Equillium grants Ono an option to purchase
rights to itolizumab
Equillium to receive an upfront payment of
approximately $26.0M (¥3.5B); eligible to receive up to
approximately $138.5M (¥18.7B) in option exercise and milestone
payments
Ono to fund Equillium’s continued research and
development of itolizumab during the exercise period
Conference call and webcast today at 8:30 a.m.
ET
Equillium, Inc. (Nasdaq: EQ), a clinical-stage biotechnology
company focused on developing novel therapeutics to treat severe
autoimmune and inflammatory disorders, and Ono Pharmaceutical Co.,
Ltd. (“Ono”), today announced an option and asset purchase
agreement through which Ono gains the exclusive option to purchase
Equillium’s rights to itolizumab, a first-in-class monoclonal
antibody targeting CD6. These rights include all therapeutic
indications and the rights to commercialize itolizumab in the
United States, Canada, Australia, and New Zealand.
“We are very pleased to partner itolizumab with Ono, a leading
Japanese pharmaceutical company dedicated to fighting disease and
pain,” said Bruce Steel, Chief Executive Officer at Equillium.
“This strategic partnership validates the potential of itolizumab
to address autoimmune and immuno-inflammatory disorders for
patients in significant need of new therapies. Through this
partnership, we have secured the resources necessary to continue
advancing our Phase 3 EQUATOR study of itolizumab in the treatment
of first-line acute graft-versus-host disease, a severe
life-threatening disease, and our ongoing EQUALISE study in lupus
nephritis. Based on our current operating plan, we expect this
strategic partnership will enable us to fund operations into 2025,
enabling us to advance our wholly-owned pipeline of multi-cytokine
inhibitors through multiple key milestones, including our ongoing
Phase 2 study of EQ101 in alopecia areata and Phase 1 study of
EQ102 in celiac disease.”
“We believe this collaboration with Equillium reinforces our
commitment to research and development and creating innovative
therapeutics in immunology,” said Gyo Sagara, President and Chief
Executive Officer of Ono. “We are very pleased to be partnering
with Equillium to develop a novel medicine for patients with
difficult-to-treat immuno-inflammatory disorders. We hope that
itolizumab will serve as our foundation for expanding our business
in the United States and pave the way for becoming a global
specialty pharmaceutical company.”
Under the terms of the agreement, Equillium will receive a
non-refundable upfront payment of approximately $26.0 million (¥3.5
billion) and will also be eligible to receive up to an aggregate of
approximately $138.5 million (¥18.7 billion) for exercise of the
option and milestone payments from development through first
commercial sale. Equillium will be responsible for the conduct of
all research and development of itolizumab, which will be fully
funded by Ono on a quarterly basis commencing July 1, 2022 through
the option period.1 The option period will expire three months
following delivery of topline data from the EQUALISE study in lupus
nephritis and interim data from the EQUATOR Phase 3 study in acute
GVHD.
Conference Call
Management will host a conference call to discuss the option and
asset purchase agreement with Ono Pharmaceutical Co., Ltd. for
analysts and institutional investors, at 8:30 a.m. ET today,
December 6, 2022. To access the call, please dial (888) 350-3846 or
(646) 960-0251 and, if needed, provide confirmation number 8770084.
A live webcast of the call will also be available on the company’s
Investor Relations page at
www.equilliumbio.com/investors/events-and-presentations/default.aspx.
The webcast will be archived for 180 days.
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 Ono Pharmaceutical
Ono Pharmaceutical Co., Ltd., headquartered in Osaka, is an
R&D-oriented pharmaceutical company committed to creating
innovative medicines in specific areas. Ono focuses its research on
the oncology, immunology, neurology and specialty research with
high medical needs as priority areas for discovery and development
of innovative medicines. For further information, please visit the
company’s website at https://www.ono-pharma.com/.
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
benefits and risks of the transactions contemplated by the option
and asset purchase agreement entered into by the Company and Ono,
including the possibility that Ono does not exercise the option,
the Company receives no further payments under the option and asset
purchase agreement other than those payable upon signing, the
possibility that, if commercialized, itolizumab proves to be more
valuable than contemplated by the option and asset purchase
agreement, the fluctuation of the foreign exchange rate, 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, EQUIP,
and EQUALISE studies, 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 anticipated timing of regulatory review and
feedback, 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; risks
related to Ono’s financial condition, willingness to continue to
fund the development of itolizumab, and decision to exercise its
option to purchase itolizumab or terminate the option and 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 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.
1 Upfront and option exercise payments are based in Japanese yen
and subject to currency exchange rates at the time of payment (U.S.
dollar amounts are estimates based on the average exchange rate on
December 2, 2022). R&D funding and milestone payments are to be
paid in U.S. dollars.
View source
version on businesswire.com: https://www.businesswire.com/news/home/20221206005379/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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