$46.3 million in cash at the end of Q3 2023
expected to provide operating runway into 2025
$1.9 million of cash used in operating
activities in Q3 2023
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, today announced financial results for the third quarter
2023 and provided corporate and clinical development updates.
“The third quarter was focused on clinical execution and
expanding education on our multi-cytokine platform and clinical
programs ahead of initial data expected later this year,” said
Bruce Steel, chief executive officer at Equillium. “We have
completed enrollment in the Phase 1b EQUALISE study of itolizumab
in patients with lupus nephritis and presented current data from
that study at the annual meeting of the American Society of
Nephrology earlier this month. We plan to provide the topline data
to Ono in early 2024, which along with the interim review of the
Phase 3 EQUATOR study in acute graft-versus-host disease, expected
in 2024, comprise the data deliverables that will trigger Ono’s
option decision. If Ono exercises its option, it would result in a
payment of approximately $331 million and significantly extend
Equillium’s cash runway. We also recently completed enrollment of
the Phase 2 study of EQ101 in alopecia areata and expect to
announce initial data from that study, as well as data from the
SAD/MAD portion of the Phase 1 study of EQ102 before the end of the
year. We believe Equillium is well positioned to create shareholder
value with near-term milestones and a strong balance sheet that we
expect to provide cash runway into 2025.”
Highlights Since Beginning of Third Quarter:
- Hosted an Analyst & Investor Day featuring Arash
Mostaghimi, MD, MPA, MPH, associate professor of dermatology at
Harvard Medical School, that highlighted Equillium’s pipeline, the
multi-cytokine platform and clinical-stage multi-cytokine
inhibitors, with a focus on EQ101, currently in a Phase 2 clinical
trial for moderate to severe alopecia areata that is now
fully-enrolled.
- Announced a presentation at the 18th Annual Peptide
Therapeutics Symposium highlighting EQ302, a second generation
orally deliverable multi-cytokine inhibitor in development to
target IL-15 and IL-21. The presentation outlined the origins of
EQ302 from its parent peptide, EQ102, and data illustrating that
adding hydrocarbon staples to a peptide can confer increased
stability in the gastrointestinal tract while retaining its
cytokine inhibitory properties.
- Announced abstracts accepted for poster presentation at the
annual meetings of the American Society of Nephrology (ASN) and the
American College of Rheumatology (ACR). The abstracts highlight
data from 17 Type B subjects in the Phase 1b EQUALISE study in
highly proteinuric lupus nephritis patients that demonstrated that
subjects had high complete and partial response rates with rapid
and deep reduction in urine protein creatinine ratio (UPCR) when
itolizumab was added to mycophenolate mofetil and
corticosteroids.
Anticipated Upcoming Milestones:
- EQ101: Phase 2 clinical study in subjects with alopecia areata
– initial data anticipated in Q4 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 (SAD)/multiple
ascending dose (MAD) data anticipated in Q4 2023, celiac disease
patient data anticipated in 2024
- Itolizumab: EQUALISE lupus nephritis topline data anticipated
to be delivered to Ono in early 2024, EQUATOR acute
graft-versus-host disease (aGVHD) interim review anticipated in
2024
Third Quarter 2023 Financial Results
Revenue for the third quarter of 2023 was $8.9 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 third
quarter of 2023 were $9.0 million, compared with $8.8 million for
the same period in 2022. The increase was primarily due to greater
clinical development expenses driven by the EQUATOR, EQ101, and
EQ102 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.
General and administrative (G&A) expenses for the
third quarter of 2023 were $3.5 million, compared with $4.5 million
for the same period in 2022. The decrease was primarily driven by
lower legal fees, overhead and employee compensation and benefits,
partially offset by an increase in other professional fees.
Net loss for the third quarter of 2023 was $3.7 million,
or $(0.11) per basic and diluted share, compared with a net loss of
$13.7 million, or $(0.40) 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 third
quarter of 2023, whereas no such revenue was recorded in the third
quarter of 2022 as it was prior to the Ono partnership. Lower total
operating expenses, lower interest expense, and greater interest
income in the third 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
$46.3 million as of September 30, 2023, compared to $48.4 million
as of June 30, 2023. Net cash used in operating activities in the
third quarter of 2023 was $1.9 million. Equillium believes that its
cash, cash equivalents and short-term investments as of September
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 &
EQ302
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 for
intravenous and subcutaneous delivery; EQ102, a first-in-class,
selective, bi-specific inhibitor of IL-15 and IL-21 for
subcutaneous delivery; EQ302, in development as a first-in-class,
selective, bi-specific inhibitor of IL-15 and IL-21 for oral
delivery.
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. EQ302: an
orally-delivered, bi-specific inhibitor of IL-15 and IL-21;
currently in preclinical development. 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, EQ102, EQ302 and itolizumab and the
expected timing of results from clinical studies, anticipated
upcoming milestones, the potential of Equillium to generate
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 and pre-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;
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 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)
September 30,
December 31,
2023
2022
Assets
Cash, cash equivalents and short-term
investments
$
46,306
$
71,023
Accounts receivable
3,769
2,838
Prepaid expenses and other assets
4,228
3,369
Operating lease right-of-use assets
922
1,191
Total assets
$
55,225
$
78,421
Current liabilities
Accounts payable and other current
liabilities
$
12,367
$
17,338
Current portion of deferred revenue
15,832
14,700
Total current liabilities
28,199
32,038
Long-term deferred revenue
2,420
10,378
Other long-term liabilities
498
4,063
Total liabilities
31,117
46,479
Total stockholders' equity
24,108
31,942
Total liabilities and stockholders'
equity
$
55,225
$
78,421
Equillium, Inc.
Condensed Consolidated
Statements of Operations
(In thousands, except share
and per share data)
(unaudited)
Three Months Ended September
30,
Nine Months Ended September
30,
2023
2022
2023
2022
Revenue
$
8,870
$
-
$
26,873
$
-
Operating expenses:
Research and development
8,974
8,771
27,855
29,022
Acquired in-process research and
development
-
-
-
23,049
General and administrative
3,519
4,466
10,340
12,047
Total operating expenses
12,493
13,237
38,195
64,118
Loss from operations
(3,623
)
(13,237
)
(11,322
)
(64,118
)
Other income (expense), net
409
(418
)
893
(1,083
)
Loss before income taxes
(3,214
)
(13,655
)
(10,429
)
(65,201
)
Income tax expense
496
-
564
-
Net loss
$
(3,710
)
$
(13,655
)
$
(10,993
)
$
(65,201
)
Net loss per common share, basic and
diluted
$
(0.11
)
$
(0.40
)
$
(0.32
)
$
(1.95
)
Weighted-average number of common shares
outstanding, basic and diluted
34,878,700
34,352,084
34,582,574
33,512,611
____________________________
1 Option exercise payment is denominated in Japanese yen (5
billion) and subject to currency exchange rates at the time of
payment.
View source
version on businesswire.com: https://www.businesswire.com/news/home/20231108064995/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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