On February 28, 2022 Humanigen, Inc. (Nasdaq: HGEN) (Humanigen), a clinical stage biopharmaceutical company focused on preventing and treating an immune hyper-response called "cytokine storm" with its lead drug candidate, lenzilumab, reported financial results for the year ended December 31, 2021, and announced corporate objectives for 2022 (Press release, Humanigen, FEB 28, 2022, View Source [SID1234609129]).
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Cameron Durrant, chairman and chief executive officer of Humanigen stated, "We initiated the development of lenzilumab, or LENZ, in May 2020 as a treatment for hypoxic COVID-19 patients. The virus and the treatment landscape continue to evolve. We believe that COVID-19 will become a serious endemic disease and will continue to impact society, healthcare systems and patients and that, if authorized or approved by regulatory agencies, LENZ, a variant-agnostic immunomodulatory antibody, could address a significant unmet need in COVID-19 for the foreseeable future. Humanigen made significant progress in developing lenzilumab over the last year, highlighted by the completion of our phase 3 study of lenzilumab in COVID-19, LIVE-AIR, and the publication of positive results from the study in The Lancet Respiratory Medicine, a world-renowned, peer-reviewed journal."
"We look forward to the announcement of the topline data from a second phase 2/3 study of lenzilumab in COVID-19, the ACTIV-5/BET-B study conducted by the National Institutes of Health, in late Q1 or early Q2. If results from ACTIV-5/BET-B in patients with a baseline C-reactive protein level less than 150mg/L build on the data from LIVE-AIR published in The Lancet, we plan to prepare and submit an amendment to our application for emergency use authorization for lenzilumab in hospitalized COVID-19 patients to the FDA, as well as regulatory submissions in the European Union and United Kingdom," Dr. Durrant continued.
Lenzilumab is an investigational product and is not currently authorized or approved in any country.
Highlights over the past year include:
Lenzilumab in COVID-19 patients
Completed the LIVE-AIR study, which showed that patients who received lenzilumab and other treatments, including steroids and/or remdesivir, had a 54% greater relative likelihood of survival without the need for invasive mechanical ventilation compared with patients receiving standard of care and placebo.
Positive results of the LIVE-AIR study were published in The Lancet Respiratory Medicine, https://www.thelancet.com/journals/lanres/article/PIIS2213-2600(21)00494-X/fulltext. The Lancet publication concluded that lenzilumab treatment of patients with COVID-19 can improve the likelihood of survival without the need for mechanical ventilation, with a safety profile comparable to placebo.
Completed enrollment of the Phase 2/3 ACTIV-5/BET-B study, sponsored by the National Institute of Allergy and Infectious Diseases, part of the National Institutes of Health, and enrolled over 400 patients in the primary analysis population (patients with a C-reactive protein level at baseline of less than 150mg/L).
FDA has guided that, if the trial is successful, the company can include the results from ACTIV-5/BET-B in an amended Emergency Use Authorization (EUA) submission for lenzilumab for the treatment of patients with COVID-19.
Lenzilumab in DLBCL, NHL, aGvHD, and CMML
Announced positive data from the Phase 1b portion of ZUMA-19, evaluating the efficacy and safety of lenzilumab in patients treated with CAR-T in diffuse large B-cell lymphoma (DLBCL). At the recommended Phase 2 dose of lenzilumab, the overall response rate (ORR) was 100% and no patient experienced severe neurotoxicity (NT) or severe cytokine release syndrome (CRS).
FDA provided guidance on the registration pathway for lenzilumab for the prevention of CAR-T therapy related toxicities including Immune Effector Cell-Associated Neurotoxicity (ICANS), which Humanigen intends to study in the registrational Phase 3 SHIELD study.
Planning to enroll the first patient in the first half of 2022 in a Phase 2/3, potentially registrational study (the RATinG study) to evaluate lenzilumab in the treatment of aGvHD at IMPACT Partnership stem cell transplant centers across the UK.
First patient dosed in Phase 2 study of lenzilumab (the PREACH-M study) in patients with Chronic Myelomonocytic Leukemia (CMML), sponsored by the company’s Australian partners.
2022 Objectives Include:
Announcing topline results from ACTIV-5/BET-B in COVID-19
Filing amended EUA with FDA for lenzilumab in COVID-19 in the US
Responding to MHRA requests for additional information on lenzilumab for the CMA in COVID-19 in the UK
Filing CMA for lenzilumab in COVID-19 under Accelerated Approval with EMA in the EU
Commencing shipments under LenzMAP, the lenzilumab managed access program for COVID-19 in the UK and multiple European countries
Continuing enrollment in the PREACH-M CMML study in Australia
Initiating the SHIELD Phase 3 registrational CAR-T study in the US
Initiating the RATinG Phase 2/3 potentially registrational aGvHD study in the UK
Initiating the C-SMART (COVID in cancer patients) study in Australia
Year Ended December 31, 2021 Financial Results
Net loss for the year ended December 31, 2021 was $236.6 million or $4.04 per share as compared to $89.5 million or $2.42 per share for the year ended December 31, 2020. The increase in net loss for the year was due to an increase in total expenses, mainly Research and Development (R&D) expense. R&D expense increased $140.4 million from $72.7 million for the year ended December 31, 2020, to $213.1 million for the year ended December 31, 2021. The increase is primarily due to an increase of $143.9 million in lenzilumab manufacturing costs, including consulting fees, and a $1.7 million increase in internal costs, primarily compensation-related, partially offset by a $5.2 million reduction in clinical trial expenses for lenzilumab.
Cash and Cash Equivalents
Net cash used in operating activities, net of balance sheet changes, was $184.0 million for the year ended December 31, 2021. During the year ended December 31, 2021, the company raised net proceeds of $65.7 million from the sale of shares of common stock under its At-the-Market offering program, drew $25.0 million under its credit facility with Hercules Capital, which provided net proceeds of $24.4 million, and completed a public offering of common stock with net proceeds of $94.2 million. As of December 31, 2021, the company had cash and cash equivalents of $70.0 million. Subsequent to December 31, 2021, the company raised net proceeds of approximately $3.7 million under its At-the-Market offering program.
A summary of key financial highlights as of and for the years ended December 31, 2021 and 2020 is as follows ($ in thousands):