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Humanigen Rings the Nasdaq Opening Bell

November 24, 2020

Recent News

Humanigen Announces Cooperative Research and Development Agreement with the U.S. government to Develop Lenzilumab for COVID-19

  • The Cooperative Research and Development Agreement (CRADA) with the Department of Defense (DoD) supports the development of lenzilumab as a potential treatment for patients with Covid-19

  • Humanigen’s development efforts complemented by full-scale, integrated team of federal leading experts dedicated to advancing lenzilumab ahead of a potential Emergency Use Authorization (EUA) submission


Webcast slide deck available for download (PDF, 1 MB)

Humanigen Announces Positive Interim Phase 3 Data of Lenzilumab™ in Patients Hospitalized with COVID-19

  • Interim data suggest clinically meaningful impact on patient recovery from COVID-19 with an estimated 37 percent more recoveries observed in lenzilumab arm of Phase 3 trial versus current standard of care

  • Data safety monitoring board recommendation demonstrates the Phase 3 trial is in the “promising zone” of the adaptive trial design

  • CRADA between Humanigen and U.S. government provides for regulatory and other support to submit an EUA and BLA

Humanigen Executes Licensing Agreement for Lenzilumab™ in COVID-19 with KPM Tech/Telcon RF Pharmaceutical for South Korea and the Philippines

  • Agreement provides Humanigen up to US$20 million in milestones and double-digit royalties on product sales

  • Transaction supports the Humanigen Asia-Pacific regional corporate development strategy

Humanigen Announces First Patient Dosed in NIH ACTIV-5/Big Effect Trial Evaluating Lenzilumab™ for COVID-19

  • First patient dosed at the Emory University School of Medicine in Atlanta, Georgia

  • Trial will evaluate lenzilumab with remdesivir, compared to placebo and remdesivir, in up to 200 patients hospitalized with COVID-19

"Lenzilumab is among 19 'front runners' among the more than 300 drug and vaccine candidates tracked on GEN’s COVID-19 Drug & Vaccine Candidate Tracker."

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Fox Video: Humanigen CEO Discusses Lenzilumab on Tucker Carlson Tonight

October 2nd, 2020

Humanigen Announces COVID-19 Case Report Demonstrating Rapid Resolution and Discharge after Single IND Emergency Use Authorization of Lenzilumab™

  • Case report demonstrated rapid resolution of hypoxemia and mobility and potential benefit of lenzilumab beyond the initial acute hyper-inflammatory window

  • After 13 weeks of hospitalization, administration of lenzilumab resulted in rapid improvement in oxygenation and subsequent discharge

Humanigen Announces Lenzilumab in COVID-19 Program Updates

  • Type B meeting with FDA provided feedback on Emergency Use Authorization submission plans

  • Phase 3 trial expanded to Brazil with seven sites actively enrolling; patients already dosed

  • 17 active trial sites in the US, including California, Texas and Florida 

  • Approval from Mexican regulatory agency to expand study in country with fourth highest reported deaths worldwide

  • Top-line data planned for the fourth quarter of 2020

Humanigen Announces Thermo Fisher Partnership to Expand Manufacturing for COVID-19 Therapeutic Candidate Lenzilumab

  • Collaboration further strengthens manufacturing capabilities and capacity in advance of potential Emergency Use Authorization in 2020

Humanigen Announces Pricing of Public Offering of Common Stock and Commencement of Trading on Nasdaq Under the Symbol “HGEN”

Humanigen and Lonza Announce Collaboration to Expand Manufacturing of Humanigen's COVID-19 Therapeutic Candidate Lenzilumab

  • Collaboration to expand lenzilumab manufacturing capacity in advance of potential Emergency Use Authorization in 2020

  • Commercial manufacturing to begin in 2021 at Lonza's manufacturing facility at Hayward

  • The collaboration is projected to take lenzilumab through product launch and commercial supply

Humanigen to Host Investor KOL Conference Call

  • Conference call and webcast scheduled for Thursday, September 3 at 11:00 a.m. EDT

Lenzilumab COVID-19 Case-Control Study Published in Mayo Clinic Proceedings Journal

  • 80% reduction in relative risk of invasive mechanical ventilation and/or death in patients treated with lenzilumab compared to the control group

  • Median time to resolution of acute respiratory distress syndrome (ARDS) reduced to one day for patients treated with lenzilumab versus eight days in control group

  • Lenzilumab patients discharged from the hospital in less than half the time compared with control group

Humanigen to Host Investor Conference Call to Discuss NIH’s Selection of Lenzilumab for Big Effect Trial

Conference call and webcast hosted August 3, 2020 at 4:30 pm EDT

Humanigen Reports Additional Analysis of Lenzilumab in Severe and Critical COVID-19 Patients

  • Lenzilumab median time to recovery of five days compares favorably to remdesivir’s 10 days in a similar patient group

  • Lenzilumab Phase 3 potential registration study ongoing in severe and critical COVID-19 patients

  • Humanigen hosted a webinar on June 16th, 2020 to discuss results of the initial cohort of patients treated with lenzilumab

Mayo Clinic Study of Humanigen’s Lenzilumab Shows Rapid Recovery and Discharge in Severe and Critical COVID-19 Patients

  • Median time to recovery and discharge of five days

  • All patients were at high risk of progression, including four patients who were in the ICU prior to receiving lenzilumab

  • No treatment emergent adverse events were attributable to lenzilumab

Humanigen Announces $71,800,000 Equity Financing

  • J.P. Morgan Securities LLC acting as placement agent

  • Financing syndicate includes Venrock Healthcare Capital Partners, Surveyor Capital (a Citadel company), HealthCor, Valiant Capital Partners, First Light Asset Management and Ghost Tree Capital

First Patient Infused in Joint Humanigen/Kite, A Gilead Company Clinical Study

  • ZUMA-19 study being conducted as part of a clinical collaboration in the U.S.

  • Study evaluating the potential effects of lenzilumab (anti-human-GM-CSF monoclonal antibody) prior to Yescarta® (axicabtagene ciloleucel) in adults with relapsed or refractory large B-cell lymphoma

Kite and Humanigen Announce Clinical Collaboration to Evaluate Investigational Combination of Yescarta® (Axicabtagene Ciloleucel) with Lenzilumab in Relapsed/Refractory Diffuse Large B-Cell Lymphoma

  • GM-CSF has been identified, through clinical correlative analysis and preclinical modeling, as a potential key signal in the inflammatory cascade triggering toxicities associated with chimeric antigen receptor T (CAR T) cell therapy

  • Emerging pre-clinical evidence suggests that lenzilumab inhibition of GM-CSF may have the potential to disrupt CAR T cell mediated inflammation without disrupting CAR T cell anti-tumor efficacy

  • Phase 1/2 Multi-Center Clinical Trial to Begin Enrolling in Q4 2019

“This collaboration with Kite will help validate the work Humanigen has done in understanding the pathophysiology of the inflammatory cascade as well as the potential role GM-CSF plays in influencing CAR T cell treatment outcomes.”

Humanigen Study of GM-CSF Neutralization with CAR-T Therapy Selected for Front Cover of Current Edition of ‘blood’®, the Official Journal of the American Society of Hematology (ASH)

  • Enhanced anti-tumor activity, improved overall survival, and an exponential increase in CAR-T cell proliferation was observed with GM-CSF neutralization

  • Lenzilumab (an anti-GM-CSF antibody) used in combination with CAR-T significantly reduces neuro-inflammation, prevents cytokine release syndrome and improves durable control of leukemic disease

  • GM-CSF neutralization with lenzilumab is a next generation strategy to improve efficacy, safety and durability of CAR-T

“This work represents a significant advance in understanding and preventing toxicities after CAR-T cell therapy. Our results strongly suggest that modulating myeloid cell behavior through GM-CSF blockade helps control CAR-T cell mediated toxicities and reduce their immunosuppressive features to improve leukemic control.”

The link to the publication is available for review at:

https://doi.org/10.1182/blood-2018-10-881722

"The more original a discovery the more obvious it seems afterwards."

Arthur Koestler

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