Cover Page
Cover Page - shares | 9 Months Ended | |
Sep. 30, 2021 | Oct. 27, 2021 | |
Cover [Abstract] | ||
Document Type | 10-Q | |
Document Quarterly Report | true | |
Document Period End Date | Sep. 30, 2021 | |
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 | |
Entity Address, Address Line Two | Suite 1200 | |
Entity Address, City or Town | Houston | |
Entity Address, State or Province | TX | |
Entity Address, Postal Zip Code | 77098 | |
City Area Code | 832 | |
Local Phone Number | 384-1100 | |
Title of 12(b) Security | Common Stock, par value $0.01 per share | |
Trading Symbol | BLCM | |
Entity Current Reporting Status | Yes | |
Entity Interactive Data Current | Yes | |
Entity Filer Category | Non-accelerated Filer | |
Entity Small Business | true | |
Entity Emerging Growth Company | false | |
Entity Shell Company | false | |
Entity Common Shares Outstanding (in shares) | 8,397,803 | |
Entity Central Index Key | 0001358403 | |
Current Fiscal Year End Date | --12-31 | |
Document Fiscal Year Focus | 2021 | |
Document Fiscal Period Focus | Q3 | |
Amendment Flag | false | |
Security Exchange Name | NASDAQ |
Condensed Consolidated Balance
Condensed Consolidated Balance Sheets - USD ($) $ in Thousands | Sep. 30, 2021 | Dec. 31, 2020 |
Current assets: | ||
Cash and cash equivalents | $ 19,266 | $ 35,495 |
Restricted cash | 1,501 | 1,501 |
Accounts receivable, interest and other receivables | 556 | 2 |
Prepaid expenses and other current assets | 1,019 | 802 |
Assets held for sale | 0 | 1,643 |
Total current assets | 22,342 | 39,443 |
Operating lease right-of-use assets | 0 | 645 |
Property and equipment, net | 27 | 189 |
Other assets | 4 | 307 |
Total assets | 22,373 | 40,584 |
Current liabilities: | ||
Accounts payable | 521 | 891 |
Accrued expenses and other current liabilities | 5,339 | 4,165 |
Warrant derivative liability | 7,842 | 10,345 |
Private placement option liability | 2,800 | 7,803 |
Current portion of lease liabilities | 0 | 825 |
Liabilities held for sale | 0 | 672 |
Total current liabilities | 16,502 | 24,701 |
Long-term lease liabilities | 0 | 344 |
Total liabilities | 16,502 | 25,045 |
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 September 30, 2021 and December 31, 2020; 452,000 shares issued and outstanding at September 30, 2021 and December 31, 2020 | 18,036 | 18,036 |
Stockholders’ deficit: | ||
Common stock, $0.01 par value; 80,000,000 shares authorized at September 30, 2021 and December 31, 2020; 8,465,549 shares issued and 8,397,803 shares outstanding at September 30, 2021; 8,385,650 shares issued and 8,317,904 shares outstanding at December 31, 2020 | 84 | 84 |
Treasury stock: 67,746 shares held at September 30, 2021 and December 31, 2020 | (5,056) | (5,056) |
Additional paid-in capital | 546,138 | 543,561 |
Accumulated other comprehensive loss | (348) | (339) |
Accumulated deficit | (552,983) | (540,747) |
Total stockholders’ deficit | (12,165) | (2,497) |
Total liabilities, redeemable preferred stock and stockholders' deficit | $ 22,373 | $ 40,584 |
Condensed Consolidated Balanc_2
Condensed Consolidated Balance Sheets (Parenthetical) - $ / shares | Sep. 30, 2021 | Dec. 31, 2020 |
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) | 80,000,000 | 80,000,000 |
Common stock, issued (in shares) | 8,465,549 | 8,385,650 |
Common stock, outstanding (in shares) | 8,397,803 | 8,317,904 |
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, shares issued (in shares) | 452,000 | 452,000 |
Preferred stock, outstanding (in shares) | 452,000 | 452,000 |
Condensed Consolidated Statemen
Condensed Consolidated Statements of Operations and Comprehensive Loss - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2021 | Sep. 30, 2020 | Sep. 30, 2021 | Sep. 30, 2020 | |
Revenues | ||||
Revenues | $ 5,000 | $ 0 | $ 5,700 | $ 0 |
Operating expenses | ||||
Research and development | 6,348 | 8,140 | 19,531 | 30,346 |
General and administrative | 1,681 | 4,163 | 5,458 | 12,095 |
Total operating expenses | 8,029 | 12,303 | 24,989 | 42,441 |
(Gain) loss on dispositions, net | 14 | 0 | 478 | (3,761) |
Loss from operations | (3,043) | (12,303) | (19,767) | (38,680) |
Other income (expense): | ||||
Interest income | 6 | 10 | 24 | 392 |
Interest expense | 0 | (725) | (4) | (2,473) |
Change in fair value of warrant and private placement option liabilities | 4,264 | 12,131 | 7,506 | 14,256 |
Other income | 6 | 0 | 5 | 0 |
Total other income (expense) | 4,276 | 11,416 | 7,531 | 12,175 |
Net income (loss) | 1,233 | (887) | (12,236) | (26,505) |
Less: undistributed earnings to participating securities | (469) | 0 | 0 | 0 |
Net income (loss) attributable to common shareholders | $ 764 | $ (887) | $ (12,236) | $ (26,505) |
Net income (loss) per common share attributable to common shareholders, basic (in dollars per share) | $ 0.08 | $ (0.18) | $ (1.21) | $ (5.25) |
Net income (loss) per common share attributable to common shareholders, diluted (in dollars per shares) | $ 0.07 | $ (0.18) | $ (1.21) | $ (5.25) |
Weighted-average shares outstanding, basic (in shares) | 10,108,388 | 5,059,779 | 10,086,246 | 5,050,603 |
Weighted-average shares outstanding, diluted (in shares) | 10,194,668 | 5,059,779 | 10,086,246 | 5,050,603 |
Other comprehensive loss: | ||||
Foreign currency translation adjustment | $ (9) | $ 36 | $ (9) | $ (26) |
Net comprehensive income (loss) | 1,224 | (851) | (12,245) | (26,531) |
Supply agreement | ||||
Revenues | ||||
Revenues | 0 | 0 | 700 | 0 |
License revenue | ||||
Revenues | ||||
Revenues | $ 5,000 | $ 0 | $ 5,000 | $ 0 |
Condensed Consolidated Statem_2
Condensed Consolidated Statements of Redeemable Convertible Preferred Stock and Stockholders’ Deficit - USD ($) $ in Thousands | Total | Common Stock | Treasury Stock | Additional Paid-In Capital | Accumulated Deficit | Accumulated Other Comprehensive Loss | Series 1 Preferred |
Preferred stock, beginning balance (in shares) at Dec. 31, 2019 | 538,000 | ||||||
Preferred stock, beginning balance at Dec. 31, 2019 | $ 21,468 | ||||||
Increase (Decrease) in Temporary Equity [Roll Forward] | |||||||
Conversion of redeemable preferred stock into common stock (in shares) | 40,000 | (4,000) | |||||
Conversion of redeemable convertible preferred stock into common stock | $ 160 | $ 1 | $ 159 | $ (160) | |||
Preferred stock, ending balance (in shares) at Mar. 31, 2020 | 534,000 | ||||||
Preferred stock, ending balance at Mar. 31, 2020 | $ 21,308 | ||||||
Balance, beginning of period (in shares) at Dec. 31, 2019 | 5,076,593 | 67,746 | |||||
Balance, beginning of period at Dec. 31, 2019 | (26,217) | $ 507 | $ (5,056) | 511,684 | $ (533,025) | $ (327) | |
Increase (Decrease) in Stockholders' Equity | |||||||
1-for-10 Reverse Stock Split | 0 | $ (457) | 457 | ||||
Share-based compensation | 1,323 | 1,323 | |||||
Issuance of common stock upon vesting of restricted stock units (in shares) | 1,045 | ||||||
Conversion of redeemable preferred stock into common stock (in shares) | 40,000 | (4,000) | |||||
Conversion of redeemable convertible preferred stock into common stock | 160 | $ 1 | 159 | $ (160) | |||
Comprehensive income (loss) | 17,563 | 17,576 | (13) | ||||
Balance, end of period (in shares) at Mar. 31, 2020 | 5,117,638 | 67,746 | |||||
Balance, end of period at Mar. 31, 2020 | (7,171) | $ 51 | $ (5,056) | 513,623 | (515,449) | (340) | |
Preferred stock, beginning balance (in shares) at Dec. 31, 2019 | 538,000 | ||||||
Preferred stock, beginning balance at Dec. 31, 2019 | $ 21,468 | ||||||
Preferred stock, ending balance (in shares) at Sep. 30, 2020 | 534,000 | ||||||
Preferred stock, ending balance at Sep. 30, 2020 | $ 21,308 | ||||||
Balance, beginning of period (in shares) at Dec. 31, 2019 | 5,076,593 | 67,746 | |||||
Balance, beginning of period at Dec. 31, 2019 | (26,217) | $ 507 | $ (5,056) | 511,684 | (533,025) | (327) | |
Increase (Decrease) in Stockholders' Equity | |||||||
Comprehensive income (loss) | (26,531) | ||||||
Balance, end of period (in shares) at Sep. 30, 2020 | 5,127,525 | 67,746 | |||||
Balance, end of period at Sep. 30, 2020 | (48,030) | $ 51 | $ (5,056) | 516,858 | (559,530) | (353) | |
Preferred stock, beginning balance (in shares) at Mar. 31, 2020 | 534,000 | ||||||
Preferred stock, beginning balance at Mar. 31, 2020 | $ 21,308 | ||||||
Preferred stock, ending balance (in shares) at Jun. 30, 2020 | 534,000 | ||||||
Preferred stock, ending balance at Jun. 30, 2020 | $ 21,308 | ||||||
Balance, beginning of period (in shares) at Mar. 31, 2020 | 5,117,638 | 67,746 | |||||
Balance, beginning of period at Mar. 31, 2020 | (7,171) | $ 51 | $ (5,056) | 513,623 | (515,449) | (340) | |
Increase (Decrease) in Stockholders' Equity | |||||||
Share-based compensation | 1,564 | 1,564 | |||||
Issuance of common stock - Employee Stock Purchase Plan (in shares) | 9,526 | ||||||
Issuance of common stock - Employee Stock Purchase Plan | 65 | $ 0 | 65 | ||||
Issuance of common stock upon vesting of restricted stock units (in shares) | 361 | ||||||
Comprehensive income (loss) | (43,243) | (43,194) | (49) | ||||
Balance, end of period (in shares) at Jun. 30, 2020 | 5,127,525 | 67,746 | |||||
Balance, end of period at Jun. 30, 2020 | (48,785) | $ 51 | $ (5,056) | 515,252 | (558,643) | (389) | |
Preferred stock, ending balance (in shares) at Sep. 30, 2020 | 534,000 | ||||||
Preferred stock, ending balance at Sep. 30, 2020 | $ 21,308 | ||||||
Increase (Decrease) in Stockholders' Equity | |||||||
Share-based compensation | 1,606 | 1,606 | |||||
Comprehensive income (loss) | (851) | (887) | 36 | ||||
Balance, end of period (in shares) at Sep. 30, 2020 | 5,127,525 | 67,746 | |||||
Balance, end of period at Sep. 30, 2020 | (48,030) | $ 51 | $ (5,056) | 516,858 | (559,530) | (353) | |
Preferred stock, beginning balance (in shares) at Dec. 31, 2020 | 452,000 | ||||||
Preferred stock, beginning balance at Dec. 31, 2020 | 18,036 | $ 18,036 | |||||
Preferred stock, ending balance (in shares) at Mar. 31, 2021 | 452,000 | ||||||
Preferred stock, ending balance at Mar. 31, 2021 | $ 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 | 903 | 903 | |||||
Exercise of restricted stock unit awards (in shares) | 369 | ||||||
Exercise of restricted stock unit awards | 0 | ||||||
Comprehensive income (loss) | (11,267) | (11,267) | |||||
Balance, end of period (in shares) at Mar. 31, 2021 | 8,386,019 | 67,746 | |||||
Balance, end of period at Mar. 31, 2021 | (12,861) | $ 84 | $ (5,056) | 544,464 | (552,014) | (339) | |
Preferred stock, beginning balance (in shares) at Dec. 31, 2020 | 452,000 | ||||||
Preferred stock, beginning balance at Dec. 31, 2020 | 18,036 | $ 18,036 | |||||
Preferred stock, ending balance (in shares) at Sep. 30, 2021 | 452,000 | ||||||
Preferred stock, ending balance at Sep. 30, 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 | |||||||
Comprehensive income (loss) | (12,245) | ||||||
Balance, end of period (in shares) at Sep. 30, 2021 | 8,465,549 | 67,746 | |||||
Balance, end of period at Sep. 30, 2021 | (12,165) | $ 84 | $ (5,056) | 546,138 | (552,983) | (348) | |
Preferred stock, beginning balance (in shares) at Mar. 31, 2021 | 452,000 | ||||||
Preferred stock, beginning balance at Mar. 31, 2021 | $ 18,036 | ||||||
Preferred stock, ending balance (in shares) at Jun. 30, 2021 | 452,000 | ||||||
Preferred stock, ending balance at Jun. 30, 2021 | $ 18,036 | ||||||
Balance, beginning of period (in shares) at Mar. 31, 2021 | 8,386,019 | 67,746 | |||||
Balance, beginning of period at Mar. 31, 2021 | (12,861) | $ 84 | $ (5,056) | 544,464 | (552,014) | (339) | |
Increase (Decrease) in Stockholders' Equity | |||||||
Share-based compensation | 821 | 821 | |||||
Exercise of restricted stock unit awards (in shares) | 79,530 | ||||||
Exercise of restricted stock unit awards | 0 | ||||||
Comprehensive income (loss) | (2,202) | (2,202) | |||||
Balance, end of period (in shares) at Jun. 30, 2021 | 8,465,549 | 67,746 | |||||
Balance, end of period at Jun. 30, 2021 | (14,242) | $ 84 | $ (5,056) | 545,285 | (554,216) | (339) | |
Preferred stock, ending balance (in shares) at Sep. 30, 2021 | 452,000 | ||||||
Preferred stock, ending balance at Sep. 30, 2021 | 18,036 | $ 18,036 | |||||
Increase (Decrease) in Stockholders' Equity | |||||||
Share-based compensation | 853 | 853 | |||||
Comprehensive income (loss) | 1,224 | 1,233 | (9) | ||||
Balance, end of period (in shares) at Sep. 30, 2021 | 8,465,549 | 67,746 | |||||
Balance, end of period at Sep. 30, 2021 | $ (12,165) | $ 84 | $ (5,056) | $ 546,138 | $ (552,983) | $ (348) |
Condensed Consolidated Statem_3
Condensed Consolidated Statements of Cash Flows - USD ($) $ in Thousands | 9 Months Ended | |
Sep. 30, 2021 | Sep. 30, 2020 | |
Cash flows from operating activities: | ||
Net loss | $ (12,236) | $ (26,505) |
Adjustments to reconcile net loss to net cash used in operating activities: | ||
Share-based compensation | 2,577 | 4,493 |
Depreciation and amortization expense | 90 | 1,229 |
Change in fair value of warrant and private placement option liabilities | (7,506) | (14,256) |
(Gain) loss on dispositions, net | 478 | (3,761) |
Amortization of right-of-use assets | 33 | 297 |
Accretion of lease liability | 23 | 371 |
Amortization of deferred issuance costs | 0 | 550 |
Changes in operating assets and liabilities: | ||
Accounts receivable, interest and other receivables | (181) | 178 |
Prepaid expenses and other assets | (216) | 103 |
Accounts payable | (370) | (1,345) |
Accrued liabilities and other | 230 | (4,629) |
Net cash used in operating activities | (17,078) | (43,275) |
Cash flows from investing activities: | ||
Proceeds from sale of property and equipment, net | 900 | 14,909 |
Purchases of property and equipment | (7) | (807) |
Net cash provided by investing activities | 893 | 14,102 |
Cash flows from financing activities: | ||
Payment on debt | 0 | (10,000) |
Proceeds from issuance of stock from employee stock purchase plan | 0 | 65 |
Payment on financing lease obligations | (35) | (56) |
Net cash used in financing activities | (35) | (9,991) |
Effect of exchange rate changes on cash | (9) | (26) |
Net change in cash, cash equivalents, and restricted cash | (16,229) | (39,190) |
Cash, cash equivalents and restricted cash at beginning of period | 36,996 | 93,816 |
Cash, cash equivalents and restricted cash at end of period | 20,767 | 54,626 |
Supplemental cash flow information: | ||
Cash paid during the period for interest | 0 | 1,973 |
Non-cash investing and financing activities: | ||
Purchases of property and equipment in accounts payables and accrued liabilities | 0 | 859 |
Leasehold improvements paid by landlord | 0 | 113 |
Conversion of redeemable preferred stock into common stock | 0 | 160 |
Reclassification of property and equipment, net to assets held for sale | $ 0 | $ 199 |
ORGANIZATION, BASIS OF PRESENTA
ORGANIZATION, BASIS OF PRESENTATION AND SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES | 9 Months Ended |
Sep. 30, 2021 | |
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 clinical stage biopharmaceutical company focused on discovering and developing novel cellular immunotherapies for various forms of cancer. Bellicum is devoting substantially all of its present efforts to developing next-generation CAR-T product candidates in cellular immunotherapy. 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. Reverse Stock Split On February 5, 2020, the Company filed a Certificate of Amendment of the Amended and Restated Certificate of Incorporation with the Secretary of State of the State of Delaware to (i) effect a reverse stock split of all issued and outstanding shares of the Company’s common stock at a ratio of 1-for-10 and (ii) reduce the number of authorized shares of the Company’s common stock from 200,000,000 to 40,000,000. The accompanying consolidated financial statements and notes to the consolidated financial statements gives retroactive effect to the reverse stock split for all periods presented. On June 15, 2020, the Company filed with the Secretary of State of the State of Delaware a Second Certificate of Amendment to the Company’s Amended and Restated Certificate of Incorporation to increase the authorized number of shares of the Company’s common stock from 40,000,000 shares to 80,000,000 shares. Basis of Presentation The accompanying unaudited condensed financial statements have been prepared in conformity with the authoritative U.S. generally accepted accounting principles (“GAAP”) for interim financial information and pursuant to Form 10-Q and Article 10 of Regulation S-X of the Securities and Exchange Commission ("SEC"). Accordingly, the accompanying unaudited condensed consolidated financial statements do not include all of the information and notes required by GAAP for complete financial statements. The unaudited interim financial statements reflect all adjustments, which, in the opinion of management, are necessary for a fair statement of the results for the periods presented. All such adjustments are of a normal and recurring nature. The operating results presented in these unaudited condensed consolidated financial statements are not necessarily indicative of the results that may be expected for any future periods. These unaudited condensed consolidated financial statements should be read in conjunction with the audited consolidated financial statements and the notes thereto in the Company’s Annual Report on Form 10-K (“Annual Report”) for the fiscal year ended December 31, 2020, as filed with the SEC on March 31, 2021. The accompanying interim condensed financial statements have been prepared on a going concern basis, which assumes that the Company will continue to realize its assets and discharge its liabilities in the normal course of business. However, as of September 30, 2021, and December 31, 2020, the Company had an accumulated deficit of $553.0 million and $540.7 million, respectively, and at September 30, 2021, the Company had cash, cash equivalents and restricted cash of approximately $20.8 million. Based on the Company’s current business plan, management believes that existing cash and cash equivalents, revenues and other cash inflows will be insufficient to fund its operations for one year from the date these financial statements are issued, and therefore, substantial doubt about the entity’s ability to continue as a going concern exists. 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. The Company has recorded losses from operations since its inception and if the Company does not successfully obtain regulatory approval and commercialize any of its product candidates, the Company will not be able to achieve profitability. The Company is subject to risks common to companies in the biotechnology industry and the future success of the Company is dependent on its ability to successfully complete the development of, and obtain regulatory approval for, its product candidates, manage the growth of the organization, obtain additional financing necessary in order to develop, launch and commercialize its product candidates, and compete successfully with other companies in its industry. 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 interim financial statements are issued based on the expected cash burn rate. The Company may be required to raise additional capital to fund future operations through the sale of additional equity, incurrence of debt, the entry into licensing or collaboration agreements with partners, grants or other sources of financing. Sufficient funds may not be available to the Company at all or on attractive terms when needed from equity or debt financings. If the Company is unable to obtain additional funding from these or other sources when needed, or to the extent needed, it may be necessary to significantly reduce its controllable and variable expenditures and current rate of spending through reductions in staff and delaying, scaling back, or suspending certain research and development, sales and marketing programs and other operational goals. Moreover, if the Company does not obtain such additional funds, there could be substantial doubt about its ability to continue as a going concern and increased risk of insolvency, which could result in a total loss of investment to the Company's stockholders and other security holders. Use of Estimates The preparation of the interim condensed consolidated financial statements in accordance with GAAP requires management to make certain estimates and judgments that affect the reported amounts of assets, liabilities, and expenses. Actual results could differ from those estimates. Revenue Recognition The Company’s sources of revenue during the nine months ended September 30, 2021 are from its supply agreement with Takeda Development Center Americas, Inc. (“Takeda”) and from its licensing agreement with The University of Texas MD Anderson Cancer Center (“MD Anderson”). Supply of Product The promised product in 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. Licenses of Intellectual Property The promised services in license agreement with MD Anderson consists of certain option and license rights to the Company’s intellectual property. If the license to the Company's intellectual property is determined to be distinct from the other performance obligations identified in the arrangement and when management believes the license to its intellectual property and products has stand-alone value, 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, adjust the measure of performance and related revenue recognition. Milestone Payments At the inception of each arrangement that includes developmental, regulatory or commercial milestone payments, we evaluate whether achieving the milestones is considered probable and estimate 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 our 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. Revenue is recognized from the satisfaction of performance obligations in the amount billable to the customer. 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, we recognize 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. Significant Accounting Policies There have been no significant changes to the accounting policies during the nine months ended September 30, 2021 as compared to the significant accounting policies described in Note 1 of the “Notes to Consolidated Financial Statements” in the Company’s audited financial statements included in its Annual Report for the fiscal year ended December 31, 2020. Cash, Cash Equivalents and Restricted Cash The Company considers all short-term, highly liquid investments with 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) September 30, 2021 December 31, 2020 Cash and cash equivalents $ 19,266 $ 35,495 Restricted cash 1,501 1,501 Total cash, cash equivalents and restricted cash shown in the statements of cash flows $ 20,767 $ 36,996 In connection with the closing of the Asset Purchase Agreement with M.D. Anderson on April 14, 2020, $1.5 million of the cash proceeds received are subject to certain escrow provisions and recorded as restricted cash. The funds are required to be held for a period of 18 months subsequent to the April 14, 2020 closing date or until any outstanding claims against the escrow are resolved, and are listed as Restricted cash at September 30, 2021, and December 31, 2020. 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 manufacturing facility in Houston, Texas. As a result of this decision, the Company reclassified the assets and liabilities associated with the leased facility as held for sale. The reclassified assets and liabilities included a right-of-use asset of $0.5 million, property and equipment of $2.3 million and the related lease liability of $0.7 million. Based on the cost to exit the lease and the net realizable value of the related assets the Company recognized an impairment charge of $1.3 million in the fourth quarter of 2020. The disposal of the assets and liabilities associated with the Houston 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. 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 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 net book value less than $0.1 million, and the related lease liability of $1 million. The Company recognized a loss on termination of $0.5 million during the first quarter of 2021. Accrued Expenses and Other Current Liabilities Accrued expenses and other liabilities consist of the following: (in thousands) September 30, 2021 December 31, 2020 Accrued payroll $ 278 $ 1,071 Accrued patient treatment costs 2,507 899 Accrued clinical research costs 1,658 1,562 Accrued manufacturing costs 252 41 Accrued professional services 289 279 Accrued other 355 313 Total accrued expenses and other current liabilities $ 5,339 $ 4,165 Certain prior year amounts have been reclassified to conform to the 2021 presentation. Expenses related to clinical studies totaling $1.2 million were reclassified from Accrued Other to Accrued Clinical Research Costs. Another $0.1 million for expenses related to drug manufacture and professional consulting services were reclassified from Accrued Other to Accrued Manufacturing Costs and Accrued Professional Services. Warrant Derivatives Freestanding warrants are classified as liabilities in the accompanying condensed consolidated balance sheets as they are exercisable for multiple underlying instruments that are potentially redeemable. The Company accounts for these warrants at fair value on the date of issuance and 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 condensed consolidated statements of operations and comprehensive loss. 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. 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. P rivate Placement Option The Company has entered into a security purchase agreement that contains a call option on preferred shares that are puttable outside the control of the Company. The Company recorded the option as a liability and measured the fair value of the option at the time of issuance. The Company will re-measure the option to fair value at each balance sheet date and record changes in fair value in other income (expense) in the accompanying condensed 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 estimates the fair value of these liabilities using a binomial lattice model, 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. Preferred Stock Preferred shares issued by the Company that are subject to mandatory redemption are classified as liability instruments in the accompanying condensed 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 condensed consolidated balance sheets. At all other times, preferred shares are classified within stockholders’ deficit. 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 based on the present value of the future minimum lease payments over the lease term at commencement date 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 non-cancellable 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 the exchange price that would be received for an asset or an exit price paid to transfer a liability in an orderly transaction between market participants in a principal market on the measurement date. Accounting standards include disclosure requirements around fair values used for certain financial instruments and establish a fair value hierarchy. The three-tier hierarchy defines a three-tiered valuation hierarchy for disclosures that prioritizes valuation inputs into three levels based on the extent to which inputs used in measuring fair value are observable in the market, as described further in Note 2. Observable inputs reflect readily obtainable data from independent sources, and unobservable inputs reflect the Company’s market assumptions. 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, and accrued liabilities 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. The costs related to preferred and common stock have been netted against the proceeds of the equity issuances. Net Income (Loss) and Net Income (Loss) per Share of Common Stock Attributable to Common Stockholders Basic and diluted net income (loss) per share attributable to common stockholders is based on the more dilutive method of either the two-class method or the treasury stock method. Basic net income (loss) per share attributable to common stockholders is calculated by dividing the net income (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. Undistributed earnings allocated to participating securities are subtracted from net income in determining net income attributable to common stockholders. Diluted net income (loss) per share gives effect to dilutive stock options, warrants and other potentially dilutive common stock equivalents outstanding during the period, assuming the exercise of all “in-the-money” common stock equivalents based on the average market price during the period. For periods of a net loss position, since the participating securities are not contractually obligated to share losses with the common stockholders, the diluted loss per share is calculated similarly to basic loss per share. For warrants that are recorded as a liability in the accompanying condensed consolidated balance sheets, the calculation of diluted loss per share requires that, to the extent the average market price of the underlying shares for the reporting period exceeds the exercise price of the warrants and the presumed exercise of the warrants is dilutive to loss per share for the period, an adjustment is made to net loss used in the calculation to remove the change in fair value of the warrants from the numerator for the period. Likewise, an adjustment to the denominator is required to reflect the related dilutive shares, if any, under the treasury stock method. The following table sets forth the computation of basic and diluted earnings per share: Three Months Ended Nine Months Ended (in thousands, except share and per share amounts) September 30, 2021 September 30, 2020 September 30, 2021 September 30, 2020 Net income (loss) per share - basic: Net income (loss) $ 1,233 $ (887) $ (12,236) $ (26,505) Less: undistributed earnings to participating securities (469) — — — Net income (loss) attributable to common shareholders $ 764 $ (887) $ (12,236) $ (26,505) Weighted-average shares outstanding, basic 10,108,388 5,059,779 10,086,246 5,050,603 Basic net income (loss) per share $ 0.08 $ (0.18) $ (1.21) $ (5.25) Net income (loss) per share - diluted: Net income (loss) attributable to common shareholders, basic $ 764 $ (887) $ (12,236) $ (26,505) Weighted-average shares outstanding, basic 10,108,388 5,059,779 10,086,246 5,050,603 Effect of dilutive securities: Stock options and restricted stock units 86,280 — — — Weighted-average shares outstanding, diluted 10,194,668 5,059,779 10,086,246 5,050,603 Diluted net income (loss) per share $ 0.07 $ (0.18) $ (1.21) $ (5.25) The following outstanding shares of common stock equivalents were excluded from the computations of diluted net income (loss) per share of common stock attributable to common stockholders for the periods presented as the effect of including such securities would be anti-dilutive. September 30, 2021 September 30, 2020 Common Stock Equivalents: Number of Shares Redeemable convertible series 1 preferred stock 4,520,000 5,340,000 Warrants to purchase common stock 11,616,080 5,750,000 Private placement option 9,675,000 9,675,000 Options to purchase common stock 1,985,277 1,142,470 Unvested shares of restricted stock units 168,980 182,227 Total common stock equivalents 27,965,337 22,089,697 New Accounting Requirements and Disclosures Fair Value Measurement In August 2018, the FASB issued ASU No. 2018-13, Fair Value Measurement (Topic 820): Disclosure Framework—Changes to the Disclosure Requirements for Fair Value Measurement, which modifies fair value disclosures and removes some disclosure requirements for both public and private companies. In addition, public companies are subject to some new disclosure requirements which requires to disclose the changes in unrealized gains and losses for the period included in other comprehensive income for recurring Level 3 fair value measurements held at the end of the reporting period and the range and weighted average of significant unobservable inputs used to develop Level 3 fair value measurements. ASU No. 2018-13 is effective for all entities for fiscal years, and interim periods within those fiscal years, beginning after December 15, 2019. Early adoption is permitted. The Company adopted the standard effective January 1, 2020 with no impact on its financial statements. Financial Instruments – Credit Losses In June 2016, the FASB issued ASU No. 2016-13, Financial Instruments — Credit Losses (Topic 326): Measurement of Credit Losses on Financial Instruments , which requires the measurement of all expected credit losses for financial assets including trade receivables held at the reporting date based on historical experience, current conditions, and reasonable and supportable forecasts. ASU No. 2016-13 is effective for fiscal years, and interim periods within those fiscal years, beginning after December 15, 2019. The Company adopted the standard effective January 1, 2020 with no material effect on its financial statements. Subsequent to the issuance of ASU 2016-13, the FASB issued ASU 2018-19, Codification Improvements to Topic 326, Financial Instruments - Credit Losses . This ASU does not change the core principle of the guidance in ASU 2016-13, instead these amendments are intended to clarify and improve operability of certain topics included within the credit losses guidance. The FASB also subsequently issued ASU No. 2019-04, Codification Improvements to Topic 326, Financial Instruments—Credit Losses, Derivatives and Hedging (Topic 815), and Financial Instruments (Topic 842) , which did not change the core principle of the guidance in ASU 2016-13 but clarified that expected recoveries of amounts previously written off and expected to be written off should be included in the valuation account and should not exceed amounts previously written off and expected to be written off. The guidance is effective for fiscal years, and interim periods within those years, beginning after December 15, 2019 for public business entities, excluding smaller reporting companies. Early adoption is permitted. As a smaller reporting company, the guidance will be effective for the Company during the first quarter of 2023. The Company is in the process of assessing the impact adoption will have on its consolidated financial statements. Income Taxes In December 2019, the FASB issued ASU No. 2019-12, Simplifying the Accounting for Income Taxes (Topic 740) . The guidance eliminates certain exceptions for recognizing deferred taxes for investments, performing intraperiod allocation and calculating income taxes in interim periods. This guidance also includes guidance to reduce complexity in certain areas, including recognizing deferred taxes for tax goodwill and allocating taxes to members of a consolidated group. ASU 2019-12 is effective for annual and interim periods in fiscal years beginning after December 15, 2019. The Company adopted the standard effective January 1, 2020 with no impact on its financial statements. Investments In January 2020, the FASB issued Accounting Standards Update No. 2020-01, Investments—Equity Securities (Topic 321), Investments—Equity Method and Joint Ventures (Topic 323), and Derivatives and Hedging (Topic 815)—Clarifying the Interactions between Topic 321, Topic 323, and Topic 815 (a consensus of the Emerging Issues Task Force) , which clarifies the interaction of the accounting for equity securities, investments accounted for under the equity method, and certain forward contracts and purchased options. This update is effective for fiscal years beginning after December 15, 2020, and interim periods within those fiscal years, and early adoption is permitted. The Company adopted the standard effective January 1, 2021 with no impact on its consolidated financial statements. |
FAIR VALUE MEASUREMENTS AND INV
FAIR VALUE MEASUREMENTS AND INVESTMENT SECURITIES | 9 Months Ended |
Sep. 30, 2021 | |
Fair Value Disclosures [Abstract] | |
FAIR VALUE MEASUREMENTS AND INVESTMENT SECURITIES | FAI R VALU E MEASUREMENTS AND INVESTMENT SECURITIES Investment Securities The following table presents the Company’s investment securities (including, if applicable, those classified on the Company’s balance sheet as cash equivalents) that are measured at fair value on a recurring basis as of September 30, 2021 and December 31, 2020: Fair Value at September 30, 2021 Fair Value at December 31, 2020 (in thousands) Level 1 Level 2 Level 3 Level 1 Level 2 Level 3 Cash equivalents: Money market funds and treasury bills $ 12,481 $ — $ — $ 27,463 $ — $ — Total cash equivalents $ 12,481 $ — $ — $ 27,463 $ — $ — As of September 30, 2021 and December 31, 2020, $1.5 million of restricted cash on the Company's balance sheet is held in a money market fund. Money market funds, U.S. Treasury, U.S. government agency-backed securities, corporate debt securities and municipal bonds 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. As of September 30, 2021, the fair values of the warrant derivative liability and the private placement option liability are classified as current liabilities in the accompanying condensed consolidated balance sheets. These liabilities will be shown as current liabilities on the balance sheet when it is deemed more probable than not by management to be exercised within one year. 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. The fair value of the warrants has been estimated with the following weighted-average assumptions, including the most sensitive input, volatility: September 30, 2021 December 31, 2020 Risk-free interest rate 0.95% 0.46% Volatility 95.00% 90.00% Expected term (years) 4.89 5.64 Inputs used to determine estimated fair value (Level 3) of the private placement option include the fair value of the underlying stock relative to the preferred share conversion price and warrant exercise price at the valuation measurement date, volatility of the price of the underlying stock, the expected term of the call option on the preferred shares and expected term of the warrants, and risk-free interest rates. The fair value of the private placement option has been estimated with the following weighted-average assumptions, including the most sensitive input, volatility: September 30, 2021 December 31, 2020 Risk-free interest rate 1.33 % 0.77 % Volatility 95.00 % 90.00 % Expected term (years) 7.00 7.00 The following table provides the warrant derivative and private placement option reported at fair value and measured on a recurring basis: Fair Value at September 30, 2021 Fair Value at December 31, 2020 (in thousands) Level 1 Level 2 Level 3 Level 1 Level 2 Level 3 Warrant derivative liability $ — $ — $ 7,842 $ — $ — $ 10,345 Private placement option liability — — 2,800 — — 7,803 Total fair value $ — $ — $ 10,642 $ — $ — $ 18,148 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 | 9 Months Ended |
Sep. 30, 2021 | |
Leases [Abstract] | |
LEASES | LEASES The Company determines whether an arrangement is a lease at its inception. Operating leases relate primarily to office space and manufacturing facilities with remaining lease terms of one year to seven years, some of which include options to extend the lease term for up to five years. Management considered the options in determining the lease term used to establish the Company's ROU assets and lease liabilities. As most of the Company's leases do not provide an implicit rate, the Company's incremental borrowing rate based on the information available at lease commencement date was used to determine the present value of lease payments. Components of lease cost are as follows: Three Months Ended Nine Months Ended (in thousands) September 30, 2021 September 30, 2020 September 30, 2021 September 30, 2020 Finance lease cost: Amortization of leased asset $ — $ 18 $ 16 $ 54 Interest on lease liabilities — 5 5 17 Operating lease cost 1 169 56 668 Short-term lease cost — 235 53 476 Total lease cost $ 1 $ 427 $ 130 $ 1,215 |
PUBLIC OFFERING AND PRIVATE PLA
PUBLIC OFFERING AND PRIVATE PLACEMENT | 9 Months Ended |
Sep. 30, 2021 | |
Statement of Stockholders' Equity [Abstract] | |
PUBLIC OFFERING AND PRIVATE PLACEMENT | PUBLIC OFFERING AND PRIVATE PLACEMENT November 2020 Underwritten Offering In November 2020, the Company closed an underwritten offering of 1,040,000 shares of its common stock, pre-funded warrants to purchase 3,109,378 shares of its common stock, and accompanying 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, or November 3, 2025. 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 “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 “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 estimated offering expenses payable by the Company, and excluding any proceeds that the Company may receive upon exercise of the Public Warrants. All of the Public Warrants sold in the 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 Public Warrants will be immediately exercisable upon issuance, provided that the holder will be 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. No Public Warrants have been exercised as of the balance sheet date. Private Placement On August 16, 2019, the Company entered into a Securities Purchase Agreement (the “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 (the “Private 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 (also, “Private Warrants”) to purchase up to 875,000 shares of common stock at an exercise price of $14.00 per share. The purchase and sale of the securities issuable under the private placement agreement may occur in two or more separate closings, each to be conducted at the Purchasers’ discretion within five days’ notice to the Company. The purchase and sale were subject to the Company’s obtaining stockholder approval for additional authorized shares of Common Stock or a reverse stock split (the “Required Stockholder Approval”), which occurred in the first quarter of 2020. The right of the Purchasers to purchase such securities will expire two and a half years after the Required Stockholder Approval, on June 15, 2022, with respect to the Series 2 Preferred Stock, and three years after such stockholder approval, on January 15, 2023, with respect to the Series 3 Preferred Stock, if not exercised prior to that date. No shares have been exercised as of the balance sheet date. The Company received $11.2 million in option proceeds, net of offering costs, upon the execution of the Securities Purchase Agreement. Total offering costs incurred by the Company related to the Public Warrants, Private Warrants and options amounted to $3.0 million. Decrease in the Company's common stock price and the time to expiration of both warrant derivative and private placement option had the most impact on the fair value. The following table reflects the fair value roll forward reconciliation of the warrant derivative and private placement option liabilities for the period ended September 30, 2021: (in thousands) Warrant Derivative Liability Private Placement Option Liability Total Balance, December 31, 2020 $ 10,345 $ 7,803 $ 18,148 Change in fair value (2,503) (5,003) (7,506) Balance, September 30, 2021 $ 7,842 $ 2,800 $ 10,642 |
REDEEMABLE CONVERTIBLE PREFERRE
REDEEMABLE CONVERTIBLE PREFERRED STOCK | 9 Months Ended |
Sep. 30, 2021 | |
Equity [Abstract] | |
REDEEMABLE CONVERTIBLE PREFERRED STOCK | REDEEMABLE CONVERTIBLE PREFERRED STOCK In August 2019, the Company sold Series 1 Preferred Stock pursuant to the 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 September 30, 2021. There were no shares of Series 2 or 3 preferred stock issued and outstanding as of September 30, 2021. As of September 30, 2021, the Company classified the Series 1 Preferred Stock as mezzanine equity, as the Series 1 preferred stock will be 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 the fifth (5th) anniversary of the initial issue date or upon a fundamental change in a redemption price. The Company does not believe a fundamental change is considered probable until it occurs. Subsequent adjustment of the amount presented in mezzanine equity to its redemption amount is unnecessary if it is not probable that the instrument will become redeemable. As of September 30, 2021, the Company did not accrete the Series 1 Preferred Stock to its redemption amount. 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 and Series 2 Preferred Stock) and $140.00 per share (for Series 3 Preferred Stock). The “Transition Date” means: • With respect to the Series 1 preferred stock, the first date following August 21, 2021, on which each of the Conditions (as defined below) is met (the “Series 1 Transition Date”); • With respect to the Series 2 preferred stock, the first date following the six-month anniversary of the Series 1 Transition Date on which each of the Conditions is met (the “Series 2 Transition Date”); and • With respect to the Series 3 preferred stock, the first date following the six-month anniversary of the Series 2 Transition Date on which each of the Conditions 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 and Series 2 preferred stock) and $35.00 per share (for the Series 3 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 will 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 | 9 Months Ended |
Sep. 30, 2021 | |
Share-based Payment Arrangement [Abstract] | |
SHARE-BASED COMPENSATION PLANS | 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 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 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, (ii) an additional 600,000 shares that were approved at the Company’s Special Meeting of Stockholders in January 2020, (iii) an additional 500,000 shares that were approved at the Company's Annual Meeting of Stockholders in June 2020, (iv) an additional 500,000 shares that were approved at the Company's Annual Meeting of Stockholders in June 2021 and plus (v) 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. The following table summarizes the stock option activity for all stock plans during the nine months ended September 30, 2021: Options and Inducement Awards Outstanding at December 31, 2020 1,510,968 Granted 823,000 Exercised — Forfeited (348,691) Outstanding at September 30, 2021 1,985,277 Exercisable at September 30, 2021 466,587 The following table summarizes the stock award activity for all stock plans during the nine months ended September 30, 2021: Restricted Stock Awards and Units Outstanding at December 31, 2020 129,861 Granted 136,626 Vested (95,001) Forfeited (2,506) Outstanding at September 30, 2021 168,980 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. During the nine-month periods ended September 30, 2020, there were 9,526 shares purchased by employees under the ESPP. The ESPP has been suspended since December 2020, resulting in the inactivity during the first, second, and third quarter of 2021. As of September 30, 2021, there were 18,488 shares available for issuance under the ESPP. A summary of activity within the ESPP follows: Nine Months Ended (in thousands) September 30, 2021 September 30, 2020 Deductions from employees $ — $ 116 Share-based compensation expense recognized — 70 Remaining share-based compensation expense — 113 Share-Based Compensation Expense The fair value of option grants is determined using the Black-Scholes option-pricing model and has been estimated with the following weighted-average assumptions: Nine Months Ended September 30, 2021 September 30, 2020 Risk-free interest rate 0.84 % 1.18 % Volatility 90.35 % 81.78 % Expected life (years) 5.63 6.03 Expected dividend yield — — Share-based compensation expense by classification for the three and nine months ended September 30, 2021 and 2020 are as follows: Three Months Ended Nine Months Ended (in thousands) September 30, 2021 September 30, 2020 September 30, 2021 September 30, 2020 Research and development $ 296 $ 668 $ 829 $ 1,877 General and administrative 557 938 1,748 2,616 Total $ 853 $ 1,606 $ 2,577 $ 4,493 |
COMMITMENTS AND CONTINGENCIES
COMMITMENTS AND CONTINGENCIES | 9 Months Ended |
Sep. 30, 2021 | |
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. 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 Agreements - 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 an obligation to pay the 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) $5.0 million upon the first achievement of certain specified clinical milestones for its licensed products, (ii) $50.0 million upon the achievement of certain specified clinical milestones for each licensed product, and (iii) $75.0 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 $5.0 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 $65.0 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 Takeda Supply Agreement On May 4, 2021, the Company entered a multi-year supply agreement with Takeda Development Center Americas, Inc. (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 for the nine months ended September 30, 2021, with the possibility of additional revenue from future sales. MD Anderson License Agreements On January 22, 2019, the Company entered into a licensing and commercialization agreement with MD Anderson (the "2019 MD Anderson License Agreement"). Under the 2019 MD Anderson License Agreement, the Company granted MD 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 MD Anderson License Agreement, MD Anderson exercised an option to grant a non-exclusive sublicense of the rights licensed by the Company to MD Anderson. MD 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. On August 31, 2021, the Company entered into a second licensing and commercialization agreement with MD Anderson (the “2021 MD Anderson Option and License Agreement”). Under the 2021 MD Anderson Option and License Agreement, MD 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 MD Anderson for the sublicense, an annual maintenance fee, and a percentage royalty on net sales of licensed products. During the third quarter of 2021, the Company received an upfront payment of $5.0 million upon execution of the agreement and granted licenses for two nominated programs. 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 currently is set for hearing on November 23, 2021. A trial date has not been set in the case. Compliance with NASDAQ Listing Rules |
ORGANIZATION, BASIS OF PRESEN_2
ORGANIZATION, BASIS OF PRESENTATION AND SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES (Policies) | 9 Months Ended |
Sep. 30, 2021 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
Basis of Presentation | Basis of PresentationThe accompanying unaudited condensed financial statements have been prepared in conformity with the authoritative U.S. generally accepted accounting principles (“GAAP”) for interim financial information and pursuant to Form 10-Q and Article 10 of Regulation S-X of the Securities and Exchange Commission ("SEC"). |
Use of Estimates | Use of Estimates The preparation of the interim condensed consolidated financial statements in accordance with GAAP requires management to make certain estimates and judgments that affect the reported amounts of assets, liabilities, and expenses. Actual results could differ from those estimates. |
Revenue Recognition | Revenue Recognition The Company’s sources of revenue during the nine months ended September 30, 2021 are from its supply agreement with Takeda Development Center Americas, Inc. (“Takeda”) and from its licensing agreement with The University of Texas MD Anderson Cancer Center (“MD Anderson”). Supply of Product The promised product in 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. Licenses of Intellectual Property The promised services in license agreement with MD Anderson consists of certain option and license rights to the Company’s intellectual property. If the license to the Company's intellectual property is determined to be distinct from the other performance obligations identified in the arrangement and when management believes the license to its intellectual property and products has stand-alone value, 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, adjust the measure of performance and related revenue recognition. Milestone Payments At the inception of each arrangement that includes developmental, regulatory or commercial milestone payments, we evaluate whether achieving the milestones is considered probable and estimate 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 our 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. Revenue is recognized from the satisfaction of performance obligations in the amount billable to the customer. 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, we recognize 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 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. |
Warrant Derivatives | Warrant Derivatives Freestanding warrants are classified as liabilities in the accompanying condensed consolidated balance sheets as they are exercisable for multiple underlying instruments that are potentially redeemable. The Company accounts for these warrants at fair value on the date of issuance and 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 condensed consolidated statements of operations and comprehensive loss. 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. 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. |
Private Placement Option | P rivate Placement Option The Company has entered into a security purchase agreement that contains a call option on preferred shares that are puttable outside the control of the Company. The Company recorded the option as a liability and measured the fair value of the option at the time of issuance. The Company will re-measure the option to fair value at each balance sheet date and record changes in fair value in other income (expense) in the accompanying condensed 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 estimates the fair value of these liabilities using a binomial lattice model, 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. |
Preferred Stock | Preferred Stock Preferred shares issued by the Company that are subject to mandatory redemption are classified as liability instruments in the accompanying condensed consolidated balance sheets and are measured at fair value at the date of issuance. Conditionally |
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. Operating leases are recognized as ROU assets and operating lease liabilities on the balance sheet based on the present value of the future minimum lease payments over the lease term at commencement date 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 non-cancellable 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 of Financial Instruments Fair value is defined as the exchange price that would be received for an asset or an exit price paid to transfer a liability in an orderly transaction between market participants in a principal market on the measurement date. Accounting standards include disclosure requirements around fair values used for certain financial instruments and establish a fair value hierarchy. The three-tier hierarchy defines a three-tiered valuation hierarchy for disclosures that prioritizes valuation inputs into three levels based on the extent to which inputs used in measuring fair value are observable in the market, as described further in Note 2. Observable inputs reflect readily obtainable data from independent sources, and unobservable inputs reflect the Company’s market assumptions. 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, and accrued liabilities 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. The costs related to preferred and common stock have been netted against the proceeds of the equity issuances. |
Net Loss and Net Loss per Share of Common Stock Attributable to Common Stockholders | Net Income (Loss) and Net Income (Loss) per Share of Common Stock Attributable to Common Stockholders Basic and diluted net income (loss) per share attributable to common stockholders is based on the more dilutive method of either the two-class method or the treasury stock method. Basic net income (loss) per share attributable to common stockholders is calculated by dividing the net income (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. Undistributed earnings allocated to participating securities are subtracted from net income in determining net income attributable to common stockholders. Diluted net income (loss) per share gives effect to dilutive stock options, warrants and other potentially dilutive common stock equivalents outstanding during the period, assuming the exercise of all “in-the-money” common stock equivalents based on the average market price during the period. For periods of a net loss position, since the participating securities are not contractually obligated to share losses with the common stockholders, the diluted loss per share is calculated similarly to basic loss per share. For warrants that are recorded as a liability in the accompanying condensed consolidated balance sheets, the calculation of diluted loss per share requires that, to the extent the average market price of the underlying shares for the reporting period exceeds the exercise price of the warrants and the presumed exercise of the warrants is dilutive to loss per share for the period, an adjustment is made to net loss used in the calculation to remove the change in fair value of the warrants from the numerator for the period. Likewise, an adjustment to the denominator is required to reflect the related dilutive shares, if any, under the treasury stock method. |
New Accounting Requirements and Disclosures | New Accounting Requirements and Disclosures Fair Value Measurement In August 2018, the FASB issued ASU No. 2018-13, Fair Value Measurement (Topic 820): Disclosure Framework—Changes to the Disclosure Requirements for Fair Value Measurement, which modifies fair value disclosures and removes some disclosure requirements for both public and private companies. In addition, public companies are subject to some new disclosure requirements which requires to disclose the changes in unrealized gains and losses for the period included in other comprehensive income for recurring Level 3 fair value measurements held at the end of the reporting period and the range and weighted average of significant unobservable inputs used to develop Level 3 fair value measurements. ASU No. 2018-13 is effective for all entities for fiscal years, and interim periods within those fiscal years, beginning after December 15, 2019. Early adoption is permitted. The Company adopted the standard effective January 1, 2020 with no impact on its financial statements. Financial Instruments – Credit Losses In June 2016, the FASB issued ASU No. 2016-13, Financial Instruments — Credit Losses (Topic 326): Measurement of Credit Losses on Financial Instruments , which requires the measurement of all expected credit losses for financial assets including trade receivables held at the reporting date based on historical experience, current conditions, and reasonable and supportable forecasts. ASU No. 2016-13 is effective for fiscal years, and interim periods within those fiscal years, beginning after December 15, 2019. The Company adopted the standard effective January 1, 2020 with no material effect on its financial statements. Subsequent to the issuance of ASU 2016-13, the FASB issued ASU 2018-19, Codification Improvements to Topic 326, Financial Instruments - Credit Losses . This ASU does not change the core principle of the guidance in ASU 2016-13, instead these amendments are intended to clarify and improve operability of certain topics included within the credit losses guidance. The FASB also subsequently issued ASU No. 2019-04, Codification Improvements to Topic 326, Financial Instruments—Credit Losses, Derivatives and Hedging (Topic 815), and Financial Instruments (Topic 842) , which did not change the core principle of the guidance in ASU 2016-13 but clarified that expected recoveries of amounts previously written off and expected to be written off should be included in the valuation account and should not exceed amounts previously written off and expected to be written off. The guidance is effective for fiscal years, and interim periods within those years, beginning after December 15, 2019 for public business entities, excluding smaller reporting companies. Early adoption is permitted. As a smaller reporting company, the guidance will be effective for the Company during the first quarter of 2023. The Company is in the process of assessing the impact adoption will have on its consolidated financial statements. Income Taxes In December 2019, the FASB issued ASU No. 2019-12, Simplifying the Accounting for Income Taxes (Topic 740) . The guidance eliminates certain exceptions for recognizing deferred taxes for investments, performing intraperiod allocation and calculating income taxes in interim periods. This guidance also includes guidance to reduce complexity in certain areas, including recognizing deferred taxes for tax goodwill and allocating taxes to members of a consolidated group. ASU 2019-12 is effective for annual and interim periods in fiscal years beginning after December 15, 2019. The Company adopted the standard effective January 1, 2020 with no impact on its financial statements. Investments In January 2020, the FASB issued Accounting Standards Update No. 2020-01, Investments—Equity Securities (Topic 321), Investments—Equity Method and Joint Ventures (Topic 323), and Derivatives and Hedging (Topic 815)—Clarifying the Interactions between Topic 321, Topic 323, and Topic 815 (a consensus of the Emerging Issues Task Force) , which clarifies the interaction of the accounting for equity securities, investments accounted for under the equity method, and certain forward contracts and purchased options. This update is effective for fiscal years beginning after December 15, 2020, and interim periods within those fiscal years, and early adoption is permitted. The Company adopted the standard effective January 1, 2021 with no impact on its consolidated financial statements. |
ORGANIZATION, BASIS OF PRESEN_3
ORGANIZATION, BASIS OF PRESENTATION AND SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES (Tables) | 9 Months Ended |
Sep. 30, 2021 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
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) September 30, 2021 December 31, 2020 Cash and cash equivalents $ 19,266 $ 35,495 Restricted cash 1,501 1,501 Total cash, cash equivalents and restricted cash shown in the statements of cash flows $ 20,767 $ 36,996 |
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) September 30, 2021 December 31, 2020 Cash and cash equivalents $ 19,266 $ 35,495 Restricted cash 1,501 1,501 Total cash, cash equivalents and restricted cash shown in the statements of cash flows $ 20,767 $ 36,996 |
Accrued Expenses and Other Liabilities | Accrued expenses and other liabilities consist of the following: (in thousands) September 30, 2021 December 31, 2020 Accrued payroll $ 278 $ 1,071 Accrued patient treatment costs 2,507 899 Accrued clinical research costs 1,658 1,562 Accrued manufacturing costs 252 41 Accrued professional services 289 279 Accrued other 355 313 Total accrued expenses and other current liabilities $ 5,339 $ 4,165 |
Earnings Per Share, Potentially Dilutive Securities | The following table sets forth the computation of basic and diluted earnings per share: Three Months Ended Nine Months Ended (in thousands, except share and per share amounts) September 30, 2021 September 30, 2020 September 30, 2021 September 30, 2020 Net income (loss) per share - basic: Net income (loss) $ 1,233 $ (887) $ (12,236) $ (26,505) Less: undistributed earnings to participating securities (469) — — — Net income (loss) attributable to common shareholders $ 764 $ (887) $ (12,236) $ (26,505) Weighted-average shares outstanding, basic 10,108,388 5,059,779 10,086,246 5,050,603 Basic net income (loss) per share $ 0.08 $ (0.18) $ (1.21) $ (5.25) Net income (loss) per share - diluted: Net income (loss) attributable to common shareholders, basic $ 764 $ (887) $ (12,236) $ (26,505) Weighted-average shares outstanding, basic 10,108,388 5,059,779 10,086,246 5,050,603 Effect of dilutive securities: Stock options and restricted stock units 86,280 — — — Weighted-average shares outstanding, diluted 10,194,668 5,059,779 10,086,246 5,050,603 Diluted net income (loss) per share $ 0.07 $ (0.18) $ (1.21) $ (5.25) The following outstanding shares of common stock equivalents were excluded from the computations of diluted net income (loss) per share of common stock attributable to common stockholders for the periods presented as the effect of including such securities would be anti-dilutive. September 30, 2021 September 30, 2020 Common Stock Equivalents: Number of Shares Redeemable convertible series 1 preferred stock 4,520,000 5,340,000 Warrants to purchase common stock 11,616,080 5,750,000 Private placement option 9,675,000 9,675,000 Options to purchase common stock 1,985,277 1,142,470 Unvested shares of restricted stock units 168,980 182,227 Total common stock equivalents 27,965,337 22,089,697 |
FAIR VALUE MEASUREMENTS AND I_2
FAIR VALUE MEASUREMENTS AND INVESTMENT SECURITIES (Tables) | 9 Months Ended |
Sep. 30, 2021 | |
Fair Value Disclosures [Abstract] | |
Summary of Assets Measured at Fair Value on a Recurring Basis | The following table presents the Company’s investment securities (including, if applicable, those classified on the Company’s balance sheet as cash equivalents) that are measured at fair value on a recurring basis as of September 30, 2021 and December 31, 2020: Fair Value at September 30, 2021 Fair Value at December 31, 2020 (in thousands) Level 1 Level 2 Level 3 Level 1 Level 2 Level 3 Cash equivalents: Money market funds and treasury bills $ 12,481 $ — $ — $ 27,463 $ — $ — Total cash equivalents $ 12,481 $ — $ — $ 27,463 $ — $ — |
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: September 30, 2021 December 31, 2020 Risk-free interest rate 0.95% 0.46% Volatility 95.00% 90.00% Expected term (years) 4.89 5.64 The fair value of the private placement option has been estimated with the following weighted-average assumptions, including the most sensitive input, volatility: September 30, 2021 December 31, 2020 Risk-free interest rate 1.33 % 0.77 % Volatility 95.00 % 90.00 % Expected term (years) 7.00 7.00 The following table provides the warrant derivative and private placement option reported at fair value and measured on a recurring basis: Fair Value at September 30, 2021 Fair Value at December 31, 2020 (in thousands) Level 1 Level 2 Level 3 Level 1 Level 2 Level 3 Warrant derivative liability $ — $ — $ 7,842 $ — $ — $ 10,345 Private placement option liability — — 2,800 — — 7,803 Total fair value $ — $ — $ 10,642 $ — $ — $ 18,148 (in thousands) Warrant Derivative Liability Private Placement Option Liability Total Balance, December 31, 2020 $ 10,345 $ 7,803 $ 18,148 Change in fair value (2,503) (5,003) (7,506) Balance, September 30, 2021 $ 7,842 $ 2,800 $ 10,642 |
LEASES (Tables)
LEASES (Tables) | 9 Months Ended |
Sep. 30, 2021 | |
Leases [Abstract] | |
Components of Lease Cost | Components of lease cost are as follows: Three Months Ended Nine Months Ended (in thousands) September 30, 2021 September 30, 2020 September 30, 2021 September 30, 2020 Finance lease cost: Amortization of leased asset $ — $ 18 $ 16 $ 54 Interest on lease liabilities — 5 5 17 Operating lease cost 1 169 56 668 Short-term lease cost — 235 53 476 Total lease cost $ 1 $ 427 $ 130 $ 1,215 |
PUBLIC OFFERING AND PRIVATE P_2
PUBLIC OFFERING AND PRIVATE PLACEMENT (Tables) | 9 Months Ended |
Sep. 30, 2021 | |
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: September 30, 2021 December 31, 2020 Risk-free interest rate 0.95% 0.46% Volatility 95.00% 90.00% Expected term (years) 4.89 5.64 The fair value of the private placement option has been estimated with the following weighted-average assumptions, including the most sensitive input, volatility: September 30, 2021 December 31, 2020 Risk-free interest rate 1.33 % 0.77 % Volatility 95.00 % 90.00 % Expected term (years) 7.00 7.00 The following table provides the warrant derivative and private placement option reported at fair value and measured on a recurring basis: Fair Value at September 30, 2021 Fair Value at December 31, 2020 (in thousands) Level 1 Level 2 Level 3 Level 1 Level 2 Level 3 Warrant derivative liability $ — $ — $ 7,842 $ — $ — $ 10,345 Private placement option liability — — 2,800 — — 7,803 Total fair value $ — $ — $ 10,642 $ — $ — $ 18,148 (in thousands) Warrant Derivative Liability Private Placement Option Liability Total Balance, December 31, 2020 $ 10,345 $ 7,803 $ 18,148 Change in fair value (2,503) (5,003) (7,506) Balance, September 30, 2021 $ 7,842 $ 2,800 $ 10,642 |
SHARE-BASED COMPENSATION PLANS
SHARE-BASED COMPENSATION PLANS (Tables) | 9 Months Ended |
Sep. 30, 2021 | |
Share-based Payment Arrangement [Abstract] | |
Stock Option Activity | The following table summarizes the stock option activity for all stock plans during the nine months ended September 30, 2021: Options and Inducement Awards Outstanding at December 31, 2020 1,510,968 Granted 823,000 Exercised — Forfeited (348,691) Outstanding at September 30, 2021 1,985,277 Exercisable at September 30, 2021 466,587 |
Stock Award Activity for All Stock Plans | The following table summarizes the stock award activity for all stock plans during the nine months ended September 30, 2021: Restricted Stock Awards and Units Outstanding at December 31, 2020 129,861 Granted 136,626 Vested (95,001) Forfeited (2,506) Outstanding at September 30, 2021 168,980 |
ESPP Activity | A summary of activity within the ESPP follows: Nine Months Ended (in thousands) September 30, 2021 September 30, 2020 Deductions from employees $ — $ 116 Share-based compensation expense recognized — 70 Remaining share-based compensation expense — 113 |
Valuation Assumptions | The fair value of option grants is determined using the Black-Scholes option-pricing model and has been estimated with the following weighted-average assumptions: Nine Months Ended September 30, 2021 September 30, 2020 Risk-free interest rate 0.84 % 1.18 % Volatility 90.35 % 81.78 % Expected life (years) 5.63 6.03 Expected dividend yield — — |
Share-Based Compensation Expense by Classification | Share-based compensation expense by classification for the three and nine months ended September 30, 2021 and 2020 are as follows: Three Months Ended Nine Months Ended (in thousands) September 30, 2021 September 30, 2020 September 30, 2021 September 30, 2020 Research and development $ 296 $ 668 $ 829 $ 1,877 General and administrative 557 938 1,748 2,616 Total $ 853 $ 1,606 $ 2,577 $ 4,493 |
ORGANIZATION, BASIS OF PRESEN_4
ORGANIZATION, BASIS OF PRESENTATION AND SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES - Narrative (Details) $ in Thousands | Mar. 15, 2021USD ($) | Apr. 14, 2020USD ($) | Feb. 05, 2020shares | Jun. 30, 2021USD ($) | Mar. 31, 2021USD ($) | Dec. 31, 2020USD ($)shares | Sep. 30, 2021USD ($)segmentsubsidiaryshares | Sep. 30, 2021USD ($)shares | Mar. 26, 2021USD ($) | Feb. 26, 2021USD ($) | Sep. 30, 2020USD ($) | Jun. 15, 2020shares | Jun. 14, 2020shares | Feb. 04, 2020shares | Dec. 31, 2019USD ($) |
Class of Stock [Line Items] | |||||||||||||||
Number of wholly-owned subsidiaries formed | subsidiary | 2 | ||||||||||||||
Number of operating segments | segment | 1 | ||||||||||||||
Number of reportable segments | segment | 1 | ||||||||||||||
Reverse stock split ratio | 0.1 | ||||||||||||||
Common stock, authorized (in shares) | shares | 40,000,000 | 80,000,000 | 80,000,000 | 80,000,000 | 80,000,000 | 40,000,000 | 200,000,000 | ||||||||
Accumulated deficit | $ (540,747) | $ (552,983) | $ (552,983) | ||||||||||||
Cash equivalents, restricted cash | 36,996 | 20,767 | 20,767 | $ 54,626 | $ 93,816 | ||||||||||
Operating lease right-of-use assets | 645 | 0 | 0 | ||||||||||||
Property and equipment, net | 189 | 27 | 27 | ||||||||||||
Accrued clinical research costs | 1,562 | $ 1,658 | $ 1,658 | ||||||||||||
Scenario, Adjustment | |||||||||||||||
Class of Stock [Line Items] | |||||||||||||||
Accrued clinical research costs | 1,200 | ||||||||||||||
Accrued manufacturing costs and accrued professional fees, current | $ 100 | ||||||||||||||
Maximum | |||||||||||||||
Class of Stock [Line Items] | |||||||||||||||
Escrow deposits related to property sales, period up to | 18 months | ||||||||||||||
2130 W. Holcombe Blvd. | |||||||||||||||
Class of Stock [Line Items] | |||||||||||||||
Escrow deposits cash proceeds received | $ 1,500 | ||||||||||||||
Research And Development Facility | Disposal Group, Held-for-sale, Not Discontinued Operations | |||||||||||||||
Class of Stock [Line Items] | |||||||||||||||
Operating lease right-of-use assets | 500 | ||||||||||||||
Property and equipment, net | 2,300 | ||||||||||||||
Operating lease, liability | 700 | ||||||||||||||
Impairment charges | $ 1,300 | ||||||||||||||
Reed Road, Houston, TX | |||||||||||||||
Class of Stock [Line Items] | |||||||||||||||
Amount paid upon closing of asset sale | $ 1,100 | ||||||||||||||
Discontinued operation, consideration, cash | 900 | ||||||||||||||
Discontinued operation, consideration, note receivable | $ 200 | ||||||||||||||
San Francisco Office Space | |||||||||||||||
Class of Stock [Line Items] | |||||||||||||||
Operating lease right-of-use assets | $ 600 | ||||||||||||||
Operating lease, liability | 1,000 | ||||||||||||||
Lease termination fee | $ 900 | ||||||||||||||
Security deposit returned | $ 200 | ||||||||||||||
Loss on termination of lease | $ 500 | ||||||||||||||
San Francisco Office Space | Equipment | |||||||||||||||
Class of Stock [Line Items] | |||||||||||||||
Operating lease right-of-use assets | $ 100 |
ORGANIZATION, BASIS OF PRESEN_5
ORGANIZATION, BASIS OF PRESENTATION, AND SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES - Reconciliation of Cash, Cash Equivalents and Restricted Cash (Details) - USD ($) $ in Thousands | Sep. 30, 2021 | Dec. 31, 2020 | Sep. 30, 2020 | Dec. 31, 2019 |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | ||||
Cash and cash equivalents | $ 19,266 | $ 35,495 | ||
Restricted cash | 1,501 | 1,501 | ||
Total cash, cash equivalents and restricted cash shown in the statements of cash flows | $ 20,767 | $ 36,996 | $ 54,626 | $ 93,816 |
ORGANIZATION, BASIS OF PRESEN_6
ORGANIZATION, BASIS OF PRESENTATION, AND SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES - Accrued Expenses and Other Liabilities (Details) - USD ($) $ in Thousands | Sep. 30, 2021 | Dec. 31, 2020 |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | ||
Accrued payroll | $ 278 | $ 1,071 |
Accrued patient treatment costs | 2,507 | 899 |
Accrued clinical research costs | 1,658 | 1,562 |
Accrued manufacturing costs | 252 | 41 |
Accrued professional services | 289 | 279 |
Accrued other | 355 | 313 |
Total accrued expenses and other current liabilities | $ 5,339 | $ 4,165 |
ORGANIZATION, BASIS OF PRESEN_7
ORGANIZATION, BASIS OF PRESENTATION AND SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES - Computation of Basic and Diluted Earnings Per Share (Details) - USD ($) $ / shares in Units, $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2021 | Sep. 30, 2020 | Sep. 30, 2021 | Sep. 30, 2020 | |
Net income (loss) per share - basic: | ||||
Net income (loss) | $ 1,233 | $ (887) | $ (12,236) | $ (26,505) |
Less: undistributed earnings to participating securities | (469) | 0 | 0 | 0 |
Net income (loss) attributable to common shareholders | $ 764 | $ (887) | $ (12,236) | $ (26,505) |
Weighted-average shares outstanding, basic (in shares) | 10,108,388 | 5,059,779 | 10,086,246 | 5,050,603 |
Basic net income (loss) per share (in dollars per share) | $ 0.08 | $ (0.18) | $ (1.21) | $ (5.25) |
Net income (loss) per share - diluted: | ||||
Net income (loss) attributable to common shareholders, basic | $ 764 | $ (887) | $ (12,236) | $ (26,505) |
Weighted-average shares outstanding, basic (in shares) | 10,108,388 | 5,059,779 | 10,086,246 | 5,050,603 |
Effect of dilutive securities: | ||||
Stock options and restricted stock units (in shares) | 86,280 | 0 | 0 | 0 |
Weighted-average shares outstanding, diluted (in shares) | 10,194,668 | 5,059,779 | 10,086,246 | 5,050,603 |
Diluted net income (loss) per share (in dollars per shares) | $ 0.07 | $ (0.18) | $ (1.21) | $ (5.25) |
ORGANIZATION, BASIS OF PRESEN_8
ORGANIZATION, BASIS OF PRESENTATION, AND SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES - Earnings (Loss) Per Share, Potentially Dilutive Securities (Details) - shares | 9 Months Ended | |
Sep. 30, 2021 | Sep. 30, 2020 | |
Earnings Per Share, Basic, by Common Class, Including Two Class Method [Line Items] | ||
Total common stock equivalents (in shares) | 27,965,337 | 22,089,697 |
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 | 5,340,000 |
Warrants to purchase common stock | ||
Earnings Per Share, Basic, by Common Class, Including Two Class Method [Line Items] | ||
Total common stock equivalents (in shares) | 11,616,080 | 5,750,000 |
Private placement option | ||
Earnings Per Share, Basic, by Common Class, Including Two Class Method [Line Items] | ||
Total common stock equivalents (in shares) | 9,675,000 | 9,675,000 |
Options to purchase common stock | ||
Earnings Per Share, Basic, by Common Class, Including Two Class Method [Line Items] | ||
Total common stock equivalents (in shares) | 1,985,277 | 1,142,470 |
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) | 168,980 | 182,227 |
FAIR VALUE OF MEASUREMENTS AND
FAIR VALUE OF MEASUREMENTS AND INVESTMENT SECURITIES - Investment Securities (Details) - USD ($) $ in Thousands | Sep. 30, 2021 | Dec. 31, 2020 |
Fair Value Inputs, Assets, Quantitative Information [Line Items] | ||
Restricted cash | $ 1,501 | $ 1,501 |
Level 1 | ||
Fair Value Inputs, Assets, Quantitative Information [Line Items] | ||
Total cash equivalents | 12,481 | 27,463 |
Level 1 | Money market funds and treasury bills | ||
Fair Value Inputs, Assets, Quantitative Information [Line Items] | ||
Total cash equivalents | 12,481 | 27,463 |
Level 2 | ||
Fair Value Inputs, Assets, Quantitative Information [Line Items] | ||
Total cash equivalents | 0 | 0 |
Level 2 | Money market funds and treasury bills | ||
Fair Value Inputs, Assets, Quantitative Information [Line Items] | ||
Total cash equivalents | 0 | 0 |
Level 3 | ||
Fair Value Inputs, Assets, Quantitative Information [Line Items] | ||
Total cash equivalents | 0 | 0 |
Level 3 | Money market funds and treasury bills | ||
Fair Value Inputs, Assets, Quantitative Information [Line Items] | ||
Total cash equivalents | $ 0 | $ 0 |
FAIR VALUE OF MEASUREMENTS AN_2
FAIR VALUE OF MEASUREMENTS AND INVESTMENT SECURITIES - Fair Value of Warrants (Details) | 9 Months Ended | 12 Months Ended | |
Sep. 30, 2021 | Sep. 30, 2020 | Dec. 31, 2020 | |
Derivative [Line Items] | |||
Risk-free interest rate | 0.84% | 1.18% | |
Volatility | 90.35% | 81.78% | |
Expected life (years) | 5 years 7 months 17 days | 6 years 10 days | |
Warrant Derivative Liability | |||
Derivative [Line Items] | |||
Risk-free interest rate | 0.95% | 0.46% | |
Volatility | 95.00% | 90.00% | |
Expected life (years) | 4 years 10 months 20 days | 5 years 7 months 20 days | |
Private Placement Option Liability | |||
Derivative [Line Items] | |||
Risk-free interest rate | 1.33% | 0.77% | |
Volatility | 95.00% | 90.00% | |
Expected life (years) | 7 years | 7 years |
FAIR VALUE OF MEASUREMENTS AN_3
FAIR VALUE OF MEASUREMENTS AND INVESTMENT SECURITIES - Derivative Liabilities Reported at Fair Value (Details) - USD ($) $ in Thousands | Sep. 30, 2021 | Dec. 31, 2020 |
Fair Value Measurement Inputs and Valuation Techniques [Line Items] | ||
Warrant derivative liability | $ 7,842 | $ 10,345 |
Private placement option liability | 2,800 | 7,803 |
Level 1 | ||
Fair Value Measurement Inputs and Valuation Techniques [Line Items] | ||
Warrant derivative liability | 0 | 0 |
Private placement option liability | 0 | 0 |
Total fair value | 0 | 0 |
Level 2 | ||
Fair Value Measurement Inputs and Valuation Techniques [Line Items] | ||
Warrant derivative liability | 0 | 0 |
Private placement option liability | 0 | 0 |
Total fair value | 0 | 0 |
Level 3 | ||
Fair Value Measurement Inputs and Valuation Techniques [Line Items] | ||
Warrant derivative liability | 7,842 | 10,345 |
Private placement option liability | 2,800 | 7,803 |
Total fair value | $ 10,642 | $ 18,148 |
LEASES - Narrative (Details)
LEASES - Narrative (Details) | Sep. 30, 2021 |
Lessee, Lease, Description [Line Items] | |
Leas term option to extend | 5 years |
Minimum | |
Lessee, Lease, Description [Line Items] | |
Remaining lease term | 1 year |
Maximum | |
Lessee, Lease, Description [Line Items] | |
Remaining lease term | 7 years |
LEASES - Components of Lease Co
LEASES - Components of Lease Cost (Details) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2021 | Sep. 30, 2020 | Sep. 30, 2021 | Sep. 30, 2020 | |
Finance lease cost: | ||||
Amortization of leased asset | $ 0 | $ 18 | $ 16 | $ 54 |
Interest on lease liabilities | 0 | 5 | 5 | 17 |
Operating lease cost | 1 | 169 | 56 | 668 |
Short-term lease cost | 0 | 235 | 53 | 476 |
Total lease cost | $ 1 | $ 427 | $ 130 | $ 1,215 |
PUBLIC OFFERING AND PRIVATE P_3
PUBLIC OFFERING AND PRIVATE PLACEMENT - Narrative (Details) - USD ($) $ / shares in Units, $ in Millions | Aug. 21, 2019 | Aug. 16, 2019 | Nov. 30, 2020 | Sep. 30, 2021 | Dec. 31, 2020 |
Class of Stock [Line Items] | |||||
Common stock, issued (in shares) | 1,040,000 | 8,465,549 | 8,385,650 | ||
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 common stock and pre-funded warrant (in shares) | 1 | ||||
Common stock, par value (in dollars per share) | $ 0.001 | $ 0.01 | $ 0.01 | ||
Warrant exercise price (in dollars per share) | $ 6.50 | ||||
Expiration period | 5 years | ||||
Proceeds from issuance of stock | $ 25 | ||||
Proceeds from issuance of redeemable convertible preferred stock in a public offering, net | $ 53.8 | ||||
Proceeds upon entering into private placement agreement | $ 11.2 | ||||
Maximum | |||||
Class of Stock [Line Items] | |||||
Price of each share of common stock and accompanying common warrant (in dollars per share) | $ 6.025 | ||||
Minimum | |||||
Class of Stock [Line Items] | |||||
Price of each share of common stock and accompanying common warrant (in dollars per share) | $ 6.024 | ||||
Series 1 redeemable convertible non-voting preferred stock | |||||
Class of Stock [Line Items] | |||||
Shares issuable per warrants (in shares) | 10 | ||||
Series 2 Preferred Stock | |||||
Class of Stock [Line Items] | |||||
Expiration period | 2 years 6 months | ||||
Public Warrants, Private Warrants And Stock Options | |||||
Class of Stock [Line Items] | |||||
Total offering costs related to warrants and options | $ 3 | ||||
Public Offering | |||||
Class of Stock [Line Items] | |||||
Shares issuable under warrants (in shares) | 5,750,000 | ||||
Price per share (in dollars per share) | $ 100 | ||||
Public Offering | Series 1 redeemable convertible non-voting preferred stock | |||||
Class of Stock [Line Items] | |||||
Number of shares of common stock sold in offering (in shares) | 575,000 | ||||
Warrants exercise price (in dollars per share) | $ 130 | ||||
Public Offering | Common Stock | |||||
Class of Stock [Line Items] | |||||
Shares issuable per warrants (in shares) | 10 | ||||
Shares issuable under warrants (in shares) | 0 | ||||
Warrants exercise price (in dollars per share) | $ 13 | ||||
Notice period for percentage change | 61 days | ||||
Public Offering | Common Stock | Maximum | |||||
Class of Stock [Line Items] | |||||
Warrants, limitations on ownership after exercise | 19.99% | ||||
Public Offering | Common Stock | Minimum | |||||
Class of Stock [Line Items] | |||||
Warrants, limitations on ownership after exercise | 9.99% | ||||
Private Placement | Series 2 Preferred Stock | |||||
Class of Stock [Line Items] | |||||
Number of shares of common stock sold in offering (in shares) | 350,000 | 350,000 | |||
Shares issuable under warrants (in shares) | 2,800,000 | ||||
Price per share (in dollars per share) | $ 100 | ||||
Warrants exercise price (in dollars per share) | $ 10 | ||||
Private Placement | Series 3 Preferred Stock | |||||
Class of Stock [Line Items] | |||||
Number of shares of common stock sold in offering (in shares) | 250,000 | 250,000 | |||
Private Placement | Preferred Stock | |||||
Class of Stock [Line Items] | |||||
Shares issuable under warrants (in shares) | 875,000 | ||||
Price per share (in dollars per share) | $ 140 | ||||
Warrants 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 | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2021 | Sep. 30, 2020 | Sep. 30, 2021 | Sep. 30, 2020 | |
Derivative Liability Rollforward [Roll Forward] | ||||
Change in fair value | $ (4,264) | $ (12,131) | $ (7,506) | $ (14,256) |
Level 3 | ||||
Derivative Liability Rollforward [Roll Forward] | ||||
Balance, December 31, 2020 | 18,148 | |||
Change in fair value | (7,506) | |||
Balance, September 30, 2021 | 10,642 | 10,642 | ||
Warrant Derivative Liability | Level 3 | ||||
Derivative Liability Rollforward [Roll Forward] | ||||
Balance, December 31, 2020 | 10,345 | |||
Change in fair value | (2,503) | |||
Balance, September 30, 2021 | 7,842 | 7,842 | ||
Private Placement Option Liability | Level 3 | ||||
Derivative Liability Rollforward [Roll Forward] | ||||
Balance, December 31, 2020 | 7,803 | |||
Change in fair value | (5,003) | |||
Balance, September 30, 2021 | $ 2,800 | $ 2,800 |
REDEEMABLE CONVERTIBLE PREFER_2
REDEEMABLE CONVERTIBLE PREFERRED STOCK (Details) - $ / shares | Aug. 16, 2019 | Sep. 30, 2021 | Nov. 30, 2020 |
Class of Stock [Line Items] | |||
Preferred stock, authorized (in shares) | 10,000,000 | ||
Preferred stock, par value (in dollars per share) | $ 0.01 | ||
Shares issuable per warrants (in shares) | 3,109,378 | ||
50-day trading volume on Nasdaq stock market (in shares) | 50,000 | ||
Average trading volume period | 50 days | ||
Series 1 redeemable convertible non-voting preferred stock | |||
Class of Stock [Line Items] | |||
Preferred stock, authorized (in shares) | 1,517,500 | ||
Preferred stock, outstanding (in shares) | 452,000 | ||
Preferred stock, issued (in shares) | 452,000 | ||
Shares issuable per warrants (in shares) | 10 | ||
Series 2 Preferred Stock | |||
Class of Stock [Line Items] | |||
Preferred stock, outstanding (in shares) | 0 | ||
Preferred stock, issued (in shares) | 0 | ||
Series 2 Preferred Stock | Private Placement | |||
Class of Stock [Line Items] | |||
Number of shares of common stock sold in offering (in shares) | 350,000 | 350,000 | |
Price per share (in dollars per share) | $ 100 | ||
Series 3 Preferred Stock | |||
Class of Stock [Line Items] | |||
Preferred stock, outstanding (in shares) | 0 | ||
Preferred stock, issued (in shares) | 0 | ||
Closing price of common stock (in dollars per share) | $ 35 | ||
Closing price of common stock threshold period | 180 days | ||
Series 3 Preferred Stock | Private Placement | |||
Class of Stock [Line Items] | |||
Number of shares of common stock sold in offering (in shares) | 250,000 | 250,000 | |
Series 1 and 2 Preferred Stock | |||
Class of Stock [Line Items] | |||
Price per share (in dollars per share) | $ 100 | ||
Closing price of common stock (in dollars per share) | $ 25 | ||
Closing price of common stock threshold period | 180 days | ||
Preferred Stock | Private Placement | |||
Class of Stock [Line Items] | |||
Price per share (in dollars per share) | $ 140 |
SHARE-BASED COMPENSATION PLAN_2
SHARE-BASED COMPENSATION PLANS - Narrative (Details) $ in Millions | 1 Months Ended | 9 Months Ended | ||||
Jun. 30, 2021shares | Nov. 30, 2020 | Jun. 30, 2020shares | Jan. 31, 2020shares | Sep. 30, 2021USD ($)planshares | Sep. 30, 2020shares | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||
Number of share-based compensation plans | plan | 5 | |||||
Expiration period | 5 years | |||||
Compensation cost not yet recognized | $ | $ 4 | |||||
Period for recognition | 1 year 7 months 6 days | |||||
2019 Equity Incentive Plan | ||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||
Number of shares authorized (in shares) | 250,000 | |||||
Additional authorized shares approved (in shares) | 500,000 | 500,000 | 600,000 | |||
2019 Equity Incentive Plan | Maximum | ||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||
Number of shares authorized (in shares) | 600,540 | |||||
Options | ||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||
Expiration period | 10 years | |||||
Options | Minimum | ||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||
Vesting period | 2 years | |||||
Options | Maximum | ||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||
Vesting period | 4 years | |||||
ESPP | ||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||
Discount rate from grant date fair market value | 15.00% | |||||
Issuance of common stock ESPP (in shares) | 9,526 | |||||
Shares available for issuance under ESPP (in shares) | 18,488 | |||||
ESPP | 2014 Employee Stock Purchase Plan | ||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||
Number of shares authorized (in shares) | 55,000 |
SHARE-BASED COMPENSATION PLAN_3
SHARE-BASED COMPENSATION PLANS - Stock Option Activity (Details) - Employee Stock Options And Inducement Option Awards | 9 Months Ended |
Sep. 30, 2021shares | |
Options and Inducement Awards | |
Outstanding at beginning of period (in shares) | 1,510,968 |
Granted (in shares) | 823,000 |
Exercised (in shares) | 0 |
Forfeited (in shares) | (348,691) |
Outstanding at end of period (in shares) | 1,985,277 |
Options and inducement awards, exercisable (in shares) | 466,587 |
SHARE-BASED COMPENSATION PLANS-
SHARE-BASED COMPENSATION PLANS- Stock Award Activity For All Stock Plans (Details) - Restricted Stock Awards and Units | 9 Months Ended |
Sep. 30, 2021shares | |
Restricted Stock Awards and Units | |
Beginning balance (in shares) | 129,861 |
Granted (in shares) | 136,626 |
Vested (in shares) | (95,001) |
Forfeited (in shares) | (2,506) |
Ending balance (in shares) | 168,980 |
SHARE-BASED COMPENSATION PLAN_4
SHARE-BASED COMPENSATION PLANS - ESPP Activity (Details) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2021 | Sep. 30, 2020 | Sep. 30, 2021 | Sep. 30, 2020 | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Share-based compensation expense recognized | $ 853 | $ 1,606 | $ 2,577 | $ 4,493 |
Remaining share-based compensation expense | 2,577 | 4,493 | ||
ESPP | ||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Deductions from employees | 0 | 116 | ||
Share-based compensation expense recognized | 0 | 70 | ||
Remaining share-based compensation expense | $ 0 | $ 113 |
SHARE-BASED COMPENSATION PLAN_5
SHARE-BASED COMPENSATION PLANS - Valuation Assumptions (Details) | 9 Months Ended | |
Sep. 30, 2021 | Sep. 30, 2020 | |
Share-based Payment Arrangement [Abstract] | ||
Risk-free interest rate | 0.84% | 1.18% |
Volatility | 90.35% | 81.78% |
Expected life (years) | 5 years 7 months 17 days | 6 years 10 days |
Expected dividend yield | 0.00% | 0.00% |
SHARE-BASED COMPENSATION PLAN_6
SHARE-BASED COMPENSATION PLANS - Expense by Classification (Details) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2021 | Sep. 30, 2020 | Sep. 30, 2021 | Sep. 30, 2020 | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Share-based compensation expense recognized | $ 853 | $ 1,606 | $ 2,577 | $ 4,493 |
Research and development | ||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Share-based compensation expense recognized | 296 | 668 | 829 | 1,877 |
General and administrative | ||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Share-based compensation expense recognized | $ 557 | $ 938 | $ 1,748 | $ 2,616 |
COMMITMENTS AND CONTINGENCIES (
COMMITMENTS AND CONTINGENCIES (Details) | Dec. 10, 2015USD ($) | Jun. 10, 2015USD ($)product | Sep. 30, 2021USD ($) | Jun. 30, 2021USD ($) | Sep. 30, 2021USD ($) | Dec. 31, 2019USD ($) |
Takeda | ||||||
Loss Contingencies [Line Items] | ||||||
Additional revenue from sales | $ 700,000 | |||||
Baylor | Licensing Agreements | ||||||
Loss Contingencies [Line Items] | ||||||
Sublicense expense | $ 500,000 | $ 600,000 | $ 600,000 | |||
Agensys, Inc. | Licensing Agreements | ||||||
Loss Contingencies [Line Items] | ||||||
Nonrefundable upfront fee | $ 3,000,000 | |||||
Milestone payments upon first achievement of specified clinical milestones | 5,000,000 | |||||
Milestone payments upon achievement of specified clinical milestones for each licensed product | 50,000,000 | |||||
Milestone payments upon achievement of sales milestones | 75,000,000 | |||||
Option exercise fee | 5,000,000 | |||||
Milestone payments reduced upon exercise of option | $ 65,000,000 | |||||
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 Pharma Inc | Licensing Agreements | ||||||
Loss Contingencies [Line Items] | ||||||
Nonrefundable upfront fee | $ 100,000 | |||||
Milestone payments upon first achievement of specified clinical milestones | $ 250,000 | |||||
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 | $ 300,000 | |||||
License costs due upon first release of product, period of payment | 10 days | |||||
License agreement, annual fee | $ 150,000 | |||||
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 | $ 2,000,000 | |||||
Termination notice period for any other breach | 90 days | |||||
Termination period, after insolvency event | 30 days | |||||
MD Anderson | ||||||
Loss Contingencies [Line Items] | ||||||
Upfront payment received | $ 5,000,000 |