Equillium, Inc. (Nasdaq: EQ), a clinical-stage biotechnology
company focused on developing novel therapeutics to treat severe
autoimmune and inflammatory disorders with high unmet medical need,
today announced financial results for the second quarter 2022 and
provided an update on its clinical development programs.
“The second quarter focused largely on the execution of our
development programs with itolizumab and our plans to advance the
clinical development of our new multi-cytokine inhibitors, EQ101
and EQ102,” said Bruce Steel, chief executive officer at Equillium.
“We are actively preparing to initiate a Phase 2 clinical study of
EQ101 in alopecia areata and a Phase 1 SAD/MAD study of EQ102 –
both of which are on track to commence during the second half of
this year. At the same time, we continue to enroll our recently
initiated Phase 3 EQUATOR study in acute graft-versus-host disease
and look forward to the pending interim data from the Phase 1b
EQUALISE study of itolizumab in patients with lupus nephritis.”
Program Highlights Since the Beginning of Q2 2022:
- Presented translational and clinical data demonstrating
itolizumab’s impact on effector T cell function in acute
graft-versus-host disease (aGVHD) and treatment associated with
high rates of overall clinical response in the treatment of aGVHD
at the Transplantation & Cellular Meetings of the American
Society of Transplantation and Cellular Therapy, and the 48th
Annual Meeting of the European Society for Blood and Marrow
Transplantation
- Announced data confirming CD6 as a target to prevent pathogenic
T cell recruitment into inflamed organs and that itolizumab-induced
reduction of CD6 from T effector cells promotes the development and
activity of T regulatory cells at the 48th Annual Meeting of the
European Society for Blood and Marrow Transplantation, and
IMMUNOLOGY2022, the annual meeting of The American Association of
Immunologists
- Introduced data from the company’s multi-cytokine inhibitor
technology and platform focusing on the design and development of
multi-specific cytokine inhibitors, and the importance of targeting
biological synergy to optimize therapeutic outcomes at the 3rd
Annual Cytokine-Based Drug Development Summit
Anticipated Upcoming Milestones & Catalysts:
- Itolizumab - EQUALISE Phase 1b study: interim data from the
Type B part of the study in patients with lupus nephritis expected
mid-2022
- EQ101 - Phase 2 study in alopecia areata initiation expected 2H
2022
- EQ102 - Phase 1 study in normal healthy volunteers (NHV) and
celiac disease patients expected to initiate in 2H 2022
Second Quarter 2022 Financial Results
Research and development (R&D) expenses for the
second quarter of 2022 were $9.5 million, compared with $6.0
million for the same period in 2021. The increase was primarily due
to greater clinical development expenses, driven by start-up costs
related to the Phase 3 EQUATOR study.
General and administrative (G&A) expenses for the
second quarter of 2022 were $4.1 million, compared with $2.9
million for the same period in 2021. The increase was primarily due
to higher legal fees related to business development activities and
greater employee compensation and consulting costs.
Net loss for the second quarter of 2022 was $14.1
million, or $(0.41) per basic and diluted share, compared with a
net loss of $9.2 million, or $(0.31) per basic and diluted share
for the same period in 2021. The increase in net loss was largely
attributable to greater operating expenses.
Cash used in operations for the second quarter of 2022
was $11.3 million compared to $12.1 million in the first quarter of
2022. Key drivers of the quarter-over-quarter decrease in cash used
in operations include payments made in the first quarter of 2022
related to 2021 annual bonuses and the Bioniz acquisition.
Cash, cash equivalents and short-term investments totaled
$57.6 million as of June 30, 2022, compared to $68.8 million as of
March 31, 2022. Equillium believes that its cash and investments,
together with its existing and available committed equity line, are
sufficient to fund its operations for at least the next 12
months.
About Itolizumab
Itolizumab is a clinical-stage, first-in-class anti-CD6
monoclonal antibody that selectively targets the CD6-ALCAM pathway.
This pathway plays a central role in modulating the activity and
trafficking of T cells that drive a number of immuno-inflammatory
diseases. Equillium acquired rights to itolizumab through an
exclusive partnership with Biocon Limited.
About Multi-Cytokine Platform: EQ101 & EQ102
Our proprietary multi-cytokine platform (MCP) generates
rationally designed composite peptides that selectively block key
cytokines at the shared receptor level targeting pathogenic
cytokine redundancies and synergies while preserving non-pathogenic
signaling. This approach provides multi-cytokine inhibition at the
receptor level and is expected to avoid the broad
immuno-suppression and off-target safety liabilities that may be
associated with other therapeutic classes, such as JAK inhibitors.
Many immune-mediated diseases are driven by the same combination of
dysregulated cytokines, and we believe identifying the key
cytokines for these diseases will allow us to target and develop
customized treatment strategies for multiple autoimmune and
inflammatory diseases.
Current MCP assets include EQ101, a first-in-class, tri-specific
inhibitor of IL-2, IL-9 and IL-15, and EQ102, a first-in-class,
selective inhibitor of IL-15 and IL-21.
About Equillium
Equillium is a clinical-stage biotechnology company leveraging a
deep understanding of immunobiology to develop novel therapeutics
to treat severe autoimmune and inflammatory disorders with high
unmet medical need. The company’s pipeline consists of the
following novel immunomodulatory assets targeting
immuno-inflammatory pathways. Itolizumab, a first-in-class
monoclonal antibody that targets the CD6-ALCAM signaling pathway
which plays a central role in the modulation of effector T cells,
is currently in a Phase 3 study for patients with acute
graft-versus-host disease (aGVHD) and is in a Phase 1b study for
patients with lupus/lupus nephritis. EQ101, a first-in-class
tri-specific cytokine inhibitor that selectively targets IL-2,
IL-9, and IL-15, is Phase 2 ready and expected to begin enrolling
patients in an alopecia areata study in the second half of 2022.
EQ102, a bi-specific cytokine inhibitor that selectively targets
IL-15 and IL-21, is ready for clinical development and expected to
begin enrolling patients in a Phase 1 study anticipated to include
normal healthy volunteers and celiac disease patients, in the
second half of 2022.
For more information, visit www.equilliumbio.com.
Forward Looking Statements
Statements contained in this press release regarding matters
that are not historical facts are "forward-looking statements"
within the meaning of the Private Securities Litigation Reform Act
of 1995. Forward-looking statements may be identified by the use of
words such as "anticipate", "believe", “could”, “continue”,
"expect", "estimate", “may”, "plan", "outlook", “future” and
"project" and other similar expressions that predict or indicate
future events or trends or that are not statements of historical
matters. Because such statements are subject to risks and
uncertainties, many of which are outside of the Company’s control,
actual results may differ materially from those expressed or
implied by such forward-looking statements. Such statements
include, but are not limited to statements regarding the potential
benefit of treating patients with aGVHD or lupus/lupus nephritis
with itolizumab, Equillium’s plans and expected timing for
developing itolizumab including the expected timing of initiating,
completing and announcing further results from the EQUALISE study,
Equillium’s plans and expected timing for developing EQ101 and
EQ102 including the expected timing of initiating, completing and
announcing further results from Phase 2 and Phase 1 studies,
respectively, the potential for any of Equillium’s ongoing or
planned clinical studies to show safety or efficacy, Equillium’s
cash runway, and Equillium’s plans and expected timing for
developing its product candidates and potential benefits of its
product candidates. Risks that contribute to the uncertain nature
of the forward-looking statements include: uncertainties related to
the abilities of the leadership team to perform as expected;
Equillium’s ability to execute its plans and strategies; risks
related to performing clinical studies; the risk that interim
results of a clinical study do not necessarily predict final
results and that one or more of the clinical outcomes may
materially change as patient enrollment continues, following more
comprehensive reviews of the data, and as more patient data become
available; potential delays in the commencement, enrollment and
completion of clinical studies and the reporting of data therefrom;
the risk that studies will not be completed as planned; Equillium’s
plans and product development, including the initiation and
completion of clinical studies and the reporting of data therefrom;
whether the results from clinical studies will validate and support
the safety and efficacy of Equillium’s product candidates; changes
in the competitive landscape; uncertainties related to Equillium’s
capital requirements; and having to use cash in ways or on timing
other than expected and the impact of market volatility on cash
reserves. These and other risks and uncertainties are described
more fully under the caption "Risk Factors" and elsewhere in
Equillium's filings and reports, which may be accessed for free by
visiting EDGAR on the SEC web site at http://www.sec.gov and on the Company’s website
under the heading “Investors.” Investors should take such risks
into account and should not rely on forward-looking statements when
making investment decisions. All forward-looking statements
contained in this press release speak only as of the date on which
they were made. Equillium undertakes no obligation to update such
statements to reflect events that occur or circumstances that exist
after the date on which they were made.
Equillium, Inc.
Condensed Consolidated Balance
Sheets
(In thousands)
(unaudited)
June 30,
December 31,
2022
2021
Cash, cash equivalents and short-term
investments
$
57,562
$
80,711
Prepaid expenses and other assets
3,492
3,049
Operating lease right-of-use assets
1,418
1,645
Total assets
$
62,472
$
85,405
Current liabilities
15,188
8,915
Long-term notes payable
5,992
8,750
Long-term operating lease liability
1,025
1,235
Total stockholders' equity
40,267
66,505
Total liabilities and stockholders'
equity
$
62,472
$
85,405
Equillium, Inc.
Condensed Consolidated
Statements of Operations
(In thousands, except share
and per share data)
(unaudited)
Three Months Ended June
30,
Six Months Ended June
30,
2022
2021
2022
2021
Operating expenses:
Research and development
$
9,488
$
5,985
$
20,251
$
11,865
Acquired in-process research and
development
-
-
23,049
-
General and administrative
4,064
2,858
7,581
5,673
Total operating expenses
13,552
8,843
50,881
17,538
Loss from operations
(13,552
)
(8,843
)
(50,881
)
(17,538
)
Other expense, net
(577
)
(315
)
(665
)
(611
)
Net loss
$
(14,129
)
$
(9,158
)
$
(51,546
)
$
(18,149
)
Net loss per common share, basic and
diluted
$
(0.41
)
$
(0.31
)
$
(1.56
)
$
(0.64
)
Weighted-average number of common shares
outstanding, basic and diluted
34,292,642
29,076,562
33,085,917
28,205,805
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version on businesswire.com: https://www.businesswire.com/news/home/20220815005539/en/
Investor Contact Michael Moore Vice President, Investor
Relations & Corporate Communications 619-302-4431
ir@equilliumbio.com
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