On November 14, 2022 Humanigen, Inc. (Nasdaq: HGEN) (Humanigen), a clinical-stage biopharmaceutical company focused on developing lenzilumab (LENZ), a first-in class antibody that neutralizes granulocyte-macrophage colony-stimulating factor (GM-CSF), reported financial results for the third quarter and nine months ended September 30, 2022 (Press release, Humanigen, NOV 14, 2022, View Source [SID1234623991]).
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In July 2022, the company announced a strategic realignment of its pipeline, resources and regulatory strategy. The company is accelerating the development of lenzilumab in chronic myelomonocytic leukemia (CMML), a rare blood cancer, for which the PREACH-M study is already underway. The company is also continuing its plans for the RATinG study in acute graft versus host disease (aGvHD) that occurs in patients undergoing bone marrow transplant. These studies are majority funded by the company’s partners. In addition, the company is currently assessing requests for investigator-initiated trials (IITs) of lenzilumab in combination with CAR-T therapies. The company also plans to continue the development of ifabotuzumab, an EpAh-3 targeted monoclonal antibody currently in Phase 1 development, as part of an antibody drug conjugate (ADC), for certain solid tumors. Under the realignment plan, the company will deemphasize the deployment of resources for the development of lenzilumab for COVID-19 and currently does not plan to pursue regulatory pathways, pending further data from ACTIV-5/BET-B or a future large-scale study in which lenzilumab may be a part. In a continuation of the strategic realignment, the company has engaged SC&H Capital, an affiliate of SC&H Group, to advise Humanigen on exploration of strategic options to maximize value around its pipeline. SC&H is an investment banking and advisory firm providing merger and acquisition (M&A), financial restructuring and related business advisory solutions to emerging and growing companies. Humanigen’s board of directors has not set a timetable for the conclusion of its review of strategic alternatives, and there can be no assurance that this process will result in any transaction.
Third Quarter and Nine Months Ended September 30, 2022 Financial Results
Net loss for the quarter ended September 30, 2022 was $23.7 million, or $0.23 per share, as compared to $66.7 million, or $1.12 per share, for the quarter ended September 30, 2021. The net loss for the nine months ended September 30, 2022 was $75.1 million or $0.95 per share, as compared to $203.1 million or $3.56 per share for the nine months ended September 30, 2021. The decrease in net loss for both periods was largely due to a decrease in expenses, mainly Research and Development (R&D) expense. R&D expense decreased by $41.9 million from $60.8 million for the three months ended September 30, 2021 to $18.9 million for the three months ended September 30, 2022 and decreased by $121.2 million from $183.8 million for the nine months ended September 30, 2021 to $62.6 million for the nine months ended September 30, 2022. The decrease in R&D expense is primarily due to decreased lenzilumab manufacturing costs for the quarter ended September 30, 2022 of $38.4 million, and for the nine months ended September 30, 2022 of $108.7 million.
Cash and Cash Equivalents
Net cash used in operating activities, net of balance sheet changes, was $62.1 million for the nine months ended September 30, 2022. During the first nine months of 2022, the company sold shares of its common stock under its At-the-Market (ATM) facility, raising net proceeds of approximately $41.8 million. As of September 30, 2022, the company had cash and cash equivalents of approximately $24.7 million.