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® 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 (“aGvHD”) associated with bone marrow transplants. The Company believes the results from its Phase 3 study in COVID-19, its Phase 1b study in CAR-T, and four other clinical trials support the mechanism of action of lenzilumab. On May 5, 2021, data from a Phase 3, multi-center, double-blind, placebo-controlled potential registrational trial of lenzilumab as a potential therapeutic for hospitalized, hypoxic patients with COVID-19 pneumonia was published on MedRxiv, a non-peer reviewed journal. The Company refers to this study as the “LIVE-AIR” study. Data from LIVE-AIR support the previously reported primary endpoint that demonstrated 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: 1.02-2.32, p=0.0403). SWOV also improved on a relative basis by 92% in subjects who received both corticosteroids and remdesivir (1.92; 1.20-3.07, nominal p=0.0067); by 3.04-fold in subjects with baseline C-reactive protein (“CRP”) levels <150 mg/L and age <85 years (3.04; 1.68–5.51, nominal p=0.0003). Survival was improved by 2.22-fold in subjects with baseline CRP<150 mg/L and age <85 years (nominal p=0.0337). Subjects with baseline CRP<150 mg/L and age <85 years demonstrated an improvement in survival and appeared to derive the greatest benefit from lenzilumab. An additional analysis of minority groups that are at greater risk of poor outcomes with COVID-19 demonstrated a nearly 9-fold relative improvement in SWOV in Black and African-American Subjects with CRP < 150 mg/L at baseline (HR: 8.90; 95%CI: 1.08-73.09, p=0.0418). The Company submitted an application for Emergency Use Authorization (“EUA”) of lenzilumab to the U.S. Food and Drug Administration (“FDA”) at the end of May 2021. As requested by FDA, the EUA application included secondary endpoints and supplemental data analysis from LIVE-AIR as well as additional stability and compatibility information required for the Chemistry Manufacturing and Control (“CMC”) section of the EUA application. Since our initial submission of the application for EUA, we have responded to several requests from FDA regarding the application. There can be no assurance that the data the Company has submitted to FDA will be sufficient for an EUA, or that FDA will not require additional information in order to grant an EUA. No formal timelines exist for the FDA to complete their review of our EUA application and as a result we are unable to give guidance on the timing of a decision by the FDA. If the EUA is granted, the Company could begin to commercialize lenzilumab for the treatment of hospitalized COVID-19 patients. COVID-19 infections are widespread and as of July 31, 2021 in the U.S., there have been reported approximately 35 million cases, over 2.4 million hospitalizations and over 610 thousand deaths. Several vaccines have been developed which show efficacy to in excess of 90%; even with the improvements in the rollout of vaccinations in the U.S., significant and further incremental uptake of vaccines beyond current levels has been limited by vaccine hesitancy, educational messages which appear to be inadequate for certain populations and politicization surrounding vaccine policy. In addition, with the widespread emergence of numerous COVID-19 variants, particularly the Delta variant which appears to be more transmissible than other variants and has been shown to allow COVID-19 infections in patients who have been fully vaccinated, the Company believes the need for therapeutics to treat hospitalized COVID-19 patients will continue to exist. The Company has been in discussion with the Medicines and Healthcare Products Regulatory Agency (“MHRA”), the pharmaceuticals and biologics regulatory agency in the United Kingdom (“UK”), for the use of lenzilumab in hospitalized COVID-19 patients and initiated a rolling submission for a Conditional Marketing Authorization (“CMA”) in mid-June 2021. The Company anticipates the submission processes to the MHRA should be completed by September 30, 2021. The Company has also initiated the process for submission of a Marketing Authorization Application (“MAA”) to the European Medicines Agency (“EMA”) for the use of lenzilumab in the European Union and anticipates the appointment of rapporteurs in the near term. The Company anticipates that the submission processes to the EMA should be completed by the end of 2021. 7 Table of Contents Lenzilumab has been selected to be part of the ongoing Accelerating COVID-19 Therapeutic Interventions and Vaccines (“ACTIV”)-5 and Big Effect Trial, in the “B” arm of the trial (“BET-B”), referred to as ACTIV-5/BET-B, which is sponsored and funded by the National Institutes of Health (“NIH”). ACTIV-5/BET-B currently has over 32 active U.S. sites enrolling and has recently expanded to a potential of 70 sites. The study is evaluating lenzilumab in combination with remdesivir, compared to placebo and remdesivir, in hospitalized COVID-19 patients with a 1:1 randomization. In July 2021, NIH advanced the ACTIV-5/BET-B study to a Phase 2/3 study and amended the protocol in a manner that aligns with the design of the LIVE-AIR study. The amended ACTIV-5/BET-B study protocol now includes at least 400 patients overall. Humanigen is providing lenzilumab and assisting the NIH to achieve the timely completion of the study. The Company intends to submit a Biologics License Application (“BLA”) to FDA for lenzilumab in the treatment of hospitalized COVID-19 patients. Since BLAs typically require more than one study, the Company plans to include the results of the expanded ACTIV-5/BET-B study as a basis for a BLA-confirmatory study for lenzilumab and believes data from ACTIV-5/BET-B, along with LIVE-AIR, should provide the sufficient size and statistical power typically required for a BLA to be submitted to FDA. If the ACTIV-5/BET-B data is favorable and the total number of patients is acceptable to FDA, the Company expects to submit the BLA in 2022. Lenzilumab has been studied in a multi-center Phase 1b trial as a sequenced therapy with Yescarta® (axicabtagene ciloleucel) to prevent CRS and neurotoxicity in patients with relapsed or refractory diffuse large B-cell lymphoma (“DLBCL”) (NCT04314843), for which the Company announced positive results. In early 2022, 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 Company currently plans to enroll approximately 250 patients in the study beginning in 2022. The Company also plans to commence 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 study 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 the study including the cost of import, labeling and distribution of the study drug, and support certain laboratory tests related to the study, but the majority of the study costs will be borne by the IMPACT Partnership. 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 in patients with chronic myelomonocytic leukemia (“CMML”). 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 at least four sites in Australia. The Company will provide lenzilumab for this study and the majority of the study costs will be borne by the partner and funded by a grant from the Medical Research Futures Fund, a research fund set up by the Australian Government. 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 its Humaneered technology to optimize 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. In addition, the Company believes its Humaneered antibodies offer further important 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 June 30, 2021, the Company had cash and cash equivalents of $120.5 million. Together with potential additional draws under the Hercules Term Loan, discussed in further detail in Note 5 below, and potential revenues from the commercial sale of lenzilumab (if an EUA in the U.S. or CMA in the UK or EU 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. 8 Table of Contents 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 further agreements to bolster its ability to supply lenzilumab in the event of receipt of an EUA or CMA or to be able to provide lenzilumab under other commercial programs. 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 a 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 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 Hercules Term Loan; upfront and milestone payments from licensees; and government funding or financial support, if offered. The Company believes that its cash and cash equivalents and available borrowings 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. 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 or CMA for lenzilumab in COVID-19 patients, may change as a result of many currently unknown factors. 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 or CMA could further constrain its cash resources. 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, manufacturing 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. |