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 (LENZ®), today provided a corporate update
and reported financial results for the first quarter ended March
31, 2022.
“A key highlight of the first quarter was the completion of
enrollment in the ACTIV-5/BET-B study. We also held a productive
Type B pre-EUA meeting with FDA where we gained alignment on the
data and statistical analysis plan to be included as part of the
amendment to our EUA for LENZ in COVID-19 patients. In concert with
the NIH, we anticipate top-line data in the primary analysis
population to be reported in the second quarter, with an amendment
to our EUA submission planned to follow,” stated Cameron Durrant,
Chairman and Chief Executive Officer, Humanigen. “We anticipate
hospitalizations from COVID-19 will continue for years to come.
Published data on LENZ, confirmed by key opinion leaders and
national guideline committees, including NIH, supports treatment
guidance based on CRP levels and first-line utilization in hypoxic
patients.”
“Hospitalizations from COVID-19 in the US continue to remain
steady with a 7-day average of 2,072 new daily hospitalizations.
While there have been more than 900,000 people already hospitalized
in the U.S. this year to date,1 synergizing results from multiple
forecasting models prepared by leading experts in epidemiology in
four different scenarios forecast additional COVID-19
hospitalizations in the United States, to range from approximately
500,000 to 1,200,000 for the remainder of 2022.2 Variant agnostic
treatments for hospitalized patients are still desperately needed,”
commented Edward Jordan, Chief Commercial Officer, Humanigen.
“As well as its clinical benefit in reducing invasive mechanical
ventilation and death, LENZ could deliver significant economic
savings to health care systems. LENZ can be used in combination
with remdesivir, which is currently used in 50% of hospitalized
COVID-19 patients in the U.S.3 Sales of the top two hospital
treatments for COVID-19 exceeded $7 billion in global revenue in
2021.4,5 We believe LENZ is well positioned to participate in this
sizable and sustainable market,” he added.
Lenzilumab is an investigational product and is not currently
authorized or approved in any country.
First Quarter and Recent Highlights:
Lenzilumab in COVID-19 patients
- 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).
- Gained alignment with the FDA during a Type B pre-EUA meeting
on the data and statistical analysis plan to be included in the
amendment to the EUA.
- Announced a peer-reviewed publication in ClinicoEconomics and
Outcomes Research outlining the potential clinical and health
economic benefits of lenzilumab, if authorized or approved for use
in the United Kingdom.
- First subject dosed in the PK study in Korea.
Lenzilumab in Development in Other Therapeutic Areas
- Gained alignment with the FDA on the protocol for the planned
registrational Phase 3 SHIELD study of lenzilumab for the
prevention of CAR-T therapy related toxicities including Immune
Effector Cell-Associated Neurotoxicity (“ICANS”), in which
Humanigen intends to enroll the first patient in the second
quarter.
- Announced a peer-reviewed publication in Leukemia, a leading
oncology and hematology journal, entitled “GM-CSF disruption in
CART cells modulates T cell activation and enhances CART cell
anti-tumor activity.”
- Notified by the University of Birmingham, UK, that the amended
Investigational Medicinal Product Dossier has been accepted by
Medicines & Healthcare products Regulatory Agency for the
“RATinG” study. Humanigen believes the first patient will be
enrolled in this Phase 2/3 potentially registrational trial for
lenzilumab to treat patients who have undergone allogeneic
hematopoietic stem cell therapy, who are at high and intermediate
risk for acute Graft versus Host Disease (“aGvHD”) in the second
quarter.
- Continued enrollment in the PREACH-M study of lenzilumab in
chronic myelomonocytic leukemia. Study sponsor planning for
expansion of clinical sites.
First Quarter Ended March 31, 2022 Financial Results
Net loss for the quarter ended March 31, 2022 was $21.3 million,
or $0.32 per share, as compared to $65.6 million, or $1.25 per
share, for the quarter ended March 31, 2021. The decrease in net
loss was due to a decrease in total expenses, mainly Research and
Development (“R&D”) expense. R&D expense decreased $42.7
million from $59.9 million for the three months ended March 31,
2021, to $17.2 million for the three months ended March 31, 2022.
The decrease is primarily due to a decrease of $35.7 million in
lenzilumab manufacturing costs.
Cash and Cash Equivalents
Net cash used in operating activities, net of balance sheet
changes, was $19.4 million for the quarter ended March 31, 2022.
During the first quarter of 2022, the company sold shares of its
common stock under its At-the-Market or “ATM” facility, raising net
proceeds of approximately $18 million. As of March 31, 2022, the
company had cash and cash equivalents of approximately $69
million.
A summary of key financial highlights as of and for the three
months ended March 31, 2022 and 2021 is as follows ($ in
thousands):
Three Months Ended March 31,
2022
2021
License revenue $
1,036
$
486
Research and development
17,220
59,934
General and administrative
4,345
4,948
Loss from
operations
(20,529
)
(64,396
)
Net loss $
(21,278
)
$
(65,567
)
Net loss per common share $
(0.32
)
$
(1.25
)
Weighted average common shares
65,590,724
52,655,756
March 31, 2022 December 31,
2021 Cash and cash
equivalents $
68,948
$
70,016
Current assets
$
71,235
$
70,971
Current liabilities
71,181
68,725
Working capital
$
54
$
2,246
About Lenzilumab
Lenzilumab is a proprietary Humaneered® first-in-class
monoclonal antibody that has been proven to neutralize GM-CSF, a
cytokine of critical importance in the hyperinflammatory cascade,
sometimes referred to as cytokine release syndrome, or cytokine
storm, associated with COVID-19 and other indications. Lenzilumab
binds to and neutralizes GM-CSF, potentially improving outcomes for
patients hospitalized with COVID-19. Humanigen believes that GM-CSF
neutralization with lenzilumab also has the potential to reduce the
hyper-inflammatory cascade known as cytokine release syndrome
common to chimeric antigen receptor T-cell (CAR-T) therapy and
acute Graft versus Host Disease (aGvHD).
In CAR-T, lenzilumab successfully achieved the pre-specified
primary endpoint at the recommended dose in a Phase 1b study with
Yescarta® in which the overall response rate was 100% and no
patient experienced severe cytokine release syndrome or severe
neurotoxicity. Based on these results, Humanigen plans to test
lenzilumab in a randomized, multicenter, potentially
registrational, Phase 3 SHIELD study to evaluate its efficacy and
safety when combined with Yescarta and Tecartus® CAR-T therapies in
non-Hodgkin lymphoma. Lenzilumab will also be tested to assess its
ability to prevent and/or treat aGvHD in patients undergoing
allogeneic hematopoietic stem cell transplantation.
A study of lenzilumab is also underway for patients with chronic
myelomonocytic leukemia exhibiting RAS pathway mutations. This
study builds on evidence from a Phase 1 study, conducted by
Humanigen, that showed RAS mutations are associated with
hyper-proliferative features, which may be sensitive to GM-CSF
neutralization.
About Humanigen, Inc.
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. 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 and in eosinophilic asthma, and
rheumatoid arthritis. For more information, visit www.humanigen.com
and follow Humanigen on LinkedIn, Twitter, and Facebook.
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
NIH; its efforts and potential timeline to make future regulatory
submissions in respect of potential emergency use authorization
from FDA for commercial use of lenzilumab in COVID-19 patients;
statements regarding Humanigen’s beliefs as to the evolving nature
of COVID-19 and the likelihood of continued hospitalizations and
the size of the future market for leading COVID-19 therapeutics;
and its other plans to initiate, continue or participate in planned
or ongoing clinical trials and otherwise explore the effectiveness
of lenzilumab and other candidates in its development portfolio as
therapies for other inflammation and immune-oncology
indications.
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
the United States and CMA in the United Kingdom and European Union)
and launch of any new pharmaceutical product; challenges associated
with manufacturing and commercializing a biologic such as
lenzilumab; the outcome of pending or future litigation or
arbitration; and the various risks and uncertainties described in
the "Risk Factors" sections and elsewhere in 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 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.
References
- Centers for Disease Control and Prevention. (2022, May 4). CDC
Covid Data tracker. Retrieved May 4, 2022, from
https://covid.cdc.gov/covid-data-tracker/#new-hospital-admissions
- COVID-19 Scenario Modeling Hub. (2022, April 30). Round 13
Model Projection. Retrieved May 1, 2022, from
https://covid19scenariomodelinghub.org/viz.html
- Gilead Sciences, Inc. (2022, April 28). Q122 Financial Results
Presentation. Retrieved May 3, 2022, from
https://investors.gilead.com/static-files/857208c8-3ef2-4d47-a7a5-433e001ed581
- Gilead Sciences, Inc. (2022, February 1). Q4 & FY21
Financial Results. Retrieved May 3, 2022, from
https://investors.gilead.com/static-files/857208c8-3ef2-4d47-a7a5-433e001ed581
- Roche (2022, February 3). 2021 Results Presentation and
Investor Update. Retrieved May 4, 2022, from
https://www.roche.com/investors/events/annual-results-2021
LENZ® and Humaneered® are trademarks of Humanigen, Inc.
Yescarta® and Tecartus® are trademarks of Gilead Sciences, Inc., or
its related companies.
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version on businesswire.com: https://www.businesswire.com/news/home/20220505005996/en/
Humanigen Investor Relations Ken Trbovich Humanigen
trbo@humanigen.com 650-410-3206
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