Document And Entity Information
Document And Entity Information - shares | 3 Months Ended | |
Mar. 31, 2023 | May 03, 2023 | |
Document Information Line Items | ||
Entity Registrant Name | HUMANIGEN, INC | |
Trading Symbol | HGEN | |
Document Type | 10-Q | |
Current Fiscal Year End Date | --12-31 | |
Entity Common Stock, Shares Outstanding | 119,080,135 | |
Amendment Flag | false | |
Entity Central Index Key | 0001293310 | |
Entity Current Reporting Status | Yes | |
Entity Filer Category | Non-accelerated Filer | |
Document Period End Date | Mar. 31, 2023 | |
Document Fiscal Year Focus | 2023 | |
Document Fiscal Period Focus | Q1 | |
Entity Small Business | true | |
Entity Emerging Growth Company | false | |
Entity Shell Company | false | |
Document Quarterly Report | true | |
Document Transition Report | false | |
Entity File Number | 001-35798 | |
Entity Incorporation, State or Country Code | DE | |
Entity Tax Identification Number | 77-0557236 | |
Entity Address, Address Line One | 830 Morris Turnpike | |
Entity Address, Address Line Two | 4th Floor | |
Entity Address, City or Town | Short Hills | |
Entity Address, State or Province | NJ | |
Entity Address, Postal Zip Code | 07078 | |
City Area Code | (973) | |
Local Phone Number | 200-3100 | |
Title of 12(b) Security | Common Stock | |
Security Exchange Name | NASDAQ | |
Entity Interactive Data Current | Yes |
Condensed Consolidated Balance
Condensed Consolidated Balance Sheets (Unaudited) - USD ($) $ in Thousands | Mar. 31, 2023 | Dec. 31, 2022 |
Current assets: | ||
Cash and cash equivalents | $ 3,096 | $ 10,155 |
Prepaid expenses and other current assets | 1,930 | 950 |
Total current assets | 5,026 | 11,105 |
Other assets | 90 | 90 |
Total assets | 5,116 | 11,195 |
Current liabilities: | ||
Accounts payable | 38,392 | 40,520 |
Accrued expenses | 14,021 | 14,791 |
Deferred revenue | 883 | 883 |
Total current liabilities | 53,296 | 56,194 |
Non-current liabilities: | ||
Deferred revenue | 1,545 | 1,766 |
Total liabilities | 54,841 | 57,960 |
Stockholders’ deficit: | ||
Common stock, $0.001 par value: 225,000,000 shares authorized at March 31, 2023 and December 31, 2022; 119,080,135 shares issued and outstanding at March 31, 2023 and December 31, 2022 | 119 | 119 |
Additional paid-in capital | 636,147 | 634,925 |
Accumulated deficit | (685,991) | (681,809) |
Total stockholders’ deficit | (49,725) | (46,765) |
Total liabilities and stockholders’ deficit | $ 5,116 | $ 11,195 |
Condensed Consolidated Balanc_2
Condensed Consolidated Balance Sheets (Unaudited) (Parentheticals) - $ / shares | Mar. 31, 2023 | Dec. 31, 2022 |
Statement of Financial Position [Abstract] | ||
Common stock, par value (in Dollars per share) | $ 0.001 | $ 0.001 |
Common stock, shares authorized | 225,000,000 | 225,000,000 |
Common stock, shares issued | 119,080,135 | 119,080,135 |
Common stock, shares outstanding | 119,080,135 | 119,080,135 |
Condensed Consolidated Statemen
Condensed Consolidated Statements of Operations (Unaudited) - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2023 | Mar. 31, 2022 | |
Revenue: | ||
Total revenue | $ 221 | $ 1,036 |
Operating expenses: | ||
Research and development | 737 | 17,220 |
General and administrative | 3,719 | 4,345 |
Total operating expenses | 4,456 | 21,565 |
Loss from operations | (4,235) | (20,529) |
Other income (expense): | ||
Interest expense | (18) | (734) |
Other income (expense), net | 71 | (15) |
Net loss | $ (4,182) | $ (21,278) |
Basic net loss per common share (in Dollars per share) | $ (0.04) | $ (0.32) |
Weighted average common shares outstanding used to calculate basic net loss per common share (in Shares) | 119,080,135 | 65,590,724 |
License revenue | ||
Revenue: | ||
Total revenue | $ 221 | $ 1,036 |
Condensed Consolidated Statem_2
Condensed Consolidated Statements of Operations (Unaudited) (Parentheticals) - $ / shares | 3 Months Ended | |
Mar. 31, 2023 | Mar. 31, 2022 | |
Income Statement [Abstract] | ||
Diluted net loss per common share | $ (0.04) | $ (0.32) |
Weighted average common shares outstanding used to calculate diluted net loss per common share | 119,080,135 | 65,590,724 |
Condensed Consolidated Statem_3
Condensed Consolidated Statements of Cash Flows (Unaudited) - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2023 | Mar. 31, 2022 | |
Operating activities: | ||
Net loss | $ (4,182) | $ (21,278) |
Adjustments to reconcile net loss to net cash used in operating activities: | ||
Stock based compensation expense | 1,222 | 1,543 |
Non-cash interest expense related to debt financing | 187 | |
Changes in operating assets and liabilities: | ||
Prepaid expenses and other assets | (980) | (1,332) |
Accounts payable | (2,128) | 3,175 |
Accrued expenses | (770) | (701) |
Deferred revenue | (221) | (1,036) |
Net cash used in operating activities | (7,059) | (19,442) |
Financing activities: | ||
Net proceeds from issuance of common stock | 18,374 | |
Net cash provided by financing activities | 18,374 | |
Net decrease in cash and cash equivalents | (7,059) | (1,068) |
Cash and cash equivalents, beginning of period | 10,155 | 70,016 |
Cash and cash equivalents, end of period | 3,096 | 68,948 |
Supplemental cash flow disclosure: | ||
Cash paid for interest | $ 550 |
Condensed Consolidated Statem_4
Condensed Consolidated Statements of Stockholders’ Deficit (Unaudited) - USD ($) $ in Thousands | Common Stock | Additional Paid-In Capital | Accumulated Deficit | Total |
Balances at Dec. 31, 2021 | $ 64 | $ 587,327 | $ (611,079) | $ (23,688) |
Balances (in Shares) at Dec. 31, 2021 | 64,027,629 | |||
Issuance of common stock, net of expenses | $ 6 | 18,368 | 18,374 | |
Issuance of common stock, net of expenses (in Shares) | 5,926,748 | |||
Stock-based compensation expense | 1,543 | 1,543 | ||
Net loss | (21,278) | (21,278) | ||
Balances at Mar. 31, 2022 | $ 70 | 607,238 | (632,357) | (25,049) |
Balances (in Shares) at Mar. 31, 2022 | 69,954,377 | |||
Balances at Dec. 31, 2022 | $ 119 | 634,925 | (681,809) | (46,765) |
Balances (in Shares) at Dec. 31, 2022 | 119,080,135 | |||
Stock-based compensation expense | 1,222 | 1,222 | ||
Net loss | (4,182) | (4,182) | ||
Balances at Mar. 31, 2023 | $ 119 | $ 636,147 | $ (685,991) | $ (49,725) |
Balances (in Shares) at Mar. 31, 2023 | 119,080,135 |
Nature of Operations
Nature of Operations | 3 Months Ended |
Mar. 31, 2023 | |
Nature of Operations [Abstract] | |
Nature of Operations | 1. Nature of Operations Description of the Business The Company is a clinical stage biopharmaceutical company, developing its portfolio of proprietary Humaneered ® ® The Company is developing lenzilumab in chronic myelomonocytic leukemia (“CMML”), a rare blood cancer, for which the Precision Approach to Chronic Myelomonocytic Leukemia (“PREACH-M”) study is underway, and is continuing its plans for the Risk Adapted Therapy in Acute GvHD (“RATinG”) study in acute graft versus host disease (“aGvHD”) that occurs in patients undergoing bone marrow transplant, as these studies are majority funded by its partners. In April 2023, the Company announced that as of December 31, 2022, eleven subjects had been dosed with lenzilumab and with current standard of care, azacytidine, in the PREACH-M study. Six subjects were evaluable based on at least three months of follow-up, including those with high risk CMML, and all demonstrated clinical benefit. In addition, LENZ appeared to be well-tolerated. The Company anticipates the first patient dosing in the RATinG study to occur in the second quarter of 2023. A leading network of centers, The Mayo Clinics, is currently progressing with an investigator-initiated trial (“IIT”) of lenzilumab in combination with CAR-T therapies. With the exception of the one lenzilumab batch in process, the Company has discontinued the manufacturing of lenzilumab and is consolidating the remaining inventory of lenzilumab bulk drug substance and drug product in a central location for potential future use. The Company is also developing iFab, an EpAh-3 targeted monoclonal antibody, currently in Phase 1 development, as part of an antibody drug conjugate (“ADC”), for certain solid tumors. See Management’s Discussion and Analysis of Financial Condition and Results of Operations included in Item 7 of the Company’s 2022 Annual Report on Form 10-K for additional information regarding the business. Liquidity and Going Concern The Condensed Consolidated Financial Statements for the three months ended March 31, 2023 were prepared on the basis of a going concern, which contemplates that the Company will be able to realize assets and discharge liabilities in the normal course of business. However, the Company has incurred net losses since its inception, and has negative operating cash flows and its total liabilities exceed total assets. These conditions raise substantial doubt about the Company’s ability to continue as a going concern. As of March 31, 2023, the Company had cash and cash equivalents of $3.1 million. Considering the Company’s current cash resources and its current and expected levels of operating expenses for the next twelve months, which includes combined accounts payable and accrued expenses recorded in the Company’s consolidated balance sheets as of March 31, 2023 of $52.4 million, certain of which are in dispute, and manufacturing commitments of $1.8 million for the remaining nine months of 2023, with no significant commitments thereafter (see Note 6 below), the Company requires additional capital to fund the Company’s planned operations. The Company intends to seek to defer payments, negotiate lower amounts or pursue other courses of action for certain amounts owed to manufacturing and other partners at March 31, 2023. In order to remain a going concern, the Company must successfully renegotiate these amounts owed, and settle disputes, including current and potential future arbitration and litigation. During 2022, the Company engaged SC&H Capital, an affiliate of SC&H Group, Inc.(“SC&H”), to advise the Company on exploration of strategic options to maximize value around its development pipeline. The Company has not set a timetable for the conclusion of its review of strategic alternatives, and there can be no assurance that this process will result in any transaction. As previously reported, the Company has executed a non-binding letter of intent and is engaged in exclusive negotiations relating to a proposed business combination with a privately held biopharmaceutical company, which contemplates a tax-free stock-for-stock merger. The Company is seeking external financing in connection with the potential business combination. There can be no assurance that the potential business combination or financing will be consummated on favorable terms or at all. The Company also may seek to raise additional capital through public or private equity offerings, including under the Controlled Equity Offering SM Basis of Presentation The accompanying interim unaudited Condensed Consolidated Financial Statements have been prepared in accordance with US generally accepted accounting principles (“US GAAP”) for interim financial information and on a basis consistent with the annual consolidated financial statements and include all adjustments necessary for the presentation of the Company’s condensed consolidated financial position, results of operations and cash flows for the periods presented. The Condensed Consolidated Financial Statements include the accounts of the Company and its wholly-owned subsidiaries. These financial statements have been prepared on a basis that assumes that the Company will continue as a going concern, which contemplates the realization of assets and the satisfaction of liabilities and commitments in the normal course of business. The December 31, 2022 Condensed Consolidated Balance Sheet was derived from the audited financial statements but does not include all disclosures required by US GAAP. These interim financial results are not necessarily indicative of the results to be expected for the year ending December 31, 2023, or for any other future annual or interim period. The accompanying unaudited Condensed Consolidated Financial Statements should be read in conjunction with the audited consolidated financial statements and the related notes thereto included in the Company’s 2022 Annual Report on Form 10-K. The preparation of financial statements in conformity with US GAAP requires management to make estimates and assumptions that affect the amounts and disclosures reported in the Condensed Consolidated Financial Statements and accompanying notes. Actual results could differ materially from those estimates. The Company believes judgment is involved in accounting for the determination of revenue recognition, fair value-based measurement of stock-based compensation and accruals. The Company evaluates its estimates and assumptions as facts and circumstances dictate. As future events and their effects cannot be determined with precision, actual results could differ from these estimates and assumptions, and those differences could be material to the Condensed Consolidated Financial Statements. |
Summary of Significant Accounti
Summary of Significant Accounting Policies | 3 Months Ended |
Mar. 31, 2023 | |
Summary of Significant Accounting Policies [Abstract] | |
Summary of Significant Accounting Policies | 2. Summary of Significant Accounting Policies The Company’s significant accounting policies are detailed in its Annual Report on Form 10-K for the year ended December 31, 2022. There have been no significant changes to the Company’s significant accounting policies during the three months ended March 31, 2023, from those previously disclosed in its 2022 Annual Report on Form 10-K. |
Potentially Dilutive Securities
Potentially Dilutive Securities | 3 Months Ended |
Mar. 31, 2023 | |
Potentially Dilutive Securities [Abstract] | |
Potentially Dilutive Securities | 3. Potentially Dilutive Securities The Company’s potentially dilutive securities, which include stock options and warrants and shares of common stock issuable upon conversion of convertible debt, have been excluded from the computation of diluted net loss per common share as the effect of including those securities would be to reduce the net loss per common share and be antidilutive. Therefore, the denominator used to calculate both basic and diluted net loss per common share is the same in each period presented. The following outstanding potentially dilutive securities have been excluded from the computations of diluted net loss per common share: As of March 31, 2023 2022 Options to purchase common stock 7,177,605 4,712,659 Warrants to purchase common stock 31,238 31,238 Convertible debt - 510,986 7,208,843 5,254,883 |
License Revenue
License Revenue | 3 Months Ended |
Mar. 31, 2023 | |
License Revenue [Abstract] | |
License Revenue | 4. License Revenue On November 3, 2020, the Company entered into a License Agreement (the “South Korea Agreement”) with KPM Tech Co., Ltd. (“KPM”) and its affiliate, Telcon RF Pharmaceutical, Inc. (together with KPM, the “Licensee”). Pursuant to the South Korea Agreement, among other things, the Company granted the Licensee a license under certain patents and other intellectual property to develop and commercialize lenzilumab for treatment of COVID-19 pneumonia, in South Korea and the Philippines (the “Territory”), subject to certain reservations and limitations. The Licensee will be responsible for gaining regulatory approval for, and subsequent commercialization of, lenzilumab in the Territory. As consideration for the license, the Licensee agreed to pay the Company (i) an up-front license fee of $6.0 million, payable promptly following the execution of the License Agreement, which was received in the fourth quarter of 2020, (ii) up to an aggregate of $14.0 million in two payments based on achievement by the Company of two specified milestones in the US, of which the first milestone was met in the first quarter of 2021 and $6.0 million (or $4.5 million net of withholding taxes and other fees and royalties) was received in the second quarter of 2021, and (iii) subsequent to the receipt by the Licensee of the requisite regulatory approvals, double-digit royalties on the net sales of lenzilumab in South Korea and the Philippines. The Licensee has agreed to certain development and commercial performance obligations. It is expected that the Company will supply lenzilumab to the Licensee for a minimum of 7.5 years at a cost-plus basis from an existing or future manufacturer. The Licensee has agreed to certain minimum purchases of lenzilumab on an annual basis. Since the provision of the license and the cooperation and assistance to be provided by the Company to the Licensee with regulatory authorities in the Territory and the Company’s obligation to serve on a joint steering committee (the “Services”) are considered a single performance obligation, the $6.0 million upfront payment (or $4.5 million net of withholding taxes and other fees and royalties) and the first milestone payment of $6.0 million (or $4.5 million net of withholding taxes and other fees and royalties, were initially being recognized as revenue ratably over the performance period through March 2023 (the “Performance Period”), the expected period over which the Company conservatively expected the Services to be performed with approval in the Territory expected by the end of March 2023. During the quarter ended September 30, 2022, the performance period was reevaluated, and the estimated end date of the performance period was adjusted to December 31, 2025. The change in estimate resulted in a decrease of $0.8 million in quarterly license revenue as compared to amounts that would have been recorded under the previous timeline. Therefore, the Company recognized license revenue totaling approximately $0.2 million and $1.0 million in the three months ended March 31, 2023 and 2022, respectively. Licensee’s purchases of lenzilumab for development purposes or for commercial requirements, represent options under the agreement and revenues will therefore be recognized when control of the product is transferred to Licensee. Contract Liabilities A contract liability of $2.4 million was recorded on the Condensed Consolidated Balance Sheets as deferred revenue as of March 31, 2023 related to the South Korea agreement. There were no contract asset or deferred contract acquisition costs as of March 31, 2023 associated with the South Korea agreement. The following table presents changes in the Company’s contract liability for the three months ended March 31, 2023 (in thousands): Balance at January 1, 2023 $ 2,649 Deductions for performance obligations satisfied: In current period (221 ) Balance at March 31, 2023 $ 2,428 |
Long-Term Debt
Long-Term Debt | 3 Months Ended |
Mar. 31, 2023 | |
Long-Term Debt [Abstract] | |
Long-Term Debt | 5. Long-Term Debt Secured Term Loan Facility On March 10, 2021, the Company executed the Loan and Security Agreement with Hercules Capital as agent for its affiliates serving as lenders thereunder (the “Term Loan”) which provided a loan in the aggregate principal amount of up to $80.0 million, in three tranches. On March 29, 2021, the Company drew the initial $25.0 million tranche under the Term Loan. After giving effect to payment of fees and expenses associated with the draw, the Company received net proceeds of approximately $24.4 million. The Term Loan bore interest at a floating rate equal to the greater of either (i) 8.75% plus the prime rate as reported in The Wall Street Journal minus 3.25%, or (ii) 8.75%. The Company was initially obligated to make monthly payments of accrued interest under the Term Loan commencing on the initial borrowing date and continuing to April 1, 2023, followed by monthly installments of principal and interest until March 1, 2025. Interest expense related to the Term Loan, recorded during the three months ended March 31, 2022, was approximately $0.7 million and the effective interest rate was 9.25%. In July 2022, the Company prepaid $25.0 million of outstanding principal, together with approximately $1.7 million of accrued interest, fees and other amounts, due under the Term Loan. In connection with the prepayment, the Term Loan with Hercules was terminated, and all obligations, liens and security interests under the Term Loan were released, discharged and satisfied. |
Commitments and Contingencies
Commitments and Contingencies | 3 Months Ended |
Mar. 31, 2023 | |
Commitments and Contingencies [Abstract] | |
Commitments and Contingencies | 6. Commitments and Contingencies Manufacturing Agreements As of March 31, 2023, the Company estimates that its commitments remaining to be incurred under its contract manufacturing organization (“CMO”) agreements are approximately $1.8 million for the remaining nine months of 2023 with no significant commitments thereafter. |
Stockholders_ Equity
Stockholders’ Equity | 3 Months Ended |
Mar. 31, 2023 | |
Stockholders’ Equity [Abstract] | |
Stockholders’ Equity | 7. Stockholders’ Equity Controlled Equity Offering On December 31, 2020, the Company entered into a Sales Agreement with Cantor, under which the Company could issue and sell, from time-to-time, shares of the Company’s common stock, having an aggregate gross sales price of up to $100 million through Cantor, as the sales agent. During the three months ended March 31, 2022, the Company issued and sold 5,926,748 shares of its common stock under the Sales Agreement for net proceeds of $18.4 million. No shares were sold under the Sales Agreement during the three months ended March 31, 2023. |
Stock-Based Compensation
Stock-Based Compensation | 3 Months Ended |
Mar. 31, 2023 | |
Stock-Based Compensation [Abstract] | |
Stock-Based Compensation | 8. Stock-Based Compensation A summary of stock option activity for the three months ended March 31, 2023 under all the Company’s options plans is as follows: Options Weighted Average Exercise Price Outstanding at January 1, 2023 7,472,056 $ 4.23 Granted - $ - Exercised - $ - Cancelled (expired) (294,451 ) $ 6.43 Outstanding at March 31, 2023 7,177,605 $ 4.14 The Company recorded stock-based compensation expense in the Condensed Consolidated Statements of Operations as follows (in thousands): Three Months Ended March 31, 2023 2022 General and administrative $ 1,105 $ 1,294 Research and development 117 249 Total stock-based compensation $ 1,222 $ 1,543 At March 31, 2023, the Company had $4.7 million of total unrecognized stock-based compensation expense, net of estimated forfeitures, related to outstanding stock options that will be recognized over a weighted-average period of 1.3 years. As of March 31, 2023, there were 2,061,764 shares available for grant under the Company’s 2020 Equity Incentive Plan. |
Litigation
Litigation | 3 Months Ended |
Mar. 31, 2023 | |
Litigation [Abstract] | |
Litigation | 9. Litigation Eversana Arbitration On May 19, 2022, Eversana Life Science Services, LLC (“Eversana”) filed a Demand for Arbitration claiming approximately $4.5 million in damages against the Company with the American Arbitration Association entitled Eversana Life Sciences, LLC v. Humanigen, Inc. Avid Settlement On February 21, 2023, the Company and Avid Bioservices, Inc. (“Avid”) entered into a Settlement Agreement (the “Avid Settlement Agreement”) providing for a conditional resolution of certain previously reported disputes between the Company and Avid arising pursuant to the commercial agreements between the two parties (collectively, the “Lenzilumab Disputes”). Pursuant to the Settlement Agreement, the Company made a one-time payment of $3.0 million to Avid (the “Settlement Payment”). In addition, the parties mutually agreed that, effective upon the expiration of 120 days from the date of the Settlement Agreement and only if Humanigen has not by such date filed for or been placed into bankruptcy or commenced an assignment for the benefit of creditors or other insolvency proceeding, the parties will dismiss the pending Lenzilumab Disputes and release and discharge each other from all existing claims, demands, causes of actions, charges and grievances of any kind arising out of, or relating to, the Lenzilumab Disputes and the commercial agreements between the parties, which were terminated in accordance with their respective terms. Thermo Litigation On October 24, 2022, one of the Company’s former CMOs, Thermo Fisher Scientific, Inc. (“Thermo”) filed a lawsuit against the Company in Delaware Superior Court ( Patheon Biologics, Inc. v. Humanigen, Inc., Securities Class Action Litigation On August 26, 2022, a putative securities class action complaint captioned Pieroni v. Humanigen Inc., et al., Greenbaum v. Humanigen Inc., et al. In re Humanigen, Inc. Securities Litigation Shareholder Derivative Litigation On January 17, 2023, a derivative lawsuit captioned Chul Yang derivatively on behalf of Humanigen, Inc. v. Durrant, et al. |
Potentially Dilutive Securiti_2
Potentially Dilutive Securities (Tables) | 3 Months Ended |
Mar. 31, 2023 | |
Potentially Dilutive Securities [Abstract] | |
Schedule of diluted net loss per common share | As of March 31, 2023 2022 Options to purchase common stock 7,177,605 4,712,659 Warrants to purchase common stock 31,238 31,238 Convertible debt - 510,986 7,208,843 5,254,883 |
License Revenue (Tables)
License Revenue (Tables) | 3 Months Ended |
Mar. 31, 2023 | |
License Revenue [Abstract] | |
Schedule of contract liability | Balance at January 1, 2023 $ 2,649 Deductions for performance obligations satisfied: In current period (221 ) Balance at March 31, 2023 $ 2,428 |
Stock-Based Compensation (Table
Stock-Based Compensation (Tables) | 3 Months Ended |
Mar. 31, 2023 | |
Stock-Based Compensation [Abstract] | |
Schedule of stock option activity | Options Weighted Average Exercise Price Outstanding at January 1, 2023 7,472,056 $ 4.23 Granted - $ - Exercised - $ - Cancelled (expired) (294,451 ) $ 6.43 Outstanding at March 31, 2023 7,177,605 $ 4.14 |
Schedule of stock-based compensation expense | Three Months Ended March 31, 2023 2022 General and administrative $ 1,105 $ 1,294 Research and development 117 249 Total stock-based compensation $ 1,222 $ 1,543 |
Nature of Operations (Details)
Nature of Operations (Details) $ in Millions | Mar. 31, 2023 USD ($) |
Nature of Operations (Details) [Line Items] | |
Cash and cash equivalents | $ 3.1 |
Accounts payable and accrued expenses | 52.4 |
Remaining commitments | 1.8 |
2022 [Member] | |
Nature of Operations (Details) [Line Items] | |
Remaining commitments | $ 1.8 |
Potentially Dilutive Securiti_3
Potentially Dilutive Securities (Details) - Schedule of diluted net loss per common share - shares | 3 Months Ended | |
Mar. 31, 2023 | Mar. 31, 2022 | |
Schedule of Diluted Net Loss Per Common Share [Abstract] | ||
Potentially dilutive securities | 7,208,843 | 5,254,883 |
Options to purchase common stock [Member] | ||
Schedule of Diluted Net Loss Per Common Share [Abstract] | ||
Potentially dilutive securities | 7,177,605 | 4,712,659 |
Warrants to purchase common stock [Member] | ||
Schedule of Diluted Net Loss Per Common Share [Abstract] | ||
Potentially dilutive securities | 31,238 | 31,238 |
Convertible Debt [Member] | ||
Schedule of Diluted Net Loss Per Common Share [Abstract] | ||
Potentially dilutive securities | 510,986 |
License Revenue (Details)
License Revenue (Details) - USD ($) $ in Millions | 3 Months Ended | ||||
Mar. 31, 2023 | Mar. 31, 2022 | Jun. 30, 2021 | Mar. 31, 2021 | Dec. 31, 2020 | |
License Revenue (Details) [Line Items] | |||||
Upfront license Payment | $ 6 | $ 6 | |||
Milestone license payments | $ 6 | $ 14 | |||
Net of withholding taxes and other fees and royalties | $ 4.5 | $ 4.5 | |||
Description of licensing agreement | It is expected that the Company will supply lenzilumab to the Licensee for a minimum of 7.5 years at a cost-plus basis from an existing or future manufacturer. | ||||
license revenue | $ 0.8 | ||||
License revenue | 0.2 | $ 1 | |||
First Milestone [Member] | |||||
License Revenue (Details) [Line Items] | |||||
Milestone license payments | 6 | ||||
Net of withholding taxes and other fees and royalties | 4.5 | ||||
South Korea Agreement [Member] | |||||
License Revenue (Details) [Line Items] | |||||
license revenue | $ 2.4 |
License Revenue (Details) - Sch
License Revenue (Details) - Schedule of contract liability - South Korea Agreement [Member] $ in Thousands | 3 Months Ended |
Mar. 31, 2023 USD ($) | |
Schedule of Contract Liability [Abstract] | |
Balance at beginning | $ 2,649 |
Deductions for performance obligations satisfied: | |
In current period | (221) |
Balance at ending | $ 2,428 |
Long-Term Debt (Details)
Long-Term Debt (Details) - Secured Term Loan Facility [Member] - USD ($) $ in Millions | 1 Months Ended | 3 Months Ended | |||
Jul. 31, 2022 | Mar. 29, 2021 | Mar. 31, 2023 | Mar. 31, 2022 | Mar. 10, 2021 | |
Long-Term Debt (Details) [Line Items] | |||||
Principal amount | $ 80 | ||||
Draw amount | $ 25 | ||||
Net proceeds | $ 24.4 | ||||
Term loan interest, description | The Term Loan bore interest at a floating rate equal to the greater of either (i) 8.75% plus the prime rate as reported in The Wall Street Journal minus 3.25%, or (ii) 8.75%. The Company was initially obligated to make monthly payments of accrued interest under the Term Loan commencing on the initial borrowing date and continuing to April 1, 2023, followed by monthly installments of principal and interest until March 1, 2025. | ||||
Interest expense | $ 0.7 | ||||
Effective interest rate | 9.25% | ||||
Outstanding principal | $ 25 | ||||
Accrued interest | $ 1.7 |
Commitments and Contingencies (
Commitments and Contingencies (Details) $ in Millions | Mar. 31, 2023 USD ($) |
Commitments and Contingencies Disclosure [Abstract] | |
Manufacturing commitments | $ 1.8 |
Stockholders_ Equity (Details)
Stockholders’ Equity (Details) - USD ($) $ in Millions | 3 Months Ended | |
Mar. 31, 2022 | Dec. 31, 2020 | |
Stockholders’ Equity (Details) [Line Items] | ||
Sale of common stock (in Shares) | 5,926,748 | |
Net proceeds | $ 18.4 | |
Cantor Fitzgerald And Co [Member] | Controlled Equity Offering [Member] | ||
Stockholders’ Equity (Details) [Line Items] | ||
Aggregate gross offering price | $ 100 |
Stock-Based Compensation (Detai
Stock-Based Compensation (Details) $ in Millions | 3 Months Ended |
Mar. 31, 2023 USD ($) shares | |
Stock-Based Compensation (Details) [Line Items] | |
Unrecognized stock-based compensation expense | $ | $ 4.7 |
Weighted-average period recognized | 1 year 3 months 18 days |
2020 Equity Incentive Plan [Member] | |
Stock-Based Compensation (Details) [Line Items] | |
Shares available | shares | 2,061,764 |
Stock-Based Compensation (Det_2
Stock-Based Compensation (Details) - Schedule of stock option activity | 3 Months Ended |
Mar. 31, 2023 $ / shares shares | |
Schedule of Stock Option Activity [Abstract] | |
Options, Beginning | shares | 7,472,056 |
Weighted Average Exercise Price, Beginning | $ / shares | $ 4.23 |
Options, Ending | shares | 7,177,605 |
Weighted Average Exercise Price, Ending | $ / shares | $ 4.14 |
Options, Granted | shares | |
Weighted Average Exercise Price, Granted | $ / shares | |
Options, Exercised | shares | |
Weighted Average Exercise Price, Exercised | $ / shares | |
Options, Cancelled (expired) | shares | (294,451) |
Weighted Average Exercise Price, Cancelled (expired) | $ / shares | $ 6.43 |
Stock-Based Compensation (Det_3
Stock-Based Compensation (Details) - Schedule of stock-based compensation expense - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2023 | Mar. 31, 2022 | |
Schedule of Stock-Based Compensation Expense [Abstract] | ||
Stock-based compensation | $ 1,222 | $ 1,543 |
General and Administrative [Member] | ||
Schedule of Stock-Based Compensation Expense [Abstract] | ||
Stock-based compensation | 1,105 | 1,294 |
Research and Development [Member] | ||
Schedule of Stock-Based Compensation Expense [Abstract] | ||
Stock-based compensation | $ 117 | $ 249 |
Litigation (Details)
Litigation (Details) - USD ($) | 1 Months Ended | 3 Months Ended | ||
Feb. 21, 2023 | Oct. 24, 2022 | May 19, 2022 | Mar. 31, 2023 | |
Litigation (Details) [Line Items] | ||||
Paid to avid | $ 3,000,000 | |||
Expiration term | 120 days | |||
Eversana Arbitration [Member] | ||||
Litigation (Details) [Line Items] | ||||
Claiming amount | $ 4,500,000 | |||
Litigation settlement amount | $ 750,000 | |||
Thermo litigation [Member] | ||||
Litigation (Details) [Line Items] | ||||
Claiming amount | $ 25,900,000 | |||
Litigation settlement amount | $ 8,000,000 | |||
Countersuit Amount | $ 37,500,000 |