Humanigen Announces Peer-Reviewed Publication in The Journal of Medical Economics Demonstrating the Clinical and Economic Benefits of Lenzilumab

Humanigen, Inc. (Nasdaq: HGEN) (“Humanigen”), a clinical-stage biopharmaceutical company focused on preventing and treating an immune hyper-response called ‘cytokine storm,’ today announced a peer-reviewed publication in the Journal of Medical Economics (https://www.tandfonline.com/doi/full/10.1080/13696998.2022.2030148) citing the clinical and associated health economic benefits of lenzilumab. The publication demonstrated, in all cases, lenzilumab plus SOC improved all specified clinical outcomes compared with SOC alone. Lenzilumab plus SOC, resulted in an estimated cost savings of $13,190 per patient (net savings of $3,190, after an assumed price of $10,000 for lenzilumab) in those receiving remdesivir with baseline C-Reactive Protein (CRP) levels <150 mg/L, and aged <85 years, the primary analysis population in the fully enrolled ACTIV-5/BET-B study. In other subpopulations, per-patient savings were also observed, including those aged <85 years with baseline CRP <150mg/L with or without remdesivir (cost savings = $11,858, net cost savings = $1,858) and within the subpopulation of Black/African American patients with baseline CRP <150mg/L (cost savings = $23,154, net cost savings = $13,154).

“This publication demonstrates the opportunity to realise significant cost savings for healthcare systems, while also improving outcomes for patients,” said Dr. Adrian Kilcoyne, Chief Medical Officer, Humanigen. “With the current omicron surge, the importance of variant-agnostic and both clinically effective and cost-effective therapies is paramount.”

This peer-reviewed publication highlights the significant costs of treating hospitalized COVID-19 patients and the economic benefits of potentially improving survival without ventilation, ventilator use, time to recovery, mortality, time in the ICU, and time to invasive mechanical ventilation, which may be associated with adding lenzilumab to standard of care from the US hospital perspective.

“During these unprecedented and challenging times, we are preparing to commercialize lenzilumab as a single day treatment which is variant-agnostic and, if authorized, a driver of clinical and economic value to patients and healthcare systems,” said Edward P. Jordan, Chief Commercial Officer, Humanigen.

About Humanigen

Lenzilumab is an investigational product and is not approved or authorized in any country.

Humanigen, Inc. (Nasdaq: HGEN) (“Humanigen”), is a clinical-stage biopharmaceutical company focused on preventing and treating an immune hyper-response called ‘cytokine storm’. Lenzilumab is a first-in class antibody that binds to and neutralizes granulocyte-macrophage colony-stimulating factor (GM-CSF). Results from preclinical models indicate GM-CSF is an upstream regulator of many inflammatory cytokines and chemokines involved in the cytokine storm. Early in the COVID-19 pandemic, investigation showed high levels of GM-CSF secreting T cells were associated with disease severity and intensive care unit admission. Humanigen’s Phase 3 LIVE-AIR study suggests early intervention with lenzilumab may prevent consequences of a full-blown cytokine storm in hospitalized patients with COVID-19. Humanigen is developing lenzilumab as a treatment for cytokine storm associated with COVID-19 and CD19-targeted CAR-T cell therapies and is also exploring the effectiveness of lenzilumab in other inflammatory conditions such as acute Graft versus Host Disease in patients undergoing allogeneic hematopoietic stem cell transplantation, eosinophilic asthma, and rheumatoid arthritis. The PREACH-M study in chronic myelomonocytic leukemia being conducted at 5 centers in Australia has begun dosing patients. Both the SHIELD study in CAR-T and the RATinG study in acute Graft versus Host Disease (aGvHD) are planned to begin enrolling in the first half of 2022, in the US and the UK respectively. Additional COVID studies which will be completed or initiated in 2022 include the NIH-sponsored ACTIV-5/BET-B study in the US and Korea and the C-SMART study being conducted in Australia. All are late-stage, clinical studies. In addition, Humanigen is progressing a Phase 1 program focused on ifabotuzumab in solid tumors.