Humanigen Reports Year-End 2021 Financial Results
Humanigen, Inc. (Nasdaq: HGEN) reported a net loss of $236.6 million for 2021, up from $89.5 million in 2020, primarily due to $213.1 million in R&D expenses, including significant manufacturing costs for lenzilumab, which aims to treat COVID-19 and other conditions. The company completed its LIVE-AIR study, demonstrating a 54% improved likelihood of survival without invasive ventilation for COVID-19 patients treated with lenzilumab. With key studies ongoing, Humanigen anticipates filing for emergency use authorization for lenzilumab in late Q1 or early Q2 2022.
- Completed the LIVE-AIR study showing a 54% improved survival likelihood without invasive ventilation for lenzilumab in COVID-19 patients.
- Positive data published in The Lancet Respiratory Medicine reinforces lenzilumab's potential effectiveness.
- FDA indicated lenzilumab's ACTIV-5/BET-B trial results could be included in an amended EUA submission.
- Net loss increased to $236.6 million for 2021 compared to $89.5 million in 2020.
- R&D expenses rose significantly to $213.1 million, primarily due to lenzilumab manufacturing costs.
“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
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 theNational 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 theUK . - 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
Net loss for the year ended
Cash and Cash Equivalents
Net cash used in operating activities, net of balance sheet changes, was
A summary of key financial highlights as of and for the years ended
Three Months Ended |
|
Year Ended |
||||||||||||||
2021 |
|
2020 |
|
2021 |
|
2020 |
||||||||||
License revenue | $ | 1,037 |
$ | 312 |
$ | 3,595 |
$ | 312 |
||||||||
|
|
|
|
|||||||||||||
Research and development | 29,358 |
28,495 |
213,115 |
72,713 |
||||||||||||
General and administrative | 4,024 |
4,112 |
23,252 |
15,797 |
||||||||||||
|
|
|
||||||||||||||
Loss from operations |
(32,345 |
) |
(32,295 |
) |
(232,772 |
) | (88,198 |
) | ||||||||
|
|
|
|
|||||||||||||
Net loss | $ | (33,540 |
) | $ | (32,295 |
) | $ | (236,649 |
) | $ | (89,535 |
) | ||||
|
|
|
|
|||||||||||||
Net loss per common share | $ | (0.53 |
) | $ | (0.63 |
) | $ | (4.04 |
) | $ | (2.42 |
) | ||||
|
|
|
|
|||||||||||||
Weighted average common shares | 63,136,915 |
51,619,695 |
58,533,637 |
36,963,030 |
|
|
|||||
Cash and cash equivalents | $ | 70,016 |
|
$ |
67,737 |
|
|
|
|
||||
Current assets | $ | 70,971 |
|
$ |
68,212 |
|
|
|
|
||||
Current liabilities | 68,725 |
|
|
20,415 |
||
|
|
|
||||
Working capital | $ | 2,246 |
|
$ |
47,797 |
About
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: Humanigen’s beliefs as to the potential benefits of lenzilumab as a treatment for hospitalized COVID-19 patients; the timeline for announcement of release of topline results from the ACTIV-5/BET-B study being conducted by
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 conduct its business as a going concern; its dependence on partners to further the development of its product candidates; the uncertainties inherent in the development, attainment of the requisite regulatory authorizations and approvals (including EUA in
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. The Company undertakes no obligation to revise or update any forward-looking statements made in this press release 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.
View source version on businesswire.com: https://www.businesswire.com/news/home/20220228005253/en/
Humanigen Investor Relations
tmorris@humanigen.com
Source:
FAQ
What were Humanigen's financial results for 2021?
What is the purpose of the lenzilumab study completed by Humanigen?
When does Humanigen expect to announce topline data for lenzilumab?