Cover
Cover - shares | 9 Months Ended | |
Sep. 30, 2022 | Nov. 10, 2022 | |
Cover [Abstract] | ||
Document Type | 10-Q | |
Document Quarterly Report | true | |
Document Period End Date | Sep. 30, 2022 | |
Document Transition Report | false | |
Entity File Number | 001-33650 | |
Entity Registrant Name | LISATA THERAPEUTICS, INC. | |
Entity Incorporation, State or Country Code | DE | |
Entity Tax Identification Number | 22-2343568 | |
Entity Address, Address Line One | 110 Allen Road, 2nd Floor | |
Entity Address, City or Town | Basking Ridge | |
Entity Address, State or Province | NJ | |
Entity Address, Postal Zip Code | 07920 | |
City Area Code | 908 | |
Local Phone Number | 842-0100 | |
Entity Information, Former Legal or Registered Name | Caladrius Biosciences, Inc. | |
Title of 12(b) Security | Common Stock, par value $0.001 per share | |
Trading Symbol | LSTA | |
Security Exchange Name | NASDAQ | |
Entity Current Reporting Status | Yes | |
Entity Interactive Data Current | Yes | |
Entity Filer Category | Non-accelerated Filer | |
Entity Small Business | true | |
Entity Emerging Growth Company | false | |
Entity Shell Company | false | |
Entity Central Index Key | 0000320017 | |
Current Fiscal Year End Date | --12-31 | |
Document Fiscal Year Focus | 2022 | |
Document Fiscal Period Focus | Q3 | |
Amendment Flag | false | |
Entity Common Stock, Shares Outstanding | 7,859,684 |
Consolidated Balance Sheets
Consolidated Balance Sheets - USD ($) $ in Thousands | Sep. 30, 2022 | Dec. 31, 2021 |
ASSETS | ||
Cash and cash equivalents | $ 31,478 | $ 24,647 |
Marketable securities | 44,052 | 70,323 |
Prepaid and other current assets | 1,760 | 1,212 |
Total current assets | 77,290 | 96,182 |
Property and equipment, net | 299 | 62 |
Finite-Lived Intangible Assets, Net | 352 | 0 |
Other assets | 588 | 764 |
Total assets | 78,529 | 97,008 |
Liabilities | ||
Accounts payable | 974 | 1,934 |
Accrued liabilities | 5,417 | 2,589 |
Total current liabilities | 6,391 | 4,523 |
Other long-term liabilities | 367 | 485 |
Total liabilities | 6,758 | 5,008 |
Commitments and Contingencies (Note 13) | ||
Stockholders' Equity | ||
Preferred stock, authorized, 20,000,000 shares Series B convertible redeemable preferred stock liquidation value, 0.000067 share of common stock, $0.01 par value; 825,000 shares designated; issued and outstanding, 10,000 shares at September 30, 2022 and December 31, 2021, respectively | 0 | 0 |
Common stock, $0.001 par value, authorized 33,333,333 shares; issued 7,863,340 and 3,986,719 shares at September 30, 2022 and December 31, 2021, respectively; and outstanding, 7,862,602 and 3,985,981 shares at September 30, 2022 and December 31, 2021, respectively | 8 | 4 |
Additional paid-in capital | 574,066 | 546,044 |
Treasury stock, at cost; 738 shares at September 30, 2022 and December 31, 2021 | (708) | (708) |
Accumulated deficit | (501,251) | (453,016) |
Accumulated other comprehensive loss | (90) | (70) |
Total Lisata Therapeutics, Inc. stockholders' equity | 72,025 | 92,254 |
Non-controlling interests | (254) | (254) |
Total stockholders' equity | 71,771 | 92,000 |
Total liabilities, non-controlling interests and stockholders' equity | $ 78,529 | $ 97,008 |
Consolidated Balance Sheets (Pa
Consolidated Balance Sheets (Parentheticals) - $ / shares | Sep. 30, 2022 | Dec. 31, 2021 |
Statement of Financial Position [Abstract] | ||
Preferred stock, shares authorized | 20,000,000 | 20,000,000 |
Preferred stock, liquidation value | 0.000067 | 0.000067 |
Preferred stock, par value (in usd per share) | $ 0.01 | $ 0.01 |
Preferred stock, shares designated | 825,000 | 825,000 |
Preferred stock, shares issued | 10,000 | 10,000 |
Common stock, par value (in usd per share) | $ 0.001 | $ 0.001 |
Common stock, shares authorized | 33,333,333 | 33,333,333 |
Common stock, shares issued | 7,863,340 | 3,986,719 |
Common stock, shares, outstanding | 7,862,602 | 3,985,981 |
Treasury stock (shares) | 738 | 738 |
Consolidated Statements of Oper
Consolidated Statements of Operations - USD ($) shares in Thousands, $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2022 | Sep. 30, 2021 | Sep. 30, 2022 | Sep. 30, 2021 | |
Operating Expenses: | ||||
Research and development | $ 3,380 | $ 4,125 | $ 9,898 | $ 13,530 |
In-process research and development | 30,393 | 0 | 30,393 | 0 |
General and administrative | 3,947 | 2,843 | 10,770 | 8,671 |
Total operating expenses | 37,720 | 6,968 | 51,061 | 22,201 |
Operating loss | (37,720) | (6,968) | (51,061) | (22,201) |
Other income (expense): | ||||
Investment income, net | 337 | 41 | 496 | 111 |
Other expense, net | 0 | 0 | (149) | (90) |
Total other income (expense) | 337 | 41 | 347 | 21 |
Net loss before benefit from income taxes and noncontrolling interests | (37,383) | (6,927) | (50,714) | (22,180) |
Benefit from income taxes | 0 | 0 | (2,479) | (1,508) |
Net loss attributable to Lisata Therapeutics, Inc. common stockholders | $ (37,383) | $ (6,927) | $ (48,235) | $ (20,672) |
Basic and diluted loss per share | ||||
Caladrius Biosciences, Inc. common stockholders - basic (in usd per share) | $ (7.88) | $ (1.74) | $ (11.28) | $ (5.76) |
Caladrius Biosciences, Inc. common stockholders - diluted (in usd per share) | $ (7.88) | $ (1.74) | $ (11.28) | $ (5.76) |
Weighted average common shares outstanding | ||||
Basic shares | 4,747 | 3,974 | 4,276 | 3,587 |
Diluted shares | 4,747 | 3,974 | 4,276 | 3,587 |
Consolidated Statements of Comp
Consolidated Statements of Comprehensive Loss - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2022 | Sep. 30, 2021 | Sep. 30, 2022 | Sep. 30, 2021 | |
Statement of Comprehensive Income [Abstract] | ||||
Net loss | $ (37,383) | $ (6,927) | $ (48,235) | $ (20,672) |
Available for sale securities - net unrealized gain (loss) | 5 | (47) | 5 | (51) |
Other Comprehensive Income (Loss), Foreign Currency Transaction and Translation Adjustment, Net of Tax | (25) | 0 | (25) | 0 |
Total other comprehensive loss | (20) | (47) | (20) | (51) |
Comprehensive loss attributable to Lisata Therapeutics, Inc. common stockholders | $ (37,403) | $ (6,974) | $ (48,255) | $ (20,723) |
Consolidated Statements of Equi
Consolidated Statements of Equity - USD ($) $ in Thousands | Total | Total Lisata Therapeutics, Inc. Stockholders' Equity | Series B Convertible Preferred Stock | Common Stock | Additional Paid-in Capital | Accumulated Other Comprehensive Loss | Accumulated Deficit | Treasury Stock | Non- Controlling Interest in Subsidiary |
Increase (Decrease) in Stockholders' Equity [Roll Forward] | |||||||||
Preferred stock, shares outstanding | 0 | ||||||||
Beginning balance at Dec. 31, 2020 | $ 32,242 | $ 32,496 | $ 0 | $ 1 | $ 458,766 | $ (13) | $ (425,550) | $ (708) | $ (254) |
Common stock, beginning balance (in shares) at Dec. 31, 2020 | 1,292,000 | ||||||||
Increase (Decrease) in Stockholders' Equity [Roll Forward] | |||||||||
Net loss | (20,672) | (20,672) | (20,672) | ||||||
Share-based compensation (in shares) | 36,000 | ||||||||
Share-based compensation | 1,391 | 1,391 | 1,391 | ||||||
Net proceeds from issuances of common stock | 85,479 | 85,479 | $ 3 | 85,476 | |||||
Net proceeds from issuance of common stock and warrants (in shares) | 2,658,000 | ||||||||
Proceeds from option exercises | 24 | 24 | 24 | ||||||
Unrealized loss on marketable securities | (51) | (51) | (51) | ||||||
Preferred stock, ending balance (in shares) at Sep. 30, 2021 | 0 | ||||||||
Common stock, ending balance (in shares) at Sep. 30, 2021 | 3,986,000 | ||||||||
Ending balance at Sep. 30, 2021 | 98,413 | 98,667 | $ 0 | $ 4 | 545,657 | (64) | (446,222) | (708) | (254) |
Increase (Decrease) in Stockholders' Equity [Roll Forward] | |||||||||
Preferred stock, shares outstanding | 0 | ||||||||
Beginning balance at Jun. 30, 2021 | 104,679 | 104,933 | $ 0 | $ 4 | 544,949 | (17) | (439,295) | (708) | (254) |
Common stock, beginning balance (in shares) at Jun. 30, 2021 | 3,967,000 | ||||||||
Increase (Decrease) in Stockholders' Equity [Roll Forward] | |||||||||
Net loss | (6,927) | (6,927) | (6,927) | ||||||
Share-based compensation (in shares) | 19,000 | ||||||||
Share-based compensation | 708 | 708 | 708 | ||||||
Unrealized loss on marketable securities | (47) | (47) | (47) | ||||||
Preferred stock, ending balance (in shares) at Sep. 30, 2021 | 0 | ||||||||
Common stock, ending balance (in shares) at Sep. 30, 2021 | 3,986,000 | ||||||||
Ending balance at Sep. 30, 2021 | $ 98,413 | 98,667 | $ 0 | $ 4 | 545,657 | (64) | (446,222) | (708) | (254) |
Increase (Decrease) in Stockholders' Equity [Roll Forward] | |||||||||
Preferred stock, shares outstanding | 0 | ||||||||
Preferred stock, shares outstanding | 10,000 | 0 | |||||||
Beginning balance at Dec. 31, 2021 | $ 92,000 | 92,254 | $ 0 | $ 4 | 546,044 | (70) | (453,016) | (708) | (254) |
Common stock, beginning balance (in shares) at Dec. 31, 2021 | 3,985,981 | 3,986,000 | |||||||
Increase (Decrease) in Stockholders' Equity [Roll Forward] | |||||||||
Net loss | $ (48,235) | (48,235) | (48,235) | ||||||
Share-based compensation (in shares) | 100,000 | ||||||||
Share-based compensation | 1,899 | 1,899 | $ 0 | 1,899 | |||||
Net proceeds from issuances of common stock | 29 | 29 | 29 | ||||||
Issuance of common stock in connection with Merger (in shares) | 3,773,000 | ||||||||
Issuance of common stock in connection with merger | 26,098 | 26,098 | $ 4 | 26,094 | |||||
Net proceeds from issuance of common stock and warrants (in shares) | 4,000 | ||||||||
Unrealized loss on marketable securities | 5 | 5 | 5 | ||||||
Foreign currency translation adjustment | $ (25) | (25) | |||||||
Preferred stock, ending balance (in shares) at Sep. 30, 2022 | 10,000 | 0 | |||||||
Common stock, ending balance (in shares) at Sep. 30, 2022 | 7,862,602 | 7,863,000 | |||||||
Ending balance at Sep. 30, 2022 | $ 71,771 | 72,025 | $ 0 | $ 8 | 574,066 | (90) | (501,251) | (708) | (254) |
Increase (Decrease) in Stockholders' Equity [Roll Forward] | |||||||||
Preferred stock, shares outstanding | 0 | ||||||||
Beginning balance at Jun. 30, 2022 | 82,137 | 82,391 | $ 0 | $ 4 | 547,032 | (70) | (463,868) | (708) | (254) |
Common stock, beginning balance (in shares) at Jun. 30, 2022 | 4,038,000 | ||||||||
Increase (Decrease) in Stockholders' Equity [Roll Forward] | |||||||||
Net loss | (37,383) | (37,383) | (37,383) | ||||||
Share-based compensation (in shares) | 52,000 | ||||||||
Share-based compensation | 939 | 939 | 940 | ||||||
Issuance of common stock in connection with Merger (in shares) | 3,773,000 | ||||||||
Issuance of common stock in connection with merger | 26,098 | 26,098 | $ 4 | 26,094 | |||||
Unrealized loss on marketable securities | 5 | 5 | 5 | ||||||
Foreign currency translation adjustment | $ (25) | (25) | |||||||
Preferred stock, ending balance (in shares) at Sep. 30, 2022 | 10,000 | 0 | |||||||
Common stock, ending balance (in shares) at Sep. 30, 2022 | 7,862,602 | 7,863,000 | |||||||
Ending balance at Sep. 30, 2022 | $ 71,771 | $ 72,025 | $ 0 | $ 8 | $ 574,066 | $ (90) | $ (501,251) | $ (708) | $ (254) |
Increase (Decrease) in Stockholders' Equity [Roll Forward] | |||||||||
Preferred stock, shares outstanding | 10,000 | 0 |
Consolidated Statements of Cash
Consolidated Statements of Cash Flows - USD ($) $ in Thousands | 9 Months Ended | |
Sep. 30, 2022 | Sep. 30, 2021 | |
Cash flows from operating activities: | ||
Net loss | $ (48,235) | $ (20,672) |
Adjustments to reconcile net loss to net cash used in operating activities: | ||
Share-based compensation | 2,168 | 1,639 |
Depreciation and amortization | 22 | 47 |
Foreign Currency Transaction Gain (Loss), Unrealized | 30,393 | 0 |
Accretion on marketable securities | 893 | 1,925 |
Changes in operating assets and liabilities: | ||
Prepaid and other current assets | 29 | (1,199) |
Other assets | 178 | 252 |
Accounts payable, accrued liabilities and other liabilities | (150) | 367 |
Net cash used in operating activities | (14,702) | (17,641) |
Cash flows from investing activities: | ||
Purchase of marketable securities | (68,481) | (137,329) |
Sale of marketable securities | 93,865 | 66,035 |
Investment in Cend Therapeutics | (3,320) | 0 |
Purchase of property and equipment | (259) | (60) |
Net cash provided by (used in) investing activities | 21,805 | (71,354) |
Cash flows from financing activities: | ||
Proceeds from exercise of options | 0 | 24 |
Tax withholding payments on net share settlement equity awards | (267) | (248) |
Net proceeds from issuance of common stock | 29 | 85,479 |
Net cash (used in) provided by financing activities | (238) | 85,255 |
Effect of exchange rate changes on cash | (34) | 0 |
Net increase (decrease) in cash and cash equivalents | 6,831 | (3,740) |
Cash and cash equivalents at beginning of period | 24,647 | 16,512 |
Cash and cash equivalents at end of period | 31,478 | 12,772 |
Supplemental disclosure of noncash investing activities: | ||
Issuance of common stock in connection with merger | 23,580 | 0 |
Incremental fair value of Cend's fully vested stock options assumed | $ 2,136 | $ 0 |
The Business
The Business | 9 Months Ended |
Sep. 30, 2022 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
The Business | The Business Overview Lisata Therapeutics, Inc. (together with its subsidiaries, “we,” “us,” “our,” “Lisata” or the “Company”) is a clinical-stage pharmaceutical company dedicated to the discovery, development and commercialization of innovative therapies for the treatment of solid tumors and other major diseases. Lisata’s lead investigational product candidate, LSTA1 (formerly known as CEND-1), is designed to activate a novel uptake pathway that allows anti-cancer drugs to penetrate solid tumors more effectively. LSTA1 actuates this active transport system in a tumor-specific manner, resulting in systemically co-administered anti-cancer drugs more efficiently penetrating and accumulating in the tumor, while normal tissues are not affected. LSTA1 also has the potential to modify the tumor microenvironment (“TME”), making tumors more susceptible to immunotherapies. LSTA1 has demonstrated favorable safety, tolerability, and activity to date in completed and ongoing clinical trials to enhance delivery of standard-of-care chemotherapy for pancreatic cancer. Lisata and its collaborators have also amassed significant non-clinical data demonstrating enhanced delivery of a range of emerging anti-cancer therapies, including immunotherapies and RNA-based therapeutics. Lisata is exploring the potential of LSTA1 to enable a variety of treatment modalities to treat a range of solid tumors more effectively. In addition, Lisata also has clinical development programs based on its autologous CD34+ cell therapy technology platform. The Company's leadership team has decades of collective biopharmaceutical and pharmaceutical product development experience across a variety of therapeutic categories and at all stages of development from preclinical through to product registration and launch. Its goal is to develop and commercialize products that address important unmet medical needs based on a broad and versatile portfolio of candidates. The Company’s current product candidates include: • LSTA1, the subject of phase 1b/2a and 2b clinical studies being conducted globally in a variety of solid tumor types, including metastatic pancreatic ductal adenocarcinoma (mPDAC), in combination with a variety of anti-cancer regimens; • XOWNA ® (LSTA16 formerly CLBS16), the subject of both a completed positive Phase 2a study (ESCaPE-CMD) and follow on Phase 2b study (FREEDOM Trial) in the United States for the treatment of coronary microvascular dysfunction (“CMD”); • HONEDRA ® (LSTA12 formerly CLBS12), recipient of SAKIGAKE designation, pursuant to which early conditional approval in Japan for the treatment of critical limb ischemia (“CLI”) and Buerger’s disease is being sought based on the current results of a clinical trial executed in Japan. HONEDRA ® was the recipient of orphan drug designation in March 2021 from the U.S. Food and Drug Administration (“FDA”) for Buerger's disease; and • LSTA201 (formerly CLBS201), the subject of a study designed to assess the safety and efficacy of CD34+ cell therapy as a regenerative treatment for patients with chronic kidney disease related to type 2 diabetes (diabetic kidney disease or “DKD”). Merger with Cend Therapeutics, Inc. and Name Change On September 15, 2022, the Company, then operating as Caladrius Biosciences, Inc. (“Caladrius"), completed its acquisition of Cend Therapeutics, Inc. (“Cend”), a Delaware corporation (the “Merger”), in accordance with the terms of the Agreement and Plan of Merger and Reorganization (the “Merger Agreement”), dated as of April 26, 2022, by and among Caladrius, Cend and CS Cedar Merger Sub, Inc. (“Merger Sub”). Pursuant to the terms set forth in the Merger Agreement and effective September 15, 2022 (the “Effective Time”): (i) Merger Sub merged with and into Cend, with Cend surviving as a wholly owned subsidiary of Caladrius, (ii) Caladrius changed its name to Lisata Therapeutics, Inc. in connection with and immediately following to the Effective Time, and (iii) Caladrius effected a 1:15 reverse stock split of its common stock (“Reverse Stock Split”) prior to the Effective Time. At the Effective Time, each share of Cend's common stock outstanding immediately prior to the Effective Time was converted into the right to receive shares of Lisata’s common stock based on an exchange ratio of 0.5338 (the “Exchange Ratio”), after taking into account the Reverse Stock Split. In connection with the Merger close, the Company issued an aggregate of 3,772,768 shares of common stock, based on the Exchange Ratio, to holders of Cend, in exchange for all of the Cend capital stock outstanding immediately prior to the closing of the Merger. Pursuant to the Merger Agreement, Lisata assumed all of the outstanding and unexercised options to purchase shares of Cend capital stock under the 2016 Equity Incentive Plan (the “Cend Plan”), and, in connection with the Merger, such options were converted into options to purchase shares of Lisata’s common stock based on the Exchange Ratio. At the closing of the Merger at the Effective Time, the Company assumed Cend's stock options to purchase an aggregate of 1,227,776 shares of the Company's common stock. Caladrius was considered to be the accounting acquirer based on the terms of the Merger Agreement and certain factors including: (i) Caladrius owned approximately 52% of the Company's outstanding shares of common stock immediately following the close of the Merger; (ii) although both entities contributed to the new management team of Lisata, the Caladrius team has more individuals on the management team and will hold the CEO, CMO and other senior management roles; (iii) Caladrius paid a premium to acquire Cend’s assets; and (iv) Caladrius was significantly larger than Cend regarding total assets, operations, and research and development activities. The Merger was accounted for as an asset acquisition as substantially all of the fair value is concentrated in in-process research and development (“IPR&D”). Cend’s assets (except for cash and working capital) were measured and recognized as an allocation of the transaction price based on their relative fair values as of the transaction date with any value associated with IPR&D with no alternative future use being expensed as reported in the consolidated statement of operations. The prior reported operating results prior to the Merger close are those of Caladrius alone. Coronavirus Considerations In December 2019, a novel strain of coronavirus (SARS-CoV-2), which causes COVID-19, was reported to have surfaced in China. In March 2020, the World Health Organization declared the outbreak of COVID-19 to be a pandemic, and the world's economies began to experience pronounced effects. Despite the FDA approval of multiple COVID-19 vaccines in late 2020, there remains uncertainty around the extent and duration of disruption and any future related financial impact cannot reasonably be estimated at this time. In response to the COVID-19 pandemic, the Company implemented a universal work from home policy as well as stringent social distancing and other hygiene policies for employees when they must be in the office. The Company's clinical study of HONEDRA ® in Japan experienced significant delays in enrollment due to the States of Emergency in effect in Japan for most of 2020, 2021, and 2022 covering Tokyo and other regions in response to an increased number of COVID-19 infections. With the Company's expectation that COVID-19 in Japan will continue to impact negatively clinical site operations and enrollment of patients in the HONEDRA ® clinical trial, it elected to suspend trial enrollment, seek a development partner and consult with the Japanese regulatory authorities regarding the submission of patient data already accrued. Caladrius' phase 2b FREEDOM Trial of XOWNA ® in the U.S. has also experienced delays in enrolling patients as a result of COVID-19. While early enrollment proceeded to plan with the first patient treated in January 2021, the impact of the COVID-19 pandemic contributed to a general slowing of enrollment, including supply chain disruptions affecting the availability of qualified catheters used in the diagnosis of CMD and/or administration of XOWNA ® as well as with a contrast agent typically used in many catheter laboratories. In May 2022, the Company announced that enrollment in the FREEDOM Trial had been suspended and that it intended to conduct an interim analysis of the data from not less than the first 20 patients enrolled using the 6-month follow-up data to evaluate the efficacy and safety of XOWNA ® in subjects with CMD. Following the analysis of results of the FREEDOM Trial subjects completing 6-month follow-up along with Key Opinion Leaders’ input, the Company’s board of directors determined that execution of a redesigned FREEDOM-like trial would be the appropriate next step, but the cost of such a trial would be prohibitively expensive to undergo without a strategic partner. Accordingly, the Company’s board of directors concluded that XOWNA ® development will only be continued if a strategic partner that can contribute the necessary capital for a redesigned trial is identified and secured. There can be no assurance that we will be able to identify such a partner and enter into an agreement with such partner on acceptable terms or at all. Reverse Stock Split On September 14, 2022, in connection with the Merger, the Company implemented the Reverse Stock Split, as authorized at the annual meeting of stockholders on September 13, 2022. The Reverse Stock Split became effective on September 14, 2022 at 5:00 pm and the Company's common stock began trading on The Nasdaq Capital Market on a post-split basis at the open of business on September 15, 2022. As of September 14, 2022, every fifteen shares of the Company’s issued and outstanding common stock (and such shares held in treasury) were automatically converted into one share of common stock, without any change in the par value per share. In addition, proportionate adjustments were made to the per share exercise price and the number of shares issuable upon the exercise of all outstanding stock options, stock appreciation rights, convertible notes and warrants to purchase shares of common stock, the number of shares issuable upon the vesting of all restricted stock awards, and the number of shares of common stock reserved for issuance pursuant to the Company’s equity incentive compensation plans. Any stockholder who would otherwise be entitled to a fractional share of common stock created as a result of the Reverse Stock Split received a cash payment equal to the product of such resulting fractional interest in one share of common stock multiplied by the closing trading price of the common stock on September 15, 2022. The Reverse Stock Split was effectuated in order to increase the per share trading price of our common stock to satisfy the $1.00 minimum bid price requirement for continued listing on The Nasdaq Capital Market. All share and per share amounts of common stock, options and warrants in the accompanying financial statements have been restated for all periods presented to give retroactive effect to the Reverse Stock Split. Accordingly, the consolidated statements of equity reflect the impact of the Reverse Stock Split by reclassifying from “common stock” to “additional paid-in capital” in an amount equal to the par value of the decreased shares resulting from the Reverse Stock Split. Basis of Presentation The accompanying unaudited Consolidated Financial Statements have been prepared in accordance with accounting principles generally accepted in the United States of America (“GAAP”) for interim financial information and with the instructions to Form 10-Q and Article 10 of Regulation S-X of the SEC for interim financial information. Accordingly, they do not include all of the information and footnotes required by generally accepted accounting principles for complete financial statements. In the opinion of management, the accompanying Consolidated Financial Statements of the Company and its subsidiaries, which are unaudited, include all normal and recurring adjustments considered necessary to present fairly the Company’s financial position as of September 30, 2022, and the results of its operations and its cash flows for the periods presented. The unaudited consolidated financial statements herein should be read together with the historical consolidated financial statements of the Company for the years ended December 31, 2021 and 2020 included in our 2021 Form 10-K. Operating results for the three and nine months ended September 30, 2022 are not necessarily indicative of the results that may be expected for the year ending December 31, 2022. Use of Estimates The preparation of financial statements in conformity with GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the consolidated financial statements. Estimates also affect the reported amounts of expenses during the reporting period. The Company bases its estimates on historical experience and other assumptions believed to be reasonable under the circumstances, the results of which form the basis for making judgments about the carrying value of assets and liabilities that are not readily apparent from other sources. The Company makes critical estimates and assumptions in determining stock-based awards values and the valuation of the Merger which was accounted for as an asset acquisition as substantially all of the fair value is concentrated in in-process research and development (“IPR&D”). Accordingly, actual results could differ from those estimates and assumptions. Principles of Consolidation The Consolidated Financial Statements include the accounts of Lisata and its wholly owned and majority owned subsidiaries and affiliates. All intercompany activities have been eliminated in consolidation. Foreign Currency Remeasurement The Company’s reporting currency is the U.S. Dollar. The functional currency of DrugCendR Australia PTY Ltd. which is a foreign subsidiary of the Company is the Australian Dollar. The assets and liabilities of DrugCendR Australia PTY Ltd. are translated into U.S. Dollars at the exchange rates in effect at each balance sheet date, and the results of operations are translated using the average exchange rates prevailing throughout the reporting period. Adjustments resulting from translating foreign functional currency financial statements into U.S. Dollars are included in the foreign currency translation adjustment, a component of accumulated other comprehensive income (loss) in stockholders' equity. |
Summary of Significant Accounti
Summary of Significant Accounting Policies | 9 Months Ended |
Sep. 30, 2022 | |
Accounting Policies [Abstract] | |
Summary of Significant Accounting Policies | Summary of Significant Accounting Policies Cash and Cash Equivalents Cash and cash equivalents include short-term, highly liquid, investments with maturities of ninety days or less when purchased. Concentration of Risks The Company is subject to credit risk from its portfolio of cash, cash equivalents and marketable securities. Under its investment policy, the Company limits amounts invested in such securities by credit rating, maturity, industry group, investment type and issuer, except for securities issued by the U.S. government. Cash is held at major banks in the United States and Australia. Therefore, the Company is not exposed to any significant concentrations of credit risk from these financial instruments. The goals of the Company's investment policy, in order of priority, are as follows: safety and preservation of principal and diversification of risk, liquidity of investments sufficient to meet cash flow requirements, and a competitive after-tax rate of return. Marketable Securities The Company determines the appropriate classification of its marketable securities at the time of purchase and reevaluates such designation at each balance sheet date. All of the Company's marketable securities are considered as available-for-sale and carried at estimated fair values and reported in cash equivalents and marketable securities. Unrealized gains and losses on available-for-sale securities are excluded from net income and reported in accumulated other comprehensive income (loss) as a separate component of stockholders' equity. Other income (expense), net includes interest, dividends, amortization of purchase premiums and discounts, realized gains and losses on sales of securities and other-than-temporary declines in the fair value of securities, if any. The cost of securities sold is based on the specific identification method. The Company regularly reviews all of its investments for other-than-temporary declines in fair value. The Company's review includes the consideration of the cause of the impairment, including the creditworthiness of the security issuers, the number of securities in an unrealized loss position, the severity and duration of the unrealized losses, whether the Company has the intent to sell the securities and whether it is more likely than not that it will be required to sell the securities before the recovery of their amortized cost basis. When the Company determines that the decline in fair value of an investment is below its accounting basis and this decline is other-than-temporary, it reduces the carrying value of the security it holds and records a loss for the amount of such decline. Property and Equipment The cost of property and equipment is depreciated over the estimated useful lives of the related assets. Depreciation is computed on the straight-line method. Repairs and maintenance expenditures that do not extend original asset lives are charged to expense as incurred. The estimated useful lives of property and equipment are as follows: Furniture and fixtures 10 years Computer equipment 3 years Software 3 years Leasehold improvements Life of lease Long-lived Assets Long-lived assets consist of property and equipment and intangibles. The assets are amortized on a straight line basis over their respective useful lives. The Company reviews long-lived assets for impairment whenever events or changes in circumstances indicate that the carrying amount of an asset exceeds the fair value of the asset. If other events or changes in circumstances indicate that the carrying amount of an asset that the Company expects to hold and use may not be recoverable, the Company will estimate the undiscounted future cash flows expected to result from the use of the asset and/or its eventual disposition, and recognize an impairment loss, if any. The impairment loss, if determined to be necessary, would be measured as the amount by which the carrying amount of the assets exceeds the fair value of the assets. Share-Based Compensation The Company expenses all share-based payment awards to employees, directors, and consultants, including grants of stock options, warrants, and restricted stock, over the requisite service period based on the grant date fair value of the awards. Consultant awards are remeasured each reporting period through vesting. For awards with performance-based vesting criteria, the Company estimates the probability of achievement of the performance criteria and recognizes compensation expense related to those awards expected to vest. The Company determines the fair value of option awards using the Black-Scholes option-pricing model which uses both historical and current market data to estimate the fair value. This method incorporates various assumptions such as the risk-free interest rate, expected volatility, expected dividend yield and expected life of the options or warrants. Stock based compensation expense also includes an estimate, which is made at the time of the grant, of the number of awards that are expected to be forfeited. The fair value of the Company’s restricted stock and restricted stock units is based on the closing market price of the Company’s common stock on the date of grant. Loss Per Share Basic loss per share is based on the weighted effect of all common shares issued and outstanding and is calculated by dividing net loss attributable to common stockholders by the weighted average shares outstanding during the period. Diluted loss per share is calculated by dividing net loss attributable to common stockholders by the weighted average number of common shares used in the basic loss per share calculation plus the number of common shares that would be issued assuming conversion of all potentially dilutive securities outstanding. Diluted loss per share is not presented as such potentially dilutive securities are anti-dilutive to losses incurred in all periods presented. Treasury Stock Treasury stock purchases are accounted for under the cost method whereby the entire cost of the acquired stock is recorded as treasury stock. Gains or losses on the subsequent reissuance of shares are credited or charged to additional paid in capital. Research and Development Costs Research and development (“R&D”) expenses include salaries, benefits, and other headcount related costs, clinical trial and related clinical manufacturing costs, contract and other outside service fees including sponsored research agreements, and facilities and overhead costs. The Company expenses the costs associated with research and development activities when incurred. To further drive the Company’s initiatives, the Company will continue targeting key governmental agencies, congressional committees and not-for-profit organizations to contribute funds for the Company’s research and development programs. The Company accounts for such grants as a deduction to the related expense in research and development operating expenses when earned. In-process Research and Development Expense Upfront payments that relate to the acquisition of a new drug compound, as well as pre-commercial milestone payments, are immediately expensed as IPR&D in the period in which they are incurred, provided that the new drug compound did not also include processes or activities that would constitute a “business” as defined under GAAP, the drug has not achieved regulatory approval for marketing and, absent obtaining such approval, has no established alternative future use. The Company accounts for contingent consideration payable upon achievement of certain regulatory, development or sales milestones in such asset acquisitions when the underlying contingency is probable and estimable. Milestone payments made to third parties subsequent to regulatory approval will be capitalized as intangible assets and amortized over the estimated remaining useful life of the related product. Intangible Asset The Company’s intangible asset consists of a single asset, Cend’s license agreement with Qilu Pharmaceutical, Co., Ltd. (“Qilu”) acquired in the Merger, with a value of $0.4 million. The intangible asset is stated at fair value and is amortized using the straight-line method over its estimated useful life of 5 years. Amortization expense was $3 thousand for the three and nine months ended September 30, 2022. The intangible asset is reviewed for potential impairment when events or circumstances indicate that carrying amounts may not be recoverable. The projected amortization expense is $71 thousand per year for the next five years. Revenue Recognition The Company evaluates license and collaboration arrangements to determine whether units of account within the arrangement exhibit the characteristics of a vendor and customer relationship. For arrangements and units of account where a customer relationship exists, the Company applies the revenue recognition guidance. The Company recognizes revenue upon the transfer of promised goods or services to customers in an amount that reflects the consideration to which the Company expects to be entitled in exchange for those goods or services. To determine revenue recognition for contracts with customers the Company performs the following five steps: (i) identify the contract(s) with a customer; (ii) identify the performance obligations in the contract; (iii) determine the transaction price; (iv) allocate the transaction price to the performance obligations in the contract; and (v) recognize revenue when (or as) the Company satisfies the performance obligations. At contract inception, the Company assesses the goods or services promised within each contract and assesses whether each promised good or service is distinct and determines those that are performance obligations. The Company then recognizes as revenue the amount of the transaction price that is allocated to the respective performance obligation when (or as) the performance obligation is satisfied. Taxes imposed by governmental authorities on the Company's revenue, such as sales taxes and withholding taxes, are excluded from net revenue. If a license to the Company’s intellectual property is determined to be distinct from the other performance obligations identified in the arrangement, the Company recognizes revenues from non-refundable, upfront fees allocated to the license when the license is transferred to the licensee and the licensee is able to use and benefit from the license. If licenses are bundled with other performance obligations, the Company would utilize judgment to assess the nature of the combined performance obligation to determine whether the combined performance obligation is satisfied over time or at a point in time and, if over time, the appropriate method of measuring progress for purposes of recognizing revenue. There was no revenue recognized for the three and nine months ended September 30, 2022. Milestones At the inception of each arrangement that includes milestone payments (variable consideration), the Company evaluates whether the milestones are considered probable of being reached and estimates the amount to be included in the transaction price using the most likely amount method. If it is probable that a significant revenue reversal would not occur, the associated milestone value is included in the transaction price. Milestone payments that are not within the Company or the Company’s collaboration partner’s control, such as regulatory approvals, are generally not considered probable of being achieved until those approvals are received. The transaction price is then allocated to each performance obligation on a relative stand-alone selling price basis, for which the Company recognizes revenue as or when the performance obligations under the contract are satisfied. At the end of each subsequent reporting period, the Company re-evaluates the probability of achievement of such milestones and any related constraint, and if necessary, adjusts the Company’s estimate of the overall transaction price. Any such adjustments are allocated on a cumulative catch-up basis to satisfied and partially satisfied performance obligations, with the consideration allocated to an ongoing performance obligation being recognized over the period of performance. Royalties For arrangements that include sales-based royalties, including milestone payments based on the level of sales, and for which the license is deemed to be the predominant item to which the royalties relate, the Company recognizes revenue at the later of (i) when the related sales occur, or (ii) when the performance obligation to which some or all of the royalty has been allocated has been satisfied (or partially satisfied). To date, the Company has not recognized any royalty revenue from any collaborative arrangement. |
Merger
Merger | 9 Months Ended |
Sep. 30, 2022 | |
Business Combination and Asset Acquisition [Abstract] | |
Merger | Merger The Merger was accounted for as an asset acquisition as substantially all of the fair value was concentrated in IPR&D. Cend’s assets (except for cash and working capital) were measured and recognized as an allocation of the transaction price based on their relative fair values as of the transaction date with any value associated with IPR&D being expensed. The fair value of total consideration was $36.1 million. The following table is a summary of the purchase price calculation (in thousands except per share data). Number of common shares of the combined company owned by Cend stockholders 3,772,768 Multiplied by the fair value per share of Lisata common stock on September 15, 2022 $6.25 Total $23,580 Carrying value of Lisata's cost method investment in Cend 10,000 Incremental fair value of Cend's fully vested stock options 2,136 Lisata transaction costs 382 Total purchase price $36,098 The allocation of the purchase price was as follows (amounts in thousands): Cash and cash equivalents $7,062 Net working capital (excluding cash) (1,690) Other liabilities (22) Acquired in-process research and development 30,393 License 355 Net assets acquired $36,098 |
Available-for-Sale-Securities
Available-for-Sale-Securities | 9 Months Ended |
Sep. 30, 2022 | |
Debt Securities, Available-for-sale [Abstract] | |
Available-for-Sale-Securities | Available-for-Sale-Securities The following table is a summary of available-for-sale securities recorded in cash and cash equivalents or marketable securities in our Consolidated Balance Sheets (in thousands): September 30, 2022 December 31, 2021 Cost Gross Unrealized Gains Gross Unrealized Losses Estimated Fair Value Cost Gross Unrealized Gains Gross Unrealized Losses Estimated Fair Value Corporate debt securities $ 39,311 $ — $ (65) $ 39,246 $ 53,135 $ — $ (65) $ 53,070 Commercial paper 14,459 — — 14,459 — — — — Money market funds 13,457 — — 13,457 18,124 — — 18,124 Municipal debt securities 170 — — 170 20,263 — (5) 20,258 Total $ 67,397 $ — $ (65) $ 67,332 $ 91,522 $ — $ (70) $ 91,452 Estimated fair values of available-for-sale securities are generally based on prices obtained from commercial pricing services. The following table summarizes the classification of the available-for-sale securities in our Consolidated Balance Sheets (in thousands): September 30, 2022 December 31, 2021 Cash equivalents $ 23,280 $ 21,129 Marketable securities 44,052 70,323 Total $ 67,332 $ 91,452 The following table summarizes our portfolio of available-for-sale securities by contractual maturity (in thousands): September 30, 2022 Amortized Cost Estimated Fair Value Less than one year $ 67,397 $ 67,332 Greater than one year — — Total $ 67,397 $ 67,332 |
Income (Loss) Per Share
Income (Loss) Per Share | 9 Months Ended |
Sep. 30, 2022 | |
Earnings Per Share [Abstract] | |
Income (Loss) Per Share | Income (Loss) Per Share For the nine months ended September 30, 2022 and 2021, the Company incurred net losses and therefore no common stock equivalents were utilized in the calculation of diluted loss per share as they are anti-dilutive. At September 30, 2022 and 2021, the Company excluded the following potentially dilutive securities (in thousands): September 30, 2022 2021 Stock Options 1,399 142 Warrants 1,424 1,424 Restricted Stock Units 48 53 |
Fair Value Measurements
Fair Value Measurements | 9 Months Ended |
Sep. 30, 2022 | |
Fair Value Disclosures [Abstract] | |
Fair Value Measurements | Fair Value Measurements The fair value of financial assets and liabilities that are being measured and reported are defined as the exchange price that would be received to sell an asset or paid to transfer a liability in an orderly transaction between market participants in the principal market at the measurement date (exit price). The Company is required to classify fair value measurements in one of the following categories: Level 1 inputs are defined as quoted prices (unadjusted) in active markets for identical assets or liabilities that the reporting entity has the ability to access at the measurement date. Level 2 inputs are defined as inputs other than quoted prices included within Level 1 that are observable for the assets or liabilities, either directly or indirectly. Level 3 inputs are defined as unobservable inputs for the assets or liabilities. Financial assets and liabilities are classified based on the lowest level of input that is significant to the fair value measurement. The Company’s assessment of the significance of a particular input to the fair value measurement requires judgment and may affect the valuation of the fair value of assets and liabilities and their placement within the fair value hierarchy levels. The following table sets forth by level within the fair value hierarchy the Company's financial assets that were accounted for at fair value on a recurring basis as of September 30, 2022 and December 31, 2021 (in thousands). September 30, 2022 December 31, 2021 Level 1 Level 2 Level 3 Total Level 1 Level 2 Level 3 Total Assets: Marketable securities - available for sale $ — $ 44,052 $ — $ 44,052 $ — $ 70,323 $ — $ 70,323 $ — $ 44,052 $ — $ 44,052 $ — $ 70,323 $ — $ 70,323 |
Accrued Liabilities
Accrued Liabilities | 9 Months Ended |
Sep. 30, 2022 | |
Accrued Liabilities [Abstract] | |
Accrued Liabilities | Accrued Liabilities Accrued liabilities as of September 30, 2022 and December 31, 2021 were as follows (in thousands): September 30, 2022 December 31, 2021 Salaries, employee benefits and related taxes $ 2,147 $ 2,034 Operating lease liabilities — current 203 229 Clinical and R&D related liabilities 2,338 — Other 729 326 Total $ 5,417 $ 2,589 |
Operating Leases
Operating Leases | 9 Months Ended |
Sep. 30, 2022 | |
Leases [Abstract] | |
Operating Leases | Operating LeasesThe Company has operating leases for two offices with terms that expire in 2023 and 2025, respectively. The Company estimates its incremental borrowing rate at lease commencement to determine the present value of lease payments as most of the Company's leases do not provide an implicit rate of return. The Company recognizes lease expense on a straight-line basis over the lease term. For lease agreements entered into or reassessed after the adoption of Topic 842, the Company elected to account for non-lease components associated with its leases and lease components as a single lease component. Each of the Company's leases includes options for the Company to extend the lease term and/or sub-lease space in whole or in part. Operating lease liabilities and right-of-use assets were recorded in the following captions of our balance sheet were as follows (in thousands): September 30, 2022 December 31, 2021 Right-of Use Assets: Other assets $ 548 $ 724 Total Right-of-Use Asset $ 548 $ 724 Operating Lease Liabilities: Accrued liabilities $ 203 $ 229 Other long-term liabilities 345 485 Total Operating Lease Liabilities $ 548 $ 714 As of September 30, 2022, the weighted average remaining lease term for our operating leases was 1.8 years, and the weighted average discount rate for our operating leases was 9.625%. Future minimum lease payments under the lease agreements as of September 30, 2022 were as follows (in thousands): Years ended Operating Leases 2022 75 2023 217 2024 190 2025 143 Total lease payments 625 Less: Amounts representing interest (77) Present value of lease liabilities $ 548 |
Stockholders' Equity
Stockholders' Equity | 9 Months Ended |
Sep. 30, 2022 | |
Equity [Abstract] | |
Stockholders' Equity | Stockholders' Equity Reverse Stock Split On September 14, 2022, in connection with the merger, we implemented the Reverse Stock Split, as described in Note 1. All share and per share amounts of common stock, options and warrants in the accompanying financial statements have been restated for all periods presented to give retroactive effect to the Reverse Stock Split. Accordingly, the consolidated statements of equity reflect the impact of the Reverse Stock Split by reclassifying from “common stock” to “additional paid-in capital” in an amount equal to the par value of the decreased shares resulting from the Reverse Stock Split. Equity Issuances Purchase Agreement In March 2019, the Company and Lincoln Park Capital Fund, LLC (“Lincoln Park”) entered into a purchase agreement (the “Purchase Agreement”) and a registration rights agreement (the “Registration Rights Agreement”), pursuant to which the Company has the right to sell to Lincoln Park shares of the Company’s common stock having an aggregate value of up to $26.0 million, subject to certain limitations and conditions set forth in the Purchase Agreement (the “Offering”). As consideration for entering into the Purchase Agreement, the Company issued to Lincoln Park an additional 181,510 shares of common stock as commitment shares. Pursuant to the Purchase Agreement, Lincoln Park purchased 250,000 shares of common stock, at a price of $4.00 per share, for a total gross purchase price of $1.0 million (the “Initial Purchase”) upon commencement. Thereafter, as often as every business day from and after one business day following the date of the Initial Purchase and over the 36-month term of the Purchase Agreement, the Company has the right, from time to time, at its sole discretion and subject to certain conditions, to direct Lincoln Park to purchase up to 100,000 shares of common stock, with such amount increasing as the closing sale price of the common stock increases; provided Lincoln Park’s obligation under any single such purchase will not exceed $2.5 million, unless the Company and Lincoln Park mutually agree to increase the maximum amount of such single purchase (each, a “Regular Purchase”). If the Company directs Lincoln Park to purchase the maximum number of shares of common stock it then may sell in a Regular Purchase, then in addition to such Regular Purchase, and subject to certain conditions and limitations in the Purchase Agreement, the Company may direct Lincoln Park in an “accelerated purchase” to purchase an additional amount of common stock that may not exceed the lesser of (i) 300% the number of shares purchased pursuant to the corresponding Regular Purchase or (ii) 30% of the total number of shares of the Company’s common stock traded during a specified period on the applicable purchase date as set forth in the Purchase Agreement. Under certain circumstances and in accordance with the Purchase Agreement, the Company may direct Lincoln Park to purchase shares in multiple accelerated purchases on the same trading day. The Company controls the timing and amount of any sales of its common stock to Lincoln Park. There is no upper limit on the price per share that Lincoln Park must pay for its common stock under the Purchase Agreement, but in no event will shares be sold to Lincoln Park on a day the closing price is less than the floor price specified in the Purchase Agreement. In all instances, the Company may not sell shares of its common stock to Lincoln Park under the purchase agreement if it would result in Lincoln Park beneficially owning more than 9.99% of its common stock. The Purchase Agreement does not limit the Company’s ability to raise capital from other sources at the Company’s sole discretion, except that (subject to certain exceptions) the Company may not enter into any Variable Rate Transaction (as defined in the Purchase Agreement, including the issuance of any floating conversion rate or variable priced equity-like securities) during the 36 months after the date of the Purchase Agreement. The Company has the right to terminate the Purchase Agreement at any time, at no cost to the Company. As of September 30, 2022, the Company had not made any sales of common stock to Lincoln Park under the Purchase Agreement other than the Initial Purchase. The agreement expired on April 1, 2022. At The Market Offering Agreement On June 4, 2021, the Company entered into an At The Market Offering Agreement (the “ATM Agreement”) with H.C. Wainwright & Co., LLC, as sales agent, in connection with an “at the market offering” under which the Company from time to time may offer and sell shares of its common stock, having an aggregate offering price of up to $50.0 million. During the nine months ended September 30, 2022 and since inception, the Company has not issued any shares under the ATM Agreement. Common Stock In connection with the Merger close, the Company issued an aggregate of 3,772,768 shares of common stock, based on the Exchange Ratio, to holders of Cend, in exchange for all of the Cend capital stock outstanding immediately prior to the closing of the Merger. Stock Options and Warrants In connection with the Merger and after giving effect to the Reverse Stock Split, the Company assumed 1,227,776 options outstanding from Cend. The options granted from the Cend Plan are exercisable at various dates as determined upon grant and will expire no more than ten years from their original date of grant. The Cend Plan stock options generally vest over a four-year term. The following table summarizes the activity for stock options and warrants for the nine months ended September 30, 2022: Stock Options Warrants Shares Weighted Average Exercise Price Weighted Average Remaining Contractual Term (Years) Aggregate Intrinsic Value (In Thousands) Shares Weighted Average Exercise Price Weighted Average Remaining Contractual Term (Years) Aggregate Intrinsic Value (In Thousands) Outstanding at December 31, 2021 142,041 $ 84.60 7.97 $ — 1,423,774 $ 42.57 4.37 $ — Changes during the period: Granted 37,458 13.49 — — Assumed through merger 1,227,776 3.77 — — Exercised — — — — Forfeited (2,910) 19.96 — — Expired (5,388) 352.31 — — Outstanding at September 30, 2022 1,398,977 $ 10.83 7.30 $ — 1,423,774 $ 42.57 3.63 $ — Vested at September 30, 2022 1,396,921 $ 10.83 7.30 $ — 1,423,774 $ 42.57 3.63 $ — Vested at September 30, 2022 1,110,635 $ 11.82 6.97 $ — 1,423,774 $ 42.57 3.63 $ — Restricted Stock During the nine months ended September 30, 2022 and 2021, the Company issued restricted stock for services as follows ($ in thousands): Nine Months Ended September 30, 2022 2021 Number of restricted stock issued 70,740 40,863 Value of restricted stock issued $ 973 $ 878 The vesting terms of restricted stock issuances are generally between one Restricted Stock Units During the nine months ended September 30, 2022 and 2021, the Company issued restricted stock units for services as follows ($ in thousands, except share data): Nine Months Ended September 30, 2022 2021 Number of restricted stock units issued 111,170 30,549 Value of restricted stock units issued $ 1,386 $ 729 |
Share-Based Compensation
Share-Based Compensation | 9 Months Ended |
Sep. 30, 2022 | |
Share-based Payment Arrangement, Noncash Expense [Abstract] | |
Share-Based Compensation | Share-Based Compensation Share-Based Compensation We utilize share-based compensation in the form of stock options, restricted stock, and restricted stock units. The following table summarizes the components of share-based compensation expense for the three and nine months ended September 30, 2022 and 2021 (in thousands): Three Months Ended September 30, Nine Months Ended September 30, 2022 2021 2022 2021 Research and development $ 271 $ 523 $ 631 $ 643 General and administrative 769 250 1,537 996 Total share-based compensation expense $ 1,040 $ 773 $ 2,168 $ 1,639 Total compensation cost related to non-vested awards not yet recognized and the weighted-average periods over which the awards were expected to be recognized at September 30, 2022 were as follows (in thousands): Stock Options Restricted Stock Units Restricted Stock Unrecognized compensation cost $ 1,577 $ 168 $ 722 Expected weighted-average period in years of compensation cost to be recognized 1.66 2.16 1.83 Total fair value of shares vested and the weighted average estimated fair values of shares granted for the nine months ended September 30, 2022 and 2021 were as follows (in thousands): Stock Options Nine Months Ended September 30, 2022 2021 Total fair value of shares vested $ 853 $ 757 Weighted average estimated fair value of shares granted $ 1.23 $ 13.59 Valuation Assumptions The fair value of stock options and warrants at the date of grant was estimated using the Black-Scholes option pricing model. The expected volatility is based upon historical volatility of the Company’s common stock. The expected term for the options is based upon observation of actual time elapsed between date of grant and exercise of options for all employees. The expected term for the warrants is based upon the contractual term of the warrants. |
Income Taxes
Income Taxes | 9 Months Ended |
Sep. 30, 2022 | |
Income Tax Disclosure [Abstract] | |
Income Taxes | Income Taxes In assessing the realizability of deferred tax assets, including the net operating loss carryforwards (“NOLs”), the Company assesses the available positive and negative evidence to estimate if sufficient future taxable income will be generated to utilize its existing deferred tax assets. Based on its assessment, the Company has provided a full valuation allowance against its net deferred tax assets as their future utilization remains uncertain at this time. As of December 31, 2021 and 2020, the Company had approximately $281 million and $264 million, respectively, of federal NOLs available to offset future taxable income expiring from 2030 through 2036. The Company performed an analysis and determined that it had an ownership change of greater than 50% over a 3-year testing period on January 25, 2021. As a result, $169 million of the $281 million of federal NOLs will expire unutilized. The Company wrote off that portion of the deferred tax asset and reduced the corresponding valuation allowance resulting in $112 million of remaining federal NOL. The write off of the deferred tax asset and the corresponding reduction in valuation allowance has no impact to the balance sheet or income statement. Losses incurred before the ownership change on January 25, 2021 will be subject to an annual limitation of $173 thousand under Internal Revenue Code Section 382, while losses incurred after January 25, 2021 will not be subject to limitations. The Company may be able to utilize additional NOLs of approximately $1.1 million per year for the first five years after this ownership change as a result of the application of the Net Unrealized Built-in Gain rules. As of December 31, 2021 and 2020, the Company had state NOLs available in New Jersey of $97 million and $99 million, respectively, California of $70 million and $70 million, respectively, and New York City of $13 million and $13 million, respectively, to offset future taxable income expiring from 2031 through 2041. In accordance with Section 382 of the Internal Revenue code, the usage of the Company’s NOLs would be limited given the change in ownership. The ultimate realization of deferred tax assets is dependent upon the generation of future taxable income during the period when those temporary differences become deductible. The Company applies the FASB’s provisions for uncertain tax positions. The Company utilizes the two-step process to determine the amount of recognized tax benefit. For tax positions meeting the more-likely-than-not threshold, the amount recognized in the consolidated financial statements is the largest benefit that has a greater than 50% likelihood of being realized upon ultimate settlement with the relevant tax authority. The Company recognizes interest and penalties associated with uncertain tax positions as a component of income tax expense. As of September 30, 2022, management does not believe the Company has any material uncertain tax positions that would require it to measure and reflect the potential lack of sustainability of a position on audit in its financial statements. The Company will continue to evaluate its uncertain tax positions in future periods to determine if measurement and recognition in its financial statements is necessary. The Company does not believe there will be any material changes in its unrecognized tax positions over the next year. For years prior to 2018, the federal statute of limitations is closed for assessing tax. The Company’s state tax returns remain open to examination for a period of three to four years from date of filing. In December 2021, the Company received preliminary approval from the New Jersey Economic Development Authority (“NJEDA”) to participate in the Technology Business Tax Certificate Transfer Program (the “Program”). The Program permits qualified companies to sell a percentage of their New Jersey net operating losses (“NJ NOLs”) to unrelated profitable corporations. On February 22, 2022, the Company received final approval from NJEDA to sell $2.5 million of its NJ NOLs related tax benefits (“NJ NOL Tax Benefits”), which was subsequently sold to a qualifying and approved buyer pursuant to the Program for net proceeds of $2.3 million. The gross proceeds of $2.5 million have been recorded as a benefit from income taxes and the loss on sale of NJ NOLs of $0.1 million recorded in other income (expense) in the consolidated financial statements. |
Australia Research and Developm
Australia Research and Development Tax Incentive | 9 Months Ended |
Sep. 30, 2022 | |
Income Tax Disclosure [Abstract] | |
Australia Research and Development Tax Incentive | Australia Research and Development Tax IncentiveThe Company’s Australian subsidiary, which conducts core research and development activities, is eligible to receive a 43.5% refundable tax incentive for qualified research and development activities. As of the nine months ended September 30, 2022, $0.4 million was recorded as an income tax incentive receivable in the consolidated balance sheets, as the Company determined that the expenses met the eligibility criteria and the amounts claimed are expected to be received shortly after the related tax returns are filed. |
Contingencies
Contingencies | 9 Months Ended |
Sep. 30, 2022 | |
Commitments and Contingencies Disclosure [Abstract] | |
Contingencies | Contingencies Contingencies From time to time, the Company is subject to legal proceedings and claims, either asserted or unasserted, that arise in the ordinary course of business. While the outcome of pending claims cannot be predicted with certainty, the Company does not believe that the outcome of any pending claims will have a material adverse effect on the Company's financial condition or operating results. In May 2021, Cend received a written threat of litigation on behalf of a Chinese entity called Lingmed Limited (“Lingmed”) claiming Lingmed was entitled to a success fee based on Cend’s Collaboration and License Agreement with Qilu Pharmaceuticals. Cend responded by denying that Lingmed is entitled to a success fee under the terms of their agreement. In May 2022, Cend was served with a complaint filed by Lingmed in the San Diego County Superior Court, alleging claims for breach of contract, fraud and declaratory relief. Cend’s response to the complaint was filed on June 6, 2022. Lingmed filed an |
License Agreements
License Agreements | 9 Months Ended |
Sep. 30, 2022 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
License Agreements | License Agreements Sanford Burnham Prebys In December 2015, Cend entered into a license agreement with Sanford Burnham Prebys (“SBP”) under which Cend was granted an exclusive, worldwide, royalty-bearing license to certain patent rights and know-how controlled by SBP related to the development of CEND-1. At the time the license agreement was entered into, Cend’s founding shareholder, now a Lisata board member, was an executive at SBP. The agreement provides the Company with the rights to grant and authorize sublicenses to use, sell, and otherwise exploit the patent rights. As consideration for the license, Cend issued a total of 382,030 shares of common stock, as adjusted for the Reverse Stock Split and Exchange Ratio. The Company is required to pay an annual license maintenance fee of $10,000 increasing to $20,000 on year seven of the agreement. The Company could also be required to make milestone payments to SBP upon completion of certain regulatory and commercial milestones. The aggregate potential milestone payments are approximately $10.6 million. The Company has also agreed to pay SBP royalties of 4% of net sales of products sold by the Company, or through a sublicense, subject to certain reductions. Additionally, the Company is obligated to pay SBP 25% of any sublicensing income. In October 2021, Cend entered into a license agreement with SBP under which Cend was granted an exclusive, royalty-bearing license to certain patent rights and know-how controlled by SBP. The agreement provides Cend with the rights to grant and authorize sublicenses to use, sell, and otherwise exploit the patent rights. The Company is required to pay an annual license maintenance fee of $20,000, increasing to $30,000 on year four of the agreement. Further, the Company could be required to make milestone payments to SBP upon completion of certain regulatory and commercial milestones. The aggregate potential milestone payments are approximately $23.2 million. The Company is obligated to pay SBP royalties of 4% of net sales of products sold by the Company or through a sublicense, subject to certain reductions. Additionally, the Company is obligated to pay SBP varying sublicense fees, ranging from 10% to 25%, dependent on when the related milestones are reached. The agreements will expire upon the later of (i) the final abandonment of all pending patent applications within the licensed patents or (ii) the expiration of the last to expire patent within the licensed patents. The agreements may be terminated in their entirety by the Company at any time by giving SBP sixty days’ prior written notice. The agreements may be terminated in their entirety by SBP if the Company, at any time, defaults in the payment of any sum when due and fails to make such payment within thirty days after receipt of written notice. The agreements may be terminated in their entirety by SBP or the Company (i) in the event of an uncured material breach by the other party, or (ii) in the event the other party (a) files for, or is involuntarily petitioned with, bankruptcy (other than dissolution or winding up for the purposes of reconstruction or amalgamation), (b) makes an assignment of all or substantially all of its assets for the benefit of creditors, or (c) has a receiver or trustee is appointed and is unable to secure a dismissal, stay or other suspension of such proceedings within thirty days. Upon termination of the agreements for any reason, all rights and obligations of the Company with respect to the patents and patent applications shall terminate and revert to SBP. SBP owned 382,030 shares of the Company’s common stock as of September 30, 2022 and is a related party. University of California at San Diego In March 2021, Cend entered into a license agreement with the University of California at San Diego (“UCSD”) under which Cend was granted an exclusive, royalty-bearing license to certain patent rights related to the development of nano-particles to modulate immune response. The agreement provides the Company with the rights to grant and authorize sublicenses to use, sell and otherwise exploit the patent rights. The Company could be required to make milestone payments to UCSD upon completion of certain regulatory and commercial milestones. The aggregate potential milestone payments are approximately $1.2 million. The Company has also agreed to pay UCSD royalties of 1.5% of net sales of products sold by the Company or through a sublicense, subject to certain reductions. Additionally, the Company agreed to pay UCSD varying sublicense fees, ranging from 10% to 20%, dependent on when the related milestones are reached. The agreement will expire upon the expiration of the longest-lived patent rights. The agreement may be terminated in its entirety by the Company at any time by giving UCSD ninety days’ prior written notice. The agreement may be terminated in its entirety by UCSD if the Company, at any time, (i) fails to perform or violates any term of the agreement and fails to cure the default within sixty days. Upon termination of the agreement for any reason, UCSD may terminate a sublicensee but will allow the Company to assign any sublicenses to UCSD provided a) that the sublicensee is in good standing upon termination of the agreement with the Company; and b) the sublicensee is not currently involved in litigation as an adverse party to UCSD. Massachusetts Institute of Technology In October 2021, Cend entered into a license agreement with the Massachusetts Institute of Technology ("MIT") under which Cend was granted an exclusive, royalty-bearing license to certain patent rights related to the development of tissue specific delivery of interfering RNA. The agreement provides the Company with the rights to grant and authorize sublicenses to use, sell, and otherwise exploit the patent rights. The Company is required to pay an annual license maintenance fee of $20,000, increasing to $25,000 for year two and three of the agreement, increasing to $50,000 on year four of the agreement and thereafter until the first commercial sale, and increasing to $150,000 each year of the agreement after the first sale. Further, the Company could be required to make milestone payments to MIT upon completion of certain regulatory and commercial milestones. The aggregate potential milestone payments are approximately $5.0 million. The Company has also agreed to pay MIT royalties of 2% of net sales of products sold by the Company or through a sublicense, subject to certain reductions. Additionally, the Company is obligated to pay MIT varying sublicense fees, ranging from 3% to 20%, dependent on when the related milestones are reached. In connection with the close of the Merger,, the Company was required to pay MIT a change of control fee of $0.3 million, which is included in accrued liabilities within the condensed consolidated balance sheets as of September 30, 2022. The agreement will expire upon the expiration or abandonment of all valid claims. The agreement may be terminated in its entirety by the Company at any time by giving MIT six months prior written notice. The agreement may be terminated in its entirety by MIT if the Company, at any time, (i) defaults in the payment of any sum when due and fails to make such payment within thirty days after receipt of written notice, or (ii) commits a material breach of its obligations under the agreement (aside from item (i)) and fails to cure that breach within sixty days after receipt of written notice. Upon termination of the agreement for any reason, the rights and licenses granted to the Company shall terminate and revert to MIT. Upon termination of the agreement for any reason, MIT may terminate a sublicensee but will allow the Company to assign any sublicenses to MIT provided that the sublicensee is in good standing upon termination of the agreement with the Company. Exclusive License and Collaboration Agreement In February 2021, Cend entered into an Exclusive License and Collaboration Agreement (the “Qilu Agreement”) in which Cend granted an exclusive license to Qilu for the development and commercialization of CEND-1 in the Territory (defined as the Greater Area of China including China, Macau, Hong Kong, and Taiwan). Under the terms of the agreement, Qilu is solely responsible for the development of CEND-1 in its Territory. In consideration for the license, Qilu made an upfront payment of $10 million to Cend, which was recognized as revenue by Cend prior to the Merger. In addition, Cend received and recognized as revenue a $5 million development milestone prior to the Merger. The Company is eligible to receive additional developmental and commercial milestone payments up to $100 million and $125 million, respectively, tiered royalties on net sales ranging from 10% to 15%, and tiered sublicensing revenues ranging from 12% to 35%. Unless terminated early, the Qilu Agreement will continue in effect until the expiration of all Qilu payment obligations. Either party may terminate the Qilu Agreement if an undisputed material breach by the other party is not cured within a defined period of time, or upon notice for insolvency-related events of the other party that are not discharged within a defined time period. Qilu may terminate the Qilu Agreement in its entirety, at any time with at least sixty days written notice. All right and obligations of Qilu with respect to such licensed patents and patent applications would terminate. |
Research Collaboration and Lice
Research Collaboration and License Agreement | 9 Months Ended |
Sep. 30, 2022 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
Research Collaboration and License Agreement | License Agreements Sanford Burnham Prebys In December 2015, Cend entered into a license agreement with Sanford Burnham Prebys (“SBP”) under which Cend was granted an exclusive, worldwide, royalty-bearing license to certain patent rights and know-how controlled by SBP related to the development of CEND-1. At the time the license agreement was entered into, Cend’s founding shareholder, now a Lisata board member, was an executive at SBP. The agreement provides the Company with the rights to grant and authorize sublicenses to use, sell, and otherwise exploit the patent rights. As consideration for the license, Cend issued a total of 382,030 shares of common stock, as adjusted for the Reverse Stock Split and Exchange Ratio. The Company is required to pay an annual license maintenance fee of $10,000 increasing to $20,000 on year seven of the agreement. The Company could also be required to make milestone payments to SBP upon completion of certain regulatory and commercial milestones. The aggregate potential milestone payments are approximately $10.6 million. The Company has also agreed to pay SBP royalties of 4% of net sales of products sold by the Company, or through a sublicense, subject to certain reductions. Additionally, the Company is obligated to pay SBP 25% of any sublicensing income. In October 2021, Cend entered into a license agreement with SBP under which Cend was granted an exclusive, royalty-bearing license to certain patent rights and know-how controlled by SBP. The agreement provides Cend with the rights to grant and authorize sublicenses to use, sell, and otherwise exploit the patent rights. The Company is required to pay an annual license maintenance fee of $20,000, increasing to $30,000 on year four of the agreement. Further, the Company could be required to make milestone payments to SBP upon completion of certain regulatory and commercial milestones. The aggregate potential milestone payments are approximately $23.2 million. The Company is obligated to pay SBP royalties of 4% of net sales of products sold by the Company or through a sublicense, subject to certain reductions. Additionally, the Company is obligated to pay SBP varying sublicense fees, ranging from 10% to 25%, dependent on when the related milestones are reached. The agreements will expire upon the later of (i) the final abandonment of all pending patent applications within the licensed patents or (ii) the expiration of the last to expire patent within the licensed patents. The agreements may be terminated in their entirety by the Company at any time by giving SBP sixty days’ prior written notice. The agreements may be terminated in their entirety by SBP if the Company, at any time, defaults in the payment of any sum when due and fails to make such payment within thirty days after receipt of written notice. The agreements may be terminated in their entirety by SBP or the Company (i) in the event of an uncured material breach by the other party, or (ii) in the event the other party (a) files for, or is involuntarily petitioned with, bankruptcy (other than dissolution or winding up for the purposes of reconstruction or amalgamation), (b) makes an assignment of all or substantially all of its assets for the benefit of creditors, or (c) has a receiver or trustee is appointed and is unable to secure a dismissal, stay or other suspension of such proceedings within thirty days. Upon termination of the agreements for any reason, all rights and obligations of the Company with respect to the patents and patent applications shall terminate and revert to SBP. SBP owned 382,030 shares of the Company’s common stock as of September 30, 2022 and is a related party. University of California at San Diego In March 2021, Cend entered into a license agreement with the University of California at San Diego (“UCSD”) under which Cend was granted an exclusive, royalty-bearing license to certain patent rights related to the development of nano-particles to modulate immune response. The agreement provides the Company with the rights to grant and authorize sublicenses to use, sell and otherwise exploit the patent rights. The Company could be required to make milestone payments to UCSD upon completion of certain regulatory and commercial milestones. The aggregate potential milestone payments are approximately $1.2 million. The Company has also agreed to pay UCSD royalties of 1.5% of net sales of products sold by the Company or through a sublicense, subject to certain reductions. Additionally, the Company agreed to pay UCSD varying sublicense fees, ranging from 10% to 20%, dependent on when the related milestones are reached. The agreement will expire upon the expiration of the longest-lived patent rights. The agreement may be terminated in its entirety by the Company at any time by giving UCSD ninety days’ prior written notice. The agreement may be terminated in its entirety by UCSD if the Company, at any time, (i) fails to perform or violates any term of the agreement and fails to cure the default within sixty days. Upon termination of the agreement for any reason, UCSD may terminate a sublicensee but will allow the Company to assign any sublicenses to UCSD provided a) that the sublicensee is in good standing upon termination of the agreement with the Company; and b) the sublicensee is not currently involved in litigation as an adverse party to UCSD. Massachusetts Institute of Technology In October 2021, Cend entered into a license agreement with the Massachusetts Institute of Technology ("MIT") under which Cend was granted an exclusive, royalty-bearing license to certain patent rights related to the development of tissue specific delivery of interfering RNA. The agreement provides the Company with the rights to grant and authorize sublicenses to use, sell, and otherwise exploit the patent rights. The Company is required to pay an annual license maintenance fee of $20,000, increasing to $25,000 for year two and three of the agreement, increasing to $50,000 on year four of the agreement and thereafter until the first commercial sale, and increasing to $150,000 each year of the agreement after the first sale. Further, the Company could be required to make milestone payments to MIT upon completion of certain regulatory and commercial milestones. The aggregate potential milestone payments are approximately $5.0 million. The Company has also agreed to pay MIT royalties of 2% of net sales of products sold by the Company or through a sublicense, subject to certain reductions. Additionally, the Company is obligated to pay MIT varying sublicense fees, ranging from 3% to 20%, dependent on when the related milestones are reached. In connection with the close of the Merger,, the Company was required to pay MIT a change of control fee of $0.3 million, which is included in accrued liabilities within the condensed consolidated balance sheets as of September 30, 2022. The agreement will expire upon the expiration or abandonment of all valid claims. The agreement may be terminated in its entirety by the Company at any time by giving MIT six months prior written notice. The agreement may be terminated in its entirety by MIT if the Company, at any time, (i) defaults in the payment of any sum when due and fails to make such payment within thirty days after receipt of written notice, or (ii) commits a material breach of its obligations under the agreement (aside from item (i)) and fails to cure that breach within sixty days after receipt of written notice. Upon termination of the agreement for any reason, the rights and licenses granted to the Company shall terminate and revert to MIT. Upon termination of the agreement for any reason, MIT may terminate a sublicensee but will allow the Company to assign any sublicenses to MIT provided that the sublicensee is in good standing upon termination of the agreement with the Company. Exclusive License and Collaboration Agreement In February 2021, Cend entered into an Exclusive License and Collaboration Agreement (the “Qilu Agreement”) in which Cend granted an exclusive license to Qilu for the development and commercialization of CEND-1 in the Territory (defined as the Greater Area of China including China, Macau, Hong Kong, and Taiwan). Under the terms of the agreement, Qilu is solely responsible for the development of CEND-1 in its Territory. In consideration for the license, Qilu made an upfront payment of $10 million to Cend, which was recognized as revenue by Cend prior to the Merger. In addition, Cend received and recognized as revenue a $5 million development milestone prior to the Merger. The Company is eligible to receive additional developmental and commercial milestone payments up to $100 million and $125 million, respectively, tiered royalties on net sales ranging from 10% to 15%, and tiered sublicensing revenues ranging from 12% to 35%. Unless terminated early, the Qilu Agreement will continue in effect until the expiration of all Qilu payment obligations. Either party may terminate the Qilu Agreement if an undisputed material breach by the other party is not cured within a defined period of time, or upon notice for insolvency-related events of the other party that are not discharged within a defined time period. Qilu may terminate the Qilu Agreement in its entirety, at any time with at least sixty days written notice. All right and obligations of Qilu with respect to such licensed patents and patent applications would terminate. |
Summary of Significant Accoun_2
Summary of Significant Accounting Policies (Policies) | 9 Months Ended |
Sep. 30, 2022 | |
Accounting Policies [Abstract] | |
Basis of Presentation | Basis of Presentation The accompanying unaudited Consolidated Financial Statements have been prepared in accordance with accounting principles generally accepted in the United States of America (“GAAP”) for interim financial information and with the instructions to Form 10-Q and Article 10 of Regulation S-X of the SEC for interim financial information. Accordingly, they do not include all of the information and footnotes required by generally accepted accounting principles for complete financial statements. In the opinion of management, the accompanying Consolidated Financial Statements of the Company and its subsidiaries, which are unaudited, include all normal and recurring adjustments considered necessary to present fairly the Company’s financial position as of September 30, 2022, and the results of its operations and its cash flows for the periods presented. The unaudited consolidated financial statements herein should be read together with the historical consolidated financial statements of the Company for the years ended December 31, 2021 and 2020 included in our 2021 Form 10-K. Operating results for the three and nine months ended September 30, 2022 are not necessarily indicative of the results that may be expected for the year ending December 31, 2022. |
Use of Estimates | Use of Estimates The preparation of financial statements in conformity with GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the consolidated financial statements. Estimates also affect the reported amounts of expenses during the reporting period. The Company bases its estimates on historical experience and other assumptions believed to be reasonable under the circumstances, the results of which form the basis for making judgments about the carrying value of assets and liabilities that are not readily apparent from other sources. The Company makes critical estimates and assumptions in determining stock-based awards values and the valuation of the Merger which was accounted for as an asset acquisition as substantially all of the fair value is concentrated in in-process research and development (“IPR&D”). Accordingly, actual results could differ from those estimates and assumptions. |
Principles of Consolidation | Principles of ConsolidationThe Consolidated Financial Statements include the accounts of Lisata and its wholly owned and majority owned subsidiaries and affiliates. All intercompany activities have been eliminated in consolidation |
Foreign Currency Remeasurement | Foreign Currency Remeasurement The Company’s reporting currency is the U.S. Dollar. The functional currency of DrugCendR Australia PTY Ltd. which is a foreign subsidiary of the Company is the Australian Dollar. The assets and liabilities of DrugCendR Australia PTY Ltd. are translated into U.S. Dollars at the exchange rates in effect at each balance sheet date, and the results of operations are translated using the average exchange rates prevailing throughout the reporting period. Adjustments resulting from translating foreign functional currency financial statements into U.S. Dollars are included in the foreign currency translation adjustment, a component of accumulated other comprehensive income (loss) in stockholders' equity. |
Concentration of Risks | Concentration of Risks The Company is subject to credit risk from its portfolio of cash, cash equivalents and marketable securities. Under its investment policy, the Company limits amounts invested in such securities by credit rating, maturity, industry group, investment type and issuer, except for securities issued by the U.S. government. Cash is held at major banks in the United States and Australia. Therefore, the Company is not exposed to any significant concentrations of credit risk from these financial instruments. The goals of the Company's investment policy, in order of priority, are as follows: safety and preservation |
Share-Based Compensation | In-process Research and Development Expense Upfront payments that relate to the acquisition of a new drug compound, as well as pre-commercial milestone payments, are immediately expensed as IPR&D in the period in which they are incurred, provided that the new drug compound did not also include processes or activities that would constitute a “business” as defined under GAAP, the drug has not achieved regulatory approval for marketing and, absent obtaining such approval, has no established alternative future use. The Company accounts for contingent consideration payable upon achievement of certain regulatory, development or sales milestones in such asset acquisitions when the underlying contingency is probable and estimable. Milestone payments made to third parties subsequent to regulatory approval will be capitalized as intangible assets and amortized over the estimated remaining useful life of the related product. Intangible Asset The Company’s intangible asset consists of a single asset, Cend’s license agreement with Qilu Pharmaceutical, Co., Ltd. (“Qilu”) acquired in the Merger, with a value of $0.4 million. The intangible asset is stated at fair value and is amortized using the straight-line method over its estimated useful life of 5 years. Amortization expense was $3 thousand for the three and nine months ended September 30, 2022. The intangible asset is reviewed for potential impairment when events or circumstances indicate that carrying amounts may not be recoverable. The projected amortization expense is $71 thousand per year for the next five years. Revenue Recognition The Company evaluates license and collaboration arrangements to determine whether units of account within the arrangement exhibit the characteristics of a vendor and customer relationship. For arrangements and units of account where a customer relationship exists, the Company applies the revenue recognition guidance. The Company recognizes revenue upon the transfer of promised goods or services to customers in an amount that reflects the consideration to which the Company expects to be entitled in exchange for those goods or services. To determine revenue recognition for contracts with customers the Company performs the following five steps: (i) identify the contract(s) with a customer; (ii) identify the performance obligations in the contract; (iii) determine the transaction price; (iv) allocate the transaction price to the performance obligations in the contract; and (v) recognize revenue when (or as) the Company satisfies the performance obligations. At contract inception, the Company assesses the goods or services promised within each contract and assesses whether each promised good or service is distinct and determines those that are performance obligations. The Company then recognizes as revenue the amount of the transaction price that is allocated to the respective performance obligation when (or as) the performance obligation is satisfied. Taxes imposed by governmental authorities on the Company's revenue, such as sales taxes and withholding taxes, are excluded from net revenue. If a license to the Company’s intellectual property is determined to be distinct from the other performance obligations identified in the arrangement, the Company recognizes revenues from non-refundable, upfront fees allocated to the license when the license is transferred to the licensee and the licensee is able to use and benefit from the license. If licenses are bundled with other performance obligations, the Company would utilize judgment to assess the nature of the combined performance obligation to determine whether the combined performance obligation is satisfied over time or at a point in time and, if over time, the appropriate method of measuring progress for purposes of recognizing revenue. There was no revenue recognized for the three and nine months ended September 30, 2022. Milestones At the inception of each arrangement that includes milestone payments (variable consideration), the Company evaluates whether the milestones are considered probable of being reached and estimates the amount to be included in the transaction price using the most likely amount method. If it is probable that a significant revenue reversal would not occur, the associated milestone value is included in the transaction price. Milestone payments that are not within the Company or the Company’s collaboration partner’s control, such as regulatory approvals, are generally not considered probable of being achieved until those approvals are received. The transaction price is then allocated to each performance obligation on a relative stand-alone selling price basis, for which the Company recognizes revenue as or when the performance obligations under the contract are satisfied. At the end of each subsequent reporting period, the Company re-evaluates the probability of achievement of such milestones and any related constraint, and if necessary, adjusts the Company’s estimate of the overall transaction price. Any such adjustments are allocated on a cumulative catch-up basis to satisfied and partially satisfied performance obligations, with the consideration allocated to an ongoing performance obligation being recognized over the period of performance. Royalties For arrangements that include sales-based royalties, including milestone payments based on the level of sales, and for which the license is deemed to be the predominant item to which the royalties relate, the Company recognizes revenue at the later of (i) when the related sales occur, or (ii) when the performance obligation to which some or all of the royalty has been allocated has been satisfied (or partially satisfied). To date, the Company has not recognized any royalty revenue from any collaborative arrangement. |
Revenue Recognition | Revenue Recognition The Company evaluates license and collaboration arrangements to determine whether units of account within the arrangement exhibit the characteristics of a vendor and customer relationship. For arrangements and units of account where a customer relationship exists, the Company applies the revenue recognition guidance. The Company recognizes revenue upon the transfer of promised goods or services to customers in an amount that reflects the consideration to which the Company expects to be entitled in exchange for those goods or services. To determine revenue recognition for contracts with customers the Company performs the following five steps: (i) identify the contract(s) with a customer; (ii) identify the performance obligations in the contract; (iii) determine the transaction price; (iv) allocate the transaction price to the performance obligations in the contract; and (v) recognize revenue when (or as) the Company satisfies the performance obligations. At contract inception, the Company assesses the goods or services promised within each contract and assesses whether each promised good or service is distinct and determines those that are performance obligations. The Company then recognizes as revenue the amount of the transaction price that is allocated to the respective performance obligation when (or as) the performance obligation is satisfied. Taxes imposed by governmental authorities on the Company's revenue, such as sales taxes and withholding taxes, are excluded from net revenue. If a license to the Company’s intellectual property is determined to be distinct from the other performance obligations identified in the arrangement, the Company recognizes revenues from non-refundable, upfront fees allocated to the license when the license is transferred to the licensee and the licensee is able to use and benefit from the license. If licenses are bundled with other performance obligations, the Company would utilize judgment to assess the nature of the combined performance obligation to determine whether the combined performance obligation is satisfied over time or at a point in time and, if over time, the appropriate method of measuring progress for purposes of recognizing revenue. There was no revenue recognized for the three and nine months ended September 30, 2022. |
Available-for-Sale-Securities (
Available-for-Sale-Securities (Tables) | 9 Months Ended |
Sep. 30, 2022 | |
Debt Securities, Available-for-sale [Abstract] | |
Schedule of Available-for-sale Securities Reconciliation | The following table is a summary of available-for-sale securities recorded in cash and cash equivalents or marketable securities in our Consolidated Balance Sheets (in thousands): September 30, 2022 December 31, 2021 Cost Gross Unrealized Gains Gross Unrealized Losses Estimated Fair Value Cost Gross Unrealized Gains Gross Unrealized Losses Estimated Fair Value Corporate debt securities $ 39,311 $ — $ (65) $ 39,246 $ 53,135 $ — $ (65) $ 53,070 Commercial paper 14,459 — — 14,459 — — — — Money market funds 13,457 — — 13,457 18,124 — — 18,124 Municipal debt securities 170 — — 170 20,263 — (5) 20,258 Total $ 67,397 $ — $ (65) $ 67,332 $ 91,522 $ — $ (70) $ 91,452 |
Schedule of Marketable Securities | Estimated fair values of available-for-sale securities are generally based on prices obtained from commercial pricing services. The following table summarizes the classification of the available-for-sale securities in our Consolidated Balance Sheets (in thousands): September 30, 2022 December 31, 2021 Cash equivalents $ 23,280 $ 21,129 Marketable securities 44,052 70,323 Total $ 67,332 $ 91,452 |
Investments Classified by Contractual Maturity Date | The following table summarizes our portfolio of available-for-sale securities by contractual maturity (in thousands): September 30, 2022 Amortized Cost Estimated Fair Value Less than one year $ 67,397 $ 67,332 Greater than one year — — Total $ 67,397 $ 67,332 |
Income (Loss) Per Share (Tables
Income (Loss) Per Share (Tables) | 9 Months Ended |
Sep. 30, 2022 | |
Earnings Per Share [Abstract] | |
Schedule of Antidilutive Securities Excluded from Computation of Earnings Per Share | At September 30, 2022 and 2021, the Company excluded the following potentially dilutive securities (in thousands): September 30, 2022 2021 Stock Options 1,399 142 Warrants 1,424 1,424 Restricted Stock Units 48 53 |
Fair Value Measurements (Tables
Fair Value Measurements (Tables) | 9 Months Ended |
Sep. 30, 2022 | |
Fair Value Disclosures [Abstract] | |
Schedule of Assets Measured at Fair Value on Recurring Basis | The following table sets forth by level within the fair value hierarchy the Company's financial assets that were accounted for at fair value on a recurring basis as of September 30, 2022 and December 31, 2021 (in thousands). September 30, 2022 December 31, 2021 Level 1 Level 2 Level 3 Total Level 1 Level 2 Level 3 Total Assets: Marketable securities - available for sale $ — $ 44,052 $ — $ 44,052 $ — $ 70,323 $ — $ 70,323 $ — $ 44,052 $ — $ 44,052 $ — $ 70,323 $ — $ 70,323 |
Accrued Liabilities (Tables)
Accrued Liabilities (Tables) | 9 Months Ended |
Sep. 30, 2022 | |
Accrued Liabilities [Abstract] | |
Schedule of Accrued Liabilities | Accrued liabilities as of September 30, 2022 and December 31, 2021 were as follows (in thousands): September 30, 2022 December 31, 2021 Salaries, employee benefits and related taxes $ 2,147 $ 2,034 Operating lease liabilities — current 203 229 Clinical and R&D related liabilities 2,338 — Other 729 326 Total $ 5,417 $ 2,589 |
Operating Leases (Tables)
Operating Leases (Tables) | 9 Months Ended |
Sep. 30, 2022 | |
Leases [Abstract] | |
Schedule of Operating Lease Liabilities and Right-of-Use Assets on Balance Sheet | Operating lease liabilities and right-of-use assets were recorded in the following captions of our balance sheet were as follows (in thousands): September 30, 2022 December 31, 2021 Right-of Use Assets: Other assets $ 548 $ 724 Total Right-of-Use Asset $ 548 $ 724 Operating Lease Liabilities: Accrued liabilities $ 203 $ 229 Other long-term liabilities 345 485 Total Operating Lease Liabilities $ 548 $ 714 |
Schedule of Future Minimum Lease Payments Under Lease Agreements | Future minimum lease payments under the lease agreements as of September 30, 2022 were as follows (in thousands): Years ended Operating Leases 2022 75 2023 217 2024 190 2025 143 Total lease payments 625 Less: Amounts representing interest (77) Present value of lease liabilities $ 548 |
Stockholders' Equity (Tables)
Stockholders' Equity (Tables) | 9 Months Ended |
Sep. 30, 2022 | |
Equity [Abstract] | |
Schedule of Stock Option and Warrants Activity | The following table summarizes the activity for stock options and warrants for the nine months ended September 30, 2022: Stock Options Warrants Shares Weighted Average Exercise Price Weighted Average Remaining Contractual Term (Years) Aggregate Intrinsic Value (In Thousands) Shares Weighted Average Exercise Price Weighted Average Remaining Contractual Term (Years) Aggregate Intrinsic Value (In Thousands) Outstanding at December 31, 2021 142,041 $ 84.60 7.97 $ — 1,423,774 $ 42.57 4.37 $ — Changes during the period: Granted 37,458 13.49 — — Assumed through merger 1,227,776 3.77 — — Exercised — — — — Forfeited (2,910) 19.96 — — Expired (5,388) 352.31 — — Outstanding at September 30, 2022 1,398,977 $ 10.83 7.30 $ — 1,423,774 $ 42.57 3.63 $ — Vested at September 30, 2022 1,396,921 $ 10.83 7.30 $ — 1,423,774 $ 42.57 3.63 $ — Vested at September 30, 2022 1,110,635 $ 11.82 6.97 $ — 1,423,774 $ 42.57 3.63 $ — |
Schedule of Restricted Stock Activity | During the nine months ended September 30, 2022 and 2021, the Company issued restricted stock for services as follows ($ in thousands): Nine Months Ended September 30, 2022 2021 Number of restricted stock issued 70,740 40,863 Value of restricted stock issued $ 973 $ 878 |
Schedule of Restricted Stock Units Activity | During the nine months ended September 30, 2022 and 2021, the Company issued restricted stock units for services as follows ($ in thousands, except share data): Nine Months Ended September 30, 2022 2021 Number of restricted stock units issued 111,170 30,549 Value of restricted stock units issued $ 1,386 $ 729 |
Share-Based Compensation (Table
Share-Based Compensation (Tables) | 9 Months Ended |
Sep. 30, 2022 | |
Share-based Payment Arrangement, Noncash Expense [Abstract] | |
Schedule Share-based Compensation Expense | The following table summarizes the components of share-based compensation expense for the three and nine months ended September 30, 2022 and 2021 (in thousands): Three Months Ended September 30, Nine Months Ended September 30, 2022 2021 2022 2021 Research and development $ 271 $ 523 $ 631 $ 643 General and administrative 769 250 1,537 996 Total share-based compensation expense $ 1,040 $ 773 $ 2,168 $ 1,639 |
Schedule of Total Compensation Cost Related to Nonvested Awards | Total compensation cost related to non-vested awards not yet recognized and the weighted-average periods over which the awards were expected to be recognized at September 30, 2022 were as follows (in thousands): Stock Options Restricted Stock Units Restricted Stock Unrecognized compensation cost $ 1,577 $ 168 $ 722 Expected weighted-average period in years of compensation cost to be recognized 1.66 2.16 1.83 |
Schedule of Fair Value of Share-based Compensation Awards | Total fair value of shares vested and the weighted average estimated fair values of shares granted for the nine months ended September 30, 2022 and 2021 were as follows (in thousands): Stock Options Nine Months Ended September 30, 2022 2021 Total fair value of shares vested $ 853 $ 757 Weighted average estimated fair value of shares granted $ 1.23 $ 13.59 |
Summary of Significant Accoun_3
Summary of Significant Accounting Policies (Details) - USD ($) $ in Thousands | Sep. 30, 2022 | Dec. 31, 2021 |
Accounting Policies [Abstract] | ||
Finite-Lived Intangible Assets, Net | $ 352 | $ 0 |
Merger (Details)
Merger (Details) - USD ($) $ / shares in Units, $ in Thousands | 9 Months Ended | ||
Sep. 30, 2022 | Sep. 14, 2022 | Dec. 31, 2021 | |
Business Acquisition [Line Items] | |||
Common stock, shares, outstanding | 7,862,602 | 3,985,981 | |
Cash and cash equivalents | $ 31,478 | $ 24,647 | |
CEND | |||
Business Acquisition [Line Items] | |||
Common stock, shares, outstanding | 3,772,768 | ||
Business Combination, Consideration Transferred, Equity Interests Issued and Issuable | $ 2,136 | ||
Business Acquisition, Share Price | $ 6.25 | ||
Business Combination, Recognized Identifiable Assets Acquired, Goodwill, and Liabilities Assumed, Net | $ 23,580 | ||
Investments in and Advance to Affiliates, Subsidiaries, Associates, and Joint Ventures | 10,000 | ||
Business Combination, Acquisition Related Costs | 382 | ||
Business Combination, Consideration Transferred | 36,098 | ||
Cash and cash equivalents | 7,062 | ||
Business Combination, Recognized Identifiable Assets Acquired and Liabilities Assumed, Liabilities | (1,690) | ||
Business Combination, Recognized Identifiable Assets Acquired and Liabilities Assumed, Noncurrent Liabilities, Other | (22) | ||
Business Combination, Recognized Identifiable Assets Acquired and Liabilities Assumed, Finite-Lived Intangibles | 30,393 | ||
Finite-lived Intangible Assets Acquired | $ 355 |
Available-for-Sale-Securities -
Available-for-Sale-Securities - Schedule of Available-for-Sale Securities Reconciliation (Details) - USD ($) $ in Thousands | Sep. 30, 2022 | Dec. 31, 2021 |
Debt Securities, Available-for-sale [Line Items] | ||
Cost | $ 67,397 | $ 91,522 |
Gross Unrealized Gains | 0 | 0 |
Gross Unrealized Losses | (65) | (70) |
Estimated Fair Value | 67,332 | 91,452 |
Corporate debt securities | ||
Debt Securities, Available-for-sale [Line Items] | ||
Cost | 39,311 | 53,135 |
Gross Unrealized Gains | 0 | 0 |
Gross Unrealized Losses | (65) | (65) |
Estimated Fair Value | 39,246 | 53,070 |
Commercial Paper | ||
Debt Securities, Available-for-sale [Line Items] | ||
Cost | 14,459 | 0 |
Gross Unrealized Gains | 0 | 0 |
Gross Unrealized Losses | 0 | 0 |
Estimated Fair Value | 14,459 | 0 |
Money market funds | ||
Debt Securities, Available-for-sale [Line Items] | ||
Cost | 13,457 | 18,124 |
Gross Unrealized Gains | 0 | 0 |
Gross Unrealized Losses | 0 | 0 |
Estimated Fair Value | 13,457 | 18,124 |
Municipal debt securities | ||
Debt Securities, Available-for-sale [Line Items] | ||
Cost | 170 | 20,263 |
Gross Unrealized Gains | 0 | 0 |
Gross Unrealized Losses | 0 | (5) |
Estimated Fair Value | $ 170 | $ 20,258 |
Available-for-Sale-Securities_2
Available-for-Sale-Securities - Classification of Available-for-Sale Securities (Details) - USD ($) $ in Thousands | Sep. 30, 2022 | Dec. 31, 2021 |
Debt Securities, Available-for-sale [Abstract] | ||
Cash equivalents | $ 23,280 | $ 21,129 |
Marketable securities | 44,052 | 70,323 |
Total | $ 67,332 | $ 91,452 |
Available-for-Sale-Securities_3
Available-for-Sale-Securities - Available-for-Sale Securities by Contractual Maturity (Details) - USD ($) $ in Thousands | Sep. 30, 2022 | Dec. 31, 2021 |
Amortized Cost | ||
Less than one year | $ 67,397 | |
Greater than one year | 0 | |
Cost | 67,397 | $ 91,522 |
Estimated Fair Value | ||
Less than one year | 67,332 | |
Greater than one year | 0 | |
Total estimated fair value | $ 67,332 | $ 91,452 |
Income (Loss) Per Share (Detail
Income (Loss) Per Share (Details) - shares shares in Thousands | 9 Months Ended | |
Sep. 30, 2022 | Sep. 30, 2021 | |
Stock Options | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Antidilutive securities excluded from computation of earnings per share | 1,399 | 142 |
Warrants | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Antidilutive securities excluded from computation of earnings per share | 1,424 | 1,424 |
Restricted Stock Units | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Antidilutive securities excluded from computation of earnings per share | 48 | 53 |
Fair Value Measurements (Detail
Fair Value Measurements (Details) - Recurring - USD ($) $ in Thousands | Sep. 30, 2022 | Dec. 31, 2021 |
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Marketable securities - available for sale | $ 44,052 | $ 70,323 |
Assets, fair value disclosure | 44,052 | 70,323 |
Level 1 | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Marketable securities - available for sale | 0 | 0 |
Assets, fair value disclosure | 0 | 0 |
Level 2 | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Marketable securities - available for sale | 44,052 | 70,323 |
Assets, fair value disclosure | 44,052 | 70,323 |
Level 3 | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Marketable securities - available for sale | 0 | 0 |
Assets, fair value disclosure | $ 0 | $ 0 |
Accrued Liabilities (Details)
Accrued Liabilities (Details) - USD ($) $ in Thousands | Sep. 30, 2022 | Dec. 31, 2021 |
Accrued Liabilities [Abstract] | ||
Salaries, employee benefits and related taxes | $ 2,147 | $ 2,034 |
Operating lease liabilities — current | 203 | 229 |
Clinical and R&D related liabilities | 2,338 | 0 |
Other | 729 | 326 |
Total accrued liabilities | $ 5,417 | $ 2,589 |
Operating Leases - Narrative (D
Operating Leases - Narrative (Details) | Sep. 30, 2022 office |
Leases [Abstract] | |
Number of offices under operating leases | 2 |
Weighted average remaining lease term for operating leases (in years) | 1 year 9 months 18 days |
Weighted average discount rate for operating leases (percent) | 9.625% |
Operating Leases - Balance Shee
Operating Leases - Balance Sheet Presentation (Details) - USD ($) $ in Thousands | Sep. 30, 2022 | Dec. 31, 2021 |
Right-of Use Assets: | ||
Right-of-use assets | $ 548 | $ 724 |
Right-of-use assets, balance sheet line item | Other assets | Other assets |
Operating Lease Liabilities: | ||
Operating lease liabilities, current | $ 203 | $ 229 |
Operating lease liabilities, noncurrent | 345 | 485 |
Operating lease liabilities | $ 548 | $ 714 |
Operating lease liabilities, current, balance sheet line item | Accrued liabilities | Accrued liabilities |
Operating lease liabilities, noncurrent, balance sheet line item | Other long-term liabilities | Other long-term liabilities |
Operating Leases - Future Minim
Operating Leases - Future Minimum Lease Payments (Details) - USD ($) $ in Thousands | Sep. 30, 2022 | Dec. 31, 2021 |
Finance Minimum Lease Payments | ||
2022 | $ 75 | |
2023 | 217 | |
2024 | 190 | |
2025 | 143 | |
Total lease payments | 625 | |
Less: Amounts representing interest | (77) | |
Present value of lease liabilities | $ 548 | $ 714 |
Stockholders' Equity - Equity I
Stockholders' Equity - Equity Issuances (Details) - USD ($) $ / shares in Units, $ in Millions | 1 Months Ended | 9 Months Ended | ||
Mar. 31, 2019 | Sep. 30, 2022 | Jun. 04, 2021 | Sep. 30, 2019 | |
Lincoln Park Agreement | ||||
Class of Stock [Line Items] | ||||
Aggregate offering amount authorized per agreement | $ 26 | |||
Commitment shares issued as consideration per agreement (in shares) | 181,510 | |||
Number of shares sold (in shares) | 250,000 | |||
Price of shares sold (in dollars per share) | $ 4 | |||
Gross price for stock transaction | $ 1 | |||
Term of agreement (in months) | 36 months | |||
Number of shares allowable to direct for Regular Purchase (in shares) | 100,000 | |||
Maximum obligation per directed purchase transaction for Regular Purchase | $ 2.5 | |||
Maximum shares allowed in Accelerated Purchase as percent of shares In Regular Purchase (percent) | 300% | |||
Maximum shares allowed in Accelerated Purchase as percent of shares traded during specified period (percent) | 30% | |||
Maximum beneficial ownership allowable per agreement (percent) | 9.99% | |||
ATM Agreement | ||||
Class of Stock [Line Items] | ||||
Aggregate offering amount authorized per agreement | $ 50 | |||
Stock issued (shares) | 0 |
Stockholders' Equity - Stock Op
Stockholders' Equity - Stock Options and Warrants (Details) - USD ($) $ / shares in Units, $ in Thousands | 9 Months Ended | 12 Months Ended |
Sep. 30, 2022 | Dec. 31, 2021 | |
Stock Options, Shares | ||
Options, Outstanding, Beginning of Period (in shares) | 142,041 | |
Options, Granted (in shares) | 37,458 | |
Options, Exercised (in shares) | 0 | |
Options, Forfeited (in shares) | (2,910) | |
Options, Expired (in shares) | (5,388) | |
Options, Outstanding, End of Period (in shares) | 1,398,977 | 142,041 |
Options, Vested and expected to vest (in shares) | 1,396,921 | |
Options, Vested (in shares) | 1,110,635 | |
Stock Options, Weighted Average Exercise Price | ||
Options, Outstanding. Beginning of Period (in dollars per share) | $ 84.60 | |
Options, Granted (in dollars per share) | 13.49 | |
Options, Exercised (in dollars per share) | 0 | |
Options, Forfeited (in dollars per share) | 19.96 | |
Options, Expired (in dollars per share) | 352.31 | |
Options, Outstanding, End of Period (in dollars per share) | 10.83 | $ 84.60 |
Options, Vested and expected to vest (in dollars per share) | 10.83 | |
Options, Vested (in dollars per share) | $ 11.82 | |
Stock Options, Weighted Average Contractual Term and Intrinsic Value | ||
Options, Outstanding, Weighted Average Remaining Contractual Term | 7 years 3 months 18 days | 7 years 11 months 19 days |
Options, Vested and expected to vest, Weighted Average Remaining Contractual Term | 7 years 3 months 18 days | |
Options, Vested, Weighted Average Remaining Contractual Term | 6 years 11 months 19 days | |
Options, Outstanding, Aggregate Intrinsic Value | $ 0 | $ 0 |
Options, Vested and expected to vest, Aggregate Intrinsic Value | 0 | |
Options, Vested, Aggregate Intrinsic Value | $ 0 | |
Warrants, Shares | ||
Warrants, Outstanding, Beginning of Period (in shares) | 1,423,774 | |
Warrants, Granted (in shares) | 0 | |
Warrants, Exercised (in shares) | 0 | |
Warrants, Forfeited (in shares) | 0 | |
Warrants, Expired (in shares) | 0 | |
Warrants, Outstanding, End of Period (in shares) | 1,423,774 | 1,423,774 |
Warrants, Vested and expected to vest (in shares) | 1,423,774 | |
Warrants, Vested (in shares) | 1,423,774 | |
Warrants, Weighted Average Exercise Price | ||
Warrants Outstanding, Beginning of Period (in dollars per share) | $ 42.57 | |
Warrants, Granted (in dollars per share) | 0 | |
Warrants, Exercised (in dollars per share) | 0 | |
Warrants, Forfeited (in dollars per share) | 0 | |
Warrants, Expired (in dollars per share) | 0 | |
Warrants Outstanding, End of Period (in dollars per share) | 42.57 | $ 42.57 |
Weighted Average Exercise Price, Warrants Vested And Expected To Vest | 42.57 | |
Warrants, Vested, Weighted Average Exercise Price (in dollars per share) | $ 42.57 | |
Warrants, Weighted Average Contractual Term and Intrinsic Value | ||
Warrants, Outstanding, Weighted Average Remaining Contractual Term | 3 years 7 months 17 days | 4 years 4 months 13 days |
Warrants, Vested and expected to vest, Weighted Average Remaining Contractual Term | 3 years 7 months 17 days | |
Warrants, Vested, Weighted Average Remaining Contractual Term | 3 years 7 months 17 days | |
Warrants Outstanding, Aggregate Intrinsic Value | $ 0 | $ 0 |
Warrants, Vested and expected to vest, Aggregate Intrinsic Value | 0 | |
Warrants, Vested, Aggregate Intrinsic Value | $ 0 |
Stockholders' Equity - Restrict
Stockholders' Equity - Restricted Stock and Restricted Stock Units (Details) - USD ($) $ / shares in Units, $ in Thousands | 9 Months Ended | |
Sep. 30, 2022 | Sep. 30, 2021 | |
Restricted Stock | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Number of shares issued | 70,740 | 40,863 |
Value of shares issued | $ 973 | $ 878 |
Weighted average estimated fair value | $ 12.46 | $ 23.85 |
Restricted Stock | Minimum | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Vesting terms (years) | 1 year | |
Restricted Stock | Maximum | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Vesting terms (years) | 4 years | |
Restricted Stock Units | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Number of shares issued | 111,170 | 30,549 |
Value of shares issued | $ 1,386 | $ 729 |
Vesting terms (years) | 1 year |
Share-Based Compensation - Shar
Share-Based Compensation - Share-Based Compensation Expense (Details) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2022 | Sep. 30, 2021 | Sep. 30, 2022 | Sep. 30, 2021 | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Total share-based compensation expense | $ 1,040 | $ 773 | $ 2,168 | $ 1,639 |
Research and development | ||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Total share-based compensation expense | 271 | 523 | 631 | 643 |
General and administrative | ||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Total share-based compensation expense | $ 1,537 | $ 996 | ||
Selling, General and Administrative Expenses [Member] | ||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Total share-based compensation expense | $ 769 | $ 250 |
Share-Based Compensation - Comp
Share-Based Compensation - Compensation Cost Not Yet Recognized (Details) $ in Thousands | 9 Months Ended |
Sep. 30, 2022 USD ($) | |
Stock Options | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |
Unrecognized compensation cost | $ 1,577 |
Expected weighted-average period in years of compensation cost to be recognized | 1 year 7 months 28 days |
Restricted Stock Units | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |
Unrecognized compensation cost | $ 168 |
Expected weighted-average period in years of compensation cost to be recognized | 2 years 1 month 28 days |
Restricted Stock | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |
Unrecognized compensation cost | $ 722 |
Expected weighted-average period in years of compensation cost to be recognized | 1 year 9 months 29 days |
Share-Based Compensation - Fair
Share-Based Compensation - Fair Value of Shares Vested and Weighted Average Estimated Fair Value of Shares Granted (Details) - Stock Options - USD ($) $ / shares in Units, $ in Thousands | 9 Months Ended | |
Sep. 30, 2022 | Sep. 30, 2021 | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Total fair value of shares vested | $ 853 | $ 757 |
Weighted average estimated fair value of shares granted | $ 1.23 | $ 13.59 |
Income Taxes (Details)
Income Taxes (Details) - USD ($) $ in Thousands | Feb. 22, 2022 | Dec. 31, 2021 | Dec. 31, 2020 |
Operating Loss Carryforwards [Line Items] | |||
Possible additional NOLs for five years resulting from Net Unrealized Built-in Gain rules | $ 1,100 | ||
Proceeds from sale of NOLs, gross | $ 2,500 | ||
Net proceeds from sale of NOLs | 2,300 | ||
Loss on sale of NOLs | $ 100 | ||
Federal | |||
Operating Loss Carryforwards [Line Items] | |||
Net operating loss carryforwards, prior to write down | 281,000 | ||
Net operating loss carryforwards | 112,000 | $ 264,000 | |
Write down of NOLs set to expire unutilized | 169,000 | ||
State | New Jersey | |||
Operating Loss Carryforwards [Line Items] | |||
Net operating loss carryforwards | 97,000 | 99,000 | |
State | California | |||
Operating Loss Carryforwards [Line Items] | |||
Net operating loss carryforwards | 70,000 | 70,000 | |
State | New York | |||
Operating Loss Carryforwards [Line Items] | |||
Net operating loss carryforwards | $ 13,000 | $ 13,000 |
Income Taxes (Details)_2
Income Taxes (Details) $ in Millions | 9 Months Ended |
Sep. 30, 2022 USD ($) | |
Income Tax Disclosure [Abstract] | |
Research tax credit rate | 43.50% |
Research tax credit | $ 0.4 |
License Agreements (Details)
License Agreements (Details) - USD ($) | Dec. 31, 2021 | Oct. 31, 2021 | Mar. 31, 2021 | Dec. 31, 2015 |
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | ||||
Annual license maintenance fee, after first sale | $ 150,000,000 | |||
Sanford Burnham Prebys | Collaborative Arrangement, Transaction with Party to Collaborative Arrangement | ||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | ||||
Shares issued under license agreement | 382,030 | |||
Annual license maintenance fee | 20,000,000 | $ 10,000,000 | ||
Annual license maintenance fee, year seven | 20,000,000 | |||
Potential milestone payments | $ 23,200,000 | $ 10,600,000 | ||
Royalties, net of sales | 4% | 4% | ||
Sublicensing fee | $ 0.25 | |||
Annual license maintenance fee, year four | $ 30,000,000 | |||
Shares held by third party | 382,030 | |||
Sanford Burnham Prebys | Collaborative Arrangement, Transaction with Party to Collaborative Arrangement | Minimum | ||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | ||||
Sublicensing fee | 0.10 | |||
Sanford Burnham Prebys | Collaborative Arrangement, Transaction with Party to Collaborative Arrangement | Maximum | ||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | ||||
Sublicensing fee | 0.25 | |||
University of California at San Diego | Collaborative Arrangement, Transaction with Party to Collaborative Arrangement | ||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | ||||
Potential milestone payments | $ 1,200,000 | |||
Royalties, net of sales | 1.50% | |||
University of California at San Diego | Collaborative Arrangement, Transaction with Party to Collaborative Arrangement | Minimum | ||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | ||||
Sublicensing fee | $ 0.10 | |||
University of California at San Diego | Collaborative Arrangement, Transaction with Party to Collaborative Arrangement | Maximum | ||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | ||||
Sublicensing fee | $ 0.20 | |||
Massachusetts Institute of Technology | Collaborative Arrangement, Transaction with Party to Collaborative Arrangement | ||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | ||||
Annual license maintenance fee | 20,000,000 | |||
Potential milestone payments | $ 5,000,000 | |||
Royalties, net of sales | 2% | |||
Annual license maintenance fee, year four | $ 50,000,000 | |||
Annual license maintenance fee, years two and three | 25,000,000 | |||
Change of control fee | 300,000 | |||
Massachusetts Institute of Technology | Collaborative Arrangement, Transaction with Party to Collaborative Arrangement | Minimum | ||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | ||||
Sublicensing fee | 0.03 | |||
Massachusetts Institute of Technology | Collaborative Arrangement, Transaction with Party to Collaborative Arrangement | Maximum | ||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | ||||
Sublicensing fee | $ 0.20 |
Research Collaboration and Li_2
Research Collaboration and License Agreement (Details) - Qilu - License - USD ($) $ in Thousands | Sep. 14, 2022 | Feb. 28, 2021 |
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | ||
Contract with customer, liability | $ 10,000 | |
Revenue from contract | $ 5,000 | |
Minimum | ||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | ||
Variable consideration amounts, milestones | $ 100,000 | |
Percentage of net sale | 10% | |
Percentage of sublicensing revenues | 12% | |
Maximum | ||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | ||
Variable consideration amounts, milestones | $ 125,000 | |
Percentage of net sale | 15% | |
Percentage of sublicensing revenues | 35% |