Document And Entity Information
Document And Entity Information - shares | 9 Months Ended | |
Sep. 30, 2022 | Nov. 09, 2022 | |
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 | Sep. 30, 2022 | |
Document Fiscal Year Focus | 2022 | |
Document Fiscal Period Focus | Q3 | |
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 | Sep. 30, 2022 | Dec. 31, 2021 |
Current assets: | ||
Cash and cash equivalents | $ 24,725 | $ 70,016 |
Prepaid expenses and other current assets | 1,153 | 955 |
Total current assets | 25,878 | 70,971 |
Other assets | 90 | 90 |
Total assets | 25,968 | 71,061 |
Current liabilities: | ||
Accounts payable | 53,340 | 44,698 |
Accrued expenses | 22,163 | 19,882 |
Deferred revenue | 884 | 4,145 |
Total current liabilities | 76,387 | 68,725 |
Non-current liabilities: | ||
Deferred revenue | 1,986 | 1,018 |
Long-term debt, net of current portion | 25,006 | |
Total liabilities | 78,373 | 94,749 |
Stockholders’ deficit: | ||
Common stock, $0.001 par value: 225,000,000 shares authorized at September 30, 2022 and December 31, 2021; 119,080,135 and 64,027,629 shares issued and outstanding at September 30, 2022 and December 31, 2021, respectively | 119 | 64 |
Additional paid-in capital | 633,675 | 587,327 |
Accumulated deficit | (686,199) | (611,079) |
Total stockholders’ deficit | (52,405) | (23,688) |
Total liabilities and stockholders’ deficit | $ 25,968 | $ 71,061 |
Condensed Consolidated Balanc_2
Condensed Consolidated Balance Sheets (Unaudited) (Parentheticals) - $ / shares | Sep. 30, 2022 | Dec. 31, 2021 |
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 | 64,027,629 |
Common stock, shares outstanding | 119,080,135 | 64,027,629 |
Condensed Consolidated Statemen
Condensed Consolidated Statements of Operations (Unaudited) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2022 | Sep. 30, 2021 | Sep. 30, 2022 | Sep. 30, 2021 | |
Revenue: | ||||
Total revenue | $ 221 | $ 1,036 | $ 2,293 | $ 2,558 |
Operating expenses: | ||||
Research and development | 18,929 | 60,811 | 62,587 | 183,757 |
General and administrative | 4,013 | 6,204 | 12,307 | 19,228 |
Total operating expenses | 22,942 | 67,015 | 74,894 | 202,985 |
Loss from operations | (22,721) | (65,979) | (72,601) | (200,427) |
Other income (expense): | ||||
Interest expense | (1,298) | (751) | (2,800) | (1,516) |
Other income (expense), net | 326 | (9) | 281 | (1,166) |
Net loss | $ (23,693) | $ (66,739) | $ (75,120) | $ (203,109) |
Basic and diluted net loss per common share (in Dollars per share) | $ (0.23) | $ (1.12) | $ (0.95) | $ (3.56) |
Weighted average common shares outstanding used to calculate basic and diluted net loss per common share (in Shares) | 101,422,027 | 59,486,626 | 79,179,209 | 56,997,039 |
License revenue | ||||
Revenue: | ||||
Total revenue | $ 221 | $ 1,036 | $ 2,293 | $ 2,558 |
Condensed Consolidated Statem_2
Condensed Consolidated Statements of Operations (Unaudited) (Parentheticals) - $ / shares | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2022 | Sep. 30, 2021 | Sep. 30, 2022 | Sep. 30, 2021 | |
Income Statement [Abstract] | ||||
Basic and diluted net loss per common share (in Dollars per share) | $ (0.24) | $ (1.12) | $ (0.96) | $ (3.56) |
Weighted average common shares outstanding used to calculate basic and diluted net loss per common share (in Shares) | 101,422,027 | 59,486,626 | 79,179,209 | 56,997,039 |
Condensed Consolidated Statem_3
Condensed Consolidated Statements of Cash Flows (Unaudited) - USD ($) $ in Thousands | 9 Months Ended | |
Sep. 30, 2022 | Sep. 30, 2021 | |
Operating activities: | ||
Net loss | $ (75,120) | $ (203,109) |
Adjustments to reconcile net loss to net cash used in operating activities: | ||
Stock based compensation expense | 4,560 | 3,815 |
Non-cash interest expense related to debt financing | 374 | |
Changes in operating assets and liabilities: | ||
Prepaid expenses and other assets | (198) | (872) |
Accounts payable | 8,642 | 30,596 |
Accrued expenses | 2,281 | 15,427 |
Deferred revenue | (2,293) | 1,983 |
Net cash used in operating activities | (62,128) | (151,786) |
Financing activities: | ||
Net proceeds from issuance of common stock | 41,843 | 134,140 |
Proceeds from exercise of stock options | 1,965 | |
Net proceeds from issuance of long-term debt | 24,444 | |
Repayment of Hercules loan | (25,006) | |
Net cash provided by financing activities | 16,837 | 160,549 |
Net increase (decrease) in cash and cash equivalents | (45,291) | 8,763 |
Cash and cash equivalents, beginning of period | 70,016 | 67,737 |
Cash and cash equivalents, end of period | 24,725 | 76,500 |
Supplemental cash flow disclosure: | ||
Cash paid for interest | $ 1,319 | $ 961 |
Condensed Consolidated Statem_4
Condensed Consolidated Statements of Stockholders’ Equity (Deficit) (Unaudited) - USD ($) $ in Thousands | Common Stock | Additional Paid-In Capital | Accumulated Deficit | Total |
Balances at Dec. 31, 2020 | $ 52 | $ 419,923 | $ (374,430) | $ 45,545 |
Balances (in Shares) at Dec. 31, 2020 | 51,626,508 | |||
Issuance of common stock, net of expenses | $ 2 | 36,104 | 36,106 | |
Issuance of common stock, net of expenses (in Shares) | 1,796,858 | |||
Issuance of common stock upon option exercise | 429 | 429 | ||
Issuance of common stock upon option exercise (in Shares) | 233,323 | |||
Stock-based compensation expense | 510 | 510 | ||
Net loss | (65,567) | (65,567) | ||
Balances at Mar. 31, 2021 | $ 54 | 456,966 | (439,997) | 17,023 |
Balances (in Shares) at Mar. 31, 2021 | 53,656,689 | |||
Balances at Dec. 31, 2020 | $ 52 | 419,923 | (374,430) | 45,545 |
Balances (in Shares) at Dec. 31, 2020 | 51,626,508 | |||
Net loss | (203,109) | |||
Balances at Sep. 30, 2021 | $ 60 | 559,835 | (577,539) | (17,644) |
Balances (in Shares) at Sep. 30, 2021 | 60,017,333 | |||
Balances at Mar. 31, 2021 | $ 54 | 456,966 | (439,997) | 17,023 |
Balances (in Shares) at Mar. 31, 2021 | 53,656,689 | |||
Issuance of common stock, net of expenses | $ 5 | 94,167 | 94,172 | |
Issuance of common stock, net of expenses (in Shares) | 5,427,017 | |||
Issuance of common stock upon option exercise | 1,432 | 1,432 | ||
Issuance of common stock upon option exercise (in Shares) | 319,153 | |||
Stock-based compensation expense | 1,871 | 1,871 | ||
Net loss | (70,803) | (70,803) | ||
Balances at Jun. 30, 2021 | $ 59 | 554,436 | (510,800) | 43,695 |
Balances (in Shares) at Jun. 30, 2021 | 59,402,859 | |||
Issuance of common stock, net of expenses | $ 1 | 3,861 | 3,862 | |
Issuance of common stock, net of expenses (in Shares) | 600,933 | |||
Issuance of common stock upon option exercise | 104 | 104 | ||
Issuance of common stock upon option exercise (in Shares) | 13,541 | |||
Stock-based compensation expense | 1,434 | 1,434 | ||
Net loss | (66,739) | (66,739) | ||
Balances at Sep. 30, 2021 | $ 60 | 559,835 | (577,539) | (17,644) |
Balances (in Shares) at Sep. 30, 2021 | 60,017,333 | |||
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, 2021 | $ 64 | 587,327 | (611,079) | $ (23,688) |
Balances (in Shares) at Dec. 31, 2021 | 64,027,629 | |||
Issuance of common stock upon option exercise (in Shares) | ||||
Net loss | $ (75,120) | |||
Balances at Sep. 30, 2022 | $ 119 | 633,675 | (686,199) | (52,405) |
Balances (in Shares) at Sep. 30, 2022 | 119,080,135 | |||
Balances at Mar. 31, 2022 | $ 70 | 607,238 | (632,357) | (25,049) |
Balances (in Shares) at Mar. 31, 2022 | 69,954,377 | |||
Issuance of common stock, net of expenses | $ 1 | 3,474 | 3,475 | |
Issuance of common stock, net of expenses (in Shares) | 1,288,561 | |||
Stock-based compensation expense | 1,635 | 1,635 | ||
Net loss | (30,149) | (30,149) | ||
Balances at Jun. 30, 2022 | $ 71 | 612,347 | (662,506) | (50,088) |
Balances (in Shares) at Jun. 30, 2022 | 71,242,938 | |||
Issuance of common stock, net of expenses | $ 48 | 19,946 | 19,994 | |
Issuance of common stock, net of expenses (in Shares) | 47,837,197 | |||
Stock-based compensation expense | 1,382 | 1,382 | ||
Net loss | (23,693) | (23,693) | ||
Balances at Sep. 30, 2022 | $ 119 | $ 633,675 | $ (686,199) | $ (52,405) |
Balances (in Shares) at Sep. 30, 2022 | 119,080,135 |
Nature of Operations
Nature of Operations | 9 Months Ended |
Sep. 30, 2022 | |
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 ® ® In July 2022, preliminary topline results from the Accelerating COVID-19 Therapeutic Interventions and Vaccines-5 (“ACTIV-5”) and Big Effect Trial, in the “B” arm of the trial (“BET-B”), referred to as the ACTIV-5/BET-B trial, were released. The study was sponsored and funded by the National Institutes of Health (“NIH”) and evaluated lenzilumab in combination with remdesivir, compared to placebo and remdesivir, in hospitalized COVID-19 patients. Based on the preliminary topline results, the trial did not achieve statistical significance on the primary endpoint, although the preliminary topline results did indicate that lenzilumab demonstrated a positive trend in mortality. The Company continues to support NIH’s further analysis of the data and a global group of leading institutions and research networks has indicated interest in including lenzilumab in their large-scale, multinational studies of COVID-19. Tocilizumab and baricitinib demonstrated mortality benefit following inclusion in REMAP-CAP and RECOVERY, despite having failed to do so in smaller studies. In connection with the release of preliminary topline data from ACTIV-5/BET-B, the Company announced a strategic realignment of its pipeline and resources and its regulatory strategy. The Company plans to accelerate the development of lenzilumab in chronic myelomonocytic leukemia (“CMML”), a rare blood cancer, for which the PREACH-M study is already underway, and to continue its plans for the RATinG study in acute graft versus host disease (“aGvHD”) that occurs in patients undergoing bone marrow transplant. Recruitment for the RATinG study is temporarily halted due to an administrative issue and the Company is currently unable to estimate when the first patient will be enrolled in the study. These studies are majority funded by the Company’s partners. In addition, the Company is currently assessing requests for investigator-initiated trials (“IIT”s) of lenzilumab in combination with CAR-T therapies; the previously planned Company-sponsored study of lenzilumab with certain CAR-T therapies has been terminated pursuant to the strategic realignment plan. The Company also plans to continue the development of iFab, an EpAh-3 targeted monoclonal antibody currently in Phase 1 development, as part of an antibody drug conjugate (“ADC”), for certain solid tumors. Under the realignment plan, the Company will deemphasize the deployment of resources for the development of lenzilumab for COVID-19 and currently does not plan to pursue regulatory pathways, pending further data from ACTIV-5/BET-B or a future large-scale study; the Named Patient program in select European Countries has been terminated. See Management’s Discussion and Analysis of Financial Condition and Results of Operations included in Item 7 of the Company’s 2021 Annual Report on Form 10-K for additional information regarding the business. Liquidity and Going Concern The Condensed Consolidated Financial Statements for the three and nine months ended September 30, 2022 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 September 30, 2022, the Company had cash and cash equivalents of $24.7 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 condensed consolidated balance sheets as of September 30, 2022 of $75.5 million, certain of which are in dispute, and manufacturing commitments of $3.2 million during the remaining three months of 2022, $2.3 million for 2023, and $3.8 million 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 commitments and amounts owed to manufacturing and other partners at September 30, 2022. In order to remain a going concern and execute its strategic realignment plan, the Company must successfully renegotiate these amounts owed, and settle disputes, including current and potential future arbitration and litigation. The Company recently engaged SC&H Capital, an affiliate of SC&H Group, (“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. The Company also may seek to raise such 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 U.S. generally accepted accounting principles (“U.S. 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, 2021 Condensed Consolidated Balance Sheet was derived from the audited financial statements but does not include all disclosures required by U.S. GAAP. These interim financial results are not necessarily indicative of the results to be expected for the year ending December 31, 2022, 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 2021 Annual Report on Form 10-K. The preparation of financial statements in conformity with U.S. 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 | 9 Months Ended |
Sep. 30, 2022 | |
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, 2021. There have been no significant changes to the Company’s significant accounting policies during the nine months ended September 30, 2022, from those previously disclosed in its 2021 Annual Report on Form 10-K. |
Potentially Dilutive Securities
Potentially Dilutive Securities | 9 Months Ended |
Sep. 30, 2022 | |
Earnings Per Share [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 September 30, 2022 2021 Options to purchase common stock 8,291,826 4,144,864 Warrants to purchase common stock 31,238 31,238 Convertible debt - 510,986 8,323,064 4,687,088 |
License Revenue
License Revenue | 9 Months Ended |
Sep. 30, 2022 | |
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 has 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 U.S., 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, are being recognized as revenue ratably over the performance period, the expected period over which the Company expects the Services to be performed (the “Performance Period”). Through June 30, 2022, revenue was being amortized through March 31, 2023, the expected end of the performance period. 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 $2.3 million in the three and nine months ended September 30, 2022, respectively, and $1.0 million and $2.6 million in the three and nine months ended September 30, 2021, respectively. Prospective periods will reflect the impact of this change in estimate. 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 $2.9 million was recorded on the Condensed Consolidated Balance Sheets as deferred revenue as of September 30, 2022 related to the South Korea agreement. There were no contract asset or deferred contract acquisition costs as of September 30, 2022 associated with the South Korea agreement. The following table presents changes in the Company’s contract liability for the nine months ended September 30, 2022 (in thousands): Balance at January 1, 2022 $ 5,163 Deductions for performance obligations satisfied: In current period (2,293 ) Balance at September 30, 2022 $ 2,870 |
Long-Term Debt
Long-Term Debt | 9 Months Ended |
Sep. 30, 2022 | |
Debt Disclosure [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 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. 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. By retiring the Term Loan, the Company is able to reduce future cash payments for interest and enhance its ability to generate additional liquidity from its intellectual property by removing the loan’s collateral requirements. Interest expense related to the Term Loan was $1.3 million and $2.8 million for the three and nine months ended September 30, 2022, respectively, and the effective interest rate was approximately 8.8% and 9.3% for the three and nine months ended September 30, 2022, respectively. Interest expense in the three months ended September 30, 2022 included $1.2 million in unamortized loan fees recognized in connection with the loan payoff. Interest expense related to the Term Loan, for the three and nine months ended September 30, 2021 was $0.7 and $1.5 million, respectively, and the effective interest rate was 9.0% for both periods. |
Commitments and Contingencies
Commitments and Contingencies | 9 Months Ended |
Sep. 30, 2022 | |
Commitments and Contingencies Disclosure [Abstract] | |
Commitments and Contingencies | 6. Commitments and Contingencies Eversana Agreement On January 10, 2021, the Company announced that it had entered into a master services agreement (the “Eversana Agreement”) with Eversana Life Science Services, LLC (“Eversana”) pursuant to which Eversana will provide the Company multiple services from its integrated commercial platform in preparation for the potential commercialization of lenzilumab. Under the Eversana Agreement, Eversana will provide the Company with services in connection with the potential launch of lenzilumab. Eversana services during 2021 comprised marketing, market access, consulting, field solutions, field operations, health economics and medical affairs. Additional services may be negotiated by the parties and set forth in statements of work delivered in accordance with the Eversana Agreement. On September 21, 2021, the Company notified Eversana that due to the EUA status in the U.S., it was terminating the initial statement of work related to commercialization support of lenzilumab for the treatment of COVID-19 in the United States. Eversana is disputing the termination notice and has requested payment of approximately $4.5 million it has asserted the Company owes for services rendered from April 1, 2021 to September 30, 2021. The Company has disputed this assertion and Eversana has filed for arbitration to resolve this dispute. See Note 10 below for more information on this dispute. Manufacturing Agreements The Company has entered into agreements with several contract manufacturing organizations (“CMOs”) to manufacture bulk drug substance (“BDS”) and to provide fill/finish services or drug product (“DP”) for lenzilumab for a potential launch of lenzilumab in anticipation of an EUA or CMA. The Company has also entered into agreements for packaging of the drug. These agreements include upfront amounts prior to commencement of manufacturing and progress payments through the course of the manufacturing process and payments for technology transfer. Since September 9, 2021, the Company has amended, and in some cases canceled, certain of these agreements, some of which were contingent on EUA, in an effort to reduce its future spending on lenzilumab production. More recently, the Company has sought to mitigate its financial commitments by ceasing additional manufacturing of lenzilumab in connection with its realignment plan. As of September 30, 2022, the Company estimates that its commitments remaining to be incurred under these agreements are approximately $3.2 million for the remaining three months of 2022, $2.3 million for 2023, and $3.8 million thereafter. The Company intends to seek to defer these and other payments, negotiate lower amounts or pursue other courses of action for these amounts, but the Company’s efforts may not be successful. The Company believes it has sufficient supply to conduct its contemplated clinical development efforts. The Company estimates the number of vials required per patient in its clinical trials is between 48 and 150. The Company has stopped all manufacturing of lenzilumab, with the exception of batches in process at one of its CMOs, Catalent Pharma Solutions, LLC (“Catalent”). As of October 31, 2022, there were an additional approximately 630,000 lenzilumab vials either in production or available for storage at Catalent. If the Company is unable to obtain regulatory approval for lenzilumab prior to the expiration of the shelf life at that time, the remaining inventory will not be available for commercial use. Catalent has notified the Company that it claims the Company is in breach of its manufacturing agreement with Catalent and has stopped all manufacturing activities being performed under the agreement. The parties are negotiating a resolution; however, approximately 630,000 lenzilumab vials at Catalent may not be released if the Company is unable to reach an agreement with Catalent. Another 594,000 lenzilumab vials are in production at one of the Company’s other CMOs, Thermo Fisher Scientific, Inc. (“Thermo”), for which material has not yet been released by the Company because the batches produced are out of specification. Nonetheless, Thermo has notified the Company that they have stopped production and have recently filed a lawsuit against the Company in Delaware Superior Court for $25.9 million. The Company denies Thermo’s claims and assertions and intends to vigorously defend against them. See Note 10 below for more information on this dispute. |
Stockholders_ Equity
Stockholders’ Equity | 9 Months Ended |
Sep. 30, 2022 | |
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. On April 14, 2022, the Company filed a prospectus in respect of the Sales Agreement which provides the Company with the ability to offer and sell shares of common stock having an aggregate offering price of up to an additional $75.0 million. During the three and nine months ended September 30, 2022, under the Sales Agreement, the Company issued and sold 47,837,197 shares of its common stock for net proceeds of $20.0 million, and 55,052,506 shares of its common stock for net proceeds of $41.8 million, respectively. During the three and nine months ended September 30, 2021, under the Sales Agreement, the Company issued and sold 600,933 shares of its common stock for net proceeds of $3.9 million, and 2,397,791 shares of its common stock for net proceeds of $40.0 million, respectively. No shares have been sold under the Sales Agreement subsequent to September 30, 2022. 2021 Underwritten Public Offering On March 30, 2021, the Company entered into an underwriting agreement (the “Underwriting Agreement”) with Jefferies LLC, Credit Suisse Securities (USA) LLC and Cantor, as representatives of the several underwriters, in connection with the public offering of 5,000,000 shares of our common stock. In addition, we granted the underwriters a 30-day option to purchase an additional 750,000 shares of our common stock. The initial offering closed on April 5, 2021. On May 3, 2021, we closed on the sale of an additional 427,017 shares of our common stock related to the exercise of the underwriters’ 30-day option. The aggregate gross proceeds from the sale of the 5,427,017 shares in the offering, inclusive of the additional shares purchased by the underwriters, were approximately $100.4 million. The net proceeds from this offering, after deducting underwriting discounts and offering costs, were approximately $94.2 million. |
Stock-Based Compensation
Stock-Based Compensation | 9 Months Ended |
Sep. 30, 2022 | |
Share-Based Payment Arrangement [Abstract] | |
Stock-Based Compensation | 8. Stock-Based Compensation A summary of stock option activity for the nine months ended September 30, 2022 under all the Company’s options plans is as follows: Options Weighted Outstanding at January 1, 2022 4,429,906 $ 7.89 Granted 4,708,969 $ 0.57 Exercised - $ - Cancelled (forfeited) (820,024 ) $ 4.37 Cancelled (expired) (27,025 ) $ 13.64 Outstanding at September 30, 2022 8,291,826 $ 4.06 The weighted average fair value of options granted during the nine months ended September 30, 2022 was $0.47 per share. The Company valued the options granted using the Black-Scholes options pricing model and the following weighted-average assumption terms for the nine months ended September 30, 2022: Nine Months Ended September 30, 2022 Exercise price $0.38 - $2.99 Market value $0.38 - $2.99 Expected term 6 years Expected volatility 104% - 109% Risk-free interest rate 1.59% - 2.89% Expected dividend yield 0% The Company recorded stock-based compensation expense in the Condensed Consolidated Statements of Operations as follows (in thousands): Three Months Ended September 30, Nine Months Ended September 30, 2022 2021 2022 2021 General and administrative $ 1,366 $ 1,077 $ 4,001 $ 2,848 Research and development 16 357 559 967 Total stock-based compensation $ 1,382 $ 1,434 $ 4,560 $ 3,815 At September 30, 2022, the Company had $7.8 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 1.7 years. As of September 30, 2022, there were 1,128,365 shares available for grant under the Company’s 2020 Equity Incentive Plan. |
License and Collaboration Agree
License and Collaboration Agreements | 9 Months Ended |
Sep. 30, 2022 | |
License and Collaboration Agreements [Abstract] | |
License and Collaboration Agreements | 9. License and Collaboration Agreements Clinical Trial Agreement with the National Institute of Allergy and Infectious Diseases On July 24, 2020, the Company entered into a clinical trial agreement (the “ACTIV-5 Clinical Trial Agreement”) with the National Institute of Allergy and Infectious Diseases (“NIAID”), part of NIH, which is part of the U.S. Government Department of Health and Human Services, as represented by the Division of Microbiology and Infectious Diseases. Pursuant to the ACTIV-5 Clinical Trial Agreement, lenzilumab was evaluated in the NIAID-sponsored ACTIV-5/BET-B trial in hospitalized patients with COVID-19. According to the preliminary topline results released in July 2022, the trial did not achieve statistical significance on the primary endpoint. The preliminary topline data showed a non-significant trend toward a reduction in mortality in the overall patient population [HR 0.72]. There were no new safety signals attributed to lenzilumab in the ACTIV-5/BET-B study. Pursuant to the ACTIV-5 Clinical Trial Agreement, NIAID served as sponsor and was responsible for funding, supervising and overseeing the ACTIV-5/BET-B trial. The Company provided lenzilumab to NIAID without charge and in quantities to ensure a sufficient supply of lenzilumab. The ACTIV-5 Clinical Trial Agreement imposed additional obligations on the Company that are reasonable and customary for clinical trial agreements of this nature, including in respect of compliance with data privacy laws and potential indemnification obligations. |
Litigation
Litigation | 9 Months Ended |
Sep. 30, 2022 | |
Disclosure Text Block Supplement [Abstract] | |
Litigation | 10. Litigation Eversana Arbitration On May 19, 2022, 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. The Company denies Eversana’s claims and assertions and will continue to vigorously defend against them. Avid Arbitration On December 17, 2021, Avid Bioservices, Inc. (“Avid”) filed a Demand for Arbitration claiming more than $20.5 million in damages against the Company with the American Arbitration Association entitled, Avid Bioservices, Inc. v. Humanigen, Inc. On January 6, 2022, the Company filed an Answer to Avid’s Demand, denying the allegations and asserting affirmative defenses. On July 1, 2022, the Company filed its own claims against Avid for: (1) Breach of Contract; (2) Declaratory Relief; and (3) Unfair Business Practices. The Company denies Avid’s claims and assertions and will continue to vigorously defend against them. Savant Litigation The Company was previously involved in litigation against Savant Neglected Diseases, LLC (“Savant”). In March 2022, the Company and Savant reached a confidential settlement. Accordingly, the litigation involving Savant was dismissed on March 31, 2022. Thermo Litigation Thermo has notified the Company that they have stopped production and have issued a demand for payment for unreleased batches. Thermo has 594,000 vials of lenzilumab that are in production, for which material has not yet been released by the Company because the batches produced are out of specification. Thermo recently 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. |
Potentially Dilutive Securiti_2
Potentially Dilutive Securities (Tables) | 9 Months Ended |
Sep. 30, 2022 | |
Earnings Per Share [Abstract] | |
Schedule of diluted net loss per common share | As of September 30, 2022 2021 Options to purchase common stock 8,291,826 4,144,864 Warrants to purchase common stock 31,238 31,238 Convertible debt - 510,986 8,323,064 4,687,088 |
License Revenue (Tables)
License Revenue (Tables) | 9 Months Ended |
Sep. 30, 2022 | |
License Revenue [Abstract] | |
Schedule of contract liability | Balance at January 1, 2022 $ 5,163 Deductions for performance obligations satisfied: In current period (2,293 ) Balance at September 30, 2022 $ 2,870 |
Stock-Based Compensation (Table
Stock-Based Compensation (Tables) | 9 Months Ended |
Sep. 30, 2022 | |
Share-Based Payment Arrangement [Abstract] | |
Schedule of stock option activity | Options Weighted Outstanding at January 1, 2022 4,429,906 $ 7.89 Granted 4,708,969 $ 0.57 Exercised - $ - Cancelled (forfeited) (820,024 ) $ 4.37 Cancelled (expired) (27,025 ) $ 13.64 Outstanding at September 30, 2022 8,291,826 $ 4.06 |
Schedule of options granted using the Black-Scholes options pricing model | Nine Months Ended September 30, 2022 Exercise price $0.38 - $2.99 Market value $0.38 - $2.99 Expected term 6 years Expected volatility 104% - 109% Risk-free interest rate 1.59% - 2.89% Expected dividend yield 0% |
Schedule of stock-based compensation expense | Three Months Ended September 30, Nine Months Ended September 30, 2022 2021 2022 2021 General and administrative $ 1,366 $ 1,077 $ 4,001 $ 2,848 Research and development 16 357 559 967 Total stock-based compensation $ 1,382 $ 1,434 $ 4,560 $ 3,815 |
Nature of Operations (Details)
Nature of Operations (Details) $ in Millions | Sep. 30, 2022 USD ($) |
Nature of Operations (Details) [Line Items] | |
Cash and cash equivalents | $ 24.7 |
Accounts payable and accrued expenses | 75.5 |
2022 [Member] | |
Nature of Operations (Details) [Line Items] | |
Remaining commitments | 3.2 |
2023 [Member] | |
Nature of Operations (Details) [Line Items] | |
Remaining commitments | 2.3 |
2024 [Member] | |
Nature of Operations (Details) [Line Items] | |
Remaining commitments | $ 3.8 |
Potentially Dilutive Securiti_3
Potentially Dilutive Securities (Details) - Schedule of diluted net loss per common share - shares | 9 Months Ended | |
Sep. 30, 2022 | Sep. 30, 2021 | |
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Potentially dilutive securities | 8,323,064 | 4,687,088 |
Options to purchase common stock [Member] | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Potentially dilutive securities | 8,291,826 | 4,144,864 |
Warrants to purchase common stock [Member] | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Potentially dilutive securities | 31,238 | 31,238 |
Convertible debt [Member] | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Potentially dilutive securities | 510,986 |
License Revenue (Details)
License Revenue (Details) - USD ($) $ in Millions | 3 Months Ended | 9 Months Ended | 12 Months Ended | |||
Sep. 30, 2022 | Sep. 30, 2021 | Mar. 31, 2021 | Sep. 30, 2022 | Sep. 30, 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 | $ 0.8 | ||||
License revenue | 0.2 | $ 1 | 2.3 | $ 2.6 | ||
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 | $ 2.9 | $ 2.9 |
License Revenue (Details) - Sch
License Revenue (Details) - Schedule of contract liability - South Korea agreement [Member] $ in Thousands | 9 Months Ended |
Sep. 30, 2022 USD ($) | |
License Revenue (Details) - Schedule of contract liability [Line Items] | |
Balance at beginning | $ 5,163 |
Deductions for performance obligations satisfied: | |
In current period | (2,293) |
Balance at ending | $ 2,870 |
Long-Term Debt (Details)
Long-Term Debt (Details) - USD ($) $ in Millions | 1 Months Ended | 3 Months Ended | 9 Months Ended | ||||
Jul. 31, 2022 | Mar. 29, 2021 | Sep. 30, 2022 | Sep. 30, 2021 | Sep. 30, 2022 | Sep. 30, 2021 | Mar. 10, 2021 | |
Long-Term Debt (Details) [Line Items] | |||||||
Interest expense | $ 1.2 | ||||||
Secured Term Loan Facility [Member] | |||||||
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. | ||||||
Converted principal amount | $ 25 | ||||||
Accrued interest | $ 1.7 | ||||||
Interest expense | $ 1.3 | $ 0.7 | $ 2.8 | $ 1.5 | |||
Effective interest rate | 8.80% | 9% | 9.30% | 9% |
Commitments and Contingencies (
Commitments and Contingencies (Details) $ in Millions | 1 Months Ended | 9 Months Ended | ||
Oct. 31, 2022 vials | May 19, 2022 USD ($) | Sep. 21, 2021 USD ($) | Sep. 30, 2022 USD ($) vials | |
Commitments and Contingencies (Details) [Line Items] | ||||
Lenzilumab vials (in vials) | vials | 630,000 | 630,000 | ||
2022 [Member] | ||||
Commitments and Contingencies (Details) [Line Items] | ||||
Manufacturing commitments | $ 3.2 | |||
2023 [Member] | ||||
Commitments and Contingencies (Details) [Line Items] | ||||
Remaining commitments | 2.3 | |||
2024 [Member] | ||||
Commitments and Contingencies (Details) [Line Items] | ||||
Remaining commitments | 3.8 | |||
Thermo litigation [Member] | ||||
Commitments and Contingencies (Details) [Line Items] | ||||
Payment requested for services rendered | $ 25.9 | |||
Lenzilumab vials (in vials) | vials | 594,000 | |||
Eversana Agreement [Member] | ||||
Commitments and Contingencies (Details) [Line Items] | ||||
Payment requested for services rendered | $ 4.5 | $ 4.5 |
Stockholders_ Equity (Details)
Stockholders’ Equity (Details) - USD ($) $ in Millions | 1 Months Ended | 3 Months Ended | 9 Months Ended | |||||
May 03, 2021 | Mar. 30, 2021 | Sep. 30, 2022 | Sep. 30, 2021 | Sep. 30, 2022 | Sep. 30, 2021 | Apr. 14, 2022 | Dec. 31, 2020 | |
Underwritten Public Offering 2021 [Member] | ||||||||
Stockholders’ Equity (Details) [Line Items] | ||||||||
Sale of additional shares of common stock | 427,017 | |||||||
Aggregate gross proceeds from sale of shares | 5,427,017 | |||||||
Shares issued in public offering, value | $ 100.4 | |||||||
Proceeds from sale of shares after offering costs | $ 94.2 | |||||||
Cantor Fitzgerald And Co [Member] | Controlled equity offering sm sales agreement [Member] | ||||||||
Stockholders’ Equity (Details) [Line Items] | ||||||||
Maximum aggregate gross offering price | $ 100 | |||||||
Additional maximum aggregate gross offering price | $ 75 | |||||||
Shares of common stock | 47,837,197 | 600,933 | 55,052,506 | 2,397,791 | ||||
Net proceeds | $ 20 | $ 3.9 | $ 41.8 | $ 40 | ||||
Jefferies LLC [Member] | Underwriting Agreement [Member] | ||||||||
Stockholders’ Equity (Details) [Line Items] | ||||||||
Shares issued in public offering | 5,000,000 | |||||||
Warrants to purchase common stock | 750,000 |
Stock-Based Compensation (Detai
Stock-Based Compensation (Details) $ / shares in Units, $ in Millions | 9 Months Ended |
Sep. 30, 2022 USD ($) $ / shares shares | |
Stock-Based Compensation (Details) [Line Items] | |
Weighted average fair value of options | $ / shares | $ 0.47 |
Unrecognized stock-based compensation expense | $ | $ 7.8 |
Weighted-average period recognized | 1 year 8 months 12 days |
2020 Equity Incentive Plan [Member] | |
Stock-Based Compensation (Details) [Line Items] | |
Shares available | shares | 1,128,365 |
Stock-Based Compensation (Det_2
Stock-Based Compensation (Details) - Schedule of stock option activity | 9 Months Ended |
Sep. 30, 2022 $ / shares shares | |
Schedule Of Stock Option Activity Abstract | |
Outstanding options at January 1, 2022 | shares | 4,429,906 |
Outstanding weighted average exercise price at January 1, 2022 | $ / shares | $ 7.89 |
Granted options | shares | 4,708,969 |
Granted weighted average exercise price | $ / shares | $ 0.57 |
Exercised options | shares | |
Exercised weighted average exercise price | $ / shares | |
Cancelled (forfeited) options | shares | (820,024) |
Cancelled (forfeited) weighted average exercise price | $ / shares | $ 4.37 |
Cancelled (expired) options | shares | (27,025) |
Cancelled (expired) weighted average exercise price | $ / shares | $ 13.64 |
Outstanding options at September 30, 2022 | shares | 8,291,826 |
Outstanding weighted average exercise price at September 30, 2022 | $ / shares | $ 4.06 |
Stock-Based Compensation (Det_3
Stock-Based Compensation (Details) - Schedule of options granted using the Black-Scholes options pricing model | 9 Months Ended |
Sep. 30, 2022 $ / shares | |
Stock-Based Compensation (Details) - Schedule of options granted using the Black-Scholes options pricing model [Line Items] | |
Expected term | 6 years |
Expected dividend yield | 0% |
Minimum [Member] | |
Stock-Based Compensation (Details) - Schedule of options granted using the Black-Scholes options pricing model [Line Items] | |
Exercise price (in Dollars per share) | $ 0.38 |
Market value (in Dollars per share) | $ 0.38 |
Expected volatility | 104% |
Risk-free interest rate | 1.59% |
Maximum [Member] | |
Stock-Based Compensation (Details) - Schedule of options granted using the Black-Scholes options pricing model [Line Items] | |
Exercise price (in Dollars per share) | $ 2.99 |
Market value (in Dollars per share) | $ 2.99 |
Expected volatility | 109% |
Risk-free interest rate | 2.89% |
Stock-Based Compensation (Det_4
Stock-Based Compensation (Details) - Schedule of stock-based compensation expense - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2022 | Sep. 30, 2021 | Sep. 30, 2022 | Sep. 30, 2021 | |
Share-Based Payment Arrangement, Expensed and Capitalized, Amount [Line Items] | ||||
Stock-based compensation | $ 1,382 | $ 1,434 | $ 4,560 | $ 3,815 |
General and Administrative Expense [Member] | ||||
Share-Based Payment Arrangement, Expensed and Capitalized, Amount [Line Items] | ||||
Stock-based compensation | 1,366 | 1,077 | 4,001 | 2,848 |
Research and Development Expense [Member] | ||||
Share-Based Payment Arrangement, Expensed and Capitalized, Amount [Line Items] | ||||
Stock-based compensation | $ 16 | $ 357 | $ 559 | $ 967 |
Litigation (Details)
Litigation (Details) - USD ($) $ in Millions | 1 Months Ended | 9 Months Ended | ||
Dec. 17, 2021 | May 19, 2022 | Sep. 21, 2021 | Sep. 30, 2022 | |
Litigation (Details) [Line Items] | ||||
Thermo litigation description | Thermo has 594,000 vials of lenzilumab that are in production, for which material has not yet been released by the Company because the batches produced are out of specification. Thermo recently filed a lawsuit against the Company in Delaware Superior Court (Patheon Biologics, Inc. v. Humanigen, Inc., Case No. N22C-10-185 MMJ) for $25.9 million. The Company denies Thermo’s claims and assertions and will vigorously defend against them. | |||
AvidArbitration[Member] | ||||
Litigation (Details) [Line Items] | ||||
Loss Contingency Damages Sought Value | $ 20.5 | |||
Paid to avid | $ 10.6 | |||
Eversana Agreement [Member] | ||||
Litigation (Details) [Line Items] | ||||
Loss Contingency Damages Sought Value | $ 4.5 | $ 4.5 |