Humanigen (HGENQ) 10-Q 13 May 21 2021 Q1 Quarterly report Financial data

Document and Entity Information

Document and Entity Information - shares	3 Months Ended
	Mar. 31, 2021	May 05, 2021
Document and Entity Information
Entity Registrant Name	HUMANIGEN, INC
Entity Central Index Key	0001293310
Document Type	10-Q
Document Period End Date	Mar. 31, 2021
Amendment Flag	false
Current Fiscal Year End Date	--12-31
Entity Current Reporting Status	Yes
Entity Filer Category	Non-accelerated Filer
Entity Common Stock, Shares Outstanding		59,083,706
Document Fiscal Year Focus	2021
Document Fiscal Period Focus	Q1
Entity Small Business	true
Entity Emerging Growth Company	false
Entity Interactive Data Current	Yes
Entity Incorporation, State or Country Code	DE
Entity File Number	001-35798
Document Quarterly Report	true
Document Transition Report	false
Entity Shell Company	false

Condensed Consolidated Balance

Condensed Consolidated Balance Sheets (Unaudited) - USD ($) $ in Thousands	Mar. 31, 2021	Dec. 31, 2020
Current assets:
Cash and cash equivalents	$ 92,892	$ 67,737
Other receivable	5,010
Prepaid expenses and other current assets	856	475
Total current assets	98,758	68,212
Other assets	90	90
Total assets	98,848	68,302
Current liabilities:
Accounts payable	43,412	15,366
Accrued expenses	5,698	3,175
Deferred revenue	4,145	1,874
Total current liabilities	53,255	20,415
Non-current liabilities:
Deferred revenue	4,126	2,342
Long-term debt	24,444
Total liabilities	81,825	22,757
Stockholders' equity:
Common stock, $0.001 par value: 225,000,000 shares authorized at March 31, 2021 and December 31, 2020; 53,656,689 and 51,626,508 shares issued and outstanding at March 31, 2021 and December 31, 2020, respectively	54	52
Additional paid-in capital	456,966	419,923
Accumulated deficit	(439,997)	(374,430)
Total stockholders' equity	17,023	45,545
Total liabilities and stockholders' equity	$ 98,848	$ 68,302

Condensed Consolidated Balanc_2

Condensed Consolidated Balance Sheets (Unaudited) (Parenthetical) - $ / shares	Mar. 31, 2021	Dec. 31, 2020
Statement of Financial Position [Abstract]
Common stock, par value	$ 0.001	$ 0.001
Common stock, shares authorized	225,000,000	225,000,000
Common stock, shares issued	53,656,689	51,626,508
Common stock, shares outstanding	53,656,689	51,626,508

Condensed Consolidated Statemen

Condensed Consolidated Statements of Operations (Unaudited) - USD ($) $ in Thousands	3 Months Ended
	Mar. 31, 2021	Mar. 31, 2020
Revenue:
Total revenue	$ 486
Operating expenses:
Research and development	59,934	659
General and administrative	4,948	1,398
Total operating expenses	64,882	2,057
Loss from operations	(64,396)	(2,057)
Other expense:
Interest expense	(19)	(410)
Other expense	(1,152)
Net loss	$ (65,567)	$ (2,467)
Basic and diluted net loss per common share	$ (1.25)	$ (0.11)
Weighted average common shares outstanding used to calculate basic and diluted net loss per common share	52,655,756	22,854,106
License [Member]
Revenue:
Total revenue	$ 486

Condensed Consolidated Statem_2

Condensed Consolidated Statements of Cash Flows (Unaudited) - USD ($) $ in Thousands	3 Months Ended
	Mar. 31, 2021	Mar. 31, 2020
Operating activities:
Net loss	$ (65,567)	$ (2,467)
Adjustments to reconcile net loss to net cash used in operating activities:
Stock based compensation expense	510	265
Issuance of common stock for payment of compensation		19
Issuance of common stock in exchange for services		13
Changes in operating assets and liabilities:
Other receivable	(5,010)
Prepaid expenses and other assets	(381)	16
Accounts payable	28,046	714
Accrued Expenses	2,523	833
Deferred revenue	4,055
Net cash used in operating activities	(35,824)	(607)
Financing activities:
Net proceeds from issuance of common stock	36,106	65
Proceeds from exercise of stock options	429
Net proceeds from issuance of long-term debt	24,444	467
Net cash provided by financing activities	60,979	532
Net increase (decrease) in cash and cash equivalents	25,155	(75)
Cash and cash equivalents, beginning of period	67,737	143
Cash and cash equivalents, end of period	92,892	68
Supplemental cash flow disclosure:
Cash paid for interest	4	2
Supplemental disclosure of non-cash investing and financing activities:
Issuance of stock options in lieu of cash compensation		133
Issuance of warrants for services		$ 1

Condensed Consolidated Statem_3

Condensed Consolidated Statements of Stockholders' Equity (Deficit) (Unaudited) - USD ($) $ in Thousands	Common Stock [Member]	Additional Paid-In Capital [Member]	Accumulated Deficit [Member]	Total
Balances at Dec. 31, 2019	$ 22	$ 270,555	$ (284,895)	$ (14,318)
Balances (in shares) at Dec. 31, 2019	22,806,890
Issuance of common stock, net of expenses		65		65
Issuance of common stock, net of expenses, shares	40,000
Issuance of common stock in exchange for services		13		13
Issuance of common stock in exchange for services, shares	5,868
Issuance of stock options for payment of compensation		133		133
Issuance of stock options for payment of compensation, shares
Issuance of common stock for payment of compensation		19		19
Issuance of common stock for payment of compensation, shares	9,599
Issuance of warrant for services		1		1
Stock-based compensation expense		265		265
Net loss			(2,467)	(2,467)
Balances at Mar. 31, 2020	$ 22	271,051	(287,362)	(16,289)
Balances (in shares) at Mar. 31, 2020	22,862,357
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, shares	1,796,858
Issuance of common stock upon option exercise		429		429
Issuance of common stock upon option exercise, 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

Nature of Operations

Nature of Operations	3 Months Ended
	Mar. 31, 2021
Organization, Consolidation and Presentation of Financial Statements [Abstract]
Nature of Operations	1. Nature of Operations Description of the Business Humanigen, Inc. (the “Company”) was incorporated on March 15, 2000 in California, reincorporated as a Delaware corporation in September 2001 as KaloBios Pharmaceuticals, Inc., and in August 2017, the Company changed its name to Humanigen, Inc. The Company is a clinical stage biopharmaceutical company, developing its portfolio of anti-inflammatory immunology and immuno-oncology monoclonal antibodies. The Company is focusing its efforts on the development of its lead product candidate, lenzilumab™, its proprietary Humaneered® (“Humaneered”) anti-human granulocyte-macrophage colony-stimulating factor (“GM-CSF”) monoclonal antibody. Lenzilumab is a monoclonal antibody that has been demonstrated to neutralize GM-CSF, a cytokine that the Company believes is of critical importance in the hyperinflammatory cascade, sometimes referred to as cytokine release syndrome (“CRS”) or cytokine storm, associated with COVID-19, chimeric antigen receptor T-cell (“CAR-T”) therapy and acute Graft versus Host Disease (“GvHD”) associated with bone marrow transplants. The Company believes the results from its Phase 3 study in COVID-19 and its Phase 1b study in CAR-T support the mechanism of action of lenzilumab. On March 29, 2021, the Company announced top-line data on the primary endpoint and one secondary endpoint from a Phase 3, multi-center, double-blind, placebo-controlled potential registrational trial of lenzilumab (the “LIVE-AIR” study) as a potential therapeutic for newly hospitalized, hypoxic patients with COVID-19 pneumonia. Additional data from the trial, subsequently published on MedRxiv, a non-peer reviewed journal, on May 5, 2021, support the previously reported primary endpoint that showed lenzilumab improved the likelihood of survival without ventilation, (“SWOV”), sometimes referred to as “ventilator-free survival”, by 54% in the modified intent-to-treat (“mITT”) population (Hazard Ratio, (“HR”): 1.54; 95%CI: 1.02-2.31, p=0.041). New analysis included in the publication showed that lenzilumab improved the likelihood of SWOV by 90% in the intent-to-treat (“ITT”) population (HR: 1.90; 1.02-3.52, nominal p=0.043) compared to placebo. SWOV also relatively improved by 92% in subjects who received both corticosteroids and remdesivir (1.92; 1.20-3.07, nominal p=0.0067); by 2.96-fold in subjects with C-reactive protein (“CRP”) levels <150 mg/L and age <85 years (2.96; 1.63–5.37, nominal p=0.0003); and by 88% in subjects hospitalized ≤2 days prior to randomization (1.88; 1.13-3.12, nominal p=0.015). Survival was improved by 2.17-fold in subjects with CRP<150 mg/L and age <85 years (2.17; 1.04-4.54, nominal p=0.040). The Company believes that the data published on MedRxiv, generated from the LIVE-AIR study support the conclusion that lenzilumab significantly improved SWOV in hospitalized, hypoxic subjects with COVID-19 pneumonia over and above treatment with remdesivir and/or corticosteroids. Subjects with CRP<150 mg/L and age <85 years demonstrated an improvement in survival and appeared to derive the greatest benefit from lenzilumab. The Company shared the topline data on the primary endpoint and one secondary endpoint (the only data then available while the remaining analysis was pending) with the U.S. Food and Drug Administration (“FDA”) in a Pre-Emergency Use Authorization (“EUA”) Type B submit an EUA application at the end of May 2021. As requested by the FDA, the EUA application will include secondary endpoints and supplemental data analysis from LIVE-AIR, including those referenced in the MedRxiv publication, as well as The Company has been in discussion with the Medicines and Healthcare Products Regulatory Agency (“MHRA”) for the use of lenzilumab in COVID-19 patients in the United Kingdom and plans to initiate a rolling submission for Conditional Marketing Authorization (“CMA”) before the end of the second quarter of 2021. The Company also plans to submit for CMA to the European Medicines Agency (“EMA”) for the use of lenzilumab in the European Union. Further, the Company is reviewing the possibility of similar submissions for approval or compassionate use in other territories or countries worldwide. As previously reported, lenzilumab has been selected to be part of the ongoing Accelerating COVID-19 Therapeutic Interventions and Vaccines (“ACTIV”)-5 and Big Effect Trial (“BET-B”), referred to as ACTIV-5/BET-B, The Company intends to submit a Biologics License Application (“BLA”) to FDA in 2022, for the use of lenzilumab in hospitalized, hypoxic COVID-19 patients. Since BLAs typically require more than one study, Lenzilumab has been studied in a multi-center Phase 1b trial as a sequenced therapy with Yescarta® (axicabtagene ciloleucel) to reduce CRS and neurotoxicity in patients with relapsed or refractory diffuse large B-cell lymphoma (“DLBCL”) (NCT04314843). This study was a standard 3+3 design with three patients administered 600 mg lenzilumab (“cohort 1”) and three patients administered 1,800 mg lenzilumab (“cohort 2”) just prior to CAR-T. The recommended Phase 2 dose was determined to be 1,800 mg. On April 19, 2021, the Company announced positive data from the ZUMA-19 study. At the recommended Phase 2 dose of lenzilumab, the Objective Response Rate (“ORR”) was 100% and no patient experienced severe cytokine release syndrome (“CRS”) or severe neurotoxicity (“NT”). In the six study patients, the ORR reported was 83% (n=5) which included four complete responses (“CR”). In cohort 1, there was no severe CRS (≥ grade 3). One patient experienced grade 3 NT with a two-day duration. At the recommended Phase 2 dose (cohort 2), ORR was 100% (n=3) and the toxicity-free CR (CRS and NT < grade 2) was 66% (n = 2). There was no severe CRS or severe NT at the recommended Phase 2 dose. There were no adverse events attributed to lenzilumab across the study. Inflammatory markers were correlated with reduced rates of CRS and NT. Lenzilumab dose-dependently reduced myeloid cytokines IL-6, IL-8, MCP-1, and IP-10 (CXCL-10) and systemic inflammatory markers CRP, ferritin, and SAA in the patients studied. As a result of this positive data and the conclusion of the Phase 1b portion of the study, the Company elected to terminate the clinical collaboration with Kite Pharmaceuticals, Inc., a Gilead company (“Kite”), which markets Yescarta. The Company intends to initiate a randomized, multi-center, potentially registrational, Phase 2 study to evaluate the efficacy and safety of lenzilumab combined with all commercially available CD19 CAR-T therapies in DLBCL. The study plans to enroll approximately 150 patients and the protocol is being submitted to FDA. The Company is also in the final planning stages for a Phase 2/3 trial for lenzilumab to treat patients who have undergone allogeneic hematopoietic stem cell therapy (“HSCT”) who are at high and intermediate risk for acute GvHD (the “Risk Adapted Therapy in Acute GvHD” or the “RATinG” study). The trial is expected to be conducted by the IMPACT Partnership, a collection of 22 stem cell transplant centers located in the United Kingdom. It is anticipated the RATinG study will begin in the fourth quarter of 2021. The Company will provide lenzilumab for this study and support certain laboratory tests related to the study. The majority of the study costs will be borne by the partner. In addition, the Company is in partnership with the South Australian Health & Medical Research Institute (“SAHMRI”) and the University of Adelaide to conduct a Phase 2 Trial studying the efficacy of lenzilumab in combination with azacitadine. The study, (“PREcision Approach to Chronic Myelomonocytic Leukemia” or “PREACH-M”) is anticipated to begin enrollment in the third quarter of 2021 and to include four sites. The Company will provide lenzilumab for this study and the majority of the study costs will be borne by the partner. The Company’s proprietary, patented Humaneered technology platform is a method for converting existing antibodies (typically murine) into engineered, high-affinity human antibodies designed for therapeutic use, particularly with acute and chronic conditions. The Company has developed or in-licensed targets or research antibodies, typically from academic institutions, and then applied our Humaneered technology to produce them. Lenzilumab and the Company’s other two product candidates, ifabotuzumab and HGEN005, are Humaneered monoclonal antibodies. The Company’s Humaneered antibodies are closer to human antibodies than chimeric or conventionally humanized antibodies and have a high affinity for their target but low immunogenicity. The Company believes its Humaneered antibodies offer additional advantages, such as high potency, a slow off-rate and a lower likelihood to induce an inappropriate immune response or infusion related reactions. See Management’s Discussion and Analysis of Financial Condition and Results of Operations in Item 2 of this Quarterly Report on Form 10-Q for additional information regarding the business. Liquidity The Company has been continuing to advance its efforts to develop lenzilumab for use in hospitalized COVID-19 pneumonia patients. As of March 31, 2021, the Company had cash and cash equivalents of $92.9 million, which included a $25.0 million draw under the Company’s secured term loan with Hercules Capital, Inc. (“Hercules”) or the (“Term Loan”) (see Note 5 below). Together with approximately $94.1 million of net proceeds from the underwritten public offering completed in the second quarter of 2021, potential additional draws under the Term Loan, and potential revenues from the commercial sale of lenzilumab (if an EUA is granted), the Company expects to be able to fund its planned operations and capital expenditure requirements, although it may pursue other funding options on an opportunistic basis to support its liquidity. As discussed in further detail in Note 6 below, the Company has entered into agreements with several contract manufacturing organizations (“CMOs”) to provide manufacturing, fill/finish and packaging services for lenzilumab, and is actively working with its existing and additional CMOs on additional agreements to bolster its ability to supply lenzilumab in the event of receipt of EUA or other conditional marketing authorization (“CMA”). Most of these additional manufacturing agreements, such as those currently in place, are expected to require payment of upfront fees upon execution and further payments against performance of the manufacturing services to be provided, often over a lengthy performance period. Given the competitive environment, it is not possible for the Company to predict when it will be in position to execute any additional manufacturing agreements, or to estimate the aggregate amount of potential future payments under such new agreements or the timing in which they may be made. If an EUA or other CMA were granted, the Company expects to be able to satisfy the bulk of the cash requirements associated with its manufacturing commitments from revenues from the commercial sale of lenzilumab, supplemented as necessary with proceeds from the sale of its equity securities; potential additional draws under the Term Loan; upfront and milestone payments from licensees; and government funding or financial support, if offered. In the first quarter of 2021 the amounts included in Research and Development for lenzilumab COVID-19 clinical studies were $7.6 million and $51.7 million for production of lenzilumab finished good. The Company believes that its cash and cash equivalents will be sufficient to fund its planned operational requirements for at least the next 12 months. This evaluation is based on relevant conditions and events that are currently known or reasonably knowable. As a result, the Company could deplete its available capital resources sooner than it currently expects, and a delay in obtaining or failure to obtain an EUA could further constrain its cash resources. The Company has based these estimates on assumptions that may prove to be wrong, and its operating projections, including its projected net revenue following the potential receipt of an EUA for lenzilumab in COVID-19 patients, may change as a result of many factors currently unknown to it. If the Company is unable to raise additional capital when needed or on acceptable terms, it would be forced to delay, reduce or eliminate its research and development programs and commercialization efforts. Alternatively, the Company might raise funds through strategic collaborations, public or private financings or other arrangements. Such funding, if needed, may not be available on favorable terms, or at all. The financial statements included herein do not include any adjustments that might result from the outcome of these uncertainties. Reclassifications Certain prior year amounts in the Condensed Consolidated Financial Statements have been reclassified to conform to the current year's presentation. Such reclassifications had no effect on prior years’ Net loss or Stockholders’ equity. 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, 2020 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, 2021, 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 2020 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, accruals and warrants. 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, 2021
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, 2020. There have been no significant changes to the Company’s significant accounting policies during the three months ended March 31, 2021, from those previously disclosed in its 2020 Annual Report on Form 10-K. In December 2019, the Financial Accounting Standards Board (“FASB”) issued Accounting Standards Update (“ASU”) No. 2019-12, Simplifying the Accounting for Income Taxes. ASU No. 2019-12 eliminates certain exceptions related to the approach for intra-period tax allocation, the methodology for calculating income taxes in an interim period and the recognition of deferred tax liabilities for outside basis differences. It also clarifies and simplifies other aspects of the accounting for income taxes. ASU 2019-12 is effective for fiscal years beginning after December 15, 2020, and interim periods within those fiscal years. The Company adopted No. ASU 2019-12 on January 1, 2021 which did not have any impact to the Company’s Condensed Consolidated Financial Statements. In August 2020, the FASB issued ASU No. 2020-06, “Accounting for Convertible Instruments and Contracts in an Entity’s Own Equity”, as part of its overall simplification initiative to reduce costs and complexity of applying accounting standards while maintaining or improving the usefulness of the information provided to users of financial statements. Among other changes, the new guidance removes from U.S. GAAP, separation models for convertible debt that require the convertible debt to be separated into a debt and equity component, unless the conversion feature is required to be bifurcated and accounted for as a derivative or the debt is issued at a substantial premium. As a result, after adopting the guidance, entities will no longer separately present such embedded conversion features in equity, and will instead account for the convertible debt wholly as debt. The new guidance also requires use of the “if-converted” method when calculating the dilutive impact of convertible debt on earnings per share, which is consistent with the Company’s current accounting treatment under the current guidance. The guidance is effective for the Company’s financial statements issued for fiscal years beginning after December 15, 2023, and interim periods within those fiscal years, with early adoption permitted, but only at the beginning of the fiscal year. The Company early adopted the new guidance on January 1, 2021, using the modified retrospective approach. The adoption did not have any impact to the Company’s Condensed Consolidated Financial Statements.

Potentially Dilutive Securities

Potentially Dilutive Securities	3 Months Ended
	Mar. 31, 2021
Potentially Dilutive Securities
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, 2021 2020 Options to purchase common stock 4,224,111 3,420,930 Warrants to purchase common stock 51,238 66,239 Convertible debt 255,493 2,295,545 4,530,842 5,782,714

License Revenue

License Revenue	3 Months Ended
	Mar. 31, 2021
License Revenue
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. The Company assessed the South Korea Agreement in accordance with Accounting Standards Codification (“ASC”) 606 – Revenue from Contracts with Customers Collaborative Arrangements The Company has concluded that the nature of its promise is to stand ready to provide Research and Development Services as needed during the Performance Period (as defined below). The Company has further concluded that for all of the increments of time during the Performance Period its promise of standing ready to provide the Services is substantially the same. While the specific tasks performed during each increment of time will vary, the nature of the overall promise to provide the Services remains the same throughout the Performance Period. Since the provision of the license and 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) which was met in the first quarter of 2021 and received in the second quarter of 2021, are being recognized as revenue ratably over the performance period through March 2023 (the “Performance Period”), the expected period over which the Company conservatively expects the Services to be performed with approval in the Territory expected by the end of March 2023. Therefore, in the three months ended March 31, 2021, the Company recognized license revenue totaling approximately $0.5 million. 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.

Long-Term Debt

Long-Term Debt	3 Months Ended
	Mar. 31, 2021
Debt Disclosure [Abstract]
Long-Term Debt	5. Long-Term Debt Secured Term Loan Facility On March 10, 2021, the Company executed a Loan and Security Agreement with Hercules as agent for its affiliates serving as lenders thereunder. The Term Loan provides a loan in the aggregate principal amount of $80 million. 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. In addition to the initial amount of $25.0 million, the Term Loan provides the Company with the potential for two additional tranches: a second tranche in the amount of $35.0 million or $25.0 million, which it may become entitled to draw through September 15, 2021 subject to the Company’s receipt of the EUA for lenzilumab for the treatment of hospitalized patients with COVID-19 pneumonia; and a third tranche of $20.0 million which the Company may become entitled to draw through June 15, 2022, at the discretion of Hercules if the Company requests additional funding in support of the Company’s strategic initiatives. The Company will be required to repay amounts borrowed by March 1, 2025, subject to a one-year extension option that it may exercise if it has received FDA approval of a BLA for the use of lenzilumab for the treatment of hospitalized patients with COVID-19 pneumonia, and the FDA-authorized label for lenzilumab is generally consistent with that sought in the Company’s BLA filing, and the Company has paid Hercules certain fees and expenses associated with the extension. Amounts drawn bear 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% (such greater amount, the “Base Interest Rate”). Subject to there not having occurred any default or event of default under the loan agreement, the Base Interest Rate will be reduced by 25 basis points upon the occurrence of each of the first three of the four following events to occur: · if the Company achieves the protocol-specified primary efficacy endpoint for the pivotal Phase 3 study of lenzilumab for COVID-19, (clinicaltrials.gov identifier NCT04351152), and receives EUA for the use of lenzilumab for the treatment of hospitalized patients with COVID-19 pneumonia; · if the Company achieves product revenue from lenzilumab that is invoiced and/or recognized as revenue (as determined in accordance with GAAP) solely from the sale of lenzilumab (“Net Lenzilumab Product Revenue”) of at least $100.0 million; · if the Company achieves Net Lenzilumab Product Revenue of at least $250.0 million; and · if the Company achieves Net Lenzilumab Product Revenue of at least $350.0 million. No principal payments will be due during an interest-only period, commencing on the initial borrowing date and continuing to April 1, 2023, subject to extension to April 1, 2024, and potentially October 1, 2024, under certain conditions. Following the interest-only period, the outstanding balance of the loan will be required to be repaid monthly, continuing through the maturity date. The Company may prepay amounts drawn under the agreement in full prior to the maturity date then in effect, subject to payment of prepayment charges equal to: · 2.0% of the amounts borrowed, if the prepayment occurs on or prior to March 29, 2022; · 1.5% of the amounts borrowed, if the prepayment occurs after March 29, 2022 and before March 29, 2023; and · 1.0% of the amounts borrowed, if the prepayment occurs after March 29, 2023 and before March 29, 2024. In addition, on the earliest to occur of (i) the maturity date, (ii) the date the Company prepays the outstanding principal amount of the Term Loan, or (iii) the date the outstanding principal amount of the Term Loan otherwise becomes due, the Company will owe Hercules an end of term (“EOT”) charge equal to 6.75% of the aggregate amount of the Term Loan funded by Hercules. As a condition to obtaining the term loan facility, the Company granted Hercules a security interest in substantially all of its assets and personal property not otherwise subject to existing or permitted liens. In addition, the loan agreement contains customary representations and warranties and events of default for a term loan facility of this size and type. Under the Term Loan, the Company also agreed to comply with certain customary affirmative and negative covenants that become effective upon the initial draw of the first tranche, including covenants to: · maintain $10.0 million unrestricted cash, which amount may be increased to $20.0 million if the Company borrows the second tranche of the Term Loan; · comply with certain requirements to provide Hercules with financial information and other rights to inspect the Company’s books and records and the collateral for the Term Loan; · refrain from incurring debt that is not expressly subordinated to the Term Loan; “Rule 144A-style” convertible notes in aggregate principal amount up to $250.0 million; and other permitted indebtedness; · refrain from granting (or permitting to exist) liens on the Company’s assets and properties, other than certain permitted liens, including in respect of its patents and other intellectual property; · refrain from making certain investments, other than permitted acquisitions and certain other permitted investments; · refrain from repurchasing the Company’s stock or paying dividends, subject to limited exceptions; · refrain from transferring any material portion of its assets; and · refrain from entering into any merger or consolidation in which the Company is not the surviving entity. All of these covenants will not apply upon repayment of any borrowings under the Term Loan. Certain of the baskets for permitted investments and other exceptions to the covenants described above will increase in the event the Company raises more than $100.0 million in unrestricted net cash proceeds from one or more bona fide equity financings prior to March 31, 2022. Further, the covenants in the loan agreement will not prohibit the Company from pursuing its strategy of entering into out-bound license agreements for lenzilumab that may be exclusive as to specific geographic regions outside the U.S., nor will the covenants prohibit the Company from entering into co-development or co-promotion or commercialization agreements relating to lenzilumab, so long as such agreements generally are negotiated on arm’s length and commercially reasonable terms. While the Term Loan is outstanding, the lenders will have the right to convert a portion of the principal amount outstanding under the Term Loan (ranging from $5.0 million to $10.0 million in the aggregate) into shares of the Company’s common stock at a conversion price equal to $19.57 per share, subject to customary anti-dilution adjustments. The following table summarizes the outstanding future payments of principal and interest associated with the Company’s Term Loan as of March 31, 2021 (in thousands): 2021 $ 1,501 2022 2,218 2023 10,800 2024 13,671 2025 5,153 Total payments 33,343 Less amount representing interest (6,655 ) Notes payable, gross 26,688 Less: Unamortized portion of EOT charge (1,688 ) Less: Unamortized discount on notes payable (213 ) Less: Unamortized debt issuance costs (343 ) Long-term debt 24,444 Less current portion - Long-term debt, net of current portion $ 24,444 Interest expense related to the Term Loan, recorded during the three months ended March 31, 2021, was approximately $18 thousand and the effective interest rate was 9.0%.

Commitments and Contingencies

Commitments and Contingencies	3 Months Ended
	Mar. 31, 2021
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 serve as the Company’s end-to-end commercial partner, providing the Company with a full suite of services in connection with the potential launch of lenzilumab. Eversana services initially will comprise 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. The Company will pay Eversana fees and reimburse it for expenses in performing the services as established in applicable statements of work. Eversana has agreed to defer its fees pending the Company’s receipt of an EUA from the FDA for lenzilumab for newly hospitalized and hypoxic COVID-19 patients. The Company has accrued $0.9 million for Eversana activities performed in the first quarter of 2021, which are included in Accrued expenses in the Condensed Consolidated Balance Sheets, with the anticipated payment upon receipt of the EUA. The Eversana Agreement provides for a one-year term and will renew for subsequent one-year terms unless either party provides a notice of non-renewal. After the first year, the Company may terminate the Eversana Agreement upon advance written notice to Eversana. The Eversana Agreement contains customary provisions allowing either party to terminate the Eversana Agreement as a result of certain changes in law and material breaches and certain insolvency events by or relating to the other party. The Eversana Agreement imposes customary mutual obligations on the parties to protect and not disclose the confidential information and intellectual property of the other, and contains insurance, non-solicitation, indemnification and limitation of liability provisions customary for service contracts of this type. Manufacturing Agreements The Company has entered into agreements with several contract manufacturing organizations (“CMOs”) to manufacture bulk drug substance (“BDS”) and fill/finish/drug product (“DP”) for our lenzilumab clinical trial activities related to COVID-19 as well as to manufacture BDS and DP for a potential launch of lenzilumab in anticipation of an EUA in 2021. The Company has also entered into agreements for packaging of the drug. These agreements represent large commitments, including upfront amounts prior to commencement of manufacturing and progress payments through the course of the manufacturing process and include payments for technology transfer. As of March 31, 2021, the Company estimates that its commitments remaining to be incurred during 2021 will amount to approximately $169 million. The agreements contain customary cancellation clauses.

Stockholders' Equity

Stockholders' Equity	3 Months Ended
	Mar. 31, 2021
Stockholders' Equity Note [Abstract]
Stockholders' Equity	7. Stockholders’ Equity Reverse Stock Split Effective September 11, 2020 (the “Effective Date”), the Company amended its charter to effect a reverse stock split at a ratio of 1-for-5 (the “Split Ratio”). No fractional shares were issued in connection with the reverse stock split. Stockholders of record otherwise entitled to receive fractional shares of common stock received cash (without interest or deduction) in lieu of such fractional share interests. The reverse stock split reduced the total number of shares of the Company’s common stock outstanding as of the Effective Date from approximately 210.9 million shares to approximately 42.2 million shares. The par value per share and other terms of the Company’s common stock were not affected by the reverse stock split, and the number of authorized shares of the Company’s common stock remains at 225,000,000. The reverse stock split resulted in a proportionate adjustment in the number of shares reserved for issuance under the 2020 Equity Plan, such that a total of 7,000,000 shares of the Company’s common stock were reserved for issuance under the 2020 Equity Plan following the Effective Date. In addition, proportionate adjustments were made to the number of shares covered by, and the exercise price applicable to, each outstanding stock option award under the 2012 Equity Plan and outstanding warrants issued by the Company, in each case to give effect to the Split Ratio and the reverse stock split. The reverse stock split was accounted for retroactively and is reflected in our common stock, stock option and warrant activity as of and during the period ended December 31, 2020 and the periods ended March 31, 2021 and 2020. Unless stated otherwise, all share data in this Quarterly Report on Form 10-Q have been adjusted, as appropriate, to reflect the reverse stock split. Controlled Equity Offering On December 31, 2020, the Company entered into a Controlled Equity Offering SM 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 (the “Underwriters”), in connection with the public offering of 5,000,000 shares of the Company’s common stock. Pursuant to the Underwriting Agreement, the Company granted the underwriters a 30-day option to purchase an additional 750,000 shares of common stock. See Note 11 for additional information.

Stock-Based Compensation

Stock-Based Compensation	3 Months Ended
	Mar. 31, 2021
Share-based Payment Arrangement [Abstract]
Stock-Based Compensation	8. Stock-Based Compensation A summary of stock option activity for the three months ended March 31, 2021 under all the Company’s options plans is as follows: Options Weighted Outstanding at January 1, 2021 3,728,149 $ 5.57 Granted 758,240 16.13 Exercised (250,242 ) (3.13 ) Cancelled (forfeited) (11,932 ) (3.33 ) Cancelled (expired) (104 ) (162.09 ) Outstanding at March 31, 2021 4,224,111 $ 7.61 The weighted average fair value of options granted during the three months ended March 31, 2021 was $13.30 per share. The Company valued the options granted using the Black-Scholes options pricing model and the following weighted-average assumption terms for the three months ended March 31, 2021: Three Months Ended March 31, 2021 Exercise price $16.07 - $17.79 Market value $16.07 - $17.79 Expected term 6 years Expected volatility 109% Risk-free interest rate 1.06% - 1.08% Expected dividend yield -% The Company recorded stock-based compensation expense in the Condensed Consolidated Statements of Operations as follows (in thousands): Three Months Ended March 31, 2021 2020 General and administrative $ 364 $ 211 Research and development $ 146 $ 54 Total stock-based compensation $ 510 $ 265 At March 31, 2021, the Company had $12.8 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 2.7 years.

License and Collaboration Agree

License and Collaboration Agreements	3 Months Ended
	Mar. 31, 2021
Goodwill and Intangible Assets Disclosure [Abstract]
License and Collaboration Agreements	9. License and Collaboration Agreements Kite Agreement On May 30, 2019, the Company entered into a clinical collaboration agreement with Kite, providing in part for conduct of a multi-center Phase 1b study of lenzilumab with Kite’s Yescarta in patients with relapsed or refractory B-cell lymphoma, including DLBCL. On April 19, 2021, the Company announced positive data from this study. As a result of this positive data and the conclusion of the Phase 1b portion of the study, the Company elected to terminate the clinical collaboration agreement with Kite (see Note 11). The Company intends to initiate a randomized, multi-center, potentially registrational, Phase 2 study to evaluate the efficacy and safety of lenzilumab combined with all commercially available CD19 CAR-T therapies in DLBCL. The study plans to enroll approximately 150 patients and the protocol is being submitted to FDA. Mayo Agreement On June 19, 2019, the Company entered into an exclusive worldwide license agreement (the “Mayo Agreement”) with the Mayo Foundation for Medical Education and Research (“Mayo”) for certain technologies used to create CAR-T cells lacking GM-CSF expression through various gene-editing tools including CRISPR-Cas9 (GM-CSF knock-out). The license covers various patent applications and know-how developed by Mayo in collaboration with the Company. These licensed technologies complement and broaden the Company’s position in the GM-CSF neutralization space and expand the Company’s discovery platform aimed at improving CAR-T to include gene-edited CAR-T cells. Pursuant to the Mayo Agreement, the Company paid $0.2 million to Mayo in June 2020, which payment was accrued in Research and development expense in June 2019. The Mayo Agreement also requires the payment of milestones and royalties upon the achievement of certain regulatory and commercialization milestones. Zurich Agreement On July 19, 2019, the Company entered into an exclusive worldwide license agreement (the “Zurich Agreement”) with the University of Zurich (“UZH”) for technology used to prevent or treat Graft versus Host Disease (“GvHD”) through GM-CSF neutralization. The Zurich Agreement covers various patent applications filed by UZH which complement and broaden the Company’s position in the application of GM-CSF and expands the Company’s development platform to include improving allogeneic Hematopoietic Stem Cell Transplantation (“HSCT”). Pursuant to the Zurich Agreement, the Company paid $0.1 million to UZH in July 2019. The Zurich Agreement also requires the payment of annual maintenance fees and milestones and royalties upon the achievement of certain regulatory and commercialization milestones. The license payment of $0.1 million was recorded as Research and development expense in July 2019. 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 is being evaluated in the NIAID-sponsored ACTIV-5/BET-B in hospitalized patients with COVID-19. The NIH created the ACTIV public-private partnership and selected lenzilumab to be evaluated in its ACTIV-5/BET-B, which is comparing lenzilumab in combination with Gilead’s investigational antiviral, remdesivir, versus placebo plus remdesivir in hospitalized COVID-19 patients. The trial is expected to enroll 100 patients in each arm of the study. Pursuant to the ACTIV-5 Clinical Trial Agreement, NIAID will serve as sponsor and will be responsible for funding, supervising and overseeing ACTIV-5/BET-B. The Company will be responsible for providing lenzilumab to NIAID without charge and in quantities to ensure a sufficient supply of lenzilumab. The ACTIV-5 Clinical Trial Agreement imposes 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. The Company will have access to data from ACTIV-5/BET-B once concluded. CRADA On November 5, 2020, the Company and the Department of Defense (“DoD”) Joint Program Executive Office for Chemical, Biological, Radiological and Nuclear Defense (“JPEO-CBRND” or “JPEO”) entered into a Cooperative Research and Development Agreement (“CRADA”) in collaboration with the Biomedical Advanced Research and Development Authority (“BARDA”), part of the Office of the Assistant Secretary for Preparedness and Response (“ASPR”) at the U.S. Department of Health and Human Services (“HHS”), in support of Operation Warp Speed (“OWS”), to assist in the development of lenzilumab, in connection with a potential EUA for COVID-19. On January 22, 2021, the Company announced an expansion of the CRADA that it had previously entered with JPEO on November 5, 2020, was subsequently co-signed by BARDA. This provides the Company with access to manufacturing capacity reserved by BARDA for fill-finish product to accelerate the drug product manufacturing of lenzilumab. Pursuant to the CRADA, the Company has been provided access to a full-scale, integrated team of OWS manufacturing, and regulatory subject matter experts, leading decision makers and statistical support in anticipation of applying for EUA and subsequently a BLA for lenzilumab as a potential treatment for COVID-19. The CRADA also provides that OWS regulatory experts will work with the Company on FDA communications, meetings and regulatory filings. The CRADA aims to support the lenzilumab Phase 3 clinical trial output, focusing on efficiently generating an EUA and BLA submission. In addition to providing access under EUA, a goal of the CRADA is to ensure lenzilumab receives the benefits provided by Public Law 115-92. The Company may receive advance purchase contracts or other benefits under Public Law 115-92, if FDA issues an EUA or BLA.

Litigation

Litigation	3 Months Ended
	Mar. 31, 2021
Litigation Settlement [Abstract]
Litigation	10. Litigation Savant Litigation On February 29, 2016, the Company entered into a binding letter of intent (the “LOI”) with Savant Neglected Diseases, LLC (“Savant”). The LOI provided that the Company would acquire certain worldwide rights relating to benznidazole from Savant. On June 30, 2016, the Company and Savant entered into an Agreement for the Manufacture, Development and Commercialization of Benznidazole for Human Use (the “MDC Agreement”), pursuant to which the Company acquired certain worldwide rights relating to benznidazole. The MDC Agreement consummates the transactions contemplated by the LOI. In addition, on June 30, 2016, the Company and Savant also entered into a Security Agreement (the “Security Agreement”), pursuant to which the Company granted Savant a continuing senior security interest in the assets and rights acquired by the Company pursuant to the MDC Agreement and certain future assets developed from those acquired assets. On June 30, 2016, in connection with the MDC Agreement, the Company issued to Savant a five-year warrant to purchase 40,000 shares of the Company’s Common Stock, at an exercise price of $11.25 per share, subject to adjustment. On May 26, 2017, the Company submitted its benznidazole Investigational New Drug Application (“IND”) to the FDA which became effective on June 26, 2017. The Company recorded expense of $1.0 million during the year ended December 31, 2017 as Research and development expense related to the milestone achievement associated with the IND being declared effective. On July 10, 2017, FDA notified the Company that it granted Orphan Drug Designation to benznidazole for the treatment of Chagas disease. The Company recorded expense of $1.0 million during the year ended December 31, 2017 as Research and development expense related to the milestone achievement associated with Orphan Drug Designation. The $2.0 million in milestone payments due Savant are included in Accrued expenses in the accompanying Condensed Consolidated Balance Sheets as of March 31, 2021 and December 31, 2020. On July 10, 2017, the Company filed a complaint against Savant in the Superior Court for the State of Delaware, New Castle County (the “Delaware Court”). KaloBios Pharmaceuticals, Inc. v. Savant Neglected Diseases, LLC On July 12, 2017, Savant removed the case to the Bankruptcy Court, claiming that the action is related to or arises under the Bankruptcy Case from which the Company emerged in July 2016. In re KaloBios Pharmaceuticals, Inc. On August 2, 2017, Savant sent a foreclosure notice to the Company, demanding that it provide the Collateral as defined in the Security Agreement for inspection and possession on August 9, 2017, with a public sale to be held on September 1, 2017. The Company moved for a Temporary Restraining Order (the “TRO”) and Preliminary Injunction in the Bankruptcy Court on August 4, 2017. Savant responded on August 7, 2017. On August 7, 2017, the Bankruptcy Court granted the Company’s motion for a TRO, entering an order prohibiting Savant from collecting on or selling the Collateral, entering our premises, issuing any default notices to us, or attempting to exercise any other remedies under the MDC Agreement or the Security Agreement. On August 9, 2017, the parties have stipulated to continue the provisions of the TRO in full force and effect until further order of the appropriate court, which the Bankruptcy Court signed that same day (the “Stipulated Order”). On January 22, 2018, Savant wrote to the Bankruptcy Court requesting dissolution of the TRO and the Stipulated Order. On January 29, 2018, the Bankruptcy Court granted the Motion to Remand and denied Savant’s request to dissolve the TRO and Stipulated Order, ordering that any request to dissolve the TRO and Stipulated Order be made to the Delaware Court. On February 13, 2018 Savant made a letter request to the Delaware Court to dissolve the TRO and Stipulated Order. Also, on February 13, 2018, the Company filed its Answer and Affirmative defenses to Savant’s Counterclaims. On February 15, 2018 the Company filed a letter of opposition to Savant’s request to dissolve the TRO and Stipulated Order and requesting a status conference. A hearing on Savant’s request to dissolve the TRO and Stipulated Order was held before the Delaware Court on March 19, 2018. The Delaware Court denied Savant’s request to dissolve the TRO and Stipulated order, which remain in effect. On April 11, 2018, the Company advised the Delaware Court that it would meet and confer with Savant regarding a proposed case management order and date for trial. On April 26, 2018 the Delaware Court so-ordered a proposed case management order submitted by the Company and Savant. The schedule in the case management order was modified by stipulation on August 24, 2018. On April 8, 2019, the Company moved to compel Savant to produce documents in response to the Company’s document requests. The parties thereafter agreed to a discovery schedule through June 30, 2019, which the Superior Court so ordered, and the parties produced documents to each other. On June 4, 2019, Savant filed a complaint against the Company and Madison Joint Venture LLC (“Madison”) in the Delaware Court of Chancery (the “Chancery Action”) seeking to “recover as damages that amounts owed to it under the MDC Agreement, and to reclaim Savant’s intellectual property,” among other things. Savant also requested leave to move to dismiss the Company’s complaint on the grounds that the Company’s transfer of assets to Madison was champertous. On June 10, 2019, the Company requested by letter that the Superior Court hold a contempt hearing because the Chancery Action violated the TRO entered by the Bankruptcy Court, the terms of which have been extended by stipulation of the parties. On June 18, 2019, the Superior Court held a telephonic status conference. The parties agreed that the Chancery Action should be consolidated with the Superior Court action, after which the Superior Court would address the parties’ motions. On July 22, 2019, the Company moved for contempt against Savant. Savant filed its opposition on July 29, 2019. On August 12, 2019, the Superior Court denied the Company’s motion for contempt. On July 23, 2019, Savant moved for summary judgment on the issue of champerty. The Company filed its response and cross-motion for summary judgment on August 27, 2019. Savant filed its reply on September 10, 2019 and the Company filed its cross-reply on September 20, 2019. The motion is fully briefed and was argued at a hearing on February 3, 2020. On August 17, 2020 the Superior Court issued a memorandum opinion denying Savant’s motion for summary judgment on the issue of champerty. On July 26, 2019, the Company moved to modify the previously agreed-upon discovery schedule to extend discovery through December 31, 2019, which the Superior Court granted. In subsequent orders, the discovery schedule was further extended until the end of June 2020. On July 30, 2019, the Company filed a motion to dismiss Savant’s Chancery Action. Savant filed an amended complaint on September 4, 2019, and the Company filed its opening brief in support of its motion to dismiss on October 11, 2019. That motion is fully briefed and was argued at a hearing on February 3, 2020. On August 17, 2020 the Superior Court issued a memorandum opinion denying the Company’s motion to dismiss Savant’s Chancery Action. On August 19, 2019, Savant moved to dismiss the Company’s amended Superior Court complaint. On September 27, 2019, the Company filed an opposition to Savant’s motion and, in the alternative, requested leave to file a second amended complaint against Savant. Savant consented to the filing of the second amended complaint and withdrew their motion to dismiss. Savant filed a partial motion to dismiss against a co-defendant on October 30, 2019. That motion is fully briefed and was argued at a hearing on February 3, 2020. At the February 3, 2020 hearing, the Court reserved judgment on the parties’ reciprocal motions. On August 17, 2020, the Superior Court issued a memorandum opinion granting in part and denying in part Savant’s motion to dismiss the Company’s amended Superior Court complaint. The Superior Court found the Company lacked standing because it assigned its interest to its co-plaintiff Madison. However, the Superior Court found that Madison had standing to proceed. Although the Company was dismissed from all counts of the Superior Court Action it continues to possess an interest in the Superior Court Action because of its ownership of Madison and remains a litigant because of Savant’s Chancery Action. Savant’s motion to dismiss the Company’s amended Superior Court complaint was denied in all other respects. On May 22, 2020, upon the request of the parties, the Superior Court stayed both Delaware actions until July 29, 2020. On June 30, 2020, Savant exercised 20,000 warrants in a cashless exercise resulting in 10,909 shares being issued to Savant. On July 24, 2020, the parties submitted a joint status report in the Delaware actions. The parties also requested a status conference with the Court to discuss moving the trial from October 2020 to some later time. On August 20, 2020, the Court held the requested status conference and ordered that a consolidated trial for the Superior Court Action and Chancery Action would be held in April 2021. The parties subsequently agreed to a five-day trial starting on April 12, 2021. On September 29, 2020, upon the request of the parties, the Superior Court revised the existing discovery schedule. Under the revised discovery schedule fact discovery closed on November 9, 2020 and expert discovery closed on December 18, 2020. On October 7, 2020, Savant moved for leave to amend its complaint in the Chancery Action to add a claim for breach of contract related to its exercise of 20,000 warrants on June 30, 2020. Savant claims that the Company’s issuance of 10,909 shares was insufficient under the warrant. On November 23, 2020, the Superior Court granted Savant’s motion for leave to amend its complaint in the Chancery Action. The Company answered the second amended complaint in the Chancery Action on December 11, 2020. On November 30, 2020, the Superior Court revised the discovery schedule to permit the Company to take additional discovery regarding Savant’s second amended complaint in the Chancery Action. Under this revised schedule, the Company had until December 18, 2020 to take additional discovery. Further, the deadline to complete expert discovery was moved to January 5, 2021. A consolidated trial for the Superior Court Action and Chancery Action remained scheduled for April 2021. On December 18, 2020, fact discovery closed. On January 5, 2021, the Company moved for leave to amend the Superior Court complaint to add Scott Freeman as a defendant. Savant opposed the motion for leave to amend on February 5, 2021. Briefing was completed on March 5, 2021. Further, the deadline for expert discovery closed. On January 19, 2021, the Company and Savant filed competing motions for summary judgment on their respective claims in the Superior Court Action and Chancery Action. Oppositions to the motions for summary judgment were filed on February 5, 2021 and replies were filed on February 24, 2021. On March 18, 2021, the Court held a hearing on the summary judgment motions and the Company’s motion for leave to amend. The Court reserved decision on the summary judgment motions, denied the Company’s motion for leave to amend and postponed the April 2021 trial. The Company is awaiting the Court’s availability to proceed with trial. Private Placement Litigation On June 15, 2020, a complaint was filed against the Company and Dr. Durrant in the Commercial Division of the Supreme Court of the State of New York. The case caption is Alliance Texas Holdings, LLC et al. v. Humanigen, Inc. et al. The Company believes that the claims made in the Alliance Texas Holdings Case are without merit, and it is prepared to defend itself vigorously. On April 19, 2021, the Company and Noble entered into a confidential settlement agreement in respect of a separate lawsuit brought by Noble related to the Private Placement (the “Noble Case”) captioned Noble Capital Markets, Inc. v. Humanigen, Inc., Case No. 9:20-CV-81131-WPD, pursuant to which the Noble Case was dismissed with prejudice.

Subsequent Events

Subsequent Events	3 Months Ended
	Mar. 31, 2021
Subsequent Events [Abstract]
Subsequent Events	11. Subsequent Events On March 30, 2021, the Company entered into the Underwriting Agreement providing for the public offering of 5,000,000 shares of the Company’s common stock. In addition, the Company granted the underwriters a 30-day option to purchase an additional 750,000 shares of its common stock. The net proceeds from this offering, after deducting underwriting discounts and estimated offering costs, are estimated to be approximately $94.1 million. The Company expects to use the net proceeds for manufacturing and inventory costs in connection with its efforts to prepare for potential commercialization of lenzilumab in the event of receipt of an EUA or other CMA for use in COVID-19 patients, as well as for working capital and other general corporate purposes. On April 19, 2021, the Company announced positive data with lenzilumab in the Phase 1b study evaluating the efficacy and safety of lenzilumab with Yescarta, the CAR-T therapy developed by Kite in patients with DLBCL. In addition, the Company announced its plans to initiate a randomized, multicenter, potentially registrational, Phase 2 study to evaluate the efficacy and safety of lenzilumab combined with all commercially available CD19 CAR-T therapies in DLBCL. In connection with its announcement of its decision to pursue the Phase 2 study, the Company also announced the termination of the clinical collaboration agreement with Kite effective on May 18, 2021, the 30 th

Potentially Dilutive Securiti_2

Potentially Dilutive Securities (Tables)	3 Months Ended
	Mar. 31, 2021
Potentially Dilutive Securities
Potentially Dilutive Securities Excluded From Computation of Diluted Net Loss Per Common Share	The following outstanding potentially dilutive securities have been excluded from the computations of diluted net loss per common share: As of March 31, 2021 2020 Options to purchase common stock 4,224,111 3,420,930 Warrants to purchase common stock 51,238 66,239 Convertible debt 255,493 2,295,545 4,530,842 5,782,714

Long-Term Debt (Tables)

Long-Term Debt (Tables)	3 Months Ended
	Mar. 31, 2021
Disclosure Text Block [Abstract]
Schedule of Outstanding Future Payments Associated Company's Term Loan	The following table summarizes the outstanding future payments of principal and interest associated with the Company’s Term Loan as of March 31, 2021 (in thousands): 2021 $ 1,501 2022 2,218 2023 10,800 2024 13,671 2025 5,153 Total payments 33,343 Less amount representing interest (6,655 ) Notes payable, gross 26,688 Less: Unamortized portion of EOT charge (1,688 ) Less: Unamortized discount on notes payable (213 ) Less: Unamortized debt issuance costs (343 ) Long-term debt 24,444 Less current portion - Long-term debt, net of current portion $ 24,444

Stock-Based Compensation (Table

Stock-Based Compensation (Tables)	3 Months Ended
	Mar. 31, 2021
Share-based Payment Arrangement [Abstract]
Schedule of Summary of Stock Option Activity	A summary of stock option activity for the three months ended March 31, 2021 under all the Company’s options plans is as follows: Options Weighted Outstanding at January 1, 2021 3,728,149 $ 5.57 Granted 758,240 16.13 Exercised (250,242 ) (3.13 ) Cancelled (forfeited) (11,932 ) (3.33 ) Cancelled (expired) (104 ) (162.09 ) Outstanding at March 31, 2021 4,224,111 $ 7.61
Schedule of Weighted-Average Assumption Terms	The Company valued the options granted using the Black-Scholes options pricing model and the following weighted-average assumption terms for the three months ended March 31, 2021: Three Months Ended March 31, 2021 Exercise price $16.07 - $17.79 Market value $16.07 - $17.79 Expected term 6 years Expected volatility 109% Risk-free interest rate 1.06% - 1.08% Expected dividend yield -%
Schedule of Stock-Based Compensation Expense	The Company recorded stock-based compensation expense in the Condensed Consolidated Statements of Operations as follows (in thousands): Three Months Ended March 31, 2021 2020 General and administrative $ 364 $ 211 Research and development $ 146 $ 54 Total stock-based compensation $ 510 $ 265

Nature of Operations (Details)

Nature of Operations (Details) - USD ($) $ in Thousands	Jul. 10, 2017	May 26, 2017	Mar. 31, 2021	Mar. 31, 2020	Dec. 31, 2020
Cash and cash equivalents			$ 92,892		$ 67,737
Secured term loan			25,000
Proceeds from the underwritten public offering			94,100
Research and development expense	$ 1,000	$ 1,000	59,934	$ 659
Lenzilumab COVID-19 clinical studies [Member]
Research and development expense			7,600
Production of lenzilumab finished good [Member]
Research and development expense			$ 51,700

Potentially Dilutive Securiti_3

Potentially Dilutive Securities (Details) - shares	3 Months Ended
	Mar. 31, 2021	Mar. 31, 2020
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items]
Antidilutive securities excluded from computations of diluted net loss per common share	4,530,842	5,782,714
Options to purchase common stock [Member]
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items]
Antidilutive securities excluded from computations of diluted net loss per common share	4,224,111	3,420,930
Warrants to purchase common stock [Member]
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items]
Antidilutive securities excluded from computations of diluted net loss per common share	51,238	66,239
Convertilbe debt [Member]
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items]
Antidilutive securities excluded from computations of diluted net loss per common share	255,493	2,295,545

License Revenue (Details)

License Revenue (Details) - USD ($) $ in Millions	3 Months Ended	12 Months Ended
	Mar. 31, 2021	Dec. 31, 2020
License Agreement Terms [Member]
Gross up-front license fee	$ 6
Aggregate licence payment received		$ 14
Description of licensing agreement	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.
Revenue recognized performance obligation description of payment	Over the performance period through March 2023 (the “Performance Period”), the expected period over which the Company conservatively expects the Services to be performed with approval in the Territory expected by the end of March 2023.
License revenue	$ 0.5
Up-front Payment Arrangement [Member]
Upfront payment	$ 4.5

Long-Term Debt (Narrative) (Det

Long-Term Debt (Narrative) (Details) - Secured Term Loan Facility [Member] - USD ($) $ / shares in Units, $ in Thousands	Mar. 10, 2021	Mar. 29, 2024	Mar. 29, 2023	Mar. 29, 2022	Mar. 31, 2021	Mar. 29, 2021
Debt Instrument [Line Items]
Aggregate principal amount	$ 80,000
Drew amount						$ 25,000
Net proceeds	$ 24,400
Interest rate description	Amounts drawn bear 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% (such greater amount, the “Base Interest Rate”). Subject to there not having occurred any default or event of default under the loan agreement, the Base Interest Rate will be reduced by 25 basis points upon the occurrence of each of the first three of the four following events to occur:
Net Lenzilumab Product Revenue	$ 100,000
Interest rate	6.75%				9.00%
Unrestricted cash	$ 10,000
Unrestricted net cash proceeds	$ 100,000
Conversion price	$ 19.57
Interest expense					$ 18
Convertible Notes Payable [Member]
Debt Instrument [Line Items]
Aggregate principal amount	$ 250,000
Subsequent Event [Member]
Debt Instrument [Line Items]
Percentage of amount borrowed if repayment occurs		1.00%	1.50%	2.00%
Minimum [Member]
Debt Instrument [Line Items]
Net Lenzilumab Product Revenue	250,000
Converted principal amount	5,000
Maximum [Member]
Debt Instrument [Line Items]
Net Lenzilumab Product Revenue	350,000
Unrestricted cash	20,000
Converted principal amount	10,000
Second tranche [Member] | Minimum [Member]
Debt Instrument [Line Items]
Drew amount	25,000
Second tranche [Member] | Maximum [Member]
Debt Instrument [Line Items]
Drew amount	35,000
Third tranche [Member]
Debt Instrument [Line Items]
Drew amount	$ 20,000

Long-Term Debt (Schedule of Out

Long-Term Debt (Schedule of Outstanding Future Payments Associated Company's Term Loan) (Details) - USD ($) $ in Thousands	Mar. 31, 2021	Dec. 31, 2020
Debt Disclosure [Abstract]
2021	$ 1,501
2022	2,218
2023	10,800
2024	13,671
2025	5,153
Total payments	33,343
Less amount representing interest	(6,655)
Notes payable, gross	26,688
Less: Unamortized portion of EOT charge	(1,688)
Less: Unamortized discount on notes payable	(213)
Less: Unamortized debt issuance costs	(343)
Long-term debt	24,444
Less current portion
Long-term debt, net of current portion	$ 24,444

Commitments and Contingencies (

Commitments and Contingencies (Details) $ in Thousands	Mar. 31, 2021USD ($)
Commitments and Contingencies Disclosure [Abstract]
Accrued expenses	$ 900
Commitments remaining	$ 169,000

Stockholders' Equity (Details)

Stockholders' Equity (Details) - USD ($) $ in Thousands	3 Months Ended
	Mar. 31, 2021	Mar. 31, 2020	Dec. 31, 2020	Sep. 11, 2020
Class of Stock [Line Items]
Reverse stock split	1-for-5
Common Stock, shares authorized upon the completion of the IPO	225,000,000		225,000,000	225,000,000
Total proceeds	$ 36,106	$ 65
Common stock, shares outstanding	53,656,689		51,626,508
Controlled Equity Offering SM Sales Agreement [Member] | Cantor Fitzgerald & Co. [Member]
Class of Stock [Line Items]
Total proceeds	$ 100,000
Private Placement [Member]
Class of Stock [Line Items]
Total proceeds	$ 36,100
Company issued shares	1,796,858
2021 Underwritten Public Offering [Member] | J.P. Morgan Securities LLC and Jefferies LLC [Member]
Class of Stock [Line Items]
Shares issued in public offering	5,000,000
Warrants to purchase common stock	750,000
2020 Equity Plan [Member]
Class of Stock [Line Items]
Shares available for future grant				7,000,000
Maximum [Member]
Class of Stock [Line Items]
Common stock, shares outstanding				210,900,000
Minimum [Member]
Class of Stock [Line Items]
Common stock, shares outstanding				42,200,000

Stock-Based Compensation (Narra

Stock-Based Compensation (Narrative) (Details) $ / shares in Units, $ in Thousands	3 Months Ended
	Mar. 31, 2021USD ($)$ / shares
Share-based Payment Arrangement [Abstract]
Weighted average fair value of options granted | $ / shares	$ 13.30
Unrecognized compensation expense | $	$ 12,800
Weighted average period for recognition	2 years 8 months 12 days

Stock-Based Compensation (Sched

Stock-Based Compensation (Schedule of Summary of Stock Option Activity) (Details)	3 Months Ended
	Mar. 31, 2021$ / sharesshares
Options
Outstanding at January 1, 2021 | shares	3,728,149
Granted | shares	758,240
Exercised | shares	(250,242)
Cancelled (forfeited) | shares	(11,932)
Cancelled (expired) | shares	(104)
Outstanding at March 31, 2021 | shares	4,224,111
Weighted Average Exercise Price
Outstanding at January 1, 2021 | $ / shares	$ 5.57
Granted | $ / shares	16.13
Exercised | $ / shares	(3.13)
Cancelled (forfeited) | $ / shares	(3.33)
Cancelled (expired) | $ / shares	(162.09)
Outstanding at March 31, 2021 | $ / shares	$ 7.61

Stock-Based Compensation (Sch_2

Stock-Based Compensation (Schedule of Weighted-Average Assumption Terms) (Details)	3 Months Ended
	Mar. 31, 2021$ / shares
Share-based Payment Arrangement, Expensed and Capitalized, Amount [Line Items]
Expected term	6 years
Expected volatility	109.00%
Expected dividend yield
Minimum [Member]
Share-based Payment Arrangement, Expensed and Capitalized, Amount [Line Items]
Exercise price	$ 16.07
Market value	$ 16.07
Risk-free interest rate	1.06%
Maximum [Member]
Share-based Payment Arrangement, Expensed and Capitalized, Amount [Line Items]
Exercise price	$ 17.79
Market value	$ 17.79
Risk-free interest rate	1.08%

Stock-Based Compensation (Stock

Stock-Based Compensation (Stock-Based Compensation Expense) (Details) - USD ($) $ in Thousands	3 Months Ended
	Mar. 31, 2021	Mar. 31, 2020
Share-based Payment Arrangement, Expensed and Capitalized, Amount [Line Items]
Stock-based compensation expense	$ 510	$ 265
General And Administrative Expense [Member]
Share-based Payment Arrangement, Expensed and Capitalized, Amount [Line Items]
Stock-based compensation expense	364	211
Research And Development Expense [Member]
Share-based Payment Arrangement, Expensed and Capitalized, Amount [Line Items]
Stock-based compensation expense	$ 146	$ 54

License and Collaboration Agr_2

License and Collaboration Agreements (Details) - USD ($) $ in Thousands	1 Months Ended	3 Months Ended
	Jul. 19, 2019	Mar. 31, 2021
Mayo Agreement [Member]
Amount paid in license agreement		$ 200
Zurich Agreement [Member]
Amount paid in license agreement	$ 100
Zurich Agreement [Member] | Research And Development Expense [Member]
Amount paid in license agreement		$ 100

Litigation (Details)

Litigation (Details) - USD ($) $ / shares in Units, $ in Thousands	Jul. 10, 2017	Jun. 19, 2020	Jun. 30, 2017	May 26, 2017	Jun. 30, 2016	Mar. 31, 2021	Mar. 31, 2020	Dec. 31, 2020	Oct. 07, 2020	Jun. 30, 2020
Research and development	$ 1,000			$ 1,000		$ 59,934	$ 659
Due to Savant						$ 2,000		$ 2,000
Savant Neglected Diseases, LLC [Member]
Number of shares called by warrant					40,000
Exercise price of warrant					$ 11.25
Exercise period of warrant					5 years
Private Placement [Member]
Amount sought under alledges		$ 4,000
Savant Neglected Diseases, LLC [Member]
Aggregate cost			$ 3,400
Deductible			500
Offset payment due			$ 2,000
Warrants exercised cashless										20,000
Shares issued										10,909
Savant Neglected Diseases, LLC [Member] | Insufficient under warrant [Member]
Shares issued									10,909
Savant Neglected Diseases, LLC [Member] | Breach of contract related to exercise of warrants [Member]
Warrants exercised cashless									20,000

Subsequent Events (Details)

Subsequent Events (Details) - 2021 Underwritten Public Offering [Member] - USD ($) $ in Thousands	Apr. 05, 2021	Mar. 31, 2021
Subsequent Event [Line Items]
Company issued common stock shares		5,000,000
Shares issued in public offering		750,000
Sale of additional shares of common stock		427,017
Proceeds from sale of shares after offering costs		$ 94,100
Subsequent Event [Member]
Subsequent Event [Line Items]
Company issued common stock shares	5,000,000