Document And Entity Information
Document And Entity Information - shares | 6 Months Ended | |
Jun. 30, 2021 | Aug. 12, 2021 | |
Document Information Line Items | ||
Entity Registrant Name | Longeveron Inc. | |
Trading Symbol | LGVN | |
Document Type | 10-Q | |
Current Fiscal Year End Date | --12-31 | |
Amendment Flag | false | |
Entity Central Index Key | 0001721484 | |
Entity Current Reporting Status | Yes | |
Entity Filer Category | Non-accelerated Filer | |
Document Period End Date | Jun. 30, 2021 | |
Document Fiscal Year Focus | 2021 | |
Document Fiscal Period Focus | Q2 | |
Entity Small Business | true | |
Entity Emerging Growth Company | true | |
Entity Shell Company | false | |
Entity Ex Transition Period | false | |
Document Quarterly Report | true | |
Document Transition Report | false | |
Entity File Number | 001-40060 | |
Entity Incorporation, State or Country Code | DE | |
Entity Tax Identification Number | 47-2174146 | |
Entity Address, Address Line One | 1951 NW 7th Avenue | |
Entity Address, Address Line Two | Suite 520 | |
Entity Address, City or Town | Miami | |
Entity Address, State or Province | FL | |
Entity Address, Postal Zip Code | 33136 | |
City Area Code | 305 | |
Local Phone Number | 909-0840 | |
Title of 12(b) Security | Class A Common Stock, par value $0.001 per share | |
Security Exchange Name | NASDAQ | |
Entity Interactive Data Current | Yes | |
Class A Common stock | ||
Document Information Line Items | ||
Entity Common Stock, Shares Outstanding | 3,411,796 | |
Class B Common stock | ||
Document Information Line Items | ||
Entity Common Stock, Shares Outstanding | 15,702,834 |
Condensed Balance Sheets
Condensed Balance Sheets - USD ($) $ in Thousands | Jun. 30, 2021 | Dec. 31, 2020 |
Current assets: | ||
Cash and cash equivalents | $ 16,833 | $ 816 |
Short-term investments | 4,555 | |
Prepaid expenses and other current assets | 593 | 52 |
Deferred offering costs | 561 | |
Accounts and grants receivable | 130 | 420 |
Total current assets | 22,111 | 1,849 |
Property and equipment, net | 3,234 | 3,597 |
Intangible assets, net | 2,390 | 1,547 |
Right-of-use (ROU) asset | 1,945 | 2,070 |
Other assets | 177 | 177 |
Total assets | 29,857 | 9,240 |
Current liabilities: | ||
Accounts payable | 149 | 1,590 |
Accrued expenses | 1,277 | 1,542 |
Current portion of lease liability | 524 | 511 |
Short-term note payable | 38 | |
Current portion of loans | 5 | 139 |
Deferred revenue | 230 | 10 |
Total current liabilities | 2,185 | 3,830 |
Long-term liabilities: | ||
Long-term loans | 145 | 311 |
Lease liability | 2,877 | 3,142 |
Total long-term liabilities | 3,022 | 3,453 |
Total liabilities | 5,207 | 7,283 |
Commitments and contingencies (Note 9) | ||
Members’ equity and stockholders’ equity: | ||
Members’ equity | 1,957 | |
Preferred stock, $0.001 par value per share, 5,000,000 shares authorized, no shares issued and outstanding at June 30, 2021; no shares authorized, issued and outstanding, at December 31, 2020 | ||
Class A common stock, $0.001 par value per share, 84,295,000 shares authorized, 3,411,796 shares issued and outstanding at June 30, 2021; no shares authorized, issued and outstanding, at December 31, 2020 | 3 | |
Class B common stock, $0.001 par value per share, 15,705,000 shares authorized, 15,702,834 shares issued and outstanding at June 30, 2021; no shares authorized, issued and outstanding, at December 31, 2020 | 16 | |
Additional paid-in capital | 59,745 | |
Stock subscription receivable | (100) | |
Accumulated deficit | (35,014) | |
Total members’ equity and stockholders’ equity | 24,650 | 1,957 |
Total liabilities, members’ equity and stockholders’ equity | $ 29,857 | $ 9,240 |
Condensed Balance Sheets (Paren
Condensed Balance Sheets (Parentheticals) - $ / shares | Jun. 30, 2021 | Dec. 31, 2020 |
Preferred stock, par value (in Dollars per share) | $ 0.001 | $ 0.001 |
Preferred stock, shares authorized | 5,000,000 | |
Preferred stock, shares issued | 0 | 0 |
Preferred stock, shares outstanding | 0 | 0 |
Class A Common Stock | ||
Common stock, par value (in Dollars per share) | $ 0.001 | $ 0.001 |
Common stock, shares authorized | 84,295,000 | |
Common stock, shares issued | 3,411,796 | |
Common stock, shares outstanding | 3,411,796 | |
Class B Common Stock | ||
Common stock, par value (in Dollars per share) | $ 0.001 | $ 0.001 |
Common stock, shares authorized | 15,705,000 | |
Common stock, shares issued | 15,702,834 | |
Common stock, shares outstanding | 15,702,834 |
Condensed Statements of Operati
Condensed Statements of Operations (Unaudited) - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2021 | Jun. 30, 2020 | Jun. 30, 2021 | Jun. 30, 2020 | |
Revenues | ||||
Grant revenue | $ 275 | $ 868 | $ 486 | $ 1,814 |
Clinical trial revenue | 214 | 379 | 762 | |
Contract revenue | 8 | 8 | ||
Total revenues | 489 | 876 | 865 | 2,584 |
Cost of revenues | 281 | 764 | 508 | 1,660 |
Gross profit | 208 | 112 | 357 | 924 |
Operating expenses | ||||
General and administrative | 3,257 | 649 | 5,460 | 1,335 |
Research and development | 1,960 | 642 | 3,309 | 930 |
Selling and marketing | 53 | 47 | 109 | 97 |
Total operating expenses | 5,270 | 1,338 | 8,878 | 2,362 |
Loss from operations | (5,062) | (1,226) | (8,521) | (1,438) |
Other income and (expenses) | ||||
Forgiveness of Paycheck Protection Program loan | 300 | |||
Interest expense | (2) | (1) | ||
Other income, net | 54 | 10 | 101 | 10 |
Total other income and (expenses), net | 52 | 10 | 400 | 10 |
Net loss | $ (5,010) | $ (1,216) | $ (8,121) | $ (1,428) |
Basic and diluted net loss per share (in Dollars per share) | $ (0.26) | $ (0.08) | $ (0.44) | $ (0.09) |
Basic and diluted weighted average common shares outstanding (in Shares) | 19,005,007 | 15,970,421 | 18,252,219 | 15,970,421 |
Condensed Statements of Members
Condensed Statements of Members’ Equity and Stockholders’ Equity (Unaudited) - USD ($) $ in Thousands | Series A Units | Series B Units | Series C Units | Class A Common Stock | Class B Common Stock | Subscription Receivable | Additional Paid-In Capital | Accumulated Deficit | Total |
Balance at Dec. 31, 2019 | $ 250 | $ 1,832 | $ 2,513 | $ (150) | $ 4,445 | ||||
Balance (in Shares) at Dec. 31, 2019 | 1,000,000 | 1,000,000 | 43,695 | ||||||
Series C units issued for cash | $ 1,100 | 1,100 | |||||||
Series C units issued for cash (in Shares) | 18,335 | ||||||||
Issuance of Series C units as payment for amounts accrued | $ 44 | 44 | |||||||
Issuance of Series C units as payment for amounts accrued (in Shares) | 734 | ||||||||
Equity-based compensation | $ 24 | 24 | |||||||
Cash received pursuant to subscription receivable | 50 | 50 | |||||||
Net loss | (1,414) | (14) | (1,428) | ||||||
Balance at Jun. 30, 2020 | $ 250 | $ 418 | $ 3,667 | (100) | 4,235 | ||||
Balance (in Shares) at Jun. 30, 2020 | 1,000,000 | 1,000,000 | 62,764 | ||||||
Balance at Mar. 31, 2020 | $ 250 | $ 1,621 | $ 3,669 | (100) | 5,440 | ||||
Balance (in Shares) at Mar. 31, 2020 | 1,000,000 | 1,000,000 | 62,764 | ||||||
Equity-based compensation | $ 11 | 11 | |||||||
Net loss | (1,203) | (13) | (1,216) | ||||||
Balance at Jun. 30, 2020 | $ 250 | $ 418 | $ 3,667 | (100) | 4,235 | ||||
Balance (in Shares) at Jun. 30, 2020 | 1,000,000 | 1,000,000 | 62,764 | ||||||
Balance at Dec. 31, 2020 | $ 250 | $ (1,777) | $ 3,584 | (100) | 1,957 | ||||
Balance (in Shares) at Dec. 31, 2020 | 1,000,000 | 1,000,000 | 62,764 | ||||||
Conversion of Units into Class A and B common stock | $ (250) | $ 1,777 | $ (3,584) | $ 16 | 28,934 | (26,893) | |||
Conversion of Units into Class A and B common stock (in Shares) | (1,000,000) | (1,000,000) | (62,764) | 338,030 | 15,702,834 | ||||
Initial public offering and overallotment of Class A common stock, net of $2,969 in issuance costs | $ 3 | 26,131 | 26,134 | ||||||
Initial public offering and overallotment of Class A common stock, net of $2,969 in issuance costs (in Shares) | 2,910,000 | ||||||||
Class A common stock, issued for consulting | 1,197 | 1,197 | |||||||
Class A common stock, issued for consulting (in Shares) | 163,766 | ||||||||
Equity-based compensation | 3,483 | 3,483 | |||||||
Net loss | (8,121) | (8,121) | |||||||
Balance at Jun. 30, 2021 | $ 3 | $ 16 | (100) | 59,745 | (35,014) | 24,650 | |||
Balance (in Shares) at Jun. 30, 2021 | 3,411,796 | 15,702,834 | |||||||
Balance at Mar. 31, 2021 | $ 3 | $ 16 | (100) | 56,580 | (30,004) | 26,495 | |||
Balance (in Shares) at Mar. 31, 2021 | 3,280,743 | 15,702,834 | |||||||
Class A common stock, issued for consulting | 946 | 946 | |||||||
Class A common stock, issued for consulting (in Shares) | 131,053 | ||||||||
Equity-based compensation | 2,219 | 2,219 | |||||||
Net loss | (5,010) | (5,010) | |||||||
Balance at Jun. 30, 2021 | $ 3 | $ 16 | $ (100) | $ 59,745 | $ (35,014) | $ 24,650 | |||
Balance (in Shares) at Jun. 30, 2021 | 3,411,796 | 15,702,834 |
Condensed Statements of Membe_2
Condensed Statements of Members’ Equity and Stockholders’ Equity (Unaudited) (Parentheticals) $ in Thousands | 6 Months Ended |
Jun. 30, 2021USD ($) | |
Statement of Stockholders' Equity [Abstract] | |
Net of issuance costs | $ 2,969 |
Condensed Statements of Cash Fl
Condensed Statements of Cash Flows (Unaudited) - USD ($) $ in Thousands | 6 Months Ended | |
Jun. 30, 2021 | Jun. 30, 2020 | |
Cash flows from operating activities | ||
Net loss | $ (8,121) | $ (1,428) |
Adjustments to reconcile net loss to net cash used in operating activities: | ||
Depreciation and amortization | 446 | 392 |
Forgiveness of Paycheck Protection Program loan | (300) | |
Change in fair value of short-term investments | (22) | |
Non-cash stock payments to employees and consultants | 264 | 44 |
Equity-based compensation | 3,483 | 23 |
Changes in operating assets and liabilities: | ||
Accounts and grants receivable | 291 | 3 |
Prepaid expenses and other current assets | (541) | (9) |
Other assets | 24 | |
Accounts payable | (1,389) | (119) |
Deferred revenue | 220 | (502) |
Accrued expenses | (188) | 51 |
ROU asset and lease liability | (127) | (105) |
Net cash used in operating activities | (5,984) | (1,626) |
Cash flows from investing activities | ||
Short-term investments | (4,533) | |
Acquisition of intangible assets | (124) | (50) |
Acquisition of property and equipment | (131) | |
Net cash used in investing activities | (4,657) | (181) |
Cash flows from financing activities | ||
Proceeds from initial public offering of common stock, net of commissions and expenses | 26,696 | |
Proceeds from issuance of Series C units | 1,100 | |
Repayments of short-term note payable | (38) | |
Proceeds of long-term notes payables | 450 | |
Proceeds from subscription agreement | 50 | |
Net cash provided by financing activities | 26,658 | 1,600 |
Increase in cash and cash equivalents | 16,017 | (207) |
Cash and cash equivalents at beginning of the period | 816 | 1,866 |
Cash and cash equivalents at end of the period | 16,833 | $ 1,659 |
Supplement Disclosure of Non-cash Investing and Financing Activities: | ||
Conversion of Series A, B and C units into Class A and B common stock | $ (2,057) |
Nature of Business, Basis of Pr
Nature of Business, Basis of Presentation, and Liquidity | 6 Months Ended |
Jun. 30, 2021 | |
Accounting Policies [Abstract] | |
Nature of Business, Basis of Presentation, and Liquidity | 1. Nature of Business, Basis of Presentation, and Liquidity Nature of business: On February 12, 2021, Longeveron LLC converted its corporate form from a Delaware limited liability company (Longeveron, LLC) to a Delaware corporation, Longeveron Inc. (the “Company,” “Longeveron” or “we,” “us,” or “our”). Longeveron LLC was formed as a Delaware limited liability company on October 9, 2014 and authorized to transact business in Florida on December 15, 2014. The Company is a clinical stage biotechnology company developing cellular therapies for specific aging-related and life-threatening conditions. The Company operates out of its leased facilities in Miami, Florida. The Company is subject to risks and uncertainties common to early-stage companies in the biotechnology industry, including, but not limited to, development by competitors of new technological innovations, dependence on licenses, protection of proprietary technology, dependence on key personnel, compliance with government regulations and the need to obtain additional financing to fund operations. Product candidates currently under development will require significant additional research and development efforts, including extensive pre-clinical studies and clinical trials and regulatory approval, prior to commercialization. These efforts require significant amounts of additional capital, adequate personnel infrastructure and extensive compliance and reporting capabilities. The Company’s product candidates are currently in development. There can be no assurance that the Company’s research and development will be successfully completed, that adequate protection for the Company’s intellectual property will be obtained, that any products developed will obtain necessary government regulatory approval or that any approved products will be commercially viable. Even if the Company’s product development efforts are successful, it is uncertain when, if ever, the Company will generate significant revenue from product sales. The Company operates in an environment of rapid technological change and substantial competition from, among others, existing pharmaceutical and biotechnology companies. In addition, the Company is dependent upon the services of its employees, partners and consultants. Initial Public Offering (“IPO”): On February 12, 2021 our Class A common stock began to trade on NASDAQ under the stock symbol “LGVN”. Pursuant to the IPO, the Company sold 2,660,000 shares of Class A common stock at a public offering price of $10.00 per share for aggregate gross proceeds of $26.6 million prior to deducting underwriting discounts, commissions, and other offering expenses. In addition, the Company granted the underwriters a 30-day option to purchase up to an additional 399,000 shares at the public offering price less the underwriting discounts and commissions. On March 15, 2021, the Company’s underwriters partially exercised its over-allotment option, resulting in the Company selling an additional 250,000 shares of Class A common stock at a public offering price of $10.00 per share for aggregate gross proceeds of $2.5 million prior to deducting underwriting discounts, commissions, and other offering expenses. Basis of presentation: The accompanying unaudited Condensed Financial Statements have been prepared in accordance with the requirements of Article 8 of Regulation S-X promulgated under the Exchange Act and, therefore, do not include all information and footnotes necessary for a fair presentation of financial position, results of operations, and cash flows in conformity with accounting principles generally accepted in the United States of America (“U.S. GAAP”). These unaudited Condensed Financial Statements should be read in conjunction with our Financial Statements and related notes, included in our Annual Report on Form 10-K for the fiscal year ended December 31, 2020, filed with the SEC. Unless otherwise stated, references to particular years or quarters refer to our fiscal years ended December 31 and the associated quarters of those fiscal years. These Condensed Financial Statements are unaudited, but include all adjustments, including normal recurring adjustments, which, in the opinion of management, are necessary to present fairly our financial position, results of operations and cash flows for the interim periods presented. The Condensed Balance Sheet as of December 31, 2020 has been derived from the audited financial statements at that date but does not include all of the information and notes required by U.S. GAAP for complete financial statements. Results of operations for interim periods are not necessarily indicative of the results that may be expected for the year as a whole. Liquidity: Since inception, the Company has been engaged in organizational activities, including raising capital, and research and development activities. The Company does not yet have a product that has been approved by the U.S. Food and Drug Administration (“FDA”), and has only generated revenues from grants, clinical trials and contract manufacturing. The Company has not yet achieved profitable operations or generated positive cash flows from operations. The Company intends to continue its efforts to raise additional equity financing, develop its intellectual property, and secure regulatory approvals to commercialize its products. There is no assurance that profitable operations, if achieved, could be sustained on a continuing basis. Further, the Company’s future operations are dependent on the success of the Company’s efforts to raise additional capital, its research and commercialization efforts, regulatory approval, and, ultimately, the market acceptance of the Company’s products. These financial statements do not include adjustments that might result from the outcome of these uncertainties. The Company has incurred recurring losses from operations since its inception, including a net loss of $8.1 million and $1.4 million for the six months ended June 30, 2021 and 2020, respectively. In addition, as of June 30, 2021, the Company had an accumulated deficit of $35.0 million. The Company expects to continue to generate operating losses for the foreseeable future. As of June 30, 2021, the Company had cash, and cash equivalents of $16.8 million and short-term investments of $4.6 million. The Company believes that its cash and cash equivalents as of June 30, 2021 will enable it to fund its operating expenses and capital expenditure requirements through at least the next 12 months from the date of issuance of these financial statements. |
Summary of Significant Accounti
Summary of Significant Accounting Policies | 6 Months Ended |
Jun. 30, 2021 | |
Accounting Policies [Abstract] | |
Summary of Significant Accounting Policies | 2. Summary of Significant Accounting Policies Use of estimates: The presentation of financial statements in conformity with U.S. 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 financial statements and the reported amounts of revenues and expenses during the reporting period. Actual results could differ from those estimates. Accounting Standard Updates In December 2019, the Financial Accounting Standards Board issued Accounting Standards Update 2019-12, “Income Taxes (Topic 740)”. The amendments in this ASU simplify the accounting for income taxes by removing certain exceptions to the general principles in Topic 740 and by clarifying and amending other areas of Topic 740. The amendments in this ASU are effective for annual and interim periods beginning after December 15, 2020. We adopted this ASU on January 1, 2021 with no material impact on our consolidated financial statements. A variety of proposed or otherwise potential accounting standards are currently under consideration by standard-setting organizations and certain regulatory agencies. Because of the tentative and preliminary nature of such proposed standards, management has not yet determined the effect, if any, that the implementation of such proposed standards would have on the Company’s financial statements. Cash and cash equivalents: The Company considers cash to consist of cash on hand and temporary investments having an original maturity of 90 days or less that are readily convertible into cash. Short-term investments: Short-term investments at June 30, 2021 consist of marketable fixed income securities, primarily corporate bonds, which are categorized as available-for-sale securities and are thus marked to market and stated at fair value in accordance with ASC 820 Fair Value Measurement Inventory: The Company will begin carrying inventory of its biological products on its balance sheets following commercial launch of such products. Inventory will consist of raw materials, biological products in process, and finished goods available for sale. The Company will determine its inventory values using the average cost method. Inventory will be valued at the lower of cost or net realizable value and will exclude units that the Company anticipates distributing for clinical evaluation. As of each of June 30, 2021 and December 31, 2020, all of the Company’s biological products were anticipated to be distributed for clinical evaluation. The Company does not currently carry any inventory for its biological products, as it has yet to launch a product for commercial distribution. Historically the Company’s operations have focused on clinical trials and discovery efforts, and accordingly, costs of manufactured clinical doses of biological product candidates were expensed as incurred, consistent with the accounting for all other research and development costs. Once the Company begins commercial distribution, costs of all newly manufactured biological products will be allocated either for use in commercial distribution, which will be carried as inventory and not expensed, or for research and development efforts, which will continue to be expensed as incurred. Accounts and grants receivable: Accounts and grants receivable include amounts due from customers, granting institutions and others. The amounts as of June 30, 2021 and December 31, 2020 are certain to be collected, and no amount has been recognized for doubtful accounts. MSCRF-TEDCO generally advance grant funds and therefore a receivable is not usually recognized. In addition, for the Clinical trial revenue, most participants pay in advance of treatment. Advanced grant funds and prepayments for the Clinical trial revenue are recorded to deferred revenue. Accounts and grants receivable by source, as of (in thousands): June 30, December 31, Alzheimer’s Association – Grant $ - $ 339 National Institutes of Health – Grant 130 66 Clinical Trial receivable - 15 Total $ 130 $ 420 Deferred offering costs: The Company recorded certain legal, professional and other third-party fees that were directly associated with in-process equity financings as deferred offering costs until the applicable equity financing was consummated. After consummation of an equity financing, these costs will be recorded in stockholders’ equity as a reduction of proceeds generated as a result of the offering. At June 30, 2021 the deferred offering costs accrued as of December 31, 2020 of $0.6 million were recorded to stockholder’s equity. Property and equipment: Property and equipment, including improvements that extend useful lives of related assets, are valued at cost, while maintenance and repairs are charged to operations as incurred. Depreciation is calculated using the straight-line method based on the estimated useful lives of the assets. Leasehold improvements are amortized over the shorter of the estimated useful life of the asset or the original term of the lease. Depreciation expense is recorded in the research and development line of the Statement of Operations as the assets are primarily related to the Company’s clinical programs. Intangible assets: Intangible assets include payments on license agreements with the Company’s co-founder and chief scientific officer (“CSO”) and the University of Miami (“UM”) (see Note 9) and legal costs incurred related to patents and trademarks. License agreements have been recorded at the value of cash consideration, common stock and membership units transferred to the respective parties when acquired. Payments on license agreements are amortized using the straight-line method over the estimated useful life of 20 and 5 years. Patents are amortized over their estimated useful life, once issued. The Company considers trademarks to have an indefinite useful life and evaluates them for impairment on an annual basis. Amortization expense is recorded in the research and development line of the Statement of Operations as the assets are primarily related to the Company’s clinical programs. Impairment of Long-Lived Assets: The Company evaluates long-lived assets for impairment, including property and equipment and intangible assets, when events or changes in circumstances indicate that the carrying value of such assets may not be recoverable. Upon the occurrence of a triggering event, the asset is reviewed to assess whether the estimated undiscounted cash flows expected from the use of the asset plus the residual value from the ultimate disposal exceeds the carrying value of the asset. If the carrying value exceeds the estimated recoverable amounts, the asset is written down to the estimated fair value. Any resulting impairment loss is reflected on the statements of operations. Upon evaluation, management determined that there was no impairment of long-lived assets as of June 30, 2021 and December 31, 2020. Deferred revenue: The unearned portion of advanced grant funds and prepayments for Clinical trial revenue, which will be recognized as revenue when the Company meets the respective performance obligations, has been presented as deferred revenue in the accompanying balance sheets. For the six months ended June 30, 2021 and 2020, the Company recognized $0 and $0.5 million, respectively, of funds that were previously classified as deferred revenue ($0.4 million and $0.3 million for the three months ended June 30, 2021 and 2020, respectively). Revenue recognition: The Company recognizes revenue when performance obligations related to respective revenue streams are met. For Grant revenue, the Company considers the performance obligation met when the grant related expenses are incurred, or supplies and materials are received. The Company is paid in tranches pursuant to terms of the related grant agreements, and then applies payments based on regular expense reimbursement submissions to grantors. There are no remaining performance obligations or variable consideration once grant expense reporting to the grantor is complete. For Clinical trial revenue, the Company considers the performance obligation met when the participant has received the treatment. The Company usually receives prepayment for these services or receives payment at the time the treatment is provided, and there are no remaining performance obligations or variable consideration once the participant received the treatment. For Contract manufacturing revenue, the Company considers the performance obligation met when the contractual obligation and / or statement of work has been satisfied. Payment terms may vary depending on specific contract terms. There are no significant judgments affecting the determination of the amount and timing of revenue recognition. Revenue by source (in thousands): Three months ended Six months ended June 30, 2021 2020 2021 2020 National Institute of Health - Grant $ 130 $ 629 $ 130 $ 1,343 Clinical trial revenue 214 - 379 762 Alzheimer’s Association - Grant 91 243 261 440 MSCRF – TEDCO 1 54 (4 ) 95 31 Contact manufacturing revenue - 8 - 8 Total $ 489 $ 876 $ 865 $ 2,584 1 Maryland Stem Cell Research Fund (MSCRF) - Maryland Technology Development Corporation (TEDCO) The Company records cost of revenues based on expenses directly related to revenue. For Grants, the Company records allocated expenses for Research and development costs to a grant as a cost of revenues. For the Clinical trial revenue directly related expenses for that program are allocated and expensed as incurred. These expenses are similar to those described under “Research and development expense” below. Research and development expense: Research and development costs are charged to expense when incurred in accordance with ASC 730. ASC 730 addresses the proper accounting and reporting for research and development costs. It identifies: 1) those activities that should be identified as research and development; 2) the elements of costs that should be identified with research and development activities, and the accounting for these costs; and 3) the financial statement disclosures related to them. Research and development costs include costs such as clinical trial expenses, contracted research and license agreement fees with no alternative future use, supplies and materials, salaries, share-based compensation, employee benefits, property and equipment depreciation and allocation of various corporate costs. The Company accrues for costs incurred by external service providers, including contract research organizations and clinical investigators, based on its estimates of service performed and costs incurred. These estimates include the level of services performed by the third parties, patient enrollment in clinical trials, administrative costs incurred by the third parties, and other indicators of the services completed. Based on the timing of amounts invoiced by service providers, the Company may also record payments made to those providers as prepaid expenses that will be recognized as expense in future periods as the related services are rendered. Concentrations of credit risk: Financial instruments which potentially subject the Company to credit risk consist principally of cash and cash equivalents, short-term investments and accounts and grants receivable. Cash and cash equivalents are held in United States financial institutions. At times, the Company may maintain balances in excess of the federally insured amounts. Income taxes: Prior to its Corporate Conversion, the Company was treated as a partnership for U.S. federal and state income tax purposes. Consequently, the Company passed its earnings and losses through to its members based on the terms of the Company’s Operating Agreement. Accordingly, no provision for income taxes is recorded in the accompanying financial statements for prior periods. Following the Corporate Conversion, the Company’s tax provision consists of taxes currently payable or receivable, plus any change during the period in deferred tax assets and liabilities. The Company uses the asset and liability method of accounting for income taxes. Under this method, deferred tax assets and liabilities are recognized for the future tax consequences attributable to differences between the financial statement carrying amounts of assets and liabilities and their respective tax basis. Deferred tax assets and liabilities are measured using enacted tax rates expected to apply to taxable income in the years in which those temporary differences are expected to be recovered or settled. The effect on deferred tax assets and liabilities of a change in tax rates is recognized in income in the period that includes the enactment date. In addition, a valuation allowance is established to reduce any deferred tax asset for which it is determined that it is more likely than not that some portion of the deferred tax asset will not be realized. The Company’s tax provision was nil for the six months ended June 30, 2021 due to net operating losses. The Company has not recorded any tax benefit for the net operating losses incurred due to the uncertainty of realizing a benefit in the future. The Company recognizes the tax benefits from uncertain tax positions that the Company has taken or expects to take on a tax return. In the unlikely event an uncertain tax position exists in which the Company could incur income taxes, the Company would evaluate whether there is a probability that the uncertain tax position taken would be sustained upon examination by a taxing authority. Reserves for uncertain tax positions would then be recorded if the Company determined it is probable that either a position would not be sustained upon examination or a payment would have to be made to a taxing authority and the amount was reasonably estimable. As of June 30, 2021 and December 31, 2020, the Company does not believe it has any uncertain tax positions that would result in the Company having a liability to the taxing authority. It is the Company’s policy to expense any interest and penalties associated with its tax obligations when they are probable and estimable. Equity-based compensation: The Company accounts for equity-based compensation expense by the measurement and recognition of compensation expense for stock-based awards based on estimated fair values on the date of grant. The fair value of the options is estimated at the date of the grant using the Black-Scholes option-pricing model. The Black-Scholes option-pricing model requires the input of highly subjective assumptions, the most significant of which are the expected share price volatility, the expected life of the option award, the risk-free rate of return, and dividends during the expected term. Because the option-pricing model is sensitive to changes in the input assumptions, different determinations of the required inputs may result in different fair value estimates of the options. Neither the Company’s stock options or restricted stock units (“RSUs”) do not trade on an active market. Volatility is a measure of the amount by which a financial variable, such as a stock price, has fluctuated (historical volatility) or is expected to fluctuate (expected volatility) during a period. Given the Company’s limited historical data, the Company utilizes the average historical volatility of similar publicly traded companies that are in the same industry. The risk-free interest rate is the average U.S. treasury rate (having a term that most closely approximates the expected life of the option) for the period in which the option was granted. The expected life is the period of time that the options granted are expected to remain outstanding. Options granted have a maximum term of ten years. The Company had insufficient historical data to utilize in determining its expected life assumptions and, therefore, uses the simplified method for determining expected life. Comprehensive Loss Comprehensive loss was equal to net loss for the six months ended June 30, 2021 and 2020. |
Short-term investments
Short-term investments | 6 Months Ended |
Jun. 30, 2021 | |
Shortterm Investments [Abstract] | |
Short-term investments | 3. Short-term investments Short-term investments consisted of the following (in thousands): June 30, 2021 Amortized Gross Unrealized Gross Unrealized Estimated Fixed income bond funds $ 4,533 22 - 4,555 Total short-term investments $ 4,533 22 - $ 4,555 As of December 31, 2020, the Company did not have any short-term investments. |
Property and equipment, net
Property and equipment, net | 6 Months Ended |
Jun. 30, 2021 | |
Property, Plant and Equipment [Abstract] | |
Property and equipment, net | 4. Property and equipment, net Major components of property and equipment are as follows (in thousands): Useful Lives June 30, December 31, Leasehold improvements 10 years $ 4,310 $ 4,310 Furniture/Lab equipment 7 years 2,059 2,059 Computer equipment 5 years 14 14 Software/Website 3 years 38 38 Total property and equipment 6,421 6,421 Less accumulated depreciation and amortization 3,187 2,824 Property and equipment, net $ 3,234 $ 3,597 Depreciation and amortization expense amounted to approximately $0.2 and $0.4 million for each of the three and six months ended June 30, 2021 and 2020, respectively. |
Intangible assets, net
Intangible assets, net | 6 Months Ended |
Jun. 30, 2021 | |
Goodwill and Intangible Assets Disclosure [Abstract] | |
Intangible assets, net | 5. Intangible assets, net Major components of intangible assets as of June 30, 2021 are as follows (in thousands): Useful Lives Cost Accumulated Total License agreements 5-20 years $ 2,043 $ (363 ) $ 1,680 Patent Costs 563 - 563 Trademark costs 147 - 147 Total $ 2,753 $ (363 ) $ 2,390 Major components of intangible assets as of December 31, 2020 are as follows: Useful Lives Cost Accumulated Total License agreements 20 years $ 1,233 $ (279 ) $ 954 Patent Costs 466 - 466 Trademark costs 127 - 127 Total $ 1,826 $ (279 ) $ 1,547 Amortization expense related to intangible assets totaled less than $0.1 million for each of the three and six months ended June 30, 2021 and 2020. Future amortization expense for intangible assets as of June 30, 2021 is approximately as follows (in thousands): Year Ending December 31, Amount 2021 $ 112 2022 224 2023 224 2024 224 2025 224 Thereafter 672 Total $ 1,680 |
Leases
Leases | 6 Months Ended |
Jun. 30, 2021 | |
Disclosure of Leases [Abstract] | |
Leases | 6. Leases In accordance with Accounting Standards Update 2016-02, “Leases (Topic 842)”, the Company records a Right-of-use (ROU) asset and a lease liability related to its operating leases (there are no finance leases). The Company’s corporate office lease expires in March 2027. As of June 30, 2021, the ROU asset and lease liability were approximately $1.9 million and $3.4 million, respectively. As of December 31, 2020, the ROU asset and lease liability were approximately $2.1 million and $3.7 million, respectively. Future minimum payments under the operating leases as of June 30, 2021 are as follows (in thousands): Year Ending December 31, Amount 2021 (remaining nine months) $ 330 2022 671 2023 687 2024 702 2025 718 Thereafter 920 Total 4,028 Less: Interest 627 Present Value of Lease Liability $ 3,401 During the three and six months ended June 30, 2021 and 2020, the Company incurred approximately $0.2 million and $0.4 million of total lease costs, respectively, that are included in the general and administrative expenses in the statements of operations. On July 1, 2020, the Company entered into a sublease agreement for a portion of its leased space for a one-year period ending June 30, 2021, with three optional one-year renewal periods, and $10,000 in monthly payments. For the six months ended June 30, 2021, $60,000 was recognized as sublease income, and is included in other income in the accompanying statements of operations. |
Members_ Equity and Stockholder
Members’ Equity and Stockholders’ Equity | 6 Months Ended |
Jun. 30, 2021 | |
Stockholders' Equity Note [Abstract] | |
Members’ Equity and Stockholders’ Equity | 7. Members’ Equity and Stockholders’ Equity IPO The Corporate Conversion undertaken immediately prior to the IPO, the Company converted its corporate form from a Delaware limited liability company to a Delaware corporation with the name change to Longeveron Inc. The conversion caused all existing Series A and B units to convert into Class B common stock and all existing Series C units to convert into Class A common stock. The purpose of the Corporate Conversion was to reorganize the Company structure so that the entity that offered the Company’s Class A common stock to the public was a Delaware corporation rather than a Delaware limited liability company, and so that the Company’s existing investors own the Company’s Class A common stock or Class B common stock rather than equity interests in a limited liability company. On March 15, 2021, the Company sold 250,000 shares of Class A common stock at a public offering price of $10.00 per share for aggregate gross proceeds of $2,500,000 prior to deducting underwriting discounts, commissions, and other offering expenses, pursuant to a partial exercise of the over-allotment option held by the underwriters. Class A Common Stock During the six months ended June 30, 2021 and prior to the Corporate Conversion, the Company issued 1,130 Series C Common Membership Units (“Series C Units”), as payment for existing consulting agreements, with an aggregate value of $0.1 million. As part of the Corporate Conversion 63,893 outstanding Series C units (which includes the units referenced in the prior sentence) converted into 344,077 shares of Class A common stock. Also, during the three and six months ended June 30, 2021, the Company issued 131,053 and 157,719 unregistered shares of Class A common stock shares, with an aggregate value of $0.9 million and $1.1 million, respectively, as payment under consulting and license agreements. During the six months ended June 30, 2020, the Company issued 18,335 Series C Units for $1.1 million in cash (none during the three months ended June 30, 2021). The Company also issued 734 Series C Units with an aggregate value of $0.1 million as payment under consulting agreements. Class B Common Stock As part of the Corporate Conversion, 2,000,000 outstanding Series A and B units were converted into 15,702,834 shares of Class B common stock. The holders of Class B common stock may convert each share of Class B common stock into one share of Class A common stock. The holders of Class B common stock are entitled to five (5) votes per share, and holders of Class A common stock are entitled to one (1) vote per share. Warrants As part of the IPO the underwriter received warrants to purchase 106,400 shares of Class A common stock. The warrants are exercisable at any time and from time to time, in whole or in part, during the four and a half-year period commencing August 12, 2021, at a price of $12.00 per Class A common stock share. Total grant date fair value of warrants estimated using the Black-Scholes pricing model was approximately $0.5 million. |
Equity Incentive Plan
Equity Incentive Plan | 6 Months Ended |
Jun. 30, 2021 | |
Share-based Payment Arrangement [Abstract] | |
Equity Incentive Plan | 8. Equity Incentive Plan RSUs As part of the IPO, on January 29, 2021, the Company adopted and approved the 2021 Incentive Award Plan (“2021 Incentive Plan”). Under the 2021 Incentive Plan, the Company may grant cash and equity incentive awards to eligible service providers in order to attract, motivate and retain the talent for which the Company competes. The material terms of the 2021 Incentive Plan are summarized below. On January 29, 2021, the Board approved the granting of 159,817 Series C RSUs under the Company’s existing 2017 Longeveron LLC Incentive Plan (the “2017 Incentive Plan”), which thereafter converted to RSUs exercisable for Class A common stock as part of the Corporate Conversion. More specifically, 159,817 RSUs were converted to 855,247 RSUs exercisable for Class A common stock. During February 2021, one employee resigned from the Company thereby forfeiting 16,113 RSUs, and 5,000 RSUs each were granted to eight of the Company’s Directors. RSUs have no exercise price and are convertible into Class A common stock shares upon meeting the vesting requirements. The RSUs shall vest, subject to the Participant’s continued Service to the Company, only upon satisfaction of both of the following criteria: ● Time-Based Vesting: Subject to the attainment of a time vesting event, the RSUs shall vest in 25% increments per year, on each of the first, second, third and fourth anniversary of the date of grant. Such yearly vesting will vest pro-rata per quarter at the end of each quarter. However, vesting of certain RSUs have been accelerated as having been earned for prior years of service, and hence are treated as earned “catch-up” awards; and ● IPO Settlement Date: The IPO settlement date is a date on the third quarterly settlement date following the Company’s IPO (this date will effectively be October 1, 2021). The fair value of each RSU grant made during 2021 will be recognized as stock-based compensation ratably over the related vesting periods, which approximates the service period, except for the Company’s Directors which vest over two years and 50% of the RSUs are vest on grant date, while the remaining vest 25% on each anniversary. As noted in the paragraph above, in order for RSUs to vest they must be held as of the IPO Settlement Date, which has been determined to be October 1, 2021. However, some RSUs with accelerated vesting as described above will be ratably vested over the seven and half month period ending on September 30, 2021. Based upon a third party valuation, the calculated fair value of each RSU was $9.00. On June 3, 2021, the Company granted 5,000 Class A common stock RSUs to a new board member. The RSUs have no exercise price. As of June 30, 2021, the Company had 879,134 RSUs granted and outstanding. RSU activity for the six months ended June 30, 2021 was as follows: Number of RSUs Outstanding at December 31, 2020 - RSU granted 895,247 RSU exercised - RSU expired/forfeited (16,113 ) Outstanding at June 30, 2021 879,134 Stock Options Stock options may be granted under the 2021 Incentive Plan. The exercise price of options is equal to the fair market value of the Company’s Class A common stock as of the grant date. Options historically granted have generally become exercisable over four years and expire ten years from the date of grant. The 2021 Incentive Plan provides for equity grants to be granted up to 5% of the outstanding common stock shares. The fair value of the options issued are estimated using the Black-Scholes option-pricing model and have the following assumptions: a dividend yield of 0%; an expected life of 10 years; volatility of 95%; and risk-free interest rate based on the grant date ranging from of 1.23% to 1.62%. Each option grant made during 2021 will be expensed ratably over the option vesting periods, which approximates the service period. As of June 30, 2021, the Company has recorded issued and outstanding options to purchase a total of 109,125 shares of Class A common stock pursuant to the 2021 Incentive Plan, at a weighted average exercise price of $5.67 per share. For the six months ended June 30, 2021: Number of Stock Options Stock options vested (based on ratable vesting) 6,822 Stock options unvested 102,303 Total stock options granted at June 30, 2021 109,125 Stock Option activity for the six months ended June 30, 2021 was as follows: Number of Stock Options Weighted Average Exercise Price Outstanding at December 31, 2020 - - Options granted 109,125 $ 5.67 Options exercised - - Options expired/forfeited - - Outstanding at June 30, 2021 109,125 $ 5.67 On April 22, 2021, the Company granted awards of 64,125 Class A common stock options to employees. The stock options awards have four-year vesting periods, that vests 25% per year, and have an exercise price of $5.73. Based upon a Black-Scholes calculation the price per share to be expensed was $5.03 and a total cost of $0.3 million would be expensed ratably over 48 months. On May 5, 2021, the Company granted an award of 10,000 Class A common stock options to an employee. The stock option award has a four-year vesting period, that vests 25% per year, and has an exercise price of $5.89. Based upon a Black-Scholes calculation the price per share to be expensed was $5.17 and a total cost of less than $0.1 million would be expensed ratably over 48 months. On May 17, 2021, the Company granted an award of 30,000 Class A common stock options to an employee. The stock option award has a four-year vesting period, that vests 25% per year, and has an exercise price of $5.29. Based upon a Black-Scholes calculation the price per share to be expensed was $4.64 and a total cost of less than $0.1 million would be expensed ratably over 48 months. On June 1, 2021, the Company granted an award of 5,000 Class A common stock options to an employee. The stock option award has a four-year vesting period, that vests 25% per year, and has an exercise price of $6.77. Based upon a Black-Scholes calculation the price per share to be expensed was $5.94 and a total cost of $0.1 million would be expensed ratably over 48 months. For the six months ended June 30, 2021 and 2020, the equity-based compensation expense amounted to approximately $3.5 million ($2.2 million for the three months ended June 30, 2021) and $24,000 ($11,000 for the three months ended June 30, 2020), respectively, which is included in the research and development and general and administrative expenses in the accompanying statements of operations for the six months ended June 30, 2021 and 2020. As of June 30, 2021, the remaining unrecognized equity based compensation of approximately $5.0 million will be recognized over approximately 2.5 years. |
Commitments and Contingencies
Commitments and Contingencies | 6 Months Ended |
Jun. 30, 2021 | |
Commitments and Contingencies Disclosure [Abstract] | |
Commitments and Contingencies | 9. Commitments and Contingencies Master Services Agreements: As of June 30, 2021, the Company had two active master services agreements with third parties to conduct its clinical trials and manage clinical research programs and clinical development services on behalf of the Company. The Company expects these agreements or amended current agreements to have total expenditures of less than $1.0 million for 2021. Consulting Services Agreement: On November 20, 2014, the Company entered into a ten-year consulting services agreement with its CSO. Under the agreement, the Company agreed to pay the CSO $270,000 annually. The compensation payments are for scientific knowledge, medical research, technical knowledge, skills, and abilities to be provided by the CSO to further develop the intellectual property rights assigned by the CSO to the Company. This agreement requires the CSO to also assign to the Company the exclusive right, title, and interest in any work product developed from his efforts during the term of this agreement. As of June 30, 2021, the Company had an accrued balance due to the CSO of $0.3 million and as of December 31, 2020 had a balance due of $0.3 million. Technology Services Agreement: On March 27, 2015, the Company entered into a technology services agreement with Optimal Networks, Inc. (a related company owned by a board member’s brother-in-law) for use of information technology services. The Company agreed to issue the related party equity incentive units in the amount equal to 50% of the charges for invoiced services, with such equity to be issued annually on or about the anniversary date of the agreement. During 2017, the Company issued 1,901 Series C Units, and on November 22, 2019 and January 29, 2021, the Company issued 820 and 410 Series C Units, respectively, as payment for an aggregate of $0.2 million of accrued technology services. The Series C units were converted to 16,755 Class A common stock shares as part of the Corporate Conversion. As of June 30, 2021, and December 31, 2020, the Company owed less than $0.1 million, pursuant to this agreement, which is included in accounts payable in the accompanying June 30, 2021 and December 31, 2020 balance sheets. Exclusive Licensing Agreements: UM Agreement On November 20, 2014, the Company entered into an exclusive license agreement with UM for the use of certain stem cell aging-related frailty technology rights developed by the CSO while employed at UM. The Company recorded the value of the membership units issued to obtain this license agreement as an intangible asset. The Company is required to pay UM up to 3% of net sales on products or services developed from the technology. The agreement extends for up to 20 years from the last date a product or process is commercialized from the technology. Under the agreement, the Company is required to pay an annual fee to UM. As of June 30, 2020, the Company had accrued $50,000 based on the terms of the agreement. In addition, on November 14, 2014, as required by the license agreement the Company issued 20,000 series C membership units valued at $0.5 million to UM. The Company recorded this $500,000 as an intangible asset that is amortized over the life of the license agreement which was defined as 20 years. As of June 30, 2021, the Company had accrued less than $0.1 million in milestone fees payable to UM based on the estimated progress to date. The UM agreement was amended on March 3, 2021 to increase the license fee due to UM. The Company agreed to pay UM an additional fee, which will be recorded as legal costs, of $0.1 million, to defray patent costs, with $70,000 due within thirty (30) days of the effective date of the amendment, and the remainder to be paid in equal installments of $7,500 on the 2 nd rd th CD271 On December 22, 2016, the Company entered into an exclusive license agreement with JMHMD Holdings, LLC, an affiliated entity of the CSO for the use of CD271 cellular therapy technology. The Company recorded the value of the cash consideration and membership units issued to obtain this license agreement as an intangible asset. The Company is required to pay as royalty 1% of the annual net sales of the licensed product(s) used, leased, or sold by or for licensee or its sub-licensees. If the Company sublicenses the technology, it is also required to pay an amount equal to 10% of the net sales of the sub-licensees. In addition, on December 23, 2016, as required by the license agreement, the Company paid an initial fee of $250,000 to JMHMD, and issued to it 10,000 Series C Units, valued at $250,000. The $0.5 million of value provided to JMHMD for the license agreement, along with professional fees of approximately $27,000, were recorded as an intangible asset that is amortized over the life of the license agreement which was defined as 20 years. Further, expenses related to the furtherance of the CD271+ technology is being capitalized and amortized as incurred over 20 years. There were no license fees due during the six months ended June 30, 2021 or year ended December 31, 2020 pertaining to this agreement. Other Royalty Under the grant award agreement with the Alzheimer’s Association, the Company may be required to make revenue sharing or distribution of revenue payments for products or inventions generated or resulting from this clinical trial program. The potential payments, although not currently defined, could result in a maximum payment of five times (5x) the award amount. Contingencies – COVID-19 Pandemic The COVID-19 outbreak has impacted, and in the future could continue to adversely impact the Company’s ability to conduct business in the future. In December 2019, it was first reported that there had been an outbreak of a novel strain of coronavirus, SARS-CoV-2, COVID-19, in China. As COVID-19 continues to spread globally, including throughout the United States, the Company may experience disruptions that could severely impact its business, including: ● impact to the financial markets; ● disruption in the ability to provide product in foreign markets; ● disruption on the ability to source materials; ● disruption in the ability to manufacture our product; ● delays or difficulties in completing the Company’s regulatory work; ● limitations on the Company’s employee resources ability to work, including because of sickness of employees or their families or the desire of employees to avoid contact with large groups of people; and ● additional repercussions on the Company’s ability to operate its business. The global outbreak of COVID-19 continues to rapidly evolve. The extent to which COVID-19 impacts the Company’s results will depend on future developments, which are highly uncertain and cannot be predicted, including new information which may emerge concerning the severity of COVID-19, the ultimate geographic spread of COVID-19, the duration of the outbreak, travel restrictions imposed by countries in which the Company conducts business, business closures or business disruption in the world, a reduction in time spent out of home and the actions taken throughout the world, including in the Company’s markets, to contain COVID-19 or treat its impact. The future impact of the outbreak is highly uncertain and cannot be predicted, and the Company cannot provide any assurance that the outbreak will not have a material adverse impact on the Company’s operations or future results or filings with regulatory health authorities. The extent of the impact to the Company, if any, will depend on future developments, including actions taken to contain COVID-19. The Company continues to monitor how the COVID-19 pandemic is affecting the Company’s employees, business, and clinical trials. In response to the spread of COVID-19, the Company has instructed all employees who can perform their essential employment duties from home to do so. The Company’s laboratory scientists, cell processing scientists and other manufacturing personnel continue to work from the Company GMP facility on a day-to-day basis, and as such cell production has been minimally impacted. When the pandemic began to emerge in the U.S., most of the Company’s ongoing clinical trials had completed enrollment, however a few subjects that were currently on study and in follow-up experienced some difficulties in adhering to the protocol schedule. Because the Company primarily enrolls elderly subjects in the trials, who are at particular risk for poor outcomes related to COVID-19 infection, the Company has experienced some disruption in executing the follow-up visits in Company protocols. While the Company believes the number of instances where a visit was missed completely is small, the Company cannot predict whether this will have a material impact on the Company clinical results in the future. If too many subjects drop-out or the protocol is no longer effective, the Company may have to restart the clinical trial entirely. |
Short-Term Note Payable
Short-Term Note Payable | 6 Months Ended |
Jun. 30, 2021 | |
Debt Disclosure [Abstract] | |
Short-term Note Payable | 10. Short-term Note Payable On September 27, 2020, the Company entered into a premium finance agreement to finance its insurance policies for approximately $63,000. The note requires down payment of $6,334, ratable monthly payments of $6,499, including interest at 5.353% and matures in June 2021. As of June 30, 2021, the outstanding balance was paid in full. |
Long-Term Loan
Long-Term Loan | 6 Months Ended |
Jun. 30, 2021 | |
Debt Disclosure [Abstract] | |
Long-term Loan | 11. Long-term Loan On April 16, 2020, the Company received a loan from the Small Business Administration (“SBA”) pursuant to the Paycheck Protection Program (“PPP”) as part of the Coronavirus Aid, Relief, and Economic Security Act (“CARES Act”) in the amount of $300,390. The loan had interest at a rate of 1.00%, and initial maturity in 24 months. It was anticipated that not more than 25% of the forgiven amount may be for non-payroll costs. The Company also received $10,000 from the SBA for the Economic Relief Fund; this amount does not need to be repaid and was recorded as Other Income for the year ended December 31, 2020. As of December 31, 2020, the outstanding balance of the PPP loan was $300,390. On March 4, 2021, the full balance due for the PPP loan was forgiven by the SBA. On May 12, 2020, the Company received a loan from the SBA pursuant to the Disaster Recovery Plan as part of the CARES Act in the amount of $150,000. The Company began repayment on July 20, 2021 of $731 per month. The note will mature in 30 years and bears an interest rate of 3.75%. Due to part of the notes being due within one year, the Company recorded $5,000 and $139,000 in the current portion of loans line on the Balance Sheet as of June 30, 2021 and December 31, 2020, respectively. Future debt obligations at June 30, 2020 for Long-term loans are as follows (in thousands): Year Ending December 31, Amount 2021 (remaining six months) $ 4 2022 3 2023 3 2024 3 2025 3 Thereafter 134 Total $ 150 |
Employee Benefits Plan
Employee Benefits Plan | 6 Months Ended |
Jun. 30, 2021 | |
Retirement Benefits [Abstract] | |
Employee Benefits Plan | 12. Employee Benefits Plan The Company sponsors a defined contribution employee benefit plan (the “Plan”) under the provisions of Section 401(k) of the Internal Revenue Code. The Plan covers substantially all full-time employees of the Company who have completed one year of service. Contributions to the Plan by the Company are at the discretion of the Board of Directors. The Company contributed approximately $31,000 and $21,000 to the Plan during the six months ended June 30, 2021 and 2020, respectively and $15,000 and $10,000 for the three months ended June 30, 2021 and 2020, respectively. |
Loss Per Share
Loss Per Share | 6 Months Ended |
Jun. 30, 2021 | |
Earnings Per Share [Abstract] | |
Loss Per Share | 13. Loss Per Share Basic and diluted net loss per share have been computed using the weighted-average number of shares of common stock outstanding during the period. We have outstanding stock-based awards that are not used in the calculation of diluted net loss per share because to do so would be anti-dilutive. These common share equivalents were as follows at June 30, 2021 and 2020: June 30, 2021 2020 RSUs 879 - Stock options 109 - Warrants 106 - Total 1,094 - |
Subsequent Events
Subsequent Events | 6 Months Ended |
Jun. 30, 2021 | |
Subsequent Events [Abstract] | |
Subsequent Events | 14. Subsequent Events On July 20, 2021, the Company granted 225,000 Class A common stock options to executives. Mr. Green was granted 75,000 Class A common stock options and Mr. Lehr, Dr. Hare and Mr. Clavijo were granted 50,000 Class A common stock options. The stock options had four-year vesting, that vests 12.5% on July 22, 2021 and the remaining vests equally over the remaining four years, and an exercise price of $6.08. Based upon a Black-Scholes calculation the price per share to be expensed was $5.32 and a total cost of $1.2 million would be expensed ratably over 48 months. Further on July 20, 2021, the Company changed the base compensation for its executive team; retroactive to February 12, 2021. The primary change was that the annual base salaries were changed for: Mr. Green, Mr. Lehr, Dr. Hare and Mr. Clavijo to $340,000, $300,000, $265,000 and $270,000. The Company also provided for an annual cash bonus which will be recorded and expensed when paid and shall be paid with the following conditions: Annual Cash Bonus for current year shall be paid at the rate of 33% of base salary for the Mr. Green and at 27% of the base salary for the Dr. Hare and at 25% of the respective base salaries for the Mr. Lehr and Mr. Clavijo, according to the following milestones/ company: 20% if budget revenues during the prior year review period meet projections; 20% if earnings/losses during the prior year review period are on budget (within 15%); 20% if stock price during the prior year review period has reached over $10/share; 20% if stock price during the prior year review period has reached over $12/share; 20% if stock price during the prior year review period has reached over $15/share. In addition, the Company granted a bonus for the completion of the IPO to Mr. Green, Mr. Lehr and Dr. Hare of $100,000, $75,000 and $75,000. The bonus would be paid out in cash and RSUs. With Mr. Green, Mr. Lehr and Dr. Hare receiving 8,223, 6,167 and 12,335 RSUs each. The RSU were issued based on a fair market value at the time of grant, July 20, 2021, of $6.08. The adjustments to base salaries and the IPO bonuses were recorded and expensed as of June 30, 2021. |
Accounting Policies, by Policy
Accounting Policies, by Policy (Policies) | 6 Months Ended |
Jun. 30, 2021 | |
Accounting Policies [Abstract] | |
Use of estimates | Use of estimates: The presentation of financial statements in conformity with U.S. 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 financial statements and the reported amounts of revenues and expenses during the reporting period. Actual results could differ from those estimates. |
Accounting Standard Updates | Accounting Standard Updates In December 2019, the Financial Accounting Standards Board issued Accounting Standards Update 2019-12, “Income Taxes (Topic 740)”. The amendments in this ASU simplify the accounting for income taxes by removing certain exceptions to the general principles in Topic 740 and by clarifying and amending other areas of Topic 740. The amendments in this ASU are effective for annual and interim periods beginning after December 15, 2020. We adopted this ASU on January 1, 2021 with no material impact on our consolidated financial statements. A variety of proposed or otherwise potential accounting standards are currently under consideration by standard-setting organizations and certain regulatory agencies. Because of the tentative and preliminary nature of such proposed standards, management has not yet determined the effect, if any, that the implementation of such proposed standards would have on the Company’s financial statements. |
Cash and cash equivalents | Cash and cash equivalents: The Company considers cash to consist of cash on hand and temporary investments having an original maturity of 90 days or less that are readily convertible into cash. |
Short-term investments: | Short-term investments: Short-term investments at June 30, 2021 consist of marketable fixed income securities, primarily corporate bonds, which are categorized as available-for-sale securities and are thus marked to market and stated at fair value in accordance with ASC 820 Fair Value Measurement |
Inventory | Inventory: The Company will begin carrying inventory of its biological products on its balance sheets following commercial launch of such products. Inventory will consist of raw materials, biological products in process, and finished goods available for sale. The Company will determine its inventory values using the average cost method. Inventory will be valued at the lower of cost or net realizable value and will exclude units that the Company anticipates distributing for clinical evaluation. As of each of June 30, 2021 and December 31, 2020, all of the Company’s biological products were anticipated to be distributed for clinical evaluation. The Company does not currently carry any inventory for its biological products, as it has yet to launch a product for commercial distribution. Historically the Company’s operations have focused on clinical trials and discovery efforts, and accordingly, costs of manufactured clinical doses of biological product candidates were expensed as incurred, consistent with the accounting for all other research and development costs. Once the Company begins commercial distribution, costs of all newly manufactured biological products will be allocated either for use in commercial distribution, which will be carried as inventory and not expensed, or for research and development efforts, which will continue to be expensed as incurred. |
Accounts and grants receivable | Accounts and grants receivable: Accounts and grants receivable include amounts due from customers, granting institutions and others. The amounts as of June 30, 2021 and December 31, 2020 are certain to be collected, and no amount has been recognized for doubtful accounts. MSCRF-TEDCO generally advance grant funds and therefore a receivable is not usually recognized. In addition, for the Clinical trial revenue, most participants pay in advance of treatment. Advanced grant funds and prepayments for the Clinical trial revenue are recorded to deferred revenue. Accounts and grants receivable by source, as of (in thousands): June 30, December 31, Alzheimer’s Association – Grant $ - $ 339 National Institutes of Health – Grant 130 66 Clinical Trial receivable - 15 Total $ 130 $ 420 |
Deferred offering costs | Deferred offering costs: The Company recorded certain legal, professional and other third-party fees that were directly associated with in-process equity financings as deferred offering costs until the applicable equity financing was consummated. After consummation of an equity financing, these costs will be recorded in stockholders’ equity as a reduction of proceeds generated as a result of the offering. At June 30, 2021 the deferred offering costs accrued as of December 31, 2020 of $0.6 million were recorded to stockholder’s equity. |
Property and equipment | Property and equipment: Property and equipment, including improvements that extend useful lives of related assets, are valued at cost, while maintenance and repairs are charged to operations as incurred. Depreciation is calculated using the straight-line method based on the estimated useful lives of the assets. Leasehold improvements are amortized over the shorter of the estimated useful life of the asset or the original term of the lease. Depreciation expense is recorded in the research and development line of the Statement of Operations as the assets are primarily related to the Company’s clinical programs. |
Intangible assets | Intangible assets: Intangible assets include payments on license agreements with the Company’s co-founder and chief scientific officer (“CSO”) and the University of Miami (“UM”) (see Note 9) and legal costs incurred related to patents and trademarks. License agreements have been recorded at the value of cash consideration, common stock and membership units transferred to the respective parties when acquired. Payments on license agreements are amortized using the straight-line method over the estimated useful life of 20 and 5 years. Patents are amortized over their estimated useful life, once issued. The Company considers trademarks to have an indefinite useful life and evaluates them for impairment on an annual basis. Amortization expense is recorded in the research and development line of the Statement of Operations as the assets are primarily related to the Company’s clinical programs. |
Impairment of Long-Lived Assets | Impairment of Long-Lived Assets: The Company evaluates long-lived assets for impairment, including property and equipment and intangible assets, when events or changes in circumstances indicate that the carrying value of such assets may not be recoverable. Upon the occurrence of a triggering event, the asset is reviewed to assess whether the estimated undiscounted cash flows expected from the use of the asset plus the residual value from the ultimate disposal exceeds the carrying value of the asset. If the carrying value exceeds the estimated recoverable amounts, the asset is written down to the estimated fair value. Any resulting impairment loss is reflected on the statements of operations. Upon evaluation, management determined that there was no impairment of long-lived assets as of June 30, 2021 and December 31, 2020. |
Deferred revenue | Deferred revenue: The unearned portion of advanced grant funds and prepayments for Clinical trial revenue, which will be recognized as revenue when the Company meets the respective performance obligations, has been presented as deferred revenue in the accompanying balance sheets. For the six months ended June 30, 2021 and 2020, the Company recognized $0 and $0.5 million, respectively, of funds that were previously classified as deferred revenue ($0.4 million and $0.3 million for the three months ended June 30, 2021 and 2020, respectively). |
Deferred revenue | Revenue recognition: The Company recognizes revenue when performance obligations related to respective revenue streams are met. For Grant revenue, the Company considers the performance obligation met when the grant related expenses are incurred, or supplies and materials are received. The Company is paid in tranches pursuant to terms of the related grant agreements, and then applies payments based on regular expense reimbursement submissions to grantors. There are no remaining performance obligations or variable consideration once grant expense reporting to the grantor is complete. For Clinical trial revenue, the Company considers the performance obligation met when the participant has received the treatment. The Company usually receives prepayment for these services or receives payment at the time the treatment is provided, and there are no remaining performance obligations or variable consideration once the participant received the treatment. For Contract manufacturing revenue, the Company considers the performance obligation met when the contractual obligation and / or statement of work has been satisfied. Payment terms may vary depending on specific contract terms. There are no significant judgments affecting the determination of the amount and timing of revenue recognition. Revenue by source (in thousands): Three months ended Six months ended June 30, 2021 2020 2021 2020 National Institute of Health - Grant $ 130 $ 629 $ 130 $ 1,343 Clinical trial revenue 214 - 379 762 Alzheimer’s Association - Grant 91 243 261 440 MSCRF – TEDCO 1 54 (4 ) 95 31 Contact manufacturing revenue - 8 - 8 Total $ 489 $ 876 $ 865 $ 2,584 1 Maryland Stem Cell Research Fund (MSCRF) - Maryland Technology Development Corporation (TEDCO) The Company records cost of revenues based on expenses directly related to revenue. For Grants, the Company records allocated expenses for Research and development costs to a grant as a cost of revenues. For the Clinical trial revenue directly related expenses for that program are allocated and expensed as incurred. These expenses are similar to those described under “Research and development expense” below. |
Research and development expense | Research and development expense: Research and development costs are charged to expense when incurred in accordance with ASC 730. ASC 730 addresses the proper accounting and reporting for research and development costs. It identifies: 1) those activities that should be identified as research and development; 2) the elements of costs that should be identified with research and development activities, and the accounting for these costs; and 3) the financial statement disclosures related to them. Research and development costs include costs such as clinical trial expenses, contracted research and license agreement fees with no alternative future use, supplies and materials, salaries, share-based compensation, employee benefits, property and equipment depreciation and allocation of various corporate costs. The Company accrues for costs incurred by external service providers, including contract research organizations and clinical investigators, based on its estimates of service performed and costs incurred. These estimates include the level of services performed by the third parties, patient enrollment in clinical trials, administrative costs incurred by the third parties, and other indicators of the services completed. Based on the timing of amounts invoiced by service providers, the Company may also record payments made to those providers as prepaid expenses that will be recognized as expense in future periods as the related services are rendered. |
Concentrations of credit risk | Concentrations of credit risk: Financial instruments which potentially subject the Company to credit risk consist principally of cash and cash equivalents, short-term investments and accounts and grants receivable. Cash and cash equivalents are held in United States financial institutions. At times, the Company may maintain balances in excess of the federally insured amounts. |
Income taxes | Income taxes: Prior to its Corporate Conversion, the Company was treated as a partnership for U.S. federal and state income tax purposes. Consequently, the Company passed its earnings and losses through to its members based on the terms of the Company’s Operating Agreement. Accordingly, no provision for income taxes is recorded in the accompanying financial statements for prior periods. Following the Corporate Conversion, the Company’s tax provision consists of taxes currently payable or receivable, plus any change during the period in deferred tax assets and liabilities. The Company uses the asset and liability method of accounting for income taxes. Under this method, deferred tax assets and liabilities are recognized for the future tax consequences attributable to differences between the financial statement carrying amounts of assets and liabilities and their respective tax basis. Deferred tax assets and liabilities are measured using enacted tax rates expected to apply to taxable income in the years in which those temporary differences are expected to be recovered or settled. The effect on deferred tax assets and liabilities of a change in tax rates is recognized in income in the period that includes the enactment date. In addition, a valuation allowance is established to reduce any deferred tax asset for which it is determined that it is more likely than not that some portion of the deferred tax asset will not be realized. The Company’s tax provision was nil for the six months ended June 30, 2021 due to net operating losses. The Company has not recorded any tax benefit for the net operating losses incurred due to the uncertainty of realizing a benefit in the future. The Company recognizes the tax benefits from uncertain tax positions that the Company has taken or expects to take on a tax return. In the unlikely event an uncertain tax position exists in which the Company could incur income taxes, the Company would evaluate whether there is a probability that the uncertain tax position taken would be sustained upon examination by a taxing authority. Reserves for uncertain tax positions would then be recorded if the Company determined it is probable that either a position would not be sustained upon examination or a payment would have to be made to a taxing authority and the amount was reasonably estimable. As of June 30, 2021 and December 31, 2020, the Company does not believe it has any uncertain tax positions that would result in the Company having a liability to the taxing authority. It is the Company’s policy to expense any interest and penalties associated with its tax obligations when they are probable and estimable. |
Equity-based compensation | Equity-based compensation: The Company accounts for equity-based compensation expense by the measurement and recognition of compensation expense for stock-based awards based on estimated fair values on the date of grant. The fair value of the options is estimated at the date of the grant using the Black-Scholes option-pricing model. The Black-Scholes option-pricing model requires the input of highly subjective assumptions, the most significant of which are the expected share price volatility, the expected life of the option award, the risk-free rate of return, and dividends during the expected term. Because the option-pricing model is sensitive to changes in the input assumptions, different determinations of the required inputs may result in different fair value estimates of the options. Neither the Company’s stock options or restricted stock units (“RSUs”) do not trade on an active market. Volatility is a measure of the amount by which a financial variable, such as a stock price, has fluctuated (historical volatility) or is expected to fluctuate (expected volatility) during a period. Given the Company’s limited historical data, the Company utilizes the average historical volatility of similar publicly traded companies that are in the same industry. The risk-free interest rate is the average U.S. treasury rate (having a term that most closely approximates the expected life of the option) for the period in which the option was granted. The expected life is the period of time that the options granted are expected to remain outstanding. Options granted have a maximum term of ten years. The Company had insufficient historical data to utilize in determining its expected life assumptions and, therefore, uses the simplified method for determining expected life. |
Comprehensive Loss | Comprehensive Loss Comprehensive loss was equal to net loss for the six months ended June 30, 2021 and 2020. |
Summary of Significant Accoun_2
Summary of Significant Accounting Policies (Tables) | 6 Months Ended |
Jun. 30, 2021 | |
Accounting Policies [Abstract] | |
Schedule of accounts and grants receivable | June 30, December 31, Alzheimer’s Association – Grant $ - $ 339 National Institutes of Health – Grant 130 66 Clinical Trial receivable - 15 Total $ 130 $ 420 |
Schedule of revenue | Three months ended Six months ended June 30, 2021 2020 2021 2020 National Institute of Health - Grant $ 130 $ 629 $ 130 $ 1,343 Clinical trial revenue 214 - 379 762 Alzheimer’s Association - Grant 91 243 261 440 MSCRF – TEDCO 1 54 (4 ) 95 31 Contact manufacturing revenue - 8 - 8 Total $ 489 $ 876 $ 865 $ 2,584 1 Maryland Stem Cell Research Fund (MSCRF) - Maryland Technology Development Corporation (TEDCO) |
Short-term investments (Tables)
Short-term investments (Tables) | 6 Months Ended |
Jun. 30, 2021 | |
Shortterm Investments [Abstract] | |
Schedule of short-term investments | June 30, 2021 Amortized Gross Unrealized Gross Unrealized Estimated Fixed income bond funds $ 4,533 22 - 4,555 Total short-term investments $ 4,533 22 - $ 4,555 |
Property and equipment, net (Ta
Property and equipment, net (Tables) | 6 Months Ended |
Jun. 30, 2021 | |
Property, Plant and Equipment [Abstract] | |
Schedule of major components of property and equipment | Useful Lives June 30, December 31, Leasehold improvements 10 years $ 4,310 $ 4,310 Furniture/Lab equipment 7 years 2,059 2,059 Computer equipment 5 years 14 14 Software/Website 3 years 38 38 Total property and equipment 6,421 6,421 Less accumulated depreciation and amortization 3,187 2,824 Property and equipment, net $ 3,234 $ 3,597 |
Intangible assets, net (Tables)
Intangible assets, net (Tables) | 6 Months Ended |
Jun. 30, 2021 | |
Goodwill and Intangible Assets Disclosure [Abstract] | |
Schedule of intangible assets | Useful Lives Cost Accumulated Total License agreements 5-20 years $ 2,043 $ (363 ) $ 1,680 Patent Costs 563 - 563 Trademark costs 147 - 147 Total $ 2,753 $ (363 ) $ 2,390 Useful Lives Cost Accumulated Total License agreements 20 years $ 1,233 $ (279 ) $ 954 Patent Costs 466 - 466 Trademark costs 127 - 127 Total $ 1,826 $ (279 ) $ 1,547 |
Schedule of future amortization expense for intangible assets | Year Ending December 31, Amount 2021 $ 112 2022 224 2023 224 2024 224 2025 224 Thereafter 672 Total $ 1,680 |
Leases (Tables)
Leases (Tables) | 6 Months Ended |
Jun. 30, 2021 | |
Leases [Abstract] | |
Schedule of future minimum payments under the operating leases | Year Ending December 31, Amount 2021 (remaining nine months) $ 330 2022 671 2023 687 2024 702 2025 718 Thereafter 920 Total 4,028 Less: Interest 627 Present Value of Lease Liability $ 3,401 |
Equity Incentive Plan (Tables)
Equity Incentive Plan (Tables) | 6 Months Ended |
Jun. 30, 2021 | |
Share-based Payment Arrangement [Abstract] | |
Schedule of fair value of each RSU activity | Number of RSUs Outstanding at December 31, 2020 - RSU granted 895,247 RSU exercised - RSU expired/forfeited (16,113 ) Outstanding at June 30, 2021 879,134 |
Schedule of issued and outstanding options | Number of Stock Options Stock options vested (based on ratable vesting) 6,822 Stock options unvested 102,303 Total stock options granted at June 30, 2021 109,125 |
Schedule of stock option activity | Number of Stock Options Weighted Average Exercise Price Outstanding at December 31, 2020 - - Options granted 109,125 $ 5.67 Options exercised - - Options expired/forfeited - - Outstanding at June 30, 2021 109,125 $ 5.67 |
Long-Term Loan (Tables)
Long-Term Loan (Tables) | 6 Months Ended |
Jun. 30, 2021 | |
Debt Disclosure [Abstract] | |
Schedule of future debt obligations for long term loans | Year Ending December 31, Amount 2021 (remaining six months) $ 4 2022 3 2023 3 2024 3 2025 3 Thereafter 134 Total $ 150 |
Loss Per Share (Tables)
Loss Per Share (Tables) | 6 Months Ended |
Jun. 30, 2021 | |
Earnings Per Share [Abstract] | |
Schedule of calculation of diluted net loss per share | June 30, 2021 2020 RSUs 879 - Stock options 109 - Warrants 106 - Total 1,094 - |
Nature of Business, Basis of _2
Nature of Business, Basis of Presentation, and Liquidity (Details) - USD ($) | Mar. 15, 2021 | Feb. 12, 2021 | Jun. 30, 2021 | Jun. 30, 2020 |
Nature of Business, Basis of Presentation, and Liquidity (Details) [Line Items] | ||||
Net loss | $ 8,100,000 | $ 1,400,000 | ||
Accumulated deficit | 35,000,000 | |||
Cash and cash equivalents | 16,800,000 | |||
Short-term investments | $ 4,600,000 | |||
Initial Public Offering [Member] | ||||
Nature of Business, Basis of Presentation, and Liquidity (Details) [Line Items] | ||||
Purchase additional shares of public offering (in Shares) | 399,000 | |||
Class A Common Stock [Member] | ||||
Nature of Business, Basis of Presentation, and Liquidity (Details) [Line Items] | ||||
Sale of stock (in Shares) | 2,910,000 | |||
Class A Common Stock [Member] | Initial Public Offering [Member] | ||||
Nature of Business, Basis of Presentation, and Liquidity (Details) [Line Items] | ||||
Sale of stock (in Shares) | 2,660,000 | |||
Sale of stock price, per share (in Dollars per share) | $ 10 | |||
Gross proceeds of initial public offering | $ 26,600,000 | |||
Class A Common Stock [Member] | Over-Allotment Option [Member] | ||||
Nature of Business, Basis of Presentation, and Liquidity (Details) [Line Items] | ||||
Sale of stock (in Shares) | 250,000 | |||
Sale of stock price, per share (in Dollars per share) | $ 10 | |||
Gross proceeds of initial public offering | $ 2,500,000 |
Summary of Significant Accoun_3
Summary of Significant Accounting Policies (Details) - USD ($) $ in Millions | 3 Months Ended | 6 Months Ended | |||
Jun. 30, 2021 | Jun. 30, 2020 | Jun. 30, 2021 | Jun. 30, 2020 | Dec. 31, 2020 | |
Summary of Significant Accounting Policies (Details) [Line Items] | |||||
Deferred offering costs | $ 0.6 | ||||
Revenue | $ 0.4 | $ 0.3 | |||
Options granted maximum term | 10 years | ||||
Finite-Lived Intangible Assets [Member] | Maximum [Member] | |||||
Summary of Significant Accounting Policies (Details) [Line Items] | |||||
intangible assets estimated useful life | 20 years | ||||
Finite-Lived Intangible Assets [Member] | Minimum [Member] | |||||
Summary of Significant Accounting Policies (Details) [Line Items] | |||||
intangible assets estimated useful life | 5 years | ||||
Clinical trial revenue [Member] | |||||
Summary of Significant Accounting Policies (Details) [Line Items] | |||||
Revenue | $ 0 | $ 0.5 |
Summary of Significant Accoun_4
Summary of Significant Accounting Policies (Details) - Schedule of accounts and grants receivable - USD ($) $ in Thousands | Jun. 30, 2021 | Dec. 31, 2020 |
Accounts, Notes, Loans and Financing Receivable [Line Items] | ||
Accounts and grants receivable | $ 130 | $ 420 |
Alzheimer’s Association - Grant [Member] | ||
Accounts, Notes, Loans and Financing Receivable [Line Items] | ||
Accounts and grants receivable | 339 | |
National Institutes of Health - Grant [Member] | ||
Accounts, Notes, Loans and Financing Receivable [Line Items] | ||
Accounts and grants receivable | 130 | 66 |
Clinical Trial receivable [Member] | ||
Accounts, Notes, Loans and Financing Receivable [Line Items] | ||
Accounts and grants receivable | $ 15 |
Summary of Significant Accoun_5
Summary of Significant Accounting Policies (Details) - Schedule of revenue - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | |||
Jun. 30, 2021 | Jun. 30, 2020 | Jun. 30, 2021 | Jun. 30, 2020 | ||
Disaggregation of Revenue [Line Items] | |||||
Revenue | $ 489 | $ 876 | $ 865 | $ 2,584 | |
National Institute of Health - Grant [Member] | |||||
Disaggregation of Revenue [Line Items] | |||||
Revenue | 130 | 629 | 130 | 1,343 | |
Clinical trial revenue [Member] | |||||
Disaggregation of Revenue [Line Items] | |||||
Revenue | 214 | 379 | 762 | ||
Alzheimer’s Association - Grant [Member] | |||||
Disaggregation of Revenue [Line Items] | |||||
Revenue | 91 | 243 | 261 | 440 | |
MSCRF – TEDCO - Grant [Member] | |||||
Disaggregation of Revenue [Line Items] | |||||
Revenue | [1] | 54 | (4) | 95 | 31 |
Contact manufacturing revenue [Member] | |||||
Disaggregation of Revenue [Line Items] | |||||
Revenue | $ 8 | $ 8 | |||
[1] | Maryland Stem Cell Research Fund (MSCRF) - Maryland Technology Development Corporation (TEDCO) |
Short-term investments (Details
Short-term investments (Details) - Schedule of short-term investments $ in Thousands | Jun. 30, 2021USD ($) |
Amortized Cost [Member] | |
Schedule of Held-to-maturity Securities [Line Items] | |
Fixed income bond funds | $ 4,533 |
Total short-term investments | 4,533 |
Gross Unrealized Gains [Member] | |
Schedule of Held-to-maturity Securities [Line Items] | |
Fixed income bond funds | 22 |
Total short-term investments | 22 |
Gross Unrealized Losses [Member] | |
Schedule of Held-to-maturity Securities [Line Items] | |
Fixed income bond funds | |
Total short-term investments | |
Estimated Fair Value [Member] | |
Schedule of Held-to-maturity Securities [Line Items] | |
Fixed income bond funds | 4,555 |
Total short-term investments | $ 4,555 |
Property and equipment, net (De
Property and equipment, net (Details) - USD ($) $ in Millions | 3 Months Ended | 6 Months Ended |
Jun. 30, 2021 | Jun. 30, 2021 | |
Property, Plant and Equipment [Abstract] | ||
Depreciation and amortization expense | $ 0.2 | $ 0.4 |
Property and equipment, net (_2
Property and equipment, net (Details) - Schedule of major components of property and equipment - USD ($) $ in Thousands | 6 Months Ended | |
Jun. 30, 2021 | Dec. 31, 2020 | |
Property, Plant and Equipment [Line Items] | ||
Property and equipment, gross | $ 6,421 | $ 6,421 |
Less accumulated depreciation and amortization | 3,187 | 2,824 |
Property and equipment, net | $ 3,234 | 3,597 |
Leasehold improvements [Member] | ||
Property, Plant and Equipment [Line Items] | ||
Property and equipment, Useful Lives | 10 years | |
Property and equipment, gross | $ 4,310 | 4,310 |
Furniture/Lab equipment [Member] | ||
Property, Plant and Equipment [Line Items] | ||
Property and equipment, Useful Lives | 7 years | |
Property and equipment, gross | $ 2,059 | 2,059 |
Computer equipment [Member] | ||
Property, Plant and Equipment [Line Items] | ||
Property and equipment, Useful Lives | 5 years | |
Property and equipment, gross | $ 14 | 14 |
Software/Website [Member] | ||
Property, Plant and Equipment [Line Items] | ||
Property and equipment, Useful Lives | 3 years | |
Property and equipment, gross | $ 38 | $ 38 |
Intangible assets, net (Details
Intangible assets, net (Details) - USD ($) $ in Millions | 3 Months Ended | 6 Months Ended |
Jun. 30, 2021 | Jun. 30, 2021 | |
Goodwill and Intangible Assets Disclosure [Abstract] | ||
Amortization expense related to intangible assets | $ 0.1 | $ 0.1 |
Intangible assets, net (Detai_2
Intangible assets, net (Details) - Schedule of intangible assets - USD ($) $ in Thousands | 6 Months Ended | 12 Months Ended |
Jun. 30, 2021 | Dec. 31, 2020 | |
Intangible assets, net (Details) - Schedule of intangible assets [Line Items] | ||
Cost | $ 2,753 | $ 1,826 |
Accumulated amortization | (363) | (279) |
Intangible assets | 2,390 | 1,547 |
Patents [Member] | ||
Intangible assets, net (Details) - Schedule of intangible assets [Line Items] | ||
Cost | 563 | 466 |
Accumulated amortization | ||
Intangible assets | 563 | $ 466 |
License agreements [Member] | ||
Intangible assets, net (Details) - Schedule of intangible assets [Line Items] | ||
Useful lives | 20 years | |
Cost | 2,043 | $ 1,233 |
Accumulated amortization | (363) | (279) |
Intangible assets | $ 1,680 | 954 |
License agreements [Member] | Minimum [Member] | ||
Intangible assets, net (Details) - Schedule of intangible assets [Line Items] | ||
Useful lives | 5 years | |
License agreements [Member] | Maximum [Member] | ||
Intangible assets, net (Details) - Schedule of intangible assets [Line Items] | ||
Useful lives | 20 years | |
Trademarks [Member] | ||
Intangible assets, net (Details) - Schedule of intangible assets [Line Items] | ||
Cost | $ 147 | 127 |
Accumulated amortization | ||
Intangible assets | $ 147 | $ 127 |
Intangible assets, net (Detai_3
Intangible assets, net (Details) - Schedule of future amortization expense for intangible assets $ in Thousands | Jun. 30, 2021USD ($) |
Schedule of future amortization expense for intangible assets [Abstract] | |
2021 | $ 112 |
2022 | 224 |
2023 | 224 |
2024 | 224 |
2025 | 224 |
Thereafter | 672 |
Total | $ 1,680 |
Leases (Details)
Leases (Details) - USD ($) | 3 Months Ended | 6 Months Ended | |||
Jun. 30, 2021 | Jun. 30, 2020 | Jun. 30, 2021 | Jun. 30, 2020 | Dec. 31, 2020 | |
Disclosure Text Block [Abstract] | |||||
Right of use asset | $ 1,900,000 | $ 1,900,000 | $ 2,100,000 | ||
Lease liability | 3,400,000 | 3,400,000 | $ 3,700,000 | ||
Lease costs | 200,000 | $ 400,000 | 200,000 | $ 400,000 | |
Monthly payments | $ 10,000 | 10,000 | |||
Sublease income | $ 60,000 |
Leases (Details) - Schedule of
Leases (Details) - Schedule of future minimum payments under the operating leases $ in Thousands | 6 Months Ended |
Jun. 30, 2021USD ($) | |
Schedule of future minimum payments under the operating leases [Abstract] | |
2021 (remaining nine months) | $ 330 |
2022 | 671 |
2023 | 687 |
2024 | 702 |
2025 | 718 |
Thereafter | 920 |
Total | 4,028 |
Less: Interest | 627 |
Present Value of Lease Liability | $ 3,401 |
Members_ Equity and Stockhold_2
Members’ Equity and Stockholders’ Equity (Details) - USD ($) | Mar. 15, 2021 | Jan. 29, 2021 | Jun. 30, 2021 | Jun. 30, 2021 | Jun. 30, 2020 |
Members’ Equity and Stockholders’ Equity (Details) [Line Items] | |||||
Conversion of outstanding shares | 159,817 | ||||
Warrants [Member] | |||||
Members’ Equity and Stockholders’ Equity (Details) [Line Items] | |||||
Fair value of warrants (in Dollars) | $ 500,000 | ||||
Class A Common Stock [Member] | |||||
Members’ Equity and Stockholders’ Equity (Details) [Line Items] | |||||
Conversion of stock, shares issued | 344,077 | ||||
Aggregate value (in Dollars) | $ 900,000 | $ 1,100,000 | |||
Conversion of outstanding shares | 855,247 | 16,755 | |||
Unregistered shares | 131,053 | 157,719 | |||
Class A Common Stock [Member] | Warrants [Member] | |||||
Members’ Equity and Stockholders’ Equity (Details) [Line Items] | |||||
Warrants to purchase of common stock shares | 106,400 | 106,400 | |||
Warrants exercise price (in Dollars per share) | $ 12 | $ 12 | |||
Class A Common Stock [Member] | Over-Allotment Option [Member] | |||||
Members’ Equity and Stockholders’ Equity (Details) [Line Items] | |||||
Sale of stock issued | 250,000 | ||||
Sale of stock price, per share (in Dollars per share) | $ 10 | ||||
Gross proceeds of initial public offering (in Dollars) | $ 2,500,000 | ||||
Series C Units [Member] | |||||
Members’ Equity and Stockholders’ Equity (Details) [Line Items] | |||||
Conversion of stock, shares issued | 1,130 | ||||
Aggregate value (in Dollars) | $ 100,000 | ||||
Conversion of outstanding shares | 63,893 | ||||
Shares issued | 18,335 | ||||
Aggregate value in cash (in Dollars) | $ 1,100,000 | ||||
Additional shares issued | 734 | ||||
Series C Units [Member] | Consulting Agreements [Member] | |||||
Members’ Equity and Stockholders’ Equity (Details) [Line Items] | |||||
Aggregate value (in Dollars) | $ 100,000 | ||||
Class B Common Stock [Member] | |||||
Members’ Equity and Stockholders’ Equity (Details) [Line Items] | |||||
Conversion of outstanding shares | 15,702,834 | ||||
Outstanding shares conversion | 2,000,000 | 2,000,000 |
Equity Incentive Plan (Details)
Equity Incentive Plan (Details) - USD ($) | Jun. 01, 2021 | May 05, 2021 | May 17, 2021 | Apr. 22, 2021 | Jan. 29, 2021 | Jun. 30, 2021 | Jun. 30, 2020 | Jun. 30, 2021 | Jun. 30, 2020 | Jun. 03, 2021 |
Equity Incentive Plan (Details) [Line Items] | ||||||||||
RSUs grant (in Shares) | 109,125 | 109,125 | ||||||||
RSUs converted (in Shares) | 159,817 | |||||||||
RSUs forfeiting (in Dollars) | $ 16,113 | |||||||||
Increments, percentage | 25.00% | |||||||||
RSUs granted and outstanding (in Shares) | 879,134 | |||||||||
Outstanding common stock shares | 5.00% | |||||||||
dividend yield | 0.00% | |||||||||
Expected life | 10 years | |||||||||
Volatility | 95.00% | |||||||||
Issued and outstanding options (in Shares) | 109,125 | 109,125 | ||||||||
Weighted average exercise price (in Dollars per share) | $ 5.67 | $ 5.67 | ||||||||
Granted awards (in Shares) | 5,000 | 10,000 | 30,000 | 64,125 | ||||||
Vesting period | 25.00% | 25.00% | 25.00% | 25.00% | ||||||
Exercise price (in Dollars per share) | $ 6.77 | $ 5.89 | $ 5.29 | $ 5.73 | ||||||
Calculation price (in Dollars per share) | $ 5.94 | $ 5.17 | $ 4.64 | $ 5.03 | ||||||
Total cost (in Dollars) | $ 100,000 | $ 100,000 | $ 100,000 | $ 300,000 | ||||||
SharebasedCompensationArrangementBySharebasedPaymentAwardExpirationPeriod | 48 months | 48 months | 48 months | 48 months | ||||||
Equity based compensation expense (in Dollars) | $ 2,200,000 | $ 11,000 | $ 3,500,000 | $ 24,000 | ||||||
Unrecognized equity based compensation (in Dollars) | $ 5,000,000 | |||||||||
Maturity term | 2 years 6 months | |||||||||
Restricted Stock Unit [Member] | ||||||||||
Equity Incentive Plan (Details) [Line Items] | ||||||||||
Restricted stock unit, per share (in Dollars per share) | $ 9 | |||||||||
Directors [Member] | ||||||||||
Equity Incentive Plan (Details) [Line Items] | ||||||||||
RSUs forfeiting (in Dollars) | $ 5,000 | |||||||||
Maximum [Member] | ||||||||||
Equity Incentive Plan (Details) [Line Items] | ||||||||||
RSUs vest grant date | 50.00% | |||||||||
Risk-free interest rate | 1.62% | |||||||||
Minimum [Member] | ||||||||||
Equity Incentive Plan (Details) [Line Items] | ||||||||||
RSUs vest grant date | 25.00% | |||||||||
Risk-free interest rate | 1.23% | |||||||||
Series C Preferred Stock [Member] | ||||||||||
Equity Incentive Plan (Details) [Line Items] | ||||||||||
RSUs grant (in Shares) | 159,817 | |||||||||
RSUs converted (in Shares) | 63,893 | |||||||||
Class A Common Stock [Member] | ||||||||||
Equity Incentive Plan (Details) [Line Items] | ||||||||||
RSUs grant (in Shares) | 5,000 | |||||||||
RSUs converted (in Shares) | 855,247 | 16,755 |
Equity Incentive Plan (Detail_2
Equity Incentive Plan (Details) - Schedule of fair value of each RSU activity | 6 Months Ended |
Jun. 30, 2021$ / sharesshares | |
Schedule of fair value of each RSU activity [Abstract] | |
Outstanding at December 31, 2020 | |
RSU granted | 895,247 |
RSU exercised (in Dollars per share) | $ / shares | |
RSU expired/forfeited | (16,113) |
Outstanding at June 30, 2021 | 879,134 |
Equity Incentive Plan (Detail_3
Equity Incentive Plan (Details) - Schedule of issued and outstanding options | Jun. 30, 2021shares |
Equity Incentive Plan (Details) - Schedule of issued and outstanding options [Line Items] | |
Total stock options granted | 109,125 |
Stock options vested [Member] | |
Equity Incentive Plan (Details) - Schedule of issued and outstanding options [Line Items] | |
Total stock options granted | 6,822 |
Stock options unvested [Member] | |
Equity Incentive Plan (Details) - Schedule of issued and outstanding options [Line Items] | |
Total stock options granted | 102,303 |
Equity Incentive Plan (Detail_4
Equity Incentive Plan (Details) - Schedule of stock option activity | 6 Months Ended |
Jun. 30, 2021shares | |
Number of Stock Options [Member] | |
Equity Incentive Plan (Details) - Schedule of stock option activity [Line Items] | |
Outstanding at December 31, 2020 | |
Options granted | 109,125 |
Options exercised | |
Options expired/forfeited | |
Outstanding at June 30, 2021 | 109,125 |
Weighted Average Exercise Price [Member] | |
Equity Incentive Plan (Details) - Schedule of stock option activity [Line Items] | |
Outstanding at December 31, 2020 | |
Options granted | 5.67 |
Options exercised | |
Options expired/forfeited | |
Outstanding at June 30, 2021 | 5.67 |
Commitments and Contingencies (
Commitments and Contingencies (Details) - USD ($) | Mar. 03, 2021 | Jan. 29, 2021 | Dec. 22, 2016 | Mar. 27, 2015 | Nov. 20, 2014 | Jun. 30, 2021 | Jun. 30, 2020 | Dec. 31, 2020 | Nov. 22, 2019 | Dec. 31, 2017 |
Commitments and Contingencies (Details) [Line Items] | ||||||||||
Company expense | $ 3,483,000 | $ 23,000 | ||||||||
Incentive units | 50.00% | |||||||||
Aggregate of accrued technology services | $ 200,000 | |||||||||
Converted shares (in Shares) | 159,817 | |||||||||
Account payable, other | 100,000 | $ 100,000 | ||||||||
Licensing agreement, description | The Company is required to pay UM up to 3% of net sales on products or services developed from the technology. The agreement extends for up to 20 years from the last date a product or process is commercialized from the technology. Under the agreement, the Company is required to pay an annual fee to UM. As of June 30, 2020, the Company had accrued $50,000 based on the terms of the agreement. In addition, on November 14, 2014, as required by the license agreement the Company issued 20,000 series C membership units valued at $0.5 million to UM. The Company recorded this $500,000 as an intangible asset that is amortized over the life of the license agreement which was defined as 20 years. As of June 30, 2021, the Company had accrued less than $0.1 million in milestone fees payable to UM based on the estimated progress to date.The UM agreement was amended on March 3, 2021 to increase the license fee due to UM. The Company agreed to pay UM an additional fee, which will be recorded as legal costs, of $0.1 million, to defray patent costs, with $70,000 due within thirty (30) days of the effective date of the amendment, and the remainder to be paid in equal installments of $7,500 on the 2nd, 3rd, and 5th year anniversaries of the effective date. The Company also agreed to issue an additional 110,387 unregistered shares of Class A common stock shares to UM. The Company recorded this $0.8 million as an intangible asset that is amortized over the life of the license agreement which was defined as 5 years. The Company and UM agreed to the following modification of the milestone payments: (a) No payment will be due upon the completion of Phase 2 clinical trials for the product; (b) a one-time payment of $0.5 million, payable within six months of the completion of the first Phase 3 clinical trial of the products (based upon the final data unblinding); (c) a one-time payment of $0.5 million payable within six months of the receipt by the Company of approval for the first new drug application, biologics application, or other marketing or licensing application for the product; and (d) a one-time payment of $0.5 million payable within six months of the first sale following product approval. | |||||||||
Legal fees | $ 100,000 | |||||||||
Defray patent costs | 70,000 | |||||||||
Installments paid | $ 7,500 | |||||||||
Issuance of additional unregistered shares (in Shares) | 110,387 | |||||||||
Intangible assets | $ 800,000 | |||||||||
Intangible asset life year | 5 years | |||||||||
Agreement, description | “Approval” refers to Product approval, licensure, or other marketing authorization by the U.S. Food and Drug Administration, or any successor agency. The amendment also provided for the Company’s license of additional technology, to the extent not previously included in the UM License, and granted the Company an exclusive option to obtain an exclusive license for (a) the HLHS IND with ckit+ cells; and (b) UMP-438 titled “Method of Determining Responsiveness to Cell Therapy in Dilated Cardiomyopathy.” | The Company is required to pay as royalty 1% of the annual net sales of the licensed product(s) used, leased, or sold by or for licensee or its sub-licensees. If the Company sublicenses the technology, it is also required to pay an amount equal to 10% of the net sales of the sub-licensees. In addition, on December 23, 2016, as required by the license agreement, the Company paid an initial fee of $250,000 to JMHMD, and issued to it 10,000 Series C Units, valued at $250,000. The $0.5 million of value provided to JMHMD for the license agreement, along with professional fees of approximately $27,000, were recorded as an intangible asset that is amortized over the life of the license agreement which was defined as 20 years. Further, expenses related to the furtherance of the CD271+ technology is being capitalized and amortized as incurred over 20 years. There were no license fees due during the six months ended June 30, 2021 or year ended December 31, 2020 pertaining to this agreement. | ||||||||
Master Services Agreements [Member] | ||||||||||
Commitments and Contingencies (Details) [Line Items] | ||||||||||
Expenditure amount | 1,000,000 | |||||||||
Consulting Services Agreement [Member] | ||||||||||
Commitments and Contingencies (Details) [Line Items] | ||||||||||
Company expense | $ 270,000 | |||||||||
Accured balance | $ 300,000 | $ 300,000 | ||||||||
Series C Units [Member] | ||||||||||
Commitments and Contingencies (Details) [Line Items] | ||||||||||
Shares issued (in Shares) | 410 | 820 | 1,901 | |||||||
Class A Common Stock [Member] | ||||||||||
Commitments and Contingencies (Details) [Line Items] | ||||||||||
Converted shares (in Shares) | 855,247 | 16,755 |
Short-Term Note Payable (Detail
Short-Term Note Payable (Details) | 1 Months Ended |
Sep. 27, 2020USD ($) | |
Debt Disclosure [Abstract] | |
Insurance policies amount | $ 63,000 |
Down payment | 6,334 |
Monthly payments | $ 6,499 |
Interest rate | 5.353% |
Long-Term Loan (Details)
Long-Term Loan (Details) - USD ($) | Jul. 20, 2021 | Jun. 30, 2021 | Dec. 31, 2020 | May 12, 2020 | Apr. 16, 2020 |
Long-Term Loan (Details) [Line Items] | |||||
Outstanding loan amount | $ 300,390 | $ 150,000 | $ 300,390 | ||
Debt instrument interest rate | 1.00% | ||||
Initial maturity | 24 months | ||||
Forgive amount, percentage | 25.00% | ||||
Economic relief fund | 10,000 | ||||
Current portion of loans | $ 5,000 | $ 139,000 | |||
Subsequent Event [Member] | |||||
Long-Term Loan (Details) [Line Items] | |||||
Debt instrument interest rate | 3.75% | ||||
Initial maturity | 30 years | ||||
Loan payments | $ 731 |
Long-Term Loan (Details) - Sche
Long-Term Loan (Details) - Schedule of future debt obligations for long term loans $ in Thousands | Jun. 30, 2021USD ($) |
Schedule of future debt obligations for long term loans [Abstract] | |
2021 (remaining six months) | $ 4 |
2022 | 3 |
2023 | 3 |
2024 | 3 |
2025 | 3 |
Thereafter | 134 |
Total | $ 150 |
Employee Benefits Plan (Details
Employee Benefits Plan (Details) - USD ($) | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2021 | Jun. 30, 2020 | Jun. 30, 2021 | Jun. 30, 2020 | |
Retirement Benefits [Abstract] | ||||
Company contribution | $ 15,000 | $ 10,000 | $ 31,000 | $ 21,000 |
Loss Per Share (Details) - Sche
Loss Per Share (Details) - Schedule of calculation of diluted net loss per share - USD ($) | 6 Months Ended | |
Jun. 30, 2021 | Jun. 30, 2020 | |
Schedule of calculation of diluted net loss per share [Abstract] | ||
RSUs | $ 879 | |
Stock options | 109 | |
Warrants | 106 | |
Total | $ 1,094 |
Subsequent Events (Details)
Subsequent Events (Details) - Subsequent Event [Member] | 1 Months Ended |
Jul. 20, 2021USD ($)$ / shares | |
Subsequent Events (Details) [Line Items] | |
Price per share expensed (in Dollars per share) | $ / shares | $ 5.32 |
Total cost expensed | $ 1,200,000 |
Percentage of cash bouns | 33.00% |
Subsequent events, description | Dr. Hare and at 25% of the respective base salaries for the Mr. Lehr and Mr. Clavijo, according to the following milestones/ company: 20% if budget revenues during the prior year review period meet projections; 20% if earnings/losses during the prior year review period are on budget (within 15%); 20% if stock price during the prior year review period has reached over $10/share; 20% if stock price during the prior year review period has reached over $12/share; 20% if stock price during the prior year review period has reached over $15/share. |
Bonus amount paid | $ 12,335 |
Fair market value | 6.08 |
Mr. Green [Member] | |
Subsequent Events (Details) [Line Items] | |
Annual base salaries | $ 340,000 |
Percentage of cash bouns | 27.00% |
Mr. Green [Member] | IPO [Member] | |
Subsequent Events (Details) [Line Items] | |
Bouns amount | $ 100,000 |
Mr. Lehr [Member] | |
Subsequent Events (Details) [Line Items] | |
Annual base salaries | 300,000 |
Bouns amount | 75,000 |
Bonus amount paid | 8,223 |
Dr. Hare [Member] | |
Subsequent Events (Details) [Line Items] | |
Annual base salaries | 265,000 |
Bouns amount | 75,000 |
Bonus amount paid | 6,167 |
Mr. Clavijo [Member] | |
Subsequent Events (Details) [Line Items] | |
Annual base salaries | $ 270,000 |