Nature of Operations	6 Months Ended
Jun. 30, 2022
Nature of Operations [Abstract]
Nature of Operations	1. Nature of Operations Description of the Business The Company is a clinical stage biopharmaceutical company, developing its portfolio of proprietary Humaneered^® anti-inflammatory immunology and immuno-oncology monoclonal antibodies. 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. Humanigen has developed or in-licensed targets or research antibodies, typically from academic institutions, and then applied its Humaneered technology to optimize them. The Company’s lead product candidate, lenzilumab, or LENZ^®, and its other product candidate, ifabotuzumab (“iFab”), 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. 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. In July 2022, preliminary topline results from the Accelerating COVID-19 Therapeutic Interventions and Vaccines-5 (“ACTIV-5”) and Big Effect Trial, in the “B” arm of the trial (“BET-B”), referred to as the ACTIV-5/BET-B trial, were released. The study was sponsored and funded by the National Institutes of Health (“NIH”) and evaluated lenzilumab in combination with remdesivir, compared to placebo and remdesivir, in hospitalized COVID-19 patients. Based on the preliminary topline results, the trial did not achieve statistical significance on the primary endpoint, although did indicate that lenzilumab demonstrated a positive trend in mortality. The Company continues to support NIH’s further analysis of the data and lenzilumab has interest from a global group of leading institutions and research networks to include lenzilumab in their large-scale, multinational studies of COVID-19. Tocilizumab and baricitinib demonstrated mortality benefit following inclusion in such studies having failed to do so in smaller studies. The Company announced a strategic realignment of its pipeline and resources and is reconsidering its regulatory strategy. The Company plans to accelerate the development of lenzilumab in chronic myelomonocytic leukemia (“CMML”), a rare blood cancer, for which the PREACH-M study is already underway, and to continue its plans for the RATinG study in acute graft versus host disease (“aGvHD”) that occurs in patients undergoing bone marrow transplant, that is expected to enroll its first patient in the third quarter of 2022. These studies are majority funded by the Company’s partners. In addition, the Company is currently assessing requests for investigator-initiated trials (“IIT”s) of lenzilumab in combination with CAR-T therapies; the previously planned SHIELD study of lenzilumab with certain CAR-T therapies has been terminated pursuant to the strategic realignment plan. The Company also plans to continue the development of iFab, an EpAh-3 targeted monoclonal antibody currently in Phase 1 development, as part of an antibody drug conjugate (“ADC”), for certain solid tumors. Under the realignment plan, the Company will deemphasize the deployment of certain resources for the development of lenzilumab for COVID-19 and currently does not plan to file for Emergency Use Authorization (“EUA”) in the United States in 2022. The Company had previously planned to respond to the rolling review written questions received last year from the Medicines and Healthcare Products Regulatory Agency (“MHRA”) following receipt of the results from the ACTIV-5/BET-B trial but does not plan to respond to these written questions in 2022. The Company no longer intends to submit a Conditional Marketing Authorization (“CMA”) for lenzilumab with an Accelerated Approval request to the European Medicines Agency (“EMA”) in 2022.The Named Patient program in select European Countries will be terminated. With the exception of lenzilumab batches in process, the Company plans to stop the manufacturing of lenzilumab. The Company plans to consolidate the remaining inventory of lenzilumab bulk drug substance and drug product in a central location for potential future use. As of July 22, 2022, there are approximately 11,500 lenzilumab treatments in production. Approximately 65,800 lenzilumab treatments will be stored and 9,000 treatments are being sent for destruction as a result of expiry of drug substance (an intermediate step to final drug product). Current shelf life of drug product is 36 months and bulk drug substance is 12 months. One of the Company’s Contract Manufacturing Organizations (“CMOs”), Catalent Pharma Solutions, LLC (“Catalent”), has notified the Company that it is in breach of its manufacturing agreement with Catalent and has issued a demand for payment for outstanding amounts owed. Catalent has demanded payment of the past due balance of $12.8 million by August 8, 2022 to cure this breach and has threatened to cancel the manufacturing agreement if payment is not made (See Note 11 below). Unless the Company complies with their demand for payment, it is unlikely the Company will be able to utilize the treatments in production and treatments for which production has been completed. Another 33,000 treatments are in production at one of the Company’s CMOs, Thermo Fisher Scientific, Inc. (“Thermo”), for which material has not yet been released by the Company, and which may require reprocessing prior to release. Thermo has notified the Company that they have stopped production and have issued a demand for payment. The Company has disputed the amounts owed to Thermo as a result of Thermo’s failure to produce usable material within stated release specifications. At this time, it is unlikely that these 33,000 treatments would be released by the Company. Inventory of treatments produced at our CMOs for which the process has not been validated or released will likely be destroyed in the future if no potential commercial use is found. See Management’s Discussion and Analysis of Financial Condition and Results of Operations included in Item 7 of the Company’s 2021 Annual Report on Form 10-K for additional information regarding the business. Liquidity and Going Concern The Condensed Consolidated Financial Statements for the three and six months ended June 30, 2022 were prepared on the basis of a going concern, which contemplates that the Company will be able to realize assets and discharge liabilities in the normal course of business. However, the Company has incurred net losses since its inception, and has negative operating cash flows and its total liabilities exceed total assets. These conditions raise substantial doubt about the Company’s ability to continue as a going concern. As of June 30, 2022, the Company had cash and cash equivalents of $47.0 million. In July 2022, as part of its strategic realignment plan, as stated in Notes 5 and 11, the Company paid amounts owed under the Loan and Security Agreement with Hercules as agent for its affiliates serving as lenders thereunder (the “Term Loan”) of $26.7 million in full settlement of the remaining outstanding principal balance, accrued interest, the end of term fee (less a $0.1 million reduction) and waiver of the $0.4 million prepayment fee, fully extinguishing and terminating the Term Loan in the process. Considering the Company’s current cash resources and its current and expected levels of operating expenses for the next twelve months, which includes combined accounts payable and accrued expenses recorded in the Company’s condensed consolidated balance sheets as of June 30, 2022 of $71.1 million, and its non-manufacturing commitments of $0.3 million and manufacturing commitments of $36.5 million during the remaining six months of 2022, $7.6 million for 2023, and $6.6 million thereafter (see Note 6 below), the Company requires additional capital to fund the Company’s planned operations. Certain of these commitments and amounts accrued at June 30, 2022 are in dispute. The Company intends to seek to defer payments, negotiate lower amounts or pursue other courses of action for certain commitments and amounts owed to manufacturing and other partners at June 30, 2022. In order to remain a going concern and execute its strategic realignment plan, the Company must successfully renegotiate these amounts owed and remaining commitments, and settle disputes, including current and potential future arbitration and litigation. Management will seek to raise such additional capital through public or private equity offerings, including under the Controlled Equity Offering^SM Sales Agreement (the “Sales Agreement”) with Cantor Fitzgerald & Co. (“Cantor”), grant financing, convertible and other debt financings, collaborations, strategic alliances, or licensing arrangements. Subsequent to June 30, 2022 and through August 10, 2022, as disclosed in Note 11 below, the Company issued and sold 33,628,000 shares of common stock pursuant to the Sales Agreement and received net proceeds of approximately $15.9 million, after deducting fees and expenses. Additional funds may not be available when the Company needs them on terms that are acceptable to the Company, or at all. If adequate funds are not available, the Company may be required to delay or reduce the scope of or eliminate one or more of its research or development programs, its commercialization efforts or its manufacturing commitments and capacity. In addition, if the Company raises additional funds through collaborations, strategic alliances, or licensing arrangements with third parties, the Company may have to relinquish rights to its technologies, future revenue streams or product candidates or to grant licenses on terms that may not be favorable to the Company. While management believes its realignment plans and its plans to raise additional funds will alleviate the conditions that raise substantial doubt about the Company’s ability to continue as a going concern, these plans are not entirely within the Company’s control and cannot be assessed as being probable of occurring. Basis of Presentation The accompanying interim unaudited Condensed Consolidated Financial Statements have been prepared in accordance with U.S. generally accepted accounting principles (“U.S. GAAP”) for interim financial information and on a basis consistent with the annual consolidated financial statements and include all adjustments necessary for the presentation of the Company’s condensed consolidated financial position, results of operations and cash flows for the periods presented. The Condensed Consolidated Financial Statements include the accounts of the Company and its wholly-owned subsidiaries. These financial statements have been prepared on a basis that assumes that the Company will continue as a going concern, which contemplates the realization of assets and the satisfaction of liabilities and commitments in the normal course of business. The December 31, 2021 Condensed Consolidated Balance Sheet was derived from the audited financial statements but does not include all disclosures required by U.S. GAAP. These interim financial results are not necessarily indicative of the results to be expected for the year ending December 31, 2022, or for any other future annual or interim period. The accompanying unaudited Condensed Consolidated Financial Statements should be read in conjunction with the audited consolidated financial statements and the related notes thereto included in the Company’s 2021 Annual Report on Form 10-K. The preparation of financial statements in conformity with U.S. GAAP requires management to make estimates and assumptions that affect the amounts and disclosures reported in the Condensed Consolidated Financial Statements and accompanying notes. Actual results could differ materially from those estimates. The Company believes judgment is involved in accounting for the determination of revenue recognition, fair value-based measurement of stock-based compensation and accruals. The Company evaluates its estimates and assumptions as facts and circumstances dictate. As future events and their effects cannot be determined with precision, actual results could differ from these estimates and assumptions, and those differences could be material to the Condensed Consolidated Financial Statements.

Nature of Operations

6 Months Ended

Jun. 30, 2022

1. Nature of Operations

Description of the Business

The Company is a clinical stage biopharmaceutical company, developing its portfolio of proprietary Humaneered^® anti-inflammatory immunology and immuno-oncology monoclonal antibodies. 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. Humanigen has developed or in-licensed targets or research antibodies, typically from academic institutions, and then applied its Humaneered technology to optimize them. The Company’s lead product candidate, lenzilumab, or LENZ^®, and its other product candidate, ifabotuzumab (“iFab”), 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. 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.

In July 2022, preliminary topline results from the Accelerating COVID-19 Therapeutic Interventions and Vaccines-5 (“ACTIV-5”) and Big Effect Trial, in the “B” arm of the trial (“BET-B”), referred to as the ACTIV-5/BET-B trial, were released. The study was sponsored and funded by the National Institutes of Health (“NIH”) and evaluated lenzilumab in combination with remdesivir, compared to placebo and remdesivir, in hospitalized COVID-19 patients. Based on the preliminary topline results, the trial did not achieve statistical significance on the primary endpoint, although did indicate that lenzilumab demonstrated a positive trend in mortality. The Company continues to support NIH’s further analysis of the data and lenzilumab has interest from a global group of leading institutions and research networks to include lenzilumab in their large-scale, multinational studies of COVID-19. Tocilizumab and baricitinib demonstrated mortality benefit following inclusion in such studies having failed to do so in smaller studies.

The Company announced a strategic realignment of its pipeline and resources and is reconsidering its regulatory strategy. The Company plans to accelerate the development of lenzilumab in chronic myelomonocytic leukemia (“CMML”), a rare blood cancer, for which the PREACH-M study is already underway, and to continue its plans for the RATinG study in acute graft versus host disease (“aGvHD”) that occurs in patients undergoing bone marrow transplant, that is expected to enroll its first patient in the third quarter of 2022. These studies are majority funded by the Company’s partners. In addition, the Company is currently assessing requests for investigator-initiated trials (“IIT”s) of lenzilumab in combination with CAR-T therapies; the previously planned SHIELD study of lenzilumab with certain CAR-T therapies has been terminated pursuant to the strategic realignment plan. The Company also plans to continue the development of iFab, an EpAh-3 targeted monoclonal antibody currently in Phase 1 development, as part of an antibody drug conjugate (“ADC”), for certain solid tumors. Under the realignment plan, the Company will deemphasize the deployment of certain resources for the development of lenzilumab for COVID-19 and currently does not plan to file for Emergency Use Authorization (“EUA”) in the United States in 2022. The Company had previously planned to respond to the rolling review written questions received last year from the Medicines and Healthcare Products Regulatory Agency (“MHRA”) following receipt of the results from the ACTIV-5/BET-B trial but does not plan to respond to these written questions in 2022. The Company no longer intends to submit a Conditional Marketing Authorization (“CMA”) for lenzilumab with an Accelerated Approval request to the European Medicines Agency (“EMA”) in 2022.The Named Patient program in select European Countries will be terminated. With the exception of lenzilumab batches in process, the Company plans to stop the manufacturing of lenzilumab. The Company plans to consolidate the remaining inventory of lenzilumab bulk drug substance and drug product in a central location for potential future use.

As of July 22, 2022, there are approximately 11,500 lenzilumab treatments in production. Approximately 65,800 lenzilumab treatments will be stored and 9,000 treatments are being sent for destruction as a result of expiry of drug substance (an intermediate step to final drug product). Current shelf life of drug product is 36 months and bulk drug substance is 12 months. One of the Company’s Contract Manufacturing Organizations (“CMOs”), Catalent Pharma Solutions, LLC (“Catalent”), has notified the Company that it is in breach of its manufacturing agreement with Catalent and has issued a demand for payment for outstanding amounts owed. Catalent has demanded payment of the past due balance of $12.8 million by August 8, 2022 to cure this breach and has threatened to cancel the manufacturing agreement if payment is not made (See Note 11 below). Unless the Company complies with their demand for payment, it is unlikely the Company will be able to utilize the treatments in production and treatments for which production has been completed. Another 33,000 treatments are in production at one of the Company’s CMOs, Thermo Fisher Scientific, Inc. (“Thermo”), for which material has not yet been released by the Company, and which may require reprocessing prior to release. Thermo has notified the Company that they have stopped production and have issued a demand for payment. The Company has disputed the amounts owed to Thermo as a result of Thermo’s failure to produce usable material within stated release specifications. At this time, it is unlikely that these 33,000 treatments would be released by the Company. Inventory of treatments produced at our CMOs for which the process has not been validated or released will likely be destroyed in the future if no potential commercial use is found.

See Management’s Discussion and Analysis of Financial Condition and Results of Operations included in Item 7 of the Company’s 2021 Annual Report on Form 10-K for additional information regarding the business.

Liquidity and Going Concern

The Condensed Consolidated Financial Statements for the three and six months ended June 30, 2022 were prepared on the basis of a going concern, which contemplates that the Company will be able to realize assets and discharge liabilities in the normal course of business. However, the Company has incurred net losses since its inception, and has negative operating cash flows and its total liabilities exceed total assets. These conditions raise substantial doubt about the Company’s ability to continue as a going concern.

As of June 30, 2022, the Company had cash and cash equivalents of $47.0 million. In July 2022, as part of its strategic realignment plan, as stated in Notes 5 and 11, the Company paid amounts owed under the Loan and Security Agreement with Hercules as agent for its affiliates serving as lenders thereunder (the “Term Loan”) of $26.7 million in full settlement of the remaining outstanding principal balance, accrued interest, the end of term fee (less a $0.1 million reduction) and waiver of the $0.4 million prepayment fee, fully extinguishing and terminating the Term Loan in the process.

Considering the Company’s current cash resources and its current and expected levels of operating expenses for the next twelve months, which includes combined accounts payable and accrued expenses recorded in the Company’s condensed consolidated balance sheets as of June 30, 2022 of $71.1 million, and its non-manufacturing commitments of $0.3 million and manufacturing commitments of $36.5 million during the remaining six months of 2022, $7.6 million for 2023, and $6.6 million thereafter (see Note 6 below), the Company requires additional capital to fund the Company’s planned operations. Certain of these commitments and amounts accrued at June 30, 2022 are in dispute. The Company intends to seek to defer payments, negotiate lower amounts or pursue other courses of action for certain commitments and amounts owed to manufacturing and other partners at June 30, 2022. In order to remain a going concern and execute its strategic realignment plan, the Company must successfully renegotiate these amounts owed and remaining commitments, and settle disputes, including current and potential future arbitration and litigation. Management will seek to raise such additional capital through public or private equity offerings, including under the Controlled Equity Offering^SM Sales Agreement (the “Sales Agreement”) with Cantor Fitzgerald & Co. (“Cantor”), grant financing, convertible and other debt financings, collaborations, strategic alliances, or licensing arrangements. Subsequent to June 30, 2022 and through August 10, 2022, as disclosed in Note 11 below, the Company issued and sold 33,628,000 shares of common stock pursuant to the Sales Agreement and received net proceeds of approximately $15.9 million, after deducting fees and expenses. Additional funds may not be available when the Company needs them on terms that are acceptable to the Company, or at all. If adequate funds are not available, the Company may be required to delay or reduce the scope of or eliminate one or more of its research or development programs, its commercialization efforts or its manufacturing commitments and capacity. In addition, if the Company raises additional funds through collaborations, strategic alliances, or licensing arrangements with third parties, the Company may have to relinquish rights to its technologies, future revenue streams or product candidates or to grant licenses on terms that may not be favorable to the Company. While management believes its realignment plans and its plans to raise additional funds will alleviate the conditions that raise substantial doubt about the Company’s ability to continue as a going concern, these plans are not entirely within the Company’s control and cannot be assessed as being probable of occurring.

Basis of Presentation

The accompanying interim unaudited Condensed Consolidated Financial Statements have been prepared in accordance with U.S. generally accepted accounting principles (“U.S. GAAP”) for interim financial information and on a basis consistent with the annual consolidated financial statements and include all adjustments necessary for the presentation of the Company’s condensed consolidated financial position, results of operations and cash flows for the periods presented.

The Condensed Consolidated Financial Statements include the accounts of the Company and its wholly-owned subsidiaries. These financial statements have been prepared on a basis that assumes that the Company will continue as a going concern, which contemplates the realization of assets and the satisfaction of liabilities and commitments in the normal course of business. The December 31, 2021 Condensed Consolidated Balance Sheet was derived from the audited financial statements but does not include all disclosures required by U.S. GAAP. These interim financial results are not necessarily indicative of the results to be expected for the year ending December 31, 2022, or for any other future annual or interim period. The accompanying unaudited Condensed Consolidated Financial Statements should be read in conjunction with the audited consolidated financial statements and the related notes thereto included in the Company’s 2021 Annual Report on Form 10-K.

The preparation of financial statements in conformity with U.S. GAAP requires management to make estimates and assumptions that affect the amounts and disclosures reported in the Condensed Consolidated Financial Statements and accompanying notes. Actual results could differ materially from those estimates. The Company believes judgment is involved in accounting for the determination of revenue recognition, fair value-based measurement of stock-based compensation and accruals. The Company evaluates its estimates and assumptions as facts and circumstances dictate. As future events and their effects cannot be determined with precision, actual results could differ from these estimates and assumptions, and those differences could be material to the Condensed Consolidated Financial Statements.