$48.4 million in cash at the end of Q2 2023
expected to provide operating runway into 2025
Fully prepaid and retired debt facility
Authorized $7.5 million stock repurchase
program
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 second quarter 2023 and provided corporate and
clinical development updates.
“We continue to advance our pipeline of wholly-owned and
partnered clinical programs, and have deleveraged our balance sheet
through the prepayment of our outstanding debt in the second
quarter of 2023,” said Bruce Steel, chief executive officer at
Equillium. “Additionally, we recently announced a stock repurchase
program which demonstrates our belief in the intrinsic value and
potential of Equillium, particularly in light of our strong cash
position, reduced operating burn and potential for additional
near-term cash income related to our strategic partnership with Ono
Pharmaceutical. We believe the stock repurchase program can
potentially create stockholder value without meaningfully affecting
our cash runway and has the potential to be accretive if Ono
exercises its option to acquire itolizumab.”
Mr. Steel added, “We also have multiple anticipated upcoming
milestones, including initial data from the EQ101 Phase 2 study in
alopecia areata expected before the end of this year. While we
continue to view the multi-cytokine programs as 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, which is fully enrolled, in
early 2024, and remain on track for the interim review of the Phase
3 EQUATOR study during 2024. The EQUALISE and EQUATOR milestones
will establish Ono’s option exercise timeline for itolizumab, which
if exercised would result in a payment of approximately $351
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 Beginning of Second Quarter:
- Promoted Maple Fung, M.D., from SVP of Clinical Development to
the position of Chief Medical Officer, where she will oversee
Equillium’s clinical development programs and the ongoing
integration of the Company’s development and translational research
efforts to advance programs through all phases of clinical
development.
- Announced a poster presentation at IMMUNOLOGY2023, the annual
meeting of The American Association of Immunologists, highlighting
that EQ102 selectively blocks IL-15 and IL-21 signaling while
preserving signaling of other gamma chain family members. The data
suggests that selective blockade of IL-15 and IL-21 inhibits the
synergistic signaling that mediates NK and T cell responses in
multiple immune disorders including celiac disease.
- Announced an ePoster presentation at the 49th Annual Meeting of
the European Society for Blood and Marrow Transplantation
highlighting data from the EQUATE study in acute graft-versus-host
disease (aGVHD). The data demonstrate Day 29 response rates were
associated with improved progression-free survival through 1 year
and that itolizumab combined with systemic corticosteroids was
associated with high rates of overall clinical response.
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 early 2024, EQUATOR aGVHD interim review anticipated in
2024
Second Quarter 2023 Financial Results
Revenue for the second quarter of 2023 was $9.1 million,
which 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
second quarter of 2023 were $9.6 million, compared with $9.5
million for the same period in 2022. The increase was primarily due
to greater clinical development expenses driven by the EQ101, EQ102
and EQUATOR clinical studies partially offset by lower costs for
our other itolizumab (EQ001) studies, and further offset by a
greater estimated Australian R&D tax incentive benefit, a
decrease in non-clinical research expenses, and a decrease in
employee compensation and benefits related to lower headcount.
General and administrative (G&A) expenses for the
second quarter of 2023 were $3.1 million, compared with $4.1
million for the same period in 2022. The decrease was primarily
driven by lower employee compensation and benefits, legal and other
professional fees, and consulting expenses.
Net loss for the second quarter of 2023 was $3.3 million,
or $(0.10) per basic and diluted share, compared with a net loss of
$14.1 million, or $(0.41) per basic and diluted share for the same
period in 2022. The decrease in net loss was primarily attributable
to revenue related to the Ono partnership recognized in the second
quarter of 2023, whereas no such revenue was recorded in the second
quarter of 2022 as it was prior to the Ono partnership. Lower total
operating expenses and greater interest income in the second
quarter of 2023 also contributed to the decrease in net loss
compared to the same period last year.
Cash, cash equivalents and short-term investments totaled
$48.4 million as of June 30, 2023, compared to $62.0 million as of
March 31, 2023. Net cash used in operating activities in the second
quarter of 2023 was $6.2 million. Net cash used in financing
activities in the second quarter of 2023 was $7.6 million, which
was driven by the prepayment and retirement of our former debt
facility. Equillium believes that its cash, cash equivalents and
short-term investments as of June 30, 2023, including after giving
effect to its stock repurchase program, 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 for developing EQ101 and EQ102 and the expected timing of
results from the Phase 2 and Phase 1 clinical studies,
respectively, Equillium’s plans for developing itolizumab and the
expected timing of results from the EQUATOR and EQUALISE studies,
anticipated upcoming milestones, the potential benefits of the
stock repurchase program, the intrinsic value and potential of
Equillium to generate long-term stockholder value, the potential
for additional near-term cash income under the asset purchase
agreement entered into between Equillium and Ono, the fluctuation
of the foreign exchange rate, Equillium’s cash runway, and the
potential benefits of Equillium’s 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; risks and uncertainties regarding
whether, when and on what terms Equillium repurchases its shares of
common stock under the stock repurchase program; whether Equillium
is able to grow its business and increase stockholder value over
time; 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; 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)
June 30,
December 31,
2023
2022
Assets
Cash, cash equivalents and short-term
investments
$
48,378
$
71,023
Accounts receivable
3,743
2,838
Prepaid expenses and other assets
5,651
3,369
Operating lease right-of-use assets
992
1,191
Total assets
$
58,764
$
78,421
Current liabilities
Accounts payable and other current
liabilities
$
10,979
$
17,338
Current portion of deferred revenue
14,239
14,700
Total current liabilities
25,218
32,038
Long-term deferred revenue
5,956
10,378
Other long-term liabilities
609
4,063
Total liabilities
31,783
46,479
Total stockholders' equity
26,981
31,942
Total liabilities and stockholders'
equity
$
58,764
$
78,421
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,
2023
2022
2023
2022
Revenue
$
9,124
$
-
$
18,003
$
-
Operating expenses:
Research and development
9,610
9,488
18,882
20,251
Acquired in-process research and
development
-
-
-
23,049
General and administrative
3,105
4,064
6,820
7,581
Total operating expenses
12,715
13,552
25,702
50,881
Loss from operations
(3,591
)
(13,552
)
(7,699
)
(50,881
)
Other income (expense), net
256
(577
)
484
(665
)
Loss before income taxes
(3,335
)
(14,129
)
(7,215
)
(51,546
)
Income tax expense
8
-
68
-
Net loss
$
(3,343
)
$
(14,129
)
$
(7,283
)
$
(51,546
)
Net loss per common share, basic and
diluted
$
(0.10
)
$
(0.41
)
$
(0.21
)
$
(1.56
)
Weighted-average number of common shares
outstanding, basic and diluted
34,449,769
34,292,642
34,432,057
33,085,917
View source
version on businesswire.com: https://www.businesswire.com/news/home/20230809660222/en/
Investor & Media Contact Equillium, Inc. Michael
Moore Vice President, Investor Relations Officer & Head of
Corporate Communications 619-302-4431 ir@equilliumbio.com
Grafico Azioni Equillium (NASDAQ:EQ)
Storico
Da Apr 2024 a Mag 2024
Grafico Azioni Equillium (NASDAQ:EQ)
Storico
Da Mag 2023 a Mag 2024