outstanding shares of common stock equivalents were excluded from the computations of diluted earnings per share of common stock attributable to common stockholders for the periods presented as the effect of including such securities would be anti-dilutive. December 31, 2022 December 31, 2021 Anti-dilutive common stock equivalents: Number of Shares Redeemable convertible series 1 preferred stock 4,520,000 4,520,000 Warrants to purchase common stock 5,750,000 5,750,000 Options to purchase common stock 3,678,176 2,140,618 Unvested shares of restricted stock units 223,133 137,504 Total anti-dilutive common stock equivalents 14,171,309 12,548,122 New Accounting Requirements and Disclosures There are no accounting standards updates (“ASUs”) that have been recently adopted or effective that have had or are expected to have a material effect on our consolidated financial statements. |
FAIR VALUE OF MEASUREMENTS AND
FAIR VALUE OF MEASUREMENTS AND INVESTMENT SECURITIES | 12 Months Ended |
Dec. 31, 2022 | |
Fair Value Disclosures [Abstract] | |
FAIR VALUE OF MEASUREMENTS AND INVESTMENT SECURITIES | FAIR VALUE OF MEASUREMENTS AND INVESTMENT SECURITIES Investment Securities The following tables present the Company’s investment securities (including those classified on the Company’s balance sheet as cash equivalents) that are measured at fair value on a recurring basis as of December 31, 2022 and 2021: Fair Value at December 31, 2022 Fair Value at December 31, 2021 (in thousands) Level 1 Level 2 Level 3 Level 1 Level 2 Level 3 Cash Equivalents: Money market funds and treasury bills $ 20,024 $ — $ — $ 42,487 $ — $ — Total Cash Equivalents $ 20,024 $ — $ — $ 42,487 $ — $ — Money market funds and U.S. Treasury bills are valued based on various observable inputs such as benchmark yields, reported trades, broker/dealer quotes, benchmark securities and bids. Warrant Derivative Liability and Private Placement Option Liability The Company’s financial liabilities recorded at fair value on a recurring basis include the fair values of the warrant derivative liability and the private placement option liability prior to its derecognition in December 2021. Inputs used to determine estimated fair value (Level 3) of the warrants include the fair value of the underlying stock relative to the warrant exercise price at the valuation measurement date, volatility of the price of the underlying stock, the expected term of the warrants, and risk-free interest rates which are derived from the U.S. Treasury yield curve in effect based on the expected term of the warrants. The fair values of the warrant derivative liability and the private placement option liability, prior to its derecognition in December 2021, are classified as current liabilities in the accompanying consolidated balance sheets. These liabilities are classified as current liabilities on the balance sheet because the exercisability of such warrants is outside of the Company’s control, and the Company does not have the unconditional right to defer settlement beyond 12 months. On December 4, 2021, the Company entered into the 2021 Securities Purchase Agreement, pursuant to which certain of the investors irrevocably waived the right to cause the Company to conduct the “First Closing” and “Second Closing” under the private placement option contained in the 2019 Securities Purchase Agreement (each term as defined in the 2019 Securities Purchase Agreement). The Company derecognized the private placement option liability and recorded a gain on change in the fair value for the year ended December 31, 2021 of $2.8 million in the accompanying statements of operations and comprehensive loss. The fair value of the warrants has been estimated with the following weighted-average assumptions, including the most sensitive input, volatility: December 31, 2022 December 31, 2021 Risk-free interest rate 4.1 % 1.22 % Volatility 102 % 94 % Expected life (years) 3.63 4.64 The following table provides the warrant derivative reported at fair value and measured on a recurring basis: Fair Value at December 31, 2022 Fair Value at December 31, 2021 (in thousands) Level 1 Level 2 Level 3 Level 1 Level 2 Level 3 Warrant derivative liability $ — $ — $ 809 $ — $ — $ 2,773 The ending balance of the Level 3 financial instruments presented above represents the Company’s best estimate of valuation and may not be substantiated by comparison to independent markets and, in many cases, could not be realized in immediate settlement of the instruments. |
LEASES
LEASES | 12 Months Ended |
Dec. 31, 2022 | |
Leases [Abstract] | |
LEASES | LEASES The Company entered into two agreements and exited its Houston and South San Francisco office locations during the first quarter of 2021 and, therefore, did not have any lease liabilities as of December 31, 2022. In connection with the lease termination and exit of the Houston office, a third party also acquired all of the property and equipment associated with the location. The consideration included an unsecured promissory note of $0.2 million with a simple interest of 4% per annum, which was due and payable on or before June 30, 2022. The payment, including accrued interest, was received in full in July 2022. Components of lease cost are as follows: (in thousands) Year Ended December 31, 2022 Year Ended December 31, 2021 Finance lease cost: Amortization of leased assets $ — $ 16 Interest on lease liabilities — 5 Operating lease cost — 56 Short-term lease cost — 53 Total lease cost $ — $ 130 Supplemental cash flow information and non-cash activity related to the Company’s operating and finance leases are as follows: (in thousands) Year Ended December 31, 2022 Year Ended December 31, 2021 Cash paid for amounts included in the measurement of lease liabilities: Operating cash flows from operating leases $ — $ 71 Operating cash flows from finance leases — 5 Financing cash flows from finance leases — 35 |
LEASES | LEASES The Company entered into two agreements and exited its Houston and South San Francisco office locations during the first quarter of 2021 and, therefore, did not have any lease liabilities as of December 31, 2022. In connection with the lease termination and exit of the Houston office, a third party also acquired all of the property and equipment associated with the location. The consideration included an unsecured promissory note of $0.2 million with a simple interest of 4% per annum, which was due and payable on or before June 30, 2022. The payment, including accrued interest, was received in full in July 2022. Components of lease cost are as follows: (in thousands) Year Ended December 31, 2022 Year Ended December 31, 2021 Finance lease cost: Amortization of leased assets $ — $ 16 Interest on lease liabilities — 5 Operating lease cost — 56 Short-term lease cost — 53 Total lease cost $ — $ 130 Supplemental cash flow information and non-cash activity related to the Company’s operating and finance leases are as follows: (in thousands) Year Ended December 31, 2022 Year Ended December 31, 2021 Cash paid for amounts included in the measurement of lease liabilities: Operating cash flows from operating leases $ — $ 71 Operating cash flows from finance leases — 5 Financing cash flows from finance leases — 35 |
PUBLIC OFFERING AND PRIVATE PLA
PUBLIC OFFERING AND PRIVATE PLACEMENT | 12 Months Ended |
Dec. 31, 2022 | |
Statement of Stockholders' Equity [Abstract] | |
PUBLIC OFFERING AND PRIVATE PLACEMENT | PUBLIC OFFERING AND PRIVATE PLACEMENT December 2021 Private Placement On December 4, 2021, the Company entered into a Securities Purchase Agreement (the “2021 Securities Purchase Agreement”) with certain institutional investors (the “Purchasers”), pursuant to which the Company agreed to issue to the Purchasers 2021 pre-funded warrants to purchase an aggregate of 20,559,210 shares of its common stock and accompanying 2021 common warrants to purchase an aggregate of 2,055,920 shares of common stock. Each pre-funded warrant to purchase one share of common stock will be sold together with a warrant to purchase one-tenth of one share of common stock at a combined unit price of $1.7024. The pre-funded warrants will be immediately exercisable at an exercise price of $0.0001 per share of common stock. The accompanying common warrants will be immediately exercisable at an exercise price of $1.69 per share of common stock and will expire seven years from the date of issuance. The gross proceeds to the Company from the private placement were approximately $35.0 million before deducting placement agent commissions and offering expenses payable by the Company, excluding any proceeds that may be received upon exercise of the accompanying warrants. In addition, pursuant to the 2021 Securities Purchase Agreement, certain of the Purchasers irrevocably waived the right to cause the Company to conduct the “First Closing” and “Second Closing” under the 2019 Securities Purchase Agreement (each term as defined in the 2019 Securities Purchase Agreement), which releases the Company of potential cash or equity obligations. The representations, warranties and covenants contained in the 2021 Securities Purchase Agreement were made only for purposes of such agreement and as of specific dates, were solely for the benefit of the parties to such agreement and may be subject to limitations agreed upon by the contracting parties. November 2020 Underwritten Offering On November 2, 2020, the Company closed an underwritten offering of 1,040,000 shares of its common stock, 2020 pre-funded warrants to purchase 3,109,378 shares of its common stock, and accompanying 2020 common warrants to purchase up to an aggregate of 4,149,378 shares of its common stock. Each share of common stock and pre-funded warrant to purchase one share of common stock was sold together with a common warrant to purchase one share of common stock. The public offering price of each share of common stock and accompanying common warrant was $6.025 and $6.024 for each pre-funded warrant. The pre-funded warrants were immediately exercisable at a price of $0.001 per share of common stock. The common warrants were immediately exercisable at an exercise price of $6.50 per share of common stock and will expire five years from the date of issuance. The shares of common stock and pre-funded warrants, and the accompanying common warrants, were issued separately and were immediately separable upon issuance. The gross proceeds to the Company were approximately $25.0 million before deducting underwriting discounts and commissions and other offering expenses. August 2019 Public Offering On August 16, 2019, the Company entered into an underwriting agreement (the “Underwriting Agreement”) with Jefferies LLC and Wells Fargo Securities, LLC, as representatives of the several underwriters named therein (the “Underwriters”), relating to an underwritten public offering (the “2019 Offering”) of 575,000 shares of the Series 1 Redeemable Convertible Non-Voting Preferred Stock of the Company (the “Series 1 Preferred Stock”) and warrants (the “2019 Public Warrants”) to purchase up to 5,750,000 shares of its common stock. Each share of Series 1 Preferred Stock was sold together with a warrant to purchase 10 shares of common stock at a combined price to the public of $100.00. Under certain circumstances, each warrant to purchase 10 shares of common stock will be exercisable, at the irrevocable election of the holder, for one share of Series 1 Preferred Stock. The offering closed on August 21, 2019, and the net proceeds to the Company from the Offering was approximately $53.8 million, after deducting underwriting discounts and commissions and offering expenses payable by the Company, and excluding any proceeds that the Company may receive upon exercise of the Public Warrants. All of the 2019 Public Warrants sold in the 2019 Offering have an exercise price of $13.00 per share of common stock or, in certain circumstances, for $130.00 per share of Series 1 Preferred Stock, subject to proportional adjustments in the event of stock splits or combinations or similar events. The 2019 Public Warrants were immediately exercisable upon issuance, provided that the holder is prohibited, subject to certain exceptions, from exercising a warrant for shares of common stock to the extent that immediately prior to or after giving effect to such exercise, the holder, together with its affiliates and other attribution parties, would own more than 9.99% of the total number of shares of common stock then issued and outstanding, which percentage may be changed at the holder’s election to a lower percentage at any time or to a higher percentage not to exceed 19.99% upon 61 days’ notice to the Company. The Public Warrants will expire on August 21, 2026, unless exercised prior to that date. The following table reflects the fair value roll forward reconciliation of the 2019 Public Warrants liabilities for the period ended December 31, 2022: (in thousands) Warrant Derivative Liability Balance, December 31, 2021 $ 2,773 Change in fair value (1,964) Balance, December 31, 2022 $ 809 Private Placement On August 16, 2019, the Company entered into a securities purchase agreement (the “2019 Securities Purchase Agreement”) with certain institutional investors named therein (the “Purchasers”), pursuant to which the Company agreed to issue in a private placement (i) 350,000 shares of its Series 2 Redeemable Convertible Non-Voting Preferred Stock (the “Series 2 Preferred Stock”), at a purchase price of $100.00 per share, and related warrants to purchase up to 2,800,000 shares of common stock at an exercise price of $10.00 per share, and (ii) 250,000 shares of its Series 3 Redeemable Convertible Non-Voting Preferred Stock (the “Series 3 Preferred Stock” and, together with the Series 1 Preferred Stock and Series 2 Preferred Stock, the “Preferred Stock”), at a purchase price of $140.00 per share, and related warrants to purchase up to 875,000 shares of common stock at an exercise price of $14.00 per share. The right of the Purchasers to purchase such securities was waived, effective as of December 4, 2021, pursuant to the 2021 Purchase Agreement. The Company received $11.2 million in net option fee proceeds, net of offering costs, upon the execution of the 2019 Securities Purchase Agreement. Pursuant to the 2021 Securities Purchase Agreement entered into on December 4, 2021, the Company derecognized the private placement option liability, and the Company is no longer obligated to issue the Series 2 Preferred Stock, Series 3 Preferred Stock, or any associated Private Warrants. A summary of warrants outstanding and exercisable as of December 31, 2022 is as follows: Warrants Outstanding Warrants Exercisable Year Issued Number Outstanding Weighted Average Remaining Contractual Life Weighted Average Exercise Price Number Exercisable Weighted Average Exercise Price (in years) (per share) (per share) 2019 5,750,000 3.64 $ 13.00 5,750,000 $ 13.00 2020 4,149,378 2.84 $ 6.50 4,149,378 $ 6.50 2020 1 1,659,752 — $ — 1,659,752 $ — 2021 2,055,920 5.94 $ 1.69 2,055,920 $ 1.69 2021 2 20,559,210 — $ — 20,559,210 $ — 34,174,260 34,174,260 |
REDEEMABLE CONVERTIBLE PREFERRE
REDEEMABLE CONVERTIBLE PREFERRED STOCK | 12 Months Ended |
Dec. 31, 2022 | |
Equity [Abstract] | |
REDEEMABLE CONVERTIBLE PREFERRED STOCK | REDEEMABLE CONVERTIBLE PREFERRED STOCK In August 2019, the Company sold Series 1 Preferred Stock pursuant to the 2019 Offering. The Company has 10,000,000 authorized shares of preferred stock with a par value of $0.01, of which the Company has designated 1,517,500 shares as Series 1 redeemable convertible non-voting preferred stock, 350,000 shares as Series 2 redeemable convertible non-voting preferred stock and 250,000 shares as Series 3 redeemable convertible non-voting preferred stock. There were 452,000 shares of Series 1 Preferred Stock issued and outstanding as of both December 31, 2022 and December 31, 2021. The Series 1 Preferred Stock was issued together with warrants for a combined purchase price of $100.00 per share of Series 1 Preferred Stock and one warrant to purchase 10 shares of common stock. There were no shares converted during December 31, 2022 and December 31, 2021. There were no shares of Series 2 or 3 Preferred Stock issued or outstanding as of December 31, 2021. The Series 2 and 3 Preferred Stock were cancelled during 2021 pursuant to the 2021 Securities Purchase Agreement. As of December 31, 2022 and 2021, the Company classified the Series 1 preferred stock within mezzanine equity, as the Series 1 preferred stock is redeemable at the option of the holders upon passage of time, which is outside of the Company’s control to prevent. The Series 1 Preferred Stock is not currently redeemable and is only redeemable upon a fundamental change or, at the option of the holder, on or after the date that is the fifth (5th) anniversary of the initial issue date of the applicable series of preferred stock, if certain Conditions have not been met (described below) before that date. The “Conditions” mean: (1) the closing price of the Company’s common stock has been equal to or exceeded $25.00 per share for 180 calendar days (for determining if the Conditions are met for the Series 1 Preferred Stock) for 180 calendar days; (2) the 50-day average trading volume of the Company’s common stock on the Nasdaq stock market is greater than 50,000 shares; and (3) a Phase 3 or Phase 2 pivotal clinical trial for one of the Company’s CAR-T product candidates has been initiated, meaning that at least one clinical trial site has been activated. A subsequent adjustment of the amount presented within mezzanine equity to its redemption amount is necessary if it is probable that the instrument will become redeemable. The Company does not believe a fundamental change is considered probable until it occurs. However, as of December 31, 2022, the Company believes that it is probable that the Conditions will not be met before the fifth (5th) anniversary of the initial issue date of the applicable series of preferred stock. Therefore, the Company will prospectively accrete the Series 1 Preferred Stock to its redemption amount of $45.2 million over the future reporting periods until the earliest redemption date. Optional Conversion Each share of Preferred Stock is initially convertible into 10 shares of Common Stock. The conversion price at which Preferred Stock may be converted into shares of common stock is subject to adjustment in connection with certain specified events. Redemption Until the applicable Transition Date (defined below), at any time on or after the date that is the fifth (5th) anniversary of the initial issue date of the applicable series of preferred stock, all or any portion of the preferred stock is redeemable at the option of the holder at a redemption price of $100.00 per share (for Series 1 Preferred Stock). The “Transition Date” means the first date following August 21, 2021, on which each of the Conditions (as defined below) is met. The “Conditions” mean: (1) the closing price of the Company’s common stock has been equal to or exceeded $25.00 per share for 180 calendar days (for determining if the Conditions are met for the Series 1 Preferred Stock) for 180 calendar days; (2) the 50-day average trading volume of the Company’s common stock on the Nasdaq stock market is greater than 50,000 shares; and (3) a Phase 3 or Phase 2 pivotal clinical trial for one of the Company’s CAR-T product candidates has been initiated, meaning that at least one clinical trial site has been activated. Dividends Shares of Preferred Stock will be entitled to receive dividends equal to (on an as-if-converted-to-common stock basis), and in the same form and manner as, dividends actually paid on shares of common stock. Liquidation Until the applicable Transition Date, in the event of a liquidation, dissolution, winding up or deemed liquidation, holders of the Preferred Stock will receive a payment equal to the applicable per share purchase price of their Preferred Stock before any proceeds are distributed to the holders of Common Stock. The liquidation preferences, protective voting provisions and redemption rights of the Preferred Stock terminate upon the occurrence of certain events. Voting Shares of Preferred Stock will generally have no voting rights, except to the extent expressly provided in the Company’s certificate of incorporation or as otherwise required by law. |
SHARE-BASED COMPENSATION PLANS
SHARE-BASED COMPENSATION PLANS | 12 Months Ended |
Dec. 31, 2022 | |
Share-Based Payment Arrangement [Abstract] | |
SHARE-BASED COMPENSATION PLANS | SHARE-BASED COMPENSATION PLANS The Company has five share-based compensation plans, including the 2019 Equity Incentive Plan the (“2019 Plan”) which was adopted in June 2019. Each plan authorizes the granting of shares of common stock and/or options to purchase common stock to employees and directors of the Company, as well as non-employee consultants, and allows the holder of the option to purchase common stock at a stated exercise price. The only plan under which the Company may currently grant equity awards is the 2019 Equity Incentive Plan although there remain outstanding awards under the other four plans. Options vest according to the terms of the grant, which may be immediately or based on the passage of time, generally over two 2019 Equity Incentive Plan The 2019 Plan is designed to secure and retain the services of the Company’s employees and directors. The 2019 Plan is successor to and continuation of the 2014 Equity Incentive Plan, as amended, the (“2014 Plan”), and no additional awards may be issued from the 2014 Plan. Subject to adjustment for certain changes in the Company’s capitalization, the aggregate number of shares of common stock that may be issued under the 2019 Plan (the “Share Reserve”) will not exceed the sum of (i) 250,000 new shares, plus (ii) an additional 600,000 shares that were approved at the Company’s Special Meeting of Stockholders in January 2020, plus (iii) an additional 500,000 shares that were approved at the Company’s Annual meeting of Stockholders in June 2020, plus (iv) an additional 500,000 shares that were approved at the Company’s Annual Meeting of Stockholders in June 2021, plus (v) an additional 2,250,000 shares that were approved at the Company’s Annual meeting of Stockholders in June 2022 and plus (vi) the Prior Plans’ Returning Shares, as defined in the 2019 Plan documents, in an amount not to exceed 600,540 shares, including any stock award granted under the 2014 Plan, 2011 Stock Option Plan, as amended, or 2006 Stock Option Plan, as amended, that were outstanding as of the date the 2019 Plan were approved by the Company’s stockholders, as such shares become available from time to time. The following shares of common stock (the “2019 Plan Returning Shares”) will also become available again for issuance under the 2019 Plan: (i) any shares subject to a stock award granted under the 2019 Plan that are not issued because such stock award expires or otherwise terminates without all of the shares covered by such stock award having been issued; (ii) any shares subject to a stock award granted under the 2019 Plan that are not issued because such stock award is settled in cash; and (iii) any shares issued pursuant to a stock award granted under the 2019 Plan that are forfeited back to or repurchased by the Company because of a failure to vest. The 2019 Plan provides for the grant of incentive stock options, non-statutory stock options, stock appreciation rights, restricted stock awards, restricted stock unit awards, performance stock awards, and other stock awards. At December 31, 2022 and 2021, outstanding awards were comprised of the following: December 31, 2022 December 31, 2021 Options 3,340,109 2,074,858 Inducement option awards 338,067 65,760 Restricted stock units 223,133 137,004 Inducement restricted stock units — 500 Total outstanding awards 3,901,309 2,278,122 Grant Date Fair Value The valuation of the share-based compensation awards is a significant accounting estimate that requires the use of judgments and assumptions that are likely to have a material impact on the financial statements. The fair value of option grants is determined using the Black-Scholes option-pricing model. Expected volatilities utilized in the model are based on historical volatility of the Company’s common stock. Similarly, the dividend yield is based on historical experience and the estimate of future dividend yields. The risk-free interest rate is derived from the U.S. Treasury yield curve in effect at the time of grant. The expected term of the options is based on the average period the stock options are expected to remain outstanding. As the Company does not have sufficient historical information to develop reasonable expectations about future exercise patterns and post-vesting employment termination behavior, the expected term is calculated as the midpoint between the weighted-average vesting term and the contractual expiration period also known as the simplified method. The fair value of the option grants has been estimated, with the following weighted-average assumptions: Year Ended December 31, 2022 December 31, 2021 Options granted 1,712,000 1,023,000 Weighted-average exercise price 1.39 2.80 Weighted-average grant date fair value 1.04 2.02 Assumptions: Risk-free interest rate 2.98 % 0.92 % Volatility 90 % 90 % Expected life (years) 5.88 5.63 Expected dividend yield — — Share-Based Compensation Activity The following table summarizes the stock option activity for all stock plans during the year ended December 31, 2022 and 2021 as follows: Options Outstanding Stock Options Weighted Average Exercise Price Weighted Average Remaining Contractual Term (in years) Aggregate Intrinsic Value (in thousands) Balance at December 31, 2020 1,510,968 $ 27.36 8.19 $ 379 Granted 1,023,000 $ 2.80 Exercised — Forfeited (393,350) $ 30.66 Balance at December 31, 2021 2,140,618 $ 15.01 8.48 $ — Granted 1,712,000 $ 1.39 Exercised — Forfeited (174,442) $ 10.41 Balance at December 31, 2022 3,678,176 $ 8.89 8.61 $ — Exercisable at December 31, 2022 1,599,680 $ 17.95 7.59 $ — There were no options exercised or cash received for the years ended December 31, 2022 and December 31, 2021. The following table summarizes the options outstanding and exercisable at December 31, 2022: Options Outstanding Options Exercisable Exercise Price Total Shares Weighted Average Remaining Contractual Term (in years) Weighted Average Exercise Price Total Shares Weighted Average Remaining Contractual Term (in years) Weighted Average Exercise Price $1.06 to $1.32 339,000 9.59 $ 1.15 — 0.00 $ — $1.33 to $1.50 1,325,000 9.62 $ 1.44 — 0.00 $ — $1.51 to $2.93 877,687 8.72 $ 2.57 531,350 8.68 $ 2.66 $2.94 to $3.88 524,000 7.99 $ 2.99 524,000 7.99 $ 2.99 $3.89 to $234.70 612,489 6.27 $ 43.38 544,330 6.15 $ 47.27 Total 3,678,176 8.61 $ 8.89 1,599,680 7.59 $ 17.95 The following table summarizes the stock award activity for all restricted stock units during the year ended December 31, 2022: Awards Outstanding Restricted Stock Awards and Units Weighted-Average Grant Date Fair Value Per Share Outstanding Aggregate Intrinsic Value (in thousands) Total Fair Value of Restricted Awards Vested (in thousands) Balance at December 31, 2020 129,861 $ 5.59 $ 458 Granted 136,626 $ 3.54 Vested (126,477) $ 5.05 $ 413 $ 659 Forfeited (2,506) $ 4.85 Balance at December 31, 2021 137,504 $ 4.06 $ 205 Granted 220,633 $ 1.13 Vested (135,004) $ 4.05 $ 207 $ 527 Forfeited — $ — Balance at December 31, 2022 223,133 $ 1.17 $ 161 2014 Employee Stock Purchase Plan The 2014 Employee Stock Purchase Plan, the “ESPP”, provides for eligible Company employees, as defined by the ESPP, to be given an opportunity to purchase the Company’s common stock at a discount, through payroll deductions, with stock purchases being made upon defined purchase dates. The ESPP authorizes the issuance of up to 55,000 shares of the Company’s common stock to participating employees and allows eligible employees to purchase shares of common stock at a 15% discount from the lesser of the grant date or purchase date fair market value. The ESPP has been suspended since December 2020. As of December 31, 2022, there were 18,488 shares available for issuance under the ESPP. There was no activity within the ESPP for the years ended December 31, 2022 and December 31, 2021. Share-Based Compensation Expense Share-based compensation expense by classification for December 31, 2022 and 2021 are as follows: Year Ended (in thousands) December 31, 2022 December 31, 2021 General and administrative $ 1,328 $ 2,275 Research and development 1,281 1,164 Total $ 2,609 $ 3,439 At December 31, 2022, total compensation cost not yet recognized was $2.4 million and the weighted-average period over which this amount is expected to be recognized is 1.68 years. The aggregate fair value of options and restricted shares vesting in the years ended December 31, 2022 and 2021 was $3.3 million and $4.3 million, respectively. |
COMMITMENTS AND CONTINGENCIES
COMMITMENTS AND CONTINGENCIES | 12 Months Ended |
Dec. 31, 2022 | |
Commitments and Contingencies Disclosure [Abstract] | |
COMMITMENTS AND CONTINGENCIES | COMMITMENTS AND CONTINGENCIES Co-Development and Co-Commercialization Agreement - Adaptimmune Therapeutics plc On December 16, 2016, the Company entered into a Co-Development and Co-Commercialization Agreement with and Adaptimmune Therapeutics plc (Adaptimmune) in order to facilitate a staged collaboration to evaluate, develop and commercialize next generation T cell therapies. Since we have stopped all development activity related to our product candidates, we are not currently performing any development efforts under this agreement. Under the Agreement, the parties agreed to evaluate the Company’s GoTCR technology (inducible MyD88/CD40 co-stimulation, or iMC) with Adaptimmune’s affinity-optimized SPEAR® T cells for the potential to create enhanced TCR product candidates. Depending on results of the preclinical proof-of-concept phase, the parties expect to progress to a two-target co-development and co-commercialization phase. To the extent necessary, and in furtherance of the parties’ proof-of-concept and co-development efforts, the parties granted each other a royalty-free, non-transferable, non-exclusive license covering their respective technologies for purposes of facilitating such proof-of-concept and co-development efforts. In addition, as to covered therapies developed under the agreement, the parties granted each other a reciprocal exclusive license for the commercialization of such therapies. With respect to any joint commercialization of a covered therapy, the parties agreed to negotiate in good faith the commercially reasonable terms of a co-commercialization agreement. The parties also agreed that any such agreement shall provide for, among other things, equal sharing of the costs of any such joint commercialization and the calculation of profit shares as set forth in the Agreement. The Agreement will expire on a country-by-country basis once the parties cease commercialization of the T cell therapies covered by the Agreement, unless earlier terminated by either party for material breach, non-performance or cessation of development, bankruptcy/insolvency, or failure to progress to co-development phase. License Agreement - Baylor In 2008, 2010, 2014 and 2016, the Company and Baylor College of Medicine (“BCM”) entered into license agreements pursuant to which the Company obtained exclusive rights to certain technologies and patent rights owned by BCM. Under the 2014 license agreement, the Company is required to pay BCM a low annual maintenance fee on each anniversary of the agreement date. The Company is also required to make royalty payments in the low single digits, subject to certain annual minimums, on net sales of products covered by the license and, to the extent the Company enters into a sublicensing agreement relating to a licensed product, the Company is also required to pay BCM a percentage in the low double-digits on all non-royalty income received from sublicensing revenue. During the second quarter of 2021, the Company determined that $0.6 million of sublicense expense was incurred in 2019 through 2020 related to the Company’s obligation to pay BCM a percentage of sublicense revenue earned by the Company under the 2014 license agreement. Management evaluated the impact of the adjustment and determined that the amount was immaterial to the consolidated financial statements for the current year and prior years. As such, the entire amount of $0.6 million was recorded during the second quarter in 2021. During the third quarter of 2021, the Company earned additional sublicense revenue and, therefore, recorded additional sublicense expense of $0.5 million. License Agreement - Agensys, Inc. On December 10, 2015, the Company and Agensys, Inc. (“Agensys”), entered into a license agreement (the “Agensys Agreement”), pursuant to which (i) Agensys granted the Company, within the field of cell and gene therapy of diseases in humans, an exclusive, worldwide license and sublicense to its patent rights directed to prostate stem cell antigen 1 (“PSCA”) and related antibodies, and (ii) the Company granted Agensys a non-exclusive, fully paid license to the Company’s patents directed to inventions that were made by the Company in the course of developing the Company’s licensed products, solely for use with Agensys therapeutic products containing a soluble antibody that binds to PSCA or, to the extent not based upon the Company’s other proprietary technology, to non-therapeutic applications of antibodies not used within the field. As consideration for the rights granted to the Company under the Agreement, the Company agreed to pay to Agensys a non-refundable upfront fee of $3.0 million, which was included in license fee expense. The Company is also required to make aggregate milestone payments to Agensys of up to (i) $5 million upon the first achievement of certain specified clinical milestones for its licensed products, (ii) $50 million upon the achievement of certain specified clinical milestones for each licensed product, and (iii) $75 million upon the achievement of certain sales milestones for each licensed product. The Agreement additionally provides that the Company will pay to Agensys a royalty that ranges from the mid to high single digits based on the level of annual net sales of licensed products by the Company, its affiliates or permitted sublicensees. The royalty payments are subject to reduction under specified circumstances. These milestone and royalty payments will be expensed as incurred. Under the Agreement, Agensys also was granted the option to obtain an exclusive license, on a product-by-product basis, from the Company to commercialize in Japan each licensed product developed under the Agensys Agreement that has completed a phase 2 clinical trial. As to each such licensed product, if Agensys or its affiliate, Astellas Pharma, Inc., exercises the option, the Agensys Agreement provides that the Company will be paid an option exercise fee of $5 million. In addition, the Agensys Agreement provides that the Company will be paid a royalty that ranges from the mid to high single digits based on the level of annual net sales in Japan of each such licensed product. If the option is exercised, the aggregate milestone payments payable by the Company to Agensys, described above with respect to each licensed product, would be reduced by up to an aggregate of $65 million upon the achievement of certain specified clinical and sales milestones. The Agensys Agreement will terminate upon the expiration of the last royalty term for the products covered by the Agensys Agreement, which is the earlier of (i) the date of expiration or abandonment of the last valid claim within the licensed patent rights covering any licensed products under the Agreement, (ii) the expiration of regulatory exclusivity as to a licensed product, and (iii) 10 years after the first commercial sale of a licensed product. Either party may terminate the Agensys Agreement upon a material breach by the other party that remains uncured following 60 days after the date of written notice of such breach (or 30 days if such material breach is related to failure to make payment of amounts due under the Agensys Agreement) or upon certain insolvency events. In addition, Agensys may terminate the Agensys Agreement immediately upon written notice to the Company if the Company or any of its affiliates or permitted sublicensees commences an interference proceeding or challenges the validity or enforceability of any of Agensys’ patent rights. License Agreement - BioVec On June 10, 2015, the Company and BioVec Pharma, Inc. (“BioVec”) entered into a license agreement (the “BioVec Agreement”) pursuant to which BioVec agreed to supply the Company with certain proprietary cell lines and granted to the Company a non-exclusive, worldwide license to certain of its patent rights and related know-how related to such proprietary cell lines. As consideration for the products supplied and rights granted to the Company under the BioVec Agreement, the Company agreed to pay to BioVec an upfront fee of $100,000 within ten ten Litigation On May 29, 2019, Bellicum was served with a second amended complaint indicating that the Company had been added as an additional defendant in an ongoing civil tort lawsuit, captioned Kelly v. Children’s Hospital of Los Angeles et al., filed in the Los Angeles County Superior Court, Case No. BC681477. On July 10, 2019 plaintiffs filed a third amended complaint seeking unspecified monetary damages including punitive damages and alleging claims for wrongful death, negligence, breach of fiduciary duty, fraud, medical battery on decedent, medical battery on individual plaintiffs, products liability - failure to warn, breach of express warranty and products liability design or manufacturing defect. Bellicum filed a demurrer and motion to strike plaintiffs’ third amended complaint, which were granted in part on August 5, 2020 with the Court dismissing (without prejudice) all claims against Bellicum with the exception of the breach of express warranty and products liability design or manufacturing defect causes of action. The Court also granted Bellicum’s motion to strike plaintiffs’ claim for punitive damages. On September 15, 2020, plaintiffs filed a fourth amended complaint alleging the same causes of action and damages against Bellicum as were pled in the third amended complaint. On November 3, 2020, Bellicum filed a demurrer and motion to strike the fourth amended complaint, which was heard by the Court on May 19, 2022. The Court sustained the demurrer without leave to amend as to the causes of action for wrongful death, negligence, fraud, battery, and products liability-failure to warn, and overruled the demurrer as to products liability-design/manufacturing defect. The Court also granted Bellicum’s motion to strike punitive damages. The parties engaged in discovery in advance of the trial date set for March 13, 2023. On November 22, 2022, Bellicum filed a motion for summary judgment seeking an order from the Court that the undisputed material facts warranted a dismissal of Bellicum from the case. On February 9, 2023, the Court held a hearing on Bellicum’s motion for summary judgment, and granted the motion. Entry of the final judgment in favor of Bellicum and against the plaintiffs is pending. |
INCOME TAXES
INCOME TAXES | 12 Months Ended |
Dec. 31, 2022 | |
Income Tax Disclosure [Abstract] | |
INCOME TAXES | INCOME TAXES The reconciliation between federal income taxes at the statutory U.S. federal income tax rate and the Company’s income tax expense for the year is as follows: (in thousands) December 31, 2022 December 31, 2021 Tax benefit at statutory rate $ (5,244) $ (2,038) Stock based compensation 207 780 Offering issuance costs and changes in fair value of warrants and private placement option (413) (3,176) Change in valuation allowance 6,066 4,718 Research and development credit (585) (288) Other (29) 4 Income tax expense $ 2 $ — Deferred income taxes reflect the net tax effect of temporary differences between the carrying amounts of assets and liabilities for financial reporting purposes, and the amounts used for income tax purposes. Significant components of the Company’s deferred taxes as of December 31, 2022 and 2021 are as follows: (in thousands) December 31, 2022 December 31, 2021 Deferred tax assets (liabilities): Net operating loss carryforward $ 104,707 $ 100,346 Stock compensation 3,838 3,541 Intangible assets 6,096 7,156 Section 174 expenses, net of amortization 1,639 — Research and development credit 18,661 18,076 Other 63 (144) Total deferred tax assets, net of deferred tax liabilities 135,004 128,975 Valuation allowance (135,004) (128,975) Net deferred tax $ — $ — Net operating loss carryforwards and research tax credits as of December 31, 2022 and 2021 are as follows: (in thousands) December 31, 2022 December 31, 2021 U.S. federal income tax net operating loss carryforwards $ 498,607 $ 477,839 U.K. net operating loss carryforwards $ — $ — U.S. federal research tax credits $ 13,569 $ 12,985 Texas research tax credits $ 5,091 $ 5,091 The Company has $277.4 million of U.S. federal net operating loss carryovers that have no expiration date and the remaining begin to expire in 2025. The U.S. Federal and state research credits will begin to expire in 2028 and 2034, respectively. No study has been performed on the research and development (R&D) credits and gross R&D credits in the amount of $18.7 million could be limited based on review by the Internal Revenue Service. The Internal Revenue Code Section 382 limits NOL and tax credit carry forwards when an ownership change of more than 50% of the value of the stock in a loss corporation occurs. Accordingly, the ability to utilize remaining NOL and tax credit carryforwards may be significantly restricted. In assessing the realization of deferred tax assets, management considers whether it is more likely than not that some portion or all of the deferred tax asset will be realized. The ultimate realization of deferred tax assets is dependent upon the Company attaining future taxable income during periods in which those temporary differences become deductible. Due to the uncertainty surrounding the realization of the benefits of its deferred assets, including NOL carryforwards, the Company has provided a 100% valuation allowance on its net deferred tax assets at December 31, 2022 and 2021. The changes in the valuation allowance were an increase of $6.0 million and an increase of $4.7 million for the years ended December 31, 2022 and 2021, respectively. The Internal Revenue Code Section 174 requires that taxpayers capitalize and amortize R&D expenses that were previously eligible for immediate expensing, for tax years commencing after January 1, 2022. Under the Code, expenses incurred within the U.S. will be amortized over a five-year period beginning with the midpoint of the year in which the expenses were paid or incurred. The expenses that are required to be capitalized will include both the qualified expenses that go into calculating the R&D tax credit and the indirect costs that can be attributed to R&D activities. For the year ended December 31, 2022, the estimated Section 174 expenses, net of amortization, are $1.6 million. |
ORGANIZATION, BASIS OF PRESEN_2
ORGANIZATION, BASIS OF PRESENTATION, AND SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES (Policies) | 12 Months Ended |
Dec. 31, 2022 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
Basis of Presentation | Basis of Presentation The accompanying financial statements have been prepared in conformity with the authoritative U.S. generally accepted accounting principles (“GAAP”). The Company has experienced net losses since its inception and as of December 31, 2022, the Company has an accumulated deficit of $575.4 million. The Company believes that there is substantial doubt that its current capital resources, which consist of cash and cash equivalents, are sufficient to fund operations through at least the next twelve months from the date the accompanying financial statements are issued. The accompanying financial statements have been prepared on a basis that assumes that the Company will continue as a going concern, and do not include any adjustments that may result from the outcome of this uncertainty. This basis of accounting contemplates the recovery of the Company’s assets and the satisfaction of the Company’s liabilities and commitments in the normal course of business and does not include any adjustments to reflect the possible future effects of the recoverability and classification of recorded asset amounts or amounts and classification of liabilities that might be necessary should the Company be unable to continue as a going concern. |
Use of Estimates | Use of Estimates The preparation of the financial statements in accordance with GAAP requires management to make certain estimates and judgments that affect the reported amounts of assets, liabilities, revenue recognition, and expenses. Actual results could differ materially from those estimates. |
Revenue Recognition | Revenue Recognition The Company’s only source of revenue in 2022 was from its option and license agreement with University of Texas M.D. Anderson Cancer Center (“M.D. Anderson”). The Company has generated revenue from its licensing agreements since 2019. Prior to 2019, the Company’s only source of revenue was from grants. The Company’s sources of revenue in 2021 were from its option and license agreements with M.D. Anderson and a supply agreement with Takeda. Takeda Supply Agreement On May 4, 2021, the Company entered a multi-year supply agreement with Takeda. The Company will supply Takeda with rimiducid for potential use in clinical trials of TAK-007 (CD19 CAR-NK cell therapy). The Company generated revenue of $0.7 million in the second quarter of 2021, with the possibility of additional revenue from future sales. The promised product in the supply agreement with Takeda consists of rimiducid including any components, drug substance, raw materials and/or excipients to be supplied by the Company. Revenue is generally recognized upon the transfer of control of promised goods to customers in an amount that reflects the consideration to which the entity expects to be entitled in exchange for those goods. M.D. Anderson License Agreements On January 22, 2019, the Company entered into a licensing and commercialization agreement with M.D. Anderson (the “2019 M.D. Anderson License Agreement”). Under the 2019 M.D. Anderson License Agreement, the Company granted M.D. Anderson non-exclusive rights in certain Caspase-9 and related technologies and use of a small molecule known as rimiducid in a certain cell therapy program. During the fourth quarter of 2019, and under the terms of the 2019 M.D. Anderson License Agreement, M.D. Anderson exercised an option to grant a non-exclusive sublicense of the rights licensed by the Company to M.D. Anderson. M.D. Anderson, as a result of this exercise, granted a sublicense that entitled the Company to receive as consideration an upfront license fee as well as additional future annual maintenance fees, milestone payments related to the achievement of pre-specified development, regulatory, and commercialization events, and royalties on net sales of licensed products. During the year ended December 31, 2022, the Company earned an annual license maintenance fee of $0.5 million. On August 31, 2021, the Company entered into a second licensing and commercialization agreement with M.D. Anderson (the “2021 M.D. Anderson Option and License Agreement”). Under the 2021 M.D. Anderson Option and License Agreement, M.D. Anderson has certain rights to the use of CaspaCIDe and rimiducid in product candidates nominated under the agreement, and receives an option to a non-exclusive license to the technology in these candidates. Upon exercise of an option and sublicense of a product candidate to a third party, the Company is entitled to a sublicense execution fee, a percentage of certain consideration received by M.D. Anderson for the sublicense, an annual maintenance fee, and a percentage royalty on net sales of licensed products. During the year ended December 31, 2022, the Company earned an annual license maintenance fee of $1.0 million for two nominated programs. Licenses of Intellectual Property Revenue is recognized from the satisfaction of performance obligations when such obligations have been fulfilled. If a license to the Company’s intellectual property is determined to be distinct from the other performance obligations identified in the arrangement, revenue is recognized from non-refundable, up-front fees allocated to the license when the license is transferred to the customer and the customer is able to use and benefit from the license. For licenses that are bundled with other promises, the Company uses judgment to assess the nature of the combined performance obligation to determine whether the combined performance obligation is satisfied over a period of time or at a point in time. If over a period of time, the Company evaluates the measure of progress each reporting period and, if necessary, adjusts the measure of performance and related revenue recognition. Milestone Payments At the inception of each arrangement that includes developmental, regulatory or commercial milestone payments, the Company evaluates whether achieving the milestones is considered probable and estimates the amount to be included in the transaction price using the most likely amount method. If it is probable that a significant revenue reversal would not occur, the value of the associated milestone is included in the transaction price. Milestone payments that are not within the Company’s control, such as approvals from regulators or where attainment of the specified event is dependent on the development activities of a third party, are not considered probable of being achieved until those approvals are received or the specified event occurs. Royalty Revenues For arrangements that include sales-based royalties, including milestone payments based on the level of sales, and the license is deemed to be the predominant item to which the royalties relate, the Company recognizes revenue at the later of (i) when the related sales occur, or (ii) when the performance obligation to which some or all of the royalty has been allocated has been satisfied (or partially satisfied). To date, no royalties have been received. |
Cash, Cash Equivalents, and Restricted Cash | Cash, Cash Equivalents, and Restricted Cash The Company considers all short-term, highly liquid investments with a maturity of three months or less from the date of purchase and that can be liquidated without prior notice or penalty, to be cash equivalents. |
Property and Equipment | Property and Equipment Furniture, equipment and software are recorded at cost and are depreciated using the straight-line method over the estimated useful lives of the related assets, which range from 3 to 5 years. |
Warrant Derivatives | Warrant Derivatives In an underwritten public offering (the “2019 Offering”), the Company issued Series 1 Redeemable Convertible Non-Voting Preferred Stock (the “Series 1 Preferred Stock”) and warrants (the “2019 Public Warrants”) to purchase its common stock. These 2019 Public Warrants are classified as liabilities in the accompanying consolidated balance sheets because the public warrants embody a conditional or unconditional obligation to repurchase the Company’s shares. The Company accounted for these warrants at fair value on the date of issuance and they are subject to re-measurement to fair value at each balance sheet date. Any change in fair value is recognized as a component of other income (expense) on the accompanying consolidated statements of operations and comprehensive loss. The Company estimates the fair value of these liabilities using the Black-Scholes valuation technique, which utilizes assumptions including (i) the fair value of the underlying stock at the valuation measurement date, (ii) volatility of the price of the underlying stock, (iii) the expected term, and (iv) risk-free interest rates. The Company will continue to adjust the liability for changes in fair value until the earlier of the exercise or expiration of the warrants or a change in control, as defined. The warrants are freely exercisable at any time from the issuance date until the expiration date, provided exercise does not cause a warrant holder to exceed a pre-determined beneficial ownership limit. See Note 4 - Public Offering and Private Placement for discussions of the 2019 Public Warrants. |
Private Placement Option | Private Placement Option Besides the 2019 Offering, the Company completed a private placement and entered into the 2019 Securities Purchase Agreement that contained a call option on preferred shares that are puttable outside the control of the Company. Prior to the fourth quarter of 2021, the Company recorded the option as a liability and measured the option at fair value. The Company re-measured the option to fair value at each balance sheet date and recorded changes in fair value in other income (expense) in the accompanying consolidated statement of operations and comprehensive loss at each reporting period. Offering expenses arising from the issuance of the private placement option were expensed as incurred. The Company estimated the fair value of these liabilities using a binomial lattice model, which utilized assumptions including (i) the fair value of the underlying stock at the valuation measurement date, (ii) volatility of the price of the underlying stock, (iii) the expected term, and (iv) risk-free interest rates. |
Preferred stock | Preferred Stock Preferred shares issued by the Company that are subject to mandatory redemption are classified as liability instruments in the accompanying consolidated balance sheets and are measured at fair value at the date of issuance. Conditionally redeemable preferred shares (including preferred shares that feature redemption rights that are either within the control of the holder or subject to |
Operating Leases | Operating Leases At the inception of a contractual arrangement, the Company determines whether the contract contains a lease by assessing whether there is an identified asset and whether the contract conveys the right to control the use of the identified asset in exchange for consideration over a period of time. If both criteria are met, upon lease commencement, the Company records a lease liability which represents the Company’s obligation to make lease payments arising from the lease, and a corresponding right-of-use (“ROU”) asset which represents the Company’s right to use an underlying asset during the lease term. |
Fair Value of Financial Instruments | Fair Value of Financial Instruments Fair value is defined as an exit price, representing the amount that would be received to sell an asset or paid to transfer a liability in an orderly transaction between market participants. As such, fair value is a market-based measurement that should be determined based on assumptions that market participants would use in pricing an asset or liability. As a basis for considering such assumptions, a fair value hierarchy has been established that prioritizes the inputs used to measure fair value. The hierarchy gives the highest priority to unadjusted quoted prices in active markets for identical assets or liabilities (Level 1 measurement) and the lowest priority to unobservable inputs (Level 3 measurement). These inputs are classified into the following hierarchy: Level 1 Inputs - quoted prices (unadjusted) in active markets for identical assets that the reporting entity has the ability to access at the measurement date; Level 2 Inputs - inputs other than quoted prices included within Level 1 that are observable for the asset, either directly or indirectly; and Level 3 Inputs - unobservable inputs for the assets. The categorization of a financial instrument within the valuation hierarchy is based upon the lowest level of input that is significant to the fair value measurement. The Company believes the recorded values of its financial instruments, including cash and cash equivalents, accounts payable, accrued liabilities, and debt approximate their fair values due to the short-term nature of these instruments. |
Financial Instruments and Credit Risks | Financial Instruments and Credit Risks Financial instruments that potentially subject the Company to credit risk include cash and cash equivalents and accounts receivable. Cash is deposited in demand accounts in federally insured domestic institutions to minimize risk. Insurance is provided through the Federal Deposit Insurance Corporation and Security Investor Protection Corporation. Although the balances in these accounts exceed the federally insured limit from time to time, the Company has not incurred losses related to these deposits. |
Equity Issuance Costs | Equity Issuance Costs Equity issuance costs represent costs paid to third parties in order to obtain equity financing. These costs have been netted against the proceeds of the equity issuances. |
Licenses and Patents, Research and Development | Licenses and Patents Licenses and patent costs for technologies that are utilized in research and development and have no alternative future use are expensed as incurred. Costs related to the license of patents from third parties and internally developed patents are classified as research and development expenses. Legal costs related to patent applications and maintenance are classified as general and administrative expenses in the accompanying consolidated statements of operations and comprehensive loss. Research and Development Research and development expenses consist of expenses incurred in performing research and development activities, including compensation and benefits for research and development employees and consultants, facilities expenses, overhead expenses, cost of laboratory supplies, manufacturing expenses, fees paid to third parties and other outside expenses. Research and development costs are expensed as incurred. Clinical trial and other development costs incurred by third parties are expensed as the contracted work is performed. The Company accrues for costs incurred as the services are being provided by monitoring the status of the clinical trial or project and the invoices received from its external service providers. The Company ’ s estimates depend on the timeliness and accuracy of the data provided by the vendors regarding the status of each project and total project spending. The Company adjusts its accrual as actual costs become known. |
Collaboration Agreements | Collaboration Agreements The Company enters into collaboration agreements that include varying arrangements regarding which parties perform and bear the costs of research and development activities. The Company may share the costs of research and development activities with a collaborator, or the Company may be reimbursed for all or a significant portion of the costs of the Company ’ s research and development activities. The Company records its internal and third-party development costs associated with these collaborations as research and development expenses. When the Company is entitled to reimbursement of all or a portion of the research and development expenses that it incurs under a collaboration, the Company records those reimbursable amounts as a deduction to the research and development expenses. If the collaboration is a cost-sharing arrangement in which both the Company and its collaborator perform development work and share costs, the Company also recognizes, as research and development expenses in the period when its collaborator incurs development expenses, the portion of the collaborator’s development expenses that the Company is obligated to reimburse. |
Contract Manufacturing Services | Contract Manufacturing Services Contract manufacturing services are expensed as incurred. Prepaid expenses are capitalized and amortized as services are performed. |
Share-Based Compensation | Share-Based Compensation The Company accounts for share-based compensation based on the measurement and recognition of compensation expense for all share-based payment awards made to employees, directors and consultants to be recognized in the financial statements, based on their fair value. |
Income Taxes | Income Taxes Income taxes are accounted for under the asset and liability method. Deferred tax assets and liabilities are recognized for the future tax consequences attributable to differences between the financial statement carrying amounts of existing assets and liabilities and their respective tax bases. This method also requires the recognition of future tax benefits such as net operating loss and tax credit carry forwards, to the extent that realization of such benefits is more likely than not. A valuation allowance is recorded when the realization of future tax benefits is uncertain. The Company records a valuation allowance for the full amount of deferred tax assets, which would otherwise be recorded for tax benefits relating to the operating loss and tax credit carryforwards, as realization of such deferred tax assets cannot be determined to be more likely than not. Deferred tax assets and liabilities are measured using enacted tax rates expected to apply to taxable income in the years in which those temporary differences are expected to be recovered or settled. The effect on deferred tax assets and liabilities of a change in tax rates is recognized in the statement of operations in the period that includes the enactment date. As of December 31, 2022, the Company had recorded a full valuation allowance on its net U.S. and foreign deferred tax assets because the Company expects that it is more likely than not that its deferred tax assets will not be realized in the foreseeable future. Should the actual amounts differ from our estimates, the amount of the valuation allowance could be materially impacted. The Company accounts for uncertain tax positions in accordance with the provisions of the Accounting Standards Codification (ASC) 740 , Income Taxes . When uncertain tax positions exist, the Company recognizes the tax benefit of tax positions to the extent that the |
Comprehensive Loss | Comprehensive LossComprehensive loss is defined as the change in equity of a business enterprise during a period, from transactions, and other events and circumstances from non-owner sources. Components of other comprehensive loss includes, among other items, unrealized gains and losses on the changes in fair value of investments and unrealized gains and losses on the change in foreign currency exchange rates. These components are added, net of their related tax effect, to the reported net loss to arrive at comprehensive loss. |
Net Loss and Net Loss per Share of Common Stock Attributable to Common Stockholders | Net Loss and Net Loss per Share of Common Stock Attributable to Common Stockholders Basic net loss per share attributable to common stockholders is calculated by dividing the net loss attributable to common stockholders by the weighted-average number of shares of common stock outstanding during the period without consideration for common stock equivalents. Diluted earnings per share is based on the more dilutive method between the two-class method and the treasury stock method and includes the effect from potential issuance of ordinary shares, such as shares issuable pursuant to the conversion of preferred stock to common stock, exercise of warrants to purchase common stock, exercise of stock options, and vesting of restricted stock units. For periods of net loss, diluted net loss per share is calculated similarly to basic net loss per share. |
New Accounting Requirements and Disclosures | New Accounting Requirements and Disclosures There are no accounting standards updates (“ASUs”) that have been recently adopted or effective that have had or are expected to have a material effect on our consolidated financial statements. |
ORGANIZATION, BASIS OF PRESEN_3
ORGANIZATION, BASIS OF PRESENTATION, AND SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES (Tables) | 12 Months Ended |
Dec. 31, 2022 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
Schedule of Cash and Cash Equivalents | The following table provides a reconciliation of cash, cash equivalents and restricted cash reported within the balance sheets that sum to the total of the same such amounts shown in the statements of cash flows. (in thousands) December 31, 2022 December 31, 2021 Cash and cash equivalents $ 21,837 $ 46,156 Restricted cash — 1,501 Total cash, cash equivalents and restricted cash shown in the statements of cash flows $ 21,837 $ 47,657 |
Cash, Cash Equivalents and Restricted Cash, Reconciliation | The following table provides a reconciliation of cash, cash equivalents and restricted cash reported within the balance sheets that sum to the total of the same such amounts shown in the statements of cash flows. (in thousands) December 31, 2022 December 31, 2021 Cash and cash equivalents $ 21,837 $ 46,156 Restricted cash — 1,501 Total cash, cash equivalents and restricted cash shown in the statements of cash flows $ 21,837 $ 47,657 |
Property and Equipment | Property and equipment consisted of the following: (in thousands, except useful lives) Estimated Useful Lives December 31, 2022 December 31, 2021 Lab equipment 5 Years 0 530 Manufacturing equipment 5 Years 0 138 Computer and office equipment 3 to 5 Years 510 841 Software 3 Years 82 94 Total 592 1,603 Less: accumulated depreciation (570) (1,591) Property and equipment, net $ 22 $ 12 |
Accrued Expenses and Other Liabilities | Accrued expenses and other liabilities consist of the following: December 31, 2022 December 31, 2021 Accrued payroll 264 $ 320 Accrued patient treatment costs 675 2,086 Accrued clinical research costs 841 479 Accrued manufacturing costs 434 328 Accrued professional services 207 305 Accrued other 56 331 Total accrued expenses and other current liabilities $ 2,477 $ 3,849 |
Schedule of Antidilutive Securities Excluded from Computation of Earnings Per Share | The following outstanding shares of common stock equivalents were excluded from the computations of diluted earnings per share of common stock attributable to common stockholders for the periods presented as the effect of including such securities would be anti-dilutive. December 31, 2022 December 31, 2021 Anti-dilutive common stock equivalents: Number of Shares Redeemable convertible series 1 preferred stock 4,520,000 4,520,000 Warrants to purchase common stock 5,750,000 5,750,000 Options to purchase common stock 3,678,176 2,140,618 Unvested shares of restricted stock units 223,133 137,504 Total anti-dilutive common stock equivalents 14,171,309 12,548,122 |
FAIR VALUE OF MEASUREMENTS AN_2
FAIR VALUE OF MEASUREMENTS AND INVESTMENT SECURITIES (Tables) | 12 Months Ended |
Dec. 31, 2022 | |
Fair Value Disclosures [Abstract] | |
Summary of Assets Measured at Fair Value on a Recurring Basis | The following tables present the Company’s investment securities (including those classified on the Company’s balance sheet as cash equivalents) that are measured at fair value on a recurring basis as of December 31, 2022 and 2021: Fair Value at December 31, 2022 Fair Value at December 31, 2021 (in thousands) Level 1 Level 2 Level 3 Level 1 Level 2 Level 3 Cash Equivalents: Money market funds and treasury bills $ 20,024 $ — $ — $ 42,487 $ — $ — Total Cash Equivalents $ 20,024 $ — $ — $ 42,487 $ — $ — The following table provides the warrant derivative reported at fair value and measured on a recurring basis: Fair Value at December 31, 2022 Fair Value at December 31, 2021 (in thousands) Level 1 Level 2 Level 3 Level 1 Level 2 Level 3 Warrant derivative liability $ — $ — $ 809 $ — $ — $ 2,773 |
Schedule of Derivative Liabilities at Fair Value | The fair value of the warrants has been estimated with the following weighted-average assumptions, including the most sensitive input, volatility: December 31, 2022 December 31, 2021 Risk-free interest rate 4.1 % 1.22 % Volatility 102 % 94 % Expected life (years) 3.63 4.64 The following table reflects the fair value roll forward reconciliation of the 2019 Public Warrants liabilities for the period ended December 31, 2022: (in thousands) Warrant Derivative Liability Balance, December 31, 2021 $ 2,773 Change in fair value (1,964) Balance, December 31, 2022 $ 809 |
LEASES (Tables)
LEASES (Tables) | 12 Months Ended |
Dec. 31, 2022 | |
Leases [Abstract] | |
Components of Lease Cost | Components of lease cost are as follows: (in thousands) Year Ended December 31, 2022 Year Ended December 31, 2021 Finance lease cost: Amortization of leased assets $ — $ 16 Interest on lease liabilities — 5 Operating lease cost — 56 Short-term lease cost — 53 Total lease cost $ — $ 130 Supplemental cash flow information and non-cash activity related to the Company’s operating and finance leases are as follows: (in thousands) Year Ended December 31, 2022 Year Ended December 31, 2021 Cash paid for amounts included in the measurement of lease liabilities: Operating cash flows from operating leases $ — $ 71 Operating cash flows from finance leases — 5 Financing cash flows from finance leases — 35 |
PUBLIC OFFERING AND PRIVATE P_2
PUBLIC OFFERING AND PRIVATE PLACEMENT (Tables) | 12 Months Ended |
Dec. 31, 2022 | |
Statement of Stockholders' Equity [Abstract] | |
Schedule of Derivative Liabilities at Fair Value | The fair value of the warrants has been estimated with the following weighted-average assumptions, including the most sensitive input, volatility: December 31, 2022 December 31, 2021 Risk-free interest rate 4.1 % 1.22 % Volatility 102 % 94 % Expected life (years) 3.63 4.64 The following table reflects the fair value roll forward reconciliation of the 2019 Public Warrants liabilities for the period ended December 31, 2022: (in thousands) Warrant Derivative Liability Balance, December 31, 2021 $ 2,773 Change in fair value (1,964) Balance, December 31, 2022 $ 809 |
Summary of Warrants Outstanding and Exercisable | A summary of warrants outstanding and exercisable as of December 31, 2022 is as follows: Warrants Outstanding Warrants Exercisable Year Issued Number Outstanding Weighted Average Remaining Contractual Life Weighted Average Exercise Price Number Exercisable Weighted Average Exercise Price (in years) (per share) (per share) 2019 5,750,000 3.64 $ 13.00 5,750,000 $ 13.00 2020 4,149,378 2.84 $ 6.50 4,149,378 $ 6.50 2020 1 1,659,752 — $ — 1,659,752 $ — 2021 2,055,920 5.94 $ 1.69 2,055,920 $ 1.69 2021 2 20,559,210 — $ — 20,559,210 $ — 34,174,260 34,174,260 |
SHARE-BASED COMPENSATION PLANS
SHARE-BASED COMPENSATION PLANS (Tables) | 12 Months Ended |
Dec. 31, 2022 | |
Share-Based Payment Arrangement [Abstract] | |
Schedule of Outstanding Awards | At December 31, 2022 and 2021, outstanding awards were comprised of the following: December 31, 2022 December 31, 2021 Options 3,340,109 2,074,858 Inducement option awards 338,067 65,760 Restricted stock units 223,133 137,004 Inducement restricted stock units — 500 Total outstanding awards 3,901,309 2,278,122 |
Weighted-Average Valuation Assumptions | The fair value of the option grants has been estimated, with the following weighted-average assumptions: Year Ended December 31, 2022 December 31, 2021 Options granted 1,712,000 1,023,000 Weighted-average exercise price 1.39 2.80 Weighted-average grant date fair value 1.04 2.02 Assumptions: Risk-free interest rate 2.98 % 0.92 % Volatility 90 % 90 % Expected life (years) 5.88 5.63 Expected dividend yield — — |
Schedule of Stock Option Activity | The following table summarizes the stock option activity for all stock plans during the year ended December 31, 2022 and 2021 as follows: Options Outstanding Stock Options Weighted Average Exercise Price Weighted Average Remaining Contractual Term (in years) Aggregate Intrinsic Value (in thousands) Balance at December 31, 2020 1,510,968 $ 27.36 8.19 $ 379 Granted 1,023,000 $ 2.80 Exercised — Forfeited (393,350) $ 30.66 Balance at December 31, 2021 2,140,618 $ 15.01 8.48 $ — Granted 1,712,000 $ 1.39 Exercised — Forfeited (174,442) $ 10.41 Balance at December 31, 2022 3,678,176 $ 8.89 8.61 $ — Exercisable at December 31, 2022 1,599,680 $ 17.95 7.59 $ — |
Summary of Options Outstanding and Exercisable | The following table summarizes the options outstanding and exercisable at December 31, 2022: Options Outstanding Options Exercisable Exercise Price Total Shares Weighted Average Remaining Contractual Term (in years) Weighted Average Exercise Price Total Shares Weighted Average Remaining Contractual Term (in years) Weighted Average Exercise Price $1.06 to $1.32 339,000 9.59 $ 1.15 — 0.00 $ — $1.33 to $1.50 1,325,000 9.62 $ 1.44 — 0.00 $ — $1.51 to $2.93 877,687 8.72 $ 2.57 531,350 8.68 $ 2.66 $2.94 to $3.88 524,000 7.99 $ 2.99 524,000 7.99 $ 2.99 $3.89 to $234.70 612,489 6.27 $ 43.38 544,330 6.15 $ 47.27 Total 3,678,176 8.61 $ 8.89 1,599,680 7.59 $ 17.95 |
Schedule of Restricted Stock Unit Activity | The following table summarizes the stock award activity for all restricted stock units during the year ended December 31, 2022: Awards Outstanding Restricted Stock Awards and Units Weighted-Average Grant Date Fair Value Per Share Outstanding Aggregate Intrinsic Value (in thousands) Total Fair Value of Restricted Awards Vested (in thousands) Balance at December 31, 2020 129,861 $ 5.59 $ 458 Granted 136,626 $ 3.54 Vested (126,477) $ 5.05 $ 413 $ 659 Forfeited (2,506) $ 4.85 Balance at December 31, 2021 137,504 $ 4.06 $ 205 Granted 220,633 $ 1.13 Vested (135,004) $ 4.05 $ 207 $ 527 Forfeited — $ — Balance at December 31, 2022 223,133 $ 1.17 $ 161 |
Schedule Share-based Compensation | Share-based compensation expense by classification for December 31, 2022 and 2021 are as follows: Year Ended (in thousands) December 31, 2022 December 31, 2021 General and administrative $ 1,328 $ 2,275 Research and development 1,281 1,164 Total $ 2,609 $ 3,439 |
INCOME TAXES (Tables)
INCOME TAXES (Tables) | 12 Months Ended |
Dec. 31, 2022 | |
Income Tax Disclosure [Abstract] | |
Reconciliation of Income Tax Expense | The reconciliation between federal income taxes at the statutory U.S. federal income tax rate and the Company’s income tax expense for the year is as follows: (in thousands) December 31, 2022 December 31, 2021 Tax benefit at statutory rate $ (5,244) $ (2,038) Stock based compensation 207 780 Offering issuance costs and changes in fair value of warrants and private placement option (413) (3,176) Change in valuation allowance 6,066 4,718 Research and development credit (585) (288) Other (29) 4 Income tax expense $ 2 $ — |
Significant Components of Deferred Taxes | Significant components of the Company’s deferred taxes as of December 31, 2022 and 2021 are as follows: (in thousands) December 31, 2022 December 31, 2021 Deferred tax assets (liabilities): Net operating loss carryforward $ 104,707 $ 100,346 Stock compensation 3,838 3,541 Intangible assets 6,096 7,156 Section 174 expenses, net of amortization 1,639 — Research and development credit 18,661 18,076 Other 63 (144) Total deferred tax assets, net of deferred tax liabilities 135,004 128,975 Valuation allowance (135,004) (128,975) Net deferred tax $ — $ — |
Summary of Net Operating Loss Carryforwards | Net operating loss carryforwards and research tax credits as of December 31, 2022 and 2021 are as follows: (in thousands) December 31, 2022 December 31, 2021 U.S. federal income tax net operating loss carryforwards $ 498,607 $ 477,839 U.K. net operating loss carryforwards $ — $ — U.S. federal research tax credits $ 13,569 $ 12,985 Texas research tax credits $ 5,091 $ 5,091 |
ORGANIZATION, BASIS OF PRESEN_4
ORGANIZATION, BASIS OF PRESENTATION, AND SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES - Narrative (Details) | 1 Months Ended | 3 Months Ended | 6 Months Ended | 12 Months Ended | ||||||
Mar. 15, 2021 USD ($) | Feb. 26, 2021 USD ($) | Jun. 30, 2021 USD ($) | Apr. 30, 2020 USD ($) | Jun. 30, 2021 USD ($) | Mar. 31, 2021 USD ($) | Jun. 30, 2022 USD ($) | Dec. 31, 2022 USD ($) segment nominatedProgram subsidiary | Dec. 31, 2021 USD ($) | Mar. 26, 2021 USD ($) | |
Class of Stock [Line Items] | ||||||||||
Number of wholly-owned subsidiaries formed | subsidiary | 2 | |||||||||
Number of reportable segments | segment | 1 | |||||||||
Number of operating segments | segment | 1 | |||||||||
Accumulated deficit | $ (575,425,000) | $ (550,452,000) | ||||||||
Operating lease, liability | 0 | |||||||||
Depreciation expense | $ 10,000 | $ 110,000 | ||||||||
Takeda | ||||||||||
Class of Stock [Line Items] | ||||||||||
Revenue recognized | $ 700,000 | |||||||||
Minimum | ||||||||||
Class of Stock [Line Items] | ||||||||||
Estimated useful lives | 3 years | |||||||||
Maximum | ||||||||||
Class of Stock [Line Items] | ||||||||||
Estimated useful lives | 5 years | |||||||||
Lab equipment | ||||||||||
Class of Stock [Line Items] | ||||||||||
Estimated useful lives | 5 years | |||||||||
San Francisco Office Space | ||||||||||
Class of Stock [Line Items] | ||||||||||
Lease termination fee | $ 900,000 | |||||||||
Security deposits refund | $ 200,000 | |||||||||
Operating lease, right-of-use asset | $ 600,000 | |||||||||
Operating lease, liability | 1,000,000 | |||||||||
Loss on termination of lease | $ 500,000 | |||||||||
San Francisco Office Space | Lab equipment | ||||||||||
Class of Stock [Line Items] | ||||||||||
Operating lease, right-of-use asset | $ 100,000 | |||||||||
U.S. Manufacturing Facility | ||||||||||
Class of Stock [Line Items] | ||||||||||
Cash proceeds subject to escrow provisions | $ 1,500,000 | |||||||||
Houston Office | Discontinued Operations, Disposed of by Sale | ||||||||||
Class of Stock [Line Items] | ||||||||||
Amount paid upon closing of asset sale | $ 1,100,000 | |||||||||
Lease exit agreement, cash receivable | 900,000 | |||||||||
Lease exit agreement, note receivable | $ 200,000 | $ 200,000 | ||||||||
Simple interest | 4% | 4% | ||||||||
MD Anderson | Licensing Agreements | ||||||||||
Class of Stock [Line Items] | ||||||||||
Number of nominated programs, license maintenance fee earned | nominatedProgram | 2 | |||||||||
MD Anderson | Licensing Agreements | 2019 M.D. Anderson License Agreement | ||||||||||
Class of Stock [Line Items] | ||||||||||
License maintenance fee earned during period | $ 500,000 | |||||||||
MD Anderson | Licensing Agreements | 2021 M.D. Anderson Option and License Agreement | ||||||||||
Class of Stock [Line Items] | ||||||||||
License maintenance fee earned during period | $ 1,000,000 |
ORGANIZATION, BASIS OF PRESEN_5
ORGANIZATION, BASIS OF PRESENTATION, AND SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES - Cash Reconciliation (Details) - USD ($) $ in Thousands | Dec. 31, 2022 | Dec. 31, 2021 | Dec. 31, 2020 |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |||
Cash and cash equivalents | $ 21,837 | $ 46,156 | |
Restricted cash | 0 | 1,501 | |
Total cash, cash equivalents and restricted cash shown in the statements of cash flows | $ 21,837 | $ 47,657 | $ 36,996 |
ORGANIZATION, BASIS OF PRESEN_6
ORGANIZATION, BASIS OF PRESENTATION, AND SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES - Property and Equipment (Details) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2022 | Dec. 31, 2021 | |
Property, Plant and Equipment [Line Items] | ||
Property and equipment, gross | $ 592 | $ 1,603 |
Less: accumulated depreciation | (570) | (1,591) |
Property and equipment, net | $ 22 | 12 |
Lab equipment | ||
Property, Plant and Equipment [Line Items] | ||
Estimated Useful Lives | 5 years | |
Property and equipment, gross | $ 0 | 530 |
Manufacturing equipment | ||
Property, Plant and Equipment [Line Items] | ||
Estimated Useful Lives | 5 years | |
Property and equipment, gross | $ 0 | 138 |
Computer and office equipment | ||
Property, Plant and Equipment [Line Items] | ||
Property and equipment, gross | $ 510 | 841 |
Software | ||
Property, Plant and Equipment [Line Items] | ||
Estimated Useful Lives | 3 years | |
Property and equipment, gross | $ 82 | $ 94 |
Minimum | ||
Property, Plant and Equipment [Line Items] | ||
Estimated Useful Lives | 3 years | |
Minimum | Computer and office equipment | ||
Property, Plant and Equipment [Line Items] | ||
Estimated Useful Lives | 3 years | |
Maximum | ||
Property, Plant and Equipment [Line Items] | ||
Estimated Useful Lives | 5 years | |
Maximum | Computer and office equipment | ||
Property, Plant and Equipment [Line Items] | ||
Estimated Useful Lives | 5 years |
ORGANIZATION, BASIS OF PRESEN_7
ORGANIZATION, BASIS OF PRESENTATION, AND SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES - Accrued Expenses and Other Liabilities (Details) - USD ($) $ in Thousands | Dec. 31, 2022 | Dec. 31, 2021 |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | ||
Accrued payroll | $ 264 | $ 320 |
Accrued patient treatment costs | 675 | 2,086 |
Accrued clinical research costs | 841 | 479 |
Accrued manufacturing costs | 434 | 328 |
Accrued professional services | 207 | 305 |
Accrued other | 56 | 331 |
Total accrued expenses and other current liabilities | $ 2,477 | $ 3,849 |
ORGANIZATION, BASIS OF PRESEN_8
ORGANIZATION, BASIS OF PRESENTATION, AND SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES - Anti-dilutive Shares Excluded From Earnings Per Share Calculations (Details) - shares | 12 Months Ended | |
Dec. 31, 2022 | Dec. 31, 2021 | |
Earnings Per Share, Basic, by Common Class, Including Two Class Method [Line Items] | ||
Total common stock equivalents (in shares) | 14,171,309 | 12,548,122 |
Redeemable convertible series 1 preferred stock | ||
Earnings Per Share, Basic, by Common Class, Including Two Class Method [Line Items] | ||
Total common stock equivalents (in shares) | 4,520,000 | 4,520,000 |
Warrants to purchase common stock | ||
Earnings Per Share, Basic, by Common Class, Including Two Class Method [Line Items] | ||
Total common stock equivalents (in shares) | 5,750,000 | 5,750,000 |
Options to purchase common stock | ||
Earnings Per Share, Basic, by Common Class, Including Two Class Method [Line Items] | ||
Total common stock equivalents (in shares) | 3,678,176 | 2,140,618 |
Unvested shares of restricted stock units | ||
Earnings Per Share, Basic, by Common Class, Including Two Class Method [Line Items] | ||
Total common stock equivalents (in shares) | 223,133 | 137,504 |
FAIR VALUE OF MEASUREMENTS AN_3
FAIR VALUE OF MEASUREMENTS AND INVESTMENT SECURITIES - Assets Measured on Recurring Basis (Details) - USD ($) $ in Thousands | Dec. 31, 2022 | Dec. 31, 2021 |
Level 1 | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Total Cash Equivalents | $ 20,024 | $ 42,487 |
Level 1 | Money market funds and treasury bills | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Total Cash Equivalents | 20,024 | 42,487 |
Level 2 | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Total Cash Equivalents | 0 | 0 |
Level 2 | Money market funds and treasury bills | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Total Cash Equivalents | 0 | 0 |
Level 3 | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Total Cash Equivalents | 0 | 0 |
Level 3 | Money market funds and treasury bills | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Total Cash Equivalents | $ 0 | $ 0 |
FAIR VALUE OF MEASUREMENTS AN_4
FAIR VALUE OF MEASUREMENTS AND INVESTMENT SECURITIES - Fair Value of Warrants (Details) - Warrant Derivative Liability - USD ($) $ in Millions | 12 Months Ended | |
Dec. 31, 2022 | Dec. 31, 2021 | |
Derivative [Line Items] | ||
Gain on change in the fair value | $ 2.8 | |
Risk-free interest rate | 4.10% | 1.22% |
Volatility | 102% | 94% |
Expected life (years) | 3 years 7 months 17 days | 4 years 7 months 20 days |
FAIR VALUE OF MEASUREMENTS AN_5
FAIR VALUE OF MEASUREMENTS AND INVESTMENT SECURITIES - Derivative Liabilities Reported at Fair Value (Details) - USD ($) $ in Thousands | Dec. 31, 2022 | Dec. 31, 2021 |
Fair Value Measurement Inputs and Valuation Techniques [Line Items] | ||
Warrant derivative liability | $ 809 | $ 2,773 |
Level 1 | ||
Fair Value Measurement Inputs and Valuation Techniques [Line Items] | ||
Warrant derivative liability | 0 | 0 |
Level 2 | ||
Fair Value Measurement Inputs and Valuation Techniques [Line Items] | ||
Warrant derivative liability | 0 | 0 |
Level 3 | ||
Fair Value Measurement Inputs and Valuation Techniques [Line Items] | ||
Warrant derivative liability | $ 809 | $ 2,773 |
LEASES - Narrative (Details)
LEASES - Narrative (Details) | 3 Months Ended | 6 Months Ended | ||
Feb. 26, 2021 USD ($) | Mar. 31, 2021 lease_agreement | Jun. 30, 2022 USD ($) | Dec. 31, 2022 USD ($) | |
Lessee, Lease, Description [Line Items] | ||||
Number of lease agreements entered into during period | lease_agreement | 2 | |||
Operating lease, liability | $ 0 | |||
Finance lease, liability | $ 0 | |||
Discontinued Operations, Disposed of by Sale | Houston Office | ||||
Lessee, Lease, Description [Line Items] | ||||
Lease exit agreement, note receivable | $ 200,000 | $ 200,000 | ||
Simple interest | 4% | 4% |
LEASES - Components of Lease Co
LEASES - Components of Lease Cost (Details) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2022 | Dec. 31, 2021 | |
Finance lease cost: | ||
Amortization of leased assets | $ 0 | $ 16 |
Interest on lease liabilities | 0 | 5 |
Operating lease cost | 0 | 56 |
Short-term lease cost | 0 | 53 |
Total lease cost | $ 0 | $ 130 |
LEASES - Supplemental Cash Flow
LEASES - Supplemental Cash Flow Information Related to Operating Leases (Details) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2022 | Dec. 31, 2021 | |
Cash paid for amounts included in the measurement of lease liabilities: | ||
Operating cash flows from operating leases | $ 0 | $ 71 |
Operating cash flows from finance leases | 0 | 5 |
Financing cash flows from finance leases | $ 0 | $ 35 |
PUBLIC OFFERING AND PRIVATE P_3
PUBLIC OFFERING AND PRIVATE PLACEMENT - Narrative (Details) - USD ($) $ / shares in Units, $ in Millions | 12 Months Ended | |||||||
Dec. 04, 2021 | Nov. 02, 2020 | Aug. 21, 2019 | Aug. 16, 2019 | Dec. 31, 2019 | Dec. 31, 2022 | Dec. 31, 2021 | Aug. 31, 2019 | |
Class of Stock [Line Items] | ||||||||
Common stock, par value (in dollars per share) | $ 0.01 | $ 0.01 | ||||||
Warrant exercise price (in dollars per share) | $ 17.95 | |||||||
Common stock, issued (in shares) | 8,682,447 | 8,497,025 | ||||||
Proceeds from issuance of redeemable convertible preferred stock in a public offering, net | $ 53.8 | |||||||
Proceeds upon entering into private placement agreement | $ 11.2 | |||||||
Series 1 Preferred | ||||||||
Class of Stock [Line Items] | ||||||||
Shares issuable per warrants (in shares) | 10 | 10 | ||||||
Price per share (in dollars per share) | $ 100 | |||||||
December 2021 Private Placement | ||||||||
Class of Stock [Line Items] | ||||||||
Shares issuable per warrants (in shares) | 20,559,210 | |||||||
Warrants to purchase aggregate shares of common stock (in shares) | 2,055,920 | |||||||
Shares purchased by selling pre-funded warrant (in shares) | 0.1 | |||||||
Price per share (in dollars per share) | $ 1.7024 | |||||||
Common stock, par value (in dollars per share) | 0.0001 | |||||||
Warrant exercise price (in dollars per share) | $ 1.69 | |||||||
Expiration period | 7 years | |||||||
Proceeds from issuance of common stock | $ 35 | |||||||
December 2021 Private Placement | Pre-Funded Warrant | ||||||||
Class of Stock [Line Items] | ||||||||
Shares purchased by selling pre-funded warrant (in shares) | 1 | |||||||
November 2020 Underwritten Offering | ||||||||
Class of Stock [Line Items] | ||||||||
Shares issuable per warrants (in shares) | 3,109,378 | |||||||
Warrants to purchase aggregate shares of common stock (in shares) | 4,149,378 | |||||||
Shares purchased by selling pre-funded warrant (in shares) | 1 | |||||||
Common stock, par value (in dollars per share) | $ 0.001 | |||||||
Warrant exercise price (in dollars per share) | $ 6.50 | |||||||
Expiration period | 5 years | |||||||
Proceeds from issuance of common stock | $ 25 | |||||||
Common stock, issued (in shares) | 1,040,000 | |||||||
November 2020 Underwritten Offering | Minimum | ||||||||
Class of Stock [Line Items] | ||||||||
Price of each share of common stock and accompanying common warrant (in dollars per share) | $ 6.024 | |||||||
November 2020 Underwritten Offering | Maximum | ||||||||
Class of Stock [Line Items] | ||||||||
Price of each share of common stock and accompanying common warrant (in dollars per share) | $ 6.025 | |||||||
Public Offering | ||||||||
Class of Stock [Line Items] | ||||||||
Price per share (in dollars per share) | $ 100 | |||||||
Shares issuable under warrants (in shares) | 5,750,000 | |||||||
Public Offering | Series 1 Preferred | ||||||||
Class of Stock [Line Items] | ||||||||
Number of shares of common stock sold in offering (in shares) | 575,000 | |||||||
Weighted Average Exercise Price (in dollars per share) | $ 130 | |||||||
Public Offering | Common Stock | ||||||||
Class of Stock [Line Items] | ||||||||
Shares issuable per warrants (in shares) | 10 | |||||||
Weighted Average Exercise Price (in dollars per share) | $ 13 | |||||||
Notice period for percentage change | 61 days | |||||||
Public Offering | Common Stock | Minimum | ||||||||
Class of Stock [Line Items] | ||||||||
Warrants, limitations on ownership after exercise | 9.99% | |||||||
Public Offering | Common Stock | Maximum | ||||||||
Class of Stock [Line Items] | ||||||||
Warrants, limitations on ownership after exercise | 19.99% | |||||||
Private Placement | Series 2 redeemable convertible non-voting preferred stock | ||||||||
Class of Stock [Line Items] | ||||||||
Price per share (in dollars per share) | $ 100 | $ 100 | ||||||
Number of shares of common stock sold in offering (in shares) | 350,000 | |||||||
Shares issuable under warrants (in shares) | 2,800,000 | |||||||
Weighted Average Exercise Price (in dollars per share) | $ 10 | |||||||
Private Placement | Series 3 redeemable convertible non-voting preferred stock | ||||||||
Class of Stock [Line Items] | ||||||||
Number of shares of common stock sold in offering (in shares) | 250,000 | |||||||
Private Placement | Preferred Stock | ||||||||
Class of Stock [Line Items] | ||||||||
Price per share (in dollars per share) | $ 140 | |||||||
Shares issuable under warrants (in shares) | 875,000 | |||||||
Weighted Average Exercise Price (in dollars per share) | $ 14 |
PUBLIC OFFERING AND PRIVATE P_4
PUBLIC OFFERING AND PRIVATE PLACEMENT - Fair Value of Derivative Liability (Details) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2022 | Dec. 31, 2021 | |
Fair Value, Warrant Derivative Liabilities, Unobservable Input Reconciliation [Roll Forward] | ||
Change in fair value | $ (1,964) | $ (15,126) |
Warrant Derivative Liability | Level 3 | ||
Fair Value, Warrant Derivative Liabilities, Unobservable Input Reconciliation [Roll Forward] | ||
Warrants and rights outstanding, beginning balance | 2,773 | |
Change in fair value | (1,964) | |
Warrants and rights outstanding, ending balance | $ 809 | $ 2,773 |
PUBLIC OFFERING AND PRIVATE P_5
PUBLIC OFFERING AND PRIVATE PLACEMENT - Summary of Warrants Outstanding and Exercisable (Details) | Dec. 31, 2022 $ / shares shares |
Warrants Outstanding | |
Number Outstanding (in shares) | 34,174,260 |
Warrants Exercisable | |
Number Exercisable (in shares) | 34,174,260 |
2019 | |
Warrants Outstanding | |
Number Outstanding (in shares) | 5,750,000 |
Weighted Average Remaining Contractual Life | 3 years 7 months 20 days |
Weighted Average Exercise Price (in dollars per share) | $ / shares | $ 13 |
Warrants Exercisable | |
Number Exercisable (in shares) | 5,750,000 |
Weighted Average Exercise Price (in dollars per share) | $ / shares | $ 13 |
2020 | |
Warrants Outstanding | |
Number Outstanding (in shares) | 4,149,378 |
Weighted Average Remaining Contractual Life | 2 years 10 months 2 days |
Weighted Average Exercise Price (in dollars per share) | $ / shares | $ 6.50 |
Warrants Exercisable | |
Number Exercisable (in shares) | 4,149,378 |
Weighted Average Exercise Price (in dollars per share) | $ / shares | $ 6.50 |
2020 | |
Warrants Outstanding | |
Number Outstanding (in shares) | 1,659,752 |
Weighted Average Remaining Contractual Life | 0 years |
Weighted Average Exercise Price (in dollars per share) | $ / shares | $ 0 |
Warrants Exercisable | |
Number Exercisable (in shares) | 1,659,752 |
Weighted Average Exercise Price (in dollars per share) | $ / shares | $ 0 |
2021 | |
Warrants Outstanding | |
Number Outstanding (in shares) | 2,055,920 |
Weighted Average Remaining Contractual Life | 5 years 11 months 8 days |
Weighted Average Exercise Price (in dollars per share) | $ / shares | $ 1.69 |
Warrants Exercisable | |
Number Exercisable (in shares) | 2,055,920 |
Weighted Average Exercise Price (in dollars per share) | $ / shares | $ 1.69 |
2021 | |
Warrants Outstanding | |
Number Outstanding (in shares) | 20,559,210 |
Weighted Average Remaining Contractual Life | 0 years |
Weighted Average Exercise Price (in dollars per share) | $ / shares | $ 0 |
Warrants Exercisable | |
Number Exercisable (in shares) | 20,559,210 |
Weighted Average Exercise Price (in dollars per share) | $ / shares | $ 0 |
REDEEMABLE CONVERTIBLE PREFER_2
REDEEMABLE CONVERTIBLE PREFERRED STOCK - Narrative (Details) - USD ($) $ / shares in Units, $ in Millions | 12 Months Ended | |||
Aug. 16, 2019 | Dec. 31, 2022 | Dec. 31, 2021 | Aug. 31, 2019 | |
Class of Stock [Line Items] | ||||
Preferred stock, authorized (in shares) | 10,000,000 | |||
Preferred stock, par value (in dollars per share) | $ 0.01 | |||
Closing price of common stock threshold period | 180 days | |||
Average trading volume period | 50 days | |||
50-day trading volume on Nasdaq stock market (in shares) | 50,000 | |||
Series 1 Preferred | ||||
Class of Stock [Line Items] | ||||
Preferred stock, authorized (in shares) | 1,517,500 | |||
Preferred stock, issued (in shares) | 452,000 | 452,000 | ||
Preferred stock, outstanding (in shares) | 452,000 | 452,000 | ||
Issuance of common stock, price (in dollars per share) | $ 100 | |||
Shares issuable per warrants (in shares) | 10 | 10 | ||
Conversion of redeemable convertible preferred stock into common stock (in shares) | 0 | |||
Closing price of common stock (in dollars per share) | $ 25 | |||
Closing price of common stock threshold period | 180 days | |||
Average trading volume period | 50 days | |||
50-day trading volume on Nasdaq stock market (in shares) | 50,000 | |||
Preferred stock, redemption amount | $ 45.2 | |||
Series 2 redeemable convertible non-voting preferred stock | ||||
Class of Stock [Line Items] | ||||
Preferred stock, authorized (in shares) | 350,000 | |||
Preferred stock, issued (in shares) | 0 | |||
Preferred stock, outstanding (in shares) | 0 | |||
Series 2 redeemable convertible non-voting preferred stock | Private Placement | ||||
Class of Stock [Line Items] | ||||
Number of shares of common stock sold in offering (in shares) | 350,000 | |||
Issuance of common stock, price (in dollars per share) | $ 100 | $ 100 | ||
Series 3 redeemable convertible non-voting preferred stock | ||||
Class of Stock [Line Items] | ||||
Preferred stock, authorized (in shares) | 250,000 | |||
Preferred stock, issued (in shares) | 0 | |||
Preferred stock, outstanding (in shares) | 0 | |||
Series 3 redeemable convertible non-voting preferred stock | Private Placement | ||||
Class of Stock [Line Items] | ||||
Number of shares of common stock sold in offering (in shares) | 250,000 |
SHARE-BASED COMPENSATION PLAN_2
SHARE-BASED COMPENSATION PLANS - Narrative (Details) | 1 Months Ended | 12 Months Ended | ||||
Jun. 30, 2022 shares | Jun. 30, 2021 shares | Jun. 30, 2020 shares | Jan. 31, 2020 shares | Dec. 31, 2022 USD ($) plan shares | Dec. 31, 2021 USD ($) | |
Share-based Goods and Nonemployee Services Transaction [Line Items] | ||||||
Number of share-based compensation plans | plan | 5 | |||||
Proceeds from stock options exercised | $ | $ 0 | $ 0 | ||||
Compensation cost not yet recognized | $ | $ 2,400,000 | |||||
Period of recognition (in years) | 1 year 8 months 4 days | |||||
Aggregate fair value of options and restricted shares vesting | $ | $ 3,300,000 | $ 4,300,000 | ||||
2019 Equity Incentive Plan | ||||||
Share-based Goods and Nonemployee Services Transaction [Line Items] | ||||||
Number of shares authorized (in shares) | 250,000 | |||||
Additional authorized shares approved (in shares) | 2,250,000 | 500,000 | 500,000 | 600,000 | ||
Options | ||||||
Share-based Goods and Nonemployee Services Transaction [Line Items] | ||||||
Expiration period | 10 years | |||||
Employee Stock | 2014 Employee Stock Purchase Plan | ||||||
Share-based Goods and Nonemployee Services Transaction [Line Items] | ||||||
Number of shares authorized (in shares) | 55,000 | |||||
ESPP common stock discount | 15% | |||||
Shares available for issuance under ESPP (in shares) | 18,488 | |||||
Minimum | Options | ||||||
Share-based Goods and Nonemployee Services Transaction [Line Items] | ||||||
Vesting period | 2 years | |||||
Maximum | 2019 Equity Incentive Plan | ||||||
Share-based Goods and Nonemployee Services Transaction [Line Items] | ||||||
Number of shares authorized (in shares) | 600,540 | |||||
Maximum | Options | ||||||
Share-based Goods and Nonemployee Services Transaction [Line Items] | ||||||
Vesting period | 4 years |
SHARE-BASED COMPENSATION PLAN_3
SHARE-BASED COMPENSATION PLANS - Outstanding Awards (Details) - shares | Dec. 31, 2022 | Dec. 31, 2021 | Dec. 31, 2020 |
Share-based Goods and Nonemployee Services Transaction [Line Items] | |||
Options outstanding (in shares) | 3,678,176 | 2,140,618 | 1,510,968 |
2019 Equity Incentive Plan | |||
Share-based Goods and Nonemployee Services Transaction [Line Items] | |||
Total awards outstanding (in shares) | 3,901,309 | 2,278,122 | |
Options | 2019 Equity Incentive Plan | |||
Share-based Goods and Nonemployee Services Transaction [Line Items] | |||
Options outstanding (in shares) | 3,340,109 | 2,074,858 | |
Inducement option awards | 2019 Equity Incentive Plan | |||
Share-based Goods and Nonemployee Services Transaction [Line Items] | |||
Options outstanding (in shares) | 338,067 | 65,760 | |
Restricted stock units | 2019 Equity Incentive Plan | |||
Share-based Goods and Nonemployee Services Transaction [Line Items] | |||
Awards other than options outstanding (in shares) | 223,133 | 137,004 | |
Inducement restricted stock units | 2019 Equity Incentive Plan | |||
Share-based Goods and Nonemployee Services Transaction [Line Items] | |||
Awards other than options outstanding (in shares) | 0 | 500 |
SHARE-BASED COMPENSATION PLAN_4
SHARE-BASED COMPENSATION PLANS - Weighted-Average Valuation Assumptions (Details) - $ / shares | 12 Months Ended | |
Dec. 31, 2022 | Dec. 31, 2021 | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Options granted (in shares) | 1,712,000 | 1,023,000 |
Options | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Options granted (in shares) | 1,712,000 | 1,023,000 |
Weighted-average exercise price (in dollars per share) | $ 1.39 | $ 2.80 |
Weighted-average grant date fair value (in dollars per share) | $ 1.04 | $ 2.02 |
Assumptions: | ||
Risk-free interest rate | 2.98% | 0.92% |
Volatility | 90% | 90% |
Expected life (years) | 5 years 10 months 17 days | 5 years 7 months 17 days |
Expected dividend yield | 0% | 0% |
SHARE-BASED COMPENSATION PLAN_5
SHARE-BASED COMPENSATION PLANS - Stock Option Activity (Details) - USD ($) $ / shares in Units, $ in Thousands | 12 Months Ended | ||
Dec. 31, 2022 | Dec. 31, 2021 | Dec. 31, 2020 | |
Outstanding Stock Options | |||
Beginning balance (in shares) | 2,140,618 | 1,510,968 | |
Granted (in shares) | 1,712,000 | 1,023,000 | |
Exercised (in shares) | 0 | 0 | |
Forfeited (in shares) | (174,442) | (393,350) | |
Ending balance (in shares) | 3,678,176 | 2,140,618 | 1,510,968 |
Exercisable at end of period (in shares) | 1,599,680 | ||
Weighted Average Exercise Price | |||
Beginning balance (in dollars per share) | $ 15.01 | $ 27.36 | |
Granted (in dollars per share) | 1.39 | 2.80 | |
Exercised (in dollars per share) | |||
Forfeited (in dollars per share) | 10.41 | 30.66 | |
Ending balance (in dollars per share) | 8.89 | $ 15.01 | $ 27.36 |
Exercisable at end of period (in dollars per share) | $ 17.95 | ||
Outstanding Stock Options, Other Disclosures | |||
Weighted-average remaining contractual term, outstanding (in years) | 8 years 7 months 9 days | 8 years 5 months 23 days | 8 years 2 months 8 days |
Weighted-average remaining contractual term, exercisable (in years) | 7 years 7 months 2 days | ||
Aggregate intrinsic value, outstanding | $ 0 | $ 0 | $ 379 |
Aggregate intrinsic value, exercisable | $ 0 |
SHARE-BASED COMPENSATION PLAN_6
SHARE-BASED COMPENSATION PLANS - Stock Options Outstanding and Exercisable (Details) - $ / shares | 12 Months Ended | ||
Dec. 31, 2022 | Dec. 31, 2021 | Dec. 31, 2020 | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Option outstanding (in shares) | 3,678,176 | ||
Weighted-average remaining contractual term, option outstanding (in years) | 8 years 7 months 9 days | 8 years 5 months 23 days | 8 years 2 months 8 days |
Weighted-average exercise price, option outstanding (in dollars per share) | $ 8.89 | ||
Option exercisable (in shares) | 1,599,680 | ||
Weighted-average remaining contractual term, option exercisable (in years) | 7 years 7 months 2 days | ||
Weighted-average exercise price (in dollars per share) | $ 17.95 | ||
$1.06 to $1.32 | |||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Exercise Price - minimum (in dollars per share) | 1.06 | ||
Exercise Price - maximum (in dollars per share) | $ 1.32 | ||
Option outstanding (in shares) | 339,000 | ||
Weighted-average remaining contractual term, option outstanding (in years) | 9 years 7 months 2 days | ||
Weighted-average exercise price, option outstanding (in dollars per share) | $ 1.15 | ||
Option exercisable (in shares) | 0 | ||
Weighted-average remaining contractual term, option exercisable (in years) | 0 years | ||
Weighted-average exercise price (in dollars per share) | $ 0 | ||
$1.33 to $1.50 | |||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Exercise Price - minimum (in dollars per share) | 1.33 | ||
Exercise Price - maximum (in dollars per share) | $ 1.50 | ||
Option outstanding (in shares) | 1,325,000 | ||
Weighted-average remaining contractual term, option outstanding (in years) | 9 years 7 months 13 days | ||
Weighted-average exercise price, option outstanding (in dollars per share) | $ 1.44 | ||
Option exercisable (in shares) | 0 | ||
Weighted-average remaining contractual term, option exercisable (in years) | 0 years | ||
Weighted-average exercise price (in dollars per share) | $ 0 | ||
$1.51 to $2.93 | |||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Exercise Price - minimum (in dollars per share) | 1.51 | ||
Exercise Price - maximum (in dollars per share) | $ 2.93 | ||
Option outstanding (in shares) | 877,687 | ||
Weighted-average remaining contractual term, option outstanding (in years) | 8 years 8 months 19 days | ||
Weighted-average exercise price, option outstanding (in dollars per share) | $ 2.57 | ||
Option exercisable (in shares) | 531,350 | ||
Weighted-average remaining contractual term, option exercisable (in years) | 8 years 8 months 4 days | ||
Weighted-average exercise price (in dollars per share) | $ 2.66 | ||
$2.94 to $3.88 | |||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Exercise Price - minimum (in dollars per share) | 2.94 | ||
Exercise Price - maximum (in dollars per share) | $ 3.88 | ||
Option outstanding (in shares) | 524,000 | ||
Weighted-average remaining contractual term, option outstanding (in years) | 7 years 11 months 26 days | ||
Weighted-average exercise price, option outstanding (in dollars per share) | $ 2.99 | ||
Option exercisable (in shares) | 524,000 | ||
Weighted-average remaining contractual term, option exercisable (in years) | 7 years 11 months 26 days | ||
Weighted-average exercise price (in dollars per share) | $ 2.99 | ||
$3.89 to $234.70 | |||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Exercise Price - minimum (in dollars per share) | 3.89 | ||
Exercise Price - maximum (in dollars per share) | $ 234.70 | ||
Option outstanding (in shares) | 612,489 | ||
Weighted-average remaining contractual term, option outstanding (in years) | 6 years 3 months 7 days | ||
Weighted-average exercise price, option outstanding (in dollars per share) | $ 43.38 | ||
Option exercisable (in shares) | 544,330 | ||
Weighted-average remaining contractual term, option exercisable (in years) | 6 years 1 month 24 days | ||
Weighted-average exercise price (in dollars per share) | $ 47.27 |
SHARE-BASED COMPENSATION PLAN_7
SHARE-BASED COMPENSATION PLANS - Restricted Stock Award Activity (Details) - Restricted Stock - USD ($) $ / shares in Units, $ in Thousands | 12 Months Ended | ||
Dec. 31, 2022 | Dec. 31, 2021 | Dec. 31, 2020 | |
Outstanding Restricted Stock Awards and Units | |||
Beginning balance (in shares) | 137,504 | 129,861 | |
Granted (in shares) | 220,633 | 136,626 | |
Vested (in shares) | (135,004) | (126,477) | |
Forfeited (in shares) | 0 | (2,506) | |
Ending balance (in shares) | 223,133 | 137,504 | |
Weighted-Average Grant Date Fair Value Per Share | |||
Beginning balance (in dollars per share) | $ 4.06 | $ 5.59 | |
Granted (in dollars per share) | 1.13 | 3.54 | |
Vested (in dollars per share) | 4.05 | 5.05 | |
Forfeited (in dollars per share) | 0 | 4.85 | |
Ending balance (in dollars per share) | $ 1.17 | $ 4.06 | |
Outstanding Aggregate Intrinsic Value | |||
Beginning balance | $ 161 | $ 205 | $ 458 |
Vested | 207 | 413 | |
Ending balance | 161 | 205 | |
Total Fair Value of Restricted Awards Vested (in thousands) | $ 527 | $ 659 |
SHARE-BASED COMPENSATION PLAN_8
SHARE-BASED COMPENSATION PLANS - Expense by Classification (Details) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2022 | Dec. 31, 2021 | |
Share-based Payment Arrangement, Expensed and Capitalized, Amount [Line Items] | ||
Total | $ 2,609 | $ 3,439 |
General and administrative | ||
Share-based Payment Arrangement, Expensed and Capitalized, Amount [Line Items] | ||
Total | 1,328 | 2,275 |
Research and development | ||
Share-based Payment Arrangement, Expensed and Capitalized, Amount [Line Items] | ||
Total | $ 1,281 | $ 1,164 |
COMMITMENTS AND CONTINGENCIES (
COMMITMENTS AND CONTINGENCIES (Details) - Licensing Agreements $ in Thousands | 3 Months Ended | 12 Months Ended | |||
Dec. 10, 2015 USD ($) | Jun. 10, 2015 USD ($) product | Sep. 30, 2021 USD ($) | Jun. 30, 2021 USD ($) | Dec. 31, 2019 USD ($) | |
Baylor | |||||
Long-term Purchase Commitment [Line Items] | |||||
Sublicense expense | $ 500 | $ 600 | $ 600 | ||
Agensys | |||||
Long-term Purchase Commitment [Line Items] | |||||
Nonrefundable upfront fee | $ 3,000 | ||||
Milestone payments upon first achievement of specified clinical milestones | 5,000 | ||||
Milestone payments upon achievement of specified clinical milestones for each licensed product | 50,000 | ||||
Milestone payments upon achievement of sales milestones | 75,000 | ||||
Option exercise fee | 5,000 | ||||
Milestone payments reduced upon exercise of option | $ 65,000 | ||||
Termination period, number of years after first commercial sale of licensed product | 10 years | ||||
Termination period, notice of failure on uncured items | 60 days | ||||
Period of notice of failure on uncured items, if material breach is related to failure to make payments | 30 days | ||||
BioVec | |||||
Long-term Purchase Commitment [Line Items] | |||||
Nonrefundable upfront fee | $ 100 | ||||
Milestone payments upon first achievement of specified clinical milestones | $ 250 | ||||
Termination period, notice of failure on uncured items | 60 days | ||||
Upfront fee payment period, number of days from effective date | 10 days | ||||
License costs due upon first release of product | $ 300 | ||||
License costs due upon first release of product, period of payment | 10 days | ||||
License agreement, annual fee | $ 150 | ||||
License agreement, annual fee period, from first IND filing | 30 days | ||||
Milestone payments, number of initial products | product | 3 | ||||
License agreement, milestone payments upon receipt of FDA or EMA registration | $ 2,000 | ||||
Termination notice period for any other breach | 90 days | ||||
Termination period, after insolvency event | 30 days |
INCOME TAXES - Reconciliation o
INCOME TAXES - Reconciliation of Income Tax Expense (Details) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2022 | Dec. 31, 2021 | |
Income Tax Disclosure [Abstract] | ||
Tax benefit at statutory rate | $ (5,244) | $ (2,038) |
Stock based compensation | 207 | 780 |
Offering issuance costs and changes in fair value of warrants and private placement option | (413) | (3,176) |
Change in valuation allowance | 6,066 | 4,718 |
Research and development credit | (585) | (288) |
Other | (29) | 4 |
Income tax expense | $ 2 | $ 0 |
INCOME TAXES - Significant Comp
INCOME TAXES - Significant Components of Deferred Taxes (Details) - USD ($) $ in Thousands | Dec. 31, 2022 | Dec. 31, 2021 |
Deferred tax assets (liabilities): | ||
Net operating loss carryforward | $ 104,707 | $ 100,346 |
Stock compensation | 3,838 | 3,541 |
Intangible assets | 6,096 | 7,156 |
Section 174 expenses, net of amortization | 1,639 | 0 |
Research and development credit | 18,661 | 18,076 |
Other | 63 | |
Other | (144) | |
Total deferred tax assets, net of deferred tax liabilities | 135,004 | 128,975 |
Valuation allowance | (135,004) | (128,975) |
Net deferred tax | $ 0 | $ 0 |
INCOME TAXES - Operating Loss C
INCOME TAXES - Operating Loss Carryforwards and Research Tax Credits (Details) - USD ($) $ in Thousands | Dec. 31, 2022 | Dec. 31, 2021 |
Operating Loss Carryforwards [Line Items] | ||
Research tax credits | $ 18,661 | $ 18,076 |
Federal | ||
Operating Loss Carryforwards [Line Items] | ||
Net operating loss carry forwards | 498,607 | 477,839 |
Research tax credits | 13,569 | 12,985 |
Foreign | ||
Operating Loss Carryforwards [Line Items] | ||
Net operating loss carry forwards | 0 | 0 |
Texas | ||
Operating Loss Carryforwards [Line Items] | ||
Research tax credits | $ 5,091 | $ 5,091 |
INCOME TAXES - Narrative (Detai
INCOME TAXES - Narrative (Details) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2022 | Dec. 31, 2021 | |
Income Tax Disclosure [Abstract] | ||
Net operating loss carryforwards, no expiration date | $ 277,400 | |
Research tax credits | $ 18,661 | $ 18,076 |
Deferred tax asset, valuation allowance, percentage | 100% | 100% |
Increase (decrease) in valuation allowance | $ 6,000 | $ 4,700 |
Section 174 expenses, net of amortization | $ 1,639 | $ 0 |