Cover
Cover - USD ($) $ in Millions | 12 Months Ended | ||
Dec. 31, 2023 | Mar. 18, 2024 | Jun. 30, 2023 | |
Cover [Abstract] | |||
Document Type | 10-K | ||
Amendment Flag | false | ||
Document Annual Report | true | ||
Document Transition Report | false | ||
Document Period End Date | Dec. 31, 2023 | ||
Document Fiscal Period Focus | FY | ||
Document Fiscal Year Focus | 2023 | ||
Current Fiscal Year End Date | --12-31 | ||
Entity File Number | 001-38022 | ||
Entity Registrant Name | MATINAS BIOPHARMA HOLDINGS, INC. | ||
Entity Central Index Key | 0001582554 | ||
Entity Tax Identification Number | 46-3011414 | ||
Entity Incorporation, State or Country Code | DE | ||
Entity Address, Address Line One | 1545 Route 206 South | ||
Entity Address, Address Line Two | Suite 302 | ||
Entity Address, City or Town | Bedminster | ||
Entity Address, State or Province | NJ | ||
Entity Address, Postal Zip Code | 07921 | ||
City Area Code | 908 | ||
Local Phone Number | 484-8805 | ||
Title of 12(b) Security | Common Stock, par value $0.0001 | ||
Trading Symbol | MTNB | ||
Security Exchange Name | NYSEAMER | ||
Entity Well-known Seasoned Issuer | No | ||
Entity Voluntary Filers | No | ||
Entity Current Reporting Status | Yes | ||
Entity Interactive Data Current | Yes | ||
Entity Filer Category | Non-accelerated Filer | ||
Entity Small Business | true | ||
Entity Emerging Growth Company | false | ||
Entity Shell Company | false | ||
Entity Public Float | $ 75.9 | ||
Entity Common Stock, Shares Outstanding | 217,482,830 | ||
Documents Incorporated by Reference [Text Block] | None | ||
ICFR Auditor Attestation Flag | false | ||
Document Financial Statement Error Correction [Flag] | false | ||
Auditor Firm ID | 274 | ||
Auditor Name | EISNERAMPER LLP | ||
Auditor Location | Iselin, New Jersey |
Consolidated Balance Sheets
Consolidated Balance Sheets - USD ($) $ in Thousands | Dec. 31, 2023 | Dec. 31, 2022 |
Current assets: | ||
Cash and cash equivalents | $ 4,787 | $ 6,830 |
Marketable debt securities | 8,969 | 21,933 |
Restricted cash – security deposit | 50 | 50 |
Prepaid expenses and other current assets | 1,737 | 5,719 |
Total current assets | 15,543 | 34,532 |
Non-current assets: | ||
Leasehold improvements and equipment - net | 1,923 | 2,091 |
Operating lease right-of-use assets - net | 3,064 | 3,613 |
Finance lease right-of-use assets - net | 21 | 30 |
In-process research and development | 3,017 | 3,017 |
Goodwill | 1,336 | 1,336 |
Restricted cash - security deposit | 200 | 200 |
Total non-current assets | 9,561 | 10,287 |
Total assets | 25,104 | 44,819 |
Current liabilities: | ||
Accounts payable | 514 | 618 |
Accrued expenses and other liabilities | 1,447 | 3,099 |
Operating lease liabilities - current | 656 | 562 |
Financing lease liabilities - current | 5 | 7 |
Total current liabilities | 2,622 | 4,286 |
Non-current liabilities: | ||
Deferred tax liability | 341 | 341 |
Operating lease liabilities - net of current portion | 2,877 | 3,533 |
Financing lease liabilities - net of current portion | 18 | 22 |
Total non-current liabilities | 3,236 | 3,896 |
Total liabilities | 5,858 | 8,182 |
Stockholders’ equity: | ||
Common stock par value $0.0001 per share, 500,000,000 shares authorized at December 31, 2023 and 2022, respectively; 217,264,526 issued and outstanding as of December 31, 2023 and 2022, respectively | 22 | 22 |
Additional paid-in capital | 195,018 | 190,070 |
Accumulated deficit | (175,573) | (152,631) |
Accumulated other comprehensive loss | (221) | (824) |
Total stockholders’ equity | 19,246 | 36,637 |
Total liabilities and stockholders’ equity | $ 25,104 | $ 44,819 |
Consolidated Balance Sheets (Pa
Consolidated Balance Sheets (Parenthetical) - $ / shares | Dec. 31, 2023 | Dec. 31, 2022 |
Statement of Financial Position [Abstract] | ||
Common stock, par value | $ 0.0001 | $ 0.0001 |
Common stock, shares authorized | 500,000,000 | 500,000,000 |
Common stock, shares issued | 217,264,526 | 217,264,526 |
Common stock, shares outsatnding | 217,264,526 | 217,264,526 |
Consolidated Statements of Oper
Consolidated Statements of Operations and Comprehensive Loss - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2023 | Dec. 31, 2022 | |
Revenue: | ||
Contract Revenue | $ 1,096 | $ 3,188 |
Costs and Expenses: | ||
Research and development | 14,489 | 16,678 |
General and administrative | 10,373 | 11,100 |
Total costs and expenses | 24,862 | 27,778 |
Loss from operations | (23,766) | (24,590) |
Sale of New Jersey net operating loss & tax credits | 484 | 3,491 |
Other income, net | 340 | 102 |
Net loss | $ (22,942) | $ (20,997) |
Net loss per share - basic | $ (0.11) | $ (0.10) |
Net loss per share - diluted | $ (0.11) | $ (0.10) |
Weighted average common shares outstanding: | ||
Weighted average common shares outstanding - basic | 217,264,526 | 216,811,439 |
Weighted average common shares outstanding - diluted | 217,264,526 | 216,811,439 |
Other comprehensive gain/(loss), net of tax | ||
Unrealized gain/(loss) on securities available-for-sale | $ 603 | $ (679) |
Other comprehensive gain/(loss), net of tax | 603 | (679) |
Comprehensive loss | $ (22,339) | $ (21,676) |
Consolidated Statements of Chan
Consolidated Statements of Changes in Stockholders' Equity - USD ($) | Common Stock [Member] | Additional Paid-in Capital [Member] | Retained Earnings [Member] | AOCI Attributable to Parent [Member] | Total |
Balance at Dec. 31, 2021 | $ 22,000 | $ 184,251,000 | $ (131,634,000) | $ (145,000) | $ 52,494,000 |
Balance, shares at Dec. 31, 2021 | 216,269,450 | ||||
Stock-based compensation | 5,228,000 | 5,228,000 | |||
Issuance of common stock upon exercise of options | 99,000 | $ 99,000 | |||
Issuance of common stock upon exercise of options, shares | 195,076 | 195,000 | |||
Issuance of common stock in exchange for warrants | 201 | $ 201 | |||
Issuance of common stock in exchange for warrants, shares | 400,000 | ||||
Issuance of common stock pursuant to license agreement amendment | 291,000 | 291,000 | |||
Issuance of common stock pursuant to license agreement amendment, shares | 400,000 | ||||
Other comprehensive income | (679,000) | (679,000) | |||
Net loss | (20,997,000) | (20,997,000) | |||
Balance at Dec. 31, 2022 | $ 22,000 | 190,070,000 | (152,631,000) | (824,000) | 36,637,000 |
Balance, shares at Dec. 31, 2022 | 217,264,526 | ||||
Stock-based compensation | 4,948,000 | $ 4,948,000 | |||
Issuance of common stock upon exercise of options, shares | |||||
Other comprehensive income | 603,000 | $ 603,000 | |||
Net loss | (22,942,000) | (22,942,000) | |||
Balance at Dec. 31, 2023 | $ 22,000 | $ 195,018,000 | $ (175,573,000) | $ (221,000) | $ 19,246,000 |
Balance, shares at Dec. 31, 2023 | 217,264,526 |
Consolidated Statements of Cash
Consolidated Statements of Cash Flows - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2023 | Dec. 31, 2022 | |
Cash flows from operating activities: | ||
Net loss | $ (22,942) | $ (20,997) |
Adjustments to reconcile net loss to net cash used in operating activities: | ||
Depreciation and amortization | 385 | 337 |
Loss on disposal of equipment | 1 | 2 |
Stock-based compensation expense | 4,948 | 5,228 |
Amortization of operating lease right-of-use assets | 548 | 542 |
Amortization of finance lease right-of-use assets | 8 | 19 |
Amortization of bond discount | 107 | 211 |
Stock issued pursuant to license agreement amendment | 291 | |
Changes in operating assets and liabilities: | ||
Prepaid expenses and other current assets | 3,983 | (4,197) |
Accounts payable | (103) | (321) |
Accrued expenses and other liabilities | (1,651) | 249 |
Operating lease liabilities | (562) | (520) |
Net cash used in operating activities | (15,278) | (19,156) |
Cash flows from investing activities: | ||
Purchases of marketable debt securities | (9,481) | |
Proceeds from sales of marketable debt securities | 13,460 | 15,250 |
Purchases of leasehold improvements and equipment | (218) | (892) |
Net cash provided by investing activities | 13,242 | 4,877 |
Cash flows from financing activities: | ||
Proceeds from exercise of options | 99 | |
Payments of capital lease liability – principal | (7) | (20) |
Net cash (used in) provided by financing activities | (7) | 79 |
Net decrease in cash, cash equivalents and restricted cash | (2,043) | (14,200) |
Cash, cash equivalents and restricted cash at beginning of period | 7,080 | 21,280 |
Cash, cash equivalents and restricted cash at end of period | 5,037 | 7,080 |
Supplemental non-cash financing and investing activities: | ||
Unrealized gain/(loss) on marketable debt securities | 603 | (679) |
Cash exercise of warrants in prepaid expenses and other current assets | (201) | |
Right-of-use asset in exchange from liabilities from an operating lease modification | (64) | |
Right-of-use asset in exchange from liabilities from finance leases | $ 14 |
Description of Business
Description of Business | 12 Months Ended |
Dec. 31, 2023 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
Description of Business | Note 1 – Description of Business Matinas BioPharma Holdings Inc. (“Holdings”) is a Delaware corporation formed in 2013. Holdings is the parent company of Matinas BioPharma, Inc. (“BioPharma”), and Matinas BioPharma Nanotechnologies, Inc. (“Nanotechnologies,” formerly known as Aquarius Biotechnologies, Inc.), its operating subsidiaries (“Nanotechnologies”, and together with “Holdings” and “BioPharma”, “the Company”). The Company is a clinical-stage biopharmaceutical company with a focus on identifying and developing novel pharmaceutical products. |
Liquidity, Plan of Operations a
Liquidity, Plan of Operations and Going Concern | 12 Months Ended |
Dec. 31, 2023 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
Liquidity, Plan of Operations and Going Concern | Note 2 – Liquidity, Plan of Operations and Going Concern The Company has experienced net losses and negative cash flows from operations each period since its inception. Through December 31, 2023, the Company had an accumulated deficit of $ 175,573 22,942 20,997 The Company has been engaged in developing its lipid nanocrystal (“LNC”) platform delivery technology and a pipeline of associated product candidates, including MAT2203 and MAT2501, since 2011. To date, the Company has not obtained regulatory approval for any of its product candidates nor generated any revenue from product sales, and the Company expects to incur significant expenses to complete development of its product candidates. The Company may never be able to obtain regulatory approval for the marketing of any of its product candidates in any indication in the United States or internationally and there can be no assurance that the Company will generate revenues or ever achieve profitability. If the Company obtains U.S. Food and Drug Administration (“FDA”) approval for one or more of its product candidates, the Company expects that its expenses will continue to increase once the Company reaches commercial launch. The Company also expects that its research and development expenses will continue to increase as it moves forward with additional clinical studies for its current product candidates and development of additional product candidates. As a result, the Company expects to continue to incur substantial losses for the foreseeable future, and that these losses will be increasing. As of December 31, 2023, the Company had cash and cash equivalents of $ 4,787 8,969 250 The ability of the Company to continue as a going concern is dependent upon control over its operating expenses, anticipated proceeds from future sales of common stock through the At-The-Market Sales Agreement (“Sales Agreement”) with BTIG, LLC. and securing additional financing. While the Company believes in the viability of this strategy and believes the actions presently being taken by the Company provide the opportunity for it to continue as a going concern, there can be no assurance the Company will be successful in its implementation. In particular, utilization of the Sales Agreement may not be viable due to market conditions and new financing may not be available on acceptable terms, or at all. These consolidated financial statements do not include any adjustments related to the recoverability and classification of asset amounts or the amounts and classification of liabilities that might be necessary if the Company is unable to continue as a going concern. |
Summary of Significant Accounti
Summary of Significant Accounting Policies | 12 Months Ended |
Dec. 31, 2023 | |
Accounting Policies [Abstract] | |
Summary of Significant Accounting Policies | Note 3 – Summary of Significant Accounting Policies Basis of presentation and principles of consolidation The accompanying consolidated financial statements include the consolidated accounts of Holdings and its wholly owned subsidiaries, BioPharma, and Nanotechnologies. The accompanying consolidated financial statements have been prepared in accordance with accounting principles generally accepted in the United States (“U.S. GAAP”) and reflect the operations of the Company and its wholly owned subsidiaries. All intercompany transactions have been eliminated in consolidation. Financial impact of events beyond our control Our financial condition and results of operations may be impacted by factors we may not be able to control, such as pandemics, global supply chain disruptions, global trade disputes and/or political instability. Increases in interest rates, especially if coupled with reduced government spending and volatility in financial markets, may have the effect of further increasing economic uncertainty and heightening these risks. Additionally, rising inflation rates may affect us by increasing operating expenses, such as employee-related costs and clinical trial expenses, negatively impacting our results of operations. The Company’s financial results for the year ended December 31, 2023 were not significantly impacted by factors beyond our control, such as those described above. However, the Company cannot predict the impact of any of these factors on future results or the Company’s ability to raise capital due to a variety of factors, including but not limited to the continued good health of Company employees, the ability of service providers and suppliers to continue to operate and deliver, the ability of the Company to maintain operations, and any government and/or public actions taken in response to these factors. Use of estimates The preparation of consolidated financial statements in conformity with U.S. GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities at the date of the financial statements and the reported amounts of revenue and expenses during the reporting period. Actual results could differ from those estimates. Significant items subject to such estimates and assumptions include, but are not limited to, the Company’s research and development expenses and the assessment of the impairment of goodwill and intangible assets. Segment and geographic information Operating segments are defined as components of an enterprise about which separate discrete information is available for evaluation by the chief operating decision maker, or decision-making group, in deciding how to allocate resources and in assessing performance. The Company views its operations and manages its business in one Cash, cash equivalents and restricted cash The Company considers all highly liquid financial instruments with original maturities of three months or less when purchased to be cash and cash equivalents and all investments with maturities of greater than three months from date of purchase are classified as marketable debt securities. Cash and cash equivalents consisted of cash in bank checking and savings accounts, money market funds and short-term U.S. treasury bonds that mature within three months of settlement date. The Company presents restricted cash with cash and cash equivalents in the Consolidated Statements of Cash Flows. Restricted cash represents funds the Company is required to set aside to cover building operating leases and other purposes. For a complete disclosure of the Company’s cash, cash equivalents and restricted cash, see Note 4 – Cash, Cash Equivalents, Restricted Cash and Marketable Debt Securities. Marketable Debt Securities Marketable debt securities, all of which are available-for-sale, consist of U.S. treasury bonds, U.S. government notes and corporate debt securities are carried at fair value, with unrealized gains and losses reported as accumulated other comprehensive loss, except for losses from impairments which are determined to be other-than-temporary. Any premium or discount arising at purchase is amortized and/or accreted to interest income and/or expense over the life of the instrument. The Company reviews its portfolio of available-for-sale debt securities, using both qualitative and quantitative factors, to determine if declines in fair value below cost have resulted from a credit-related loss or other factors. Realized gains and losses and declines in value judged to be other-than-temporary are included in the determination of net loss and are included in other income, net. Fair values are based on quoted market prices at the reporting date. Interest and dividends on available-for-sale securities are included in other income, net. For a complete disclosure of the Company’s marketable debt securities, see Note 4 – Cash, Cash Equivalents, Restricted Cash and Marketable Debt Securities. Concentration of credit risk The Company’s financial instruments that are exposed to concentrations of credit risk consist primarily of cash, cash equivalents, restricted cash and marketable debt securities. The Company’s investment policy is to invest only in institutions that meet high credit quality standards and establishes limits on the amount and time to maturity of investments with any individual counterparty. Balances are maintained at U.S. financial institutions and may from time to time exceed the Federal Deposit Insurance Corporation (“FDIC”) insurance limit of $ 250 Leasehold improvements and equipment Leasehold improvements and equipment are stated at cost less accumulated depreciation and amortization. Depreciation on equipment is computed using the straight-line method over the estimated useful lives of the assets, which range from three ten years Upon retirement or sale, the cost of assets disposed of and related accumulated depreciation and amortization is removed from the accounts and any resulting gain or loss is included in loss from operations. Expenditures for repairs and maintenance are charged to expense as incurred. For a complete disclosure of the Company’s leasehold improvements and equipment, see Note 6 – Leasehold Improvements and Equipment. Goodwill and other intangible assets Goodwill is recorded when consideration paid for an acquired entity exceeds the fair value of the net assets acquired. Goodwill is not amortized but rather is assessed for impairment at least annually on a reporting unit basis, or more frequently when events and circumstances indicate the goodwill may be impaired. U.S. GAAP provides that the Company has the option to perform a qualitative assessment to determine whether it is more-likely-than-not that the fair value of a reporting unit is less than its carrying amount. If the Company determines this is the case, the Company can perform further quantitative analysis to identify and measure the amount of goodwill impairment loss to be recognized, if any. A reporting unit is an operating segment, or one level below an operating segment. Historically, the Company has conducted its business in a single operating segment and reporting unit. For the year ended December 31, 2023, due primarily to there being substantial doubt about the ability of the Company to continue as a going concern, the Company assessed goodwill impairment by performing a quantitative analysis for its reporting unit. As part of the quantitative review, the Company considered whether its fair value, determined as the price a market participant would be willing to pay in a potential acquisition of the Company, exceeds its carrying value, including goodwill. Based on the results of the Company’s assessment, it was determined that its goodwill was not impaired. For the year ended December 31, 2022, the Company assessed goodwill impairment by performing a qualitative analysis for its reporting unit. As part of the qualitative review, the Company considered relevant events and circumstances, with an emphasis on the fact that the Company’s fair value, as determined by its market capitalization, was well in excess of its book value. Based on the results of the Company’s assessment, it was determined that it is more-likely-than-not that its goodwill was not impaired. Indefinite lived intangible assets are composed of in-process research and development (“IPR&D”) and represent projects acquired in a business combination that have not reached technological feasibility or that lack regulatory approval at the time of acquisition. These IPR&D assets are reviewed for impairment annually, or sooner if events or changes in circumstances indicate that the carrying amount of the asset may not be recoverable, and upon establishment of technological feasibility or regulatory approval. An impairment loss, if any, is calculated by comparing the fair value of the asset to its carrying value. If the asset’s carrying value exceeds its fair value, an impairment loss is recorded for the difference and its carrying value is reduced accordingly. Similar to the impairment test for goodwill, the Company may perform a qualitative review of its indefinite-lived intangible assets for impairment in order to determine the necessity of performing a quantitative analysis to identify and measure the amount of impairment loss to be recognized, if any. For the year ended December 31, 2023, the Company performed a quantitative analysis, using a discounted cash flow approach to determine fair value, and concluded that its indefinite-lived assets were not impaired. For the year ended December 31, 2022, the Company used the qualitative approach and concluded that it was more-likely-than-not that its indefinite-lived assets were not impaired. Leases The Financial Accounting Standards Board (the “FASB”) Accounting Standards Codification (“ASC”) Topic 842, “Leases”, establishes a right-of-use (“ROU”) model that requires a lessee to recognize a ROU asset and lease liability on the balance sheet for all leases with a term longer than 12 months. Leases will be classified as either finance or operating, with classification affecting the pattern and classification of expense recognition in the income statement. Lessor accounting under the new standard is substantially unchanged. Additional qualitative and quantitative disclosures are also required. For a complete disclosure of the Company’s leases, see Note 8 – Leases. Income taxes Deferred taxes are provided on a liability method whereby deferred tax assets are recognized for deductible temporary differences and operating loss and tax credit carry forwards and deferred tax liabilities are recognized for taxable temporary differences. Temporary differences are the differences between the reported amounts of assets and liabilities and their tax bases. Deferred tax assets are reduced by a valuation allowance when, in the opinion of management, it is more likely than not that some portion or all of the deferred tax assets will not be realized. Deferred tax assets and liabilities are adjusted for the effects of changes in tax laws and rates in the period that includes the enactment date. The Company adopted the provisions of ASC 740-10 and has analyzed its filing positions in 2023 and 2022 in jurisdictions where it may be obligated to file returns. The Company believes that its income tax filing position and deductions will be sustained on audit and does not anticipate any adjustments that will result in a material change to its financial position. Therefore, no reserves for uncertain income tax positions have been recorded. The Company’s policy is to recognize interest and/or penalties related to income tax matters in income tax expense. The Company had no Since the Company incurred net operating losses in every tax year since inception, the 2014 through 2022 income tax returns are subject to examination and adjustments by the Internal Revenue Service for at least three years following the year in which the tax attributes are utilized. Fair Value Measurements As defined in ASC 820 “Fair Value Measurement”, fair value measurements should be disclosed separately by three levels of the fair value hierarchy. For assets and liabilities recorded at fair value, it is the Company’s policy to maximize the use of observable inputs (quoted prices in active markets) and minimized the use of unobservable inputs (the Company’s assumptions) when developing fair value measurements, in accordance with the established fair value hierarchy. For a complete disclosure of the Company’s fair value measurements, see Note 5 – Fair Value Measurements. Stock-based compensation Stock-based compensation to employees consist of stock option grants and restricted shares. The Company accounts for stock-based compensation under the provisions of ASC 718-10, Compensation – Stock Compensation The Company accounts for equity instruments issued to non-employees in accordance with the provisions of ASC Topic 505, subtopic 50, Equity-Based Payments to Non-Employees The resulting compensation expense for both employee and non-employee awards is generally recognized on a straight-line basis over the requisite service period of the award. Basic and diluted net loss per common share Net loss per share information is determined using the two-class method, which includes the weighted-average number of shares of common stock outstanding during the period and other securities. Under the two-class method, basic net loss per share attributable to common stockholders is computed by dividing the net income attributable to common stockholders by the weighted-average number of shares of common stock outstanding during the period. Diluted net loss per share attributable to common stockholders is computed using the more dilutive of (1) the two-class method or (2) the if-converted method. During the years ended December 31, 2023 and 2022, diluted earnings per common share is the same as basic earnings per common share because, as the Company incurred a net loss during each period presented, the potentially dilutive securities from the assumed exercise of all outstanding stock options and warrants would have an anti-dilutive effect. The reconciliation of the diluted shares as of December 31, 2023 and 2022 are as follows: Schedule of Anti-dilutive Securities As of December 31, 2023 2022 Stock options 46,708 34,739 Warrants — 238 Total 46,708 34,977 Revenue recognition Pursuant to Topic 606, the Company recognizes revenue to depict the transfer of promised goods or services to a customer in an amount that reflects the consideration to which the entity expects to be entitled in exchange for those goods or services. To achieve this core principle, Topic 606 outlines a five-step process for recognizing revenue from customer contracts that includes i) identification of the contract with a customer, ii) identification of the performance obligations in the contract, iii) determining the transaction price, iv) allocating the transaction price to the separate performance obligations in the contract, and v) recognizing revenue associated with performance obligations as they are satisfied. At contract inception, the Company assesses the goods or services promised within each contract and assess whether each promised good or service is distinct and determine those that are performance obligations. The Company then recognizes as revenue the amount of the transaction price that is allocated to the respective performance obligation when the performance obligation is satisfied. For the years ended December 31, 2023 and 2022, the Company’s revenues primarily consist of contract research revenue from the BioNTech Agreement to evaluate the combination of mRNA formats utilizing the Company’s proprietary LNC Platform. For a complete disclosure of the Company’s Revenue Recognition, see Note 9 – Revenue Recognition, Collaboration Agreements, and Other Research and Development Agreements. On December 12, 2019, the Company entered into a feasibility study agreement (the “Agreement”) with Genentech, Inc. (“Genentech”). This feasibility study involves the development of oral formulations using the Company’s LNC Platform, which enables the development of a wide range of difficult-to-deliver molecules. Under the terms of the Agreement, Genentech paid the Company a total of $ 100 33 33 0 Collaboration Agreements The Company assess whether its collaboration agreements are subject to ASC Topic 808, Collaborative Arrangements The terms of such arrangements typically include payments to the Company for one or more of the following: up-front fees; development and regulatory payments; product supply services; research and development cost reimbursements; profit-sharing arrangements; and royalties on certain products if they are successfully commercialized. As part of the accounting for these arrangements, the Company develops assumptions that require judgment to determine the standalone selling price for each performance obligation identified in the contract. These key assumptions may include forecasted revenues, clinical development timelines and costs, reimbursement rates for personnel costs, discount rates and probabilities of technical and regulatory success. Up-front License Fees: Research and Development Milestone Payments: Research and Development Cost Reimbursements: Research and Development Arrangement: 88 811 Research and development expenses Research and development expenses primarily consist of costs associated with the preclinical and clinical development of our product candidate portfolio, including the following: ● external research and development expenses incurred under arrangements with third parties, such as contract research organizations (“CROs”) and other vendors and contract manufacturing organizations (“CMOs”) for the production of drug substance and drug product; and ● employee-related expenses, including salaries, benefits and share-based compensation expense. Research and development expenses also include costs of acquired product licenses and related technology rights where there is no alternative future use, costs of prototypes used in research and development, consultant fees and amounts paid to certain of our collaborative partners. All research and development expenses are charged to operations as incurred in accordance with FASB ASC Topic 730, Research and Development. The Company accounts for non-refundable advance payments for goods and services that will be used in future research and development activities as expenses when the service has been performed or when the goods have been received, rather than when the payment is made. Accrued Research and Development Expenses As part of the process of preparing the Company’s financial statements, the Company is required to estimate its accrued expenses. This process involves reviewing quotations and contracts, identifying services that have been performed on the Company’s behalf and estimating the level of service performed and the associated cost incurred for the service when the Company has not yet been invoiced or otherwise notified of the actual cost. Certain of the Company’s service providers invoice the Company monthly in arrears for services performed or when contractual milestones are met. The Company makes estimates of its accrued expenses as of each balance sheet date in its financial statements based on facts and circumstances known to the Company at that time. The Company periodically confirms the accuracy of its estimates with the service providers and adjust if necessary. The significant estimates in the Company’s accrued research and development expenses are related to expenses incurred with respect to CROs, CMOs and other vendors in connection with research and development and manufacturing activities. The Company bases its expense related to CROs and CMOs on its estimates of the services received and efforts expended pursuant to quotations and contracts with such vendors that conduct research and development and manufacturing activities on its behalf. The financial terms of these agreements are subject to negotiation, vary from contract to contract and may result in uneven payment flows. There may be instances in which payments made to the Company’s vendors will exceed the level of services provided and result in a prepayment of the applicable research and development or manufacturing expense. In accruing service fees, the Company estimates the time period over which services will be performed and the level of effort to be expended in each period. If the actual timing of the performance of services or the level of effort varies from its estimate, the Company adjust the accrual or prepaid expense accordingly. Although the Company does not expect its estimates to be materially different from amounts actually incurred, the Company’s understanding of the status and timing of services performed relative to the actual status and timing of services performed may vary and could result in us reporting amounts that are too high or too low in any particular period. There have been no material changes in estimates for the periods presented. Patent expenses Legal fees and other direct costs incurred in obtaining and protecting patents are also expensed as incurred and are included in general and administrative expenses in the consolidated statements of operations. Other comprehensive loss Other comprehensive loss consists of net gains/(losses) and unrealized losses on marketable debt securities available-for-sale and is presented in the Consolidated Statements of Operations and Comprehensive Loss. Recent accounting pronouncements In November 2023, the FASB issued Accounting Standard Update (“ASU”) No. 2023-07, Segment Reporting (Topic 280): Improvements to Reportable Segment Disclosures In December 2023, the FASB issued ASU No. 2023-09, Income Taxes (Topic 740): Improvements to Income Tax Disclousres (“ASU 2023-09”) |
Cash, Cash Equivalents, Restric
Cash, Cash Equivalents, Restricted Cash and Marketable Debt Securities | 12 Months Ended |
Dec. 31, 2023 | |
Cash and Cash Equivalents [Abstract] | |
Cash, Cash Equivalents, Restricted Cash and Marketable Debt Securities | Note 4 – Cash, Cash Equivalents, Restricted Cash and Marketable Debt Securities The Company considers all highly liquid financial instruments with original maturities of three months or less when purchased to be cash and cash equivalents and all investments with maturities of greater than three months from date of purchase are classified as marketable debt securities. Cash and cash equivalents consisted of cash in bank checking and savings accounts, money market funds and short-term U.S. treasury bonds that mature within three months of settlement date. Cash, Cash Equivalents and Restricted Cash The Company presents restricted cash with cash and cash equivalents in the Consolidated Statements of Cash Flows. Restricted cash at each of December 31, 2023 and 2022 of $ 250 The following table provides a reconciliation of cash, cash equivalents and restricted cash reported in the Consolidated Balance Sheets to the total of the amounts in the Consolidated Statements of Cash Flows as of December 31, 2023, December 31, 2022 and December 31, 2021: Schedule of Cash, Cash Equivalents and Restricted Cash December 31, 2023 December 31, 2022 December 31, 2021 Cash and cash equivalents $ 4,787 $ 6,830 $ 21,030 Restricted cash included in current/non-current assets 250 250 250 Cash, cash equivalents and restricted cash in the statement of cash flows $ 5,037 $ 7,080 $ 21,280 Marketable Debt Securities The Company has classified its investments in marketable debt securities as available-for-sale and as a current asset. The Company’s investments in marketable debt securities are carried at fair value, with unrealized gains and losses included as a separate component of stockholders’ equity. Unrealized losses and gains are classified as other comprehensive (loss)/income and costs are determined on a specific identification basis. Realized gains and losses from marketable debt securities are recorded in other income, net. The Company did not incur any realized gains and losses during the years ended December 31, 2023 and 2022. For the years ended December 31, 2023 and 2022, the Company recorded unrealized gains/(losses) of $ 603 679 221 824 The following tables summarize the Company’s marketable debt securities as of December 31, 2023: Schedule of Marketable Debt Securities Amortized Unrealized Unrealized Cost Gain (Loss) Fair Value U.S. Treasury Bonds $ 999 $ — $ (3 ) $ 996 U.S. Government Notes 8,191 — (218 ) 7,973 Total marketable debt securities $ 9,190 $ — $ (221 ) $ 8,969 All debt securities classified as available-for-sale are due to mature within one year of December 31, 2023. The Company’s marketable debt securities for the year ended December 31, 2022 consisted of the following: Amortized Cost Unrealized Gain Unrealized (Loss) Fair Value U.S. Treasury Bonds $ 993 $ — $ (34 ) $ 959 U.S. Government Notes 16,324 — (721 ) 15,603 Corporate Debt Securities 5,440 — (69 ) 5,371 Total marketable debt securities $ 22,757 $ — $ (824 ) $ 21,933 Maturities of debt securities classified as available-for-sale were as follows at December 31, 2022: Schedule of Maturities of Debt Securities Available-for-sale Fair Value Due within one year $ 13,240 Due after one year through five years 8,693 $ 21,933 The Company determined that the unrealized (losses) and gains are temporary as of December 31, 2023 and 2022. Unrealized (losses) and gains generally are the result of increases in the risk premiums required by market participants rather than an adverse change in cash flows for a fundamental weakness in the credit quality of the issuer or underlying assets. |
Fair Value Measurements
Fair Value Measurements | 12 Months Ended |
Dec. 31, 2023 | |
Fair Value Disclosures [Abstract] | |
Fair Value Measurements | Note 5 - Fair Value Measurements The Company uses the fair value hierarchy to measure the value of its financial instruments. The fair value hierarchy is based on inputs to valuation techniques that are used to measure fair value that are either observable or unobservable. Observable inputs reflect assumptions market participants would use in pricing an asset or liability based on market data obtained from independent sources, while unobservable inputs reflect a reporting entity’s pricing based upon its own market assumptions. The basis for fair value measurements for each level within the hierarchy is described below: ● Level 1 – Quoted prices for identical assets or liabilities in active markets. ● Level 2 – Quoted prices for identical or similar assets and liabilities in markets that are not active; or other model-derived valuations whose inputs are directly or indirectly observable or whose significant value drivers are observable. ● Level 3 – Valuations derived from valuation techniques in which one or more significant inputs to the valuation model are unobservable and for which assumptions are used based on management estimates. The Company utilizes valuation techniques that maximize the use of observable inputs and minimize the use of unobservable inputs to the extent possible as well as considers counterparty credit risk in its assessment of fair value. The carrying amounts of cash equivalents, current portion of restricted cash, prepaid expenses and other current assets, accounts payable, current portion of lease liabilities and accrued expenses approximate fair value due to the short-term nature of these instruments. A summary of the assets and liabilities carried at fair value in accordance with the hierarchy defined above is as follows: Schedule of Fair Value Measurement of Assets and Liabilities Fair Value Hierarchy December 31, 2023 Total (Level 1) (Level 2) (Level 3) Assets Marketable Debt Securities: U.S. Treasury Bonds $ 996 $ 996 $ — $ — U.S. Government Notes 7,973 — 7,973 — Total $ 8,969 $ 996 $ 7,973 $ — Fair Value Hierarchy December 31, 2022 Total (Level 1) (Level 2) (Level 3) Assets Marketable Debt Securities: U.S. Treasury Bonds $ 959 $ 959 $ — $ — U.S. Government Notes 15,603 — 15,603 — Corporate Debt Securities 5,371 — 5,371 — Total $ 21,933 $ 959 $ 20,974 $ — U.S. treasury bonds are classified within Level 1 of the fair value hierarchy because they are valued using quoted market prices for identical assets in active markets. Marketable debt securities consisting of U.S. government notes and corporate debt securities are classified as Level 2 and are valued using quoted market prices in markets that are not active. |
Leasehold Improvements and Equi
Leasehold Improvements and Equipment | 12 Months Ended |
Dec. 31, 2023 | |
Property, Plant and Equipment [Abstract] | |
Leasehold Improvements and Equipment | Note 6 – Leasehold Improvements and Equipment Leasehold improvements and equipment, summarized by major category, consist of the following for the years ended December 31, 2023 and 2022: Schedule of Leasehold Improvements and Equipment December 31, 2023 December 31, 2022 Equipment $ 2,463 $ 2,305 Leasehold improvements 1,155 1,155 Total 3,618 3,460 Leasehold improvements and equipment, gross 3,618 3,460 Less: accumulated depreciation and amortization 1,695 1,369 Leasehold improvements and equipment, net $ 1,923 $ 2,091 Depreciation and amortization expense for the years ended December 31, 2023 and 2022 was $ 385 337 218 892 60 59 7 5 |
Accrued Expenses and Other Liab
Accrued Expenses and Other Liabilities | 12 Months Ended |
Dec. 31, 2023 | |
Payables and Accruals [Abstract] | |
Accrued Expenses and Other Liabilities | Note 7 – Accrued Expenses and Other Liabilities Accrued expenses and other liabilities, summarized by major category, consist of the following for years ended December 31, 2023 and 2022: Schedule of Accrued Expenses 2023 2022 As of December 31, 2023 2022 Payroll and incentives $ 1,176 $ 1,705 General and administrative expenses 196 455 Research and development expenses 75 130 Deferred revenue * — 721 Other deferred liabilities ** — 88 Total $ 1,447 $ 3,099 * At December 31, 2022, the balance included $ 688 33 ** At December 31, 2022, the balance of $ 88 |
Leases
Leases | 12 Months Ended |
Dec. 31, 2023 | |
Leases | |
Leases | Note 8 – Leases The Company has various lease agreements including leases of office space, a laboratory and manufacturing facility, and various equipment. Some leases include purchase, termination or extension options for one or more years. Operating and finance leases are presented in the Company’s consolidated balance sheets as right-of-use assets from leases, current lease liabilities and long-term lease liabilities. The assets and liabilities from our leases are recognized at the lease commencement date based on the present value of remaining lease payments over the lease term using the Company’s incremental borrowing rates or implicit rates, when readily determinable. Short-term leases, which have an initial term of 12 months or less, are not recorded on the balance sheet. As the Company’s operating leases do not provide implicit rates, the Company has utilized its incremental borrowing rate, determined based on the long-term borrowing costs of companies with similar credit profiles, to record its lease obligations. The Company’s finance leases provide readily determinable implicit rates. For operating leases, the Company recognizes the minimum rental expense on a straight-line basis based on the fixed components of a lease arrangement. The Company will amortize this expense over the term of the lease beginning with the lease commencement date. Operating lease obligations On November 1, 2013, the Company entered into a 7 13 14 20 23 On December 15, 2016, the Company entered into a 10-year, 3-month 43 64 586 200 The Company incurred lease expense for its operating leases of $ 902 872 548 542 Finance Leases The Company incurred interest expense on its finance leases of $ 3 1 8 19 The following table presents information about the amount and timing of liabilities arising from the Company’s operating leases and finance leases as of December 31, 2023: Schedule of Maturity of Operating and Finance Leases Liabilities Maturity of Lease Liabilities Operating Lease Liabilities Finance Lease Liabilities 2024 $ 956 $ 7 2025 998 7 2026 1,040 7 2027 944 7 2028 273 — Thereafter 138 — Total undiscounted operating lease payments $ 4,349 $ 28 Less: Imputed interest 816 5 Present value of operating lease liabilities $ 3,533 $ 23 Weighted average remaining lease term in years 4.3 3.9 Weighted average discount rate 9.2 % 11.6 % The following table presents information about the amount and timing of liabilities arising from the Company’s operating leases and finance leases as of December 31, 2022: Maturity of Lease Liabilities Operating Lease Liabilities Finance Lease Liabilities 2023 $ 916 $ 10 2024 956 7 2025 998 7 2026 1,040 7 2027 944 7 Thereafter 411 — Total undiscounted operating lease payments $ 5,265 $ 38 Less: Imputed interest 1,170 9 Present value of operating lease liabilities $ 4,095 $ 29 Weighted average remaining lease term in years 5.3 4.5 Weighted average discount rate 9.2 % 11.1 % |
Revenue Recognition, Collaborat
Revenue Recognition, Collaboration Agreements, and Other Research and Development Agreements | 12 Months Ended |
Dec. 31, 2023 | |
Revenue Recognition Collaboration Agreements And Other Research And Development Agreements | |
Revenue Recognition, Collaboration Agreements, and Other Research and Development Agreements | Note 9 – Revenue Recognition, Collaboration Agreements, and Other Research and Development Agreements BioNTech Research Collaboration On April 8, 2022, the Company entered into the BioNTech Agreement to evaluate the combination of mRNA formats utilizing the Company’s proprietary LNC Platform. Under the terms of the BioNTech Agreement, the Company received an exclusivity fee in the amount of $ 2,750 The Company assessed the BioNTech Agreement under ASC 808 Collaboration Arrangements Revenue from Contracts with Customers The $ 2,750 For the year ended December 31, 2023, $ 688 375 Cystic Fibrosis Foundation Therapeutics Development Award On November 19, 2020, the Company entered into an award agreement (the “CFF Agreement”) with the Cystic Fibrosis Foundation (“CFF”), pursuant to which it received a Therapeutics Development Award of up to $ 4,234 484 321 As of December 31, 2023, the Company has received $ 3,635 4,555 0 88 88 811 Genentech Feasibility Study Agreement On December 12, 2019, the Company entered into the Genentech Agreement which involves the development of oral formulations using the Company’s LNC Platform. Under the terms of the Genentech Agreement, Genentech paid the Company a total of $ 100 33 License Agreement Through the acquisition of Aquarius, the Company acquired a license from Rutgers University, The State University of New Jersey (successor in interest to the University of Medicine and Dentistry of New Jersey) for certain patents related to the LNC Platform (the “License Agreement”). The Second Amended and Restated Exclusive License Agreement provides for, among other things, the payment of (1) royalties on a tiered basis between low single digits and the mid-single digits of net sales of products using such licensed technology, (2) a one-time sales milestone fee of $100 when and if sales of products using the licensed technology reach the specified sales threshold and (3) an annual license fee of $50 over the term of the License Agreement. The term of the License Agreement will remain in effect until the expiration of the last-to-expire patent rights licensed or seven and one-half years from the date of the first commercial sale of a licensed product under this agreement, whichever is later. |
Commitments
Commitments | 12 Months Ended |
Dec. 31, 2023 | |
Commitments and Contingencies Disclosure [Abstract] | |
Commitments | Note 10 – Commitments Royalty payment rights Pursuant to the terms of the Certificate of Designations of Preferences, Rights and Limitations (the “Certificate of Designations”) for our Series A Preferred Stock, the Company may be required to pay royalties of up to $ 35 the Company will be required to pay to certain former holders of its Series A Preferred Stock, in aggregate, a royalty equal to (i) 4.5% of Net Sales (as defined in the Certificate of Designations), subject in all cases to a cap of $25 million per calendar year, and (ii) 7.5% of Licensing Proceeds (as defined in the Certificate of Designations), subject in all cases to a cap of $10 million per calendar year. The Royalty Payment Rights will expire when the patents covering the applicable product expire, which is currently expected to be in 2033 Employment agreements The Company also has employment agreements with certain employees which require the funding of a specific level of payments, if certain events, such as a change in control, termination without cause or retirement, occur. Other normal business operating agreements In addition, in the course of normal business operations, the Company enters into agreements with contract service providers to assist in the performance of research and development and manufacturing activities. Expenditures to these third parties represent significant costs in clinical development and may require upfront payments and long-term commitments of cash. Subject to required notice periods and obligations under binding purchase orders, the Company can elect to discontinue the work under these agreements at any time. Legal proceedings The Company is not currently a party to any legal proceedings, and the Company is not aware of any claims or actions pending or threatened against its business. In the future, the Company might from time to time become involved in litigation relating to claims arising from our ordinary course of business. |
Income Taxes
Income Taxes | 12 Months Ended |
Dec. 31, 2023 | |
Income Tax Disclosure [Abstract] | |
Income Taxes | Note 11 – Income Taxes The Company utilizes the liability method of accounting for deferred income taxes. Under this method, deferred tax liabilities and assets are recognized for the expected future tax consequences of temporary differences between the carrying amounts and the tax basis of assets and liabilities. A valuation allowance is established against deferred tax assets when, based on the weight of available evidence, it is more likely than not that some or all of the deferred tax assets will not be realized. The Company’s policy is to record interest and penalties on uncertain tax positions as income tax expense. As of December 31, 2023 and 2022, the Company does not believe any material uncertain tax positions were present. Accordingly, interest and penalties have not been accrued due to an uncertain tax position. The components of the income tax provision are as follows: Schedule of Income Tax Provision 2023 2022 Year Ended December 31, 2023 2022 Current expense (benefit): Federal $ — $ — State — — Foreign — — Total current expense (benefit): $ — $ — Deferred expense (benefit): Federal $ — $ — State — — Foreign — — Total deferred expense (benefit): $ — $ — Total income tax expense (benefit): $ — $ — Deferred income taxes reflect the net effects of temporary differences between the carrying amounts of assets and liabilities for financial reporting purposes and the amounts used for income tax purposes. A reconciliation of the statutory U.S. federal rate to the Company’s effective tax rate is as follows: Schedule of Effective Income Tax Rate Reconciliation 2023 2022 Year Ended December 31, 2023 2022 Income at U.S. Statutory Rate 21.00 % 21.00 % State Taxes, net of Federal benefit 7.91 % 7.65 % Permanent Differences (1.20 )% (1.25 )% Tax Credits 2.49 % 2.52 % Valuation Allowance (30.19 )% (29.92 )% Effective income tax rate 0.00 % 0.00 % The Company has no current income taxes payable other than certain state minimum taxes which are included in general and administrative expenses. Significant components of the Company’s deferred tax assets (liabilities) for 2023 and 2022 consist of the following: Schedule of Deferred Tax Assets and Liabilities 2023 2022 Year Ended December 31, 2023 2022 Share-based Compensation $ 5,383 $ 4,512 Depreciation and Amortization (23 ) (18 ) Accrued Liability 307 481 Net Operating Loss Carry-forwards 25,146 21,755 R&D Credit Carryforwards 4,432 3,773 R&D Section 174 Costs 5,953 4,268 Other 1 (1 ) IPR&D (851 ) (851 ) ROU Asset (870 ) (1,027 ) ROU Liability 996 1,155 Total Deferred tax assets $ 40,474 $ 34,047 Valuation allowance (40,815 ) (34,388 ) Net deferred tax asset (liability) $ (341 ) $ (341 ) On March 27, 2020, the Coronavirus Aid, Relief, and Economic Security (CARES) Act was signed into law making several changes to the Internal Revenue Code. The changes include but are not limited to: increasing the limitation on the amount of deductible interest expense, allowing companies to carryback certain net operating losses, and increasing the amount of net operating loss carryforwards that corporations can use to offset taxable income. The tax law changes in the Act did not have a material impact on the Company’s income tax provision. In assessing the realizability of deferred tax assets, the Company considers whether it is more likely than not that some portion or all of the deferred tax assets will not be realized. The ultimate realization of deferred tax assets is dependent upon the generation of taxable income during the periods in which the temporary differences representing net future deductible amounts become deductible, and is impacted by the Company’s ability to carryforward losses to years in which the Company has taxable income. Due to the Company’s history of losses and lack of other positive evidence to support taxable income, the Company has recorded a valuation allowance against those deferred tax assets that are not expected to be realized. The valuation allowances were $ 40,815 34,388 31,023 6,427 3,365 As of December 31, 2023, the Company had Federal net operating loss carryforwards of $ 38,080 77,025 4,432 Utilization of the net operating losses and general business tax credits carryforwards may be subject to a substantial limitation under Sections 382 and 383 of the Internal Revenue Code of 1986 due to changes in ownership of the Company that have occurred previously or that could occur in the future. These ownership changes may limit the amount of net operating losses and general business tax credits carryforwards that can be utilized annually to offset future taxable income and tax, respectively. In general, an ownership change, as defined by Section 382, results from transactions increasing the ownership of certain stockholders or public groups in the stock of a corporation by more than 50 percentage points over a three-year period. The Company has not completed a study to determine whether it had undergone an ownership change since the Company’s inception. Under the Tax Cuts and Jobs Act of 2017, research and development costs are no longer fully deductible and are required to be capitalized and amortized for U.S. tax purposes effective January 1, 2022. The mandatory capitalization requirement increases our deferred tax assets. Sale of net operating losses (NOLs) & tax credits The Company recognized $ 484 3,491 In addition, the Tax Cuts and Jobs Act, signed into law on December 22, 2017 imposes significant additional limitations on the deductibility of interest and limits NOL deductions to 80% of net taxable income for losses arising in taxable years beginning after December 31, 2017. |
Stockholders_ Equity
Stockholders’ Equity | 12 Months Ended |
Dec. 31, 2023 | |
Equity [Abstract] | |
Stockholders’ Equity | Note 12 – Stockholders’ Equity At-The-Market Equity Offering On July 2, 2020, the Company entered into an At-The-Market Sales Agreement (the “Sales Agreement”) with BTIG, LLC (“BTIG”), pursuant to which the Company may offer and sell, from time to time, through BTIG, as sales agent and/or principal, shares of its common stock having an aggregate offering price of up to $ 50,000 3 44,247 Common Stock On February 8, 2022, the Company issued 400,000 the Company and Rutgers. The agreement provides for (1) royalties on a tiered basis between low single digits and the mid-single digits of net sales of products using such licensed technology, (2) a one-time sales milestone fee of $100,000 when and if sales of products using the licensed technology reach the specified sales threshold and (3) an annual license fee of $50,000 over the term of the license agreement. There was also a reduction in the consideration paid to Rutgers in the event of a sublicense to a third party of the exclusive patent rights granted pursuant to the Agreement. 291 400,000 0.728 Preferred Stock In accordance with the Certificate of Incorporation, the Company is authorized to issue 10,000,000 0.001 Warrants As of December 31, 2023, the Company did not have any outstanding warrants to purchase shares of common stock. A summary of warrants outstanding as of December 31, 2023 and 2022 is presented below: Schedule of Shareholder Equity Warrants Outstanding Shares Outstanding at December 31, 2021 988 Issued — Exercised (400 ) Expired (350 ) Outstanding at December 31, 2022 238 Issued — Exercised — Expired (238 ) Outstanding at December 31, 2023 — |
Accumulated Other Comprehensive
Accumulated Other Comprehensive Income/(Loss) | 12 Months Ended |
Dec. 31, 2023 | |
Equity [Abstract] | |
Accumulated Other Comprehensive Income/(Loss) | Note 13 – Accumulated Other Comprehensive Income/(Loss) The following table summarizes the changes in accumulated other comprehensive income/(loss) by components during the years ended December 31, 2023 and 2022: Schedule of Components of Accumulated Other Comprehensive (Loss) Income Net Unrealized Gains/(Losses) on Available-for-Sale Securities Accumulated Other Comprehensive Income/(Loss) Balance, December 31, 2021 $ (145 ) $ (145 ) Net unrealized loss on securities available-for-sale (679 ) (679 ) Balance, December 31, 2022 $ (824 ) $ (824 ) Net unrealized gain on securities available-for-sale 603 603 Balance, December 31, 2023 $ (221 ) $ (221 ) All components of accumulated other comprehensive income/(loss) are net of tax. |
Stock-based Compensation
Stock-based Compensation | 12 Months Ended |
Dec. 31, 2023 | |
Share-Based Payment Arrangement [Abstract] | |
Stock-based Compensation | Note 14 – Stock-based Compensation The Company’s Amended and Restated 2013 Equity Compensation Plan (the “Plan”) provides for the granting of incentive stock options, nonqualified stock options, restricted stock units, performance units, and stock purchase rights to eligible employees, officers, non-employee directors and other individual service providers. Options under the Plan may be granted at prices not less than 100% of the fair value three four The term of the options is no longer than ten years 54,293,819 With the approval of the Board of Directors and a majority of shareholders, effective May 8, 2014, the Plan was amended and restated. The amendment provides for an automatic increase in the number of shares of common stock available for issuance under the Plan each January (with Board approval), commencing January 1, 2015 4 The Company recognized stock-based compensation expense (options and restricted share grants) in the following expense categories of its consolidated statements of operations as follows: Schedule of Recognized Stock-Based Compensation Year Ended December 31, 2023 2022 Research and Development $ 2,120 $ 2,400 General and Administrative 2,828 2,828 Total $ 4,948 $ 5,228 The following table contains information about the Company’s stock plan at December 31, 2023: Schedule of Equity Compensation Plan by Arrangements Awards Reserved for Issuance Awards Issued & Exercised Awards Available for Grant 2013 Equity Compensation Plan (in thousands) 54,294 * 51,389 ** 2,905 * Increased by 8,691 4 ** Includes both stock grants and option grants Stock Options The following table summarizes the Company’ stock option activity and related information for the period from January 1, 2022 to December 31, 2023 (options in thousands): Schedule of Stock Option Activity Number of Options Weighted Average Exercise Price Weighted Average Contractual Term in Years Outstanding at January 1, 2022 28,184 $ 1.21 7.2 Granted 8,509 0.56 Exercised (195 ) 0.51 Forfeited (175 ) 0.96 Expired (1,584 ) 1.06 Outstanding at December 31, 2022 34,739 $ 1.07 7.1 Granted 13,928 0.24 Exercised — - Forfeited (296 ) 0.63 Expired (1,663 ) 0.94 Outstanding at December 31, 2023 46,708 $ 0.83 7.4 The following table summarizes outstanding options at December 31, 2023, by their exercise price (options in thousands): Summary of Outstanding Options Range of Exercise Prices Number Outstanding Weighted Average Exercise Price Per Share $ 0.15 0.69 22,128 $ 0.35 $ 0.73 0.92 9,684 $ 0.86 $ 0.93 1.28 6,659 $ 1.11 $ 1.36 3.32 8,237 $ 1.88 46,708 $ 0.83 As of December 31, 2023, the number of vested shares underlying outstanding options was 24,507,007 1.18 22 0.22 7,836 2.6 All outstanding options expire ten years 25 The resulting compensation expense for stock options is generally recognized on a straight-line basis over the requisite service period of the award. The following weighted-average assumptions were used to calculate share-based compensation for the comparative periods presented: Schedule of Compensation Expense for Stock Options For the Year Ended December 31, 2023 2022 Volatility 91.2 120.5 % 92.1 98.7 % Risk-free interest rate 3.50 4.69 % 1.57 4.32 % Dividend yield 0.0 % 0.0 % Expected life 6.0 6.0 The Company does not have sufficient historical information to develop reasonable expectations about future exercise patterns and post-vesting employment termination behavior. Hence, the Company uses the “simplified method” described in Staff Accounting Bulletin (SAB) 107 to estimated the expected term of share option grants. The expected stock price volatility assumption is based on the Company’s historical stock price volatility. |
Subsequent Events
Subsequent Events | 12 Months Ended |
Dec. 31, 2023 | |
Subsequent Events [Abstract] | |
Subsequent Events | Note 15 – Subsequent Events None. |
Summary of Significant Accoun_2
Summary of Significant Accounting Policies (Policies) | 12 Months Ended |
Dec. 31, 2023 | |
Accounting Policies [Abstract] | |
Basis of presentation and principles of consolidation | Basis of presentation and principles of consolidation The accompanying consolidated financial statements include the consolidated accounts of Holdings and its wholly owned subsidiaries, BioPharma, and Nanotechnologies. The accompanying consolidated financial statements have been prepared in accordance with accounting principles generally accepted in the United States (“U.S. GAAP”) and reflect the operations of the Company and its wholly owned subsidiaries. All intercompany transactions have been eliminated in consolidation. |
Financial impact of events beyond our control | Financial impact of events beyond our control Our financial condition and results of operations may be impacted by factors we may not be able to control, such as pandemics, global supply chain disruptions, global trade disputes and/or political instability. Increases in interest rates, especially if coupled with reduced government spending and volatility in financial markets, may have the effect of further increasing economic uncertainty and heightening these risks. Additionally, rising inflation rates may affect us by increasing operating expenses, such as employee-related costs and clinical trial expenses, negatively impacting our results of operations. The Company’s financial results for the year ended December 31, 2023 were not significantly impacted by factors beyond our control, such as those described above. However, the Company cannot predict the impact of any of these factors on future results or the Company’s ability to raise capital due to a variety of factors, including but not limited to the continued good health of Company employees, the ability of service providers and suppliers to continue to operate and deliver, the ability of the Company to maintain operations, and any government and/or public actions taken in response to these factors. |
Use of estimates | Use of estimates The preparation of consolidated financial statements in conformity with U.S. GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities at the date of the financial statements and the reported amounts of revenue and expenses during the reporting period. Actual results could differ from those estimates. Significant items subject to such estimates and assumptions include, but are not limited to, the Company’s research and development expenses and the assessment of the impairment of goodwill and intangible assets. |
Segment and geographic information | Segment and geographic information Operating segments are defined as components of an enterprise about which separate discrete information is available for evaluation by the chief operating decision maker, or decision-making group, in deciding how to allocate resources and in assessing performance. The Company views its operations and manages its business in one |
Cash, cash equivalents and restricted cash | Cash, cash equivalents and restricted cash The Company considers all highly liquid financial instruments with original maturities of three months or less when purchased to be cash and cash equivalents and all investments with maturities of greater than three months from date of purchase are classified as marketable debt securities. Cash and cash equivalents consisted of cash in bank checking and savings accounts, money market funds and short-term U.S. treasury bonds that mature within three months of settlement date. The Company presents restricted cash with cash and cash equivalents in the Consolidated Statements of Cash Flows. Restricted cash represents funds the Company is required to set aside to cover building operating leases and other purposes. For a complete disclosure of the Company’s cash, cash equivalents and restricted cash, see Note 4 – Cash, Cash Equivalents, Restricted Cash and Marketable Debt Securities. |
Marketable Debt Securities | Marketable Debt Securities Marketable debt securities, all of which are available-for-sale, consist of U.S. treasury bonds, U.S. government notes and corporate debt securities are carried at fair value, with unrealized gains and losses reported as accumulated other comprehensive loss, except for losses from impairments which are determined to be other-than-temporary. Any premium or discount arising at purchase is amortized and/or accreted to interest income and/or expense over the life of the instrument. The Company reviews its portfolio of available-for-sale debt securities, using both qualitative and quantitative factors, to determine if declines in fair value below cost have resulted from a credit-related loss or other factors. Realized gains and losses and declines in value judged to be other-than-temporary are included in the determination of net loss and are included in other income, net. Fair values are based on quoted market prices at the reporting date. Interest and dividends on available-for-sale securities are included in other income, net. For a complete disclosure of the Company’s marketable debt securities, see Note 4 – Cash, Cash Equivalents, Restricted Cash and Marketable Debt Securities. |
Concentration of credit risk | Concentration of credit risk The Company’s financial instruments that are exposed to concentrations of credit risk consist primarily of cash, cash equivalents, restricted cash and marketable debt securities. The Company’s investment policy is to invest only in institutions that meet high credit quality standards and establishes limits on the amount and time to maturity of investments with any individual counterparty. Balances are maintained at U.S. financial institutions and may from time to time exceed the Federal Deposit Insurance Corporation (“FDIC”) insurance limit of $ 250 |
Leasehold improvements and equipment | Leasehold improvements and equipment Leasehold improvements and equipment are stated at cost less accumulated depreciation and amortization. Depreciation on equipment is computed using the straight-line method over the estimated useful lives of the assets, which range from three ten years Upon retirement or sale, the cost of assets disposed of and related accumulated depreciation and amortization is removed from the accounts and any resulting gain or loss is included in loss from operations. Expenditures for repairs and maintenance are charged to expense as incurred. For a complete disclosure of the Company’s leasehold improvements and equipment, see Note 6 – Leasehold Improvements and Equipment. |
Goodwill and other intangible assets | Goodwill and other intangible assets Goodwill is recorded when consideration paid for an acquired entity exceeds the fair value of the net assets acquired. Goodwill is not amortized but rather is assessed for impairment at least annually on a reporting unit basis, or more frequently when events and circumstances indicate the goodwill may be impaired. U.S. GAAP provides that the Company has the option to perform a qualitative assessment to determine whether it is more-likely-than-not that the fair value of a reporting unit is less than its carrying amount. If the Company determines this is the case, the Company can perform further quantitative analysis to identify and measure the amount of goodwill impairment loss to be recognized, if any. A reporting unit is an operating segment, or one level below an operating segment. Historically, the Company has conducted its business in a single operating segment and reporting unit. For the year ended December 31, 2023, due primarily to there being substantial doubt about the ability of the Company to continue as a going concern, the Company assessed goodwill impairment by performing a quantitative analysis for its reporting unit. As part of the quantitative review, the Company considered whether its fair value, determined as the price a market participant would be willing to pay in a potential acquisition of the Company, exceeds its carrying value, including goodwill. Based on the results of the Company’s assessment, it was determined that its goodwill was not impaired. For the year ended December 31, 2022, the Company assessed goodwill impairment by performing a qualitative analysis for its reporting unit. As part of the qualitative review, the Company considered relevant events and circumstances, with an emphasis on the fact that the Company’s fair value, as determined by its market capitalization, was well in excess of its book value. Based on the results of the Company’s assessment, it was determined that it is more-likely-than-not that its goodwill was not impaired. Indefinite lived intangible assets are composed of in-process research and development (“IPR&D”) and represent projects acquired in a business combination that have not reached technological feasibility or that lack regulatory approval at the time of acquisition. These IPR&D assets are reviewed for impairment annually, or sooner if events or changes in circumstances indicate that the carrying amount of the asset may not be recoverable, and upon establishment of technological feasibility or regulatory approval. An impairment loss, if any, is calculated by comparing the fair value of the asset to its carrying value. If the asset’s carrying value exceeds its fair value, an impairment loss is recorded for the difference and its carrying value is reduced accordingly. Similar to the impairment test for goodwill, the Company may perform a qualitative review of its indefinite-lived intangible assets for impairment in order to determine the necessity of performing a quantitative analysis to identify and measure the amount of impairment loss to be recognized, if any. For the year ended December 31, 2023, the Company performed a quantitative analysis, using a discounted cash flow approach to determine fair value, and concluded that its indefinite-lived assets were not impaired. For the year ended December 31, 2022, the Company used the qualitative approach and concluded that it was more-likely-than-not that its indefinite-lived assets were not impaired. |
Leases | Leases The Financial Accounting Standards Board (the “FASB”) Accounting Standards Codification (“ASC”) Topic 842, “Leases”, establishes a right-of-use (“ROU”) model that requires a lessee to recognize a ROU asset and lease liability on the balance sheet for all leases with a term longer than 12 months. Leases will be classified as either finance or operating, with classification affecting the pattern and classification of expense recognition in the income statement. Lessor accounting under the new standard is substantially unchanged. Additional qualitative and quantitative disclosures are also required. For a complete disclosure of the Company’s leases, see Note 8 – Leases. |
Income taxes | Income taxes Deferred taxes are provided on a liability method whereby deferred tax assets are recognized for deductible temporary differences and operating loss and tax credit carry forwards and deferred tax liabilities are recognized for taxable temporary differences. Temporary differences are the differences between the reported amounts of assets and liabilities and their tax bases. Deferred tax assets are reduced by a valuation allowance when, in the opinion of management, it is more likely than not that some portion or all of the deferred tax assets will not be realized. Deferred tax assets and liabilities are adjusted for the effects of changes in tax laws and rates in the period that includes the enactment date. The Company adopted the provisions of ASC 740-10 and has analyzed its filing positions in 2023 and 2022 in jurisdictions where it may be obligated to file returns. The Company believes that its income tax filing position and deductions will be sustained on audit and does not anticipate any adjustments that will result in a material change to its financial position. Therefore, no reserves for uncertain income tax positions have been recorded. The Company’s policy is to recognize interest and/or penalties related to income tax matters in income tax expense. The Company had no Since the Company incurred net operating losses in every tax year since inception, the 2014 through 2022 income tax returns are subject to examination and adjustments by the Internal Revenue Service for at least three years following the year in which the tax attributes are utilized. |
Fair Value Measurements | Fair Value Measurements As defined in ASC 820 “Fair Value Measurement”, fair value measurements should be disclosed separately by three levels of the fair value hierarchy. For assets and liabilities recorded at fair value, it is the Company’s policy to maximize the use of observable inputs (quoted prices in active markets) and minimized the use of unobservable inputs (the Company’s assumptions) when developing fair value measurements, in accordance with the established fair value hierarchy. For a complete disclosure of the Company’s fair value measurements, see Note 5 – Fair Value Measurements. |
Stock-based compensation | Stock-based compensation Stock-based compensation to employees consist of stock option grants and restricted shares. The Company accounts for stock-based compensation under the provisions of ASC 718-10, Compensation – Stock Compensation The Company accounts for equity instruments issued to non-employees in accordance with the provisions of ASC Topic 505, subtopic 50, Equity-Based Payments to Non-Employees The resulting compensation expense for both employee and non-employee awards is generally recognized on a straight-line basis over the requisite service period of the award. |
Basic and diluted net loss per common share | Basic and diluted net loss per common share Net loss per share information is determined using the two-class method, which includes the weighted-average number of shares of common stock outstanding during the period and other securities. Under the two-class method, basic net loss per share attributable to common stockholders is computed by dividing the net income attributable to common stockholders by the weighted-average number of shares of common stock outstanding during the period. Diluted net loss per share attributable to common stockholders is computed using the more dilutive of (1) the two-class method or (2) the if-converted method. During the years ended December 31, 2023 and 2022, diluted earnings per common share is the same as basic earnings per common share because, as the Company incurred a net loss during each period presented, the potentially dilutive securities from the assumed exercise of all outstanding stock options and warrants would have an anti-dilutive effect. The reconciliation of the diluted shares as of December 31, 2023 and 2022 are as follows: Schedule of Anti-dilutive Securities As of December 31, 2023 2022 Stock options 46,708 34,739 Warrants — 238 Total 46,708 34,977 |
Revenue recognition | Revenue recognition Pursuant to Topic 606, the Company recognizes revenue to depict the transfer of promised goods or services to a customer in an amount that reflects the consideration to which the entity expects to be entitled in exchange for those goods or services. To achieve this core principle, Topic 606 outlines a five-step process for recognizing revenue from customer contracts that includes i) identification of the contract with a customer, ii) identification of the performance obligations in the contract, iii) determining the transaction price, iv) allocating the transaction price to the separate performance obligations in the contract, and v) recognizing revenue associated with performance obligations as they are satisfied. At contract inception, the Company assesses the goods or services promised within each contract and assess whether each promised good or service is distinct and determine those that are performance obligations. The Company then recognizes as revenue the amount of the transaction price that is allocated to the respective performance obligation when the performance obligation is satisfied. For the years ended December 31, 2023 and 2022, the Company’s revenues primarily consist of contract research revenue from the BioNTech Agreement to evaluate the combination of mRNA formats utilizing the Company’s proprietary LNC Platform. For a complete disclosure of the Company’s Revenue Recognition, see Note 9 – Revenue Recognition, Collaboration Agreements, and Other Research and Development Agreements. On December 12, 2019, the Company entered into a feasibility study agreement (the “Agreement”) with Genentech, Inc. (“Genentech”). This feasibility study involves the development of oral formulations using the Company’s LNC Platform, which enables the development of a wide range of difficult-to-deliver molecules. Under the terms of the Agreement, Genentech paid the Company a total of $ 100 33 33 0 |
Collaboration Agreements | Collaboration Agreements The Company assess whether its collaboration agreements are subject to ASC Topic 808, Collaborative Arrangements The terms of such arrangements typically include payments to the Company for one or more of the following: up-front fees; development and regulatory payments; product supply services; research and development cost reimbursements; profit-sharing arrangements; and royalties on certain products if they are successfully commercialized. As part of the accounting for these arrangements, the Company develops assumptions that require judgment to determine the standalone selling price for each performance obligation identified in the contract. These key assumptions may include forecasted revenues, clinical development timelines and costs, reimbursement rates for personnel costs, discount rates and probabilities of technical and regulatory success. Up-front License Fees: Research and Development Milestone Payments: Research and Development Cost Reimbursements: Research and Development Arrangement: 88 811 |
Research and development expenses | Research and development expenses Research and development expenses primarily consist of costs associated with the preclinical and clinical development of our product candidate portfolio, including the following: ● external research and development expenses incurred under arrangements with third parties, such as contract research organizations (“CROs”) and other vendors and contract manufacturing organizations (“CMOs”) for the production of drug substance and drug product; and ● employee-related expenses, including salaries, benefits and share-based compensation expense. Research and development expenses also include costs of acquired product licenses and related technology rights where there is no alternative future use, costs of prototypes used in research and development, consultant fees and amounts paid to certain of our collaborative partners. All research and development expenses are charged to operations as incurred in accordance with FASB ASC Topic 730, Research and Development. The Company accounts for non-refundable advance payments for goods and services that will be used in future research and development activities as expenses when the service has been performed or when the goods have been received, rather than when the payment is made. Accrued Research and Development Expenses As part of the process of preparing the Company’s financial statements, the Company is required to estimate its accrued expenses. This process involves reviewing quotations and contracts, identifying services that have been performed on the Company’s behalf and estimating the level of service performed and the associated cost incurred for the service when the Company has not yet been invoiced or otherwise notified of the actual cost. Certain of the Company’s service providers invoice the Company monthly in arrears for services performed or when contractual milestones are met. The Company makes estimates of its accrued expenses as of each balance sheet date in its financial statements based on facts and circumstances known to the Company at that time. The Company periodically confirms the accuracy of its estimates with the service providers and adjust if necessary. The significant estimates in the Company’s accrued research and development expenses are related to expenses incurred with respect to CROs, CMOs and other vendors in connection with research and development and manufacturing activities. The Company bases its expense related to CROs and CMOs on its estimates of the services received and efforts expended pursuant to quotations and contracts with such vendors that conduct research and development and manufacturing activities on its behalf. The financial terms of these agreements are subject to negotiation, vary from contract to contract and may result in uneven payment flows. There may be instances in which payments made to the Company’s vendors will exceed the level of services provided and result in a prepayment of the applicable research and development or manufacturing expense. In accruing service fees, the Company estimates the time period over which services will be performed and the level of effort to be expended in each period. If the actual timing of the performance of services or the level of effort varies from its estimate, the Company adjust the accrual or prepaid expense accordingly. Although the Company does not expect its estimates to be materially different from amounts actually incurred, the Company’s understanding of the status and timing of services performed relative to the actual status and timing of services performed may vary and could result in us reporting amounts that are too high or too low in any particular period. There have been no material changes in estimates for the periods presented. |
Patent expenses | Patent expenses Legal fees and other direct costs incurred in obtaining and protecting patents are also expensed as incurred and are included in general and administrative expenses in the consolidated statements of operations. |
Other comprehensive loss | Other comprehensive loss Other comprehensive loss consists of net gains/(losses) and unrealized losses on marketable debt securities available-for-sale and is presented in the Consolidated Statements of Operations and Comprehensive Loss. |
Recent accounting pronouncements | Recent accounting pronouncements In November 2023, the FASB issued Accounting Standard Update (“ASU”) No. 2023-07, Segment Reporting (Topic 280): Improvements to Reportable Segment Disclosures In December 2023, the FASB issued ASU No. 2023-09, Income Taxes (Topic 740): Improvements to Income Tax Disclousres (“ASU 2023-09”) |
Summary of Significant Accoun_3
Summary of Significant Accounting Policies (Tables) | 12 Months Ended |
Dec. 31, 2023 | |
Accounting Policies [Abstract] | |
Schedule of Anti-dilutive Securities | Schedule of Anti-dilutive Securities As of December 31, 2023 2022 Stock options 46,708 34,739 Warrants — 238 Total 46,708 34,977 |
Cash, Cash Equivalents, Restr_2
Cash, Cash Equivalents, Restricted Cash and Marketable Debt Securities (Tables) | 12 Months Ended |
Dec. 31, 2023 | |
Cash and Cash Equivalents [Abstract] | |
Schedule of Cash, Cash Equivalents and Restricted Cash | The following table provides a reconciliation of cash, cash equivalents and restricted cash reported in the Consolidated Balance Sheets to the total of the amounts in the Consolidated Statements of Cash Flows as of December 31, 2023, December 31, 2022 and December 31, 2021: Schedule of Cash, Cash Equivalents and Restricted Cash December 31, 2023 December 31, 2022 December 31, 2021 Cash and cash equivalents $ 4,787 $ 6,830 $ 21,030 Restricted cash included in current/non-current assets 250 250 250 Cash, cash equivalents and restricted cash in the statement of cash flows $ 5,037 $ 7,080 $ 21,280 |
Schedule of Marketable Debt Securities | The following tables summarize the Company’s marketable debt securities as of December 31, 2023: Schedule of Marketable Debt Securities Amortized Unrealized Unrealized Cost Gain (Loss) Fair Value U.S. Treasury Bonds $ 999 $ — $ (3 ) $ 996 U.S. Government Notes 8,191 — (218 ) 7,973 Total marketable debt securities $ 9,190 $ — $ (221 ) $ 8,969 Amortized Cost Unrealized Gain Unrealized (Loss) Fair Value U.S. Treasury Bonds $ 993 $ — $ (34 ) $ 959 U.S. Government Notes 16,324 — (721 ) 15,603 Corporate Debt Securities 5,440 — (69 ) 5,371 Total marketable debt securities $ 22,757 $ — $ (824 ) $ 21,933 |
Schedule of Maturities of Debt Securities Available-for-sale | Maturities of debt securities classified as available-for-sale were as follows at December 31, 2022: Schedule of Maturities of Debt Securities Available-for-sale Fair Value Due within one year $ 13,240 Due after one year through five years 8,693 $ 21,933 |
Fair Value Measurements (Tables
Fair Value Measurements (Tables) | 12 Months Ended |
Dec. 31, 2023 | |
Fair Value Disclosures [Abstract] | |
Schedule of Fair Value Measurement of Assets and Liabilities | A summary of the assets and liabilities carried at fair value in accordance with the hierarchy defined above is as follows: Schedule of Fair Value Measurement of Assets and Liabilities Fair Value Hierarchy December 31, 2023 Total (Level 1) (Level 2) (Level 3) Assets Marketable Debt Securities: U.S. Treasury Bonds $ 996 $ 996 $ — $ — U.S. Government Notes 7,973 — 7,973 — Total $ 8,969 $ 996 $ 7,973 $ — Fair Value Hierarchy December 31, 2022 Total (Level 1) (Level 2) (Level 3) Assets Marketable Debt Securities: U.S. Treasury Bonds $ 959 $ 959 $ — $ — U.S. Government Notes 15,603 — 15,603 — Corporate Debt Securities 5,371 — 5,371 — Total $ 21,933 $ 959 $ 20,974 $ — |
Leasehold Improvements and Eq_2
Leasehold Improvements and Equipment (Tables) | 12 Months Ended |
Dec. 31, 2023 | |
Property, Plant and Equipment [Abstract] | |
Schedule of Leasehold Improvements and Equipment | Leasehold improvements and equipment, summarized by major category, consist of the following for the years ended December 31, 2023 and 2022: Schedule of Leasehold Improvements and Equipment December 31, 2023 December 31, 2022 Equipment $ 2,463 $ 2,305 Leasehold improvements 1,155 1,155 Total 3,618 3,460 Leasehold improvements and equipment, gross 3,618 3,460 Less: accumulated depreciation and amortization 1,695 1,369 Leasehold improvements and equipment, net $ 1,923 $ 2,091 |
Accrued Expenses and Other Li_2
Accrued Expenses and Other Liabilities (Tables) | 12 Months Ended |
Dec. 31, 2023 | |
Payables and Accruals [Abstract] | |
Schedule of Accrued Expenses | Accrued expenses and other liabilities, summarized by major category, consist of the following for years ended December 31, 2023 and 2022: Schedule of Accrued Expenses 2023 2022 As of December 31, 2023 2022 Payroll and incentives $ 1,176 $ 1,705 General and administrative expenses 196 455 Research and development expenses 75 130 Deferred revenue * — 721 Other deferred liabilities ** — 88 Total $ 1,447 $ 3,099 * At December 31, 2022, the balance included $ 688 33 ** At December 31, 2022, the balance of $ 88 |
Leases (Tables)
Leases (Tables) | 12 Months Ended |
Dec. 31, 2023 | |
Leases | |
Schedule of Maturity of Operating and Finance Leases Liabilities | The following table presents information about the amount and timing of liabilities arising from the Company’s operating leases and finance leases as of December 31, 2023: Schedule of Maturity of Operating and Finance Leases Liabilities Maturity of Lease Liabilities Operating Lease Liabilities Finance Lease Liabilities 2024 $ 956 $ 7 2025 998 7 2026 1,040 7 2027 944 7 2028 273 — Thereafter 138 — Total undiscounted operating lease payments $ 4,349 $ 28 Less: Imputed interest 816 5 Present value of operating lease liabilities $ 3,533 $ 23 Weighted average remaining lease term in years 4.3 3.9 Weighted average discount rate 9.2 % 11.6 % The following table presents information about the amount and timing of liabilities arising from the Company’s operating leases and finance leases as of December 31, 2022: Maturity of Lease Liabilities Operating Lease Liabilities Finance Lease Liabilities 2023 $ 916 $ 10 2024 956 7 2025 998 7 2026 1,040 7 2027 944 7 Thereafter 411 — Total undiscounted operating lease payments $ 5,265 $ 38 Less: Imputed interest 1,170 9 Present value of operating lease liabilities $ 4,095 $ 29 Weighted average remaining lease term in years 5.3 4.5 Weighted average discount rate 9.2 % 11.1 % |
Income Taxes (Tables)
Income Taxes (Tables) | 12 Months Ended |
Dec. 31, 2023 | |
Income Tax Disclosure [Abstract] | |
Schedule of Income Tax Provision | The components of the income tax provision are as follows: Schedule of Income Tax Provision 2023 2022 Year Ended December 31, 2023 2022 Current expense (benefit): Federal $ — $ — State — — Foreign — — Total current expense (benefit): $ — $ — Deferred expense (benefit): Federal $ — $ — State — — Foreign — — Total deferred expense (benefit): $ — $ — Total income tax expense (benefit): $ — $ — |
Schedule of Effective Income Tax Rate Reconciliation | Deferred income taxes reflect the net effects of temporary differences between the carrying amounts of assets and liabilities for financial reporting purposes and the amounts used for income tax purposes. A reconciliation of the statutory U.S. federal rate to the Company’s effective tax rate is as follows: Schedule of Effective Income Tax Rate Reconciliation 2023 2022 Year Ended December 31, 2023 2022 Income at U.S. Statutory Rate 21.00 % 21.00 % State Taxes, net of Federal benefit 7.91 % 7.65 % Permanent Differences (1.20 )% (1.25 )% Tax Credits 2.49 % 2.52 % Valuation Allowance (30.19 )% (29.92 )% Effective income tax rate 0.00 % 0.00 % |
Schedule of Deferred Tax Assets and Liabilities | Significant components of the Company’s deferred tax assets (liabilities) for 2023 and 2022 consist of the following: Schedule of Deferred Tax Assets and Liabilities 2023 2022 Year Ended December 31, 2023 2022 Share-based Compensation $ 5,383 $ 4,512 Depreciation and Amortization (23 ) (18 ) Accrued Liability 307 481 Net Operating Loss Carry-forwards 25,146 21,755 R&D Credit Carryforwards 4,432 3,773 R&D Section 174 Costs 5,953 4,268 Other 1 (1 ) IPR&D (851 ) (851 ) ROU Asset (870 ) (1,027 ) ROU Liability 996 1,155 Total Deferred tax assets $ 40,474 $ 34,047 Valuation allowance (40,815 ) (34,388 ) Net deferred tax asset (liability) $ (341 ) $ (341 ) |
Stockholders_ Equity (Tables)
Stockholders’ Equity (Tables) | 12 Months Ended |
Dec. 31, 2023 | |
Equity [Abstract] | |
Schedule of Shareholder Equity Warrants Outstanding | Schedule of Shareholder Equity Warrants Outstanding Shares Outstanding at December 31, 2021 988 Issued — Exercised (400 ) Expired (350 ) Outstanding at December 31, 2022 238 Issued — Exercised — Expired (238 ) Outstanding at December 31, 2023 — |
Accumulated Other Comprehensi_2
Accumulated Other Comprehensive Income/(Loss) (Tables) | 12 Months Ended |
Dec. 31, 2023 | |
Equity [Abstract] | |
Schedule of Components of Accumulated Other Comprehensive (Loss) Income | The following table summarizes the changes in accumulated other comprehensive income/(loss) by components during the years ended December 31, 2023 and 2022: Schedule of Components of Accumulated Other Comprehensive (Loss) Income Net Unrealized Gains/(Losses) on Available-for-Sale Securities Accumulated Other Comprehensive Income/(Loss) Balance, December 31, 2021 $ (145 ) $ (145 ) Net unrealized loss on securities available-for-sale (679 ) (679 ) Balance, December 31, 2022 $ (824 ) $ (824 ) Net unrealized gain on securities available-for-sale 603 603 Balance, December 31, 2023 $ (221 ) $ (221 ) |
Stock-based Compensation (Table
Stock-based Compensation (Tables) | 12 Months Ended |
Dec. 31, 2023 | |
Share-Based Payment Arrangement [Abstract] | |
Schedule of Recognized Stock-Based Compensation | The Company recognized stock-based compensation expense (options and restricted share grants) in the following expense categories of its consolidated statements of operations as follows: Schedule of Recognized Stock-Based Compensation Year Ended December 31, 2023 2022 Research and Development $ 2,120 $ 2,400 General and Administrative 2,828 2,828 Total $ 4,948 $ 5,228 |
Schedule of Equity Compensation Plan by Arrangements | The following table contains information about the Company’s stock plan at December 31, 2023: Schedule of Equity Compensation Plan by Arrangements Awards Reserved for Issuance Awards Issued & Exercised Awards Available for Grant 2013 Equity Compensation Plan (in thousands) 54,294 * 51,389 ** 2,905 * Increased by 8,691 4 ** Includes both stock grants and option grants |
Schedule of Stock Option Activity | The following table summarizes the Company’ stock option activity and related information for the period from January 1, 2022 to December 31, 2023 (options in thousands): Schedule of Stock Option Activity Number of Options Weighted Average Exercise Price Weighted Average Contractual Term in Years Outstanding at January 1, 2022 28,184 $ 1.21 7.2 Granted 8,509 0.56 Exercised (195 ) 0.51 Forfeited (175 ) 0.96 Expired (1,584 ) 1.06 Outstanding at December 31, 2022 34,739 $ 1.07 7.1 Granted 13,928 0.24 Exercised — - Forfeited (296 ) 0.63 Expired (1,663 ) 0.94 Outstanding at December 31, 2023 46,708 $ 0.83 7.4 |
Summary of Outstanding Options | The following table summarizes outstanding options at December 31, 2023, by their exercise price (options in thousands): Summary of Outstanding Options Range of Exercise Prices Number Outstanding Weighted Average Exercise Price Per Share $ 0.15 0.69 22,128 $ 0.35 $ 0.73 0.92 9,684 $ 0.86 $ 0.93 1.28 6,659 $ 1.11 $ 1.36 3.32 8,237 $ 1.88 46,708 $ 0.83 |
Schedule of Compensation Expense for Stock Options | Schedule of Compensation Expense for Stock Options For the Year Ended December 31, 2023 2022 Volatility 91.2 120.5 % 92.1 98.7 % Risk-free interest rate 3.50 4.69 % 1.57 4.32 % Dividend yield 0.0 % 0.0 % Expected life 6.0 6.0 |
Liquidity, Plan of Operations_2
Liquidity, Plan of Operations and Going Concern (Details Narrative) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2023 | Dec. 31, 2022 | Dec. 31, 2021 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |||
Accumulated deficit | $ 175,573 | $ 152,631 | |
Net loss | 22,942 | 20,997 | |
Cash and cash equivalents | 4,787 | 6,830 | $ 21,030 |
Marketable securities | 8,969 | 21,933 | |
Restricted cash | $ 250 | $ 250 | $ 250 |
Schedule of Anti-dilutive Secur
Schedule of Anti-dilutive Securities (Details) - shares shares in Thousands | 12 Months Ended | |
Dec. 31, 2023 | Dec. 31, 2022 | |
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Anti-dilutive earnings per share, amount | 46,708 | 34,977 |
Share-Based Payment Arrangement, Option [Member] | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Anti-dilutive earnings per share, amount | 46,708 | 34,739 |
Warrant [Member] | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Anti-dilutive earnings per share, amount | 238 |
Summary of Significant Accoun_4
Summary of Significant Accounting Policies (Details Narrative) $ in Thousands | 12 Months Ended | ||
Dec. 12, 2019 USD ($) | Dec. 31, 2023 USD ($) Segment | Dec. 31, 2022 USD ($) | |
Property, Plant and Equipment [Line Items] | |||
Number of operating segment | Segment | 1 | ||
Number of reportable segment | Segment | 1 | ||
Cash FDIC insured amount | $ 250 | ||
Accrual for interest or penalties | 0 | ||
Cystic Fibrosis Foundation Therapeutics Development Award [Member] | |||
Property, Plant and Equipment [Line Items] | |||
Research and development, costs incurred | 88 | $ 811 | |
Genentech Feasibility Study Agreement [Member] | |||
Property, Plant and Equipment [Line Items] | |||
Revenue recognized | $ 33 | $ 33 | $ 0 |
Three Molecules [Member] | Genentech Feasibility Study Agreement [Member] | |||
Property, Plant and Equipment [Line Items] | |||
Revenue recognized | $ 100 | ||
Minimum [Member] | |||
Property, Plant and Equipment [Line Items] | |||
Leasehold improvements and equipment, useful life | 3 years | ||
Maximum [Member] | |||
Property, Plant and Equipment [Line Items] | |||
Leasehold improvements and equipment, useful life | 10 years |
Schedule of Cash, Cash Equivale
Schedule of Cash, Cash Equivalents and Restricted Cash (Details) - USD ($) $ in Thousands | Dec. 31, 2023 | Dec. 31, 2022 | Dec. 31, 2021 |
Cash and Cash Equivalents [Abstract] | |||
Cash and cash equivalents | $ 4,787 | $ 6,830 | $ 21,030 |
Restricted cash included in current/non-current assets | 250 | 250 | 250 |
Cash, cash equivalents and restricted cash in the statement of cash flows | $ 5,037 | $ 7,080 | $ 21,280 |
Schedule of Marketable Debt Sec
Schedule of Marketable Debt Securities (Details) - USD ($) $ in Thousands | Dec. 31, 2023 | Dec. 31, 2022 |
Debt Securities, Held-to-Maturity, Allowance for Credit Loss [Line Items] | ||
Debt Securities, Available-for-Sale, Amortized Cost | $ 9,190 | $ 22,757 |
Debt Securities, Available-for-Sale, Accumulated Gross Unrealized Gain, before Tax | ||
Debt Securities, Available-for-Sale, Accumulated Gross Unrealized Loss, before Tax | (221) | (824) |
Debt Securities, Available-for-Sale | 8,969 | 21,933 |
US Treasury Securities [Member] | ||
Debt Securities, Held-to-Maturity, Allowance for Credit Loss [Line Items] | ||
Debt Securities, Available-for-Sale, Amortized Cost | 999 | 993 |
Debt Securities, Available-for-Sale, Accumulated Gross Unrealized Gain, before Tax | ||
Debt Securities, Available-for-Sale, Accumulated Gross Unrealized Loss, before Tax | (3) | (34) |
Debt Securities, Available-for-Sale | 996 | 959 |
US Government Agencies Debt Securities [Member] | ||
Debt Securities, Held-to-Maturity, Allowance for Credit Loss [Line Items] | ||
Debt Securities, Available-for-Sale, Amortized Cost | 8,191 | 16,324 |
Debt Securities, Available-for-Sale, Accumulated Gross Unrealized Gain, before Tax | ||
Debt Securities, Available-for-Sale, Accumulated Gross Unrealized Loss, before Tax | (218) | (721) |
Debt Securities, Available-for-Sale | $ 7,973 | $ 15,603 |
Schedule of Marketable Securiti
Schedule of Marketable Securities (Details) - USD ($) $ in Thousands | Dec. 31, 2023 | Dec. 31, 2022 |
Debt Securities, Held-to-Maturity, Allowance for Credit Loss [Line Items] | ||
Debt Securities, Available-for-Sale, Amortized Cost | $ 9,190 | $ 22,757 |
Debt Securities, Available-for-Sale, Accumulated Gross Unrealized Gain, before Tax | ||
Debt Securities, Available-for-Sale, Accumulated Gross Unrealized Loss, before Tax | (221) | (824) |
Debt Securities, Available-for-Sale | 8,969 | 21,933 |
US Treasury Securities [Member] | ||
Debt Securities, Held-to-Maturity, Allowance for Credit Loss [Line Items] | ||
Debt Securities, Available-for-Sale, Amortized Cost | 999 | 993 |
Debt Securities, Available-for-Sale, Accumulated Gross Unrealized Gain, before Tax | ||
Debt Securities, Available-for-Sale, Accumulated Gross Unrealized Loss, before Tax | (3) | (34) |
Debt Securities, Available-for-Sale | 996 | 959 |
US Government Agencies Debt Securities [Member] | ||
Debt Securities, Held-to-Maturity, Allowance for Credit Loss [Line Items] | ||
Debt Securities, Available-for-Sale, Amortized Cost | 8,191 | 16,324 |
Debt Securities, Available-for-Sale, Accumulated Gross Unrealized Gain, before Tax | ||
Debt Securities, Available-for-Sale, Accumulated Gross Unrealized Loss, before Tax | (218) | (721) |
Debt Securities, Available-for-Sale | $ 7,973 | 15,603 |
Corporate Debt Securities [Member] | ||
Debt Securities, Held-to-Maturity, Allowance for Credit Loss [Line Items] | ||
Debt Securities, Available-for-Sale, Amortized Cost | 5,440 | |
Debt Securities, Available-for-Sale, Accumulated Gross Unrealized Gain, before Tax | ||
Debt Securities, Available-for-Sale, Accumulated Gross Unrealized Loss, before Tax | (69) | |
Debt Securities, Available-for-Sale | $ 5,371 |
Schedule of Maturities of Debt
Schedule of Maturities of Debt Securities Available-for-sale (Details) $ in Thousands | Dec. 31, 2022 USD ($) |
Cash and Cash Equivalents [Abstract] | |
Due within one year, Fair Value | $ 13,240 |
Due after one year through five years, Fair Value | 8,693 |
Debt securities available-for-sale, Fair Value | $ 21,933 |
Cash, Cash Equivalents, Restr_3
Cash, Cash Equivalents, Restricted Cash and Marketable Debt Securities (Details Narrative) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2023 | Dec. 31, 2022 | Dec. 31, 2021 | |
Cash and Cash Equivalents [Abstract] | |||
Restricted cash | $ 250 | $ 250 | $ 250 |
Unrealized gain/(loss) on marketable securities | 603 | (679) | |
Accumulated unrealized losses | $ 221 | $ 824 |
Schedule of Fair Value Measurem
Schedule of Fair Value Measurement of Assets and Liabilities (Details) - USD ($) $ in Thousands | Dec. 31, 2023 | Dec. 31, 2022 |
Fair Value, off-Balance-Sheet Risks, Disclosure Information [Line Items] | ||
Total | $ 8,969 | $ 21,933 |
Fair Value, Inputs, Level 1 [Member] | ||
Fair Value, off-Balance-Sheet Risks, Disclosure Information [Line Items] | ||
Total | 996 | 959 |
Fair Value, Inputs, Level 2 [Member] | ||
Fair Value, off-Balance-Sheet Risks, Disclosure Information [Line Items] | ||
Total | 7,973 | 20,974 |
Fair Value, Inputs, Level 3 [Member] | ||
Fair Value, off-Balance-Sheet Risks, Disclosure Information [Line Items] | ||
Total | ||
US Treasury Securities [Member] | ||
Fair Value, off-Balance-Sheet Risks, Disclosure Information [Line Items] | ||
Total | 996 | 959 |
US Treasury Securities [Member] | Fair Value, Inputs, Level 1 [Member] | ||
Fair Value, off-Balance-Sheet Risks, Disclosure Information [Line Items] | ||
Total | 996 | 959 |
US Treasury Securities [Member] | Fair Value, Inputs, Level 2 [Member] | ||
Fair Value, off-Balance-Sheet Risks, Disclosure Information [Line Items] | ||
Total | ||
US Treasury Securities [Member] | Fair Value, Inputs, Level 3 [Member] | ||
Fair Value, off-Balance-Sheet Risks, Disclosure Information [Line Items] | ||
Total | ||
US Government Agencies Debt Securities [Member] | ||
Fair Value, off-Balance-Sheet Risks, Disclosure Information [Line Items] | ||
Total | 7,973 | 15,603 |
US Government Agencies Debt Securities [Member] | Fair Value, Inputs, Level 1 [Member] | ||
Fair Value, off-Balance-Sheet Risks, Disclosure Information [Line Items] | ||
Total | ||
US Government Agencies Debt Securities [Member] | Fair Value, Inputs, Level 2 [Member] | ||
Fair Value, off-Balance-Sheet Risks, Disclosure Information [Line Items] | ||
Total | 7,973 | 15,603 |
US Government Agencies Debt Securities [Member] | Fair Value, Inputs, Level 3 [Member] | ||
Fair Value, off-Balance-Sheet Risks, Disclosure Information [Line Items] | ||
Total | ||
Corporate Debt Securities [Member] | ||
Fair Value, off-Balance-Sheet Risks, Disclosure Information [Line Items] | ||
Total | 5,371 | |
Corporate Debt Securities [Member] | Fair Value, Inputs, Level 1 [Member] | ||
Fair Value, off-Balance-Sheet Risks, Disclosure Information [Line Items] | ||
Total | ||
Corporate Debt Securities [Member] | Fair Value, Inputs, Level 2 [Member] | ||
Fair Value, off-Balance-Sheet Risks, Disclosure Information [Line Items] | ||
Total | 5,371 | |
Corporate Debt Securities [Member] | Fair Value, Inputs, Level 3 [Member] | ||
Fair Value, off-Balance-Sheet Risks, Disclosure Information [Line Items] | ||
Total |
Schedule of Leasehold Improveme
Schedule of Leasehold Improvements and Equipment (Details) - USD ($) $ in Thousands | Dec. 31, 2023 | Dec. 31, 2022 |
Property, Plant and Equipment [Line Items] | ||
Leasehold improvements and equipment, gross | $ 3,618 | $ 3,460 |
Less: accumulated depreciation and amortization | 1,695 | 1,369 |
Leasehold improvements and equipment, net | 1,923 | 2,091 |
Equipment [Member] | ||
Property, Plant and Equipment [Line Items] | ||
Leasehold improvements and equipment, gross | 2,463 | 2,305 |
Leasehold Improvements [Member] | ||
Property, Plant and Equipment [Line Items] | ||
Leasehold improvements and equipment, gross | $ 1,155 | $ 1,155 |
Leasehold Improvements and Eq_3
Leasehold Improvements and Equipment (Details Narrative) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2023 | Dec. 31, 2022 | |
Property, Plant and Equipment [Line Items] | ||
Depreciation and amortization expenses | $ 385 | $ 337 |
Purchase of equipment and leasehold improvements | 218 | 892 |
Assets value write-off | 60 | 7 |
Accumulated depreciation expense | 59 | 5 |
Equipment [Member] | ||
Property, Plant and Equipment [Line Items] | ||
Purchase of equipment and leasehold improvements | 218 | 892 |
Leasehold Improvements [Member] | ||
Property, Plant and Equipment [Line Items] | ||
Purchase of equipment and leasehold improvements | $ 218 | $ 892 |
Schedule of Accrued Expenses (D
Schedule of Accrued Expenses (Details) - USD ($) $ in Thousands | Dec. 31, 2023 | Dec. 31, 2022 | |
Payables and Accruals [Abstract] | |||
Payroll and incentives | $ 1,176 | $ 1,705 | |
General and administrative expenses | 196 | 455 | |
Research and development expenses | 75 | 130 | |
Deferred revenue * | [1] | 721 | |
Other deferred liabilities ** | [2] | 88 | |
Total | $ 1,447 | $ 3,099 | |
[1]At December 31, 2022, the balance included $ 688 33 88 |
Schedule of Accrued Expenses _2
Schedule of Accrued Expenses (Details) (Parenthetical) - USD ($) $ in Thousands | 12 Months Ended | |||
Dec. 31, 2023 | Apr. 08, 2022 | Dec. 31, 2022 | ||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | ||||
Deferred revenue | [1] | $ 88 | ||
Cystic Fibrosis Foundation Therapeutics Development Award [Member] | ||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | ||||
Deferred revenue | 88 | |||
BioNTech Agreement [Member] | ||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | ||||
Revenue recognized | $ 2,750 | 688 | ||
BioNTech Agreement [Member] | License and Service [Member] | ||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | ||||
Revenue recognized | 688 | |||
BioNTech Agreement [Member] | Health Care, Patient Service [Member] | ||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | ||||
Revenue recognized | $ 375 | |||
Genentech Agreement [Member] | ||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | ||||
Revenue recognized | $ 33 | |||
[1]At December 31, 2022, the balance of $ 88 |
Schedule of Maturity of Operati
Schedule of Maturity of Operating and Finance Leases Liabilities (Details) - USD ($) $ in Thousands | Dec. 31, 2023 | Dec. 31, 2022 |
Lessee, Operating Lease, Liability, to be Paid, Fiscal Year Maturity [Abstract] | ||
Operating lease liabilities, 2023 | $ 916 | |
Operating lease liabilities, 2024 | $ 956 | 956 |
Operating lease liabilities, 2025 | 998 | 998 |
Operating lease liabilities, 2026 | 1,040 | 1,040 |
Operating lease liabilities, 2027 | 944 | 944 |
Operating lease liabilities, 2028 | 273 | |
Operating lease liabilities, Thereafter | 138 | 411 |
Total undiscounted operating lease payments | 4,349 | 5,265 |
Operating lease liabilities, Less: Imputed interest | 816 | 1,170 |
Present value of operating lease liabilities | $ 3,533 | $ 4,095 |
Operating lease liabilities, weighted average remaining lease term in years | 4 years 3 months 18 days | 5 years 3 months 18 days |
Operating lease liabilities, weighted average discount rate | 9.20% | 9.20% |
Finance Lease, Liability, to be Paid, Fiscal Year Maturity [Abstract] | ||
Finance lease liabilities, 2023 | $ 10 | |
Finance lease liabilities, 2024 | $ 7 | 7 |
Finance lease liabilities, 2025 | 7 | 7 |
Finance lease liabilities, 2026 | 7 | 7 |
Finance lease liabilities, 2027 | 7 | 7 |
Finance lease liabilities, 2028 | ||
Finance lease liabilities, Thereafter | ||
Total undiscounted finance lease payments | 28 | 38 |
Finance lease liabilities, Less: Imputed interest | 5 | 9 |
Present value of finance lease liabilities | $ 23 | $ 29 |
Finance lease liabilities, weighted average remaining lease term in years | 3 years 10 months 24 days | 4 years 6 months |
Finance lease liabilities, weighted average discount rate | 11.60% | 11.10% |
Leases (Details Narrative)
Leases (Details Narrative) - USD ($) $ in Thousands | 12 Months Ended | ||||
Sep. 13, 2022 | Dec. 15, 2016 | Nov. 01, 2013 | Dec. 31, 2023 | Dec. 31, 2022 | |
Leases | |||||
Operating lease option to extend, description | Some leases include purchase, termination or extension options for one or more years. | ||||
Operating lease, terms | 10 years 3 months | 7 years | |||
Lease monthly rent expense | $ 20 | $ 43 | $ 13 | ||
Increase of rent expenses | $ 23 | 64 | $ 14 | ||
Security deposit | $ 586 | $ 200 | |||
Operating lease interest expense | 902 | $ 872 | |||
Operating lease right-of-use assets | 548 | 542 | |||
Finance lease interest expense | 3 | 1 | |||
Finance lease right-of-use assets | $ 8 | $ 19 |
Revenue Recognition, Collabor_2
Revenue Recognition, Collaboration Agreements, and Other Research and Development Agreements (Details Narrative) - USD ($) $ in Thousands | 12 Months Ended | ||||||
Apr. 08, 2022 | Nov. 19, 2021 | Nov. 19, 2020 | Dec. 12, 2019 | Dec. 31, 2023 | Dec. 31, 2022 | ||
Therapeutics development award | $ 1,096 | $ 3,188 | |||||
Other Liabilities | [1] | 88 | |||||
License Agreement Terms [Member] | |||||||
License agreement description | The Second Amended and Restated Exclusive License Agreement provides for, among other things, the payment of (1) royalties on a tiered basis between low single digits and the mid-single digits of net sales of products using such licensed technology, (2) a one-time sales milestone fee of $100 when and if sales of products using the licensed technology reach the specified sales threshold and (3) an annual license fee of $50 over the term of the License Agreement. The term of the License Agreement will remain in effect until the expiration of the last-to-expire patent rights licensed or seven and one-half years from the date of the first commercial sale of a licensed product under this agreement, whichever is later. | ||||||
Cystic Fibrosis Foundation Therapeutics Development Award [Member] | |||||||
Other Liabilities | 88 | ||||||
Research and development, costs incurred | $ 88 | 811 | |||||
BioNTech Agreement [Member] | |||||||
Revenue recognized | $ 2,750 | 688 | |||||
CFF Agreement [Member] | |||||||
Grants receivable | 3,635 | ||||||
Additional milestone payment | 4,555 | ||||||
CFF Agreement [Member] | Accrued Liabilities [Member] | |||||||
Other Liabilities | 0 | 88 | |||||
CFF Agreement [Member] | Cystic Fibrosis Foundation [Member] | Cystic Fibrosis Foundation Therapeutics Development Award [Member] | |||||||
Therapeutics development award | $ 4,234 | ||||||
Previously received awards | $ 484 | ||||||
Additional milestone payment | $ 321 | ||||||
Genentech Feasibility Study Agreement [Member] | |||||||
Revenue recognized | $ 33 | $ 33 | $ 0 | ||||
Genentech Feasibility Study Agreement [Member] | Three Molecules [Member] | |||||||
Revenue recognized | $ 100 | ||||||
[1]At December 31, 2022, the balance of $ 88 |
Commitments (Details Narrative)
Commitments (Details Narrative) $ in Millions | 12 Months Ended |
Dec. 31, 2023 USD ($) | |
Royalty Agreement Terms [Member] | |
Royalty compensation, description | the Company will be required to pay to certain former holders of its Series A Preferred Stock, in aggregate, a royalty equal to (i) 4.5% of Net Sales (as defined in the Certificate of Designations), subject in all cases to a cap of $25 million per calendar year, and (ii) 7.5% of Licensing Proceeds (as defined in the Certificate of Designations), subject in all cases to a cap of $10 million per calendar year. The Royalty Payment Rights will expire when the patents covering the applicable product expire, which is currently expected to be in 2033 |
Series A Preferred Stock [Member] | |
Payments for royalty | $ 35 |
Schedule of Income Tax Provisio
Schedule of Income Tax Provision (Details) - USD ($) | 12 Months Ended | |
Dec. 31, 2023 | Dec. 31, 2022 | |
Income Tax Disclosure [Abstract] | ||
Federal | ||
State | ||
Foreign | ||
Total current expense (benefit): | ||
Federal | ||
State | ||
Foreign | ||
Total deferred expense (benefit): | ||
Total income tax expense (benefit): |
Schedule of Effective Income Ta
Schedule of Effective Income Tax Rate Reconciliation (Details) | 12 Months Ended | |
Dec. 31, 2023 | Dec. 31, 2022 | |
Income Tax Disclosure [Abstract] | ||
Income at U.S. Statutory Rate | 21% | 21% |
State Taxes, net of Federal benefit | 7.91% | 7.65% |
Permanent Differences | (1.20%) | (1.25%) |
Tax Credits | 2.49% | 2.52% |
Valuation Allowance | (30.19%) | (29.92%) |
Effective income tax rate | 0% | 0% |
Schedule of Deferred Tax Assets
Schedule of Deferred Tax Assets and Liabilities (Details) - USD ($) $ in Thousands | Dec. 31, 2023 | Dec. 31, 2022 | Dec. 31, 2021 |
Income Tax Disclosure [Abstract] | |||
Share-based Compensation | $ 5,383 | $ 4,512 | |
Depreciation and Amortization | (23) | (18) | |
Accrued Liability | 307 | 481 | |
Net Operating Loss Carry-forwards | 25,146 | 21,755 | |
R&D Credit Carryforwards | 4,432 | 3,773 | |
R&D Section 174 Costs | 5,953 | 4,268 | |
Other | 1 | (1) | |
IPR&D | (851) | (851) | |
ROU Asset | (870) | (1,027) | |
ROU Liability | 996 | 1,155 | |
Total Deferred tax assets | 40,474 | 34,047 | |
Valuation allowance | (40,815) | (34,388) | $ (31,023) |
Net deferred tax asset (liability) | $ (341) | $ (341) |
Income Taxes (Details Narrative
Income Taxes (Details Narrative) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2023 | Dec. 31, 2022 | Dec. 31, 2021 | |
Operating Loss Carryforwards [Line Items] | |||
Deferred tax assets valuation allowance | $ 40,815 | $ 34,388 | $ 31,023 |
Change in deferred tax asset, amount | 6,427 | 3,365 | |
Operating loss carryforwards with no expiration | 38,080 | ||
R&D Credit Carryforwards | 4,432 | 3,773 | |
Sale of net operating losses | $ 484 | $ 3,491 | |
Operating Loss Carryforwards, Limitations on Use | In addition, the Tax Cuts and Jobs Act, signed into law on December 22, 2017 imposes significant additional limitations on the deductibility of interest and limits NOL deductions to 80% of net taxable income for losses arising in taxable years beginning after December 31, 2017. | ||
Indefinite Carryforward Period [Member] | |||
Operating Loss Carryforwards [Line Items] | |||
Operating loss carryforwards with no expiration | $ 77,025 |
Schedule of Shareholder Equity
Schedule of Shareholder Equity Warrants Outstanding (Details) - shares | 12 Months Ended | |
Dec. 31, 2023 | Dec. 31, 2022 | |
Equity [Abstract] | ||
Shares outstanding, beginning | 238 | 988 |
Shares issued | ||
Shares exercised | (400) | |
Shares expired | (238) | (350) |
Shares outstanding, ending | 238 |
Schedule of Components of Accum
Schedule of Components of Accumulated Other Comprehensive (Loss) Income (Details) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2023 | Dec. 31, 2022 | |
Equity [Abstract] | ||
Net unrealized loss on securities available-for-sale, beginning balance | $ (824) | $ (145) |
Accumulated other comprehensive gain/ (loss), beginning balance | (824) | (145) |
Net unrealized loss on securities available-for-sale | 603 | (679) |
Accumulated other comprehensive gain/ (loss), available-for-sale | 603 | (679) |
Net unrealized loss on securities available-for-sale, ending balance | (221) | (824) |
Accumulated other comprehensive gain/ (loss), ending balance | $ (221) | $ (824) |
Stockholders_ Equity (Details N
Stockholders’ Equity (Details Narrative) - USD ($) $ / shares in Units, $ in Thousands | 12 Months Ended | |||
Feb. 08, 2022 | Jul. 02, 2020 | Dec. 31, 2023 | Dec. 31, 2022 | |
Subsidiary, Sale of Stock [Line Items] | ||||
Research and development expense | $ 14,489 | $ 16,678 | ||
Preferred stock shares authorized | 10,000,000 | |||
Preferred stock, par value | $ 0.001 | |||
Restated Exclusive License Agreement [Member] | ||||
Subsidiary, Sale of Stock [Line Items] | ||||
Stock issued during new issued, shares | 400,000 | |||
Terms of agreement | the Company and Rutgers. The agreement provides for (1) royalties on a tiered basis between low single digits and the mid-single digits of net sales of products using such licensed technology, (2) a one-time sales milestone fee of $100,000 when and if sales of products using the licensed technology reach the specified sales threshold and (3) an annual license fee of $50,000 over the term of the license agreement. There was also a reduction in the consideration paid to Rutgers in the event of a sublicense to a third party of the exclusive patent rights granted pursuant to the Agreement. | |||
Research and development expense | $ 291 | |||
Share price | $ 0.728 | |||
Underwritten Public Offering [Member] | Sales Agreement [Member] | ||||
Subsidiary, Sale of Stock [Line Items] | ||||
Aggregate offering price for sale of stock | $ 50,000 | $ 44,247 | ||
Sale of stock percentage | 3% |
Schedule of Recognized Stock-Ba
Schedule of Recognized Stock-Based Compensation (Details) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2023 | Dec. 31, 2022 | |
Share-Based Payment Arrangement, Expensed and Capitalized, Amount [Line Items] | ||
Share-based compensation expense | $ 4,948 | $ 5,228 |
Research and Development Expense [Member] | ||
Share-Based Payment Arrangement, Expensed and Capitalized, Amount [Line Items] | ||
Share-based compensation expense | 2,120 | 2,400 |
General and Administrative Expense [Member] | ||
Share-Based Payment Arrangement, Expensed and Capitalized, Amount [Line Items] | ||
Share-based compensation expense | $ 2,828 | $ 2,828 |
Schedule of Equity Compensation
Schedule of Equity Compensation Plan by Arrangements (Details) - 2013 Equity Compensation Plan [Member] shares in Thousands | 12 Months Ended | |
Dec. 31, 2023 shares | ||
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] | ||
Awards Reserved for Issuance | 54,294 | [1] |
Awards Issued & Exercised | 51,389 | [2] |
Awards Available for Grant | 2,905 | |
[1]Increased by 8,691 4 |
Schedule of Equity Compensati_2
Schedule of Equity Compensation Plan by Arrangements (Details) (Parenthetical) - shares shares in Thousands | 12 Months Ended | ||
May 08, 2014 | Dec. 31, 2022 | Jan. 02, 2023 | |
Share-Based Payment Arrangement [Abstract] | |||
Increased shares of common stock outstanding | 8,691 | ||
Percentage for common stock outstanding | 4% | 4% |
Schedule of Stock Option Activi
Schedule of Stock Option Activity (Details) - $ / shares shares in Thousands | 12 Months Ended | ||
Dec. 31, 2023 | Dec. 31, 2022 | Dec. 31, 2021 | |
Share-Based Payment Arrangement [Abstract] | |||
Number of options, outstanding at beginning | 34,739 | 28,184 | |
Weighted average exercise price, outstanding at beginning | $ 1.07 | $ 1.21 | |
Weighted average contractual term in years | 7 years 4 months 24 days | 7 years 1 month 6 days | 7 years 2 months 12 days |
Number of options, granted | 13,928 | 8,509 | |
Weighted average exercise price, granted | $ 0.24 | $ 0.56 | |
Number of options, exercised | (195) | ||
Weighted average exercise price, exercised | $ 0.51 | ||
Number of options, forfeited | (296) | (175) | |
Weighted average exercise price, forfeited | $ 0.63 | $ 0.96 | |
Number of options, expired | (1,663) | (1,584) | |
Weighted average exercise price, expired | $ 0.94 | $ 1.06 | |
Number of options, outstanding at ending | 46,708 | 34,739 | 28,184 |
Weighted average exercise price, outstanding at beginning ending | $ 0.83 | $ 1.07 | $ 1.21 |
Summary of Outstanding Options
Summary of Outstanding Options (Details) shares in Thousands | 12 Months Ended |
Dec. 31, 2023 $ / shares shares | |
Share-Based Payment Arrangement, Option, Exercise Price Range [Line Items] | |
Number of options outstanding | shares | 46,708 |
Weighted average exercise price per share | $ 0.83 |
Exercise Price One [Member] | |
Share-Based Payment Arrangement, Option, Exercise Price Range [Line Items] | |
Exercise price, minimum | 0.15 |
Exercise price, maximum | $ 0.69 |
Number of options outstanding | shares | 22,128 |
Weighted average exercise price per share | $ 0.35 |
Exercise Price Two [Member] | |
Share-Based Payment Arrangement, Option, Exercise Price Range [Line Items] | |
Exercise price, minimum | 0.73 |
Exercise price, maximum | $ 0.92 |
Number of options outstanding | shares | 9,684 |
Weighted average exercise price per share | $ 0.86 |
Exercise Price Three [Member] | |
Share-Based Payment Arrangement, Option, Exercise Price Range [Line Items] | |
Exercise price, minimum | 0.93 |
Exercise price, maximum | $ 1.28 |
Number of options outstanding | shares | 6,659 |
Weighted average exercise price per share | $ 1.11 |
Exercise Price Four [Member] | |
Share-Based Payment Arrangement, Option, Exercise Price Range [Line Items] | |
Exercise price, minimum | 1.36 |
Exercise price, maximum | $ 3.32 |
Number of options outstanding | shares | 8,237 |
Weighted average exercise price per share | $ 1.88 |
Schedule of Compensation Expens
Schedule of Compensation Expense for Stock Options (Details) | 12 Months Ended | |
Dec. 31, 2023 | Dec. 31, 2022 | |
Share-Based Payment Arrangement [Abstract] | ||
Volatility, minimum | 91.20% | 92.10% |
Volatility, maximum | 120.50% | 98.70% |
Risk-free interest rate, minimum | 3.50% | 1.57% |
Risk-free interest rate, maximum | 4.69% | 4.32% |
Dividend yield | 0% | 0% |
Expected life | 6 years | 6 years |
Stock-based Compensation (Detai
Stock-based Compensation (Details Narrative) - USD ($) $ / shares in Units, $ in Thousands | 12 Months Ended | ||
May 08, 2014 | Dec. 31, 2023 | Dec. 31, 2022 | |
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] | |||
Share-based payment award increase of shares offering date | January 1, 2015 | ||
Percentage for common stock outstanding | 4% | 4% | |
Number of option vested | 24,507,007 | ||
Option vested price per share | $ 1.18 | ||
Option intrinsic value | $ 22 | ||
Aggregate intrinsic price | $ 0.22 | ||
Unrecognized share-based compensation | $ 7,836 | ||
Share-based compensation weighted average period | 2 years 7 months 6 days | ||
Outstanding options expire | All outstanding options expire | ||
Expiration period | 10 years | ||
Vesting rights percentage | 25% | ||
2013 Equity Compensation Plan [Member] | |||
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] | |||
Option granted description | granted at prices not less than 100% of the fair value | ||
Option term | The term of the options is no longer than ten years | ||
Number of common stock issued under plan | 54,293,819 | ||
2013 Equity Compensation Plan [Member] | Minimum [Member] | |||
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] | |||
Option vested period | 3 years | ||
2013 Equity Compensation Plan [Member] | Maximum [Member] | |||
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] | |||
Option vested period | 4 years |