UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

 

FORM 8-K

 

CURRENT REPORT

 

Pursuant to Section 13 or 15(d) of
the Securities Exchange Act of 1934

 

Date of Report (Date of earliest event reported): March 29, 2021

Humanigen, Inc.

(Exact name of registrant as specified in its charter)

 

Delaware   001-35798   77-0557236
(State or other Jurisdiction of
Incorporation)
  (Commission File No.)  

(IRS Employer Identification No.)

 

 

533 Airport Boulevard, Suite 400

Burlingame, CA 94010

(Address of principal executive offices, including zip code)

 

(650) 243-3100

(Registrant’s telephone number, including area code)

 

(Former Name or Former Address, if Changed Since Last Report)

 

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions (see General Instruction A.2):

 

¨ Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

 

¨ Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

 

¨ Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

 

¨ Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

 

Securities registered pursuant to Section 12(b) of the Act:

 

Title of each class Trading Symbol(s) Name of each exchange on which registered
Common Stock HGEN The Nasdaq Stock Market LLC

 

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (17 CFR §230.405) or Rule 12b-2 of the Securities Exchange Act of 1934 (17 CFR §240.12b-2).

 

Emerging growth company ¨

 

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐

 

     
 

 

Item 7.01.

Regulation FD Disclosure

 

On March 29, 2021, Humanigen, Inc. (the “Company”) issued a press release announcing top-line data from its pivotal Phase 3 trial of lenzilumabTM in patients hospitalized with COVID-19. A copy of the press release is attached hereto as Exhibit 99.1 and is incorporated herein by reference.

 

On March 29, 2021, the Company hosted a conference call for investors and other interested stakeholders to discuss the top-line data from the Phase 3 lenzilumab trial. A copy of the presentation materials discussed on the conference call is furnished as Exhibit 99.2 to this report. A copy of the presentation is also available on the Company's website, www.humanigen.com.

 

Cautionary Note Regarding Forward-Looking Statements

 

This Current Report on Form 8-K, including Exhibit 99.1 and Exhibit 99.2, contains forward-looking statements. Forward-looking statements reflect management's current knowledge, assumptions, judgment and expectations regarding future performance or events. Although management believes that the expectations reflected in such statements are reasonable, they give no assurance that such expectations will prove to be correct and you should be aware that actual events or results may differ materially from those contained in the forward-looking statements. Words such as “will,” “expect,” “intend,” “plan,” “potential,” “possible,” “goals,” “accelerate,” “continue,” and similar expressions identify forward-looking statements, including, without limitation, statements regarding the Company’s expectations regarding the timeline to file for and potential to obtain emergency use authorization (EUA) and a Biologics License Application (BLA) for lenzilumab as a COVID-19 therapy. These forward-looking statements are subject to a number of risks and uncertainties including, but not limited to, the risks inherent in the Company’s lack of profitability and need for additional capital to grow its business; the Company’s dependence on partners to further the development of its product candidates; the uncertainties inherent in the development, attainment of the requisite regulatory approvals or authorization for emergency or broader patient use for lenzilumab and launch of lenzilumab; challenges associated with the manufacturing of lenzilumab, and potential changes to the schedule for such manufacturing efforts; the outcome of pending or future litigation; and the various risks and uncertainties described in the “Risk Factors” sections and elsewhere in the Humanigen's periodic and other filings with the Securities and Exchange Commission.

 

All forward-looking statements are expressly qualified in their entirety by this cautionary notice. You should not place undue reliance on any forward-looking statements, which speak only as of the date of this filing. The Company undertakes no obligation to revise or update any forward-looking statements made in this filing to reflect events or circumstances after the date hereof or to reflect new information or the occurrence of unanticipated events, except as required by law.

 

Certain Information

 

The information in this Item 7.01, including Exhibit 99.1 and Exhibit 99.2, is being furnished pursuant to Item 7.01 of Form 8-K and shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended, or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference into any of the Company’s filings under the Securities Act of 1933, as amended, except to the extent expressly set forth by specific reference in such a filing.

 

     
 

 

Item 9.01. Financial Statements and Exhibits

 

(d) Exhibits

 

Exhibit No. Exhibit Description
   
99.1 Press release, dated March 29, 2021
99.2 Phase 3 Top-Line Results Presentation

 

     
 

 

SIGNATURES

 

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

 

 

  Humanigen, Inc.
   
   
  By:  /s/ Cameron Durrant  
    Name: Cameron Durrant
Title:   Chairman of the Board and Chief Executive Officer

 

Dated: March 29, 2021

 

 

 

 

 

 

 

Exhibit 99.1

 

Humanigen Reports Positive Phase 3 Topline Results Demonstrating That Lenzilumab™ Improves Survival Without Need for Mechanical Ventilation in Hospitalized Patients With COVID-19

 

· Lenzilumab improved the relative likelihood of survival without need for invasive mechanical ventilation (IMV) by 54%, achieving the primary endpoint of the Phase 3 study
· Clinical improvement was observed over and above other treatments, including steroids and/or remdesivir

 

 

 

BURLINGAME, Calif.--(BUSINESS WIRE)--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, today announced positive topline results from its Phase 3 clinical trial evaluating the efficacy and safety of lenzilumab in patients hospitalized with COVID-19. Trial results 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 IMV compared with patients receiving placebo and other treatments. These results are statistically significant.

 

     
 

 

“The results from our Phase 3 clinical trial with lenzilumab treatment were associated with better outcomes in hospitalized hypoxic COVID-19 patients who had not yet progressed to the point of requiring IMV,” said Cameron Durrant, MD, MBA, Chief Executive Officer, Humanigen. “Additionally, the trial incorporated a diverse population with various comorbidities, most commonly a body mass index above 30, which is representative of a real-world, high-risk population. Our next step is to submit an application for Emergency Use Authorization (EUA) to the Food and Drug Administration (FDA) as soon as possible. We are also sharing these results with US governmental agencies and other authorities worldwide.”

 

“Mayo Clinic is pleased to have been part of the investigation of lenzilumab from the earliest days of the development program in COVID-19 and are excited by these data,” said Andrew Badley, MD, Professor of Infectious Diseases, and Professor and Chair of the Department of Molecular Medicine at Mayo Clinic. “If lenzilumab is authorized for emergency use by FDA, and based on our clinical trial experience to date, it may then be considered a part of our treatment armamentarium for newly hospitalized patients with COVID-19.”

 

Study results demonstrate that lenzilumab significantly improved patient outcomes. The study achieved its primary endpoint of ventilator-free survival measured through day 28 following treatment (HR: 1.54; 95%CI: 1.03-2.33, p=0.0365). Ventilator-free survival is a validated and reliable measure used in studies that evaluate respiratory distress.1 The Kaplan-Meier estimate for IMV and/or death was 15.6% (95%CI: 11.5-21.0) in the lenzilumab arm versus 22.1% (95%CI: 17.4-27.9) in the placebo arm, representing a 54% improvement in the relative likelihood of survival without the need for IMV. Although this study was not powered to demonstrate a difference in mortality, a favorable trend in mortality was observed: 9.6% (95%CI: 6.4-14.2) in the lenzilumab arm compared with 13.9% (95%CI: 10.1-19.0) in the placebo arm (HR: 1.39; 95%CI: 0.82-2.39; p=0.2287). Approximately 88% of patients received dexamethasone (or other steroids), 62% received remdesivir, and 57% received both, balanced across both arms of the study. Serious adverse events (SAEs) were balanced in both study arms and the SAE profile was similar to that previously documented in prior lenzilumab studies. In this study, lenzilumab appeared to be safe and well-tolerated; no new SAEs were identified, and none were attributed to lenzilumab.

 

“The data strongly suggest that lenzilumab improved outcomes for hospitalized patients with COVID-19 pneumonia,” said Zelalem Temesgen, MD, Professor of Medicine at Mayo Clinic and Principal Investigator of the Phase 3 trial. “The dosing regimen used in this study was specifically designed for hospitalized patients with COVID-19 pneumonia as a potential foundational therapy. Lenzilumab could make the difference between going on a ventilator, which reduces one’s chance of survival, and leaving the hospital alive.”

 

     
 

 

“It is impressive to see lenzilumab achieve this milestone. At Emory University, a key center in the National Institutes of Health (NIH) ACTIV-5 study, which is currently enrolling, we are hopeful that lenzilumab will emerge as a valuable therapy for newly hospitalized patients. We believe there may be future opportunities to study lenzilumab in even larger trials, and further explore lenzilumab’s impact on mortality rates,” added Vincent Marconi, MD, Professor of Medicine at Emory University School of Medicine.

 

About the Lenzilumab Phase 3 Study

 

This study was a randomized, double-blind, placebo-controlled, multi-center Phase 3 trial for the treatment and prevention of serious and potentially fatal outcomes in patients who were hospitalized with COVID-19 pneumonia. The primary objective was to assess whether lenzilumab, in addition to other treatments, which included dexamethasone (or other steroids) and/or remdesivir, could alleviate the immune-mediated cytokine release syndrome (CRS) and improve ventilator-free survival. Ventilator-free survival is a composite endpoint of time to death and time to IMV, which is a robust measure that is less prone to favor a treatment with discordant effects on survival or days free of ventilation.1 The trial enrolled 520 patients in 29 sites in the US and Brazil who were at least 18 years of age; experienced blood oxygen saturation (SpO2) of less than or equal to 94%; or required low-flow supplemental oxygen, or high-flow oxygen support, or non-invasive positive pressure ventilation (NIPPV); and were hospitalized but did not require IMV. Following enrollment, subjects were randomized to receive three infusions of either lenzilumab or placebo, each infusion separated by eight hours over a 24-hour period with other treatments. The primary endpoint was the difference between lenzilumab treatment and placebo treatment in ventilator-free survival through 28 days following treatment. Key secondary endpoints, also measured through 28 days, included ventilator-free days, duration of ICU stay, incidence of invasive mechanical ventilation, extracorporeal membrane oxygenation (ECMO), and/or death, time to death, all-cause mortality, and time to recovery. Results of the trial are planned to be submitted for potential publication in a peer-reviewed journal.

 

     
 

 

About Humanigen, Inc.

 

Humanigen, Inc. is developing its portfolio of clinical and pre-clinical therapies for the treatment of cancers and infectious diseases via its novel, cutting-edge GM-CSF neutralization and gene-knockout platforms. Humanigen’s immediate focus is to prevent or minimize cytokine release syndrome that precedes severe lung dysfunction in hospitalized and hypoxic patients with COVID-19 pneumonia. Humanigen is also working to create next-generation combinatory gene-edited CAR-T therapies using strategies to improve efficacy while employing GM-CSF gene knockout technologies to control toxicity. In addition, Humanigen is developing its own portfolio of proprietary first-in-class EphA3-CAR-T for various solid cancers and EMR1-CAR-T for various eosinophilic disorders. Humanigen is also exploring the effectiveness of its GM-CSF neutralization technologies (either through the use of lenzilumab as a neutralizing antibody or through GM-CSF gene knockout) in combination with other CAR-T, bispecific or natural killer (NK) T-cell-engaging immunotherapy treatments to break the efficacy/toxicity linkage, including to prevent and/or treat Graft versus Host Disease (GvHD) in patients undergoing allogeneic hematopoietic stem cell transplantation (HSCT). Additionally, Humanigen and Kite, a Gilead Company, are evaluating lenzilumab in combination with Yescarta® (axicabtagene ciloleucel) in patients with relapsed or refractory large B-cell lymphoma in a clinical collaboration. For more information, visit www.humanigen.com and follow Humanigen on LinkedIn, Twitter, and Facebook.

 

Humanigen Forward-Looking Statements

 

All statements other than statements of historical facts contained in this press release are forward-looking statements. Forward-looking statements reflect management's current knowledge, assumptions, judgment, and expectations regarding future performance or events. Although management believes that the expectations reflected in such statements are reasonable, they give no assurance that such expectations will prove to be correct, and you should be aware that actual events or results may differ materially from those contained in the forward-looking statements. Words such as "will," "expect," "intend," "plan," "potential," "possible," "goals," "accelerate," "continue," and similar expressions identify forward-looking statements, including, without limitation, statements regarding our potential request for and receipt of an Emergency Use Authorization from FDA for lenzilumab in COVID-19; and our other plans relating to lenzilumab as a result of the release of the topline results.

 

Forward-looking statements are subject to a number of risks and uncertainties including, but not limited to, the risks inherent in our lack of profitability and need for additional capital to grow our business; our dependence on partners to further the development of our product candidates; the uncertainties inherent in the development, attainment of the requisite regulatory authorizations and approvals and launch of any new pharmaceutical product; the outcome of pending or future litigation; and the various risks and uncertainties described in the "Risk Factors" sections of our latest annual and quarterly reports and other filings with the SEC.

 

     
 

 

All forward-looking statements are expressly qualified in their entirety by this cautionary notice. You should not rely upon any forward-looking statements as predictions of future events. We undertake no obligation to revise or update any forward-looking statements made in this presentation to reflect events or circumstances after the date hereof, to reflect new information or the occurrence of unanticipated events, to update the reasons why actual results could differ materially from those anticipated in the forward-looking statements, in each case, except as required by law.

 

For media resources, including product images and fact sheet, please click here.

 

___________________________

 

1 Novack V, Beitler JR, Yitshak-Sade M, Thompson BT, Schoenfeld DA, Rubenfeld G, et al. Alive and Ventilator Free: A Hierarchical, Composite Outcome for Clinical Trials in the Acute Respiratory Distress Syndrome. Critical care medicine. 2020;48(2):158-66

 

Contacts

 

Humanigen Media
Grace Catlett
RXMD
Gcatlett@rxmedyn.com
516-318-8563

 

Humanigen Investors
Alan Lada
Solebury Trout
ALada@SoleburyTrout.com
617-221-8006

 

 

 

 

 

 

Exhibit 99.2

  

Humanigen Lenzilumab Phase 3 Results 3.29.21

 

 
 

2 Cautionary Note Regarding Forward - Looking Statements All statements other than statements of historical facts contained in this presentation are forward - looking statements . Forward - looking statements reflect management's current knowledge, assumptions, judgment, and expectations regarding future performance or events . Although management believes that the expectations reflected in such statements are reasonable, they give no assurance that such expectations will prove to be correct, and you should be aware that actual events or results may differ materially from those contained in the forward - looking statements . Words such as "will," "expect," "intend," "plan," "potential," "possible," "goals," "accelerate," "continue," and similar expressions identify forward - looking statements, including, without limitation, statements regarding our potential request for and receipt of an Emergency Use Authorization from FDA for lenzilumab in COVID - 19 ; and our other plans relating to lenzilumab as a result of the release of the topline results . Forward - looking statements are subject to a number of risks and uncertainties including, but not limited to, the risks inherent in our lack of profitability and need for additional capital to grow our business ; our dependence on partners to further the development of our product candidates ; the uncertainties inherent in the development, attainment of the requisite regulatory authorizations and approvals and launch of any new pharmaceutical product ; the outcome of pending or future litigation ; and the various risks and uncertainties described in the "Risk Factors" sections of our latest annual and quarterly reports and other filings with the SEC . All forward - looking statements are expressly qualified in their entirety by this cautionary notice . You should not rely upon any forward - looking statements as predictions of future events . We undertake no obligation to revise or update any forward - looking statements made in this presentation to reflect events or circumstances after the date hereof, to reflect new information or the occurrence of unanticipated events, to update the reasons why actual results could differ materially from those anticipated in the forward - looking statements, in each case, except as required by law .

 

 
 

3 Lenzilumab Overview Lenzilumab is administered intravenously in three equal infusions completed in a single day Humaneered ® Best - in - Class Antibody x Neutralizes GM - CSF to prevent and treat Cytokine Storm x Reduced immunogenicity x Highest binding affinity x Slowest off - rate Dosing Regime x Specifically designed to neutralize GM - CSF both in serum and lung tissue to prevent and treat Cytokine Storm x Adequate tissue concentration for 7 days to halt Cytokine Storm and associated inflammation Convenient Care x For newly hospitalized patients with SARS - CoV - 2 pneumonia, pre - IMV x Administered intravenously in 3 doses, 8 hours apart, in a single day x Potential foundational therapy to which other treatments can be added Lenzilumab is the first and only COVID - 19 therapy to improve ventilator - free survival when added to other treatments, including steroids and/or remdesivir, in a randomized, double - blind, placebo - controlled, multi - center Phase 3 clinical trial Lenzilumab is a dual - action therapy, which may dampen the harmful inflammatory response and safely replenish T - Cells in newly hospitalized and hypoxic COVID - 19 patients who may have received other COVID - 19 therapies Lenzilumab is safe and well - tolerated in clinical trials

 

 
 

4 GM - CSF: A Driver of COVID - 19 • UK government - funded, independent study linked GM - CSF to severe COVID - 19 • Largest confirmatory inflammatory mediator study conducted to date • GM - CSF associated with inflammatory and thrombotic consequences of the immune response • GM - CSF levels detected in first 4 days correlated with disease severity • GM - CSF levels 10x higher in patients who died from COVID - 19 • Elevated levels of GM - CSF associated with risk factors for severe COVID - 19 (age and diabetes) March 10, 2021

 

 
 

5 Lenzilumab Phase 3 Study Design Early intervention with lenzilumab to prevent and treat Cytokine Storm and prevent progression to invasive mechanical ventilation (IMV) and/or death • Randomized , double - blind, placebo - controlled, multi - center pivotal trial NCT 04351152 • All subjects received other treatment, which may have included corticosteroids and/or remdesivir Primary Endpoint: ▪ Ventilator - free survival Key Secondary Endpoints: ▪ Ventilator - free days* ▪ Duration of ICU stay* ▪ Survival ▪ Time to recovery * • Adults ≥ 18 years • Hospitalized • Confirmed SARS - CoV - 2 COVID - 19 pneumonia • SpO 2 ≤ 94% and pre - IMV • Concomitant medications included steroids (88%), remdesivir (62%) or both (57%) Follow - up Assessment Day 60 Enrollment Screening Randomization Lenzilumab, 600 mg IV Q8H x3 Day 1 Placebo IV Q8H x3 Treatment Phase Follow - up Phase Daily assessments while hospitalized Endpoint Assessment Through Day 28 Evaluated through Day 28 * Secondary endpoints undergoing evaluation

 

 
 

6 Demographics and Baseline Characteristics ( mITT Population) Characteristics Lenzilumab (N=236) Placebo (N=243) Overall (N=479) Age Mean (SD) 60.5 (13.5) 60.5 (14.3) 60.5 (13.9) Median (Min - Max) 62.0 (28 - 98) 62.0 (22 - 96) 62.0 (22 - 98) < 65 years old (%) 60.2 58.4 59.3 ≥65 years old (%) 39.8 41.6 40.7 Gender Male (%) 64.8 64.6 64.7 Ethnicity Hispanic or Latino (%) 35.2 42.0 38.6 Not Hispanic or Latino (%) 64.0 56.8 60.3 Race White (%) 69.9 73.3 71.6 Black or African American (%) 16.1 13.6 14.8 Asian (%) 4.2 2.1 3.1 American Indian / Alaska Native (%) 1.7 0.0 0.8 Other (%) 8.1 11.0 9.7 Body Mass Index Median (Min - Max) 31.5 (20.3 - 75.5) 30.5 (18.3 - 75.2) 31.1 (18.3 - 75.5) ≥30 Kg/m 2 (%) 57.6 52.7 55.1 Clinical Status at Baseline SpO 2 ≤ 94% or low - flow oxygen (%) 61.9 57.6 59.7 High - flow oxygen or NIPPV (%) 38.1 42.4 40.3

 

 
 

7 Primary Endpoint: Ventilator - Free Survival ( mITT Population) Endpoint Hazard Ratio (95%CI) Lenzilumab vs Placebo Kaplan - Meier Event Estimate (95%CI) Lenzilumab Placebo p value 1 ° Ventilator - Free Survival (%) 1.54 (1.03 – 2.33) 15.6 (11.5 – 21.0) 22.1 (17.4 – 27.9) 0.0365 2 ° Survival (%) 1.39 (0.82 – 2.39) 9.6 (6.4 – 14.2) 13.9 (10.1 – 19.0) 0.2287 60 65 70 75 80 85 90 95 100 0 2 4 6 8 10 12 14 16 18 20 22 24 26 28 Ventilation - Free Survival (%, KM Estimate) Time (Days) Lenzilumab 236 (100) 227 (96) 216 (92) 208 (88) 199 (84) 196 (83) 194 (82) 193 (82) Placebo 243 (100) 226 (93) 204 (84) 191 (79) 188 (77) 185 (76) 185 (76) 184 (76) Patients at Risk: n (%) Lenzilumab Placebo 0

 

 
 

8 Ventilator - Free Survival: A Surrogate for Survival Ventilator - free survival may act as a surrogate e ndpoint for survival • Hazard ratio (HR) for ventilator - free survival approximates the HR for survival in the RECOVERY studies • Ventilator - free survival may provide a signal of survival benefit with fewer patients • Ventilator - free survival is a robust measure less prone to favor a treatment with discordant effects on survival and days free of ventilation ‡ Only large trials can determine mortality † • Dexamethasone > 6 , 100 patients • Tocilizumab > 4 , 100 patients Treatment Ventilator - Free Survival Increased Likelihood of Survival Hazard Ratio Without IMV Survival Increased Likelihood Hazard Ratio of Survival RECOVERY TRIAL* Dexamethasone* 1.15 15% 1.16 16% Tocilizumab* 1.18 18% 1.14 14% HUMANIGEN PHASE 3 TRIAL Lenzilumab 1.54 (SS) 54% 1.39 39% (NS) SS – Statistically significant NS – Not statistically significant

 

 
 

9 Safety: Balanced Between Treatment Arms Characteristics Lenzilumab (N=255) Subjects n, % Placebo (N=257) Subjects n, % Overall (N=512) Subjects n, % Serious Adverse Events 63 (24.7) 76 (29.6) 139 (27.1) Respiratory 60 (23.5) 67 (26.1) 127 (24.8) Cardiac 12 (4.7) 13 (5.1) 25 (4.9) Infection/Infestation 9 (3.5) 9 (3.5) 18 (3.5) Vascular 5 (2.0) 10 (3.9) 15 (2.9) General / Administration Site 3 (1.2) 9 (3.5) 12 (2.3) Renal and Urinary 3 (1.2) 8 (3.1) 11 (2.1) Gastrointestinal 1 (0.4) 3 (1.2) 4 (0.8) Nervous System 1 (0.4) 3 (1.2) 4 (0.8) Blood and Lymphatic 1 (0.4) 0 (0) 1 (0.2)

 

 
 

10 Summary COVID - 19 • Neutralizes GM - CSF, a driver of Cytokine Storm • Prevents and treats Cytokine Storm to reduce progression to IMV and/or death • For newly hospitalized and hypoxic patients with COVID - 19 pneumonia • Convenient dosing regimen to which other treatments, including steroids and/or remdesivir, can be added • Favorable safety profile with no treatment - related serious adverse events reported • Dosing regimen specifically designed to neutralize GM - CSF in both serum and lung to prevent Cytokine Storm induced by COVID - 19 and other triggers Potential for broad application across multiple indications • Favorable safety profile • Ability to establish novel combination regimens with potential best - in - class profiles • Utility across the immunology/inflammation, immuno - oncology, and cell therapy space

 

 
 

11 Timeline 2021 Topline COVID - 19 Phase 3 Results Pre - EUA Meetings With FDA EUA Application EUA Granted Assuming Emergency Use Authorization by FDA Lenzilumab Distribution Update CMC ACTIV - 5 March 29, 2021 Submit BLA

 

 
 

12 Humanigen Lenzilumab Phase 3 Results