Cover
Cover | 6 Months Ended |
Jun. 30, 2023 shares | |
Cover [Abstract] | |
Document Type | 10-Q |
Amendment Flag | false |
Document Quarterly Report | true |
Document Transition Report | false |
Document Period End Date | Jun. 30, 2023 |
Document Fiscal Period Focus | Q2 |
Document Fiscal Year Focus | 2023 |
Current Fiscal Year End Date | --12-31 |
Entity File Number | 001-38630 |
Entity Registrant Name | Aridis Pharmaceuticals, Inc. |
Entity Central Index Key | 0001614067 |
Entity Tax Identification Number | 47-2641188 |
Entity Incorporation, State or Country Code | DE |
Entity Address, Address Line One | 983 University Avenue |
Entity Address, Address Line Two | Bldg. B |
Entity Address, City or Town | Los Gatos |
Entity Address, State or Province | CA |
Entity Address, Postal Zip Code | 95032 |
City Area Code | (408) |
Local Phone Number | 385-1742 |
Title of 12(b) Security | Common Stock |
Trading Symbol | ARDS |
Entity Current Reporting Status | Yes |
Entity Interactive Data Current | Yes |
Entity Filer Category | Non-accelerated Filer |
Entity Small Business | true |
Entity Emerging Growth Company | true |
Elected Not To Use the Extended Transition Period | false |
Entity Shell Company | false |
Entity Common Stock, Shares Outstanding | 36,077,532 |
Condensed Consolidated Balance
Condensed Consolidated Balance Sheets - USD ($) $ in Thousands | Jun. 30, 2023 | Dec. 31, 2022 |
Current assets: | ||
Cash and cash equivalents | $ 19 | $ 4,876 |
Restricted cash | 183 | |
Accounts receivable | 200 | 1,000 |
Other receivables | 100 | 240 |
Contract costs | 1,986 | |
Prepaid asset | 3,565 | 3,341 |
Total current assets | 3,884 | 11,626 |
Property and equipment, net | 569 | 730 |
Right-of-use assets, net | 1,188 | 1,417 |
Intangible assets, net | 14 | 17 |
Restricted cash, non-current | 500 | 500 |
Contract costs, non-current | 78 | |
Other assets | 327 | 327 |
Total assets | 6,482 | 14,695 |
Current liabilities: | ||
Accounts payable | 6,237 | 2,308 |
Accrued liabilities | 8,461 | 9,564 |
Lease liabilities | 563 | 538 |
Contract liabilities | 380 | 20,173 |
Note payable | 519 | |
Note payable (at fair value) | 4,730 | 3,781 |
Other liabilities | 23 | 15 |
Total current liabilities | 20,394 | 36,898 |
Contract liabilities, non-current | 737 | |
Lease liabilities, non-current | 1,002 | 1,292 |
Total liabilities | 21,396 | 38,927 |
Commitments and contingencies (Note 12) | ||
Stockholders’ deficit: | ||
Preferred stock (par value $0.0001; 60,000,000 shares authorized; zero shares issued and outstanding as of June 30, 2023 and December 31, 2022) | ||
Common stock (par value $0.0001; 100,000,000 shares authorized; 36,077,532 and 27,033,532 shares issued and outstanding as of June 30, 2023 and December 31, 2022) | 4 | 3 |
Additional paid-in capital | 168,894 | 166,380 |
Accumulated other comprehensive income | 6,526 | 5,051 |
Accumulated deficit | (190,338) | (195,666) |
Total stockholders’ deficit | (14,914) | (24,232) |
Total liabilities and stockholders’ deficit | $ 6,482 | $ 14,695 |
Condensed Consolidated Balanc_2
Condensed Consolidated Balance Sheets (Parenthetical) - $ / shares | Jun. 30, 2023 | Dec. 31, 2022 |
Statement of Financial Position [Abstract] | ||
Preferred stock, par value | $ 0.0001 | $ 0.0001 |
Preferred stock, shares authorized | 60,000,000 | 60,000,000 |
Preferred stock, shares issued | 0 | 0 |
Preferred stock, shares outstanding | 0 | 0 |
Common stock, par value | $ 0.0001 | $ 0.0001 |
Common stock, shares authorized | 100,000,000 | 100,000,000 |
Common stock, shares issued | 36,077,532 | 27,033,532 |
Common stock, shares outstanding | 36,077,532 | 27,033,532 |
Condensed Consolidated Statemen
Condensed Consolidated Statements of Operations (Unaudited) - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2023 | Jun. 30, 2022 | Jun. 30, 2023 | Jun. 30, 2022 | |
Revenue: | ||||
Total revenue | $ 19,647 | $ 292 | $ 20,729 | $ 1,479 |
Operating expenses: | ||||
Research and development | 4,668 | 6,348 | 10,199 | 12,798 |
General and administrative | 1,310 | 1,681 | 3,124 | 3,842 |
Total operating expenses | 5,978 | 8,029 | 13,323 | 16,640 |
Loss from operations | 13,669 | (7,737) | 7,406 | (15,161) |
Other income (expense): | ||||
Interest income (expense), net | 3 | 8 | 30 | (240) |
Other income | 26 | 23 | 51 | 45 |
Change in fair value of note payable | (1,554) | (273) | (2,159) | (389) |
Net income (loss) | $ 12,144 | $ (7,979) | $ 5,328 | $ (15,745) |
Earnings (net loss) per share: | ||||
Basic | $ 0.34 | $ (0.45) | $ 0.16 | $ (0.89) |
Diluted | $ 0.33 | $ (0.45) | $ 0.16 | $ (0.89) |
Weighted-average common shares outstanding used in computing net loss per share available to common stockholders: | ||||
Basic | 36,077,532 | 17,701,592 | 33,261,841 | 17,701,592 |
Diluted | 36,572,960 | 17,701,592 | 33,917,422 | 17,701,592 |
Other comprehensive (loss) income | $ 614 | $ 1,475 | $ 1,844 | |
Total comprehensive income (loss) | 12,758 | (7,979) | 6,803 | (13,901) |
Grant [Member] | ||||
Revenue: | ||||
Total revenue | 45 | 292 | 1,127 | 1,479 |
License [Member] | ||||
Revenue: | ||||
Total revenue | $ 19,602 | $ 19,602 |
Condensed Consolidated Statem_2
Condensed Consolidated Statements of Changes in Stockholders' Deficit (Unaudited) - USD ($) $ in Thousands | Common Stock [Member] | Additional Paid-in Capital [Member] | Retained Earnings [Member] | AOCI Attributable to Parent [Member] | Total |
Balances at Dec. 31, 2021 | $ 2 | $ 152,183 | $ (165,295) | $ (13,110) | |
Balance, shares at Dec. 31, 2021 | 17,701,592 | ||||
Stock-based compensation | 812 | 812 | |||
Net income (loss) | (15,745) | (15,745) | |||
Stock options issued in exchange for accrued liability | 107 | 107 | |||
Issuance of common stock for consulting services | 3 | 3 | |||
Balances at Jun. 30, 2022 | $ 2 | 153,105 | (181,040) | (27,933) | |
Balance, shares at Jun. 30, 2022 | 17,701,592 | ||||
Balances at Mar. 31, 2022 | $ 2 | 152,650 | (173,061) | (20,409) | |
Balance, shares at Mar. 31, 2022 | 17,701,592 | ||||
Stock-based compensation | 348 | 348 | |||
Net income (loss) | (7,979) | (7,979) | |||
Stock options issued in exchange for accrued liability | 107 | 107 | |||
Balances at Jun. 30, 2022 | $ 2 | 153,105 | (181,040) | (27,933) | |
Balance, shares at Jun. 30, 2022 | 17,701,592 | ||||
Balances at Dec. 31, 2022 | $ 3 | 166,380 | (195,666) | 5,051 | (24,232) |
Balance, shares at Dec. 31, 2022 | 27,033,532 | ||||
Change in fair value - notes payable | 1,475 | 1,475 | |||
Stock-based compensation | 455 | 455 | |||
Net income (loss) | 5,328 | 5,328 | |||
Issuance of common stock in registered direct offering, net of issuance costs | $ 1 | 2,056 | 2,057 | ||
Issuance of common stock in registered direct offering, net of issuance costs, shares | 6,000,000 | ||||
Issuance of common stock upon exercise of warrants | $ 0 | 3 | 3 | ||
Issuance of common stock for PF warrant exercise, shares | 3,044,000 | ||||
Balances at Jun. 30, 2023 | $ 4 | 168,894 | (190,338) | 6,526 | (14,914) |
Balance, shares at Jun. 30, 2023 | 36,077,532 | ||||
Balances at Mar. 31, 2023 | $ 4 | 168,684 | (202,482) | 5,912 | (27,882) |
Balance, shares at Mar. 31, 2023 | 36,077,532 | ||||
Change in fair value - notes payable | 614 | 614 | |||
Stock-based compensation | 210 | 210 | |||
Net income (loss) | 12,144 | 12,144 | |||
Balances at Jun. 30, 2023 | $ 4 | $ 168,894 | $ (190,338) | $ 6,526 | $ (14,914) |
Balance, shares at Jun. 30, 2023 | 36,077,532 |
Condensed Consolidated Statem_3
Condensed Consolidated Statements of Cash Flows (Unaudited) - USD ($) | 6 Months Ended | |
Jun. 30, 2023 | Jun. 30, 2022 | |
Cash flows from operating activities: | ||
Net income (loss) | $ 5,328,000 | $ (15,745,000) |
Adjustments to reconcile net loss to net cash used in operating activities: | ||
Depreciation and amortization | 150,000 | 262,000 |
Asset impairment | 33,000 | |
Stock-based compensation expense | 455,000 | 812,000 |
Other comprehensive income, industry specific credit risk on notes payable | 1,475,000 | |
Issuance of common stock in exchange for consulting services | 3,000 | |
Change in fair value of note payable | (801,000) | 389,000 |
Non-cash debt issuance expense | 250,000 | |
Changes in operating assets and liabilities: | ||
Accounts Receivable | 800,000 | (1,000,000) |
Other receivables | 140,000 | (352,000) |
Prepaid asset | (224,000) | 808,000 |
Contract asset | 2,064,000 | |
Other assets | 5,000 | |
Lease liabilities | (36,000) | (11,000) |
Accounts payable | 3,929,000 | (2,684,000) |
Accrued liabilities and other liabilities | (1,095,000) | 1,155,000 |
Contract liabilities | (20,530,000) | (230,000) |
Net cash used in operating activities | (8,345,000) | (16,305,000) |
Cash flows from investing activities: | ||
Purchase of property and equipment | (33,000) | |
Proceeds from disposal of property and equipment | 14,000 | |
Net cash provided by (used) in investing activities | 14,000 | (33,000) |
Cash flows from financing activities: | ||
Proceeds from note payable | 1,750,000 | 5,000,000 |
Proceeds from issuance of common stock and warrants, net | 2,057,000 | |
Payment on financing of insurance premium | (519,000) | (696,000) |
Proceeds from pre-funded warrants exercises | 3,000 | |
Net cash provided by financing activities | 3,291,000 | 4,304,000 |
Net (decrease) in cash, cash equivalents and restricted cash | (5,040,000) | (12,034,000) |
Cash, cash equivalents and restricted cash at: | ||
Beginning of period | 5,559,000 | 19,986,000 |
End of period | 519,000 | 7,952,000 |
Supplemental cash flow disclosures: | ||
Cash paid for taxes | 8,000 | 2,000 |
Supplemental noncash investing and financing activities: | ||
Right-of-use assets obtained with corresponding lease liability | 1,877,000 | |
Stock options issued in exchange for accrued liability | $ 107,000 |
Description of Business and Bas
Description of Business and Basis of Presentation | 6 Months Ended |
Jun. 30, 2023 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
Description of Business and Basis of Presentation | 1. Description of Business and Basis of Presentation Organization Aridis Pharmaceuticals, Inc. (the “Company” or “we” or “our” or “us”) was established as a California limited liability corporation in 2003. The Company converted to a Delaware C corporation on May 21, 2014. Our principal place of business is in Los Gatos, California. We are a late-stage biopharmaceutical company focused on developing new breakthrough therapies for infectious diseases and addressing the growing problem of antibiotic resistance. The Company has a deep, diversified portfolio of clinical and pre-clinical stage non-antibiotic anti-infective product candidates that are complemented by a fully human monoclonal antibody discovery platform technology. The Company’s suite of anti-infective monoclonal antibodies offers opportunities to profoundly alter the current trajectory of increasing antibiotic resistance and improve the health outcome of many of the most serious life-threatening infections particularly in hospital settings. Basis of Presentation and Consolidation The accompanying condensed consolidated financial statements include the amounts of the Company and our wholly owned subsidiaries and have been prepared in accordance with U.S. generally accepted accounting principles (“GAAP”) for interim financial information and in accordance with the instructions to Form 10-Q and applicable rules of Regulation S-X. Accordingly, they do not include all of the information and footnotes required by GAAP for complete financial statements. The condensed consolidated financial statements have been prepared on the same basis as the annual consolidated financial statements. In the opinion of management, the accompanying condensed consolidated financial statements reflect all adjustments (consisting only of normal recurring adjustments) considered necessary for a fair presentation. These condensed consolidated financial statements should be read in conjunction with the audited consolidated financial statements and notes thereto for the preceding fiscal year included in the Company’s Annual Report on Form 10-K filed with the United States Securities and Exchange Commission (“SEC”) on May 22, 2023. The condensed consolidated financial statements include the accounts of the Company and its two one one Going Concern The Company has had recurring losses from operations since inception and had negative cash flows from operating activities during the six months ended June 30, 2023, and the year ended December 31, 2022. Management expects to incur operating losses and negative cash flows from operations in the foreseeable future as the Company continues its product development programs. The forecasted outflow of cash for at least a one-year period from the expected condensed consolidated financial statement issuance date, is in excess of the cash available on-hand. The Company’s research and development expenses and resulting cash burn during the six months ended June 30, 2023, were largely due to costs associated with customary study closure activities associated with the recently completed Phase 3 study of AR-301 for the treatment of ventilator associated pneumonia (“VAP”) caused by the Staphylococcus aureus aureus The Company plans to fund its cash flow needs through future debt and/or equity financings which we may obtain through one or more public or private equity offerings, debt financings, government or other third-party funding, strategic alliances and licensing or collaboration arrangements. If the Company is unable to obtain funding, the Company could be forced to delay, reduce or eliminate its research and development programs or future commercialization efforts, which could adversely affect its future business prospects and its ability to continue as a going concern. The Company believes that its current available cash and cash equivalents, including cash received in August 2023 from equity raise proceeds, will not be sufficient to fund its planned expenditures and meet the Company’s obligations for at least the one-year period following its consolidated financial statement issuance date. In the absence of equity or debt financing, or other capital sources, including grant funding, potential collaborations or other strategic transactions, management anticipates that existing cash resources will not be sufficient to meet operating and liquidity needs on or before October 31, 2023. The accompanying condensed consolidated financial statements have been prepared on a going concern basis that contemplates the realization of assets and discharge of liabilities in their normal course of business. There is substantial doubt about the Company’s ability to continue as a going concern for one year after the date that these condensed consolidated financial statements are issued. These condensed consolidated financial statements do not include any adjustments that might be necessary from the outcome of this uncertainty. |
Summary of Significant Accounti
Summary of Significant Accounting Policies | 6 Months Ended |
Jun. 30, 2023 | |
Accounting Policies [Abstract] | |
Summary of Significant Accounting Policies | 2. Summary of Significant Accounting Policies Use of Estimates The preparation of the condensed consolidated financial statements requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities as of the date of the condensed consolidated financial statements and the reported amounts of expenses during the reporting period. Such estimates include those related to the evaluation of our ability to continue as a going concern, best estimate of standalone selling price of revenue deliverables, useful life of long-lived assets, classification of deferred revenue, income taxes, assumptions used in the Black-Scholes-Merton (“BSM”) model to calculate the fair value of stock-based compensation, deferred tax asset valuation allowances, and preclinical study and clinical trial accruals. Actual results could differ from those estimates. Concentrations Credit Risk The Company’s cash and cash equivalents are maintained at financial institutions in the United States of America. Deposits held by these institutions may exceed the amount of insurance provided on such deposits. Customer Risk The Company recognized $ 45,000 1.1 5% 16% 79% 5% 0.3 1.5 17% 28% 55% 100% The Company recognized $ 19.6 no Accounts receivable from one customer were $ 0.2 1.0 Cash, Cash Equivalents and Restricted Cash The Company considers all highly liquid investments purchased with an original maturity of three months or less to be cash equivalents. Cash and cash equivalents consist primarily of checking account and money market fund account balances. Restricted cash consists of deposits for a letter of credit that the Company has provided to secure its obligations under its facility lease as well as grant funds identified for the specific grant project. The following table provides a reconciliation of cash, cash equivalents and restricted cash within the condensed consolidated balance sheets which, in aggregate, represent the amount reported in the condensed consolidated statements of cash flows (in thousands): Schedule of Cash, Cash Equivalents and Restricted Cash June 30, December 31, 2023 2022 Cash and cash equivalents $ 19 $ 4,876 Restricted cash – current - 183 Restricted cash – non-current 500 500 Total cash, cash equivalents and restricted cash $ 519 $ 5,559 Accounts Receivable and Allowance for Doubtful Accounts Accounts receivables are recorded at the invoiced amount and do not bear interest. The Company considers the creditworthiness of its customers but does not require collateral in advance of a sale. The Company evaluates collectability and maintains an allowance for doubtful accounts for estimated losses inherent in its accounts receivable portfolio when necessary. The allowance is based on the Company’s best estimate of the amount of losses in the Company’s existing accounts receivable, which is based on customer creditworthiness, facts and circumstances specific to outstanding balances, and payment terms. Account balances are charged off against the allowance after all means of collection have been exhausted and the potential for recovery is considered remote. As of June 30, 2023, and December 31, 2022, there were $ 0.2 1.0 Operating Leases The Company determines if an arrangement is or contains a lease at inception by assessing whether the arrangement contains an identified asset and whether it has the right to control the identified asset. Right-of-use (“ROU”) assets represent the Company’s right to use an underlying asset for the lease term and lease liabilities represent the Company’s obligation to make lease payments arising from the lease. Lease liabilities are recognized at the lease commencement date based on the present value of future lease payments over the lease term. ROU assets are based on the measurement of the lease liability and also include any lease payments made prior to or on lease commencement and lease incentives and initial direct costs incurred, as applicable. As the implicit rate in the Company’s leases is generally unknown, the Company used its incremental borrowing rate of 6% Prior to adoption of ASC 842, Leases Property and Equipment Property and equipment are stated at cost less accumulated depreciation. Depreciation and amortization are computed using the straight-line method over the estimated useful lives of the assets, generally between three five years Intangible Assets Intangible assets are recorded at cost and amortized over the estimated useful life of the asset. Intangible assets consist of licenses with various institutions whereby the Company has rights to use intangible property obtained from such institutions. Impairment of Long-Lived Assets The Company reviews long-lived assets for impairment whenever events or changes in circumstances indicate that the carrying amount of an asset may not be recoverable. Recoverability is measured by comparison of the carrying amount to the future undiscounted net cash flows which the assets are expected to generate. If such assets are considered to be impaired, the impairment is measured by the excess of the carrying amount of the assets over fair value less the costs to sell the assets, generally determined using the projected discounted future net cash flows arising from the asset. There have been no 227,000 Revenue Recognition The Company recognizes revenue based on Accounting Standards Codification (“ASC”) 606, Revenue from Contracts with Customers To determine revenue recognition for arrangements that the Company determines are within the scope of ASC 606, the Company performs the following five steps: (i) identify the contract(s) with a customer; (ii) identify the performance obligations in the contract; (iii) determine the transaction price; (iv) allocate the transaction price to the performance obligations in the contract; and (v) recognize revenue at a point in time, or over time, as the entity satisfies performance obligations. The Company only applies the five-step model to contracts when it is probable that it will collect the consideration it is entitled to in exchange for the goods or services it transfers to the customer. At contract inception, once the contract is determined to be within the scope of ASC 606, the Company assesses the goods or services promised within each contract, determines those that are performance obligations, and assesses whether each promised good or service is distinct. The Company then recognizes as revenue the amount of the transaction price that is allocated to the respective performance obligation when (or as) the performance obligation is satisfied. As part of the accounting for customer arrangements, the Company must use judgment to determine: a) the number of performance obligations based on the determination under step (ii) above; b) the transaction price under step (iii) above; and c) the standalone selling price for each performance obligation identified in the contract for the allocation of the transaction price in step (iv) above. The Company uses judgment to determine whether milestones or other variable consideration should be included in the transaction price. The transaction price is allocated to each performance obligation on a relative standalone selling price basis. In developing the standalone price for a performance obligation, the Company considers applicable market conditions and relevant entity-specific factors, including factors that were contemplated in negotiating the agreement with the customer and estimated costs. The Company recognizes revenue as or when the performance obligations under the contract are satisfied. The Company receives payments from its customers based on payment schedules established in each contract. The Company records any amounts received prior to satisfying the revenue recognition criteria as deferred revenue on its condensed consolidated balance sheets. Amounts recognized as revenue, but not yet received or invoiced are recorded within other receivables on the condensed consolidated balance sheet. Amounts are recorded as other receivables on the condensed consolidated balance sheet when our right to consideration is unconditional. The Company does not assess whether a contract has a significant financing component if the expectation at contract inception is such that the period between payment by the customer and the transfer of a majority of the promised goods or services to the customer will be one year or less. Contract Assets The incremental costs of obtaining a contract under ASC 606 (i.e., costs that would not have been incurred if the contract had not been obtained) are recognized as an asset in the Company’s condensed consolidated balance sheets if the Company expects to recover them (see Note 6). Capitalized costs will be amortized to the respective expenses using a systematic basis that mirrors the pattern in which the Company transfers control of the goods and service to the customer. At each reporting date, the Company determines whether the capitalized costs to obtain a contract are impaired by comparing the carrying amount of the asset to the remaining amount of consideration that the Company received and expects to receive less the costs that relate to providing services under the relevant contract. Capitalized contract assets were zero 2.1 no 2.1 Contract Liabilities Amounts received prior to satisfying the above revenue recognition criteria, or in which the Company has an unconditional right to payment, are recorded as deferred revenue in the Company’s condensed consolidated balance sheets. The Company has estimated the classification between current and noncurrent deferred revenue related to the respective license agreement within its condensed consolidated balance sheets at June 30, 2023, and December 31, 2022 (see Note 6). Research and Development Research and development costs are expensed to operations as incurred. Our research and development expenses consist primarily of: ● salaries and related overhead expenses, which include stock-based compensation and benefits for personnel in research and development functions; ● fees paid to consultants and contract research organizations, or CROs, including in connection with our preclinical studies and clinical trials and other related clinical trial fees, such as for investigator grants, patient screening, laboratory work, clinical trial material management and statistical compilation and analyses; ● costs related to acquiring and manufacturing clinical trial materials; ● costs related to compliance with regulatory requirements; and ● payments related to licensed products and technologies. Costs for certain development activities are recognized based on an evaluation of the progress to completion of specific tasks using information and data provided to us by our vendors and clinical sites. Nonrefundable advance payments for goods or services to be received in future periods for use in research and development activities are deferred and capitalized. The capitalized amounts are then expensed as the related goods are delivered or when the services are performed. Stock-Based Compensation The Company recognizes compensation expense for all stock-based awards based on the grant-date estimated fair values, which the Company determines using the BSM option pricing model, on a straight-line basis over the requisite service period for the award. The Company accounts for forfeitures as they occur. The BSM option pricing model incorporates various highly sensitive assumptions, including the fair value of our common stock, expected volatility, expected term and risk-free interest rates. The weighted average expected life of options was calculated using the simplified method as prescribed by the SEC’s Staff Accounting Bulletin, Topic 14 (“SAB Topic 14”). This decision was based on the lack of relevant historical data due to our limited historical experience. In addition, due to our limited historical data, the estimated volatility also reflects the application of SAB Topic 14, incorporating the historical volatility of comparable companies whose stock prices are publicly available. The risk-free interest rate for the periods within the expected term of the option is based on the U.S. Treasury yield in effect at the time of grant. The dividend yield was zero, as we have never declared or paid dividends and have no plans to do so in the foreseeable future. Income Taxes The Company accounts for income taxes under the liability method. Under this method, deferred tax assets and liabilities are determined based on the difference between the financial statement and tax basis of assets and liabilities using enacted tax rates in effect for the year in which the differences are expected to affect taxable income. Valuation allowances are established when necessary to reduce deferred tax assets to the amounts expected to be realized. The Company assesses all material positions taken in any income tax return, including all significant uncertain positions, in all tax years that are still subject to assessment or challenge by the relevant taxing authorities. Assessing an uncertain tax position begins with the initial determination of the position’s sustainability and is measured at the largest amount of benefit that is greater than 50% likely of being realized upon ultimate settlement. At each balance sheet date, unresolved uncertain tax positions must be reassessed, and the Company will determine whether (i) the factors underlying the sustainability assertion have changed and (ii) the amount of the recognized benefit is still appropriate. The recognition and measurement of tax benefits requires significant judgment. Judgments concerning the recognition and measurement of a tax benefit might change as new information becomes available. The Company’s policy is to recognize interest or penalties related to income tax matters in income tax expense. Other Comprehensive Income Other comprehensive income is derived from the change in credit risk calculated by our fair value option valuation in connection with the Note Purchase Agreements with Streeterville Capital, LLC. Accumulated other comprehensive income increased from $ 5.1 6.5 Earnings (Net Loss) Per Share Basic earnings (net loss) per share is calculated by dividing net income (loss) for the period by the weighted-average number of common shares outstanding during the period, without consideration for potentially dilutive securities. Diluted net earnings (net loss) per share is computed by dividing the net income (loss) by the weighted-average number of common shares and potentially dilutive securities outstanding for the period. For the three and six months ended June 30, 2023 the number of shares used to compute basic earnings (net loss) per share were 36.1 33.3 36.6 33.9 Schedule of Computation of the Basic and Diluted Net Loss Per Share Three Months Ended Six Months Ended June 30, June 30, 2023 2022 2023 2022 (unaudited) (unaudited) (unaudited) (unaudited) Numerator: Net income (loss) available to common stockholders (basic and diluted) $ 12,144 $ (7,979 ) $ 5,328 $ (15,745 ) Denominator: Weighted-average common shares outstanding used in computing net loss per share available to common stockholders: Basic 36,077,532 17,701,592 33,261,841 17,701,592 Diluted 36,572,960 17,701,592 33,917,422 17,701,592 Earnings (net loss) per share to common stockholders, basic and diluted Basic $ 0.34 $ (0.45 ) $ 0.16 $ (0.89 ) Diluted $ 0.33 $ (0.45 ) $ 0.16 $ (0.89 ) The following potentially dilutive securities were excluded from the computation of diluted earnings (net loss) per share for the periods presented because including them would have been antidilutive: Schedule of Potentially Dilutive Securities were Excluded from the Computation of Diluted Net Loss Per Share 2023 2022 Six Months Ended June 30, 2023 2022 (unaudited) (unaudited) Stock options to purchase common stock 2,012,847 2,105,715 Common stock warrants 10,742,404 3,592,905 Potentially dilutive securities 12,755,251 5,698,620 JOBS Act Accounting Election The JOBS Act permits an “emerging growth company” such as us to take advantage of an extended transition period to comply with new or revised accounting standards applicable to public companies. We are choosing to take advantage of this provision and, as a result, we will adopt the extended transition period available under the JOBS Act until the earlier of the date we (i) are no longer an emerging growth company or (ii) affirmatively and irrevocably opt out of the extended transition period provided under the JOBS Act. New Accounting Pronouncements ASU 2016-02 - Accounting for Lease Obligation (“ASU 2016-02”) In February 2016, the Financial Accounting Standards Board (FASB) issued ASU No. 2016-02, Leases (Topic 842). This guidance requires lessees to recognize leases on the balance sheet and disclose key information about leasing arrangements. ASU 2016-02 establishes a right-of-use model (ROU) that requires a lessee to recognize an ROU asset and lease liability on the balance sheet for all leases with a term longer than 12 months. The Company adopted this standard effective January 1, 2022, as required, retrospectively through a cumulative effect adjustment. The new standard provides a number of optional practical expedients in transition. The Company elected the “package of practical expedients,” which permits the Company not to reassess, under ASU 2016-02, prior conclusions about lease identification, lease classification and initial direct costs. The new standard also provides practical expedients for an entity’s ongoing accounting. The Company elected to utilize the short-term lease recognition exemption for all leases that qualify. This means, for those short-term leases that qualify, the Company will not recognize ROU assets or lease liabilities. The Company also elected to separate lease and non-lease components for facility leases. Adoption of this guidance resulted in the recognition of lease liabilities of $ 2.3 1.9 |
Fair Value Disclosure
Fair Value Disclosure | 6 Months Ended |
Jun. 30, 2023 | |
Fair Value Disclosures [Abstract] | |
Fair Value Disclosure | 3. Fair Value Disclosure Fair value is defined as the exchange price that would be received for an asset or an exit price paid to transfer a liability in the principal or most advantageous market for the asset or liability in an orderly transaction between market participants on the measurement date. Valuation techniques used to measure fair value must maximize the use of observable inputs and minimize the use of unobservable inputs. The fair value hierarchy defines a three-level valuation hierarchy for disclosure of fair value measurements as follows: Level 1 Unadjusted quoted prices in active markets for identical assets or liabilities; Level 2 Inputs other than quoted prices included within Level 1 that are observable, unadjusted quoted prices in markets that are not active, or other inputs that are observable or can be corroborated by observable market data for substantially the full term of the related assets or liabilities; and Level 3 Unobservable inputs that are supported by little or no market activity for the related assets or liabilities. The following tables set forth the fair value of the Company’s consolidated financial instruments that were measured at fair value on a recurring basis as of June 30, 2023 and December 31, 2022 (in thousands): Schedule of Fair Value on Recurring Basis June 30, 2023 Liabilities measured at fair value on a recurring basis Level 1 Level 2 Level 3 Total Notes payable (fair value) — — 4,730 4,730 Total liabilities measured at fair value — — 4,730 4,730 December 31, 2022 Level 1 Level 2 Level 3 Total Notes payable (fair value) — — 3,781 3,781 Total liabilities measured at fair value — — 3,781 3,781 The change in the estimated fair value of the Level 3 liability is summarized below: Schedule of Estimated Fair Value Year ended December 31, 2022 Streeterville Notes Payable Beginning fair value of Level 3 liability 5,282 Borrowings on notes payable 5,000 Repayments (1,800 ) Change in fair value 850 Gain on valuation (500 ) Change in instrument specific credit risk (5,051 ) Ending fair value of Level 3 liability 3,781 Six months ended June 30, 2023 Streeterville Notes Payable Beginning fair value of Level 3 liability 3,781 Borrowings on notes payable 1,750 Repayments (1,485 ) Change in fair value 2,159 Change in instrument specific credit risk (1,475 ) Ending fair value of Level 3 liability 4,730 Streeterville Note The fair value of the Streeterville Note as of June 30, 2023 amounting to $ 4.7 The Company determined and performed the valuations of the Streeterville Note with the assistance of an independent valuation service provider. On a quarterly basis, the Company considers the main Level 3 inputs used as follows: ● Discount rate for the Streeterville notes was determined using a comparison of various effective yields on bonds as of the valuation date. ● Weighted probability of cash outflows was estimated based on the entity’s knowledge of the business and how the current economic environment is likely to impact the timing of the cash outflows, attributed to the different repayment features of the notes. The following table summarizes the quantitative information about the significant unobservable inputs used in Level 3 fair value measurement for the periods ended June 30, 2023 and December 31, 2022: Schedule of Unobservable Inputs in Fair Value Measurement Range of Inputs (risk free rate) Unobservable Inputs 2023 2022 Risk free rate 5.0% 5.5 % 2.1% 4.7 % Option adjusted spread 15.0 % 10.0 % Illiquidity discount 3.75 % 2.5 % Concluded discount rate 8.75% 9.25 % 4.75% 8.5 % The categorization of a financial instrument within the valuation hierarchy is based upon the lowest level of input that is significant to the fair value measurement. The Company has elected the fair value option for calculating the value of its Notes Payable and are classified as Level 3. The carrying value of the Company’s cash and cash equivalents, restricted cash, prepaid assets and other current assets, other assets, accounts payable, accrued liabilities, and insurance financing note payable approximate fair value due to the short-term nature of these items. |
Balance Sheet Components
Balance Sheet Components | 6 Months Ended |
Jun. 30, 2023 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
Balance Sheet Components | 4. Balance Sheet Components Property and Equipment, net Property and equipment, net consist of the following (in thousands): Schedule of Property and Equipment, Net June 30, December 31, 2023 2022 (unaudited) Lab equipment $ 2,232 $ 2,246 Leasehold improvements 527 527 Total property and equipment 2,759 2,773 Less: Accumulated depreciation (2,190 ) (2,043 ) Property and equipment, net $ 569 $ 730 Depreciation expense was approximately $ 61,000 130,000 147,000 261,000 Intangible Assets, net Intangible assets, net consist of the following (in thousands): Schedule of Intangible Assets, Net June 30, December 31, 2023 2022 (unaudited) Licenses $ 81 $ 81 Less: Accumulated amortization (67 ) (64 ) Intangible assets, net $ 14 $ 17 Amortization expense was approximately $ 2,000 3,000 Licenses Broad Institute of MIT and Harvard — Non-Exclusive Manufacturing License Agreement In January 2021, we entered into a non-exclusive manufacturing licensing agreement with the Broad Institute of MIT and Harvard (the “Broad Institute”) to make and manufacture CRISPR Modified Cell Lines, CRISPR Modified Animals and CRISPR Modified Plants. These license rights permit the non-exclusive use of the CRISPR Technology for the creation of and improvement of yield from protein and mAb production cell lines, which is one of the core components of the APEX TM Pursuant to this agreement, the Company is obligated to pay to the Broad Institute an issue fee of $ 25,000 50,000 100,000 7% 0.5% MedImmune Limited — License Agreement In July 2021, the Company executed a license agreement effective July 12, 2021 and entered into an amendment to the license agreement on August 9, 2021 (collectively the “MedImmune License Agreement”) with MedImmune Limited (“MedImmune”), pursuant to which MedImmune granted the Company an exclusive worldwide license for the development and commercialization of suvratoxumab, a Phase 3 ready fully human monoclonal antibody targeting the staphylococcus aureus alpha toxin (the “Licensed Product”). As consideration for the MedImmune License Agreement, the Company issued 884,956 5.0 5.0 As additional consideration, the Company will pay MedImmune milestone payments upon the achievement of certain regulatory approvals, for one licensed product, up to a total aggregate amount of $ 30.0 85.0 12.5% 15 On March 20 th Accrued Liabilities Accrued liabilities consist of the following (in thousands): Schedule of Accrued Liabilities June 30, December 31, 2023 2022 (unaudited) Research and development services $ 7,928 $ 9,000 Payroll related expenses 519 456 Professional services and other 14 108 Accrued liabilities $ 8,461 $ 9,564 |
Equity Method Investment
Equity Method Investment | 6 Months Ended |
Jun. 30, 2023 | |
Equity Method Investments and Joint Ventures [Abstract] | |
Equity Method Investment | 5. Equity Method Investment On February 11, 2018, the Company entered into a joint venture agreement (the “JV Agreement”) with Shenzhen Hepalink Pharmaceutical Group Co., Ltd., a related party, principal shareholder of the Company, and a Chinese entity (“Hepalink”), to develop and commercialize products for infectious diseases. Under the terms of the JV Agreement, the Company contributed $ 1.0 49% On August 6, 2018, the Company entered into an amendment to the JV Agreement with Hepalink whereby the Company agreed to additionally contribute an exclusive, revocable, and royalty-free right and license to its AR-105 product candidate in the Territory. Pursuant to the JV Agreement and the amendment, Hepalink initially owns 51% 7.2 10.8 The Company evaluated the accounting for the JV Agreement entered into noting that it did not meet the accounting definition of a joint venture and instead meets the definition of a variable interest entity. The Company concluded that it is not the primary beneficiary of the JV Entity and therefore is not required to consolidate the entity. This conclusion was based on the fact that the equity-at-risk is insufficient to support operations without additional investment and that the Company does not hold decision-making power over activities that significantly impact the JV Entity’s operations. The Company accounted for its investment in the JV Entity as an equity method investment. The Company recorded the equity method investment at $ 1.0 0 The Company recognized no losses from the operations of the JV Entity for the three and six months ended June 30, 2023 and 2022, respectively. As of June 30, 2023 and December 31, 2022, the Company’s equity method investment in the JV Entity was $ 0 On August 21, 2023, Aridis Pharmaceuticals, Inc. (the “Company”) sent written notice to Shenzhen Arimab Biopharmaceuticals Co., Ltd. (“Arimab”) stating that as of August 21, 2023, the Amended and Restated Technology License and Collaboration Agreement between Arimab, a joint venture of the Company and Shenzhen Hepalink Pharmaceutical Group Co., Ltd. dated as of August 6, 2018 (the “Agreement”) would terminate pursuant to Section 11.2 of the Agreement. |
Development and License Agreeme
Development and License Agreements | 6 Months Ended |
Jun. 30, 2023 | |
Development And License Agreements | |
Development and License Agreements | 6. Development and License Agreements Agreement with Innovative Medicines Initiative Joint Undertaking In March 2021, the Company entered into an agreement (the IMI JU Agreement) with the Innovative Medicines Initiative (IMI) funded consortium COMBACTE-NET to collaborate with other participants in a joint undertaking (the IMI JU) to combat bacterial resistance in Europe. The project facilitates a pan-European clinical trial network to test antibiotics and other drugs to prevent and treat various infections. This project commenced on January 1, 2013 with an initial duration of seven years. It has since been extended to October 31, 2023. The project has 46 participants including European Federation of Pharmaceutical Industries and Associations (EFPIA) companies, universities, research organizations, public bodies, non-profit groups, subject matter experts, and third parties. The Company’s primary role in the project is to help lead a Phase 3, randomized, double-blind, placebo-controlled trial to evaluate efficacy of suvratoxumab in the prevention of S. aureus The academic COMBACTE-NET consortium partners initially pay for all costs incurred at EU clinical sites and subsequently bills the Company for 25% of such costs. Specifically, we are billed for 25% of eligible costs during the entire fiscal year six to seven months following the fiscal year. The work at these sites is performed entirely by third-party subcontractors. As such, we reimburse the 25% at the passed-through invoice amounts. There is no reimbursement for costs incurred at non-EU sites. Under the IMI JU Agreement, the Company will own all results, findings, and intellectual property generated by the project and is entitled to receive any benefits these items bring. As such, these costs are deemed research and development expenditures. Considering our obligation to repay a portion of costs incurred, we determined this agreement is under the scope of ASC Subtopic 730-20, Research and Development Arrangements. Further, as the parties in the IMI JU Agreement are active participants and are exposed to significant risks and rewards dependent on the commercial success of the research, this agreement is also under the scope of ASC Topic 808, Collaborative Arrangements. Research and development costs incurred at non-EU sites are recognized as incurred. The Company recognized research and development expenses of $ 1.5 0.5 5.5 Research and development costs incurred at EU sites are recognized as incurred for 25% of these costs. Research and development expenses of approximately $ 1.9 2.3 3.8 0.3 1.7 2.9 1.5 1.0 In-kind contributions we make to the program will be expensed as R&D at their fair value when made. If the fair value of an in-kind contribution we make to the IMI JU differs from its carrying amount, we will recognize a gain or loss on disposition. No Cystic Fibrosis Foundation Development Agreement In December 2016, the Company received an award from the Cystic Fibrosis Foundation (“CFF”), which was executed under the Development Program Letter Agreement (the “CFF Agreement”), for approximately $ 2.9 200,000 7.5 7.6 150,000 As of the adoption date of ASC 606 on January 1, 2019 (the “Adoption Date”), the Company identified the following promises with regards to the clinical research activities under the CFF Agreement that represent an initial contract of: a) Phase 1 single ascending dose (“SAD”) clinical trial, which consists of the satisfied development-based milestones and one development-based milestone in progress which was accounted for as a single performance obligation; and contingent promises of: b) Phase 1 multiple ascending dose (“MAD”) clinical trial, which consists of one development-based milestone that had not yet been started, and c) Phase 2a clinical trial, which consists of four development-based milestones that had not yet been started. Of these promises, the Phase 1 SAD clinical trial was determined to be a distinct performance obligation as of the Adoption Date. For the clinical research activities related to the Phase 1 MAD clinical trial and the Phase 2a clinical trial that had not yet been started, the Company was contingently obligated to perform these clinical research activities only after the previous milestones, which achievement was uncertain, had been met. The Company determined that the consideration for the Phase 1 SAD clinical trial contract included several development-based milestones, which had been achieved as of the Adoption Date, totaling approximately $ 1.7 1.0 1.0 3.8 3.9 The Company determined the consideration for the Phase 2a clinical trial contract totals approximately $ 3.8 The Company determined that the clinical research activities under the CFF Agreement should be recognized over time by calculating the amount of revenue to recognize in any given period by accumulating the total related costs incurred for the respective clinical research activities related to that distinct performance obligation using the input method (cost-to-cost) and applies that percentage of completion to the transaction price at each reporting period. The Company believes this method best depicts the transfer of control to the customer, which occurs as the costs related to the clinical research activities are incurred. The Company determined as of June 30, 2023, the transaction price for the Phase 2a clinical trial contract was $ 3.2 0.4 The Company recognized grant revenue from the CFF Agreement of approximately $ 45,000 894,000 36,000 815,000 Gates Foundation Grant Agreement On October 15, 2021, the Company entered into an agreement with the Bill and Melinda Gates Foundation (“Gates Foundation” or “BMGF”) by executing a Grant Agreement identified as Investment ID INV-033376 (“Grant”). The goal of the Grant Agreement is to develop durable approaches to block the infection and transmission of pathogens. For providing research and development services under the Grant Agreement, the Gates Foundation has agreed to compensate the Company $ 1.93 Under the Grant Agreement, the Gates Foundation made an upfront payment of $ 1.93 The Company will conduct research and development services up until the proof-of-concept study is completed, at which point the Gates Foundation will determine whether to approve further grant funding for transmission studies or end the study in which case the Company will no longer provide any significant goods or services. The Company will partner with three main subcontractors to deliver the scope of work described in the investment document. The Grant Agreement is considered within the scope of ASC 606 as the parties have a customer/vendor relationship and are not exposed equally to the risks and rewards of the research and development services contemplated in the Grant Agreement. The Company identified the following promises under the Agreement: 1) research and development services, 2) global access commitment, 3) humanitarian license, 4) publication if requested by the Gates Foundation, and 5) intellectual property reporting upon request. The Company determined that these promises are not distinct from each other, and therefore represent one performance obligation. Since the Company is required to update the Gates Foundation on technical progress during each stage of the Funded Development, the ability to access research and development results represents the Gates Foundation’s consumption of the benefits from the Company’s research and development activities. As such, research and development services revenue are recognized over time. At each reporting period, the amount of revenue to recognize is calculated using the input method (cost-to-cost), by comparing cumulative costs incurred to the total estimated costs to perform the research and development services and applying that percentage of completion to the transaction price. The Company believes this method best depicts the transfer of control to the customer, which occurs as the costs related to the research and development services are incurred. The Company recognized approximately $ 0 183,000 132,000 252,000 Serum License Agreement In July 2019, the Company and Serum International B.V. (“SIBV”), an affiliate of Serum Institute of India Private Limited, entered into an option agreement which granted SIBV the option to license multiple programs from the Company and access the Company’s MabIgX® platform technology for asset identification and selection. The Company received an upfront cash payment of $ 5 801,820 10 In September 2019, the Company and Serum AMR Products (“SAMR”), a party under common ownership of SIBV, entered into a License, Development and Commercialization Agreement (the “License Agreement”). Pursuant to the License Agreement, the Company granted to SAMR exclusive licenses, and rights to sublicense, certain patent rights and technology related know-how to the Company’s products AR-301, AR-105, AR-101 (i.e. exclusive rights to, among other things, develop, distribute, market, promote, sell, import and otherwise commercialize) in (a) the country of India, and (b) all other countries of the world except the USA, Canada, EU Territory, UK, China, Australia, South Korea, Brazil, New Zealand, and Japan (products AR-105 and AR-101 countries do not exclude South Korea and Brazil) (the “Limited Territory”); and AR-201 (i.e. exclusive rights to, among other things, develop, manufacture, make, distribute, market, promote, sell, import and otherwise commercialize) in all countries of the world except China, Hong Kong, Macau and Taiwan (the “Worldwide Territory”) (the “licenses and know-how”). Further, the License Agreement grants SAMR an option for the Company to provide research services using its MabIgX® platform technology for the identification of up to five (5) candidates including product development of these identified candidates and an exclusive license to develop, manufacture, make, distribute, market, promote, sell, import and otherwise commercialize these development products in the Worldwide Territory (the “research and development option”). Pursuant to the License Agreement, the Company will provide development support related to the licensed products above in order to assist SAMR in its efforts to develop, receive regulatory approval, and manufacture and sell the licensed products in SAMR’s authorized territories which will be performed under the direction of a Joint Steering Committee (“JSC”) which the Company will participate in (collectively “development support services”). In addition, under the License Agreement, SAMR was granted an exclusive manufacturing license option as the initial license granted above for AR-301, AR-105 and AR-101 does not allow for manufacturing. This manufacturing option provides incremental rights related to these products beyond what is granted as part of the licensing discussed above (the “manufacturing rights option”). If this option is exercised, after SAMR has met certain requirements to exercise the option as defined in the License Agreement, it would provide for an exclusive license for use by SAMR to manufacture and supply the products for SAMR’s own use in the Limited Territory and to manufacture and supply these products to the Company, or their affiliates, for the Company’s use outside the Limited Territory. Should SAMR exercise the development and research option or the manufacturing rights option discussed above, SAMR and the Company shall negotiate in good faith the economic terms around these arrangements. If a third-party sublicensee of AR-301, AR-105 and AR-101 wishes to manufacture these products by itself for the territory for which it has a license from the Company, then the Company shall have the right to buy back the manufacturing rights for all territories outside of the Limited Territory by paying to SAMR $5 million. Under the License Agreement, the Company received upfront payments totaling $ 15 5 42.5 Given the equity investment by SIBV was negotiated in conjunction with the option agreement, which resulted in the execution of the License Agreement, all arrangements were evaluated as a single agreement and amounts were allocated to the elements of the arrangement based on their fair value. The Company recorded approximately $ 5.0 5.4 441,000 4.6 19.6 15.0 4.6 The License Agreement is determined to be within the scope of ASC 606, as the transaction represents a contract with a customer where the participants function in a customer/vendor relationship and are not exposed equally to the risks and rewards of the activities contemplated under the License Agreement. Using the concepts of ASC 606, the Company identified the following performance obligations under the License Agreement: 1) the transfer of licenses of the intellectual property for AR-301, AR-101, AR-105 and AR-201, inclusive of the related technology know-how conveyance (referred to as the license and know-how above); and 2) the Company to deliver ongoing development support services related to the licensed products and the Company’s participation in the JSC (referred to as the development support services above); and identified the following material promises under the License Agreement: 3) SAMR was granted a research and development option of up to five identified product candidates for the Company to perform including specific development services (the research and development option referred to above); and 4) SAMR was granted an exclusive manufacturing license option which would provide for incremental manufacturing rights related to AR-301, AR-105 and AR-101 beyond what is granted in the License Agreement (the manufacturing rights option referred to above). The Company concluded that the performance obligations and material promises identified are separate and distinct from each other. The Company is also entitled to additional payments from SAMR of up to $ 42.5 The Company determined that the transaction price under the License Agreement was $ 19.6 15.0 4.6 19.6 14.5 79,000 892,000 4.1 On May 3, 2023, the Company sent written notice to Serum AMR Products stating that as of May 8, 2023, the License Agreement would terminate pursuant to Section 13.3(a) of the License Agreement for nonfulfillment of development obligations under the License Agreement. As a result of termination of the License Agreement, the Company recognized approximately $ 19.6 Kermode Licensing and Product Discovery Agreement In February 2021, the Company entered into an out-licensing and product discovery agreement, and a statement of work, collectively (the “Kermode Agreement”), with Kermode Biotechnologies, Inc. (“Kermode”). Under the terms of this agreement, Kermode will fund for one year the discovery of product candidates for African Swine Fever Virus (“ASFV”) with an option to include the discovery of product candidates for swine influenza virus (“SIV”). Kermode also received exclusive rights to all mAbs and vaccines discovered for veterinary uses and rights to a non-exclusive license to use the Company’s ʎPEX technology platform for further development activities. The Company retained exclusive rights to mAbs and vaccines discovered for human uses. In March 2021, the Company received a nonrefundable upfront payment of $ 500,000 250,000 250,000 The Kermode Agreement is within the scope of ASC 606 as the parties have a customer/vendor relationship and are not exposed equally to the risks and rewards of the activities contemplated in the Kermode Agreement. The Company identified the following promises under the Kermode Agreement: 1) research and development services, and 2) license rights of the ʎPEX Platform and mAbs and vaccines (“Program IP”). The Company determined that these promises are not distinct from each other, and therefore represent one performance obligation. As of March 31, 2022, the transaction price of the Kermode Agreement was $ 1,000,000 500,000 500,000 The Company determined that the one performance obligation under the Kermode Agreement should be recognized over time. At each reporting period, the amount of revenue to recognize will be calculated using the input method (cost-to-cost), by comparing cumulative costs incurred to the total estimated costs to perform all four phases of the research and development activities and applying that percentage of completion to the transaction price. The Company believes this method best depicts the transfer of control to the customer, which occurs as the costs related to the research and development activities are incurred. The Company recognized approximately $ 0 51,000 125,000 413,000 |
Notes Payable
Notes Payable | 6 Months Ended |
Jun. 30, 2023 | |
Debt Disclosure [Abstract] | |
Notes Payable | 7. Notes Payable Note Purchase Agreement On November 23, 2021, the Company entered into an agreement (“Note Purchase Agreement”) with Streeterville Capital, LLC (Lender), pursuant to which we issued to the Lender a secured promissory note (Note) in the aggregate principal amount of $ 5,250,000 250,000 6% November 23, 2023 450,000 5,250,000 February 21, 2024 495,000 450,000 45,000 Payments of each redemption amount must be made in cash. Pursuant to the Note, the Company can defer all redemption payments that the Lender could otherwise elect to make during any calendar month on three (3) separate occasions by providing written notice to Lender at least three (3) trading days prior to the first day of each such calendar month for which it wishes to defer redemptions for that month. In the event the Company elects to defer, the aggregate principal amount plus accrued but unpaid interest (Outstanding Amount) shall automatically be increased by (a) 0.5% 1% 1.5% 105% 107.5% 110% On September 30, 2022, the Company signed an amendment to promissory note #2. Subject to certain provisions and so long as no Event of Default has occurred, then in addition to the three (3) deferral rights previously available, the Company shall have the right to exercise additional monthly deferrals until March 31, 2023 (each, an “Additional Deferral”). Each time Borrower exercises an Additional Deferral the Outstanding Balance will automatically be increased by 1.5% In April 2023, the Company entered into a Note Purchase and Loan Restructuring Agreement with Streeterville Capital, LLC modifying the principal amount of Note #2 from approximately $ 5,250,000 9,287,000 2,500,000 Pursuant to the Note Purchase Agreement, we are subject to certain covenants, including the obligations to: (i) timely file all reports required to be filed under Sections 13 or 15(d) of the Securities Exchange Act of 1934, as amended (the “Exchange Act”) and not terminate its status as an issuer required to file reports under the Exchange Act; (ii) maintain listing of our common stock on a securities exchange; and (iii) avoid trading in our common stock from being suspended, halted, chilled, frozen or otherwise ceased. The Company was in compliance with all covenants as of March 31, 2023. On April 17, 2023, the Company was no longer in compliance as it didn’t meet the timely filing of the annual report on 10-K. The Company has received a waiver from the lender for this covenant which also included waiving compliance for timely filing of the May 15, 2023 10Q filing for the period ended March 31, 2023. The Note is secured by the Company’s MabIgX assets and Note #2 is secured by all of the Company’s assets. On July 20, 2023, Streeterville provided a waiver with respect to the breach of Section 4(ii) of that certain Note Purchase Agreement dated November 23, 2021, in connection with the recent delisting of the Company’s common stock from Nasdaq to OTC Markets Pink Sheets. This in turn means that no such Event of Default has occurred pursuant to Section 4.1(l) of Secured Promissory Note #1 dated November 23, 2021, with respect to the recent delisting. Additionally, Streeterville provided a waiver with respect to the breach of Section 4(ii) and 4(iii) of that certain Note Purchase and Loan Restructuring Agreement dated April 26, 2023, in connection with the recent delisting of the Company’s common stock from Nasdaq to OTC Markets Pink Sheets. This in turn means that no such Triggering Event has occurred pursuant to Section 4.1(h) of Secured Promissory Note dated April 26, 2023, with respect to the recent delisting. On August 31, 2023, Streeterville provided a waiver with respect to the breach of Section 4(i) of that certain Note Purchase and Loan Restructuring Agreement dated April 26, 2023, in connection with the delinquent filing of the Company’s Quarterly Report for the period ended June 30, 2023 on Form 10-Q with the SEC. This in turn means that no such Triggering Event has occurred pursuant to Section 4.1(h) of Secured Promissory Note dated April 26, 2023, with respect to the delinquent filing. The fair value measurement includes interest, at the stated rate, and this separate amount is not reflected in the consolidated statement of operations. The Company has recorded a liability of approximately $ 4.7 Insurance Financing The Company obtained financing for certain Director & Officer liability insurance policy premiums. The agreement assigns First Insurance Funding (Lender) a first priority lien on and security interest in the financed policies and any additional premium required in the financed policies including (a) all returned or unearned premiums, (b) all additional cash contributions or collateral amounts assessed by the insurance companies in relation to the financed policies and financed by Lender, (c) any credits generated by the financed policies, (d) dividend payments, and (e) loss payments which reduce unearned premiums. If any circumstances exist in which premiums related to any Financed Policy could become fully earned in the event of loss, Lender shall be named a loss-payee with respect to such policy. The total premiums, taxes and fees financed is approximately $ 0.9 5.129% 0.5 |
Warrants
Warrants | 6 Months Ended |
Jun. 30, 2023 | |
Warrants | |
Warrants | 8. Warrants In August 2021, the Company entered into a Securities Purchase Agreement (the “August 2021 Securities Purchase Agreement”) with an institutional investor, pursuant to which the Company agreed to offer, issue and sell to this investor, in a registered direct offering, 1,300,000 3,647,556 2,473,778 5.053 5.052 0.001 25.0 22.6 Each Warrant is exercisable for one 5.00 4.99% 9.99 0.001 4.99% 9.99 The Company measured the fair value of the Common Stock and Pre-Funded Warrants based on the Company’s closing stock price on the date the August 2021 Purchase Agreement was entered into and the fair value of the Warrants was based upon a BSM valuation model. The BSM valuation model used the following assumptions: expected term of seven years 97% 0.96% 0% 22.6 4.4 12.2 6 In December 2021, all of the Pre-Funded Warrants were exercised. A total of 3,647,556 4,000 In October 2022, the Company entered into a Securities Purchase Agreement (the “October 2022 Securities Purchase Agreement”) with a certain institutional and accredited investor, pursuant to which the Company agreed to offer, issue and sell to this investor, in a registered direct offering, 1,800,000 5,407,208 7,207,208 1.11 1.109 0.001 1.11 8.0 7.9 The 2021 Pre-Funded Warrants and 2022 Pre-Funded Warrants (collectively, “the Pre-Funded Warrants”) were offered in lieu of shares of Common Stock to the Purchaser whose purchase of shares of Common Stock in the offerings would otherwise result in the Purchaser, together with its affiliates and certain related parties, beneficially owning more than 4.99% 9.99% 0.001 4.99% 9.99% In connection with the October 2022 Securities Purchase Agreement, the Company entered into a Warrant Amendment (the “Warrant Amendment”) with the investor to amend the 2021 Warrants. Pursuant to the Warrant Amendment, the 2021 Warrants were amended, effective upon the closing of the October 2022 Securities Purchase Agreement, so that the amended warrants have a reduced exercise price from $ 5.00 2.00 0.716 0.843 314,170 In January 2023, Armistice exercised 3,044,000 |
Common Stock
Common Stock | 6 Months Ended |
Jun. 30, 2023 | |
Equity [Abstract] | |
Common Stock | 9. Common Stock As of June 30, 2023 the Company had reserved the following common stock for future issuance: Schedule of Common Stock Reserved for Future Issuance Shares reserved for exercise of outstanding options to purchase common stock 2,322,576 Shares reserved for vesting of restricted stock units 315,540 Shares reserved for exercise of outstanding warrants to purchase common stock 10,742,404 Shares reserved for issuance of future options 245,442 Total 13,625,962 Securities Purchase Agreement In March 2023, the Company entered into a Securities Purchase Agreement (the “Purchase Agreement”) with certain institutional and accredited investors (the “Purchasers”), pursuant to which the Company agreed to issue and sell, in a registered direct offering (the “Offering”), 6,000,000 0.0001 0.38 2.28 2.1 In December 2022, the Company entered into a Securities Purchase Agreement with the Cystic Fibrosis Foundation (CFF) in which we agreed to offer, issue and sell 5,168,732 0.0001 0.94 0.2 5.0 On October 5, 2022, the Company entered into a securities purchase agreement (the “October 2022 Purchase Agreement”) with a certain institutional and accredited investor (the “Purchaser”), relating to the issuance and sale of 1,800,000 0.0001 5,407,208 1.11 7,207,208 8 In March 2021, the Company entered into a Securities Purchase Agreement (the “March 2021 Securities Purchase Agreement”) with certain institutional and individual investors (the “Purchasers”), pursuant to which the Company agreed to offer, issue and sell to the Purchasers, in a registered direct offering, an aggregate of 1,037,405 0.0001 7.0 6.4 MedImmune Limited License Agreement Effective July 12, 2021, the Company entered into the MedImmune License Agreement, pursuant to which MedImmune granted the Company an exclusive worldwide license for the development and commercialization of suvratoxumab, a Phase 3 ready fully human monoclonal antibody targeting Staphylococcus aureus 884,956 884,956 6.5 6.5 On March 20, 2023, we received written notice from MedImmune Limited that it has terminated that certain License Agreement by and between MedImmune and us dated as of July 12, 2021, and as amended by Amendment No. 1 to License Agreement, dated as of August 9, 2021 (the “License Agreement”), pursuant to Section 9.2.1 of the License Agreement for non-payment of the Upfront Cash Payment which was due on December 31, 2021. The notice states that such termination shall be effective on March 30, 2023. As a result of the termination notice, the on-going AR-320-003 Phase 3 clinical study has been put on hold. We do not agree that we are in material breach of the License Agreement. Based on the failure of MedImmune to assist in the necessary technology transfer pursuant to Section 3.5.2 of the License Agreement, we notified MedImmune on March 24, 2023 that it was in material breach of Section 3.5.2 and requested that the material breach be cured as soon as possible. |
Stock-Based Compensation
Stock-Based Compensation | 6 Months Ended |
Jun. 30, 2023 | |
Share-Based Payment Arrangement [Abstract] | |
Stock-Based Compensation | 10. Stock-Based Compensation Equity Incentive Plan In May 2014, the Company adopted and the shareholders approved the 2014 Equity Incentive Plan (the 2014 Plan). Under the 2014 Plan, 233,722 10% In June 2020, the adoption of an amendment to the 2014 Plan to eliminate the evergreen provision and set the number of shares of common stock reserved for issuance thereunder to 2,183,692 In June 2022, the shareholder approved an additional 750,000 Stock Options The number of shares, terms, and vesting periods are determined by the Company’s Board of Directors or a committee thereof on an option by option basis. Options generally vest ratably over service periods of up to four years ten years Stock option activity for the six months ended June 30, 2023 is represented in the following table: Share-based Compensation, Stock Options, Activity Options Outstanding Shares Weighted- Available Number of Average for Grant Shares Exercise Price Balances at December 31, 2022 396,014 2,111,379 $ 7.36 Options granted (54,000 ) 54,000 $ 0.46 Options cancelled 113,060 (62,435 ) $ 1.72 Balances at March 31, 2023 455,074 2,102,944 $ 7.35 Options granted (377,500 ) 377,500 $ 0.16 Options cancelled 167,868 (157,868 ) $ 0.16 Balances at June 30, 2023 245,442 2,322,576 $ 6.18 The Company estimated the fair value of options using the BSM option valuation model. The fair value of options is being amortized on a straight-line basis over the requisite service period of the awards. The fair value of the options granted during the three and six month periods ended June 30, 2023 and 2022 were estimated using the following assumptions: Schedule of Share-based Payment Award, Stock Options, Valuation Assumptions Three Months Ended Six Months Ended June 30, June 30, 2023 2022 2023 2022 Expected term (in years) 6.00 6.00 6.00 6.00 Expected volatility 99% 100 % 99% 100 % 99% 100 % 99% 100 % Risk-free interest-rate 4.04% 4.90 % 2.44% 3.03 % 4.28% 4.90 % 1.72% 3.03 % Dividend yield 0 % 0 % 0 % 0 % During the three and six month periods ended June 30, 2023, the Company granted options to purchase 377,500 431,500 0.16 258,934 334,569 0.84 0.95 There were no Stock-Based Compensation The following table presents stock-based compensation expense related to stock options and RSUs (in thousands): Schedule of Employee Service Share-based Compensation, Allocation of Recognized Period Costs 2023 2022 2023 2022 Three Months Ended Six Months Ended June 30, June 30, 2023 2022 2023 2022 (unaudited) (unaudited) (unaudited) (unaudited) Research and development $ 149 $ 169 $ 293 $ 332 General and administrative 61 287 162 480 Total $ 210 $ 456 $ 455 $ 812 As of June 30, 2023, total unrecognized stock-based compensation expenses related to unvested stock options and RSUs was approximately $ 0.9 2.3 |
Related Parties
Related Parties | 6 Months Ended |
Jun. 30, 2023 | |
Related Party Transactions [Abstract] | |
Related Parties | 11. Related Parties Joint Venture On February 11, 2018, the Company entered into a Joint Venture (“JV”) Agreement with Hepalink which is a related party and principal shareholder in the Company, pursuant to which the Company formed a JV Entity for developing and commercializing products for infectious diseases in the greater China territories. It was agreed by the parties that the Company shall be reimbursed for certain legal and contract manufacturing expenses related to the clinical drug supply for a Phase 3 clinical study of AR-301 and the clinical drug supply for a clinical study of AR-105. For the three months ended June 30, 2023, and 2022, the Company recorded approximately $ 0 16,000 17,000 33,000 On August 21, 2023, Aridis Pharmaceuticals, Inc. (the “Company”) sent written notice to Shenzhen Arimab Biopharmaceuticals Co., Ltd. (“Arimab”) stating that as of August 21, 2023, the Amended and Restated Technology License and Collaboration Agreement between Arimab, a joint venture of the Company and Shenzhen Hepalink Pharmaceutical Group Co., Ltd. dated as of August 6, 2018 (the “Agreement”) would terminate pursuant to Section 11.2 of the Agreement. Serum International B.V. In July 2019, the Company issued 801,820 10 On May 3, 2023, the Company sent written notice to SAMR stating that as of May 8, 2023, the License Agreement would terminate pursuant to Section 13.3(a) of the License Agreement for nonfulfillment of development obligations under the License Agreement. As a result of termination of the License Agreement, the Company recognized approximately $ 19.6 The Company recorded an impairment loss of approximately $ 2.1 Cystic Fibrosis Foundation On December 7, 2022, the Company entered into a Securities Purchase Agreement (the “Purchase Agreement”) with the Cystic Fibrosis Foundation ( “CFF”), pursuant to which the Company agreed to offer, issue and sell to CFF in a private placement (the “PIPE”) 5,168,732 0.0001 0.938 4.85 |
Commitments and Contingencies
Commitments and Contingencies | 6 Months Ended |
Jun. 30, 2023 | |
Commitments and Contingencies Disclosure [Abstract] | |
Commitments and Contingencies | 12. Commitments and Contingencies Facility Lease The Company determines if an arrangement is a finance lease, operating lease or short-term lease at inception, or as applicable, and accounts for the arrangement under the relevant accounting literature. Currently, the Company is only party to a non-cancelable office space operating lease. Under the relevant guidance, the Company recognizes operating lease ROU assets and liabilities based on the present value of the future minimum lease payments over the lease term at the commencement date, using the Company’s assumed incremental borrowing rate of 6% In October 2020, the Company entered into a new lease agreement (the “Lease Agreement”) with Boccardo Corporation (the “Landlord”) pursuant to which the Company leased approximately 15,129 378,000 five three 500,000 As of January 1, 2022, the Company adopted ASC 842, Leases 6% 1.9 2.3 Schedule of Operating Lease Assets And Liabilities ROU assets, net $ 1,188 Current portion of lease liabilities (included in current liabilities) 563 Lease liabilities, less current portion 1,002 Total lease liabilities $ 1,565 The future minimum lease payments for the new facility as of June 30, 2023 are as follows (in thousands): Schedule of Future Minimum Rental Payments for Operating Leases Period ending: Year ending December 31, 2023 315 Year ending December 31, 2024 646 Year ending December 31, 2025 666 Thereafter 57 Total lease payments 1,684 Less: imputed interest (119 ) Present value of operating lease liabilities $ 1,565 Indemnification In the normal course of business, the Company enters into contracts and agreements that contain a variety of representations and warranties and provide for general indemnifications. The Company’s exposure under these agreements is unknown because it involves claims that may be made against the Company in the future but have not yet been made. To date, the Company has not paid any claims or been required to defend any action related to its indemnification obligations. However, the Company may incur charges in the future as a result of these indemnification obligations. License Agreements The Company has entered into various collaboration and licensing agreements that provide it with access to certain technology and patent rights. Under the terms of the agreements, the Company may be required to make milestone payments upon achievement of certain development and regulatory activities. None of these events occurred as of June 30, 2023. See “Development and License Agreements” in Note 6 of our Notes to the Condensed Consolidated Financial Statements. Contingencies From time to time, the Company may have certain contingent liabilities that arise in the ordinary course of its business activities. The Company accrues a liability for such matters when it is probable that a potential loss will be incurred and such amount can be reasonably estimated. As of June 30, 2023, and December 31, 2022, no accruals have been made related to commitments and contingencies. From time to time, the Company may be involved in various legal proceedings, claims and litigation arising in the ordinary course of business. See below Legal Proceedings ongoing at June 30, 2023. Legal Proceedings A complaint was filed in February 2020 in the New York State Supreme Court against the Company by an investor who invested in the Company’s preferred stock in July 2017 prior to the Company’s IPO in August 2018. The complaint alleges, among other things, that the Company breached its contract and fiduciary duty, by not issuing additional securities to the investor as a result of the Company’s IPO. The plaintiff is asking for approximately $ 277,000 531,687 The Company submitted a complaint in Superior Court of the State of California, County of Santa Clara, against our former landlord on October 22, 2021, asserting claims for breach of contract, breach of the covenant of good faith and fair dealing, wrongful eviction/constructive eviction and unjust enrichment and violation of the unfair competition law. The claims arise from rent increases and the termination of the tenancy that we allege were not permitted by the agreement with the landlord. We seek to recover rent paid under protest, our deposit, moving and relocation expenses and consequential damages arising from disruption to our operations. The Company filed a first amended complaint on July 18, 2022 asserting the same claims. The landlord has filed a cross-complaint for damage to property and attorneys’ fees. Discovery in the case is proceeding and no trial date has been set. The parties have agreed to mediate the dispute and have selected a mediator. The court has set a trial setting conference for February 20, 2024. The Company accrues a liability for such matters when it is probable that potential loss will be incurred and such amount can be reasonably estimated. As of June 30, 2023, and December 31, 2022, no Grant Income The Company receives various grants that are subject to audit by the grantors or their representatives. Such audits could result in requests for reimbursement for expenditures disallowed under the terms of the grant. As of June 30, 2023, management has complied with all of the required grant terms. There are no grant audits currently in process. Cystic Fibrosis Foundation Agreement In December 2016, the Company received an award for up to $ 2.9 7.5 Kermode Agreement In February 2021, the Company entered into the Kermode Agreement, in which the Company received an upfront payment of $ 500,000 250,000 250,000 5% |
Subsequent Events
Subsequent Events | 6 Months Ended |
Jun. 30, 2023 | |
Subsequent Events [Abstract] | |
Subsequent Events | 13. Subsequent Events On July 17, 2023, Aridis Pharmaceuticals, Inc. (the “Company”) received written notice (the “Notice”) from the Nasdaq Stock Market, LLC (“Nasdaq”) that it would delist the Company’s shares of common stock from the Nasdaq Capital Market upon the opening of trading on July 19, 2023. The Company’s common stock will be traded on the OTC Pink Sheets and the Company will seek to establish relationships with market makers to provide additional trading opportunities in the Company’s stock. In August 2023, the Company entered into a Securities Purchase Agreement (the “August 2023 Securities Purchase Agreement”) with a certain institutional and accredited investor, pursuant to which the Company agreed to offer, issue and sell to this investor, in a registered direct offering, 4,000,000 6,000,000 10,000,000 0.20 0.1999 0.001 0.20 2.0 1.7 |
Summary of Significant Accoun_2
Summary of Significant Accounting Policies (Policies) | 6 Months Ended |
Jun. 30, 2023 | |
Accounting Policies [Abstract] | |
Use of Estimates | Use of Estimates The preparation of the condensed consolidated financial statements requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities as of the date of the condensed consolidated financial statements and the reported amounts of expenses during the reporting period. Such estimates include those related to the evaluation of our ability to continue as a going concern, best estimate of standalone selling price of revenue deliverables, useful life of long-lived assets, classification of deferred revenue, income taxes, assumptions used in the Black-Scholes-Merton (“BSM”) model to calculate the fair value of stock-based compensation, deferred tax asset valuation allowances, and preclinical study and clinical trial accruals. Actual results could differ from those estimates. |
Concentrations | Concentrations Credit Risk The Company’s cash and cash equivalents are maintained at financial institutions in the United States of America. Deposits held by these institutions may exceed the amount of insurance provided on such deposits. Customer Risk The Company recognized $ 45,000 1.1 5% 16% 79% 5% 0.3 1.5 17% 28% 55% 100% The Company recognized $ 19.6 no Accounts receivable from one customer were $ 0.2 1.0 |
Cash, Cash Equivalents and Restricted Cash | Cash, Cash Equivalents and Restricted Cash The Company considers all highly liquid investments purchased with an original maturity of three months or less to be cash equivalents. Cash and cash equivalents consist primarily of checking account and money market fund account balances. Restricted cash consists of deposits for a letter of credit that the Company has provided to secure its obligations under its facility lease as well as grant funds identified for the specific grant project. The following table provides a reconciliation of cash, cash equivalents and restricted cash within the condensed consolidated balance sheets which, in aggregate, represent the amount reported in the condensed consolidated statements of cash flows (in thousands): Schedule of Cash, Cash Equivalents and Restricted Cash June 30, December 31, 2023 2022 Cash and cash equivalents $ 19 $ 4,876 Restricted cash – current - 183 Restricted cash – non-current 500 500 Total cash, cash equivalents and restricted cash $ 519 $ 5,559 |
Accounts Receivable and Allowance for Doubtful Accounts | Accounts Receivable and Allowance for Doubtful Accounts Accounts receivables are recorded at the invoiced amount and do not bear interest. The Company considers the creditworthiness of its customers but does not require collateral in advance of a sale. The Company evaluates collectability and maintains an allowance for doubtful accounts for estimated losses inherent in its accounts receivable portfolio when necessary. The allowance is based on the Company’s best estimate of the amount of losses in the Company’s existing accounts receivable, which is based on customer creditworthiness, facts and circumstances specific to outstanding balances, and payment terms. Account balances are charged off against the allowance after all means of collection have been exhausted and the potential for recovery is considered remote. As of June 30, 2023, and December 31, 2022, there were $ 0.2 1.0 |
Operating Leases | Operating Leases The Company determines if an arrangement is or contains a lease at inception by assessing whether the arrangement contains an identified asset and whether it has the right to control the identified asset. Right-of-use (“ROU”) assets represent the Company’s right to use an underlying asset for the lease term and lease liabilities represent the Company’s obligation to make lease payments arising from the lease. Lease liabilities are recognized at the lease commencement date based on the present value of future lease payments over the lease term. ROU assets are based on the measurement of the lease liability and also include any lease payments made prior to or on lease commencement and lease incentives and initial direct costs incurred, as applicable. As the implicit rate in the Company’s leases is generally unknown, the Company used its incremental borrowing rate of 6% Prior to adoption of ASC 842, Leases |
Property and Equipment | Property and Equipment Property and equipment are stated at cost less accumulated depreciation. Depreciation and amortization are computed using the straight-line method over the estimated useful lives of the assets, generally between three five years |
Intangible Assets | Intangible Assets Intangible assets are recorded at cost and amortized over the estimated useful life of the asset. Intangible assets consist of licenses with various institutions whereby the Company has rights to use intangible property obtained from such institutions. |
Impairment of Long-Lived Assets | Impairment of Long-Lived Assets The Company reviews long-lived assets for impairment whenever events or changes in circumstances indicate that the carrying amount of an asset may not be recoverable. Recoverability is measured by comparison of the carrying amount to the future undiscounted net cash flows which the assets are expected to generate. If such assets are considered to be impaired, the impairment is measured by the excess of the carrying amount of the assets over fair value less the costs to sell the assets, generally determined using the projected discounted future net cash flows arising from the asset. There have been no 227,000 |
Revenue Recognition | Revenue Recognition The Company recognizes revenue based on Accounting Standards Codification (“ASC”) 606, Revenue from Contracts with Customers To determine revenue recognition for arrangements that the Company determines are within the scope of ASC 606, the Company performs the following five steps: (i) identify the contract(s) with a customer; (ii) identify the performance obligations in the contract; (iii) determine the transaction price; (iv) allocate the transaction price to the performance obligations in the contract; and (v) recognize revenue at a point in time, or over time, as the entity satisfies performance obligations. The Company only applies the five-step model to contracts when it is probable that it will collect the consideration it is entitled to in exchange for the goods or services it transfers to the customer. At contract inception, once the contract is determined to be within the scope of ASC 606, the Company assesses the goods or services promised within each contract, determines those that are performance obligations, and assesses whether each promised good or service is distinct. The Company then recognizes as revenue the amount of the transaction price that is allocated to the respective performance obligation when (or as) the performance obligation is satisfied. As part of the accounting for customer arrangements, the Company must use judgment to determine: a) the number of performance obligations based on the determination under step (ii) above; b) the transaction price under step (iii) above; and c) the standalone selling price for each performance obligation identified in the contract for the allocation of the transaction price in step (iv) above. The Company uses judgment to determine whether milestones or other variable consideration should be included in the transaction price. The transaction price is allocated to each performance obligation on a relative standalone selling price basis. In developing the standalone price for a performance obligation, the Company considers applicable market conditions and relevant entity-specific factors, including factors that were contemplated in negotiating the agreement with the customer and estimated costs. The Company recognizes revenue as or when the performance obligations under the contract are satisfied. The Company receives payments from its customers based on payment schedules established in each contract. The Company records any amounts received prior to satisfying the revenue recognition criteria as deferred revenue on its condensed consolidated balance sheets. Amounts recognized as revenue, but not yet received or invoiced are recorded within other receivables on the condensed consolidated balance sheet. Amounts are recorded as other receivables on the condensed consolidated balance sheet when our right to consideration is unconditional. The Company does not assess whether a contract has a significant financing component if the expectation at contract inception is such that the period between payment by the customer and the transfer of a majority of the promised goods or services to the customer will be one year or less. Contract Assets The incremental costs of obtaining a contract under ASC 606 (i.e., costs that would not have been incurred if the contract had not been obtained) are recognized as an asset in the Company’s condensed consolidated balance sheets if the Company expects to recover them (see Note 6). Capitalized costs will be amortized to the respective expenses using a systematic basis that mirrors the pattern in which the Company transfers control of the goods and service to the customer. At each reporting date, the Company determines whether the capitalized costs to obtain a contract are impaired by comparing the carrying amount of the asset to the remaining amount of consideration that the Company received and expects to receive less the costs that relate to providing services under the relevant contract. Capitalized contract assets were zero 2.1 no 2.1 Contract Liabilities Amounts received prior to satisfying the above revenue recognition criteria, or in which the Company has an unconditional right to payment, are recorded as deferred revenue in the Company’s condensed consolidated balance sheets. The Company has estimated the classification between current and noncurrent deferred revenue related to the respective license agreement within its condensed consolidated balance sheets at June 30, 2023, and December 31, 2022 (see Note 6). |
Research and Development | Research and Development Research and development costs are expensed to operations as incurred. Our research and development expenses consist primarily of: ● salaries and related overhead expenses, which include stock-based compensation and benefits for personnel in research and development functions; ● fees paid to consultants and contract research organizations, or CROs, including in connection with our preclinical studies and clinical trials and other related clinical trial fees, such as for investigator grants, patient screening, laboratory work, clinical trial material management and statistical compilation and analyses; ● costs related to acquiring and manufacturing clinical trial materials; ● costs related to compliance with regulatory requirements; and ● payments related to licensed products and technologies. Costs for certain development activities are recognized based on an evaluation of the progress to completion of specific tasks using information and data provided to us by our vendors and clinical sites. Nonrefundable advance payments for goods or services to be received in future periods for use in research and development activities are deferred and capitalized. The capitalized amounts are then expensed as the related goods are delivered or when the services are performed. |
Stock-Based Compensation | Stock-Based Compensation The Company recognizes compensation expense for all stock-based awards based on the grant-date estimated fair values, which the Company determines using the BSM option pricing model, on a straight-line basis over the requisite service period for the award. The Company accounts for forfeitures as they occur. The BSM option pricing model incorporates various highly sensitive assumptions, including the fair value of our common stock, expected volatility, expected term and risk-free interest rates. The weighted average expected life of options was calculated using the simplified method as prescribed by the SEC’s Staff Accounting Bulletin, Topic 14 (“SAB Topic 14”). This decision was based on the lack of relevant historical data due to our limited historical experience. In addition, due to our limited historical data, the estimated volatility also reflects the application of SAB Topic 14, incorporating the historical volatility of comparable companies whose stock prices are publicly available. The risk-free interest rate for the periods within the expected term of the option is based on the U.S. Treasury yield in effect at the time of grant. The dividend yield was zero, as we have never declared or paid dividends and have no plans to do so in the foreseeable future. |
Income Taxes | Income Taxes The Company accounts for income taxes under the liability method. Under this method, deferred tax assets and liabilities are determined based on the difference between the financial statement and tax basis of assets and liabilities using enacted tax rates in effect for the year in which the differences are expected to affect taxable income. Valuation allowances are established when necessary to reduce deferred tax assets to the amounts expected to be realized. The Company assesses all material positions taken in any income tax return, including all significant uncertain positions, in all tax years that are still subject to assessment or challenge by the relevant taxing authorities. Assessing an uncertain tax position begins with the initial determination of the position’s sustainability and is measured at the largest amount of benefit that is greater than 50% likely of being realized upon ultimate settlement. At each balance sheet date, unresolved uncertain tax positions must be reassessed, and the Company will determine whether (i) the factors underlying the sustainability assertion have changed and (ii) the amount of the recognized benefit is still appropriate. The recognition and measurement of tax benefits requires significant judgment. Judgments concerning the recognition and measurement of a tax benefit might change as new information becomes available. The Company’s policy is to recognize interest or penalties related to income tax matters in income tax expense. |
Other Comprehensive Income | Other Comprehensive Income Other comprehensive income is derived from the change in credit risk calculated by our fair value option valuation in connection with the Note Purchase Agreements with Streeterville Capital, LLC. Accumulated other comprehensive income increased from $ 5.1 6.5 |
Earnings (Net Loss) Per Share | Earnings (Net Loss) Per Share Basic earnings (net loss) per share is calculated by dividing net income (loss) for the period by the weighted-average number of common shares outstanding during the period, without consideration for potentially dilutive securities. Diluted net earnings (net loss) per share is computed by dividing the net income (loss) by the weighted-average number of common shares and potentially dilutive securities outstanding for the period. For the three and six months ended June 30, 2023 the number of shares used to compute basic earnings (net loss) per share were 36.1 33.3 36.6 33.9 Schedule of Computation of the Basic and Diluted Net Loss Per Share Three Months Ended Six Months Ended June 30, June 30, 2023 2022 2023 2022 (unaudited) (unaudited) (unaudited) (unaudited) Numerator: Net income (loss) available to common stockholders (basic and diluted) $ 12,144 $ (7,979 ) $ 5,328 $ (15,745 ) Denominator: Weighted-average common shares outstanding used in computing net loss per share available to common stockholders: Basic 36,077,532 17,701,592 33,261,841 17,701,592 Diluted 36,572,960 17,701,592 33,917,422 17,701,592 Earnings (net loss) per share to common stockholders, basic and diluted Basic $ 0.34 $ (0.45 ) $ 0.16 $ (0.89 ) Diluted $ 0.33 $ (0.45 ) $ 0.16 $ (0.89 ) The following potentially dilutive securities were excluded from the computation of diluted earnings (net loss) per share for the periods presented because including them would have been antidilutive: Schedule of Potentially Dilutive Securities were Excluded from the Computation of Diluted Net Loss Per Share 2023 2022 Six Months Ended June 30, 2023 2022 (unaudited) (unaudited) Stock options to purchase common stock 2,012,847 2,105,715 Common stock warrants 10,742,404 3,592,905 Potentially dilutive securities 12,755,251 5,698,620 |
JOBS Act Accounting Election | JOBS Act Accounting Election The JOBS Act permits an “emerging growth company” such as us to take advantage of an extended transition period to comply with new or revised accounting standards applicable to public companies. We are choosing to take advantage of this provision and, as a result, we will adopt the extended transition period available under the JOBS Act until the earlier of the date we (i) are no longer an emerging growth company or (ii) affirmatively and irrevocably opt out of the extended transition period provided under the JOBS Act. |
New Accounting Pronouncements | New Accounting Pronouncements ASU 2016-02 - Accounting for Lease Obligation (“ASU 2016-02”) In February 2016, the Financial Accounting Standards Board (FASB) issued ASU No. 2016-02, Leases (Topic 842). This guidance requires lessees to recognize leases on the balance sheet and disclose key information about leasing arrangements. ASU 2016-02 establishes a right-of-use model (ROU) that requires a lessee to recognize an ROU asset and lease liability on the balance sheet for all leases with a term longer than 12 months. The Company adopted this standard effective January 1, 2022, as required, retrospectively through a cumulative effect adjustment. The new standard provides a number of optional practical expedients in transition. The Company elected the “package of practical expedients,” which permits the Company not to reassess, under ASU 2016-02, prior conclusions about lease identification, lease classification and initial direct costs. The new standard also provides practical expedients for an entity’s ongoing accounting. The Company elected to utilize the short-term lease recognition exemption for all leases that qualify. This means, for those short-term leases that qualify, the Company will not recognize ROU assets or lease liabilities. The Company also elected to separate lease and non-lease components for facility leases. Adoption of this guidance resulted in the recognition of lease liabilities of $ 2.3 1.9 |
Summary of Significant Accoun_3
Summary of Significant Accounting Policies (Tables) | 6 Months Ended |
Jun. 30, 2023 | |
Accounting Policies [Abstract] | |
Schedule of Cash, Cash Equivalents and Restricted Cash | The following table provides a reconciliation of cash, cash equivalents and restricted cash within the condensed consolidated balance sheets which, in aggregate, represent the amount reported in the condensed consolidated statements of cash flows (in thousands): Schedule of Cash, Cash Equivalents and Restricted Cash June 30, December 31, 2023 2022 Cash and cash equivalents $ 19 $ 4,876 Restricted cash – current - 183 Restricted cash – non-current 500 500 Total cash, cash equivalents and restricted cash $ 519 $ 5,559 |
Schedule of Computation of the Basic and Diluted Net Loss Per Share | Schedule of Computation of the Basic and Diluted Net Loss Per Share Three Months Ended Six Months Ended June 30, June 30, 2023 2022 2023 2022 (unaudited) (unaudited) (unaudited) (unaudited) Numerator: Net income (loss) available to common stockholders (basic and diluted) $ 12,144 $ (7,979 ) $ 5,328 $ (15,745 ) Denominator: Weighted-average common shares outstanding used in computing net loss per share available to common stockholders: Basic 36,077,532 17,701,592 33,261,841 17,701,592 Diluted 36,572,960 17,701,592 33,917,422 17,701,592 Earnings (net loss) per share to common stockholders, basic and diluted Basic $ 0.34 $ (0.45 ) $ 0.16 $ (0.89 ) Diluted $ 0.33 $ (0.45 ) $ 0.16 $ (0.89 ) |
Schedule of Potentially Dilutive Securities were Excluded from the Computation of Diluted Net Loss Per Share | The following potentially dilutive securities were excluded from the computation of diluted earnings (net loss) per share for the periods presented because including them would have been antidilutive: Schedule of Potentially Dilutive Securities were Excluded from the Computation of Diluted Net Loss Per Share 2023 2022 Six Months Ended June 30, 2023 2022 (unaudited) (unaudited) Stock options to purchase common stock 2,012,847 2,105,715 Common stock warrants 10,742,404 3,592,905 Potentially dilutive securities 12,755,251 5,698,620 |
Fair Value Disclosure (Tables)
Fair Value Disclosure (Tables) | 6 Months Ended |
Jun. 30, 2023 | |
Fair Value Disclosures [Abstract] | |
Schedule of Fair Value on Recurring Basis | The following tables set forth the fair value of the Company’s consolidated financial instruments that were measured at fair value on a recurring basis as of June 30, 2023 and December 31, 2022 (in thousands): Schedule of Fair Value on Recurring Basis June 30, 2023 Liabilities measured at fair value on a recurring basis Level 1 Level 2 Level 3 Total Notes payable (fair value) — — 4,730 4,730 Total liabilities measured at fair value — — 4,730 4,730 December 31, 2022 Level 1 Level 2 Level 3 Total Notes payable (fair value) — — 3,781 3,781 Total liabilities measured at fair value — — 3,781 3,781 |
Schedule of Estimated Fair Value | The change in the estimated fair value of the Level 3 liability is summarized below: Schedule of Estimated Fair Value Year ended December 31, 2022 Streeterville Notes Payable Beginning fair value of Level 3 liability 5,282 Borrowings on notes payable 5,000 Repayments (1,800 ) Change in fair value 850 Gain on valuation (500 ) Change in instrument specific credit risk (5,051 ) Ending fair value of Level 3 liability 3,781 Six months ended June 30, 2023 Streeterville Notes Payable Beginning fair value of Level 3 liability 3,781 Borrowings on notes payable 1,750 Repayments (1,485 ) Change in fair value 2,159 Change in instrument specific credit risk (1,475 ) Ending fair value of Level 3 liability 4,730 |
Schedule of Unobservable Inputs in Fair Value Measurement | The following table summarizes the quantitative information about the significant unobservable inputs used in Level 3 fair value measurement for the periods ended June 30, 2023 and December 31, 2022: Schedule of Unobservable Inputs in Fair Value Measurement Range of Inputs (risk free rate) Unobservable Inputs 2023 2022 Risk free rate 5.0% 5.5 % 2.1% 4.7 % Option adjusted spread 15.0 % 10.0 % Illiquidity discount 3.75 % 2.5 % Concluded discount rate 8.75% 9.25 % 4.75% 8.5 % |
Balance Sheet Components (Table
Balance Sheet Components (Tables) | 6 Months Ended |
Jun. 30, 2023 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
Schedule of Property and Equipment, Net | Property and equipment, net consist of the following (in thousands): Schedule of Property and Equipment, Net June 30, December 31, 2023 2022 (unaudited) Lab equipment $ 2,232 $ 2,246 Leasehold improvements 527 527 Total property and equipment 2,759 2,773 Less: Accumulated depreciation (2,190 ) (2,043 ) Property and equipment, net $ 569 $ 730 |
Schedule of Intangible Assets, Net | Intangible assets, net consist of the following (in thousands): Schedule of Intangible Assets, Net June 30, December 31, 2023 2022 (unaudited) Licenses $ 81 $ 81 Less: Accumulated amortization (67 ) (64 ) Intangible assets, net $ 14 $ 17 |
Schedule of Accrued Liabilities | Accrued liabilities consist of the following (in thousands): Schedule of Accrued Liabilities June 30, December 31, 2023 2022 (unaudited) Research and development services $ 7,928 $ 9,000 Payroll related expenses 519 456 Professional services and other 14 108 Accrued liabilities $ 8,461 $ 9,564 |
Common Stock (Tables)
Common Stock (Tables) | 6 Months Ended |
Jun. 30, 2023 | |
Equity [Abstract] | |
Schedule of Common Stock Reserved for Future Issuance | As of June 30, 2023 the Company had reserved the following common stock for future issuance: Schedule of Common Stock Reserved for Future Issuance Shares reserved for exercise of outstanding options to purchase common stock 2,322,576 Shares reserved for vesting of restricted stock units 315,540 Shares reserved for exercise of outstanding warrants to purchase common stock 10,742,404 Shares reserved for issuance of future options 245,442 Total 13,625,962 |
Stock-Based Compensation (Table
Stock-Based Compensation (Tables) | 6 Months Ended |
Jun. 30, 2023 | |
Share-Based Payment Arrangement [Abstract] | |
Share-based Compensation, Stock Options, Activity | Stock option activity for the six months ended June 30, 2023 is represented in the following table: Share-based Compensation, Stock Options, Activity Options Outstanding Shares Weighted- Available Number of Average for Grant Shares Exercise Price Balances at December 31, 2022 396,014 2,111,379 $ 7.36 Options granted (54,000 ) 54,000 $ 0.46 Options cancelled 113,060 (62,435 ) $ 1.72 Balances at March 31, 2023 455,074 2,102,944 $ 7.35 Options granted (377,500 ) 377,500 $ 0.16 Options cancelled 167,868 (157,868 ) $ 0.16 Balances at June 30, 2023 245,442 2,322,576 $ 6.18 |
Schedule of Share-based Payment Award, Stock Options, Valuation Assumptions | Schedule of Share-based Payment Award, Stock Options, Valuation Assumptions Three Months Ended Six Months Ended June 30, June 30, 2023 2022 2023 2022 Expected term (in years) 6.00 6.00 6.00 6.00 Expected volatility 99% 100 % 99% 100 % 99% 100 % 99% 100 % Risk-free interest-rate 4.04% 4.90 % 2.44% 3.03 % 4.28% 4.90 % 1.72% 3.03 % Dividend yield 0 % 0 % 0 % 0 % |
Schedule of Employee Service Share-based Compensation, Allocation of Recognized Period Costs | The following table presents stock-based compensation expense related to stock options and RSUs (in thousands): Schedule of Employee Service Share-based Compensation, Allocation of Recognized Period Costs 2023 2022 2023 2022 Three Months Ended Six Months Ended June 30, June 30, 2023 2022 2023 2022 (unaudited) (unaudited) (unaudited) (unaudited) Research and development $ 149 $ 169 $ 293 $ 332 General and administrative 61 287 162 480 Total $ 210 $ 456 $ 455 $ 812 |
Commitments and Contingencies (
Commitments and Contingencies (Tables) | 6 Months Ended |
Jun. 30, 2023 | |
Commitments and Contingencies Disclosure [Abstract] | |
Schedule of Operating Lease Assets And Liabilities | Schedule of Operating Lease Assets And Liabilities ROU assets, net $ 1,188 Current portion of lease liabilities (included in current liabilities) 563 Lease liabilities, less current portion 1,002 Total lease liabilities $ 1,565 |
Schedule of Future Minimum Rental Payments for Operating Leases | The future minimum lease payments for the new facility as of June 30, 2023 are as follows (in thousands): Schedule of Future Minimum Rental Payments for Operating Leases Period ending: Year ending December 31, 2023 315 Year ending December 31, 2024 646 Year ending December 31, 2025 666 Thereafter 57 Total lease payments 1,684 Less: imputed interest (119 ) Present value of operating lease liabilities $ 1,565 |
Description of Business and B_2
Description of Business and Basis of Presentation (Details Narrative) | 6 Months Ended |
Jun. 30, 2023 Segment Subsidiary | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
Wholly owned subsidiaries | Subsidiary | 2 |
Operating segments | 1 |
Reporting segments | 1 |
Schedule of Cash, Cash Equivale
Schedule of Cash, Cash Equivalents and Restricted Cash (Details) - USD ($) $ in Thousands | Jun. 30, 2023 | Dec. 31, 2022 | Jun. 30, 2022 | Dec. 31, 2021 |
Accounting Policies [Abstract] | ||||
Cash and cash equivalents | $ 19 | $ 4,876 | ||
Restricted cash – current | 183 | |||
Restricted cash – non-current | 500 | 500 | ||
Total cash, cash equivalents and restricted cash | $ 519 | $ 5,559 | $ 7,952 | $ 19,986 |
Schedule of Computation of the
Schedule of Computation of the Basic and Diluted Net Loss Per Share (Details) - USD ($) $ / shares in Units, $ in Thousands | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2023 | Jun. 30, 2022 | Jun. 30, 2023 | Jun. 30, 2022 | |
Accounting Policies [Abstract] | ||||
Net income (loss) available to common stockholders, basic | $ 12,144 | $ (7,979) | $ 5,328 | $ (15,745) |
Net income (loss) available to common stockholders, diluted | $ 12,144 | $ (7,979) | $ 5,328 | $ (15,745) |
Weighted-average common shares outstanding used in computing net loss per share available to common stockholders, basic | 36,077,532 | 17,701,592 | 33,261,841 | 17,701,592 |
Weighted-average common shares outstanding used in computing net loss per share available to common stockholders, diluted | 36,572,960 | 17,701,592 | 33,917,422 | 17,701,592 |
Net loss per share to common stockholders, basic | $ 0.34 | $ (0.45) | $ 0.16 | $ (0.89) |
Net loss per share to common stockholders, diluted | $ 0.33 | $ (0.45) | $ 0.16 | $ (0.89) |
Schedule of Potentially Dilutiv
Schedule of Potentially Dilutive Securities were Excluded from the Computation of Diluted Net Loss Per Share (Details) - shares | 6 Months Ended | |
Jun. 30, 2023 | Jun. 30, 2022 | |
Potentially dilutive securities | 12,755,251 | 5,698,620 |
Common Stock [Member] | Share-Based Payment Arrangement, Option [Member] | ||
Potentially dilutive securities | 2,012,847 | 2,105,715 |
Common Stock [Member] | Warrant [Member] | ||
Potentially dilutive securities | 10,742,404 | 3,592,905 |
Summary of Significant Accoun_4
Summary of Significant Accounting Policies (Details Narrative) - USD ($) | 3 Months Ended | 6 Months Ended | 12 Months Ended | |||
Jun. 30, 2023 | Jun. 30, 2022 | Jun. 30, 2023 | Jun. 30, 2022 | Dec. 31, 2022 | Jan. 01, 2022 | |
Product Information [Line Items] | ||||||
Revenue | $ 19,647,000 | $ 292,000 | $ 20,729,000 | $ 1,479,000 | ||
Accounts receivable | 200,000 | 200,000 | $ 1,000,000 | |||
Allowance for doubtful accounts | $ 200,000 | $ 200,000 | 1,000,000 | |||
Incremental borrowing rate | 6% | 6% | ||||
Impairment of long-lived assets | 33,000 | 227,000 | ||||
Contract with customer assets | $ 0 | 0 | 2,100,000 | |||
Capitalized contract cost, amortization | 0 | $ 0 | ||||
Impairments | 2,100,000 | |||||
Accumulated other comprehensive income | $ 6,526,000 | $ 6,526,000 | 5,051,000 | |||
Weighted-average common shares outstanding used in computing net loss per share available to common stockholders, basic | 36,077,532 | 17,701,592 | 33,261,841 | 17,701,592 | ||
Weighted-average common shares outstanding used in computing net loss per share available to common stockholders, diluted | 36,572,960 | 17,701,592 | 33,917,422 | 17,701,592 | ||
Operating lease | $ 1,565,000 | $ 1,565,000 | $ 2,300,000 | |||
Operating lease ROU | $ 1,188,000 | $ 1,188,000 | 1,417,000 | $ 1,900,000 | ||
Minimum [Member] | ||||||
Product Information [Line Items] | ||||||
Estimated useful life | 3 years | 3 years | ||||
Maximum [Member] | ||||||
Product Information [Line Items] | ||||||
Estimated useful life | 5 years | 5 years | ||||
Customer One [Member] | ||||||
Product Information [Line Items] | ||||||
Accounts receivable | $ 200,000 | $ 200,000 | $ 1,000,000 | |||
Revenue from Contract with Customer Benchmark [Member] | Customer Concentration Risk [Member] | One Customer [Member] | ||||||
Product Information [Line Items] | ||||||
Revenue | 45,000 | |||||
Revenue from Contract with Customer Benchmark [Member] | Customer Concentration Risk [Member] | Three Customer [Member] | ||||||
Product Information [Line Items] | ||||||
Revenue | $ 300,000 | $ 1,100,000 | $ 1,500,000 | |||
Revenue from Contract with Customer Benchmark [Member] | Customer Concentration Risk [Member] | Customer One [Member] | ||||||
Product Information [Line Items] | ||||||
Concentration risk percentage | 17% | 5% | 17% | |||
Revenue from Contract with Customer Benchmark [Member] | Customer Concentration Risk [Member] | Customer Two [Member] | ||||||
Product Information [Line Items] | ||||||
Concentration risk percentage | 28% | 16% | 28% | |||
Revenue from Contract with Customer Benchmark [Member] | Customer Concentration Risk [Member] | Customer Three [Member] | ||||||
Product Information [Line Items] | ||||||
Concentration risk percentage | 55% | 79% | 55% | |||
Revenue from Contract with Customer Benchmark [Member] | Customer Concentration Risk [Member] | Customer [Member] | ||||||
Product Information [Line Items] | ||||||
Concentration risk percentage | 5% | 100% | ||||
License [Member] | Customer Concentration Risk [Member] | One Customer [Member] | ||||||
Product Information [Line Items] | ||||||
Revenue | $ 19,600,000 | $ 0 | $ 19,600,000 | $ 0 |
Schedule of Fair Value on Recur
Schedule of Fair Value on Recurring Basis (Details) - USD ($) $ in Thousands | Jun. 30, 2023 | Dec. 31, 2022 |
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Notes payable, fair value disclosure | $ 4,730 | $ 3,781 |
Total liabilities measured at fair value | 4,730 | 3,781 |
Fair Value, Recurring [Member] | Fair Value, Inputs, Level 1 [Member] | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Notes payable, fair value disclosure | ||
Total liabilities measured at fair value | ||
Fair Value, Recurring [Member] | Fair Value, Inputs, Level 2 [Member] | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Notes payable, fair value disclosure | ||
Total liabilities measured at fair value | ||
Fair Value, Recurring [Member] | Fair Value, Inputs, Level 3 [Member] | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Notes payable, fair value disclosure | 4,730 | 3,781 |
Total liabilities measured at fair value | $ 4,730 | $ 3,781 |
Schedule of Estimated Fair Valu
Schedule of Estimated Fair Value (Details) - USD ($) $ in Thousands | 6 Months Ended | 12 Months Ended |
Jun. 30, 2023 | Dec. 31, 2022 | |
Fair Value Disclosures [Abstract] | ||
Beginning fair value of Level 3 liability | $ 3,781 | $ 5,282 |
Borrowings on notes payable | 1,750 | 5,000 |
Repayments | (1,485) | (1,800) |
Change in fair value | 2,159 | 850 |
Gain on valuation | (500) | |
Change in instrument specific credit risk | (1,475) | (5,051) |
Ending fair value of Level 3 liability | $ 4,730 | $ 3,781 |
Schedule of Unobservable Inputs
Schedule of Unobservable Inputs in Fair Value Measurement (Details) | Jun. 30, 2023 | Dec. 31, 2022 |
Measurement Input, Risk Free Interest Rate [Member] | Minimum [Member] | ||
Fair Value Measurement Inputs and Valuation Techniques [Line Items] | ||
Range of unobservable inputs | 5 | 2.01 |
Measurement Input, Risk Free Interest Rate [Member] | Maximum [Member] | ||
Fair Value Measurement Inputs and Valuation Techniques [Line Items] | ||
Range of unobservable inputs | 5.5 | 4.7 |
Option Adjusted Spread [Member] | ||
Fair Value Measurement Inputs and Valuation Techniques [Line Items] | ||
Range of unobservable inputs | 15 | 10 |
Illiquidity Discount [Member] | ||
Fair Value Measurement Inputs and Valuation Techniques [Line Items] | ||
Range of unobservable inputs | 3.75 | 2.5 |
Concluded Discount Rate [Member] | Minimum [Member] | ||
Fair Value Measurement Inputs and Valuation Techniques [Line Items] | ||
Range of unobservable inputs | 8.75 | 4.75 |
Concluded Discount Rate [Member] | Maximum [Member] | ||
Fair Value Measurement Inputs and Valuation Techniques [Line Items] | ||
Range of unobservable inputs | 9.25 | 8.5 |
Fair Value Disclosure (Details
Fair Value Disclosure (Details Narrative) - USD ($) $ in Thousands | Jun. 30, 2023 | Dec. 31, 2022 |
Fair Value Disclosures [Abstract] | ||
Notes payable fair value disclosure | $ 4,730 | $ 3,781 |
Schedule of Property and Equipm
Schedule of Property and Equipment, Net (Details) - USD ($) $ in Thousands | Jun. 30, 2023 | Dec. 31, 2022 |
Property, Plant and Equipment [Line Items] | ||
Total property and equipment | $ 2,759 | $ 2,773 |
Less: Accumulated depreciation | (2,190) | (2,043) |
Property and equipment, net | 569 | 730 |
Machinery and Equipment [Member] | ||
Property, Plant and Equipment [Line Items] | ||
Total property and equipment | 2,232 | 2,246 |
Leasehold Improvements [Member] | ||
Property, Plant and Equipment [Line Items] | ||
Total property and equipment | $ 527 | $ 527 |
Schedule of Intangible Assets,
Schedule of Intangible Assets, Net (Details) - USD ($) $ in Thousands | Jun. 30, 2023 | Dec. 31, 2022 |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | ||
Licenses | $ 81 | $ 81 |
Less: Accumulated amortization | (67) | (64) |
Intangible assets, net | $ 14 | $ 17 |
Schedule of Accrued Liabilities
Schedule of Accrued Liabilities (Details) - USD ($) $ in Thousands | Jun. 30, 2023 | Dec. 31, 2022 |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | ||
Research and development services | $ 7,928 | $ 9,000 |
Payroll related expenses | 519 | 456 |
Professional services and other | 14 | 108 |
Accrued liabilities | $ 8,461 | $ 9,564 |
Balance Sheet Components (Detai
Balance Sheet Components (Details Narrative) - USD ($) | 3 Months Ended | 6 Months Ended | ||||
Jun. 30, 2023 | Jun. 30, 2022 | Jun. 30, 2023 | Jun. 30, 2022 | Dec. 31, 2022 | Jul. 31, 2021 | |
Depreciation and amortization expense | $ 61,000 | $ 130,000 | $ 147,000 | $ 261,000 | ||
Amortization expense | 2,000 | $ 2,000 | $ 3,000 | 3,000 | ||
Medimmune Customer [Member] | Minimum [Member] | ||||||
Percentage for royalty payments based on net sales volume | 12.50% | |||||
Medimmune Customer [Member] | Maximum [Member] | ||||||
Percentage for royalty payments based on net sales volume | 15% | |||||
Medimmune Limited [Member] | Medimmune License Agreement [Member] | ||||||
Issuance of common stock, shares | 884,956 | |||||
Contractual liability | $ 5,000,000 | |||||
Medimmune Limited [Member] | Medimmune License Agreement [Member] | Sales [Member] | ||||||
Total aggregate milestone payments | 85,000,000 | $ 85,000,000 | ||||
Medimmune Limited [Member] | Medimmune License Agreement [Member] | One Licensed Product [Member] | ||||||
Total aggregate milestone payments | 30,000,000 | 30,000,000 | ||||
Medimmune Limited [Member] | Medimmune License Agreement [Member] | Accrued Liabilities [Member] | ||||||
Minimum research funding agreed to provide | $ 5,000,000 | 5,000,000 | $ 5,000,000 | |||
Broad Institute of Mit and Harvard [Member] | ||||||
Issue fee | $ 25,000 | |||||
Royalty expense as a percentage of service income | 7% | |||||
Percentage of end product net sales | 0.50% | |||||
Broad Institute of Mit and Harvard [Member] | 2022 [Member] | ||||||
Annual license maintenance fee | $ 50,000 | |||||
Broad Institute of Mit and Harvard [Member] | 2023 [Member] | ||||||
Annual license maintenance fee | $ 100,000 |
Equity Method Investment (Detai
Equity Method Investment (Details Narrative) - Joint Venture Agreement [Member] - USD ($) | Jun. 30, 2023 | Dec. 31, 2022 | Aug. 06, 2018 | Feb. 11, 2018 |
Shenzhen Hepalink Pharmaceutical Group Co., Ltd. [Member] | ||||
Schedule of Equity Method Investments [Line Items] | ||||
Percentage of ownership interest | 51% | 49% | ||
Equity method investment, minimum future investment obligation | $ 10,800,000 | |||
Shenzhen Hepalink Pharmaceutical Group Co., Ltd. [Member] | ||||
Schedule of Equity Method Investments [Line Items] | ||||
Minimum research funding agreed to provide | 7,200,000 | $ 1,000,000 | ||
Equity method investment | $ 0 | $ 0 | $ 1,000,000 | |
Carryover basis of license contributed | $ 0 |
Development and License Agree_2
Development and License Agreements (Details Narrative) - USD ($) | 1 Months Ended | 3 Months Ended | 6 Months Ended | 12 Months Ended | |||||||||||||
Oct. 15, 2021 | Dec. 31, 2022 | Dec. 31, 2021 | Mar. 31, 2021 | Sep. 30, 2019 | Jul. 31, 2019 | Nov. 30, 2018 | Dec. 31, 2016 | Jun. 30, 2023 | Jun. 30, 2022 | Jun. 30, 2023 | Jun. 30, 2022 | Dec. 31, 2022 | Dec. 31, 2019 | Mar. 31, 2022 | Jun. 30, 2020 | Mar. 31, 2019 | |
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |||||||||||||||||
Development and license agreements description | The academic COMBACTE-NET consortium partners initially pay for all costs incurred at EU clinical sites and subsequently bills the Company for 25% of such costs. Specifically, we are billed for 25% of eligible costs during the entire fiscal year six to seven months following the fiscal year. The work at these sites is performed entirely by third-party subcontractors. As such, we reimburse the 25% at the passed-through invoice amounts. There is no reimbursement for costs incurred at non-EU sites. | ||||||||||||||||
Research and development expense | $ 4,668,000 | $ 6,348,000 | $ 10,199,000 | $ 12,798,000 | |||||||||||||
Liabilities | $ 38,927,000 | 21,396,000 | 21,396,000 | $ 38,927,000 | |||||||||||||
Gain or loss on disposition | 0 | 0 | |||||||||||||||
License revenue | 19,647,000 | 292,000 | 20,729,000 | 1,479,000 | |||||||||||||
License [Member] | |||||||||||||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |||||||||||||||||
License revenue | 19,602,000 | 19,602,000 | |||||||||||||||
Cystic Fibrosis Foundation Development Agreement [Member] | |||||||||||||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |||||||||||||||||
Amount of award | 7,600,000 | $ 7,500,000 | $ 2,900,000 | ||||||||||||||
Award, upfront payment received | $ 200,000 | ||||||||||||||||
Additional amount of award | 150,000 | ||||||||||||||||
Deferred revenue, current | 400,000 | 400,000 | |||||||||||||||
License revenue | 45,000 | 36,000 | 894,000 | 815,000 | |||||||||||||
Grants Foundation Grant Agreement [Member] | |||||||||||||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |||||||||||||||||
Revenue recognized | 0 | 132,000 | 183,000 | 252,000 | |||||||||||||
Grants Foundation Grant Agreement [Member] | Bill and Melinda Gates Foundation [Member] | |||||||||||||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |||||||||||||||||
Amount of compensation | $ 1,930,000 | ||||||||||||||||
Upfront payment received | $ 1,930,000 | ||||||||||||||||
Serum License Agreement [Member] | |||||||||||||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |||||||||||||||||
Upfront payment received | $ 15,000,000 | $ 5,000,000 | |||||||||||||||
Maximum additional payments entitled | 42,500,000 | ||||||||||||||||
Fair value of net proceeds | $ 5,000,000 | ||||||||||||||||
Fair value of gross proceeds | 5,400,000 | ||||||||||||||||
Issuance costs from equity allocation | $ 441,000 | ||||||||||||||||
Deferred revenue from equity allocation | 4,600,000 | 4,600,000 | |||||||||||||||
Contractual liability | 19,600,000 | ||||||||||||||||
Deferred revenue based on upfront payments | 15,000,000 | ||||||||||||||||
License fees | 19,600,000 | ||||||||||||||||
Deferred revenue based on upfront payments | 15,000,000 | 15,000,000 | |||||||||||||||
Contractual liability | 19,600,000 | 19,600,000 | |||||||||||||||
Serum License Agreement [Member] | License and Service [Member] | |||||||||||||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |||||||||||||||||
Contractual liability | 14,500,000 | 14,500,000 | |||||||||||||||
Serum License Agreement [Member] | Development Support Services [Member] | |||||||||||||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |||||||||||||||||
Business development support services | 79,000 | ||||||||||||||||
Serum License Agreement [Member] | Research and Development Option [Member] | |||||||||||||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |||||||||||||||||
Contractual liability | 892,000 | 892,000 | |||||||||||||||
Serum License Agreement [Member] | Manufacturing Rights Option [Member] | |||||||||||||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |||||||||||||||||
Manufacturing rights option | 4,100,000 | ||||||||||||||||
Serum License Agreement [Member] | License [Member] | |||||||||||||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |||||||||||||||||
License revenue | 19,600,000 | ||||||||||||||||
Serum License Agreement [Member] | Maximum [Member] | |||||||||||||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |||||||||||||||||
Maximum additional payments entitled | 42,500,000 | ||||||||||||||||
Kermode Licensing and Product Discovery Agreement [Member] | |||||||||||||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |||||||||||||||||
Revenue recognized | 0 | $ 125,000 | 51,000 | $ 413,000 | |||||||||||||
Maximum additional payments entitled | $ 250,000 | 250,000 | |||||||||||||||
Gross transaction price | $ 1,000,000 | ||||||||||||||||
Kermode Licensing and Product Discovery Agreement [Member] | Research and Development Option [Member] | |||||||||||||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |||||||||||||||||
Nonrefundable upfront payment | 500,000 | ||||||||||||||||
Kermode Licensing and Product Discovery Agreement [Member] | License [Member] | |||||||||||||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |||||||||||||||||
Upfront payment received | $ 500,000 | ||||||||||||||||
Non-EUSites [Member] | |||||||||||||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |||||||||||||||||
Research and development expense | 1,500,000 | 500,000 | 5,500,000 | ||||||||||||||
EU Site [Member] | |||||||||||||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |||||||||||||||||
Research and development expense | 1,900,000 | 2,300,000 | 3,800,000 | ||||||||||||||
Gross expenses contributed services amount | 300,000 | 1,700,000 | 2,900,000 | ||||||||||||||
Liabilities | $ 1,000,000 | $ 1,500,000 | 1,500,000 | 1,000,000 | |||||||||||||
Several Development Based Milestones [Member] | Cystic Fibrosis Foundation Development Agreement [Member] | |||||||||||||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |||||||||||||||||
Probable transaction price performance obligations | $ 1,700,000 | ||||||||||||||||
One Development Based Milestone in Progress [Member] | Cystic Fibrosis Foundation Development Agreement [Member] | |||||||||||||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |||||||||||||||||
Amount of probable variable consideration | $ 1,000,000 | ||||||||||||||||
Amount of probable variable consideration | $ 1,000,000 | ||||||||||||||||
Four Develpoment Based Milestones [Member] | Cystic Fibrosis Foundation Development Agreement [Member] | |||||||||||||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |||||||||||||||||
Amount of variable consideration | 3,800,000 | ||||||||||||||||
Amount of total variable consideration | $ 3,900,000 | ||||||||||||||||
Three Develpoment Based Milestones [Member] | Cystic Fibrosis Foundation Development Agreement [Member] | |||||||||||||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |||||||||||||||||
Amount of variable consideration | $ 3,200,000 | ||||||||||||||||
Restricted Stock [Member] | Serum License Agreement [Member] | |||||||||||||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |||||||||||||||||
Restricted common stock issuance | 801,820 | ||||||||||||||||
Private placement, value | $ 10,000,000 |
Notes Payable (Details Narrativ
Notes Payable (Details Narrative) - USD ($) | 1 Months Ended | 6 Months Ended | |||||
May 23, 2022 | Feb. 21, 2022 | Nov. 23, 2021 | Sep. 30, 2022 | Jun. 30, 2023 | Apr. 30, 2023 | Dec. 31, 2022 | |
Short-Term Debt [Line Items] | |||||||
Percent of prepayment | 1.50% | ||||||
Notes payable current | $ 519,000 | ||||||
Insurance Financing Note Payable [Member] | |||||||
Short-Term Debt [Line Items] | |||||||
Notes payable current | $ 500,000 | ||||||
Total premiums, taxes and fees financed | $ 900,000 | ||||||
Annual interest rate | 5.129% | ||||||
Two Notes [Member] | |||||||
Short-Term Debt [Line Items] | |||||||
Notes payable current | $ 4,700,000 | ||||||
Minimum [Member] | |||||||
Short-Term Debt [Line Items] | |||||||
Original principal amount | $ 5,250,000 | ||||||
Maximum [Member] | |||||||
Short-Term Debt [Line Items] | |||||||
Original principal amount | 9,287,000 | ||||||
Investment amount | $ 2,500,000 | ||||||
Debt Instrument Increase Accrued Interest First Exercise [Member] | |||||||
Short-Term Debt [Line Items] | |||||||
Increase in unpaid interest | 0.50% | ||||||
Debt Instrument Increase Accrued Interest Second Exercise [Member] | |||||||
Short-Term Debt [Line Items] | |||||||
Increase in unpaid interest | 1% | ||||||
Debt Instrument Increase Accrued Interest Third Exercise [Member] | |||||||
Short-Term Debt [Line Items] | |||||||
Increase in unpaid interest | 1.50% | ||||||
Three Month Anniversary [Member] | |||||||
Short-Term Debt [Line Items] | |||||||
Percent of prepayment | 105% | ||||||
Three Month or Before Six Month Anniversary [Member] | |||||||
Short-Term Debt [Line Items] | |||||||
Percent of prepayment | 107.50% | ||||||
After Six Month Anniversary [Member] | |||||||
Short-Term Debt [Line Items] | |||||||
Percent of prepayment | 110% | ||||||
Streeterville Capital Llc [Member] | Note Purchase Agreement [Member] | |||||||
Short-Term Debt [Line Items] | |||||||
Original principal amount | $ 5,250,000 | $ 5,250,000 | |||||
Original issue discount | $ 250,000 | ||||||
Interest rate | 6% | ||||||
Maturity date | Feb. 21, 2024 | Nov. 23, 2023 | |||||
Maximum monthly redemption amount | $ 450,000 | $ 495,000 | |||||
Debt instrument periodic payment principal | 450,000 | ||||||
Prepayment premium (fee) | $ 45,000 |
Warrants (Details Narrative)
Warrants (Details Narrative) - USD ($) | 1 Months Ended | 3 Months Ended | 6 Months Ended | |||||||||
Dec. 07, 2022 | Oct. 05, 2022 | Dec. 31, 2022 | Oct. 31, 2022 | Dec. 31, 2021 | Aug. 31, 2021 | Mar. 31, 2021 | Jun. 30, 2023 | Jun. 30, 2022 | Jun. 30, 2023 | Jun. 30, 2022 | Jan. 31, 2023 | |
Net proceeds | $ 2,057,000 | |||||||||||
Exercise price of warrants | $ 0.001 | $ 0.001 | ||||||||||
Expected term | 6 years | 6 years | 6 years | 6 years | ||||||||
Dividend yield | 0% | 0% | 0% | 0% | ||||||||
Warrants to purchase common stock | 13,625,962 | 13,625,962 | 3,044,000 | |||||||||
Original Terms [Member] | ||||||||||||
Value per warrant | 0.716 | |||||||||||
Modified Terms [Member] | ||||||||||||
Value per warrant | $ 0.843 | |||||||||||
Maximum [Member] | ||||||||||||
Expected volatility | 100% | 100% | 100% | 100% | ||||||||
Risk-free interest-rate | 4.90% | 3.03% | 4.90% | 3.03% | ||||||||
Minimum [Member] | ||||||||||||
Expected volatility | 99% | 99% | 99% | 99% | ||||||||
Risk-free interest-rate | 4.04% | 2.44% | 4.28% | 1.72% | ||||||||
Prefunded Warrants [Member] | ||||||||||||
Number of shares issuable per warrant | 3,647,556 | |||||||||||
Warrant exercise price | $ 4,000 | |||||||||||
Prefunded Warrants [Member] | Securities Purchase Agreement [Member] | ||||||||||||
Issuance of common stock in registered direct offering, net of issuance costs, shares | 1,800,000 | |||||||||||
Warrant to purchase number of common stock | 5,407,208 | |||||||||||
Exercise price of warrants | $ 1.109 | |||||||||||
Exercise price | $ 1.11 | |||||||||||
Prefunded Warrants [Member] | Securities Purchase Agreement [Member] | Maximum [Member] | ||||||||||||
Warrant to purchase number of common stock | 7,207,208 | |||||||||||
Securities Purchase Agreement [Member] | ||||||||||||
Issuance of common stock in registered direct offering, net of issuance costs, shares | 5,168,732 | 1,800,000 | 5,168,732 | 1,300,000 | 1,037,405 | |||||||
Warrant to purchase number of common stock | 5,407,208 | |||||||||||
Combined purchase price for each common stock and accompanying warrant | $ 5.053 | |||||||||||
Combined purchase price for each pre-funded warrant and accompanying warrant | 5.052 | |||||||||||
Difference between combined purchase price for each share of common stock and accompanying warrant to pre-funded warrant and accompanying warrant | $ 0.001 | |||||||||||
Gross proceeds | $ 8,000,000 | $ 25,000,000 | $ 7,000,000 | |||||||||
Net proceeds | $ 4,850,000 | $ 7,900,000 | $ 5,000,000 | 22,600,000 | $ 6,400,000 | |||||||
Exercise price | $ 0.938 | $ 1.11 | $ 0.94 | |||||||||
Securities Purchase Agreement [Member] | Common Stock Shares and the Warrants Shares | ||||||||||||
Net proceeds | 22,600,000 | |||||||||||
Relative fair value of the common stock shares | 4,400,000 | |||||||||||
Relative fair value of the prefunded warrants | 12,200,000 | |||||||||||
Relative fair value of the warrants issued | $ 6,000,000 | |||||||||||
Securities Purchase Agreement [Member] | Prefunded Warrants [Member] | ||||||||||||
Warrant to purchase number of common stock | 3,647,556 | |||||||||||
Exercise price of warrants | $ 0.001 | |||||||||||
Percentage of ownership on issue of outstanding common stock for warrants | 4.99% | 4.99% | ||||||||||
Percentage on issue of outstanding common stock for warrants | 9.99% | 9.99% | ||||||||||
Securities Purchase Agreement [Member] | Warrant [Member] | ||||||||||||
Warrant to purchase number of common stock | 2,473,778 | |||||||||||
Number of shares issuable per warrant | 1 | |||||||||||
Exercise price of warrants | $ 5 | |||||||||||
Percentage of ownership on issue of outstanding common stock for warrants | 4.99% | 4.99% | ||||||||||
Percentage on issue of outstanding common stock for warrants | 9.99% | 9.99% | ||||||||||
Expected term | 7 years | |||||||||||
Expected volatility | 97% | |||||||||||
Risk-free interest-rate | 0.96% | |||||||||||
Dividend yield | 0% | |||||||||||
Issuance of warrants | $ 314,170 | |||||||||||
Securities Purchase Agreement [Member] | Warrant [Member] | Maximum [Member] | ||||||||||||
Exercise price of warrants | $ 2 | |||||||||||
Securities Purchase Agreement [Member] | Warrant [Member] | Minimum [Member] | ||||||||||||
Exercise price of warrants | $ 5 |
Schedule of Common Stock Reserv
Schedule of Common Stock Reserved for Future Issuance (Details) - shares | Jun. 30, 2023 | Jan. 31, 2023 |
Accumulated Other Comprehensive Income (Loss) [Line Items] | ||
Total common stock for future issuance | 13,625,962 | 3,044,000 |
Warrant [Member] | ||
Accumulated Other Comprehensive Income (Loss) [Line Items] | ||
Total common stock for future issuance | 10,742,404 | |
Share-Based Payment Arrangement, Option [Member] | ||
Accumulated Other Comprehensive Income (Loss) [Line Items] | ||
Total common stock for future issuance | 2,322,576 | |
Restricted Stock Units (RSUs) [Member] | ||
Accumulated Other Comprehensive Income (Loss) [Line Items] | ||
Total common stock for future issuance | 315,540 | |
Future Options [Member] | ||
Accumulated Other Comprehensive Income (Loss) [Line Items] | ||
Total common stock for future issuance | 245,442 |
Common Stock (Details Narrative
Common Stock (Details Narrative) - USD ($) $ / shares in Units, $ in Thousands | 1 Months Ended | 3 Months Ended | 6 Months Ended | 12 Months Ended | ||||||||
Dec. 07, 2022 | Oct. 05, 2022 | Jul. 12, 2021 | Dec. 31, 2022 | Aug. 31, 2021 | Mar. 31, 2021 | Jun. 30, 2023 | Mar. 31, 2023 | Jun. 30, 2022 | Jun. 30, 2023 | Jun. 30, 2022 | Dec. 31, 2021 | |
Accumulated Other Comprehensive Income (Loss) [Line Items] | ||||||||||||
Common stock, par value per share | $ 0.0001 | $ 0.0001 | $ 0.0001 | |||||||||
Proceeds from issuance of common stock, net | $ 2,057 | |||||||||||
Research and development | $ 4,668 | $ 6,348 | $ 10,199 | $ 12,798 | ||||||||
Securities Purchase Agreement [Member] | ||||||||||||
Accumulated Other Comprehensive Income (Loss) [Line Items] | ||||||||||||
Common stock, par value per share | $ 0.0001 | $ 0.0001 | $ 0.0001 | $ 0.0001 | ||||||||
Proceeds from issuance of common stock, net | $ 4,850 | $ 7,900 | $ 5,000 | $ 22,600 | $ 6,400 | |||||||
Issuance of common stock in registered direct offering, net of issuance costs, shares | 5,168,732 | 1,800,000 | 5,168,732 | 1,300,000 | 1,037,405 | |||||||
Shares issued, price per share | $ 0.938 | $ 1.11 | $ 0.94 | |||||||||
Warrants granted for services | $ 200 | |||||||||||
Purchase of warrant shares | 5,407,208 | |||||||||||
Unregistered warrant to purchase shares | 7,207,208 | |||||||||||
Aggregate gross proceeds from issuance of common stock | $ 8,000 | $ 25,000 | $ 7,000 | |||||||||
Medimmune Limited License Agreement [Member] | ||||||||||||
Accumulated Other Comprehensive Income (Loss) [Line Items] | ||||||||||||
Research and development | $ 6,500 | |||||||||||
Common Stock [Member] | ||||||||||||
Accumulated Other Comprehensive Income (Loss) [Line Items] | ||||||||||||
Issuance of common stock in registered direct offering, net of issuance costs, shares | 6,000,000 | |||||||||||
Common Stock [Member] | Medimmune Limited License Agreement [Member] | ||||||||||||
Accumulated Other Comprehensive Income (Loss) [Line Items] | ||||||||||||
Stock issued shares | 884,956 | |||||||||||
Stock issued value | $ 6,500 | |||||||||||
Securities Purchase Agreement [Member] | Common Stock [Member] | ||||||||||||
Accumulated Other Comprehensive Income (Loss) [Line Items] | ||||||||||||
Number of shares | 6,000,000 | |||||||||||
Common stock, par value per share | $ 0.0001 | |||||||||||
Share price | $ 0.38 | |||||||||||
Proceeds from issuance of common stock, net | $ 2,280 | |||||||||||
Proceeds from issuance of stock | $ 2,100 |
Share-based Compensation, Stock
Share-based Compensation, Stock Options, Activity (Details) - $ / shares | 3 Months Ended | 6 Months Ended | |||
Jun. 30, 2023 | Mar. 31, 2023 | Jun. 30, 2022 | Jun. 30, 2023 | Jun. 30, 2022 | |
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] | |||||
Shares Available for Grant, beginning | 455,074 | 396,014 | 396,014 | ||
Shares Available for Grant, Options granted | (377,500) | (54,000) | |||
Number of Shares, Stock option granted | 377,500 | 258,934 | 431,500 | 334,569 | |
Shares Available for Grant, Options cancelled | 167,868 | 113,060 | |||
Shares Available for Grant, ending | 245,442 | 455,074 | 245,442 | ||
Options/RSU Outstanding [Member] | |||||
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] | |||||
Number of Shares, beginning of the period | 2,102,944 | 2,111,379 | 2,111,379 | ||
Weighted-Average Exercise Price, beginning | $ 7.35 | $ 7.36 | $ 7.36 | ||
Number of Shares, Stock option granted | 377,500 | 54,000 | |||
Weighted-Average Exercise Price, Options granted | $ 0.16 | $ 0.46 | |||
Number of Shares, Options cancelled | (157,868) | (62,435) | |||
Weighted-Average Exercise Price, Options cancelled | $ 0.16 | $ 1.72 | |||
Number of Shares, end of the period | 2,322,576 | 2,102,944 | 2,322,576 | ||
Weighted-Average Exercise Price, ending | $ 6.18 | $ 7.35 | $ 6.18 |
Schedule of Share-based Payment
Schedule of Share-based Payment Award, Stock Options, Valuation Assumptions (Details) | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2023 | Jun. 30, 2022 | Jun. 30, 2023 | Jun. 30, 2022 | |
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] | ||||
Expected term | 6 years | 6 years | 6 years | 6 years |
Dividend yield | 0% | 0% | 0% | 0% |
Minimum [Member] | ||||
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] | ||||
Expected volatility | 99% | 99% | 99% | 99% |
Risk-free interest-rate | 4.04% | 2.44% | 4.28% | 1.72% |
Maximum [Member] | ||||
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] | ||||
Expected volatility | 100% | 100% | 100% | 100% |
Risk-free interest-rate | 4.90% | 3.03% | 4.90% | 3.03% |
Schedule of Employee Service Sh
Schedule of Employee Service Share-based Compensation, Allocation of Recognized Period Costs (Details) - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2023 | Jun. 30, 2022 | Jun. 30, 2023 | Jun. 30, 2022 | |
Share-Based Payment Arrangement, Expensed and Capitalized, Amount [Line Items] | ||||
Total | $ 210 | $ 456 | $ 455 | $ 812 |
Research and Development Expense [Member] | ||||
Share-Based Payment Arrangement, Expensed and Capitalized, Amount [Line Items] | ||||
Total | 149 | 169 | 293 | 332 |
General and Administrative Expense [Member] | ||||
Share-Based Payment Arrangement, Expensed and Capitalized, Amount [Line Items] | ||||
Total | $ 61 | $ 287 | $ 162 | $ 480 |
Stock-Based Compensation (Detai
Stock-Based Compensation (Details Narrative) - USD ($) $ / shares in Units, $ in Millions | 1 Months Ended | 3 Months Ended | 6 Months Ended | |||
May 31, 2014 | Jun. 30, 2023 | Jun. 30, 2022 | Jun. 30, 2023 | Jun. 30, 2022 | Jun. 30, 2020 | |
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] | ||||||
Vesting period | 4 years | |||||
Vesting period | 10 years | |||||
Number of shares, stock option granted | 377,500 | 258,934 | 431,500 | 334,569 | ||
Weighted-average grant date fair value | $ 0.16 | $ 0.84 | $ 0.16 | $ 0.95 | ||
Stock option exercised | 0 | 0 | 0 | 0 | ||
Share-Based Payment Arrangement, Option [Member] | ||||||
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] | ||||||
Unrecognized stock-based compensation expenses related to stock options | $ 0.9 | $ 0.9 | ||||
Unrecognized stock-based compensation expenses expected to be recognized | 2 years 3 months 18 days | |||||
2014 Equity Incentive Plan [Member] | ||||||
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] | ||||||
Reserved for issuance | 2,183,692 | |||||
2014 Equity Incentive Plan [Member] | Employees Directors and Consultants [Member] | ||||||
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] | ||||||
Reserved for issuance | 750,000 | 750,000 | ||||
2014 Equity Incentive Plan [Member] | Employees [Member] | Minimum [Member] | ||||||
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] | ||||||
Voting rights of all classes of stock | 10% | |||||
2014 Equity Incentive Plan [Member] | Common Stock [Member] | Employees Directors and Consultants [Member] | ||||||
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] | ||||||
Reserved for issuance | 233,722 |
Related Parties (Details Narrat
Related Parties (Details Narrative) - USD ($) | 1 Months Ended | 3 Months Ended | 6 Months Ended | 12 Months Ended | |||||||
Dec. 07, 2022 | Oct. 05, 2022 | Dec. 31, 2022 | Aug. 31, 2021 | Mar. 31, 2021 | Jul. 31, 2019 | Jun. 30, 2023 | Jun. 30, 2022 | Jun. 30, 2023 | Jun. 30, 2022 | Dec. 31, 2022 | |
Related Party Transaction [Line Items] | |||||||||||
Issuance of common stock, value | $ 2,057,000 | ||||||||||
Total revenue | $ 19,647,000 | $ 292,000 | 20,729,000 | $ 1,479,000 | |||||||
Capitalized contract costs | $ 2,100,000 | $ 0 | $ 0 | $ 2,100,000 | |||||||
Common stock, par value | $ 0.0001 | $ 0.0001 | $ 0.0001 | $ 0.0001 | |||||||
Proceeds from issuance of common stock, net | $ 2,057,000 | ||||||||||
Securities Purchase Agreement [Member] | |||||||||||
Related Party Transaction [Line Items] | |||||||||||
Issuance of common stock in registered direct offering, net of issuance costs, shares | 5,168,732 | 1,800,000 | 5,168,732 | 1,300,000 | 1,037,405 | ||||||
Common stock, par value | $ 0.0001 | $ 0.0001 | $ 0.0001 | $ 0.0001 | 0.0001 | ||||||
Shares issued, price per share | $ 0.938 | $ 1.11 | $ 0.94 | $ 0.94 | |||||||
Proceeds from issuance of common stock, net | $ 4,850,000 | $ 7,900,000 | $ 5,000,000 | $ 22,600,000 | $ 6,400,000 | ||||||
License [Member] | |||||||||||
Related Party Transaction [Line Items] | |||||||||||
Total revenue | $ 19,602,000 | 19,602,000 | |||||||||
Serum International BV [Member] | |||||||||||
Related Party Transaction [Line Items] | |||||||||||
Issuance of common stock in registered direct offering, net of issuance costs, shares | 801,820 | ||||||||||
Issuance of common stock, value | $ 10,000,000 | ||||||||||
Serum International BV [Member] | License [Member] | |||||||||||
Related Party Transaction [Line Items] | |||||||||||
Total revenue | 19,600,000 | ||||||||||
Capitalized contract costs | 2,100,000 | 2,100,000 | |||||||||
Shenzen Hepalink Pharmaceutical Group Co Ltd [Member] | |||||||||||
Related Party Transaction [Line Items] | |||||||||||
Reduction to operating expenses on reimbursed to JV entity | $ 0 | $ 16,000 | |||||||||
Shenzen Hepalink Pharmaceutical Group Co Ltd [Member] | Other Receivables [Member] | |||||||||||
Related Party Transaction [Line Items] | |||||||||||
Reduction to operating expenses on reimbursed to JV entity | $ 17,000 | $ 33,000 |
Schedule of Operating Lease Ass
Schedule of Operating Lease Assets And Liabilities (Details) - USD ($) $ in Thousands | Jun. 30, 2023 | Dec. 31, 2022 | Jan. 01, 2022 |
Commitments and Contingencies Disclosure [Abstract] | |||
ROU assets, net | $ 1,188 | $ 1,417 | $ 1,900 |
Current portion of lease liabilities (included in current liabilities) | 563 | 538 | |
Lease liabilities, less current portion | 1,002 | $ 1,292 | |
Operating Lease, Liability | $ 1,565 | $ 2,300 |
Schedule of Future Minimum Rent
Schedule of Future Minimum Rental Payments for Operating Leases (Details) - USD ($) $ in Thousands | Jun. 30, 2023 | Jan. 01, 2022 |
Commitments and Contingencies Disclosure [Abstract] | ||
Year ending December 31, 2023 | $ 315 | |
Year ending December 31, 2024 | 646 | |
Year ending December 31, 2025 | 666 | |
Thereafter | 57 | |
Total lease payments | 1,684 | |
Less: imputed interest | (119) | |
Present value of operating lease liabilities | $ 1,565 | $ 2,300 |
Commitments and Contingencies_2
Commitments and Contingencies (Details Narrative) | 1 Months Ended | 6 Months Ended | 12 Months Ended | |||||||
Dec. 31, 2021 USD ($) | Feb. 28, 2021 USD ($) | Feb. 29, 2020 USD ($) | Jun. 30, 2023 USD ($) | Dec. 31, 2022 USD ($) | Jan. 01, 2022 USD ($) | Dec. 31, 2020 USD ($) | Oct. 31, 2020 ft² | Nov. 30, 2018 USD ($) | Dec. 31, 2016 USD ($) | |
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | ||||||||||
Incremental borrowing rate | 6% | |||||||||
Percentage of discount | 6% | |||||||||
Right-of-use assets, net | $ 1,188,000 | $ 1,417,000 | $ 1,900,000 | |||||||
Operating lease | 1,565,000 | $ 2,300,000 | ||||||||
Compensatory damages sought | $ 277,000 | |||||||||
Original purchase price | $ 531,687 | |||||||||
Liability recognized | 0 | 0 | ||||||||
Lease Agreement [Member] | ||||||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | ||||||||||
Area of building space | ft² | 15,129 | |||||||||
Leasehold improvements may be reimbursed | $ 378,000 | |||||||||
Initial term | 5 years | |||||||||
Renewal term | 3 years | |||||||||
Amount of letter of credit as security deposit to the Landlord | 500,000 | $ 500,000 | ||||||||
Arrangement Other than Collaborative [Member] | ||||||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | ||||||||||
Deferred Compensation Arrangement with Individual, Cash Award Granted, Amount | $ 7,500,000 | $ 2,900,000 | ||||||||
Kermode Agreement | ||||||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | ||||||||||
Upfront payment received | $ 500,000 | |||||||||
Royalty | 5% | |||||||||
Kermode Agreement | Milestone One [Member] | ||||||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | ||||||||||
Milestone payment received | $ 250,000 | |||||||||
Kermode Agreement | Milestone Two [Member] | ||||||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | ||||||||||
Milestone payment received | $ 250,000 |
Subsequent Events (Details Narr
Subsequent Events (Details Narrative) - USD ($) $ / shares in Units, $ in Thousands | 1 Months Ended | 6 Months Ended | |||||||
Dec. 07, 2022 | Oct. 05, 2022 | Aug. 31, 2023 | Dec. 31, 2022 | Aug. 31, 2021 | Mar. 31, 2021 | Jun. 30, 2023 | Jun. 30, 2022 | Oct. 31, 2022 | |
Subsequent Event [Line Items] | |||||||||
Excercise price, per share | $ 0.001 | $ 0.001 | |||||||
Net proceeds | $ 2,057 | ||||||||
Securities Purchase Agreement [Member] | |||||||||
Subsequent Event [Line Items] | |||||||||
Issuance of common stock in registered direct offering, net of issuance costs, shares | 5,168,732 | 1,800,000 | 5,168,732 | 1,300,000 | 1,037,405 | ||||
Class of Warrant or Right, Number of Securities Called by Warrants or Rights | 5,407,208 | ||||||||
Exercise price | $ 0.938 | $ 1.11 | $ 0.94 | ||||||
Gross proceeds | $ 8,000 | $ 25,000 | $ 7,000 | ||||||
Net proceeds | $ 4,850 | $ 7,900 | $ 5,000 | $ 22,600 | $ 6,400 | ||||
Subsequent Event [Member] | |||||||||
Subsequent Event [Line Items] | |||||||||
Excercise price, per share | $ 0.001 | ||||||||
Subsequent Event [Member] | Securities Purchase Agreement [Member] | |||||||||
Subsequent Event [Line Items] | |||||||||
Gross proceeds | $ 2,000 | ||||||||
Net proceeds | $ 1,700 | ||||||||
Prefunded Warrants [Member] | Securities Purchase Agreement [Member] | |||||||||
Subsequent Event [Line Items] | |||||||||
Class of Warrant or Right, Number of Securities Called by Warrants or Rights | 3,647,556 | ||||||||
Excercise price, per share | $ 0.001 | ||||||||
Warrant [Member] | Securities Purchase Agreement [Member] | |||||||||
Subsequent Event [Line Items] | |||||||||
Class of Warrant or Right, Number of Securities Called by Warrants or Rights | 2,473,778 | ||||||||
Excercise price, per share | $ 5 | ||||||||
Securities Purchase Agreement [Member] | Prefunded Warrants [Member] | |||||||||
Subsequent Event [Line Items] | |||||||||
Issuance of common stock in registered direct offering, net of issuance costs, shares | 1,800,000 | ||||||||
Class of Warrant or Right, Number of Securities Called by Warrants or Rights | 5,407,208 | ||||||||
Exercise price | $ 1.11 | ||||||||
Excercise price, per share | $ 1.109 | ||||||||
Securities Purchase Agreement [Member] | Prefunded Warrants [Member] | Subsequent Event [Member] | |||||||||
Subsequent Event [Line Items] | |||||||||
Issuance of common stock in registered direct offering, net of issuance costs, shares | 4,000,000 | ||||||||
Class of Warrant or Right, Number of Securities Called by Warrants or Rights | 6,000,000 | ||||||||
Exercise price | $ 0.20 | ||||||||
Excercise price, per share | $ 0.1999 | ||||||||
Securities Purchase Agreement [Member] | Warrant [Member] | Subsequent Event [Member] | |||||||||
Subsequent Event [Line Items] | |||||||||
Class of Warrant or Right, Number of Securities Called by Warrants or Rights | 10,000,000 |