Document and Entity Information
Document and Entity Information - shares | 9 Months Ended | |
Sep. 30, 2021 | Oct. 31, 2021 | |
Cover [Abstract] | ||
Document Type | 10-Q | |
Document Quarterly Report | true | |
Document Period End Date | Sep. 30, 2021 | |
Document Transition Report | false | |
Entity File Number | 001-38630 | |
Entity Registrant Name | Aridis Pharmaceuticals, Inc. | |
Entity Incorporation, State or Country Code | DE | |
Entity Tax Identification Number | 47-2641188 | |
Entity Address, Address Line One | 983 University Avenue, 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 | |
Security Exchange Name | NASDAQ | |
Entity Current Reporting Status | Yes | |
Entity Small Business | true | |
Entity Emerging Growth Company | true | |
Entity Ex Transition Period | false | |
Entity Shell Company | false | |
Entity Filer Category | Non-accelerated Filer | |
Entity Interactive Data Current | Yes | |
Entity Common Stock, Shares Outstanding | 14,054,036 | |
Entity Central Index Key | 0001614067 | |
Current Fiscal Year End Date | --12-31 | |
Document Fiscal Year Focus | 2021 | |
Document Fiscal Period Focus | Q3 | |
Amendment Flag | false |
Condensed Consolidated Balance
Condensed Consolidated Balance Sheets - USD ($) | Sep. 30, 2021 | Dec. 31, 2020 |
Current assets: | ||
Cash and cash equivalents | $ 18,221,000 | $ 8,232,000 |
Accounts receivable | 1,000,000 | 0 |
Other receivables | 222,000 | 368,000 |
Contract costs | 1,961,000 | 1,973,000 |
Prepaid expenses | 2,177,000 | 2,182,000 |
Total current assets | 23,581,000 | 12,755,000 |
Property and equipment, net | 1,446,000 | 1,258,000 |
Intangible assets, net | 23,000 | 27,000 |
Restricted cash | 500,000 | 500,000 |
Contract costs, non-current | 102,000 | 90,000 |
Other assets | 433,000 | 487,000 |
Total assets | 26,085,000 | 15,117,000 |
Current liabilities: | ||
Accounts payable | 2,644,000 | 1,886,000 |
Accrued liabilities | 6,560,000 | 1,330,000 |
Deferred revenue | 19,583,000 | 18,748,000 |
Note payable | 0 | 439,000 |
Other liabilities | 100,000 | 37,000 |
Total current liabilities | 28,887,000 | 22,440,000 |
Deferred revenue, non-current | 971,000 | 854,000 |
Note payable, non-current | 0 | 276,000 |
Other liabilities | 382,000 | 228,000 |
Total liabilities | 30,240,000 | 23,798,000 |
Commitments and contingencies (Note 11) | ||
Stockholders' deficit: | ||
Preferred stock (par value $0.0001; 60,000,000 shares authorized; zero shares issued and outstanding as of September 30, 2021 and December 31, 2020) | 0 | |
Common stock (par value $0.0001; 100,000,000 shares authorized; 14,054,036 and 10,065,727 shares issued and outstanding as of September 30, 2021 and December 31, 2020, respectively) | 1,000 | 1,000 |
Additional paid-in capital | 152,329,000 | 114,420,000 |
Accumulated deficit | (156,485,000) | (123,102,000) |
Total stockholders' deficit | (4,155,000) | (8,681,000) |
Total liabilities and stockholders' deficit | $ 26,085,000 | $ 15,117,000 |
Condensed Consolidated Balanc_2
Condensed Consolidated Balance Sheets (Parenthetical) - $ / shares | Sep. 30, 2021 | Dec. 31, 2020 |
Condensed Consolidated Balance Sheets | ||
Preferred stock, par value (in dollars per share) | $ 0.0001 | $ 0.0001 |
Preferred stock, shares authorized (in shares) | 60,000,000 | 60,000,000 |
Preferred stock, shares issued (in shares) | 0 | 0 |
Preferred stock, shares outstanding (in shares) | 0 | 0 |
Common stock, par value (in dollars per share) | $ 0.0001 | $ 0.0001 |
Common stock, shares authorized (in shares) | 100,000,000 | 100,000,000 |
Common stock, shares issued (in shares) | 14,054,036 | 10,065,727 |
Common stock, shares outstanding (in shares) | 14,054,036 | 10,065,727 |
Condensed Consolidated Statemen
Condensed Consolidated Statements of Operations - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2021 | Sep. 30, 2020 | Sep. 30, 2021 | Sep. 30, 2020 | |
Revenue: | ||||
Revenue | $ 515 | $ 548 | $ 1,000 | |
Operating expenses: | ||||
Research and development | 19,842 | $ 4,161 | 29,370 | 12,725 |
General and administrative | 1,699 | 1,631 | 5,337 | 4,853 |
Total operating expenses | 21,541 | 5,792 | 34,707 | 17,578 |
Loss from operations | (21,026) | (5,792) | (34,159) | (16,578) |
Other income (expense): | ||||
Interest income, net | 1 | 6 | 2 | 77 |
Other income | 23 | 52 | ||
Gain on extinguishment of Paycheck Protection Program loan | 722 | |||
Share of loss from equity method investment | 0 | (9) | ||
Net loss | (21,002) | (5,786) | (33,383) | (16,510) |
Deemed dividends | (3,141) | (4,127) | ||
Net loss available to common stockholders | $ (24,143) | $ (5,786) | $ (37,510) | $ (16,510) |
Weighted-average common shares outstanding used in computing net loss per share available to common stockholders, basic and diluted | 12,454,119 | 8,923,374 | 11,314,058 | 8,922,052 |
Net loss per share to common stockholders, basic and diluted | $ (1.94) | $ (0.65) | $ (3.32) | $ (1.85) |
Grant revenue | ||||
Revenue: | ||||
Revenue | $ 417 | $ 417 | $ 1,000 | |
License revenue | ||||
Revenue: | ||||
Revenue | $ 98 | $ 131 |
Condensed Consolidated Statem_2
Condensed Consolidated Statements of Changes in Stockholders' Deficit - USD ($) $ in Thousands | Preferred Stock | Common Stock | Additional Paid-In Capital | Accumulated Deficit | Total |
Balances at the beginning of the period at Dec. 31, 2019 | $ 1 | $ 104,404 | $ (100,769) | $ 3,636 | |
Balances at the beginning of the period (in shares) at Dec. 31, 2019 | 8,918,461 | ||||
Changes in equity | |||||
Exercise of stock options | 14 | 14 | |||
Exercise of stock options (in shares) | 4,913 | ||||
Stock-based compensation | 1,562 | 1,562 | |||
Net loss | (16,510) | (16,510) | |||
Balances at the end of the period at Sep. 30, 2020 | $ 1 | 105,980 | (117,279) | (11,298) | |
Balances at the end of the period (shares) at Sep. 30, 2020 | 8,923,374 | ||||
Balances at the beginning of the period at Jun. 30, 2020 | $ 1 | 105,418 | (111,493) | (6,074) | |
Balances at the beginning of the period (in shares) at Jun. 30, 2020 | 8,923,374 | ||||
Changes in equity | |||||
Stock-based compensation | 562 | 562 | |||
Net loss | (5,786) | (5,786) | |||
Balances at the end of the period at Sep. 30, 2020 | $ 1 | 105,980 | (117,279) | (11,298) | |
Balances at the end of the period (shares) at Sep. 30, 2020 | 8,923,374 | ||||
Balances at the beginning of the period at Dec. 31, 2020 | $ 1 | 114,420 | (123,102) | (8,681) | |
Balances at the beginning of the period (in shares) at Dec. 31, 2020 | 10,065,727 | ||||
Changes in equity | |||||
Issuance of common stock and warrants in registered direct offering, net of issuance costs | 29,711 | 29,711 | |||
Issuance of common stock and warrants in registered direct offering, net of issuance costs (in shares) | 2,337,405 | ||||
Issuance of common stock in connection with license agreement | 6,460 | 6,460 | |||
Issuance of common stock in connection with license agreement (in shares) | 884,956 | ||||
Deemed dividends (in shares) | 759,389 | ||||
Issuance of common stock for consulting services | 33 | 33 | |||
Issuance of common stock for consulting services (in shares) | 5,000 | ||||
Exercise of stock options | 5 | $ 5 | |||
Exercise of stock options (in shares) | 1,559 | 1,559 | |||
Stock-based compensation | 1,700 | $ 1,700 | |||
Net loss | (33,383) | (33,383) | |||
Balances at the end of the period at Sep. 30, 2021 | $ 1 | 152,329 | (156,485) | (4,155) | |
Balances at the end of the period (shares) at Sep. 30, 2021 | 14,054,036 | ||||
Balances at the beginning of the period at Jun. 30, 2021 | $ 0 | $ 1 | 121,995 | (135,483) | (13,487) |
Balances at the beginning of the period (in shares) at Jun. 30, 2021 | 0 | 11,234,480 | |||
Changes in equity | |||||
Issuance of common stock and warrants in registered direct offering, net of issuance costs | 23,294 | 23,294 | |||
Issuance of common stock and warrants in registered direct offering, net of issuance costs (in shares) | 1,300,000 | ||||
Issuance of common stock in connection with license agreement | 6,460 | 6,460 | |||
Issuance of common stock in connection with license agreement (in shares) | 884,956 | ||||
Deemed dividends (in shares) | 634,600 | ||||
Stock-based compensation | 580 | 580 | |||
Net loss | (21,002) | (21,002) | |||
Balances at the end of the period at Sep. 30, 2021 | $ 1 | $ 152,329 | $ (156,485) | $ (4,155) | |
Balances at the end of the period (shares) at Sep. 30, 2021 | 14,054,036 |
Condensed Consolidated Statem_3
Condensed Consolidated Statements of Cash Flows - USD ($) $ in Thousands | 9 Months Ended | |
Sep. 30, 2021 | Sep. 30, 2020 | |
Cash flows from operating activities: | ||
Net loss | $ (33,383) | $ (16,510) |
Adjustments to reconcile net loss to net cash used in operating activities: | ||
Depreciation and amortization | 278 | 252 |
Stock-based compensation expense | 1,700 | 1,562 |
Issuance of common stock in connection with license agreement | 6,460 | |
Issuance of common stock in exchange for consulting services | 33 | |
Gain on extinguishment of Paycheck Protection Program loan | (722) | |
Share of loss from equity method investment | 0 | 9 |
Changes in operating assets and liabilities: | ||
Accounts receivable | (1,000) | |
Other receivables | 335 | 263 |
Prepaid expenses | 5 | 702 |
Contract costs | 0 | (488) |
Other assets | 0 | (30) |
Accounts payable | 824 | (522) |
Accrued liabilities and other | 5,311 | (619) |
Deferred revenue | 952 | |
Net cash used in operating activities | (19,207) | (15,381) |
Cash flows from investing activities: | ||
Purchase of property and equipment | (573) | (33) |
Net cash used in investing activities | (573) | (33) |
Cash flows from financing activities: | ||
Proceeds from issuance of common stock and warrants, net | 29,764 | |
Proceeds from Paycheck Protection Program loan | 0 | 715 |
Proceeds from stock option exercises | 5 | 14 |
Net cash provided by financing activities | 29,769 | 729 |
Net decrease in cash, cash equivalents and restricted cash | 9,989 | (14,685) |
Cash, cash equivalents and restricted cash at: | ||
Beginning of period | 8,732 | 20,897 |
End of period | 18,721 | 6,212 |
Supplemental cash flow disclosures: | ||
Cash paid for taxes | 2 | $ 2 |
Supplemental noncash investing and financing activities: | ||
Property and equipment additions | $ 119 |
Description of Business and Bas
Description of Business and Basis of Presentation | 9 Months Ended |
Sep. 30, 2021 | |
Description of Business and Basis of Presentation | |
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 complimented 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 (unaudited) include the accounts 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 Rule 10-01 of Regulation S-X. Accordingly, they do not include all the information and footnotes required by GAAP for complete financial statements. The condensed consolidated financial statements (unaudited) have been prepared on the same basis as the annual consolidated financial statements. In the opinion of management, the accompanying condensed consolidated financial statements (unaudited) reflect all adjustments (consisting only of normal recurring adjustments) considered necessary for a fair presentation. These condensed consolidated financial statements (unaudited) 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 March 30, 2021. The condensed consolidated financial statements (unaudited) include the accounts of the Company and its two wholly-owned subsidiaries, Aridis Biopharmaceuticals, LLC and Aridis Pharmaceuticals, C.V. All intercompany balances and transactions have been eliminated in consolidation. The Company operates in one segment. Management uses one measurement of profitability and does not segregate its business for internal reporting. COVID-19 The COVID-19 outbreak in the United States has caused business disruption. The extent of the impact of COVID-19 on the Company’s operational and financial performance will depend on certain developments, including the duration and spread of the outbreak, and impact on the Company’s clinical trials, employees and vendors, all of which are uncertain and cannot be predicted. The on-going COVID-19 pandemic has caused an impact on patient enrollment globally and the rate of clinical site activations and depending on the rate of resolution of the on-going COVID-19 pandemic, it could further delay the progress of the Company’s clinical trials. In addition, the manufacturing of clinical trial drug supplies has been delayed. At this point, however, the extent to which COVID-19 may impact the Company’s financial condition or results of operations is uncertain. Going Concern The Company has had recurring losses from operations since inception and negative cash flows from operating activities during the three and nine months ended September 30, 2021 and the year ended December 31, 2020. Management expects to incur additional operating losses and negative cash flows from operations in the foreseeable future as the Company continues its product development programs. The Company’s research and development expenses and resulting cash burn during the nine months ended September 30, 2021, were largely due to costs associated with the Phase 3 study of AR-301 for the treatment of ventilator associated pneumonia (“VAP”) caused by the Staphylococcus aureus (S. aureus) S. aureus The on-going COVID-19 pandemic is affecting the United States and global economies. The pandemic has affected the Company and is likely to continue to affect the Company and its third parties, on which the Company relies, by causing disruptions in the clinical trial supplies for the product candidates and the conduct of current and future clinical trials. Additionally, as the duration of the COVID-19 pandemic is difficult to assess or predict, the impact of the COVID-19 pandemic on the global financial markets may reduce our ability to access capital, which could negatively impact the Company’s short-term and long-term liquidity. These effects could have a material impact on the Company’s liquidity, capital resources, operations and business and those of the third parties on which the Company relies. The Company plans to fund its losses from operations through current cash on hand and future debt and 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 will not be sufficient to fund its planned expenditures and meet the Company’s obligations for at least the one-year period following its condensed consolidated financial statement issuance date. 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 | 9 Months Ended |
Sep. 30, 2021 | |
Summary of Significant Accounting Policies | |
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. Concentration of Risk 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 For the three months ended September 30, 2021, one customer accounted for 81% of total revenue and the other customer accounted for 19% of total revenue, and for the nine months ended September 30, 2021, one customer accounted for 76% of total revenue and the other customer accounted for 24% of total revenue. For the nine months ended September 30, 2020 one customer accounted for 100% of total revenue. There was no revenue for the three months ended September 30, 2020. Both customers are located in the United States. As of September 30, 2021, there was one customer that accounted for 100% of accounts receivable and as of December 31, 2020, there were no accounts receivable. 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. 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): September 30, December 31, 2021 2020 Cash and cash equivalents $ 18,221 $ 8,232 Restricted cash 500 500 Total cash, cash equivalents and restricted cash $ 18,721 $ 8,732 Accounts Receivable and Allowance for Doubtful Accounts Accounts receivable are recorded at the invoiced amount and do not bear interest. The Company considers the credit worthiness 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 September 30, 2021 there was $1.0 million in accounts receivable and no allowance for doubtful accounts and as of December 31, 2020, there were no accounts receivable Property and Equipment Property and equipment are stated at cost less accumulated depreciation. Depreciation and amortization is computed using the straight-line method over the estimated useful lives of the assets, generally between three 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 such impairments of long-lived assets as of September 30, 2021 and December 31, 2020. 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 or not 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. For the three and nine months ended September 30, 2021 and 2020, there was no amortization of the contract assets and there have been no impairments as of September 30, 2021. Deferred Revenue 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 September 30, 2021 and December 31, 2020 (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. Comprehensive Loss The Company has no items of comprehensive income or loss other than net loss. Loss Per Share Basic loss per share is calculated by dividing net loss for the period by the weighted-average number of common shares outstanding during the period, without consideration for potentially dilutive securities. Diluted net loss per share is computed by dividing the net loss by the weighted-average number of common shares and potentially dilutive securities outstanding for the period. In March 2021 and in August 2021, the Company issued 124,789 and 634,600 dividend shares, respectively, to certain common stockholders with a fair value of approximately $986,000 and approximately $3.1 million, respectively, For the three and nine months ended September 30, 2021 and 2020, there is no difference in the number of shares used to compute basic and diluted net loss per share due to the Company’s net loss position. The following table presents the computation of the basic and diluted net loss per share to common stockholders (in thousands, except share and per share data): Three Months Ended Nine Months Ended September 30, September 30, 2021 2020 2021 2020 Numerator: (unaudited) (unaudited) (unaudited) (unaudited) Net loss available to common stockholders (basic and diluted) $ (24,143) $ (5,786) $ (37,510) $ (16,510) Denominator: Weighted-average common shares outstanding used in computing net loss per share available to common stockholders, basic and diluted 12,454,119 8,923,374 11,314,058 8,922,052 Net loss per share to common stockholders, basic and diluted $ (1.94) $ (0.65) $ (3.32) $ (1.85) The following potentially dilutive securities were excluded from the computation of diluted net loss per share for the periods presented because including them would have been antidilutive: Three & Nine Months Ended September 30, 2021 2020 (unaudited) (unaudited) Stock options to purchase common stock 1,739,743 1,543,978 Common stock warrants 4,106,569 1,733,322 Pre-funded common stock warrants 3,647,556 — 9,493,868 3,277,300 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. Recently Issued Accounting Pronouncements not yet adopted as of September 30, 2021 Accounting Standards Update 2016-02 and 2018-11 In February 2016, the FASB issued ASU 2016-02, Leases (ASC 842) Leases Leases (ASC 842)—Targeted Improvements Codification improvements This guidance was effective for public business entities for fiscal years beginning after December 15, 2018, including interim periods within those fiscal years. In November 2019, the FASB deferred the effective date for adopting the leasing standard updates for private companies, not-for-profit organizations, and smaller reporting companies. In June 2020, the FASB issued additional deferral guidance that defers the effective date of the leasing standard updates for one year for entities in the “all other” category and public not-for-profit entities that have not yet issued financial statements adopting the standard. The deferrals of the standard are intended to provide relief to nonpublic companies and not-for-profit entities that have had their implementation efforts delayed by the COVID-19 pandemic. Accounting Standards Update 2016-13 In June 2016, the FASB issued ASU 2016-13, “ Financial Instruments—Credit Losses (ASC 326) Accounting Standards Update 2019-12 In December 2019, the FASB issued ASU 2019-12, “ Simplifying the Accounting for Income Taxes (ASC 740) |
Fair Value Disclosure
Fair Value Disclosure | 9 Months Ended |
Sep. 30, 2021 | |
Fair Value Disclosure | |
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 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 carrying value of the Company’s cash and cash equivalents, prepaid expenses and other current assets, other assets, accounts payable, accrued liabilities, and note payable approximate fair value due to the short-term nature of these items. |
Balance Sheet Components
Balance Sheet Components | 9 Months Ended |
Sep. 30, 2021 | |
Balance Sheet Components | |
Balance Sheet Components | 4. Balance Sheet Components Property and Equipment, net Property and equipment, net consist of the following (in thousands): September 30, December 31, 2021 2020 (unaudited) Lab equipment $ 2,329 $ 2,200 Computer equipment and software 25 25 Construction in progress 521 188 Total property and equipment 2,875 2,413 Less: Accumulated depreciation (1,429) (1,155) Property and equipment, net $ 1,446 $ 1,258 Depreciation expense was approximately $93,000 and $83,000 for the three months ended September 30, 2021 and 2020, respectively, and approximately $274,000 and $248,000 for the nine months ended September 30, 2021 and 2020, respectively. In October 2020, the Company entered into a lease agreement for its new headquarters facility in Los Gatos, California (see Note 12). The Company moved into the new facility in December 2020 and recorded approximately $521,000 and $188,000 as of September 30, 2021 and December 31, 2020, respectively, in construction in progress related to leasehold improvements made by the Company related to the new facility. Intangible Assets, net Intangible assets, net consist of the following (in thousands): September 30, December 31, 2021 2020 (unaudited) Licenses $ 81 $ 81 Less: Accumulated amortization (58) (54) Intangible assets, net $ 23 $ 27 Amortization expense was approximately $1,000 and $2,000 for the three months ended September 30, 2021 and 2020, respectively, and approximately $4,000 for both nine month periods ended September 30, 2021 and 2020. Licenses The Broad Institute of MIT and Harvard — Non-Exclusive Manufacturing Licensing Agreement The Company entered into a non-exclusive manufacturing licensing agreement with the Broad Institute of MIT and Harvard University (the “Broad Institute”) in January 2021 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 ʎPEX TM Pursuant to this agreement, the Company is obligated to pay to the Broad Institute an issue fee of $25,000, an annual license maintenance fee of $50,000 in 2022, and fees of $100,000 in 2023 and each year thereafter. Additionally, the Company is obligated to pay a royalty of a single digit percentage of all service income received from a customer for the manufacture, sale or transfer of CRISPR modified cell line, CRISPR Modified Animals and CRISPR Modified Plants or end products, as well as a small royalty (a fraction of a percent) on end product net sales from use of any commercialized product that contains any small or large molecule made through the use of a CRISPR modified cell line, CRISPR Modified Animals and CRISPR Modified Plants. The term of the license agreement continues until all patents and filed patent applications, included within the licensed Broad Institute patents, have expired or been abandoned. 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 shares of its common stock to MedImmune and a $5.0 million cash payment is due to MedImmune upon the earlier of (i) a registered direct offering in which the Company receives third-party funding or (ii) December 31, 2021. The $5.0 million liability has not been paid and therefore has been included in accrued liabilities within the Company’s condensed consolidated balance sheet at September 30, 2021, and recorded as research and development expense within its condensed consolidated statement of operations for the three and nine months ended September 30, 2021. The fair value of the 884,956 shares of the Company’s common stock issued in connection with the MedImmune License agreement is approximately $6.5 million (see Note 9) which the Company recognized as research and development expense within its condensed consolidated statement of operations and additional paid-in capital within equity in its condensed consolidated balance sheet during the three and nine months ended September 30, 2021. 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 million and sales related milestone payments of up to $85.0 million. There are no development milestone payments. MedImmune is entitled to royalty payments based on aggregate net sales in the low to mid-teens. Further, until delivery of an interim data readout, or an interim futility analysis, from the first Phase 3 clinical study for any indication, MedImmune has a right of first negotiation regarding any commercial rights that the Company intends to sub-license. The term of the MedImmune License Agreement continues until the expiration of the last royalty term for the last licensed product as defined in the license agreement. Accrued Liabilities Accrued liabilities consist of the following (in thousands): September 30, December 31, 2021 2020 (unaudited) License fees $ 5,008 $ — Research and development services 957 872 Payroll related expenses 341 279 Professional services and other 254 179 Accrued liabilities $ 6,560 $ 1,330 |
Equity Method Investment
Equity Method Investment | 9 Months Ended |
Sep. 30, 2021 | |
Equity Method Investment | |
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 million and the license of its technology relating to the Company’s AR-101 and AR-301 product candidates for use in the joint venture company named Shenzhen Arimab BioPharmaceuticals Co., Ltd. (the “JV Entity”) in the territories of the Republic of China, Hong Kong, Macau and Taiwan (the “Territory”) and initially owns 49% of the JV Entity. On July 2, 2018, the JV Entity received final approval from the government of the People’s Republic of China. 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 (see Note 11). 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% of the JV Entity and is obligated to contribute the equivalent of $7.2 million to the JV Entity. Additionally, Hepalink is obligated to make an additional equity investment of $10.8 million or more at the time of the JV Entity’s first future financing. 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 million which represents the Company’s contribution into the JV Entity. The Company’s license contributed to the JV Entity was recorded at its carryover basis of zero. The Company recognized losses from the operations of the JV Entity of zero and $9,000 for the nine months ended September 30, 2021 and 2020, respectively. The Company did not recognize any losses from the operations of the JV Entity for the three months ended September 30, 2021 and 2020, as the net book value of the equity method investment has been zero since March 31, 2020. |
Collaboration, Development and
Collaboration, Development and License Agreements | 9 Months Ended |
Sep. 30, 2021 | |
Collaboration, Development and License Agreements | |
Collaboration, Development and License Agreements | 6. Development and License Agreements 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 million. Under the CFF Agreement, CFF made an upfront payment of $200,000 and will make milestone payments to the Company as certain milestones defined in the agreement are met. The milestones relate to pre-clinical and clinical research activities. The agreement also specifies that we are obligated to cumulatively spend on the development program at least an equal amount that the Company receives from the CFF. In the event that we do not spend as much as we received under the agreement, we are obligated to return any overage to the CFF. In November 2018, the CFF increased the award to approximately $7.5 million. 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 clinical research activities related to the Phase 1 MAD clinical trial and the Phase 2a clinical trial that had not been started were evaluated to determine if they should be considered variable consideration or contingent promises akin to optional purchases under ASC 606. The Company concluded that these two promises that have not been started are contingent promises because there is substantive uncertainty about the contingent event occurring (i.e. milestones being achieved) and the contingent event requires additional distinct services and incremental payments from the CFF. The Company determined that these contingent promises did not provide the CFF with any material rights. The Phase 1 MAD clinical trial and the Phase 2a clinical trial will be accounted for as separate contracts at the time the Company is obligated to perform the underlying clinical research activities. 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 million, and the one development-based milestone in progress as of the Adoption Date of $1.0 million became probable during the quarter ended March 31, 2019. Prior to March 31, 2019, the amount of the one development-based milestone in progress as of the Adoption Date could not be included in the transaction price as it was contingent on successful completion of Phase 1 SAD clinical trial, and it was not probable that significant reversal of cumulative revenue recognized would not occur if this milestone were included in the transaction price. The Company determined the consideration for the Phase 1 MAD clinical trial contract included one development-based milestone of $1.0 million which became probable of achievement and was achieved during the quarter ended June 30, 2020. Prior to June 30, 2020, the amount of the one development-based milestone could not be included in the transaction price for this contract as it was contingent on successful completion of the Phase 1 MAD clinical trial, and it was not probable that a significant reversal of cumulative revenue recognized would not occur if this milestone were included in the transaction price. The Company determined the consideration for the Phase 2a clinical trial contract totals approximately $3.8 million which includes four development-based milestones. The milestones under the CFF Agreement are development-based milestones related to pre-clinical and clinical research activities and the realization of or recognition of revenue associated with the milestones as determined by the completion of the milestones and, if applicable, review and approval of the achievement by the CFF. Each development-based milestone payment has specific criteria that needs to be met, some examples of which include, the completion of certain study activities and approval to move to the next activity. At every reporting period, the Company evaluates the individual facts and circumstances of the development-based milestone to assess whether the revenue attributable to the development-based milestone in progress should be constrained. The constraint assessment by the Company includes an analysis of the key judgements and considerations used for each milestone which include, but are not limited to, the nature and amount of work to be performed, if the work is subject to the approval of the CFF, clinical data and uncertainty with regards to the results of the clinical studies, and the probability of successful clinical studies. The constraint will be removed once the Company achieves the development-based milestone or has determined that there is probable completion of the development-based milestone, and it has also concluded that it is not probable that revenue recognized attributable to the development-based milestone will result in a significant reversal of revenue in the future. 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. For the three and nine months ended September 30, 2021, the Company recognized revenue of approximately $417,000 from the CFF Agreement, 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 $5.0 million upon execution of this option agreement. In connection with the option agreement, SIBV made an equity investment whereby the Company issued 801,820 shares of its restricted common stock in a private placement to SIBV for total gross proceeds of $10.0 million. As a result of this transaction, SIBV and its affiliates, are considered related parties to the Company. 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”). Under the License Agreement, the Company received upfront payments totaling $15.0 million, of which $5.0 million was received in July 2019 through the option agreement referred to above. 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 and AR-201 in certain territories as defined in the License Agreement (the “licenses and know-how”), and granted 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 of these products in certain territories (the “research and development option”). Further, under the License Agreement the Company will provide development support related to the licensed products in order to assist SAMR in its efforts around 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 does not allow for manufacturing of certain products. 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 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 certain territories by paying to SAMR $5.0 million. 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 million, which represented the fair value of the restricted common stock issued of $5.4 million, net of $441,000 of issuance costs, to stockholders’ equity within the Company’s consolidated balance sheet as of December 31, 2019. The Company allocated the net $4.6 million from the equity investment, after deducting commissions and offering costs, to the License Agreement. Therefore, the Company recorded approximately $19.6 million to deferred revenue based on the $15.0 million from upfront payments under the License Agreement and approximately $4.6 million from the equity allocation. 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 million, conditioned upon the achievement of specified milestones related to completion of certain trials and regulatory approvals as defined in the License Agreement. Further, the Company may receive additional royalty-based payments from SAMR if certain sales levels on licensed products are achieved as defined in the License Agreement. The Company concluded that these milestones and royalty payments each contain a significant uncertainty associated with a future event. As such, these milestone and royalty payments are constrained at contract inception and are not included in the transaction price as the Company could not conclude that it is probable a significant reversal in the amount of cumulative revenue recognized will not occur surrounding these payments. At the end of each reporting period, the Company will update its assessment of whether the milestone and royalty payments are constrained by considering both the likelihood and magnitude of the potential revenue reversal. At September 30, 2021 and December 31, 2020 the Company performed an assessment and determined that these milestone and royalty payments are constrained. The Company determined that the transaction price under the License Agreement was $19.6 million, consisting of the $15.0 million from upfront payments under the License Agreement and approximately $4.6 million from the equity allocation as noted above, which was allocated among the performance obligations and material promises based on their respective related standalone selling prices. The Company allocated the $19.6 million transaction price to the following: approximately $14.5 million to the licenses and know-how; approximately $79,000 to the development support services; approximately $892,000 to the research and development option; and approximately $4.1 million to the manufacturing rights option. The Company determined that the intellectual property licensed under the License Agreement represents functional intellectual property and it has significant standalone functionality and therefore should be recognized at a point in time upon satisfying the performance obligations. The Company will satisfy the performance obligations upon transfer of the licenses and know-how to SAMR, and expects to satisfy these performance obligations by the end of the third quarter of 2022. The Company determined that no performance obligations or material promises were satisfied as of September 30, 2021, and therefore, no revenue related to the License Agreement was recognized for the three and nine months ended September 30, 2021 and 2020. The Company has recorded contract liabilities resulting from the License Agreement of approximately $18.6 million and $18.7 million to deferred revenue, current, and approximately $971,000 and $854,000 to deferred revenue, noncurrent, on its condensed consolidated balance sheets as of September 30, 2021 and December 31, 2020, respectively. The Company capitalized a contract asset resulting from the License Agreement of approximately $2.1 million related to the incremental costs of obtaining the License Agreement on its condensed consolidated balance sheets, of which approximately $2.0 million and $2.0 million is classified as current, and approximately $102,000 and $90,000 is classified as noncurrent, as of September 30, 2021 and December 31, 2020, respectively. K ermode 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 and will receive two milestone payments of $250,000 each from Kermode after certain research and development phases in the agreement are completed. The Kermode Agreement defines four phases of research and development activities. The Company is also entitled to royalty payments based on future net sales if Kermode is ultimately successful in commercializing product candidates. 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 September 30, 2021, the transaction price of the Kermode Agreement was $500,000, consisting of the nonrefundable upfront payment. The two milestone payments, totaling $500,000, and potential royalty payments were not included in the transaction price, as it was not probable that a significant reversal of cumulative revenue recognized would not occur if these amounts were included. At the end of each reporting period, the Company will update its assessment of whether the milestone payments and royalties are constrained by considering both the likelihood and magnitude of the potential revenue reversal. 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. For the three and nine months ended September 30, 2021, the Company recognized approximately $98,000 and $131,000, respectively, in revenue related to the Kermode Agreement. The Company has recorded the remaining portion of the nonrefundable upfront payment as a contract liability of approximately $369,000 to deferred revenue, current, on its condensed consolidated balance sheet as of September 30, 2021. |
Paycheck Protection Program Loa
Paycheck Protection Program Loan | 9 Months Ended |
Sep. 30, 2021 | |
Paycheck Protection Program Loan | |
Paycheck Protection Program Loan | 7. Paycheck Protection Program Loan The Company applied for and received a loan, which is in the form of a note dated May 1, 2020, from Silicon Valley Bank (“SVB”) in the aggregate amount of approximately $715,000 (the “Loan”), pursuant to the Paycheck Protection Program (the “PPP”). The PPP, established as part of the Coronavirus Aid, Relief and Economic Security Act (“CARES Act”), provides for loans to qualifying businesses for amounts up to 2.5 times of the average monthly payroll expenses of the qualifying business. The loans and accrued interest may be forgiven as long as the borrower uses the loan proceeds for eligible purposes, including payroll, benefits, rent and utilities, and maintains its payroll levels. The amount of loan forgiveness will be reduced if the borrower terminates employees or reduces salaries during the covered period. The Loan was payable over two years at an interest rate of 1% per annum, with an estimated deferral of payments until mid-2021. The Company is required to pay principal and interest on the Loan in equal monthly installments estimated to begin in mid-2021 and the outstanding interest balance accrued during the deferral period is to be paid on the maturity date, which is May 1, 2022. The Loan may be prepaid by the Company at any time prior to maturity with no prepayment penalties. The Loan contains events of default (as defined in the PPP Loan agreement), in which the occurrence could result in the acceleration of all amounts due under the Loan. The Company’s Loan forgiveness application was submitted to the Small Business Administration (“SBA”) in October 2020. Since the forgiveness of the Loan was outside the Company’s control, the Company accounted for its PPP Loan as debt. At December 31, 2020, the Company recognized the entire amount of the PPP Loan proceeds of approximately $715,000 as a note payable, and classified approximately $439,000 as current and $276,000 as noncurrent, in its condensed consolidated balance sheet. The Company recognized approximately $0 and $3,000, for the three and nine months ended September 30, 2021, respectively, and for the three and nine months ended September 30, 2020, the Company recognized approximately $1,000 and $3,000, respectively, in interest expense in its condensed consolidated statements of operations. In May 2021, the Company received confirmation that the PPP Loan was forgiven by the SBA and was legally released from its financial obligation by the lender, SVB. As such, for the nine months ended September 30, 2021, the Company recognized in its condensed consolidated statement of operations a gain on extinguishment of PPP Loan of approximately $722,000, which includes the PPP Loan principal of approximately $715,000 and accrued interest of approximately $7,000. At September 30, 2021, the Company had no liabilities related to the PPP Loan recorded in its condensed consolidated balance sheet. |
Warrants
Warrants | 9 Months Ended |
Sep. 30, 2021 | |
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 shares of its Common Stock, pre-funded warrants to purchase up to an aggregate of 3,647,556 shares of Common Stock (the ”Pre-Funded Warrants”), and warrants to purchase up to 2,473,778 shares of Common Stock (the “Warrants”). The combined purchase price of each share of Common Stock and accompanying Warrants is $5.053 per share. The combined purchase price of each Pre-Funded Warrant and accompanying Warrant is $5.052 (equal to the combined purchase price per share of Common Stock and accompanying Warrant, minus $0.001). The Company received gross proceeds of approximately $25.0 million, and after deducting the placement agent fees and expenses and offering costs, net proceeds were approximately $23.3 million (see Note 9). Each Warrant is exercisable for one share of Common Stock at an exercise price of $5.00 per share. The Warrants are immediately exercisable and will expire seven years from the original issuance date, or August 4, 2028. 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 Offering would otherwise result in the Purchaser, together with its affiliates and certain related parties, beneficially owning more than 4.99% (or, at the election of the Purchaser, 9.99%) of the Company’s outstanding Common Stock immediately following the consummation of this Offering. Each Pre-Funded Warrant is exercisable for one share of Common Stock at an exercise price of $0.001 per share. The Pre-Funded Warrants are immediately exercisable and may be exercised at any time until all of the Pre-Funded Warrants are exercised in full. A holder (together with its affiliates) may not exercise any portion of the Warrant or Pre-Funded Warrant, as applicable, to the extent that the holder would own more than 4.99% (or, at the holder’s option upon issuance, 9.99%) of the Company’s outstanding Common Stock immediately after exercise, as such percentage ownership is determined in accordance with the terms of the Warrant or Pre-Funded Warrant, as applicable. The exercise price of the Warrants and the Pre-Funded Warrants are subject to adjustment in the event of any stock dividends and splits, reverse stock split, recapitalization, reorganization or similar transaction, as described in the Warrants and Pre-Funded Warrants. Each of the Warrants and the Pre-Funded Warrants may be exercised on a “cashless” basis under certain circumstances set forth in the Warrants and Pre-Funded Warrants. 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, expected volatility of approximately 97%, risk-free interest rate of 0.96%, and dividend yield of 0%. The Company used the relative fair value method to allocate the net proceeds received from the sale of the Common Stock, the Pre-Funded Warrants and the Warrants of approximately $23.3 million. The Company recorded approximately $4.4 million, $12.2 million and $6.7 million, which represented the relative fair value of the Common Stock, Pre-Funded Warrants and Warrants, respectively, to stockholders’ deficit within the Company’s condensed consolidated balance sheet. |
Common Stock
Common Stock | 9 Months Ended |
Sep. 30, 2021 | |
Common Stock | |
Common Stock | 9. Common Stock As of September 30, 2021 (unaudited), the Company had reserved the following common stock for future issuance: Shares reserved for exercise of outstanding warrants to purchase common stock 4,106,569 Shares reserved for exercise of outstanding pre-funded warrants to purchase common stock 3,647,556 Shares reserved for exercise of outstanding options to purchase common stock 1,739,743 Shares reserved for issuance of future options 393,815 Total 9,887,683 March 2021 Securities Purchase Agreement 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 shares (the “Shares”) of the Company’s common stock, par value $0.0001 per share (“Common Stock”) for aggregate gross proceeds to the Company of approximately $7.0 million, and after deducting commissions and offering costs, net proceeds were approximately $6.4 million. In October 2020, shares of Common Stock were sold in a registered direct offering in which each share contains a price based anti-dilution rights. If the Company issues additional securities at a purchase price less than the purchase price paid by these respective holders, the Company shall issue additional common shares equal to the difference of the number of common shares that each respective shareholder would have received if they paid the subsequent lower price, and the number of shares each respective shareholder originally received. As a result of the March 2021 registered direct offering price per share being less than the October 2020 registered direct offering price per share, the Company was obligated to issue an additional 124,789 shares of unregistered Common Stock to the investors in the Company’s October 2020 registered direct offering pursuant to the anti-dilutive provisions of the October 2020 Securities Purchase Agreement. In March 2021, the Company issued 124,789 dividend shares to certain common stockholders with a fair value of approximately $986,000, which the Company recorded as a credit to additional paid-in capital, and since the Company has an accumulated deficit, the corresponding debit to additional paid-in capital, resulting in no dollar impact within the Company’s condensed consolidated statement of changes in stockholders’ deficit for the nine months ended September 30, 2021. 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 alpha toxin (see Note 4). As part of the consideration for the MedImmune License Agreement, the Company issued 884,956 shares of its’s common stock to MedImmune. The fair value of the 884,956 shares of the Company’s common stock issued in connection with the MedImmune License agreement is approximately $6.5 million. The Company measured the fair value of the common stock issued to MedImmune based on the Company’s closing stock price on the effective date of the MedImmune License Agreement. The Company recognized the $6.5 million as research and development expense within its condensed consolidated statement of operations and additional paid-in capital within equity in its condensed consolidated balance sheet during the three and nine months ended September 30, 2021. August 2021 Securities Purchase Agreement 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 shares of its Common Stock, pre-funded warrants to purchase up to an aggregate of 3,647,556 shares of Common Stock (the “Pre-Funded Warrants”), and warrants to purchase up to 2,473,778 shares of Common Stock (the “Warrants”). The combined purchase price of each share of Common Stock and accompanying Warrants is $5.053 per share. The combined purchase price of each Pre-Funded Warrant and accompanying Warrant is $5.052 (equal to the combined purchase price per share of Common Stock and accompanying Warrant, minus $0.001). The Company received gross proceeds of approximately $25.0 million, and after deducting the placement agent fees and expenses and offering costs, net proceeds were approximately $23.3 million (see Note 8). As a result of this registered direct offering price per share being less than the October 2020 and March 2021 registered direct offerings price per share, the Company was obligated to issue an additional 634,600 shares of unregistered Common Stock to the investors in the Company’s October 2020 and March 2021 registered direct offerings pursuant to the anti-dilutive provisions of the October 2020 and March 2021 Securities Purchase Agreements. In August 2021, the Company issued 634,600 dividend shares to certain common stockholders with a fair value of approximately $3.1 million, which the Company recorded as a credit to additional paid-in capital, and since the Company has an accumulated deficit, the corresponding debit to additional paid-in capital, resulting in no dollar impact within the Company’s condensed consolidated statement of changes in stockholders’ deficit for the nine months ended September 30, 2021. |
Stock-Based Compensation
Stock-Based Compensation | 9 Months Ended |
Sep. 30, 2021 | |
Stock-Based Compensation | |
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 shares of the Company’s common stock were initially reserved for the issuance of stock options to employees, directors, and consultants, under terms and provisions established by the Board of Directors. Under the terms of the 2014 Plan, options may be granted at an exercise price not less than fair market value. For employees holding more than 10% of the voting rights of all classes of stock, the exercise prices for incentive stock options may not be less than 110% of fair market value, as determined by the Board of Directors. The terms of options granted under the 2014 Plan may not exceed ten years. 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 shares was approved by the Company’s stockholders. 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 and expire ten years from the date of grant. Stock option activity for the nine months ended September 30, 2021 is represented in the following table: Options Outstanding Weighted- Shares Available Number of Average for Grant Shares Exercise Price Balances at December 31, 2020 584,161 1,550,956 $ 9.43 Additional shares reserved — — — Options granted (224,140) 224,140 7.20 Options exercised — (1,559) 2.89 Options cancelled 33,794 (33,794) 10.81 Balances at September 30, 2021 393,815 1,739,743 $ 9.12 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 nine months ended September 30, 2021 and the three and nine months ended September 30, 2020 were estimated using the following assumptions: Three Months Ended Nine Months Ended September 30, September 30, 2021 2020 2021 2020 Expected term (in years) — 6.00 6.00 6.00 Expected volatility — 99% 99% - 100% 84% - 99% Risk-free interest-rate — 0.38% 0.75% - 1.14% 0.38% - 1.73% Dividend yield — 0% 0% 0% During the three months ended September 30, 2021, the Company did not There were no options exercised during both three month periods ended September 30, 2021 and 2020. There were 1,559 options exercised during the nine months ended September 30, 2021, and the aggregate intrinsic value of these options exercised was approximately $5,000. There were 4,913 options exercised during the nine months ended September 30, 2020, and the aggregate intrinsic value of these options exercised was approximately $17,000. Stock-Based Compensation The following table presents stock-based compensation expense related to stock options (in thousands): Three Months Ended Nine Months Ended September 30, September 30, 2021 2020 2021 2020 (unaudited) (unaudited) (unaudited) (unaudited) Research and development $ 170 $ 156 $ 502 $ 431 General and administrative 410 406 1,198 1,131 Total $ 580 $ 562 $ 1,700 $ 1,562 As of September 30, 2021, total unrecognized stock-based compensation expenses related to unvested stock options was approximately $2.8 million, which is expected to be recognized on a straight-line basis over a weighted-average period of approximately 2.0 years. |
Related Parties
Related Parties | 9 Months Ended |
Sep. 30, 2021 | |
Related Parties | |
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 September 30, 2021 and 2020, the Company recorded approximately $14,000 and $0, respectively, and for the nine months ended September 30, 2021 and 2020, the Company recorded approximately $60,000 and $184,000, respectively, as a reduction to operating expenses in the condensed consolidated statements of operations for amounts reimbursed to the Company by the JV Entity under this arrangement. As of September 30, 2021 and December 31, 2020, the Company recorded approximately $28,000 and $3,000, respectively, in other receivables on the condensed consolidated balance sheets for amounts owed to the Company by the JV Entity under this arrangement and the Company expects the amounts to be collectable and as a result, no reserve for uncollectability was established. Serum International B.V. In July 2019, the Company issued 801,820 shares of its restricted common stock in a private placement to Serum International B.V. (“SIBV”), an affiliate of Serum Institute of India Private Limited, for total gross proceeds of $10.0 million. As a result of this transaction, SIBV and its affiliates are considered related parties to the Company. 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”) (see Note 6). The Company determined that no performance obligations or material promises were satisfied as of September 30, 2021, and therefore, no revenue related to the License Agreement was recognized for the three and nine months ended September 30, 2021 and, 2020. The Company has recorded contract liabilities resulting from the License Agreement of approximately $18.6 million and $18.7 million to deferred revenue, current, and approximately $971,000 and $854,000 to deferred revenue, noncurrent, on its condensed consolidated balance sheets as of September 30, 2021 and December 31, 2020, respectively. The Company capitalized a contract asset resulting from the License Agreement of approximately $2.1 million related to the incremental costs of obtaining the License Agreement on its condensed consolidated balance sheets, of which approximately $2.0 million and $2.0 million is classified as current, and approximately $102,000 and $90,000 is classified as noncurrent, as of September 30, 2021 and December 31, 2020, respectively. Common Stock Purchase In July 2021, two members of the Company’s board of directors and its Chief Executive Officer purchased 12,175 shares of the Company’s common stock for a total purchase price of approximately $60,000. In September 2021, its Chief Medical Officer purchased 5,100 shares of the Company’s common stock for a total purchase price of approximately $21,000. The Company’s common stock shares were purchased in the open market at market price. |
Commitments and Contingencies
Commitments and Contingencies | 9 Months Ended |
Sep. 30, 2021 | |
Commitments and Contingencies | |
Commitments and Contingencies | 12. Commitments and Contingencies Facility Lease 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 square feet of office and laboratory space in Los Gatos, California. In December 2020, the Company moved into the new facility which serves as the Company’s corporate headquarters and the Company has made leasehold improvements to the new facility of which approximately $378,000 may be reimbursed by the Landlord as certain criteria are met as defined in the Lease Agreement. The lease commenced in December 2020 and has an approximate five year term with a three year renewal option. Rental payments by the Company commenced on February 1, 2021. In connection with the Lease Agreement, the Company was required to deliver a security deposit in the form of a letter of credit of $500,000 to the Landlord which is classified as restricted cash, noncurrent, in the Company’s condensed consolidated balance sheet. The future minimum lease payments for the new facility as of September 30, 2021 are as follows (in thousands): Period ending : Three months ending December 31, 2021 $ 149 Year ending December 31, 2022 610 Year ending December 31, 2023 628 Year ending December 31, 2024 646 Year ending December 31, 2025 666 Thereafter 57 Total $ 2,756 Rent expense was approximately $156,000 and $129,000 for the three months ended September 30, 2021 and 2020, respectively, and $474,000 and $344,000 for the nine months ended September 30, 2021 and 2020, respectively. The Company has recorded approximately $77,000 and $37,000 to deferred rent and lease incentive obligation, classified as current other liabilities, and approximately $382,000 and $223,000 to deferred rent and lease incentive obligation, classified as noncurrent other liabilities, on its condensed consolidated balance sheets as of September 30, 2021 and December 31, 2020, respectively. 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. 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 future expenditures will be made and such expenditures can be reasonably estimated. As of September 30, 2021 and December 31, 2020, 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 for legal complaints filed during the year ended December 31, 2020, and as of September 30, 2021, there were no other pending legal proceedings. 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 in compensatory damages. The parties are currently in fact discovery. The Company believes that the claims in this complaint are without merit and intends to defend vigorously against them. In September 2021, Cantor Fitzgerald & Co. (“Cantor”) filed a complaint in the Supreme Court of the State of New York, County of New York, against the Company alleging that it breached a letter agreement with Cantor and owe Cantor approximately $1.8 million, including attorney’s fees for a financing fee related to the Company’s equity offering in August 2021. The Company believes that the claims in this complaint are without merit and intend to defend vigorously against them. The Company has filed an answer to the complaint and the parties have scheduled a mediation proceeding. 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; however, management believes that these disallowances, if any, would be immaterial. Cystic Fibrosis Foundation Agreement In December 2016, the Company received an award for up to $2.9 million from the CFF to advance research on potential drugs utilizing inhaled gallium citrate anti-infective. In November 2018, the CFF increased the award to $7.5 million. Under the award agreement, the CFF will make payments to the Company as certain milestones are met. The award agreement also contains a provision whereby if the Company spends less on developing a potential drug utilizing inhaled gallium citrate anti-infective than the Company actually receives under this award agreement, the Company will be required to return the excess portion of the award to the CFF. At the end of any reporting period, if the Company determines that the cumulative amount spent on this program is less than the cumulative cash received from the CFF, the Company will record the excess amount received as a liability. No liability related to this excess amount was recorded by the Company as of September 30, 2021 and December 31, 2020. In the event that development efforts are successful and the Company commercializes a drug from these related development efforts, the Company will be subject to paying to CFF a one-time amount over time equal to nine times the actual net award received from CFF. Such amount shall be paid in not more than five annual installments, as follows: within ninety days of the end of the calendar year in which the first commercial sale occurs, and within ninety days of the end of each subsequent calendar year until the net amount received from CFF is repaid. The Company shall pay 15% of net sales for that calendar year up to the amount of the net award received from CFF (except that in the fifth installment, if any, the Company shall pay the remaining unpaid portion of the net award received from CFF). In the event that the Company licenses rights to the product in the field to a third-party, sells the product, or consummates a change of control transaction prior to the first commercial sale, the Company shall pay to CFF an amount equal to 15% of the amounts received by the Company and its shareholders in connection with such disposition (whether paid upfront or in accordance with subsequent milestones and whether paid in cash or property) up to nine times the actual net award received from CFF. The payment shall be made within sixty days after the closing of such a transaction. In the event that the development efforts are delayed, which result from events within the Company’s control, for more than one hundred eighty (180) consecutive days at any time before the first commercialization of the drug from the related development efforts, the CFF may provide an interruption notice to the Company, or in lieu of the interruption license, pay to the CFF an amount greater than two times the award received plus interest up to the time of such election. The Company then has thirty (30) days to respond to such notice. If the Company does not respond within thirty (30) days, an interruption license shall be effective. The interruption license to the CFF is an exclusive, worldwide license under the development program technology to manufacture, have manufactured, license, use, sell, offer to sell, and support the product in the field and includes financial conditions for both parties. None of these events have occurred as of September 30, 2021. Kermode Agreement In February 2021, the Company entered into the Kermode Agreement, in which the Company received an upfront payment of $500,000 and will receive additional milestone payments from Kermode as certain phases defined in the agreement are completed. The Company is also entitled to additional payments from Kermode for royalty payments on future net sales (see Note 6). In the event that the research and development efforts under the agreement are successful and if the Company elects to develop and commercialize products under certain provisions contained in the agreement, the Company shall pay to Kermode a single digit percentage royalty of net sales from those products. None of these events occurred as of September 30, 2021. MedImmune Limited License Agreement In July 2021, the Company executed the MedImmune License Agreement (see Note 4). As additional consideration under this agreement, 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 million and sales related milestone payments of up to $85.0 million. There are no development milestone payments. MedImmune is entitled to royalty payments based on aggregate net sales in the low to mid-teens. Further, until delivery of an interim data readout, or an interim futility analysis, from the first Phase 3 clinical study for any indication, MedImmune has a right of first negotiation regarding any commercial rights that the Company intends to sub-license. None of these events occurred as of September 30, 2021. |
Subsequent Events
Subsequent Events | 9 Months Ended |
Sep. 30, 2021 | |
Subsequent Events | |
Subsequent Events | 13. Subsequent Events The Company submitted a complaint in Superior Court of the State of California, County of Santa Clara, against its former landlord on October 22, 2021, asserting claims for breach of contract, breach of the covenant of good faith and fair dealing, unjust enrichment and violation of the unfair competition law. The claims arise from rent increases and the termination of the tenancy the Company allege were not permitted by the agreement with the landlord. The Company seeks to recover rent paid under protest, its deposit, moving and relocation expenses and consequential damages arising from disruption to its operations. The Company will account for any possible gain that may result from this complaint upon settlement. |
Summary of Significant Accoun_2
Summary of Significant Accounting Policies (Policies) | 9 Months Ended |
Sep. 30, 2021 | |
Summary of Significant Accounting Policies | |
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. |
Concentration of Risk | Concentration of Risk 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 For the three months ended September 30, 2021, one customer accounted for 81% of total revenue and the other customer accounted for 19% of total revenue, and for the nine months ended September 30, 2021, one customer accounted for 76% of total revenue and the other customer accounted for 24% of total revenue. For the nine months ended September 30, 2020 one customer accounted for 100% of total revenue. There was no revenue for the three months ended September 30, 2020. Both customers are located in the United States. As of September 30, 2021, there was one customer that accounted for 100% of accounts receivable and as of December 31, 2020, there were no accounts receivable. |
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. 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): September 30, December 31, 2021 2020 Cash and cash equivalents $ 18,221 $ 8,232 Restricted cash 500 500 Total cash, cash equivalents and restricted cash $ 18,721 $ 8,732 |
Accounts Receivable and Allowance for Doubtful Accounts | Accounts Receivable and Allowance for Doubtful Accounts Accounts receivable are recorded at the invoiced amount and do not bear interest. The Company considers the credit worthiness 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 September 30, 2021 there was $1.0 million in accounts receivable and no allowance for doubtful accounts and as of December 31, 2020, there were no accounts receivable |
Property and Equipment | Property and Equipment Property and equipment are stated at cost less accumulated depreciation. Depreciation and amortization is computed using the straight-line method over the estimated useful lives of the assets, generally between three |
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 such impairments of long-lived assets as of September 30, 2021 and December 31, 2020. |
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 or not 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. For the three and nine months ended September 30, 2021 and 2020, there was no amortization of the contract assets and there have been no impairments as of September 30, 2021. Deferred Revenue |
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. |
Comprehensive Loss | Comprehensive Loss The Company has no items of comprehensive income or loss other than net loss. |
Loss Per Share | Loss Per Share Basic loss per share is calculated by dividing net loss for the period by the weighted-average number of common shares outstanding during the period, without consideration for potentially dilutive securities. Diluted net loss per share is computed by dividing the net loss by the weighted-average number of common shares and potentially dilutive securities outstanding for the period. In March 2021 and in August 2021, the Company issued 124,789 and 634,600 dividend shares, respectively, to certain common stockholders with a fair value of approximately $986,000 and approximately $3.1 million, respectively, For the three and nine months ended September 30, 2021 and 2020, there is no difference in the number of shares used to compute basic and diluted net loss per share due to the Company’s net loss position. The following table presents the computation of the basic and diluted net loss per share to common stockholders (in thousands, except share and per share data): Three Months Ended Nine Months Ended September 30, September 30, 2021 2020 2021 2020 Numerator: (unaudited) (unaudited) (unaudited) (unaudited) Net loss available to common stockholders (basic and diluted) $ (24,143) $ (5,786) $ (37,510) $ (16,510) Denominator: Weighted-average common shares outstanding used in computing net loss per share available to common stockholders, basic and diluted 12,454,119 8,923,374 11,314,058 8,922,052 Net loss per share to common stockholders, basic and diluted $ (1.94) $ (0.65) $ (3.32) $ (1.85) The following potentially dilutive securities were excluded from the computation of diluted net loss per share for the periods presented because including them would have been antidilutive: Three & Nine Months Ended September 30, 2021 2020 (unaudited) (unaudited) Stock options to purchase common stock 1,739,743 1,543,978 Common stock warrants 4,106,569 1,733,322 Pre-funded common stock warrants 3,647,556 — 9,493,868 3,277,300 |
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. |
Recently Issued Accounting Pronouncements not yet adopted as of June 30, 2021 | Recently Issued Accounting Pronouncements not yet adopted as of September 30, 2021 Accounting Standards Update 2016-02 and 2018-11 In February 2016, the FASB issued ASU 2016-02, Leases (ASC 842) Leases Leases (ASC 842)—Targeted Improvements Codification improvements This guidance was effective for public business entities for fiscal years beginning after December 15, 2018, including interim periods within those fiscal years. In November 2019, the FASB deferred the effective date for adopting the leasing standard updates for private companies, not-for-profit organizations, and smaller reporting companies. In June 2020, the FASB issued additional deferral guidance that defers the effective date of the leasing standard updates for one year for entities in the “all other” category and public not-for-profit entities that have not yet issued financial statements adopting the standard. The deferrals of the standard are intended to provide relief to nonpublic companies and not-for-profit entities that have had their implementation efforts delayed by the COVID-19 pandemic. Accounting Standards Update 2016-13 In June 2016, the FASB issued ASU 2016-13, “ Financial Instruments—Credit Losses (ASC 326) Accounting Standards Update 2019-12 In December 2019, the FASB issued ASU 2019-12, “ Simplifying the Accounting for Income Taxes (ASC 740) |
Summary of Significant Accoun_3
Summary of Significant Accounting Policies (Tables) | 9 Months Ended |
Sep. 30, 2021 | |
Summary of Significant Accounting Policies | |
Reconciliation 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): September 30, December 31, 2021 2020 Cash and cash equivalents $ 18,221 $ 8,232 Restricted cash 500 500 Total cash, cash equivalents and restricted cash $ 18,721 $ 8,732 |
Schedule of computation of the basic and diluted net loss per share | Three Months Ended Nine Months Ended September 30, September 30, 2021 2020 2021 2020 Numerator: (unaudited) (unaudited) (unaudited) (unaudited) Net loss available to common stockholders (basic and diluted) $ (24,143) $ (5,786) $ (37,510) $ (16,510) Denominator: Weighted-average common shares outstanding used in computing net loss per share available to common stockholders, basic and diluted 12,454,119 8,923,374 11,314,058 8,922,052 Net loss per share to common stockholders, basic and diluted $ (1.94) $ (0.65) $ (3.32) $ (1.85) |
Schedule of potentially dilutive securities were excluded from the computation of diluted net loss per share | Three & Nine Months Ended September 30, 2021 2020 (unaudited) (unaudited) Stock options to purchase common stock 1,739,743 1,543,978 Common stock warrants 4,106,569 1,733,322 Pre-funded common stock warrants 3,647,556 — 9,493,868 3,277,300 |
Balance Sheet Components (Table
Balance Sheet Components (Tables) | 9 Months Ended |
Sep. 30, 2021 | |
Balance Sheet Components | |
Schedule of property and equipment, net | Property and equipment, net consist of the following (in thousands): September 30, December 31, 2021 2020 (unaudited) Lab equipment $ 2,329 $ 2,200 Computer equipment and software 25 25 Construction in progress 521 188 Total property and equipment 2,875 2,413 Less: Accumulated depreciation (1,429) (1,155) Property and equipment, net $ 1,446 $ 1,258 |
Schedule of intangible assets, net | Intangible assets, net consist of the following (in thousands): September 30, December 31, 2021 2020 (unaudited) Licenses $ 81 $ 81 Less: Accumulated amortization (58) (54) Intangible assets, net $ 23 $ 27 |
Schedule of accrued liabilities | Accrued liabilities consist of the following (in thousands): September 30, December 31, 2021 2020 (unaudited) License fees $ 5,008 $ — Research and development services 957 872 Payroll related expenses 341 279 Professional services and other 254 179 Accrued liabilities $ 6,560 $ 1,330 |
Common Stock (Tables)
Common Stock (Tables) | 9 Months Ended |
Sep. 30, 2021 | |
Common Stock | |
Schedule of company reserved common stock for future issuance | As of September 30, 2021 (unaudited), the Company had reserved the following common stock for future issuance: Shares reserved for exercise of outstanding warrants to purchase common stock 4,106,569 Shares reserved for exercise of outstanding pre-funded warrants to purchase common stock 3,647,556 Shares reserved for exercise of outstanding options to purchase common stock 1,739,743 Shares reserved for issuance of future options 393,815 Total 9,887,683 |
Stock-Based Compensation (Table
Stock-Based Compensation (Tables) | 9 Months Ended |
Sep. 30, 2021 | |
Stock-Based Compensation | |
Schedule of stock option activity | Options Outstanding Weighted- Shares Available Number of Average for Grant Shares Exercise Price Balances at December 31, 2020 584,161 1,550,956 $ 9.43 Additional shares reserved — — — Options granted (224,140) 224,140 7.20 Options exercised — (1,559) 2.89 Options cancelled 33,794 (33,794) 10.81 Balances at September 30, 2021 393,815 1,739,743 $ 9.12 |
Schedule of fair value of the options granted estimated using assumptions | Three Months Ended Nine Months Ended September 30, September 30, 2021 2020 2021 2020 Expected term (in years) — 6.00 6.00 6.00 Expected volatility — 99% 99% - 100% 84% - 99% Risk-free interest-rate — 0.38% 0.75% - 1.14% 0.38% - 1.73% Dividend yield — 0% 0% 0% |
Schedule of stock-based compensation expense related to stock options | The following table presents stock-based compensation expense related to stock options (in thousands): Three Months Ended Nine Months Ended September 30, September 30, 2021 2020 2021 2020 (unaudited) (unaudited) (unaudited) (unaudited) Research and development $ 170 $ 156 $ 502 $ 431 General and administrative 410 406 1,198 1,131 Total $ 580 $ 562 $ 1,700 $ 1,562 |
Commitments and Contingencies (
Commitments and Contingencies (Tables) | 9 Months Ended |
Sep. 30, 2021 | |
Commitments and Contingencies | |
Schedule of future minimum lease payments for the new facility | The future minimum lease payments for the new facility as of September 30, 2021 are as follows (in thousands): Period ending : Three months ending December 31, 2021 $ 149 Year ending December 31, 2022 610 Year ending December 31, 2023 628 Year ending December 31, 2024 646 Year ending December 31, 2025 666 Thereafter 57 Total $ 2,756 |
Description of Business and B_2
Description of Business and Basis of Presentation (Details) | 9 Months Ended |
Sep. 30, 2021segmentsubsidiary | |
Description of Business and Basis of Presentation | |
Subsidiaries (in subsidiaries) | subsidiary | 2 |
Operating segments (in segments) | 1 |
Reporting segments (in segments) | 1 |
Summary of Significant Accoun_4
Summary of Significant Accounting Policies - Concentrations (Details) | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2021USD ($)customer | Sep. 30, 2021USD ($)customer | Sep. 30, 2020customer | Dec. 31, 2020USD ($) | |
Summary of Significant Accounting Policies | ||||
Accounts receivable | $ | $ 1,000,000 | $ 1,000,000 | $ 0 | |
Customer 1 | Customer risk | ||||
Summary of Significant Accounting Policies | ||||
Number of customers | 1 | 1 | 1 | |
Contract revenue | Customer 1 | Customer risk | ||||
Summary of Significant Accounting Policies | ||||
Concentration risk percentage | 81.00% | 76.00% | 100.00% | |
Contract revenue | Customer 2 | Customer risk | ||||
Summary of Significant Accounting Policies | ||||
Concentration risk percentage | 19.00% | 24.00% | ||
Accounts receivable | Customer 1 | Customer risk | ||||
Summary of Significant Accounting Policies | ||||
Number of customers | 1 | |||
Concentration risk percentage | 100.00% |
Summary of Significant Accoun_5
Summary of Significant Accounting Policies - Cash, Cash Equivalents and Restricted Cash (Details) - USD ($) $ in Thousands | Sep. 30, 2021 | Dec. 31, 2020 | Sep. 30, 2020 | Dec. 31, 2019 |
Summary of Significant Accounting Policies | ||||
Cash and cash equivalents | $ 18,221 | $ 8,232 | ||
Restricted cash | 500 | 500 | ||
Total cash, cash equivalents and restricted cash | $ 18,721 | $ 8,732 | $ 6,212 | $ 20,897 |
Summary of Significant Accoun_6
Summary of Significant Accounting Policies - Accounts Receivable and Allowance for Doubtful Accounts (Details) - USD ($) | Sep. 30, 2021 | Dec. 31, 2020 |
Summary of Significant Accounting Policies | ||
Accounts receivable | $ 1,000,000 | $ 0 |
Allowance for doubtful accounts | $ 0 | $ 0 |
Summary of Significant Accoun_7
Summary of Significant Accounting Policies - Property and Equipment and Impairment of Long-Lived Assets (Details) | 9 Months Ended |
Sep. 30, 2021 | |
Minimum | |
Property and Equipment, net | |
Estimated useful life (in years) | 3 years |
Maximum | |
Property and Equipment, net | |
Estimated useful life (in years) | 5 years |
Summary of Significant Accoun_8
Summary of Significant Accounting Policies - Impairment of Long-Lived Assets (Details) - USD ($) | 9 Months Ended | 12 Months Ended |
Sep. 30, 2021 | Dec. 31, 2020 | |
Summary of Significant Accounting Policies | ||
Impairments of long-lived assets | $ 0 | $ 0 |
Summary of Significant Accoun_9
Summary of Significant Accounting Policies - Revenue Recognition (Details) - USD ($) | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2021 | Sep. 30, 2020 | Sep. 30, 2021 | Sep. 30, 2020 | |
Summary of Significant Accounting Policies | ||||
Amortization of contract assets | $ 0 | $ 0 | $ 0 | $ 0 |
Impairments of contract assets | $ 0 |
Summary of Significant Accou_10
Summary of Significant Accounting Policies - Stock-Based Compensation (Details) | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2021 | Sep. 30, 2020 | Sep. 30, 2021 | Sep. 30, 2020 | |
Summary of Significant Accounting Policies | ||||
Dividend yield (in percent) | 0.00% | 0.00% | 0.00% | 0.00% |
Summary of Significant Accou_11
Summary of Significant Accounting Policies - Loss Per Share (Details) - USD ($) | 1 Months Ended | 3 Months Ended | 9 Months Ended | |||
Aug. 31, 2021 | Sep. 30, 2021 | Mar. 31, 2021 | Sep. 30, 2020 | Sep. 30, 2021 | Sep. 30, 2020 | |
Summary of Significant Accounting Policies | ||||||
Fair value of dividend shares issued to common stockholders | $ (3,141,000) | $ (4,127,000) | ||||
Numerator: | ||||||
Net loss available to common stockholders (basic and diluted) | $ (24,143,000) | $ (5,786,000) | $ (37,510,000) | $ (16,510,000) | ||
Denominator: | ||||||
Weighted-average common shares outstanding used in computing net loss per share available to common stockholders, basic and diluted | 12,454,119 | 8,923,374 | 11,314,058 | 8,922,052 | ||
Net loss per share to common stockholders, basic and diluted | $ (1.94) | $ (0.65) | $ (3.32) | $ (1.85) | ||
Potentially dilutive securities excluded from computation of diluted net loss per share | 9,493,868 | 3,277,300 | ||||
Common Stock | ||||||
Summary of Significant Accounting Policies | ||||||
Dividend shares to its common stock stockholders | 634,600 | 124,789 | ||||
Fair value of dividend shares issued to common stockholders | $ 3,100,000 | $ 986,000 | ||||
Options | Common Stock | ||||||
Denominator: | ||||||
Potentially dilutive securities excluded from computation of diluted net loss per share | 1,739,743 | 1,543,978 | ||||
Warrants | Common Stock | ||||||
Denominator: | ||||||
Potentially dilutive securities excluded from computation of diluted net loss per share | 4,106,569 | 1,733,322 | ||||
Pre-funded warrants | Common Stock | ||||||
Denominator: | ||||||
Potentially dilutive securities excluded from computation of diluted net loss per share | 3,647,556 |
Balance Sheet Components - Prop
Balance Sheet Components - Property and Equipment, net (Details) - USD ($) | 3 Months Ended | 9 Months Ended | |||
Sep. 30, 2021 | Sep. 30, 2020 | Sep. 30, 2021 | Sep. 30, 2020 | Dec. 31, 2020 | |
Property and Equipment, net | |||||
Total property and equipment | $ 2,875,000 | $ 2,875,000 | $ 2,413,000 | ||
Less: Accumulated depreciation | (1,429,000) | (1,429,000) | (1,155,000) | ||
Property and equipment, net | 1,446,000 | 1,446,000 | 1,258,000 | ||
Depreciation expense | 93,000 | $ 83,000 | 274,000 | $ 248,000 | |
Lab equipment | |||||
Property and Equipment, net | |||||
Total property and equipment | 2,329,000 | 2,329,000 | 2,200,000 | ||
Computer equipment and software | |||||
Property and Equipment, net | |||||
Total property and equipment | 25,000 | 25,000 | 25,000 | ||
Construction in progress | |||||
Property and Equipment, net | |||||
Total property and equipment | $ 521,000 | $ 521,000 | $ 188,000 |
Balance Sheet Components - Inta
Balance Sheet Components - Intangible Assets, net (Details) - USD ($) | 3 Months Ended | 9 Months Ended | |||
Sep. 30, 2021 | Sep. 30, 2020 | Sep. 30, 2021 | Sep. 30, 2020 | Dec. 31, 2020 | |
Balance Sheet Components | |||||
Licenses | $ 81,000 | $ 81,000 | $ 81,000 | ||
Less: Accumulated amortization | (58,000) | (58,000) | (54,000) | ||
Intangible assets, net | 23,000 | 23,000 | $ 27,000 | ||
Amortization expense | $ 1,000 | $ 2,000 | $ 4,000 | $ 4,000 |
Balance Sheet Components - Lice
Balance Sheet Components - Licenses (Details) | 9 Months Ended |
Sep. 30, 2021USD ($) | |
Issue fee | $ 25,000 |
The UAB Research Foundation | |
Minimum research funding agreed to provide | 50,000 |
Maximum contingent milestone payments | $ 100,000 |
Balance Sheet Components - Medi
Balance Sheet Components - Medimmune Limited License Agreement (Details) - USD ($) $ in Thousands | Aug. 09, 2021 | Sep. 30, 2021 | Sep. 30, 2020 | Sep. 30, 2021 | Sep. 30, 2020 |
Research and development | $ 19,842 | $ 4,161 | $ 29,370 | $ 12,725 | |
Issuance of stock | 23,294 | $ 29,711 | |||
Medimmune Limited | License Agreement | |||||
Issuance of common stock (in shares) | 884,956 | 884,956 | |||
Contractual obligation, cash payment | $ 5,000 | ||||
Issuance of stock | $ 6,500 | ||||
Medimmune Limited | License Agreement | Research and development | |||||
Total aggregate milestone payments | 0 | 0 | |||
Medimmune Limited | Maximum | License Agreement | Sales | |||||
Total aggregate milestone payments | 85,000 | 85,000 | |||
Medimmune Limited | Maximum | One license product | License Agreement | |||||
Total aggregate milestone payments | 30,000 | 30,000 | |||
Medimmune Limited | Other Liabilities | License Agreement | |||||
Contractual liability | $ 5,000 | $ 5,000 |
Balance Sheet Components - Accr
Balance Sheet Components - Accrued Liabilities (Details) - USD ($) $ in Thousands | Sep. 30, 2021 | Dec. 31, 2020 |
Balance Sheet Components | ||
License fees | $ 5,008 | |
Research and development services | 957 | $ 872 |
Payroll related expenses | 341 | 279 |
Professional services and other | 254 | 179 |
Accrued liabilities | $ 6,560 | $ 1,330 |
Equity Method Investment (Detai
Equity Method Investment (Details) - USD ($) | Feb. 11, 2018 | Sep. 30, 2021 | Sep. 30, 2020 | Mar. 31, 2020 | Aug. 06, 2018 |
Equity Method Investment | |||||
Loss from equity method investment | $ 0 | $ 9,000 | |||
JV Entity | |||||
Equity Method Investment | |||||
Contribution into the JV Entity | $ 1,000,000 | ||||
Percentage of ownership interest | 49.00% | ||||
Contributions owed to the joint venture | 1,000,000 | ||||
Loss from equity method investment | 0 | $ 9,000 | |||
Carryover basis of license contributed | $ 0 | ||||
Equity method investment | $ 0 | ||||
Hepalink | JV Entity | |||||
Equity Method Investment | |||||
Contractual obligation, cash payment | $ 7,200,000 | ||||
Percentage of ownership interest | 51.00% | ||||
Minimum amount obligated to make an additional equity investment at first future financing | $ 10,800,000 |
Collaboration, Development an_2
Collaboration, Development and License Agreements - Cystic Fibrosis Foundation Development Agreement (Details) - USD ($) | 1 Months Ended | 3 Months Ended | 9 Months Ended | 12 Months Ended | |||||
Nov. 30, 2018 | Sep. 30, 2021 | Sep. 30, 2020 | Jun. 30, 2020 | Sep. 30, 2021 | Sep. 30, 2020 | Dec. 31, 2016 | Dec. 31, 2020 | Mar. 31, 2019 | |
Collaborative Arrangements and Non-collaborative Arrangement Transactions | |||||||||
Deferred revenue | $ 19,583,000 | $ 19,583,000 | $ 18,748,000 | ||||||
Revenue | 515,000 | 548,000 | $ 1,000,000 | ||||||
Phase 1 MAD | |||||||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions | |||||||||
Amount of achieved consideration | $ 1,000,000 | ||||||||
CFF | |||||||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions | |||||||||
Amount of award | $ 7,500,000 | $ 2,900,000 | |||||||
Upfront payment received from CFF | $ 200,000 | ||||||||
Revenue recognized | 0 | ||||||||
Deferred revenue | 583,000 | 583,000 | |||||||
Revenue | $ 1,000,000 | $ 1,000,000 | |||||||
CFF | Phase 1 SAD | |||||||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions | |||||||||
Amount of probable transaction price | $ 1,700,000 | ||||||||
Amount of probable variable consideration | $ 1,000,000 | ||||||||
CFF | Phase 2a Clinical Trial | |||||||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions | |||||||||
Gross transaction price | $ 1,000,000 | 1,000,000 | |||||||
Amount of variable consideration | 3,800,000 | ||||||||
Revenue | $ 417,000 |
Collaboration, Development an_3
Collaboration, Development and License Agreements - Serum License Agreement (Details) - USD ($) | 1 Months Ended | 3 Months Ended | 9 Months Ended | ||||
Sep. 30, 2019 | Jul. 31, 2019 | Sep. 30, 2021 | Sep. 30, 2020 | Sep. 30, 2021 | Sep. 30, 2020 | Dec. 31, 2020 | |
Collaborative Arrangements and Non-collaborative Arrangement Transactions | |||||||
Issuance of stock | $ 23,294,000 | $ 29,711,000 | |||||
Revenue from Contract with Customer, Excluding Assessed Tax | 515,000 | 548,000 | $ 1,000,000 | ||||
Deferred revenue, noncurrent | 971,000 | 971,000 | $ 854,000 | ||||
Capitalized contract cost, Current | 1,961,000 | 1,961,000 | 1,973,000 | ||||
Capitalized contract cost, Noncurrent | 102,000 | 102,000 | 90,000 | ||||
Deferred revenue | 19,583,000 | 19,583,000 | 18,748,000 | ||||
License revenue | |||||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions | |||||||
Revenue from Contract with Customer, Excluding Assessed Tax | 98,000 | 131,000 | |||||
Revenue | 0 | $ 0 | 0 | 0 | |||
Licenses and know-how | |||||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions | |||||||
Contractual liability | 14,500,000 | 14,500,000 | |||||
Development support services | |||||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions | |||||||
Contractual liability | 79,000 | 79,000 | |||||
Research and Development Option | |||||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions | |||||||
Contractual liability | 892,000 | 892,000 | |||||
Manufacturing rights option | |||||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions | |||||||
Contractual liability | 4,100,000 | 4,100,000 | |||||
License Agreement with SIBV | |||||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions | |||||||
Upfront payment received | $ 15,000,000 | $ 5,000,000 | |||||
CFF | |||||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions | |||||||
Revenue from Contract with Customer, Excluding Assessed Tax | 1,000,000 | 1,000,000 | |||||
Revenue recognized | 0 | ||||||
Deferred revenue | 583,000 | 583,000 | |||||
License Agreement with SAMR | |||||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions | |||||||
Buy back manufacturing rights | $ 5,000,000 | ||||||
Maximum additional payments entitled | 42,500,000 | ||||||
License Agreement and Option Agreement | |||||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions | |||||||
Contractual liability | 19,600,000 | 19,600,000 | |||||
Deferred revenue based on upfront payments | 15,000,000 | 15,000,000 | |||||
Deferred revenue from equity allocation | 4,600,000 | 4,600,000 | |||||
Kermode Licensing and Product Discovery Agreement | |||||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions | |||||||
Upfront payment received | 500,000 | ||||||
Revenue recognized | 98,000 | 131,000 | |||||
Deferred revenue | 369,000 | 369,000 | |||||
Kermode Licensing and Product Discovery Agreement | Upfront payment | |||||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions | |||||||
Upfront payment received | 500,000 | ||||||
Maximum additional payments entitled | 250,000 | ||||||
Kermode Licensing and Product Discovery Agreement | License revenue | Upfront payment | |||||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions | |||||||
Maximum additional payments entitled | 500,000 | ||||||
Serum International B.V. ("SIBV") | |||||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions | |||||||
Issuance of common stock (in shares) | 801,820 | ||||||
Issuance of stock | $ 10,000,000 | ||||||
Contractual liability | 19,600,000 | 19,600,000 | |||||
Serum International B.V. ("SIBV") | License revenue | |||||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions | |||||||
Capitalized contract costs | 2,100,000 | 2,100,000 | 2,100,000 | ||||
Revenue | 0 | $ 0 | 0 | $ 0 | |||
Deferred revenue, noncurrent | 971,000 | 971,000 | 854,000 | ||||
Capitalized contract cost, Current | 2,000,000 | 2,000,000 | 2,000,000 | ||||
Capitalized contract cost, Noncurrent | 102,000 | 102,000 | 90,000 | ||||
Deferred revenue | 18,600,000 | 18,600,000 | 18,700,000 | ||||
Serum International B.V. ("SIBV") | License Agreement with SIBV | |||||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions | |||||||
Contractual liability | 19,600,000 | 19,600,000 | |||||
Deferred revenue based on upfront payments | 15,000,000 | 15,000,000 | |||||
Deferred revenue from equity allocation | 4,600,000 | 4,600,000 | |||||
Issuance costs from equity allocation | $ 4,600,000 | 4,600,000 | |||||
Deferred revenue, noncurrent | 854,000 | ||||||
Capitalized contract cost, Noncurrent | $ 90,000 | ||||||
Restricted common stock | Serum International B.V. ("SIBV") | |||||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions | |||||||
Issuance of common stock (in shares) | 801,820 | ||||||
Issuance of stock | $ 10,000,000 | ||||||
Proceeds from sale of restricted common stock and upfront payment | 5,400,000 | ||||||
Fair value of net proceeds | 441,000 | ||||||
Payments of Stock Issuance Costs | $ 5,000,000 |
Paycheck Protection Program L_2
Paycheck Protection Program Loan (Details) - USD ($) | May 01, 2020 | Sep. 30, 2021 | Sep. 30, 2020 | Sep. 30, 2021 | Sep. 30, 2020 | Dec. 31, 2020 |
Debt Instrument [Line Items] | ||||||
Gain on extinguishment of Paycheck Protection Program loan | $ 722,000 | |||||
Note payable current | $ 0 | 0 | $ 439,000 | |||
Note payable, noncurrent | 0 | 0 | 276,000 | |||
Liabilities | 30,240,000 | 30,240,000 | 23,798,000 | |||
Paycheck Protection Program (the "PPP") | ||||||
Debt Instrument [Line Items] | ||||||
Gain on extinguishment of Paycheck Protection Program loan | 722,000 | 722,000 | ||||
Aggregate loan amount granted | $ 715,000 | 715,000 | 715,000 | |||
Debt instrument maturity period | 2 years | |||||
Effective interest rate | 1.00% | |||||
Accrued interest | 7,000 | 7,000 | ||||
Note payable | 0 | 0 | 715,000 | |||
Note payable current | 439,000 | |||||
Note payable, noncurrent | $ 276,000 | |||||
Interest expense | $ 0 | $ 1,000 | $ 3,000 | $ 3,000 |
Warrants - Warrants Issued in R
Warrants - Warrants Issued in Registered Direct Offering (Details) - USD ($) $ / shares in Units, $ in Millions | 1 Months Ended | 3 Months Ended | 9 Months Ended | |||
Aug. 31, 2021 | Sep. 30, 2021 | Mar. 31, 2021 | Sep. 30, 2020 | Sep. 30, 2021 | Sep. 30, 2020 | |
Class of Warrant or Right [Line Items] | ||||||
Expected term (in years) | 0 years | 6 years | 6 years | 6 years | ||
Expected volatility | 0.00% | 99.00% | ||||
Risk-free interest-rate | 0.00% | 0.38% | ||||
Dividend yield (in percent) | 0.00% | 0.00% | 0.00% | 0.00% | ||
Securities Purchase Agreement | ||||||
Class of Warrant or Right [Line Items] | ||||||
Issuance of common stock (in shares) | 1,300,000 | 1,037,405 | ||||
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 from issuance of common stock | $ 25 | $ 7 | ||||
Proceeds from issuance of common stock, net | 23.3 | $ 6.4 | ||||
Relative fair value of the Common Stock Shares | 4.4 | |||||
Relative fair value of the prefunded warrants | 12.2 | |||||
Relative fair value of the Warrant Shares | $ 6.7 | |||||
Securities Purchase Agreement | Pre-Funded Warrants | ||||||
Class of Warrant or Right [Line Items] | ||||||
Warrant to purchase number of Common Stock (in shares) | 3,647,556 | |||||
Exercise price of warrants (in dollars per share) | $ 0.001 | |||||
Number of shares issuable per warrant | 1 | |||||
Percentage of ownership on issue of outstanding common stock for warrants | 4.99% | |||||
Percentage on issue of outstanding common stock for warrants | 9.99 | |||||
Securities Purchase Agreement | Warrants | ||||||
Class of Warrant or Right [Line Items] | ||||||
Warrant to purchase number of Common Stock (in shares) | 2,473,778 | |||||
Exercise price of warrants (in dollars per share) | $ 5 | |||||
Expiration term of warrants | 7 years | |||||
Number of shares issuable per warrant | 1 | |||||
Percentage of ownership on issue of outstanding common stock for warrants | 4.99% | |||||
Percentage on issue of outstanding common stock for warrants | 9.99 | |||||
Expected term (in years) | 7 years | |||||
Expected volatility | 97.00% | |||||
Risk-free interest-rate | 0.96% | |||||
Dividend yield (in percent) | 0.00% | |||||
Securities Purchase Agreement | Common Stock Shares and the Warrants Shares | ||||||
Class of Warrant or Right [Line Items] | ||||||
Proceeds from issuance of common stock, net | $ 23.3 |
Common Stock (Details)
Common Stock (Details) | Sep. 30, 2021shares |
Common Stock for future issuance | |
Total common stock for future issuance | 9,887,683 |
Options | |
Common Stock for future issuance | |
Total common stock for future issuance | 1,739,743 |
Pre-funded common stock warrants | |
Common Stock for future issuance | |
Total common stock for future issuance | 3,647,556 |
Future Options | |
Common Stock for future issuance | |
Total common stock for future issuance | 393,815 |
Warrants | |
Common Stock for future issuance | |
Total common stock for future issuance | 4,106,569 |
Common Stock - March 2021 Secur
Common Stock - March 2021 Securities Purchase Agreement (Details) - USD ($) | 1 Months Ended | 3 Months Ended | 9 Months Ended | ||||
Aug. 31, 2021 | Mar. 31, 2021 | Jul. 31, 2019 | Sep. 30, 2021 | Mar. 31, 2021 | Sep. 30, 2021 | Dec. 31, 2020 | |
Common Stock for future issuance | |||||||
Common stock, par value per share (in dollars per share) | $ 0.0001 | $ 0.0001 | $ 0.0001 | ||||
Fair value of dividend shares issued to common stockholders | $ (3,141,000) | $ (4,127,000) | |||||
Serum International B.V. ("SIBV") | |||||||
Common Stock for future issuance | |||||||
Issuance of common stock (in shares) | 801,820 | ||||||
Serum International B.V. ("SIBV") | Restricted common stock | |||||||
Common Stock for future issuance | |||||||
Issuance of common stock (in shares) | 801,820 | ||||||
Securities Purchase Agreement | |||||||
Common Stock for future issuance | |||||||
Issuance of common stock (in shares) | 1,300,000 | 1,037,405 | |||||
Common stock, par value per share (in dollars per share) | $ 0.0001 | $ 0.0001 | |||||
Aggregate gross proceeds from issuance of common stock | $ 25,000,000 | $ 7,000,000 | |||||
Proceeds from issuance of common stock, net | $ 23,300,000 | $ 6,400,000 | |||||
Dividend shares to its common stock stockholders | 634,600 | 124,789 | |||||
Fair value of dividend shares issued to common stockholders | $ 3,100,000 | $ 986,000 |
Common Stock - MedImmune Limite
Common Stock - MedImmune Limited License Agreement (Details) - USD ($) $ in Thousands | Jul. 12, 2021 | Sep. 30, 2021 | Sep. 30, 2020 | Sep. 30, 2021 | Sep. 30, 2020 |
Common Stock for future issuance | |||||
Research and development | $ 19,842 | $ 4,161 | $ 29,370 | $ 12,725 | |
MedImmune Limited License Agreement | |||||
Common Stock for future issuance | |||||
Research and development | $ 6,500 | $ 6,500 | |||
MedImmune Limited License Agreement | Common Stock | |||||
Common Stock for future issuance | |||||
Stock issued shares | 884,956 | ||||
Stock issued value | $ 6,500 |
Common Stock - August 2021 Secu
Common Stock - August 2021 Securities Purchase Agreement (Details) - USD ($) | 1 Months Ended | 3 Months Ended | 9 Months Ended | |||
Aug. 31, 2021 | Mar. 31, 2021 | Sep. 30, 2021 | Mar. 31, 2021 | Sep. 30, 2021 | Dec. 31, 2020 | |
Common Stock for future issuance | ||||||
Common stock, par value per share (in dollars per share) | $ 0.0001 | $ 0.0001 | $ 0.0001 | |||
Fair value of dividend shares issued to common stockholders | $ (3,141,000) | $ (4,127,000) | ||||
Securities Purchase Agreement | ||||||
Common Stock for future issuance | ||||||
Issuance of common stock (in shares) | 1,300,000 | 1,037,405 | ||||
Common stock, par value per share (in dollars per share) | $ 0.0001 | $ 0.0001 | ||||
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 from issuance of common stock | $ 25,000,000 | $ 7,000,000 | ||||
Proceeds from issuance of common stock, net | $ 23,300,000 | $ 6,400,000 | ||||
Dividend shares to its common stock stockholders | 634,600 | 124,789 | ||||
Fair value of dividend shares issued to common stockholders | $ 3,100,000 | $ 986,000 | ||||
Securities Purchase Agreement | Pre-Funded Warrants | ||||||
Common Stock for future issuance | ||||||
Warrant to purchase number of Common Stock (in shares) | 3,647,556 | |||||
Securities Purchase Agreement | Warrants | ||||||
Common Stock for future issuance | ||||||
Warrant to purchase number of Common Stock (in shares) | 2,473,778 |
Stock-Based Compensation - (Det
Stock-Based Compensation - (Details) - shares | 1 Months Ended | |
May 31, 2014 | Jun. 30, 2020 | |
Stock-Based Compensation | ||
Reserved for issuance (in shares) | 233,722 | 2,183,692 |
Voting rights of all classes of stock (in percent) | 10.00% | |
Exercise price for incentive stock options to the percentage of fair market value | 110.00% | |
Options | ||
Stock-Based Compensation | ||
Vesting period (in years) | 4 years | |
Expiration period (in years) | 10 years |
Stock-Based Compensation - Stoc
Stock-Based Compensation - Stock option activity (Details) - $ / shares | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2021 | Sep. 30, 2020 | Sep. 30, 2021 | Sep. 30, 2020 | |
Shares Available for Grant | ||||
Beginning of the period (in shares) | 584,161 | |||
Options granted (in shares) | 0 | (26,667) | (224,140) | (200,177) |
Options exercised (in shares) | 0 | 0 | 1,559 | 4,913 |
Options cancelled (in shares) | 33,794 | |||
End of the period (in shares) | 393,815 | 393,815 | ||
Number of options | ||||
Number of Shares, beginning of the period (in shares) | 1,550,956 | |||
Number of Shares, Stock option granted | 0 | 26,667 | 224,140 | 200,177 |
Number of Shares, Options exercised (in shares) | (1,559) | |||
Number of Shares, Options cancelled (in shares) | (33,794) | |||
Number of Shares, end of the period (in shares) | 1,739,743 | 1,739,743 | ||
Weighted average exercise price | ||||
Weighted-Average Exercise Price, beginning of the period (in dollars per share) | $ 9.43 | |||
Weighted-Average Exercise Price, Options granted (in dollars per share) | 7.20 | |||
Weighted-Average Exercise Price, Options exercised (in dollars per share) | 2.89 | |||
Weighted-Average Exercise Price, Options cancelled (in dollars per share) | 10.81 | |||
Weighted-Average Exercise Price, end of the period (in dollars per share) | $ 9.12 | $ 9.12 |
Stock-Based Compensation - Assu
Stock-Based Compensation - Assumptions (Details) - shares | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2021 | Sep. 30, 2020 | Sep. 30, 2021 | Sep. 30, 2020 | |
Fair value of the options granted, estimated using assumptions | ||||
Expected term (in years) | 0 years | 6 years | 6 years | 6 years |
Expected volatility, minimum | 99.00% | 84.00% | ||
Expected volatility, maximum | 100.00% | 99.00% | ||
Expected volatility | 0.00% | 99.00% | ||
Risk-free interest-rate | 0.00% | 0.38% | ||
Risk-free interest-rate, minimum | 0.75% | 0.38% | ||
Risk-free interest-rate, maximum | 1.14% | 1.73% | ||
Dividend yield (in percent) | 0.00% | 0.00% | 0.00% | 0.00% |
Granted (in shares) | 0 | 26,667 | 224,140 | 200,177 |
Stock-Based Compensation - Expe
Stock-Based Compensation - Expenses (Details) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2021 | Sep. 30, 2020 | Sep. 30, 2021 | Sep. 30, 2020 | |
Stock-Based Compensation | ||||
Total stock-based compensation expense | $ 580 | $ 562 | $ 1,700 | $ 1,562 |
Research and development | ||||
Stock-Based Compensation | ||||
Total stock-based compensation expense | 170 | 156 | 502 | 431 |
General and administrative | ||||
Stock-Based Compensation | ||||
Total stock-based compensation expense | $ 410 | $ 406 | $ 1,198 | $ 1,131 |
Stock-Based Compensation - Addi
Stock-Based Compensation - Additional information (Details) - USD ($) | 1 Months Ended | 3 Months Ended | 9 Months Ended | |||
May 31, 2014 | Sep. 30, 2021 | Sep. 30, 2020 | Sep. 30, 2021 | Sep. 30, 2020 | Jun. 30, 2020 | |
Stock-Based Compensation | ||||||
Reserved for issuance (in shares) | 233,722 | 2,183,692 | ||||
Voting rights of all classes of stock (in percent) | 10.00% | |||||
Exercise price for incentive stock options to the percentage of fair market value | 110.00% | |||||
Number of Shares, Stock option granted | 0 | 26,667 | 224,140 | 200,177 | ||
Weighted-average grant date fair value (in dollars per share) | $ 5.10 | $ 5.04 | $ 4.69 | |||
Aggregate intrinsic value | $ 5,000 | $ 17,000 | ||||
Options exercised (in shares) | 0 | 0 | 1,559 | 4,913 | ||
Options | ||||||
Stock-Based Compensation | ||||||
Vesting period (in years) | 4 years | |||||
Expiration period (in years) | 10 years | |||||
Unrecognized stock-based compensation expenses related to stock options | $ 2,800,000 | $ 2,800,000 | ||||
Unrecognized stock-based compensation expenses expected to be recognized | 2 years |
Related Parties (Details)
Related Parties (Details) - USD ($) | 1 Months Ended | 3 Months Ended | 9 Months Ended | |||
Jul. 31, 2019 | Sep. 30, 2021 | Sep. 30, 2020 | Sep. 30, 2021 | Sep. 30, 2020 | Dec. 31, 2020 | |
Related parties | ||||||
Issuance of stock | $ 23,294,000 | $ 29,711,000 | ||||
Deferred revenue | 19,583,000 | 19,583,000 | $ 18,748,000 | |||
Deferred revenue, noncurrent | 971,000 | 971,000 | 854,000 | |||
Capitalized contract cost, Current | 1,961,000 | 1,961,000 | 1,973,000 | |||
Capitalized contract cost, Noncurrent | $ 102,000 | $ 102,000 | 90,000 | |||
Common Stock | ||||||
Related parties | ||||||
Issuance of common stock (in shares) | 1,300,000 | 2,337,405 | ||||
License revenue | ||||||
Related parties | ||||||
Revenue | $ 0 | $ 0 | $ 0 | $ 0 | ||
Shenzhen Hepalink Pharmaceutical Group Co., Ltd.("Hepalink") | ||||||
Related parties | ||||||
Reduction to operating expenses on reimbursed to JV entity | 14,000 | 0 | 60,000 | 184,000 | ||
Serum International B.V. ("SIBV") | ||||||
Related parties | ||||||
Issuance of common stock (in shares) | 801,820 | |||||
Issuance of stock | $ 10,000,000 | |||||
Serum International B.V. ("SIBV") | License revenue | ||||||
Related parties | ||||||
Revenue | 0 | $ 0 | 0 | $ 0 | ||
Deferred revenue | 18,600,000 | 18,600,000 | 18,700,000 | |||
Deferred revenue, noncurrent | 971,000 | 971,000 | 854,000 | |||
Capitalized contract costs | 2,100,000 | 2,100,000 | 2,100,000 | |||
Capitalized contract cost, Current | 2,000,000 | 2,000,000 | 2,000,000 | |||
Capitalized contract cost, Noncurrent | 102,000 | 102,000 | 90,000 | |||
Other receivables | Shenzhen Hepalink Pharmaceutical Group Co., Ltd.("Hepalink") | ||||||
Related parties | ||||||
Outstanding receivable for reimbursable expenses | $ 28,000 | $ 28,000 | $ 3,000 |
Related Parties - Common Stock
Related Parties - Common Stock Purchase (Details) | 1 Months Ended | |
Sep. 30, 2021USD ($)shares | Jul. 31, 2021USD ($)directorshares | |
Related Party Transaction [Line Items] | ||
Number of member to purchase of share in open market | director | 2 | |
Chief Executive Officer | ||
Related Party Transaction [Line Items] | ||
Share purchased | shares | 12,175 | |
Purchase price | $ | $ 60,000 | |
Chief Medical Officer [Member] | ||
Related Party Transaction [Line Items] | ||
Share purchased | shares | 5,100 | |
Purchase price | $ | $ 21,000,000 |
Commitments and Contingencies -
Commitments and Contingencies - Facility lease - (Details) | Oct. 31, 2020USD ($)ft² |
Commitments and Contingencies | |
Area of Land | 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 |
Commitments and Contingencies_2
Commitments and Contingencies - Future minimum lease payments (Details) $ in Thousands | Sep. 30, 2021USD ($) |
Commitments and Contingencies | |
Nine months ending December 31, 2021 | $ 149 |
Year ending December 31, 2022 | 610 |
Year ending December 31, 2023 | 628 |
Year ending December 31, 2024 | 646 |
Year ending December 31, 2025 | 666 |
Thereafter | 57 |
Total | $ 2,756 |
Commitments and Contingencies_3
Commitments and Contingencies - Leases and Contingencies (Details) - USD ($) | 1 Months Ended | 3 Months Ended | 9 Months Ended | ||||
Sep. 30, 2021 | Feb. 29, 2020 | Sep. 30, 2021 | Sep. 30, 2020 | Sep. 30, 2021 | Sep. 30, 2020 | Dec. 31, 2020 | |
Commitments and Contingencies | |||||||
Rent expense | $ 156,000 | $ 129,000 | $ 474,000 | $ 344,000 | |||
Deferred rent | $ 77,000 | 77,000 | 77,000 | $ 382,000 | |||
Lease incentive obligation | 37,000 | $ 37,000 | $ 37,000 | $ 223,000 | |||
Compensatory damages sought | $ 1,800,000 | $ 277,000 |
Commitments and Contingencies_4
Commitments and Contingencies - Cystic Fibrosis Foundation Agreement and Joint Venture Agreement (Details) - CF Foundation | 1 Months Ended | |||
Dec. 31, 2016USD ($)iteminstallment | Sep. 30, 2021USD ($) | Dec. 31, 2020USD ($) | Nov. 30, 2018USD ($) | |
Cystic Fibrosis Foundation Agreement | ||||
Amount of award received for advance research on potential drugs | $ 2,900,000 | $ 7,500,000 | ||
Excess amount recorded as liability | $ 0 | $ 0 | ||
Period for payment of annual installments | 90 days | |||
Maximum percentage of awarded amount of net sales | 15.00% | |||
Number of multiplication on awarded amount payable if change of control prior to completion of the first commercial sale | item | 9 | |||
Payment of amount received in connection with Disposition Transaction (as a percent) | 15.00% | |||
Maximum | ||||
Cystic Fibrosis Foundation Agreement | ||||
Number of annual installments for repayment of award | installment | 5 |
Commitments and Contingencies_5
Commitments and Contingencies - Kermode Agreement (Details) | 1 Months Ended |
Feb. 28, 2021USD ($) | |
Kermode Agreement | |
Long-term Purchase Commitment [Line Items] | |
Upfront payment received | $ 500,000 |
Commitments and Contingencies_6
Commitments and Contingencies - Medimmune Limited License Agreement (Details) | Jul. 31, 2021USD ($) |
Subsequent Events | |
Total aggregate payments upon achievement of certain regulatory approvals | $ 30,000,000 |
Total aggregate payments upon achievement of sales related milestone | 85,000,000 |
Total aggregate payments upon achievement of development related milestone | $ 0 |