Cover
Cover - USD ($) $ in Millions | 12 Months Ended | ||
Dec. 31, 2021 | Mar. 04, 2022 | Jun. 30, 2021 | |
Cover [Abstract] | |||
Document Type | 10-K | ||
Amendment Flag | false | ||
Document Annual Report | true | ||
Document Transition Report | false | ||
Document Period End Date | Dec. 31, 2021 | ||
Document Fiscal Period Focus | FY | ||
Document Fiscal Year Focus | 2021 | ||
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 | NYSE | ||
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 | $ 160 | ||
Entity Common Stock, Shares Outstanding | 216,864,526 | ||
Documents Incorporated by Reference [Text Block] | None. | ||
Auditor Firm ID | 247 | ||
Auditor Name | EISNERAMPER LLP | ||
Auditor Location | Iselin, New Jersey |
Consolidated Balance Sheets
Consolidated Balance Sheets - USD ($) | Dec. 31, 2021 | Dec. 31, 2020 |
Current assets: | ||
Cash and cash equivalents | $ 21,029,806 | $ 12,432,481 |
Marketable securities | 28,592,049 | 46,246,573 |
Restricted cash | 50,000 | 136,000 |
Prepaid expenses and other current assets | 1,321,466 | 2,739,791 |
Total current assets | 50,993,321 | 61,554,845 |
Non-current assets: | ||
Leasehold improvements and equipment - net | 1,537,728 | 1,523,950 |
Operating lease right-of-use assets - net | 4,218,890 | 3,276,639 |
Finance lease right-of-use assets - net | 22,270 | 58,007 |
In-process research and development | 3,017,377 | 3,017,377 |
Goodwill | 1,336,488 | 1,336,488 |
Restricted cash - security deposits | 200,000 | 200,000 |
Total non-current assets | 10,332,753 | 9,412,461 |
Total assets | 61,326,074 | 70,967,306 |
Current liabilities: | ||
Accounts payable | 938,270 | 349,941 |
Accrued expenses and other liabilities | 2,850,888 | 2,795,329 |
Operating lease liabilities - current | 538,546 | 391,498 |
Financing lease liabilities - current | 21,039 | 30,853 |
Total current liabilities | 4,348,743 | 3,567,621 |
Non-current liabilities: | ||
Deferred tax liability | 341,265 | 341,265 |
Operating lease liabilities - net of current portion | 4,140,387 | 3,304,063 |
Financing lease liabilities - net of current portion | 2,621 | 23,660 |
Total non-current liabilities | 4,484,273 | 3,668,988 |
Total liabilities | 8,833,016 | 7,236,609 |
Stockholders’ equity: | ||
Series B Convertible preferred stock, stated value $1,000 per share, 8,000 shares authorized as of December 31, 2021 and 2020, respectively; 0 and 4,361 shares issued and outstanding as of December 31, 2021 and 2020, respectively | 3,797,705 | |
Common stock par value $0.0001 per share, 500,000,000 shares authorized at December 31, 2021 and 2020, respectively; 216,269,450 and 200,113,431 issued and outstanding as of December 31, 2021 and 2020, respectively | 21,627 | 20,010 |
Additional paid-in capital | 184,251,138 | 167,192,003 |
Accumulated deficit | (131,634,208) | (107,507,193) |
Accumulated other comprehensive (loss)/income | (145,499) | 228,172 |
Total stockholders’ equity | 52,493,058 | 63,730,697 |
Total liabilities and stockholders’ equity | $ 61,326,074 | $ 70,967,306 |
Consolidated Balance Sheets (Pa
Consolidated Balance Sheets (Parenthetical) - $ / shares | Dec. 31, 2021 | Dec. 31, 2020 |
Statement of Financial Position [Abstract] | ||
Series B Convertible preferred stock, par value | $ 1,000 | $ 1,000 |
Series B Convertible preferred stock, shares authorized | 8,000 | 8,000 |
Series B Convertible preferred stock, shares issued | 0 | 4,361 |
Series B Convertible preferred stock, shares outstanding | 0 | 4,361 |
Common stock, par value | $ 0.0001 | $ 0.0001 |
Common stock, shares authorized | 500,000,000 | 500,000,000 |
Common stock, shares issued | 216,269,450 | 200,113,431 |
Common stock, shares outstanding | 216,269,450 | 200,113,431 |
Consolidated Statements of Oper
Consolidated Statements of Operations and Comprehensive Loss - USD ($) | 12 Months Ended | |
Dec. 31, 2021 | Dec. 31, 2020 | |
Revenue: | ||
Contract research revenue | $ 33,333 | $ 158,333 |
Costs and Expenses: | ||
Research and development | 14,583,283 | 14,358,918 |
General and administrative | 10,184,805 | 10,005,967 |
Total costs and expenses | 24,768,088 | 24,364,885 |
Loss from operations | (24,734,755) | (24,206,552) |
Sale of New Jersey net operating loss | 1,328,470 | 1,073,289 |
Other income, net | 122,870 | 686,425 |
Net loss | (23,283,415) | (22,446,838) |
Preferred stock series B accumulated dividends | (395,799) | (793,442) |
Net loss attributable to common shareholders | $ (23,679,214) | $ (23,240,280) |
Net loss attributable to common shareholders per share – basic and diluted | $ (0.11) | $ (0.12) |
Basic and diluted | 210,178,332 | 196,894,628 |
Other comprehensive (loss)/income, net of tax | ||
Net unrealized (loss)/gain on securities available-for-sale | $ (373,671) | $ 237,537 |
Reclassification of realized gain on securities available-for-sale to net loss | (8,485) | |
Other comprehensive (loss)/income, net of tax | (373,671) | 229,052 |
Comprehensive loss attributable to shareholders | $ (23,657,086) | $ (22,217,786) |
Consolidated Statements of Chan
Consolidated Statements of Changes in Stockholders Equity - USD ($) | Redeemable Convertible Preferred Stock B [Member]Preferred Stock [Member] | Common Stock [Member] | Additional Paid-in Capital [Member] | Retained Earnings [Member] | AOCI Attributable to Parent [Member] | Total |
Beginning balance, value at Dec. 31, 2019 | $ 3,985,805 | $ 16,315 | $ 113,427,897 | $ (84,377,555) | $ (880) | $ 33,051,582 |
Balance, shares at Dec. 31, 2019 | 4,577 | 163,156,984 | ||||
Stock-based compensation | 4,184,141 | 4,184,141 | ||||
Issuance of common stock as compensation for services | $ 38 | 390,604 | 390,642 | |||
Issuance of common stock as compensation for services, shares | 379,385 | |||||
Issuance of common stock in exchange for preferred shares B | $ (188,100) | $ 43 | 188,057 | |||
Issuance of common stock in exchange for preferred shares B, shares | (216) | 432,000 | ||||
Issuance of common stock in public offering, net of stock issuance costs | $ 3,226 | 46,700,984 | 46,704,210 | |||
Issuance of common stock in public offering, net of stock issuance costs, shares | 32,260,000 | |||||
Issuance of common stock in exchange for Options | $ 79 | 820,248 | 820,327 | |||
Issuance of common stock in exchange for Options, shares | 782,073 | |||||
Issuance of common stock in exchange for Warrants | $ 172 | 797,409 | 797,581 | |||
Issuance of common stock in exchange for Warrants, shares | 1,737,389 | |||||
Stock dividends | $ 137 | 682,663 | (682,800) | |||
Stock dividend, shares | 1,365,600 | |||||
Other comprehensive income loss | 229,052 | 229,052 | ||||
Issuance of common stock pursuant to the Aquarius Merger | ||||||
Issuance of common stock pursuant to the Aquarius Merger, shares | ||||||
Net loss | (22,446,838) | (22,446,838) | ||||
Ending balance, value at Dec. 31, 2020 | $ 3,797,705 | $ 20,010 | 167,192,003 | (107,507,193) | 228,172 | 63,730,697 |
Balance, shares at Dec. 31, 2020 | 4,361 | 200,113,431 | ||||
Stock-based compensation | 4,192,082 | 4,192,082 | ||||
Issuance of common stock as compensation for services | $ 4 | 31,748 | 31,752 | |||
Issuance of common stock as compensation for services, shares | 31,769 | |||||
Issuance of common stock in exchange for preferred shares B | $ (3,797,705) | $ 873 | 3,796,832 | |||
Issuance of common stock in exchange for preferred shares B, shares | (4,361) | 8,722,000 | ||||
Issuance of common stock in public offering, net of stock issuance costs | $ 302 | 5,580,169 | 5,580,471 | |||
Issuance of common stock in public offering, net of stock issuance costs, shares | 3,023,147 | |||||
Issuance of common stock in exchange for Options | $ 107 | 1,415,035 | 1,415,142 | |||
Issuance of common stock in exchange for Options, shares | 1,076,946 | |||||
Issuance of common stock in exchange for Warrants | $ 12 | (12) | ||||
Issuance of common stock in exchange for Warrants, shares | 114,957 | |||||
Stock dividends | $ 169 | 843,431 | (843,600) | |||
Stock dividend, shares | 1,687,200 | |||||
Other comprehensive income loss | (373,671) | (373,671) | ||||
Issuance of common stock pursuant to the Aquarius Merger | $ 150 | 1,199,850 | 1,200,000 | |||
Issuance of common stock pursuant to the Aquarius Merger, shares | 1,500,000 | |||||
Net loss | (23,283,415) | (23,283,415) | ||||
Ending balance, value at Dec. 31, 2021 | $ 21,627 | $ 184,251,138 | $ (131,634,208) | $ (145,499) | $ 52,493,058 | |
Balance, shares at Dec. 31, 2021 | 216,269,450 |
Consolidated Statements of Ch_2
Consolidated Statements of Changes in Stockholders Equity (Parenthetical) - USD ($) | 12 Months Ended | |
Dec. 31, 2021 | Dec. 31, 2020 | |
Common Stock [Member] | ||
Stock issuance cost | $ 172,592 | $ 3,308,790 |
Consolidated Statements of Cash
Consolidated Statements of Cash Flows - USD ($) | 12 Months Ended | |
Dec. 31, 2021 | Dec. 31, 2020 | |
Cash flows from operating activities: | ||
Net loss | $ (23,283,415) | $ (22,446,838) |
Adjustments to reconcile net loss to net cash used in operating activities: | ||
Depreciation and amortization | 244,395 | 231,058 |
Loss on disposal of equipment | 2,207 | |
Stock-based compensation expense | 4,292,355 | 4,564,787 |
Amortization of operating lease right-of-use assets | 501,359 | 484,568 |
Amortization of finance lease right-of-use assets | 35,737 | 58,961 |
Amortization of bond discount | 250,453 | 239,831 |
Realized gain on sale of marketable securities | 8,485 | |
Stock issued pursuant to the Aquarius Merger Agreement charged to Research and Development | 1,200,000 | |
Changes in operating assets and liabilities: | ||
Operating lease liabilities | (460,239) | (423,741) |
Prepaid expenses and other current assets | 1,349,804 | (611,397) |
Accounts payable | 588,329 | (329,369) |
Accrued expenses and other liabilities | 55,560 | 855,819 |
Net cash used in operating activities | (15,223,455) | (17,367,836) |
Cash flows from investing activities: | ||
Purchases of marketable securities | (23,194,600) | (72,106,359) |
Proceeds from sales of marketable securities | 40,225,000 | 31,445,156 |
Purchases of leasehold improvements and equipment | (260,380) | (5,749) |
Net cash provided by/(used in) investing activities | 16,770,020 | (40,666,952) |
Cash flows from financing activities: | ||
Net proceeds from public offering of common stock | 5,580,471 | 46,704,210 |
Proceeds from exercise of warrants | 797,581 | |
Proceeds from exercise of options | 1,415,142 | 599,713 |
Payments of capital lease liability – principal | (30,853) | (54,673) |
Net cash provided by financing activities | 6,964,760 | 48,046,831 |
Net increase/(decrease) in cash, cash equivalents and restricted cash | 8,511,325 | (9,987,957) |
Cash, cash equivalents and restricted cash at beginning of period | 12,768,481 | 22,756,438 |
Cash, cash equivalents and restricted cash at end of period | 21,279,806 | 12,768,481 |
Supplemental non-cash financing and investing activities: | ||
Unrealized (loss)/gain on marketable securities | (373,671) | 229,052 |
Cashless exercise of warrants | 12 | |
Stock dividends issued | 843,600 | 682,800 |
Non-cash prepaid from exercise of options | 220,614 | |
Preferred stock conversion into common stock - series B | 3,797,705 | 188,100 |
Unearned restricted stock grants | 68,521 | |
Right-of-use asset in exchange from liabilities from operating lease | $ 1,443,610 |
Description of Business
Description of Business | 12 Months Ended |
Dec. 31, 2021 | |
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” or “the Company”). The Company is a clinical-stage biopharmaceutical company with a focus on identifying and developing novel pharmaceutical products. |
Liquidity and Plan of Operation
Liquidity and Plan of Operations | 12 Months Ended |
Dec. 31, 2021 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
Liquidity and Plan of Operations | Note 2 – Liquidity and Plan of Operations The Company has experienced net losses and negative cash flows from operations each period since its inception. Through December 31, 2021, the Company had an accumulated deficit of approximately $ 131.6 million. The Company’s net loss for the years ended December 31, 2021 and 2020 were approximately $ 23.3 million and $ 22.4 million, respectively. The Company has been engaged in developing LYPDISO (formerly MAT9001) as well as 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. Assuming the Company obtains 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. To continue to fund operations, during January 2021, the Company sold 3,023,147 5.8 5.6 32,600,000 50.0 46.7 As of December 31, 2021, the Company had cash and cash equivalents of approximately $ 21.0 28.6 0.3 |
Summary of Significant Accounti
Summary of Significant Accounting Policies | 12 Months Ended |
Dec. 31, 2021 | |
Accounting Policies [Abstract] | |
Summary of Significant Accounting Policies | Note 3 – Summary of Significant Accounting Policies Basis of presentation and principles of consolidation The accompanying audited 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 of America (“U.S. GAAP”) and reflect the operations of the Company and its wholly owned subsidiaries. All intercompany transactions have been eliminated in consolidation. COVID-19 In March 2020, the World Health Organization declared COVID-19 a global pandemic. This contagious disease outbreak, which has continued to spread, and any related adverse public health developments, has adversely affected workforces, economics, and financial markets globally, potentially leading to an economic downturn. The Company has been actively monitoring the COVID-19 pandemic and its impact globally. The financial results for the year ended December 31, 2021 were not significantly impacted by COVID-19. However, the Company cannot predict the impact of the progression of the COVID-19 pandemic 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 suppliers to continue to operate and deliver, the ability of the Company to maintain operations, any further government and/or public actions taken in response to the pandemic and ultimately the length of the pandemic. 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, the assessment of the impairment of goodwill and intangible assets, level 3 fair value measurement of financial instruments, income tax valuations, the determination of stock-based compensation and contingent consideration. 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 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 Securities. Marketable Securities Marketable securities, all of which are available-for-sale, consist of U.S. treasury bonds, U.S. government notes, corporate debt securities and state and municipal bonds. Marketable securities are carried at fair value, with unrealized gains and losses reported as accumulated other comprehensive (loss)/income, except for losses from impairments which are determined to be other-than-temporary. 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 securities, see Note 4 – Cash, Cash Equivalents, Restricted Cash and Marketable 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 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 are insured by the Federal Deposit Insurance Corporation (“FDIC”) up to regulatory limits. The Company has not experienced any credit losses associated with its balances in such accounts. Leasehold improvements and equipment Equipment and leasehold improvements 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 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 determine this is the case, the Company can perform further 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 years ended December 31, 2021 and 2020, the Company assessed goodwill impairment by performing a qualitative test for its reporting unit. As part of the qualitative review, the Company considered its cash position and its ability to obtain additional financing in the near term to meet its operational and strategic goals and substantiate the value of its business. Based on the results of the Company’s assessment, it was determined that it is more-likely-than-not that the fair value of the reporting unit is greater than its carrying amount. There were no 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 approach for testing indefinite-lived intangible assets for impairment. The Company used the qualitative approach and concluded that it was more-likely-than-not that its indefinite-lived assets were not impaired during the years ended December 31, 2021 and 2020. 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. Preferred stock dividends S ubject to provisions detailed more fully in Note 12, Stockholders’ Equity, shares of Series B Preferred Stock earned dividends at rates of 10% , 15% and 20% once per year on the first, second and third anniversary, respectively, of June 19, 2018. The dividends were paid when earned to the holders of the Series B Preferred Stock in the form of shares of the Company’s common stock. 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. The Company adopted the provisions of Accounting Standard Codification 740-10 and has analyzed its filing positions in 2021 and 2020 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 2020 income tax returns are subject to examination and adjustments by the IRS 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 that are recognized in the consolidated statement of operations based on their fair values at the date of grant. 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 stock-based 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 that participate in dividends (a “participating security”). The Company considered its Preferred Stock to be participating securities because they included rights to participate in dividends with the common stock. 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. The net loss attributable to common stockholders is calculated by adjusting the net loss of the Company for the accretion on the Preferred Stock. Net losses are not allocated to preferred stockholders as they do not have an obligation to share in the Company’s net losses. In periods with net income attributable to common stockholders, the Company would allocate net income first to preferred stockholders based on dividend rights under the Company’s certificate of incorporation and then to preferred and common stockholders based on ownership interests. 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, 2021 and 2020, 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, warrants and conversion of preferred stock, would have an anti-dilutive effect. The reconciliation of the diluted shares as of December 31, 2021 and 2020 are as follows (in thousands): Schedule of Anti-dilutive Securities As of December 31, 2021 2020 Stock options 28,184 22,551 Preferred Stock and accrued dividend upon conversion - 8,722 Warrants 988 1,328 Total 29,172 32,601 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, 2020, the Company’s revenues primarily consist of a research grant to provide research and development services to the Cystic Fibrosis Foundation (“CFF”). The grant contract has a single performance obligation that is recognized over time as the services are performed. There are no contract assets or liabilities associated with this grant. The Company had approximately $ 125 On December 12, 2019, the Company entered into a feasibility study agreement (the “Agreement”) with Genentech, Inc. (“Genentech”). This feasibility study will involve the development of oral formulations using the Company’s LNC platform delivery technology, 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 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: 2.2 0.1 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 income/(loss) Other comprehensive income/(loss) consists of net gains/(losses) and unrealized losses on marketable securities available-for-sale and is presented in the Consolidated Statements of Operations. Recently adopted accounting pronouncements In December 2019, the FASB Issued Accounting Standard Update 2019-12, “Income Taxes, (Topic 740): Simplifying the Accounting for Income Taxes”. This standard removes certain exceptions to the general principles and improves consistent application of and simplify GAAP for other areas of Topic 740 by clarifying and amending existing guidance. This standard is effective for fiscal years, and interim periods within those fiscal years, beginning after December 15, 2020. The Company adopted the new standard effective January 1, 2021 with no material impact on the Company’s consolidated financial statements. |
Cash, Cash Equivalents, Restric
Cash, Cash Equivalents, Restricted Cash and Marketable Securities | 12 Months Ended |
Dec. 31, 2021 | |
Cash and Cash Equivalents [Abstract] | |
Cash, Cash Equivalents, Restricted Cash and Marketable Securities | Note 4 – Cash, Cash Equivalents, Restricted Cash and Marketable 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 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 represents funds the Company is required to set aside to cover building operating leases and other purposes. 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, 2021, December 31, 2020 and December 31, 2019 (in thousands): Schedule of Cash, Cash Equivalents and Restricted Cash December 31, December 31, December 31, Cash and cash equivalents $ 21,030 $ 12,432 $ 22,170 Restricted cash included in current/long term assets 250 336 586 Cash, cash equivalents and restricted cash in the statements of cash flows $ 21,280 $ 12,768 $ 22,756 Marketable Securities The Company has classified its investments in marketable securities as available-for-sale and as a current asset. The Company’s investments in marketable securities are carried at fair value, with unrealized gains and losses included as a separate component of stockholders’ equity. Unrealized gains and losses are classified as other comprehensive (loss)/income and costs are determined on a specific identification basis. Realized gains and losses from our marketable securities are recorded in other income, net. For the years ended December 31, 2021 and 2020, the Company recorded unrealized (losses)/gains of approximately ($ 374) 238 0 9 145 228 The following tables summarizes the Company’s marketable securities for the year ended December 31, 2021 consisted of the following (in thousands): Summary of Marketable Securities Amortized Cost Unrealized Gain Unrealized (Loss) Fair Value Amortized Cost Unrealized Gain Unrealized (Loss) Fair Value U.S. Government Notes $ 19,395 $ 2 $ (120 ) $ 19,277 Corporate Debt Securities 9,092 — (27 ) 9,065 State and Municipal Bonds 250 — — 250 Total marketable securities $ 28,737 $ 2 $ (147 ) $ 28,592 Maturities of debt securities classified as available-for-sale were as follows at December 31, 2021 (in thousands): Schedule of Maturities of Debt Securities Available-for-sale Fair Value Net Carrying Amount Due within one year $ 8,257 $ 8,310 Due after one year through five years 20,335 20,402 $ 28,592 $ 28,712 The following tables summarizes the Company’s marketable securities for the year ended December 31, 2020 consisted of the following (in thousands): Amortized Cost Unrealized Gain Unrealized (Loss) Fair Value Amortized Cost Unrealized Gain Unrealized (Loss) Fair Value U.S. Treasury Bonds $ 18,293 $ 136 $ — $ 18,429 U.S. Government Notes 22,148 82 — 22,230 Corporate Debt Securities 4,303 3 — 4,306 State and Municipal Bonds 1,275 7 — 1,282 Total marketable securities $ 46,019 $ 228 $ — $ 46,247 Maturities of debt securities classified as available-for-sale were as follows at December 31, 2020 (in thousands): Fair Value Net Carrying Amount Due within one year $ 31,438 $ 31,602 Due after one year through five years 14,809 14,845 $ 46,247 $ 46,447 The Company determined that the unrealized (losses) and gains are deemed to be temporary as of December 31, 2021 and 2020. 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. The Company has the ability and intent to hold these investments until maturity. The Company does not consider the investment in marketable securities to be other-than-temporarily impaired at December 31, 2021 and 2020. |
Fair Value Measurements
Fair Value Measurements | 12 Months Ended |
Dec. 31, 2021 | |
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 certain cash and cash equivalents, current portion of restricted cash, marketable securities, prepaid expenses and other current assets, accounts payable, current portion of lease liability 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 (in thousands): Schedule of Fair Value Measurement of Assets and Liabilities Fair Value Hierarchy December 31, 2021 Total (Level 1) (Level 2) (Level 3) Assets Marketable Securities: U.S. Government Notes $ 19,277 $ — $ 19,277 $ — Corporate Debt Securities 9,065 — 9,065 — State and Municipal Bonds 250 — 250 — Total $ 28,592 $ — $ 28,592 $ — Fair Value Hierarchy December 31, 2020 Total (Level 1) (Level 2) (Level 3) Assets Marketable Securities: U.S. Treasury Bonds $ 18,429 $ 18,429 $ — $ — U.S. Government Notes 22,230 — 22,230 — Corporate Debt Securities 4,306 — 4,306 — State and Municipal Bonds 1,282 — 1,282 — Total $ 46,247 $ 18,429 $ 27,818 $ — 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 securities consisting of U.S. government notes, corporate debt securities and state and municipal bonds 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, 2021 | |
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, 2021 and 2020 (in thousands): Schedule of Leasehold Improvements and Equipment December 30, December 31, Equipment $ 1,640 $ 1,443 Leasehold improvements 935 878 Total 2,575 2,321 Less: accumulated depreciation and amortization 1,037 797 Leasehold improvements and equipment, net $ 1,538 $ 1,524 Depreciation and amortization expense for the years ended December 31, 2021 and 2020 was approximately $ 244 231 260 6 6 4 no |
Accrued Expenses and Other Liab
Accrued Expenses and Other Liabilities | 12 Months Ended |
Dec. 31, 2021 | |
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, 2021 and 2020 (in thousands): Schedule of Accrued Expenses 2021 2020 As of December 31, 2021 2020 Payroll and incentives $ 1,343 $ 1,094 General and administrative expenses 195 280 Research and development expenses 381 778 Deferred revenue and other deferred liabilities * 932 643 Total $ 2,851 $ 2,795 * At December 31, 2021, the balance included approximately $ 899 33 577 67 |
Leases
Leases | 12 Months Ended |
Dec. 31, 2021 | |
Leases | |
Leases | Note 8 – Leases The Company has various lease agreements with terms up to 10 years Some leases include purchase, termination or extension options for one or more years. Operating lease obligations On November 1, 2013, the Company entered into a 7 13,000 14,000 On September 23, 2020, the Company entered into an amendment to the Bedminster lease. Pursuant to the amendment, the Company leased an additional 3,034 seven years On December 15, 2016, the Company entered into a 10-year, 3-month 43,000 64,000 586,000 200,000 The assets and liabilities from operating and finance 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. The Company’s operating leases do not provide an implicit rate that can readily be determined. Therefore, the Company uses a discount rate based on its incremental borrowing rate, which is determined using the average of borrowing rates explicitly stated in the Company’s finance leases. The Company incurred lease expense for its operating leases of approximately $ 852 814 501 485 Finance Leases The Company incurred interest expense on its finance leases of approximately $ 3 7 36 59 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, 2021 (in thousands): Schedule of Maturity of Operating and Finance Leases Liabilities Maturity of Lease Liabilities Operating Lease Liabilities Finance Lease Liabilities 2022 $ 883 $ 22 2023 922 2 2024 962 - 2025 1,004 - 2026 1,046 - Thereafter 1,112 - Total undiscounted operating lease payments $ 5,929 $ 24 Less: Imputed interest 1,250 - Present value of operating lease liabilities $ 4,679 $ 24 Weighted average remaining lease term in years 6.1 0.9 Weighted average discount rate 7.8 % 7.8 % The following table presents information about the amount and timing of liabilities arising from the Company’s operating and finance leases as of December 31, 2020 (in thousands): Maturity of Lease Liabilities Operating Lease Liabilities Finance Lease Liabilities 2021 $ 685 $ 34 2022 645 19 2023 677 2 2024 710 - 2025 745 - Thereafter 1,458 - Total undiscounted operating lease payments $ 4,920 $ 55 Less: Imputed interest 1,224 - Present value of operating lease liabilities $ 3,696 $ 55 Weighted average remaining lease term in years 6.7 1.7 Weighted average discount rate 8.4 % 8.1 % |
Collaboration Agreements, Licen
Collaboration Agreements, License and Other Research and Development Agreements | 12 Months Ended |
Dec. 31, 2021 | |
Research and Development [Abstract] | |
Collaboration Agreements, License and Other Research and Development Agreements | Note 9 - Collaboration Agreements, License and Other Research and Development Agreements Cystic Fibrosis Foundation Therapeutics Development Award On November 19, 2020, the Company entered into an award agreement (the “Agreement”) with CFF, pursuant to which it received a Therapeutics Development Award of up to $ 4.2 484,249 321 The first payment under the Agreement, in the amount of $ 650 2.5 899 If the Company ceases to use commercially reasonable efforts directed to the development of MAT2501 in the Field, (an “Interruption”) and fails to resume the development of the Product after receiving from CFF notice of an Interruption, then the Company must either repay the amount of the Award actually received by the Company, or grant to CFF (1) an exclusive (even as to the Company), worldwide, perpetual, sublicensable license under technology developed under the Agreement that covers the Product for use in treating infections in CF patients (the “CF Field”), and (2) a non-exclusive, worldwide license under certain background intellectual property covering the Product, to the extent necessary to commercialize the Product in the CF Field. Pursuant to the terms of the Agreement, the Company is obligated to make royalty payments to CFF contingent upon commercialization of the Product in the Field up to a maximum of five (5) times the Award or approximately $ 21.2 4.2 The term of the Agreement commenced on November 19, 2020 and expires on the earlier of the date on which the Company has paid CFF all of the fixed royalty payments set forth therein, the effective date of any license granted to CFF following an Interruption, or upon earlier termination of the Agreement. Either CFF or the Company may terminate the agreement for cause, which includes the Company’s material failure to achieve certain development milestones. The Company’s payment obligations survive the termination of the Agreement. The Company concluded that the CFF award is in the scope of ASC 808. Accordingly, as discussed in Note 3, the award amounts received from CFF upon achievement of certain milestones are recognized as credits to research and development expenses in the period the Development Program’s expenses are incurred. During the years ended December 31, 2021 and 2020, the Company recognized $ 2.2 0.1 Genentech Feasibility Study Agreement On December 12, 2019, the Company entered into a feasibility study agreement (the “Agreement”) with Genentech, Inc. (“Genentech”). This feasibility study agreement will involve the development of oral formulations using the Company’s LNC platform delivery technology, which enables the development of a wide range of difficult-to-deliver molecules. Under the terms of the Agreement, Genentech shall pay to the Company a total of $100.0 thousand for three molecules, or approximately $33 thousand per molecule, which will be recognized upon the Company fulfilling its obligations for each molecule under the Agreement. 100 33 Other Research and development agreements The Company has financial obligations resulting from Cooperative Research and Development Agreements (“CRADAs”) entered into with the with the National Institute of Allergy and Infectious Diseases (“NIH”) as follows: ● On February 19, 2016, the Company agreed to provide funds in the amount of $ 200,000 three years 200,000 ● On April 2, 2019, the Company agreed to provide funds in the amount of $ 157,405 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 the LNC platform delivery technology. 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 $ 100,000 50,000 |
Commitments
Commitments | 12 Months Ended |
Dec. 31, 2021 | |
Commitments and Contingencies Disclosure [Abstract] | |
Commitments | Note 10 – Commitments Royalty payment rights On September 12, 2016 the Company conducted a final closing of a private placement offering to accredited investors of shares of the Company’s Series A Preferred Stock. As part of this offer, the investors received royalty payment rights if and when the Company generates sales of its MAT2203 or MAT2501 product candidates. Pursuant to the terms of the Series A Certificate of Designation, the Company may be required to pay royalties of up to $ 35 the Company is required to pay to the holders of the Series A Preferred Stock, subject to certain vesting requirements, in the aggregate, a royalty (the “Royalty Payment Rights”) equal to (i) 4.5% of Net Sales (as defined in the Series A Certificate of Designation), subject in all cases to a cap of $ 25 10 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 & 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. |
Income Taxes
Income Taxes | 12 Months Ended |
Dec. 31, 2021 | |
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, 2021 and 2020, 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 (in thousands): Schedule of Income Tax Provision Year Ended December 31, 2021 2020 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 Year Ended December 31, 2021 2020 Income at US Statutory Rate 21.00 % 21.00 % State Taxes, net of Federal benefit 1.97 % 2.95 % Permanent Differences (0.82 )% (1.28 )% Tax Credits 2.16 % 0.75 % Valuation Allowance (25.21 )% (24.53 )% Discrete items 0.91 % 1.11 % 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 2021 and 2020 consist of the following (in thousands): Schedule of Deferred Tax Assets and Liabilities Year Ended December 31, 2021 2020 Share-based Compensation $ 3,575 $ 3,220 Depreciation and Amortization 166 (119 ) Accrued Liability 377 307 Net Operating Loss Carry-forwards 24,076 19,927 R&D Credit Carryforwards 3,207 2,264 Other (1 ) (10 ) IPR&D (848 ) (848 ) ROU Asset (1,186 ) (921 ) ROU Liability 1,315 1,045 Total Deferred tax assets $ 30,681 $ 24,865 Valuation allowance (31,023 ) (25,206 ) 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: 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 approximately $ 31.0 million, $ 25.2 million and $ 19.7 5.8 million and $ 5.5 As of December 31, 2021, the Company had Federal net operating loss carryforwards of approximately $ 38.1 2032 63.3 3.2 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 Sale of net operating losses (NOLs) The Company recognized approximately $ 1.3 million and $ 1.1 million for the years ended December 31, 2021 and 2020, respectively, in connection with the sale of certain State of New Jersey Net Operating Losses (“NOL”) and Research and Development (“R&D”) tax credits to a third party under the New Jersey Technology Business Tax Certificate Transfer Program. 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 . This NOL limitation was suspended for years 2018 through 2020 as a result of the CARES Act. |
Stockholders_ Equity
Stockholders’ Equity | 12 Months Ended |
Dec. 31, 2021 | |
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 (“ATM”) 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 $ 50,000,000 3 3,023,147 5.8 5.6 Common Stock On September 3, 2021, the Company issued 1,500,000 1.2 1,500,000 0.80 On January 14, 2020, the Company closed on an underwritten public offering of 32,260,000 1.55 per share. The Company generated gross proceeds of approximately $ 50.0 million and net proceeds of approximately $ 46.7 million, after deducting underwriting discounts and commissions and other estimated offering expenses. In addition, the Company granted the underwriters a 30-day option to purchase up to approximately 4.8 million additional shares of its common stock on the same terms and conditions. No additional shares of the Company’s common stock were sold pursuant to this option. Preferred Stock In accordance with the Certificate of Incorporation, the Company is authorized to issue 10,000,000 0.001 1,600,000 8,000 Series B Preferred Stock During 2021 and prior to June 19, 2021, 143 286,000 4,218 2,000 8,436,000 0 4,361 Conversion: Prior to the automatic conversion of Series B Preferred Stock on June 19, 2021, and subject to certain ownership limitations, each share of Series B Preferred Stock was convertible into shares of the Company’s common stock at any time at the option of the holder at an initial conversion price of $ 0.50 8,436,000 Dividends: Subject to certain ownership limitations, holders of the Series B Preferred Stock received dividends paid in the Company’s common stock as follows: (i) a number of shares of common stock equal to 10% of the shares of common stock underlying the Series B Preferred Stock then held by such holder on June 19, 2019, (ii) a number of shares of common stock equal to 15% of the shares of common stock underlying the Series B Preferred Stock then held by such holder on June 19, 2020 and (iii) a number of shares of common stock equal to 20% of the shares of common stock underlying the Series B Preferred Stock then held by such holder on June 19, 2021. Based on an accounting of the holders of record of Series B Preferred Stock on June 19, 2021 and 2020, the Company made dividend payments totaling 1,687,200 1,365,600 Warrants All warrants issued by the Company are exercisable immediately upon issuance and have a five-year term. The warrants may be exercised at any time in whole or in part upon payment of the applicable exercise price until expiration. No fractional shares will be issued upon the exercise of the warrants. The exercise price and the number of shares purchasable upon the exercise of the warrants are subject to adjustment upon the occurrence of certain events, which include stock dividends, stock splits, combinations and reclassifications of the Company’s capital stock or other similar changes to the equity structure of the Company. The warrants do not have a redemption feature. They may be exercised on a cashless basis at the holder’s option. The warrants are classified as equity instruments. As of December 31, 2021, the Company had outstanding warrants to purchase an aggregate of 988,000 0.50 0.75 Summary of Shareholders Equity Warrants Outstanding Shares Outstanding at December 31, 2019 5,397 Issued - Exercised (2,549 ) Tendered - Expired (1,493 ) Outstanding at December 31, 2020 1,328 * Outstanding at January 01, 2021 Issued - Exercised (320 )** Tendered - Expired (20 ) Outstanding at December 31, 2021 988 *** * Weighted average exercise price for outstanding warrants is $ 0.55 ** Converted into approximately 115 *** Weighted average exercise price for outstanding warrants is $ 0.56 |
Accumulated Other Comprehensive
Accumulated Other Comprehensive (Loss)/Income | 12 Months Ended |
Dec. 31, 2021 | |
Equity [Abstract] | |
Accumulated Other Comprehensive (Loss)/Income | Note 13 – Accumulated Other Comprehensive (Loss)/Income The following table summarizes the changes in accumulated other comprehensive (loss)/income by components during the years ended December 31, 2021 and 2020 (in thousands): Schedule of Components of Accumulated Other Comprehensive (Loss)/Income Net Unrealized (Losses)/Gains on Available-for-Sale Securities Accumulated Other Comprehensive (Loss)/Gain Balance, December 31, 2019 $ (1 ) $ (1 ) Net unrealized gain on securities available-for-sale 237 237 Reclassification of realized gain on securities available-for-sale to net loss (8 ) (8 ) Net current period other comprehensive gain 229 229 Balance, December 31, 2020 $ 228 $ 228 Net unrealized loss on securities available-for-sale (373 ) (373 ) Net current period other comprehensive loss (374 ) (374 ) Balance, December 31, 2021 $ (146 ) $ (146 ) All components of accumulated other comprehensive (loss)/income are net of tax. |
Stock-based Compensation
Stock-based Compensation | 12 Months Ended |
Dec. 31, 2021 | |
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. Options under the Plan may be granted at prices not less than 100% of the fair value of the shares three four years The term of the options is no longer than ten years 36,952,460 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 its consolidated statements of operations as follows (in thousands): Schedule of Recognized Stock-Based Compensation Year Ended December 31, 2021 2020 Research and Development $ 1,870 $ 1,897 General and Administrative 2,422 2,668 Total $ 4,292 $ 4,565 The following table contains information about the Company’s stock plan at December 31, 2020: Schedule of Equity Compensation Plan by Arrangements Awards Reserved for Issuance Awards Issued & Exercised Awards Available for Grant 2013 Equity Compensation Plan (in thousands) 36,952 * 32,669 ** 4,283 * Increased by 8,005 4% ** Includes both stock grants and option grants The following table summarizes the Company’ stock option activity and related information for the period from January 1, 2020 to December 31, 2021 (options in thousands): Schedule of Stock Option Activity Number of Options Weighted Average Exercise Price Weighted Average Contractual Term in Years Outstanding at December 31, 2019 17,529 $ 1.11 6.2 Granted 6,501 $ 1.59 Exercised (826 ) 0.74 Forfeited (72 ) $ 1.11 Cancelled - - Expired (581 ) $ 1.25 Outstanding at December 31, 2020 22,551 $ 1.26 6.9 Granted 10,976 $ 1.11 Exercised (1,077 ) $ 0.60 Forfeited (2,824 ) $ 1.08 Cancelled - - Expired (1,441 ) $ 1.98 Outstanding at December 31, 2021 28,184 $ 1.21 7.2 The following table summarizes outstanding options at December 31, 2021, by their exercise price (options in thousands): Summary of Outstanding Options Range of Exercise Prices Number Outstanding Weighted Average Exercise Price Per Share $ 0.41 0.69 1,935 $ 0.49 $ 0.74 1.12 15,940 $ 0.93 $ 1.24 1.61 6,525 $ 1.35 $ 2.27 3.32 3,784 $ 2.50 28,184 $ 1.21 As of December 31, 2021, the number of vested shares underlying outstanding options was 14,625,397 1.20 2.5 1.01 11.7 2.9 All outstanding options expire ten years 25% During the years ended December 31, 2021 and 2020, the Company granted restricted stock awards for 31,769 379,385 100 292 The Company recognizes compensation expense for stock option awards and restricted stock awards on a straight-line basis over the applicable service period of the award. The service period is generally the vesting period, with the exception of awards granted subject to a vendor’s consulting agreement, whereby the award vesting period and the service period defined pursuant to the terms of the consulting agreement may be different. Beginning January 1, 2020, stock options issued to consultants are recorded at fair value on the date of grant and the award is recognized as an expense on a straight-line basis over the requisite service period. The following weighted-average assumptions were used to calculate share-based compensation for the comparative periods presented: Schedule of Stock Option Awards and Restricted Stock Awards For the Year Ended December 31, 2021 2020 Volatility 98.4 % - 101.6 % 100.5 107.4 % Risk-free interest rate 0.47 1.28 % 0.34 1.74 % 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 the Company’s historical stock price volatility. |
Subsequent Events
Subsequent Events | 12 Months Ended |
Dec. 31, 2021 | |
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, 2021 | |
Accounting Policies [Abstract] | |
Basis of presentation and principles of consolidation | Basis of presentation and principles of consolidation The accompanying audited 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 of America (“U.S. GAAP”) and reflect the operations of the Company and its wholly owned subsidiaries. All intercompany transactions have been eliminated in consolidation. |
COVID-19 | COVID-19 In March 2020, the World Health Organization declared COVID-19 a global pandemic. This contagious disease outbreak, which has continued to spread, and any related adverse public health developments, has adversely affected workforces, economics, and financial markets globally, potentially leading to an economic downturn. The Company has been actively monitoring the COVID-19 pandemic and its impact globally. The financial results for the year ended December 31, 2021 were not significantly impacted by COVID-19. However, the Company cannot predict the impact of the progression of the COVID-19 pandemic 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 suppliers to continue to operate and deliver, the ability of the Company to maintain operations, any further government and/or public actions taken in response to the pandemic and ultimately the length of the pandemic. |
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, the assessment of the impairment of goodwill and intangible assets, level 3 fair value measurement of financial instruments, income tax valuations, the determination of stock-based compensation and contingent consideration. |
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 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 Securities. |
Marketable Securities | Marketable Securities Marketable securities, all of which are available-for-sale, consist of U.S. treasury bonds, U.S. government notes, corporate debt securities and state and municipal bonds. Marketable securities are carried at fair value, with unrealized gains and losses reported as accumulated other comprehensive (loss)/income, except for losses from impairments which are determined to be other-than-temporary. 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 securities, see Note 4 – Cash, Cash Equivalents, Restricted Cash and Marketable 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 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 are insured by the Federal Deposit Insurance Corporation (“FDIC”) up to regulatory limits. The Company has not experienced any credit losses associated with its balances in such accounts. |
Leasehold improvements and equipment | Leasehold improvements and equipment Equipment and leasehold improvements 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 |
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 determine this is the case, the Company can perform further 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 years ended December 31, 2021 and 2020, the Company assessed goodwill impairment by performing a qualitative test for its reporting unit. As part of the qualitative review, the Company considered its cash position and its ability to obtain additional financing in the near term to meet its operational and strategic goals and substantiate the value of its business. Based on the results of the Company’s assessment, it was determined that it is more-likely-than-not that the fair value of the reporting unit is greater than its carrying amount. There were no 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 approach for testing indefinite-lived intangible assets for impairment. The Company used the qualitative approach and concluded that it was more-likely-than-not that its indefinite-lived assets were not impaired during the years ended December 31, 2021 and 2020. |
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. |
Preferred stock dividends | Preferred stock dividends S ubject to provisions detailed more fully in Note 12, Stockholders’ Equity, shares of Series B Preferred Stock earned dividends at rates of 10% , 15% and 20% once per year on the first, second and third anniversary, respectively, of June 19, 2018. The dividends were paid when earned to the holders of the Series B Preferred Stock in the form of shares of the Company’s common stock. |
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. The Company adopted the provisions of Accounting Standard Codification 740-10 and has analyzed its filing positions in 2021 and 2020 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 2020 income tax returns are subject to examination and adjustments by the IRS 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 that are recognized in the consolidated statement of operations based on their fair values at the date of grant. 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 stock-based 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 that participate in dividends (a “participating security”). The Company considered its Preferred Stock to be participating securities because they included rights to participate in dividends with the common stock. 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. The net loss attributable to common stockholders is calculated by adjusting the net loss of the Company for the accretion on the Preferred Stock. Net losses are not allocated to preferred stockholders as they do not have an obligation to share in the Company’s net losses. In periods with net income attributable to common stockholders, the Company would allocate net income first to preferred stockholders based on dividend rights under the Company’s certificate of incorporation and then to preferred and common stockholders based on ownership interests. 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, 2021 and 2020, 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, warrants and conversion of preferred stock, would have an anti-dilutive effect. The reconciliation of the diluted shares as of December 31, 2021 and 2020 are as follows (in thousands): Schedule of Anti-dilutive Securities As of December 31, 2021 2020 Stock options 28,184 22,551 Preferred Stock and accrued dividend upon conversion - 8,722 Warrants 988 1,328 Total 29,172 32,601 |
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, 2020, the Company’s revenues primarily consist of a research grant to provide research and development services to the Cystic Fibrosis Foundation (“CFF”). The grant contract has a single performance obligation that is recognized over time as the services are performed. There are no contract assets or liabilities associated with this grant. The Company had approximately $ 125 On December 12, 2019, the Company entered into a feasibility study agreement (the “Agreement”) with Genentech, Inc. (“Genentech”). This feasibility study will involve the development of oral formulations using the Company’s LNC platform delivery technology, 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 |
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: 2.2 0.1 |
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 income/(loss) | Other comprehensive income/(loss) Other comprehensive income/(loss) consists of net gains/(losses) and unrealized losses on marketable securities available-for-sale and is presented in the Consolidated Statements of Operations. |
Recently adopted accounting pronouncements | Recently adopted accounting pronouncements In December 2019, the FASB Issued Accounting Standard Update 2019-12, “Income Taxes, (Topic 740): Simplifying the Accounting for Income Taxes”. This standard removes certain exceptions to the general principles and improves consistent application of and simplify GAAP for other areas of Topic 740 by clarifying and amending existing guidance. This standard is effective for fiscal years, and interim periods within those fiscal years, beginning after December 15, 2020. The Company adopted the new standard effective January 1, 2021 with no material impact on the Company’s consolidated financial statements. |
Summary of Significant Accoun_3
Summary of Significant Accounting Policies (Tables) | 12 Months Ended |
Dec. 31, 2021 | |
Accounting Policies [Abstract] | |
Schedule of Anti-dilutive Securities | Schedule of Anti-dilutive Securities As of December 31, 2021 2020 Stock options 28,184 22,551 Preferred Stock and accrued dividend upon conversion - 8,722 Warrants 988 1,328 Total 29,172 32,601 |
Cash, Cash Equivalents, Restr_2
Cash, Cash Equivalents, Restricted Cash and Marketable Securities (Tables) | 12 Months Ended |
Dec. 31, 2021 | |
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, 2021, December 31, 2020 and December 31, 2019 (in thousands): Schedule of Cash, Cash Equivalents and Restricted Cash December 31, December 31, December 31, Cash and cash equivalents $ 21,030 $ 12,432 $ 22,170 Restricted cash included in current/long term assets 250 336 586 Cash, cash equivalents and restricted cash in the statements of cash flows $ 21,280 $ 12,768 $ 22,756 |
Summary of Marketable Securities | The following tables summarizes the Company’s marketable securities for the year ended December 31, 2021 consisted of the following (in thousands): Summary of Marketable Securities Amortized Cost Unrealized Gain Unrealized (Loss) Fair Value Amortized Cost Unrealized Gain Unrealized (Loss) Fair Value U.S. Government Notes $ 19,395 $ 2 $ (120 ) $ 19,277 Corporate Debt Securities 9,092 — (27 ) 9,065 State and Municipal Bonds 250 — — 250 Total marketable securities $ 28,737 $ 2 $ (147 ) $ 28,592 The following tables summarizes the Company’s marketable securities for the year ended December 31, 2020 consisted of the following (in thousands): Amortized Cost Unrealized Gain Unrealized (Loss) Fair Value Amortized Cost Unrealized Gain Unrealized (Loss) Fair Value U.S. Treasury Bonds $ 18,293 $ 136 $ — $ 18,429 U.S. Government Notes 22,148 82 — 22,230 Corporate Debt Securities 4,303 3 — 4,306 State and Municipal Bonds 1,275 7 — 1,282 Total marketable securities $ 46,019 $ 228 $ — $ 46,247 |
Schedule of Maturities of Debt Securities Available-for-sale | Maturities of debt securities classified as available-for-sale were as follows at December 31, 2021 (in thousands): Schedule of Maturities of Debt Securities Available-for-sale Fair Value Net Carrying Amount Due within one year $ 8,257 $ 8,310 Due after one year through five years 20,335 20,402 $ 28,592 $ 28,712 Maturities of debt securities classified as available-for-sale were as follows at December 31, 2020 (in thousands): Fair Value Net Carrying Amount Due within one year $ 31,438 $ 31,602 Due after one year through five years 14,809 14,845 $ 46,247 $ 46,447 |
Fair Value Measurements (Tables
Fair Value Measurements (Tables) | 12 Months Ended |
Dec. 31, 2021 | |
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 (in thousands): Schedule of Fair Value Measurement of Assets and Liabilities Fair Value Hierarchy December 31, 2021 Total (Level 1) (Level 2) (Level 3) Assets Marketable Securities: U.S. Government Notes $ 19,277 $ — $ 19,277 $ — Corporate Debt Securities 9,065 — 9,065 — State and Municipal Bonds 250 — 250 — Total $ 28,592 $ — $ 28,592 $ — Fair Value Hierarchy December 31, 2020 Total (Level 1) (Level 2) (Level 3) Assets Marketable Securities: U.S. Treasury Bonds $ 18,429 $ 18,429 $ — $ — U.S. Government Notes 22,230 — 22,230 — Corporate Debt Securities 4,306 — 4,306 — State and Municipal Bonds 1,282 — 1,282 — Total $ 46,247 $ 18,429 $ 27,818 $ — |
Leasehold Improvements and Eq_2
Leasehold Improvements and Equipment (Tables) | 12 Months Ended |
Dec. 31, 2021 | |
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, 2021 and 2020 (in thousands): Schedule of Leasehold Improvements and Equipment December 30, December 31, Equipment $ 1,640 $ 1,443 Leasehold improvements 935 878 Total 2,575 2,321 Less: accumulated depreciation and amortization 1,037 797 Leasehold improvements and equipment, net $ 1,538 $ 1,524 |
Accrued Expenses and Other Li_2
Accrued Expenses and Other Liabilities (Tables) | 12 Months Ended |
Dec. 31, 2021 | |
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, 2021 and 2020 (in thousands): Schedule of Accrued Expenses 2021 2020 As of December 31, 2021 2020 Payroll and incentives $ 1,343 $ 1,094 General and administrative expenses 195 280 Research and development expenses 381 778 Deferred revenue and other deferred liabilities * 932 643 Total $ 2,851 $ 2,795 * At December 31, 2021, the balance included approximately $ 899 33 577 67 |
Leases (Tables)
Leases (Tables) | 12 Months Ended |
Dec. 31, 2021 | |
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, 2021 (in thousands): Schedule of Maturity of Operating and Finance Leases Liabilities Maturity of Lease Liabilities Operating Lease Liabilities Finance Lease Liabilities 2022 $ 883 $ 22 2023 922 2 2024 962 - 2025 1,004 - 2026 1,046 - Thereafter 1,112 - Total undiscounted operating lease payments $ 5,929 $ 24 Less: Imputed interest 1,250 - Present value of operating lease liabilities $ 4,679 $ 24 Weighted average remaining lease term in years 6.1 0.9 Weighted average discount rate 7.8 % 7.8 % The following table presents information about the amount and timing of liabilities arising from the Company’s operating and finance leases as of December 31, 2020 (in thousands): Maturity of Lease Liabilities Operating Lease Liabilities Finance Lease Liabilities 2021 $ 685 $ 34 2022 645 19 2023 677 2 2024 710 - 2025 745 - Thereafter 1,458 - Total undiscounted operating lease payments $ 4,920 $ 55 Less: Imputed interest 1,224 - Present value of operating lease liabilities $ 3,696 $ 55 Weighted average remaining lease term in years 6.7 1.7 Weighted average discount rate 8.4 % 8.1 % |
Income Taxes (Tables)
Income Taxes (Tables) | 12 Months Ended |
Dec. 31, 2021 | |
Income Tax Disclosure [Abstract] | |
Schedule of Income Tax Provision | The components of the income tax provision are as follows (in thousands): Schedule of Income Tax Provision Year Ended December 31, 2021 2020 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 Year Ended December 31, 2021 2020 Income at US Statutory Rate 21.00 % 21.00 % State Taxes, net of Federal benefit 1.97 % 2.95 % Permanent Differences (0.82 )% (1.28 )% Tax Credits 2.16 % 0.75 % Valuation Allowance (25.21 )% (24.53 )% Discrete items 0.91 % 1.11 % 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 2021 and 2020 consist of the following (in thousands): Schedule of Deferred Tax Assets and Liabilities Year Ended December 31, 2021 2020 Share-based Compensation $ 3,575 $ 3,220 Depreciation and Amortization 166 (119 ) Accrued Liability 377 307 Net Operating Loss Carry-forwards 24,076 19,927 R&D Credit Carryforwards 3,207 2,264 Other (1 ) (10 ) IPR&D (848 ) (848 ) ROU Asset (1,186 ) (921 ) ROU Liability 1,315 1,045 Total Deferred tax assets $ 30,681 $ 24,865 Valuation allowance (31,023 ) (25,206 ) Net deferred tax asset (liability) $ (341 ) $ (341 ) |
Stockholders_ Equity (Tables)
Stockholders’ Equity (Tables) | 12 Months Ended |
Dec. 31, 2021 | |
Equity [Abstract] | |
Summary of Shareholders Equity Warrants Outstanding | Summary of Shareholders Equity Warrants Outstanding Shares Outstanding at December 31, 2019 5,397 Issued - Exercised (2,549 ) Tendered - Expired (1,493 ) Outstanding at December 31, 2020 1,328 * Outstanding at January 01, 2021 Issued - Exercised (320 )** Tendered - Expired (20 ) Outstanding at December 31, 2021 988 *** * Weighted average exercise price for outstanding warrants is $ 0.55 ** Converted into approximately 115 *** Weighted average exercise price for outstanding warrants is $ 0.56 |
Accumulated Other Comprehensi_2
Accumulated Other Comprehensive (Loss)/Income (Tables) | 12 Months Ended |
Dec. 31, 2021 | |
Equity [Abstract] | |
Schedule of Components of Accumulated Other Comprehensive (Loss)/Income | The following table summarizes the changes in accumulated other comprehensive (loss)/income by components during the years ended December 31, 2021 and 2020 (in thousands): Schedule of Components of Accumulated Other Comprehensive (Loss)/Income Net Unrealized (Losses)/Gains on Available-for-Sale Securities Accumulated Other Comprehensive (Loss)/Gain Balance, December 31, 2019 $ (1 ) $ (1 ) Net unrealized gain on securities available-for-sale 237 237 Reclassification of realized gain on securities available-for-sale to net loss (8 ) (8 ) Net current period other comprehensive gain 229 229 Balance, December 31, 2020 $ 228 $ 228 Net unrealized loss on securities available-for-sale (373 ) (373 ) Net current period other comprehensive loss (374 ) (374 ) Balance, December 31, 2021 $ (146 ) $ (146 ) |
Stock-based Compensation (Table
Stock-based Compensation (Tables) | 12 Months Ended |
Dec. 31, 2021 | |
Share-based Payment Arrangement [Abstract] | |
Schedule of Recognized Stock-Based Compensation | The Company recognized stock-based compensation expense (options and restricted share grants) in its consolidated statements of operations as follows (in thousands): Schedule of Recognized Stock-Based Compensation Year Ended December 31, 2021 2020 Research and Development $ 1,870 $ 1,897 General and Administrative 2,422 2,668 Total $ 4,292 $ 4,565 |
Schedule of Equity Compensation Plan by Arrangements | The following table contains information about the Company’s stock plan at December 31, 2020: Schedule of Equity Compensation Plan by Arrangements Awards Reserved for Issuance Awards Issued & Exercised Awards Available for Grant 2013 Equity Compensation Plan (in thousands) 36,952 * 32,669 ** 4,283 * Increased by 8,005 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, 2020 to December 31, 2021 (options in thousands): Schedule of Stock Option Activity Number of Options Weighted Average Exercise Price Weighted Average Contractual Term in Years Outstanding at December 31, 2019 17,529 $ 1.11 6.2 Granted 6,501 $ 1.59 Exercised (826 ) 0.74 Forfeited (72 ) $ 1.11 Cancelled - - Expired (581 ) $ 1.25 Outstanding at December 31, 2020 22,551 $ 1.26 6.9 Granted 10,976 $ 1.11 Exercised (1,077 ) $ 0.60 Forfeited (2,824 ) $ 1.08 Cancelled - - Expired (1,441 ) $ 1.98 Outstanding at December 31, 2021 28,184 $ 1.21 7.2 |
Summary of Outstanding Options | The following table summarizes outstanding options at December 31, 2021, by their exercise price (options in thousands): Summary of Outstanding Options Range of Exercise Prices Number Outstanding Weighted Average Exercise Price Per Share $ 0.41 0.69 1,935 $ 0.49 $ 0.74 1.12 15,940 $ 0.93 $ 1.24 1.61 6,525 $ 1.35 $ 2.27 3.32 3,784 $ 2.50 28,184 $ 1.21 |
Schedule of Stock Option Awards and Restricted Stock Awards | Schedule of Stock Option Awards and Restricted Stock Awards For the Year Ended December 31, 2021 2020 Volatility 98.4 % - 101.6 % 100.5 107.4 % Risk-free interest rate 0.47 1.28 % 0.34 1.74 % Dividend yield 0.0 % 0.0 % Expected life 6.0 6.0 |
Liquidity and Plan of Operati_2
Liquidity and Plan of Operations (Details Narrative) - USD ($) | Jan. 14, 2020 | Jan. 31, 2021 | Dec. 31, 2021 | Dec. 31, 2020 | Dec. 31, 2019 |
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |||||
Accumulated deficit | $ 131,634,208 | $ 107,507,193 | |||
Net loss | 23,300,000 | 22,400,000 | |||
Gross proceeds from public offering of common stock | $ 50,000,000 | 5,580,471 | 46,704,210 | ||
Net proceeds from public offering of common stock | 46,700,000 | ||||
Cash and cash equivalents | 21,029,806 | 12,432,481 | $ 22,170,000 | ||
Marketable securities | 28,592,049 | $ 46,246,573 | |||
Restricted cash | $ 300,000 | ||||
Underwritten Public Offering [Member] | |||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |||||
Gross proceeds from public offering of common stock | 50,000,000 | ||||
Net proceeds from public offering of common stock | $ 46,700,000 | ||||
At The Market Sales Agreement [Member] | |||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |||||
Proceeds from public offering, gross | $ 5,800,000 | ||||
Gross proceeds from public offering of common stock | $ 5,600,000 | ||||
Common Stock [Member] | |||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |||||
Number of underwritten public offering of common stock | 32,260,000 | 3,023,147 | 32,260,000 | ||
Common Stock [Member] | Underwritten Public Offering [Member] | |||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |||||
Number of underwritten public offering of common stock | 32,600,000 |
Schedule of Anti-dilutive Secur
Schedule of Anti-dilutive Securities (Details) - shares shares in Thousands | 12 Months Ended | |
Dec. 31, 2021 | Dec. 31, 2020 | |
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Anti-dilutive earnings per share, amount | 29,172 | 32,601 |
Stock Options [Member] | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Anti-dilutive earnings per share, amount | 28,184 | 22,551 |
Preferred Stock and Accrued Dividend Upon Conversion [Member] | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Anti-dilutive earnings per share, amount | 8,722 | |
Warrant [Member] | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Anti-dilutive earnings per share, amount | 988 | 1,328 |
Summary of Significant Accoun_4
Summary of Significant Accounting Policies (Details Narrative) | Dec. 12, 2019USD ($) | Jun. 19, 2018 | Dec. 31, 2021USD ($)Segment | Dec. 31, 2020USD ($) |
Property, Plant and Equipment [Line Items] | ||||
Number of operating segment | Segment | 1 | |||
Goodwill impairments | $ 0 | $ 0 | ||
Accrual for interest or penalties | 0 | |||
Revenue | 33,333 | 158,333 | ||
CFF Agreement [Member] | ||||
Property, Plant and Equipment [Line Items] | ||||
Research and Development, costs incurred | 2,200,000 | 100,000 | ||
Genentech [Member] | ||||
Property, Plant and Equipment [Line Items] | ||||
Revenue | 33,000 | 33,000 | ||
Per Molecules [Member] | Genentech [Member] | ||||
Property, Plant and Equipment [Line Items] | ||||
Revenue | $ 33,000 | 33,000 | ||
CFF Research Grant Revenue [Member] | ||||
Property, Plant and Equipment [Line Items] | ||||
Revenue | $ 125,000 | |||
Feasibility Study Agreement [Member] | Three Molecules [Member] | Genentech [Member] | ||||
Property, Plant and Equipment [Line Items] | ||||
Proceeds from sale of productive assets | $ 100,000 | |||
Feasibility Study Agreement [Member] | Per Molecules [Member] | Genentech [Member] | ||||
Property, Plant and Equipment [Line Items] | ||||
Proceeds from sale of productive assets | $ 33,000 | |||
Series B Preferred Stock [Member] | First Anniversary [Member] | ||||
Property, Plant and Equipment [Line Items] | ||||
Preferred Stock, Dividend Rate, Percentage | 10.00% | |||
Series B Preferred Stock [Member] | Second Anniversary [Member] | ||||
Property, Plant and Equipment [Line Items] | ||||
Preferred Stock, Dividend Rate, Percentage | 15.00% | |||
Series B Preferred Stock [Member] | Third Anniversary [Member] | ||||
Property, Plant and Equipment [Line Items] | ||||
Preferred Stock, Dividend Rate, Percentage | 20.00% | |||
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 ($) | Dec. 31, 2021 | Dec. 31, 2020 | Dec. 31, 2019 |
Cash and Cash Equivalents [Abstract] | |||
Cash and cash equivalents | $ 21,029,806 | $ 12,432,481 | $ 22,170,000 |
Restricted cash included in current/long term assets | 250,000 | 336,000 | 586,000 |
Cash, cash equivalents and restricted cash in the statements of cash flows | $ 21,280,000 | $ 12,768,000 | $ 22,756,000 |
Summary of Marketable Securitie
Summary of Marketable Securities (Details) - USD ($) $ in Thousands | Dec. 31, 2021 | Dec. 31, 2020 |
Debt Securities, Held-to-maturity, Allowance for Credit Loss [Line Items] | ||
Amortized Cost | $ 28,737 | $ 46,019 |
Unrealized Gain | 2 | 228 |
Unrealized (Loss) | 147 | |
Fair Value | 28,592 | 46,247 |
Debt Securities, Available-for-sale, Accumulated Gross Unrealized Loss, before Tax | (147) | |
US Government Agencies Debt Securities [Member] | ||
Debt Securities, Held-to-maturity, Allowance for Credit Loss [Line Items] | ||
Amortized Cost | 19,395 | 22,148 |
Unrealized Gain | 2 | 82 |
Unrealized (Loss) | 120 | |
Fair Value | 19,277 | 22,230 |
Debt Securities, Available-for-sale, Accumulated Gross Unrealized Loss, before Tax | (120) | |
Corporate Debt Securities [Member] | ||
Debt Securities, Held-to-maturity, Allowance for Credit Loss [Line Items] | ||
Amortized Cost | 9,092 | 4,303 |
Unrealized Gain | 3 | |
Unrealized (Loss) | 27 | |
Fair Value | 9,065 | 4,306 |
Debt Securities, Available-for-sale, Accumulated Gross Unrealized Loss, before Tax | (27) | |
US States and Political Subdivisions Debt Securities [Member] | ||
Debt Securities, Held-to-maturity, Allowance for Credit Loss [Line Items] | ||
Amortized Cost | 250 | 1,275 |
Unrealized Gain | 7 | |
Unrealized (Loss) | ||
Fair Value | 250 | 1,282 |
Debt Securities, Available-for-sale, Accumulated Gross Unrealized Loss, before Tax | ||
US Treasury Securities [Member] | ||
Debt Securities, Held-to-maturity, Allowance for Credit Loss [Line Items] | ||
Amortized Cost | 18,293 | |
Unrealized Gain | 136 | |
Unrealized (Loss) | ||
Fair Value | 18,429 | |
Debt Securities, Available-for-sale, Accumulated Gross Unrealized Loss, before Tax |
Schedule of Maturities of Debt
Schedule of Maturities of Debt Securities Available-for-sale (Details) - USD ($) $ in Thousands | Dec. 31, 2021 | Dec. 31, 2020 |
Cash and Cash Equivalents [Abstract] | ||
Due within one year, fair value | $ 8,257 | $ 31,438 |
Due within one year, net carrying amount | 8,310 | 31,602 |
Due after one year through five years, fair value | 20,335 | 14,809 |
Due after one year through five years, net carrying amount | 20,402 | 14,845 |
Debt Securities Available-for-sale, fair value | 28,592 | 46,247 |
Debt Securities Available-for-sale, net carrying amount | $ 28,712 | $ 46,447 |
Cash, Cash Equivalents, Restr_3
Cash, Cash Equivalents, Restricted Cash and Marketable Securities (Details Narrative) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2021 | Dec. 31, 2020 | |
Cash and Cash Equivalents [Abstract] | ||
Marketable securities, unrealized gain loss | $ 374 | $ 238 |
Net realized loss | 0 | 9 |
Net accumulated unrealized gain | $ 145 | $ 228 |
Schedule of Fair Value Measurem
Schedule of Fair Value Measurement of Assets and Liabilities (Details) - USD ($) $ in Thousands | Dec. 31, 2021 | Dec. 31, 2020 |
Fair Value, Off-balance Sheet Risks, Disclosure Information [Line Items] | ||
Marketable Securities | $ 28,592 | $ 46,247 |
Fair Value, Inputs, Level 1 [Member] | ||
Fair Value, Off-balance Sheet Risks, Disclosure Information [Line Items] | ||
Marketable Securities | 18,429 | |
Fair Value, Inputs, Level 2 [Member] | ||
Fair Value, Off-balance Sheet Risks, Disclosure Information [Line Items] | ||
Marketable Securities | 28,592 | 27,818 |
Fair Value, Inputs, Level 3 [Member] | ||
Fair Value, Off-balance Sheet Risks, Disclosure Information [Line Items] | ||
Marketable Securities | ||
US Government Agencies Debt Securities [Member] | ||
Fair Value, Off-balance Sheet Risks, Disclosure Information [Line Items] | ||
Marketable Securities | 19,277 | 22,230 |
US Government Agencies Debt Securities [Member] | Fair Value, Inputs, Level 1 [Member] | ||
Fair Value, Off-balance Sheet Risks, Disclosure Information [Line Items] | ||
Marketable Securities | ||
US Government Agencies Debt Securities [Member] | Fair Value, Inputs, Level 2 [Member] | ||
Fair Value, Off-balance Sheet Risks, Disclosure Information [Line Items] | ||
Marketable Securities | 19,277 | 22,230 |
US Government Agencies Debt Securities [Member] | Fair Value, Inputs, Level 3 [Member] | ||
Fair Value, Off-balance Sheet Risks, Disclosure Information [Line Items] | ||
Marketable Securities | ||
Corporate Debt Securities [Member] | ||
Fair Value, Off-balance Sheet Risks, Disclosure Information [Line Items] | ||
Marketable Securities | 9,065 | 4,306 |
Corporate Debt Securities [Member] | Fair Value, Inputs, Level 1 [Member] | ||
Fair Value, Off-balance Sheet Risks, Disclosure Information [Line Items] | ||
Marketable Securities | ||
Corporate Debt Securities [Member] | Fair Value, Inputs, Level 2 [Member] | ||
Fair Value, Off-balance Sheet Risks, Disclosure Information [Line Items] | ||
Marketable Securities | 9,065 | 4,306 |
Corporate Debt Securities [Member] | Fair Value, Inputs, Level 3 [Member] | ||
Fair Value, Off-balance Sheet Risks, Disclosure Information [Line Items] | ||
Marketable Securities | ||
State and Municipal Bonds [Member] | Fair Value, Inputs, Level 3 [Member] | ||
Fair Value, Off-balance Sheet Risks, Disclosure Information [Line Items] | ||
Marketable Securities | ||
US States and Political Subdivisions Debt Securities [Member] | ||
Fair Value, Off-balance Sheet Risks, Disclosure Information [Line Items] | ||
Marketable Securities | 250 | 1,282 |
US States and Political Subdivisions Debt Securities [Member] | Fair Value, Inputs, Level 1 [Member] | ||
Fair Value, Off-balance Sheet Risks, Disclosure Information [Line Items] | ||
Marketable Securities | ||
US States and Political Subdivisions Debt Securities [Member] | Fair Value, Inputs, Level 2 [Member] | ||
Fair Value, Off-balance Sheet Risks, Disclosure Information [Line Items] | ||
Marketable Securities | 250 | 1,282 |
US States and Political Subdivisions Debt Securities [Member] | Fair Value, Inputs, Level 3 [Member] | ||
Fair Value, Off-balance Sheet Risks, Disclosure Information [Line Items] | ||
Marketable Securities | ||
US Treasury Securities [Member] | ||
Fair Value, Off-balance Sheet Risks, Disclosure Information [Line Items] | ||
Marketable Securities | 18,429 | |
US Treasury Securities [Member] | Fair Value, Inputs, Level 1 [Member] | ||
Fair Value, Off-balance Sheet Risks, Disclosure Information [Line Items] | ||
Marketable Securities | 18,429 | |
US Treasury Securities [Member] | Fair Value, Inputs, Level 2 [Member] | ||
Fair Value, Off-balance Sheet Risks, Disclosure Information [Line Items] | ||
Marketable Securities | ||
US Treasury Securities [Member] | Fair Value, Inputs, Level 3 [Member] | ||
Fair Value, Off-balance Sheet Risks, Disclosure Information [Line Items] | ||
Marketable Securities |
Schedule of Leasehold Improveme
Schedule of Leasehold Improvements and Equipment (Details) - USD ($) | Dec. 31, 2021 | Dec. 31, 2020 |
Property, Plant and Equipment [Line Items] | ||
Total | $ 2,575,000 | $ 2,321,000 |
Less: accumulated depreciation and amortization | 1,037,000 | 797,000 |
Leasehold improvements and equipment, net | 1,537,728 | 1,523,950 |
Equipment [Member] | ||
Property, Plant and Equipment [Line Items] | ||
Total | 1,640,000 | 1,443,000 |
Leasehold Improvements [Member] | ||
Property, Plant and Equipment [Line Items] | ||
Total | $ 935,000 | $ 878,000 |
Leasehold Improvements and Eq_3
Leasehold Improvements and Equipment (Details Narrative) - USD ($) | 12 Months Ended | |
Dec. 31, 2021 | Dec. 31, 2020 | |
Property, Plant and Equipment [Abstract] | ||
Depreciation and amortization expenses | $ 244,000 | $ 231,000 |
Purchase of equipment and leasehold improvements | 260,380 | 5,749 |
Asset write-off | 6,000 | $ 0 |
Accumulated depreciation expense | $ 4,000 |
Schedule of Accrued Expenses (D
Schedule of Accrued Expenses (Details) - USD ($) | Dec. 31, 2021 | Dec. 31, 2020 | |
Payables and Accruals [Abstract] | |||
Payroll and incentives | $ 1,343,000 | $ 1,094,000 | |
General and administrative expenses | 195,000 | 280,000 | |
Research and development expenses | 381,000 | 778,000 | |
Other Accrued Liabilities, Current | [1] | 932,000 | 643,000 |
Total | $ 2,850,888 | $ 2,795,329 | |
[1] | At December 31, 2021, the balance included approximately $ 899 33 577 67 |
Schedule of Accrued Expenses _2
Schedule of Accrued Expenses (Details) (Parenthetical) - USD ($) $ in Thousands | Dec. 31, 2021 | Dec. 31, 2020 |
CFF Agreement [Member] | ||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | ||
Deferred liability | $ 899 | $ 577 |
Genentech Feasibility Study Agreement [Member] | ||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | ||
Deferred revenue | $ 33 | $ 67 |
Schedule of Maturity of Operati
Schedule of Maturity of Operating and Finance Leases Liabilities (Details) - USD ($) | Dec. 31, 2021 | Dec. 31, 2020 |
Leases | ||
Operating Lease Liabilities, 2022 | $ 883,000 | $ 685,000 |
Finance Lease Liabilities, 2022 | 22,000 | 34,000 |
Operating Lease Liabilities, 2023 | 922,000 | 645,000 |
Finance Lease Liabilities, 2023 | 2,000 | 19,000 |
Operating Lease Liabilities, 2024 | 962,000 | 677,000 |
Finance Lease Liabilities, 2024 | 2,000 | |
Operating Lease Liabilities, 2025 | 1,004,000 | 710,000 |
Finance Lease Liabilities, 2025 | ||
Operating Lease Liabilities, 2026 | 1,046 | 745,000 |
Finance Lease Liabilities, 2026 | ||
Operating Lease Liabilities, Thereafter | 1,112,000 | 1,458,000 |
Finance Lease Liabilities, Thereafter | ||
Total undiscounted operating lease payments | 5,929,000 | 4,920,000 |
Total undiscounted finance lease payments | 24,000 | 55,000 |
Operating Lease Liabilities, less: Imputed interest | 1,250,000 | 1,224,000 |
Finance Lease Liabilities, less: Imputed interest | ||
Present value of operating lease liabilities | 4,679,000 | 3,696,000 |
Present value of finance lease liabilities | $ 24,000 | $ 55,000 |
Operating Lease Liabilities, weighted average remaining lease term in years | 6 years 1 month 6 days | 6 years 8 months 12 days |
Finance Lease Liabilities, weighted average remaining lease term in years | 10 months 24 days | 1 year 8 months 12 days |
Operating Lease Liabilities, weighted average discount rate | 7.80% | 8.40% |
Finance Lease Liabilities, weighted average discount rate | 7.80% | 8.10% |
Leases (Details Narrative)
Leases (Details Narrative) | Sep. 23, 2020ft² | Dec. 15, 2016USD ($) | Nov. 01, 2013USD ($) | Dec. 31, 2021USD ($) | Dec. 31, 2020USD ($) |
Leases | |||||
Operating lease, Terms | 10 years 3 months | 7 years | 10 years | ||
Operating lease, description | Some leases include purchase, termination or extension options for one or more years. | ||||
Lease monthly rent expense | $ 43,000 | $ 13,000 | |||
Increase of rent expenses | 64,000 | $ 14,000 | |||
Area of land | ft² | 3,034 | ||||
Operating lease extended term | seven years | ||||
Security deposit | $ 586,000 | ||||
Security deposit at present | $ 200,000 | ||||
Lease expense | 852,000 | $ 814,000 | |||
Operating lease right-of-use assets amortization expenses | 501,359 | 484,568 | |||
Finance lease, interest expense | 3,000 | 7,000 | |||
Finance lease right-of-use assets amortization expenses | $ 35,737 | $ 58,961 |
Collaboration Agreements, Lic_2
Collaboration Agreements, License and Other Research and Development Agreements (Details Narrative) - USD ($) | Nov. 19, 2021 | Nov. 19, 2020 | Dec. 12, 2019 | Apr. 16, 2019 | Feb. 19, 2016 | Dec. 31, 2021 | Dec. 31, 2020 | Dec. 13, 2019 | Apr. 02, 2019 |
Research and development expenses | $ 14,583,283 | $ 14,358,918 | |||||||
Revenue | 33,333 | 158,333 | |||||||
Cooperative Research And Development Agreements [Member] | |||||||||
Remaining balance lease term amount | $ 200,000 | ||||||||
Initial term | 3 years | ||||||||
Other commitment | $ 200,000 | ||||||||
Funds provide for support | $ 157,405 | ||||||||
Cystic Fibrosis Foundation [Member] | |||||||||
Amount received from agreement | 2,500,000 | ||||||||
Genentech [Member] | |||||||||
Revenue | 33,000 | 33,000 | |||||||
Award Agreement [Member] | Cystic Fibrosis Foundation [Member] | |||||||||
Therapeutics development award | $ 4,200,000 | ||||||||
Proceeds from award | 484,249 | ||||||||
Additional milestone payment | $ 321,000 | ||||||||
Royalty payable | 21,200,000 | ||||||||
Research and development expenses | 2,200,000 | 100,000 | |||||||
Award Agreement [Member] | Cystic Fibrosis Foundation [Member] | Upon Achievement Of Sales Milestones [Member] | |||||||||
Royalty payable | $ 4,200,000 | ||||||||
Award Agreement [Member] | Cystic Fibrosis Foundation [Member] | Prepaid Expenses and Other Current Assets [Member] | |||||||||
Grants Receivable | 650,000 | ||||||||
Award Agreement [Member] | Cystic Fibrosis Foundation [Member] | Accrued Expense And Other Current Liabilities [Member] | |||||||||
Other Liabilities | $ 899,000 | ||||||||
Genentech Feasibility Study Agreement [Member] | Genentech [Member] | |||||||||
Agreement description | Genentech shall pay to the Company a total of $100.0 thousand for three molecules, or approximately $33 thousand per molecule, which will be recognized upon the Company fulfilling its obligations for each molecule under the Agreement. | ||||||||
Deferred revenue | $ 100,000 | ||||||||
License Agreement [Member] | |||||||||
Milestone fee | 100,000 | ||||||||
Annual license fee | $ 50,000 |
Commitments (Details Narrative)
Commitments (Details Narrative) - Series A Preferred Stock [Member] $ in Millions | Sep. 12, 2016USD ($) |
Loss Contingencies [Line Items] | |
Royalty payment rights, description | the Company is required to pay to the holders of the Series A Preferred Stock, subject to certain vesting requirements, in the aggregate, a royalty (the “Royalty Payment Rights”) equal to (i) 4.5% of Net Sales (as defined in the Series A Certificate of Designation), subject in all cases to a cap of $25 million per calendar year, and (ii) 7.5% of Licensing Proceeds (as defined in the Series A Certificate of Designation), subject in all cases to a cap of $10 million per calendar year. |
Royalty payment rights expire description | The Royalty Payment Rights will expire when the patents covering the applicable product expire, which is currently expected to be in 2033 |
Maximum [Member] | |
Loss Contingencies [Line Items] | |
Accrued royalties | $ 35 |
Maximum [Member] | Net Sales [Member] | |
Loss Contingencies [Line Items] | |
Accrued royalties | 25 |
Maximum [Member] | Net Sales [Member] | |
Loss Contingencies [Line Items] | |
Accrued royalties | $ 10 |
Schedule of Income Tax Provisio
Schedule of Income Tax Provision (Details) - USD ($) | 12 Months Ended | |
Dec. 31, 2021 | Dec. 31, 2020 | |
Income Tax Disclosure [Abstract] | ||
Federal | ||
State | ||
Foreign | ||
Total current expense (benefit): | ||
Federal | ||
State | ||
Foreign | ||
Total deferred expense (benefit): | ||
Total income tax expense (benefit): |
Schedule of Effective Income Ta
Schedule of Effective Income Tax Rate Reconciliation (Details) | 12 Months Ended | |
Dec. 31, 2021 | Dec. 31, 2020 | |
Income Tax Disclosure [Abstract] | ||
Income at US Statutory Rate | 21.00% | 21.00% |
State Taxes, net of Federal benefit | 1.97% | 2.95% |
Permanent Differences | (0.82%) | (1.28%) |
Tax Credits | 2.16% | 0.75% |
Valuation Allowance | (25.21%) | (24.53%) |
Discrete items | 0.91% | 1.11% |
Effective income tax rate | 0.00% | 0.00% |
Schedule of Deferred Tax Assets
Schedule of Deferred Tax Assets and Liabilities (Details) - USD ($) $ in Thousands | Dec. 31, 2021 | Dec. 31, 2020 | Dec. 31, 2019 |
Income Tax Disclosure [Abstract] | |||
Share-based Compensation | $ 3,575 | $ 3,220 | |
Depreciation and Amortization | 166 | (119) | |
Accrued Liability | 377 | 307 | |
Net Operating Loss Carry-forwards | 24,076 | 19,927 | |
R&D Credit Carryforwards | 3,207 | 2,264 | |
Other | (1) | (10) | |
IPR&D | (848) | (848) | |
ROU Asset | (1,186) | (921) | |
ROU Liability | 1,315 | 1,045 | |
Total Deferred tax assets | 30,681 | 24,865 | |
Valuation allowance | (31,023) | (25,206) | $ (19,700) |
Net deferred tax asset (liability) | $ (341) | $ (341) |
Income Taxes (Details Narrative
Income Taxes (Details Narrative) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2021 | Dec. 31, 2020 | Dec. 31, 2019 | |
Tax Credit Carryforward [Line Items] | |||
Deferred Tax Assets, Valuation Allowance | $ 31,023 | $ 25,206 | $ 19,700 |
Valuation Allowance, Deferred Tax Asset, Increase (Decrease), Amount | 5,800 | 5,500 | |
Operating loss carryforwards | $ 38,100 | ||
Operating loss carryforwards, expiration year | 2032 | ||
Operating loss carryforwards with no expiration | $ 63,300 | ||
Sale of net operating losses | $ 1,300 | $ 1,100 | |
[custom:LimitationsOnNetOperatingLossDeductibilityDescription] | 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 | ||
Federal and State research and development tax credit carry forwards [Member] | |||
Tax Credit Carryforward [Line Items] | |||
Operating loss carryforwards | $ 3,200 |
Summary of Shareholders Equity
Summary of Shareholders Equity Warrants Outstanding (Details) - shares | 12 Months Ended | |||
Dec. 31, 2021 | Dec. 31, 2020 | |||
Equity [Abstract] | ||||
Shares Outstanding, beginning | 1,328,000 | [1] | 5,397,000 | |
Shares Issued | ||||
Shares Exercised | (320,000) | [2] | (2,549,000) | |
Shares Tendered | ||||
Shares Expired | (20,000) | (1,493,000) | ||
Shares Outstanding, ending | 988,000 | [3] | 1,328,000 | [1] |
[1] | Weighted average exercise price for outstanding warrants is $ 0.55 | |||
[2] | Converted into approximately 115 | |||
[3] | Weighted average exercise price for outstanding warrants is $ 0.56 |
Summary of Shareholders Equit_2
Summary of Shareholders Equity Warrants Outstanding (Details) (Parenthetical) - $ / shares | Dec. 31, 2021 | Dec. 31, 2020 |
Equity [Abstract] | ||
Weighted average of exercise price for outstanding warrants | $ 0.56 | $ 0.55 |
Number of warrant common stock converted | 115,000 |
Schedule of Components of Accum
Schedule of Components of Accumulated Other Comprehensive (Loss)/Income (Details) - USD ($) | 12 Months Ended | |
Dec. 31, 2021 | Dec. 31, 2020 | |
Equity [Abstract] | ||
Net Unrealized Gains (Losses) on Available-for-Sale Securities, Beginning Balance | $ 228,000 | $ (1,000) |
Accumulated Other Comprehensive (Loss)/Gain, Beginning Balance | 228,172 | (1,000) |
Net Unrealized Gains (Losses) on Available-for-Sale Securities, Net unrealized gain (loss) on securities available-for-sale | (373,000) | 237,000 |
Accumulated Other Comprehensive (Loss)/Gain, Net unrealized gain (loss) on securities available-for-sale | (373,000) | 237,000 |
Net Unrealized Gains (Losses) on Available-for-Sale Securities, Reclassification of realized gain on securities available-for-sale to net loss | (8,000) | |
Accumulated Other Comprehensive (Loss)/Gain, Reclassification of realized gain on securities available-for-sale to net loss | (8,000) | |
Net Unrealized Gains (Losses) on Available-for-Sale Securities, Net current period other comprehensive loss | (374,000) | 229,000 |
Accumulated Other Comprehensive (Loss)/Gain, Net current period other comprehensive loss | (374,000) | 229,000 |
Net Unrealized Gains (Losses) on Available-for-Sale Securities, Ending Balance | (146,000) | $ 228,000 |
Accumulated Other Comprehensive (Loss)/Gain, Ending Balance | $ (146,000) |
Stockholders_ Equity (Details N
Stockholders’ Equity (Details Narrative) - USD ($) | Sep. 03, 2021 | Jul. 19, 2021 | Jun. 19, 2021 | Jun. 19, 2021 | Jun. 18, 2021 | Jul. 02, 2020 | Jan. 14, 2020 | Jan. 31, 2021 | Dec. 31, 2021 | Dec. 31, 2020 | Jun. 19, 2020 | Jun. 19, 2018 |
Subsidiary, Sale of Stock [Line Items] | ||||||||||||
Net proceeds from public offering of common stock | $ 50,000,000 | $ 5,580,471 | $ 46,704,210 | |||||||||
Research and Development Expense | $ 14,583,283 | $ 14,358,918 | ||||||||||
Net proceeds from public offering of common stock | $ 46,700,000 | |||||||||||
Preferred stock shares authorized | 8,000 | 8,000 | ||||||||||
Preferred stock par value | $ 1,000 | $ 1,000 | ||||||||||
Preferred stock, shares outstanding | 0 | 4,361 | ||||||||||
Common stock, shares outstanding | 216,269,450 | 200,113,431 | ||||||||||
Number of warrant to purchase of common stock | 988,000 | |||||||||||
Maximum [Member] | ||||||||||||
Subsidiary, Sale of Stock [Line Items] | ||||||||||||
Class of warrant or right, exercise price of warrants or rights | $ 0.50 | |||||||||||
Minimum [Member] | ||||||||||||
Subsidiary, Sale of Stock [Line Items] | ||||||||||||
Class of warrant or right, exercise price of warrants or rights | $ 0.75 | |||||||||||
Common Stock [Member] | ||||||||||||
Subsidiary, Sale of Stock [Line Items] | ||||||||||||
Share price | $ 1.55 | |||||||||||
Issuance of common stock in public offering, shares | 32,260,000 | 3,023,147 | 32,260,000 | |||||||||
Shares converted | 2,000 | |||||||||||
Shares issued upon conversion | 8,436,000 | |||||||||||
Series A Preferred Stock [Member] | ||||||||||||
Subsidiary, Sale of Stock [Line Items] | ||||||||||||
Preferred stock shares authorized | 10,000,000 | |||||||||||
Preferred stock par value | $ 0.001 | |||||||||||
Series A Preferred Stock [Member] | Designated [Member] | ||||||||||||
Subsidiary, Sale of Stock [Line Items] | ||||||||||||
Preferred stock shares authorized | 1,600,000 | |||||||||||
Series B Preferred Stock [Member] | ||||||||||||
Subsidiary, Sale of Stock [Line Items] | ||||||||||||
Preferred stock shares authorized | 8,000 | |||||||||||
Shares converted | 4,218 | 143 | 143 | |||||||||
Preferred stock, shares outstanding | 4,361 | 0 | ||||||||||
Liquidity value and dividends description | (i) a number of shares of common stock equal to 10% of the shares of common stock underlying the Series B Preferred Stock then held by such holder on June 19, 2019, (ii) a number of shares of common stock equal to 15% of the shares of common stock underlying the Series B Preferred Stock then held by such holder on June 19, 2020 and (iii) a number of shares of common stock equal to 20% of the shares of common stock underlying the Series B Preferred Stock then held by such holder on June 19, 2021. Based on an accounting of the holders of record of Series B Preferred Stock on June 19, 2021 and 2020, the Company made dividend payments totaling 1,687,200 and 1,365,600 shares of common stock, respectively | |||||||||||
Common stock, shares outstanding | 1,687,200 | 1,687,200 | 1,365,600 | |||||||||
Series B Preferred Stock [Member] | Holders [Member] | ||||||||||||
Subsidiary, Sale of Stock [Line Items] | ||||||||||||
Number of preferred stock shares converted | 8,436,000 | |||||||||||
Common Stock [Member] | ||||||||||||
Subsidiary, Sale of Stock [Line Items] | ||||||||||||
Shares converted | 286,000 | 286,000 | ||||||||||
Aquarius Merger Agreement [Member] | Holders Of Aquarius Biotechnologies Inc [Member] | Unregistered Shares [Member] | ||||||||||||
Subsidiary, Sale of Stock [Line Items] | ||||||||||||
Business acquisition, equity iterest issued or issuable, shares | 1,500,000 | |||||||||||
Research and Development Expense | $ 1,200,000 | |||||||||||
Share price | $ 0.80 | |||||||||||
Conversion price per share | $ 0.50 | $ 0.50 | ||||||||||
Underwritten Public Offering [Member] | ||||||||||||
Subsidiary, Sale of Stock [Line Items] | ||||||||||||
Net proceeds from public offering of common stock | $ 50,000,000 | |||||||||||
Net proceeds from public offering of common stock | $ 46,700,000 | |||||||||||
Underwritten Public Offering [Member] | Common Stock [Member] | ||||||||||||
Subsidiary, Sale of Stock [Line Items] | ||||||||||||
Issuance of common stock in public offering, shares | 32,600,000 | |||||||||||
Underwritten Public Offering [Member] | Sales Agreement [Member] | ||||||||||||
Subsidiary, Sale of Stock [Line Items] | ||||||||||||
Aggregate offering price for sale of stock | $ 50,000,000 | |||||||||||
Sale of stock percentage | 3.00% | |||||||||||
Sale of stock shares | 3,023,147 | |||||||||||
Proceeds from issuance of common stock | $ 5,800,000 | |||||||||||
Net proceeds from public offering of common stock | $ 5,600,000 |
Schedule of Recognized Stock-Ba
Schedule of Recognized Stock-Based Compensation (Details) - USD ($) | 12 Months Ended | |
Dec. 31, 2021 | Dec. 31, 2020 | |
Share-based Payment Arrangement, Expensed and Capitalized, Amount [Line Items] | ||
Share-based compensation expense | $ 4,292,355 | $ 4,564,787 |
Research and Development Expense [Member] | ||
Share-based Payment Arrangement, Expensed and Capitalized, Amount [Line Items] | ||
Share-based compensation expense | 1,870,000 | 1,897,000 |
General and Administrative Expense [Member] | ||
Share-based Payment Arrangement, Expensed and Capitalized, Amount [Line Items] | ||
Share-based compensation expense | $ 2,422,000 | $ 2,668,000 |
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, 2020shares | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Awards Reserved for Issuance | 36,952 | [1] |
Awards Issued | 32,669 | [2] |
Awards Available for Grant | 4,283 | |
[1] | Increased by 8,005 4% | |
[2] | Includes both stock grants and option grants |
Schedule of Equity Compensati_2
Schedule of Equity Compensation Plan by Arrangements (Details) (Parenthetical) - shares shares in Thousands | May 08, 2014 | Dec. 31, 2020 | Jan. 02, 2021 |
Share-based Payment Arrangement [Abstract] | |||
Increased shares of common stock outstanding | 8,005 | ||
Percentage for common stock outstanding | 4.00% | 4.00% |
Schedule of Stock Option Activi
Schedule of Stock Option Activity (Details) - $ / shares | 12 Months Ended | ||
Dec. 31, 2021 | Dec. 31, 2020 | Dec. 31, 2019 | |
Share-based Payment Arrangement [Abstract] | |||
Number of Options, Outstanding at Beginning | 22,551,000 | 17,529,000 | |
Weighted average Exercise Price, Outstanding at Beginning | $ 1.26 | $ 1.11 | |
Weighted Average Contractual Term in Years, Ending | 7 years 2 months 12 days | 6 years 10 months 24 days | 6 years 2 months 12 days |
Number of Options, Granted | 10,976,000 | 6,501,000 | |
Weighted average Exercise Price, Granted | $ 1.11 | $ 1.59 | |
Number of Options, Exercised | (1,077,000) | (826,000) | |
Weighted average Exercise Price, Exercised | $ 0.60 | $ 0.74 | |
Number of Options, Forfeited | (2,824,000) | (72,000) | |
Weighted average Exercise Price, Forfeited | $ 1.08 | $ 1.11 | |
Number of Options, Cancelled | |||
Weighted average Exercise Price, Cancelled | |||
Number of Options, Expired | (1,441,000) | (581,000) | |
Weighted average Exercise Price, Expired | $ 1.98 | $ 1.25 | |
Number of Options, Outstanding at Ending | 28,184,000 | 22,551,000 | 17,529,000 |
Weighted average Exercise Price, Outstanding at Ending | $ 1.21 | $ 1.26 | $ 1.11 |
Summary of Outstanding Options
Summary of Outstanding Options (Details) | 12 Months Ended |
Dec. 31, 2021$ / sharesshares | |
Share-based Payment Arrangement, Option, Exercise Price Range [Line Items] | |
Number of options outstanding | shares | 28,184,000 |
Weighted Average Exercise Price Per Share | $ 1.21 |
Exercise Price One [Member] | |
Share-based Payment Arrangement, Option, Exercise Price Range [Line Items] | |
Exercise price, minimum | 0.41 |
Exercise price, maximum | $ 0.69 |
Number of options outstanding | shares | 1,935,000 |
Weighted Average Exercise Price Per Share | $ 0.49 |
Exercise Price Two [Member] | |
Share-based Payment Arrangement, Option, Exercise Price Range [Line Items] | |
Exercise price, minimum | 0.74 |
Exercise price, maximum | $ 1.12 |
Number of options outstanding | shares | 15,940,000 |
Weighted Average Exercise Price Per Share | $ 0.93 |
Exercise Price Three [Member] | |
Share-based Payment Arrangement, Option, Exercise Price Range [Line Items] | |
Exercise price, minimum | 1.24 |
Exercise price, maximum | $ 1.61 |
Number of options outstanding | shares | 6,525,000 |
Weighted Average Exercise Price Per Share | $ 1.35 |
Exercise Price Four [Member] | |
Share-based Payment Arrangement, Option, Exercise Price Range [Line Items] | |
Exercise price, minimum | 2.27 |
Exercise price, maximum | $ 3.32 |
Number of options outstanding | shares | 3,784,000 |
Weighted Average Exercise Price Per Share | $ 2.50 |
Schedule of Stock Option Awards
Schedule of Stock Option Awards and Restricted Stock Awards (Details) | 12 Months Ended | |
Dec. 31, 2021 | Dec. 31, 2020 | |
Share-based Payment Arrangement [Abstract] | ||
Volatility, minimum | 98.40% | 100.50% |
Volatility, maximum | 101.60% | 107.40% |
Risk-free interest rate, minimum | 0.47% | 0.34% |
Risk-free interest rate, maximum | 1.28% | 1.74% |
Dividend yield | 0.00% | 0.00% |
Expected life | 6 years | 6 years |
Stock-based Compensation (Detai
Stock-based Compensation (Details Narrative) - USD ($) | May 08, 2014 | Dec. 31, 2021 | Dec. 31, 2020 |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Share-based payment award increase of shares offering date | January 1, 2015 | ||
Share-based Compensation Arrangement by Share-based Payment Award, Percentage of Outstanding Stock Maximum | 4.00% | 4.00% | |
Number of option vested | 14,625,397 | ||
Option vested price per share | $ 1.20 | ||
Option intrinsic value | $ 2,500 | ||
Aggregate intrinsic price | $ 1.01 | ||
Unrecognized share-based compensation | $ 11,700,000 | ||
Share-based compensation weighted average period | 2 years 10 months 24 days | ||
Vesting description | All outstanding options expire ten years from date of grant. Options granted to employees prior to 2018 vest in equal monthly installments over three years. Beginning in 2018, options granted to employees vest over four years, with 25% of the shares vesting on the first annual anniversary of grant and the remaining shares vesting in 36 equal monthly installments over the following 3 years. A portion of options granted to consultants vests over four years, with the remaining vesting being based upon the achievement of certain performance milestones, which are tied to either financing or drug development initiatives | ||
Stock options expire term | 10 years | ||
Number of restricted stock awards granted | 31,769 | 379,385 | |
General and administrative expense | $ 100,000 | $ 292,000 | |
Share-based Payment Arrangement, Option [Member] | |||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Stock option shares vesting percentage | 25.00% | ||
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 of the shares | ||
Option term | The term of the options is no longer than ten years | ||
Number of common stock issued under plan | 36,952,460 | ||
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 |