Announced positive interim results from the
EQUALISE study of itolizumab in highly proteinuric lupus nephritis
patients: by week 28, 83% achieved complete or partial response,
and 67% achieved > 80% reduction in urine protein creatinine
ratio
Announced the pending acquisition of Metacrine,
expected to add $35 million in cash at closing to Equillium’s
balance sheet and extend operating runway into 2024
Initiated Phase 2 study of EQ101 in alopecia
areata and Phase 1 study of EQ102 in healthy volunteers and celiac
disease patients
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 third quarter 2022 and
provided an update on its clinical development programs.
“I am proud of what our team has accomplished in the third
quarter, including executing a definitive agreement to acquire
Metacrine and announcing interim data from the Type B portion of
the EQUALISE study in lupus nephritis. Since then, we have also
initiated two new studies – a Phase 2 study of EQ101 in subjects
with alopecia areata, and a Phase 1 study of EQ102 that will be
positioned to treat patients with celiac disease,” said Bruce
Steel, chief executive officer at Equillium. “The Metacrine
acquisition will meaningfully strengthen our cash position, which
at closing is expected to add approximately $35 million to the
balance sheet and extend our cash runway into 2024, taking us
through multiple data catalysts from three different clinical
programs over the next year.”
Highlights Since the Beginning of Q3 2022:
- Announced definitive merger agreement to acquire Metacrine in
an all-stock transaction, anticipated to add $35 million in cash to
Equillium’s balance sheet at closing. The acquisition also includes
Metacrine’s farnesoid X receptor (FXR) platform, including lead
molecule MET642, an orally delivered FXR agonist that is a
potential first-in-class, non-immunosuppressive treatment for
inflammatory bowel disease.
- Announced positive interim results from the Type B portion of
the EQUALISE study of itolizumab in subjects with lupus nephritis.
Subjects were highly proteinuric with a baseline mean urine protein
creatinine ratio (UPCR) of 5.8 g/g. Clinically meaningful responses
were observed:
- By week 28 (or end of study):
- 3 of 6 (50%) subjects achieved complete response (UPCR
< 0.7 g/g)
- 2 of 6 (33%) subjects achieved partial response (UPCR
> 50% reduction)
- 4 of 6 (67%) subjects achieved greater than 80% reduction in
UPCR
- In all subjects receiving more than one dose:
- 8 of 12 (67%) subjects achieved greater than 50% reduction in
UPCR
- 60% average reduction in UPCR (over 3g of proteinuria)
- Subjects titrated steroid dose to < 7.5 mg/day consistent with EULAR/ERA-EDTA
recommendations
- Initiated a multicenter, Phase 2 open-label, proof-of-concept
study of EQ101 in adult subjects between 18 and 60 years of age,
with at least 35% scalp hair loss due to alopecia areata.
Approximately 30 subjects will be enrolled in the study where they
will be dosed intravenously once weekly for 24 weeks.
- Initiated a Phase 1 randomized, double-blind,
placebo-controlled study of EQ102 administered subcutaneously as
single or multiple doses in up to 64 healthy volunteers. The first
cohort of eight study participants has been completed and the
second cohort has initiated.
- Presented data highlighting:
- EQ101, a first-in-class, tri-specific cytokine inhibitor
selectively targeting IL-2, IL-9 and IL-15 at the receptor level,
that may afford significant advantages over other approaches to the
treatment of alopecia areata, including JAK inhibition, at the 6th
Annual Dermatology Drug Development Summit
- Urinary soluble ALCAM (sALCAM) could be a potential biomarker
of disease severity in lupus nephritis (LN) and indicative of a
patient’s response to treatment at annual meeting of the American
College of Rheumatology
- 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
- Therapeutic potential for multi-cytokine inhibitors such as
EQ101 and EQ102, as potentially effective strategies for the
treatment of certain autoimmune diseases at the Annual La Jolla
Immunology Conference
Anticipated Upcoming Milestones & Catalysts:
- Itolizumab – EQUALISE Phase 1b study: topline data from the
Type B part of the study in patients with lupus nephritis expected
mid-2023
- EQ101 – Phase 2 study in subjects with alopecia areata: data
expected in 2023
- EQ102 – Phase 1 study in healthy volunteers and subjects with
celiac disease: data expected in 2023
Third Quarter 2022 Financial Results
Research and development (R&D) expenses for the third
quarter of 2022 were $8.8 million, compared with $7.0 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
third quarter of 2022 were $4.5 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 overhead expenses.
Net loss for the third quarter of 2022 was $13.7 million,
or $(0.40) per basic and diluted share, compared with a net loss of
$10.3 million, or $(0.35) per basic and diluted share for the same
period in 2021. The increase in net loss was largely attributable
to greater operating expenses.
Cash, cash equivalents and short-term investments totaled
$44.5 million as of September 30, 2022, compared to $57.6 million
as of June 30, 2022. Equillium believes that its cash and
investments, together with the additional cash that will be
acquired with the expected closing of the Metacrine acquisition,
will be sufficient to fund its operations into 2024.
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, 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 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 is a first-in-class
tri-specific cytokine inhibitor that selectively targets IL-2,
IL-9, and IL-15. Equillium is currently enrolling patients in a
Phase 2 proof-of-concept study of EQ101 for patients with alopecia
areata. EQ102 is a bi-specific cytokine inhibitor that selectively
targets IL-15 and IL-21. Equillium is currently enrolling patients
in a Phase 1 study of EQ102, including healthy volunteers and
celiac disease patients.
For more information, visit www.equilliumbio.com.
Additional Information and Where to Find It
This communication does not constitute an offer to sell or the
solicitation of an offer to buy any securities or a solicitation of
any vote or approval with respect to the proposed merger or
otherwise. No offer of securities shall be made except by means of
a prospectus meeting the requirements of Section 10 of the
Securities Act of 1933, as amended. In connection with Metacrine,
Inc.’s pending acquisition by Equillium, Inc., Equillium filed a
registration statement on Form S-4 (File No. 333-268024) containing
a joint proxy statement/prospectus of Equillium and Metacrine and
other documents concerning the proposed merger with the Securities
and Exchange Commission (the “SEC”). EQUILLIUM URGES
INVESTORS TO READ THE JOINT PROXY STATEMENT/PROSPECTUS AND THESE
OTHER MATERIALS CAREFULLY BECAUSE THEY CONTAIN IMPORTANT
INFORMATION ABOUT EQUILLIUM, METACRINE AND THE PROPOSED MERGER.
Investors may obtain free copies of the joint proxy
statement/prospectus and other documents filed by Equillium and
Metacrine with the SEC at the SEC’s website at www.sec.gov. Free
copies of the joint proxy statement/prospectus and Equillium’s
other SEC filings are also available on Equillium’s website at
www.equilliumbio.com.
Equillium, Metacrine and their respective directors, executive
officers, certain members of management and certain employees may
be deemed, under SEC rules, to be participants in the solicitation
of proxies with respect to the proposed merger. Information
regarding Equillium’s officers and directors is included in
Equillium’s Definitive Proxy Statement on Schedule 14A filed with
the SEC on April 13, 2022 with respect to its 2022 Annual Meeting
of Stockholders. This document is available free of charge at the
SEC’s website at www.sec.gov or by going to Equillium’s Investors
page on its corporate website at www.equilliumbio.com. Information
regarding Metacrine’s officers and directors is included in
Metacrine’s Definitive Proxy Statement on Schedule 14A filed with
the SEC on April 7, 2022 with respect to its 2022 Annual Meeting of
Stockholders. This document is available free of charge at the
SEC’s website at www.sec.gov or by going to Metacrine’s Investors
page on its corporate website at www.metacrine.com. Additional
information regarding the persons who may, under the rules of the
SEC, be deemed participants in the solicitation of proxies in
connection with the proposed Merger, and a description of their
direct and indirect interests in the proposed Merger, which may
differ from the interests of Equillium’s stockholders or
Metacrine’s stockholders generally, will be set forth in the joint
proxy statement/prospectus when it is filed with the SEC.
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, including the reliance on the closing of the merger
with Metacrine to fund its current operations for the next 12
months, and Equillium’s plans and expected timing for developing
its product candidates, potential benefits of its product
candidates, the expected benefits of Equillium’s planned
acquisition of Metacrine, including the potential benefits of
Metacrine’s FXR platform. Risks that contribute to the uncertain
nature of the forward-looking statements include: the lack of
assurances that the proposed merger with Metacrine will close; the
net cash position of Metacrine; 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)
September 30,
December 31,
2022
2021
Cash, cash equivalents and short-term
investments
$
44,522
$
80,711
Prepaid expenses and other assets
2,790
3,049
Operating lease right-of-use assets
1,319
1,645
Total assets
$
48,631
$
85,405
Current liabilities
14,930
8,915
Long-term notes payable
4,616
8,750
Long-term operating lease liabilities
925
1,235
Total stockholders' equity
28,160
66,505
Total liabilities and stockholders'
equity
$
48,631
$
85,405
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,
2022
2021
2022
2021
Operating expenses:
Research and development
$
8,771
$
6,965
$
29,022
$
18,830
Acquired in-process research and
development
-
-
23,049
-
General and administrative
4,466
2,896
12,047
8,569
Total operating expenses
13,237
9,861
64,118
27,399
Loss from operations
(13,237)
(9,861)
(64,118)
(27,399)
Other expense, net
(418)
(421)
(1,083)
(1,032)
Net loss
$
(13,655)
$
(10,282)
$
(65,201)
$
(28,431)
Net loss per common share, basic and
diluted
$
(0.40)
$
(0.35)
$
(1.95)
$
(0.99)
Weighted-average number of common shares
outstanding, basic and diluted
34,352,084
29,382,806
33,512,611
28,602,450
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version on businesswire.com: https://www.businesswire.com/news/home/20221114005448/en/
Investor Contact Michael Moore Vice President, Investor
Relations & Corporate Communications 619-302-4431
ir@equilliumbio.com
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