$62.0 million cash balance at the end of Q1
2023 expected to provide operating runway into 2025
Presented Phase 1b EQUATE data in aGVHD
highlighting rapid and durable rates of overall clinical response,
clinical response associated with improved progression-free
survival through one year, and steroid tapering of 99% at Day
169
Equillium, Inc. (Nasdaq: EQ), 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, today announced financial
results for the first quarter 2023 and provided corporate and
clinical development updates.
“In the first quarter of 2023, we made excellent progress
advancing Equillium’s wholly-owned multi-cytokine inhibitors, EQ101
and EQ102, in their respective clinical programs in alopecia areata
and first-in-human development, as well as continuing to advance
our pivotal Phase 3 EQUATOR study in aGVHD and Phase 1b EQUALISE
study in lupus nephritis,” said Bruce Steel, chief executive
officer at Equillium. “With the Ono Pharmaceutical partnership now
in place, and Equillium in a strong financial position, our team is
focused on achieving near-term milestones in the multi-cytokine
programs before the end of the year, including initial data from
the EQ101 Phase 2 study in alopecia areata. While we believe the
multi-cytokine programs represent a significant source of long-term
value, we remain highly engaged in the ongoing development of
itolizumab and plan to report topline data from the EQUALISE study
in lupus nephritis in the first half of 2024 and remain currently
on track for the interim review of the Phase 3 EQUATOR study later
in 2024. We look forward to these two milestones as they will
establish Ono’s option exercise timeline for itolizumab, which if
exercised would result in a payment of approximately $371 million
and significantly extend Equillium’s cash runway.”
1
Option exercise payment is denominated in
Japanese yen (5 billion) and subject to currency exchange rates at
the time of payment.
Highlights Since the Beginning of 2023:
- Announced oral and ePoster presentations at the Tandem Meetings
of the American Society of Transplantation and Cellular Therapy and
the Annual Meeting of the European Society for Blood and Marrow
Transplantation, respectively, highlighting additional long-term
data from the Phase 1b EQUATE study in acute graft-versus-host
disease (aGVHD). The data demonstrate promising outcomes in
subjects with severe aGVHD, notably rapid and durable high rates of
overall clinical response, Day 29 response associated with improved
progression-free survival through one year and that responders were
able to taper steroids by 70% at Day 29 and 99% at Day 169.
Equillium is now actively enrolling the pivotal Phase 3 EQUATOR
study in aGVHD (NCT05263999).
Anticipated Upcoming Milestones:
- EQ101: Phase 2 clinical study in subjects with alopecia areata
– initial data anticipated in 2H 2023, topline data anticipated in
mid-2024
- EQ102: Phase 1 first-in-human study in healthy volunteers and
subjects with celiac disease – single ascending dose/multiple
ascending dose data anticipated in 2H 2023, celiac disease patient
data anticipated in 2024
- Itolizumab: EQUALISE lupus nephritis topline data anticipated
in 1H 2024, EQUATOR aGVHD interim review anticipated in 2024
First Quarter 2023 Financial Results
Revenue for the first quarter of 2023 was $8.9 million
and was derived from itolizumab development funding from Ono
Pharmaceutical Co, Ltd. (Ono) and amortization of the upfront
payment from Ono.
Research and development (R&D) expenses for the first
quarter of 2023 were $9.3 million, compared with $10.8 million for
the same period in 2022. The decrease was primarily due to a
decrease in employee compensation and benefits related to lower
headcount, a greater estimated Australian R&D tax incentive and
a decrease in non-clinical research expenses, partially offset by
an increase in clinical development expenses primarily related to
the EQ102 and EQUATOR clinical studies.
General and administrative (G&A) expenses for the
first quarter of 2023 were $3.7 million, compared with $3.5 million
for the same period in 2023. The increase was primarily driven by
greater legal and other professional fees, partially offset by
lower employee compensation and benefits, directors and officers
insurance expenses, and consulting expenses.
Net loss for the first quarter of 2023 was $3.9 million,
or $(0.11) per basic and diluted share, compared with a net loss of
$37.4 million, or $(1.17) per basic and diluted share for the same
period in 2022. The decrease in net loss was primarily attributable
to acquired in-process research and development (IPR&D)
expenses in the first quarter of 2022 resulting from the Bioniz
acquisition. Revenue related to the Ono partnership, including
amortization of the upfront payment and itolizumab development
funding in the first quarter of 2023 also contributed to the lower
net loss compared to the first quarter of 2022, which was prior to
the Ono partnership.
Cash, cash equivalents and short-term investments totaled
$62.0 million as of March 31, 2023, compared to $71.0 million as of
December 31, 2022. Cash used in operating activities in the first
quarter of 2023 was $8.0 million, which included payment of $2.6
million for annual bonuses to employees. Equillium believes that
its cash, cash equivalents and short-term investments will be
sufficient to fund its operations into 2025.
About Multi-Cytokine Platform and EQ101 & EQ102
Our proprietary multi-cytokine platform 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 is expected to avoid the broad
immuno-suppression and off-target safety liabilities that may be
associated with other therapeutic classes, such as Janus kinase
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 platform assets include EQ101, a first-in-class,
selective, tri-specific inhibitor of IL-2, IL-9 and IL-15, and
EQ102, a first-in-class, selective, bi-specific inhibitor of IL-15
and IL-21.
About Itolizumab
Itolizumab is a clinical-stage, first-in-class anti-CD6
monoclonal antibody that selectively targets the CD6-ALCAM
signaling pathway to downregulate pathogenic T effector cells while
preserving T regulatory cells critical for maintaining a balanced
immune response. This pathway plays a central role in modulating
the activity and trafficking of T cells that drive a number of
immuno-inflammatory diseases.
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 first-in-class immunomodulatory assets targeting
immuno-inflammatory pathways. EQ101: a tri-specific cytokine
inhibitor that selectively targets IL-2, IL-9, and IL-15; currently
under evaluation in a Phase 2 proof-of-concept clinical study of
patients with alopecia areata. EQ102: a bi-specific cytokine
inhibitor that selectively targets IL-15 and IL-21; currently under
evaluation in a Phase 1 first-in-human clinical study to include
healthy volunteers and celiac disease patients. Itolizumab: a
monoclonal antibody that targets the CD6-ALCAM signaling pathway
which plays a central role in the modulation of effector T cells;
currently under evaluation in a Phase 3 clinical study of patients
with acute graft-versus-host disease (aGVHD) and a Phase 1b
clinical study of patients with lupus/lupus nephritis. Equillium
acquired rights to itolizumab through an exclusive partnership with
Biocon Limited and has entered a strategic partnership with Ono
Pharmaceutical Co., Ltd. for the development and commercialization
of itolizumab under an option and asset purchase agreement.
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 Equillium’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 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 clinical studies,
respectively, the potential for any of Equillium’s ongoing or
planned clinical studies to show safety or efficacy, the 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 EQUATE, EQUATOR and
EQUALISE studies, Equillium’s anticipated timing of regulatory
review and feedback, the potential benefits and risks of the
transactions contemplated by the asset purchase agreement entered
into between Equillium and Ono, including the possibility that Ono
does not exercise the option, Equillium receives no further
payments under the asset purchase agreement other than those
already received, the fluctuation of the foreign exchange rate,
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: Equillium’s ability to
execute its plans and strategies; risks related to performing
clinical studies; the risk that initial and 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; risks related to Ono’s
financial condition, willingness to continue to fund the
development of itolizumab, and decision to exercise its option, if
ever, to purchase itolizumab or terminate the asset purchase
agreement; 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 the Securities and Exchange
Commission’s website at www.sec.gov and on Equillium’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, except as required by
law.
Equillium, Inc. Condensed
Consolidated Balance Sheets (In thousands) (unaudited)
March 31,
December 31,
2023
2022
Assets
Cash, cash equivalents and short-term
investments
$
61,992
$
71,023
Accounts receivable
3,424
2,838
Prepaid expenses and other assets
5,260
3,369
Operating lease right-of-use assets
1,114
1,191
Total assets
$
71,790
$
78,421
Current liabilities
Accounts payable and other current
liabilities
$
17,253
$
17,338
Current portion of deferred revenue
14,767
14,700
Total current liabilities
32,020
32,038
Long-term deferred revenue
7,941
10,378
Other long-term liabilities
2,560
4,063
Total liabilities
42,521
46,479
Total stockholders' equity
29,269
31,942
Total liabilities and stockholders'
equity
$
71,790
$
78,421
Equillium, Inc. Condensed
Consolidated Statements of Operations (In thousands, except share
and per share data) (unaudited)
Three Months Ended
March 31,
2023
2022
Revenue
$
8,879
$
-
Operating expenses:
Research and development
9,272
10,763
Acquired in-process research and
development
-
23,049
General and administrative
3,715
3,517
Total operating expenses
12,987
37,329
Loss from operations
(4,108
)
(37,329
)
Other income (expense), net
228
(88
)
Loss before income taxes
(3,880
)
(37,417
)
Income tax expense
60
-
Net loss
$
(3,940
)
$
(37,417
)
Net loss per common share, basic and
diluted
$
(0.11
)
$
(1.17
)
Weighted-average number of common shares
outstanding, basic and diluted
34,414,149
31,865,783
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version on businesswire.com: https://www.businesswire.com/news/home/20230511005715/en/
Investor & Media Contact Equillium, Inc. Michael
Moore Vice President, Investor Relations Officer & Head of
Corporate Communications 619-302-4431 ir@equilliumbio.com
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