Expected to add $33 million in cash at closing
to Equillium’s balance sheet and extend operating runway into
2024
Acquisition includes novel drug candidate
MET642, an orally delivered Phase 2 ready FXR agonist for
ulcerative colitis
Preston Klassen, M.D., MHS, to be appointed to
the Board of Directors
Equillium, Inc. (Nasdaq: EQ) and Metacrine Inc. (Nasdaq: MTCR),
today announced that the two companies have entered into a
definitive merger agreement pursuant to which Equillium will
acquire Metacrine in an all-stock transaction. The transaction is
anticipated to add $33 million in cash to Equillium’s balance sheet
at closing, which is expected to extend the company’s cash runway
into 2024. The transaction has been approved by the boards of
directors of both companies.
“The acquisition of Metacrine meaningfully strengthens
Equillium’s cash position,” said Bruce Steel, chief executive
officer at Equillium. “As we continue to execute on our ongoing
clinical development programs this cash runway extension is
expected to see us through multiple data catalysts and operational
milestones, including our interim data readout from the Type B
portion of the EQUALISE study in lupus nephritis patients in the
coming weeks followed by topline data in 2023; the initiation of a
Phase 2 clinical study of EQ101 in alopecia areata; initiation of a
Phase 1 SAD/MAD study of EQ102 in normal healthy volunteers and
celiac patients; and interim data from both EQ101 and EQ102. While
prioritizing our ongoing studies, we will carefully evaluate
strategic partnership options to advance the acquired MET642
program, an orally delivered Phase 2 ready FXR agonist program in
ulcerative colitis. Dr. Preston Klassen, president and CEO of
Metacrine, is ideally suited to help us in this endeavor and we are
pleased to announce his appointment to Equillium’s Board of
Directors in conjunction with the closing of the transaction.”
“I’m honored to be joining this experienced and talented team,”
said Preston Klassen, M.D., MHS, president and chief executive
officer of Metacrine. “I look forward to working with the Equillium
team to advance their exciting pipeline of clinical programs and
explore strategic opportunities for MET642. I strongly believe that
Metacrine shareholders will benefit from long-term value created by
the combination of our companies.”
Through the acquisition, Equillium adds 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
(IBD), including ulcerative colitis (UC) and Crohn’s disease.
MET642 is expected to address multiple aspects of IBD pathogenesis
including maintenance of epithelial barrier function and reduction
of bacterial translocation. Equillium will be seeking a strategic
partner with which to advance this program.
Transaction Details
The transaction consideration will be comprised entirely of
stock, where Equillium will issue stock valued at a 25% premium
over the net cash delivered at closing, which is estimated to be
approximately $26 million. Net cash is total cash, cash
equivalents, and short-term investments, adjusted by certain
factors including debt, which includes term debt with an
outstanding principal of $15 million, and other liabilities, as
defined in the merger agreement. The stock value will be based on
Equillium’s 10-day volume weighted average closing price calculated
ten trading days prior to closing, subject to a share price collar
ranging from $2.70 to $4.50. In addition, Equillium has agreed to
terms on an amended debt facility with Metacrine’s current lender,
K2 HealthVentures LLC, whereby Equillium would assume Metacrine’s
existing loan with an outstanding principal balance of $15 million,
along with potential access to an additional $10 million of
committed debt capital. Concurrent with the transaction closing,
Equillium intends to retire its existing debt facility with Oxford
Finance LLC and SVB, which currently has an outstanding principal
balance of $10 million. After paying off its existing debt
facility, Equillium expects to add an estimated $33 million of cash
to its balance sheet at closing. Equillium is not planning to
retain any current Metacrine employees and expects to assume
minimal operating expenses while maintaining sole discretion over
the timing and extent of advancing development of the Metacrine
programs. The acquisition is anticipated to close late 2022 pending
approval from both Equillium and Metacrine shareholders, Metacrine
having minimum net cash of $23 million, and other customary closing
conditions.
Preston Klassen, M.D., MHS, has served as president and chief
executive officer and as a member of the board of directors of
Metacrine since June 2020. From March 2017 to June 2020, Dr.
Klassen served as executive vice president, head of research and
development and chief medical officer of Arena Pharmaceuticals,
Inc. From June 2016 to March 2017, he was chief medical officer of
Laboratoris Sanifit S.L., and from November 2009 to May 2016, was
executive vice president, head of global development at Orexigen
Therapeutics, Inc. Dr. Klassen also held several positions of
increasing responsibility at Amgen Inc., including therapeutic area
head for nephrology. Before joining Amgen, he was a faculty member
in the Division of Nephrology at Duke University Medical Center.
Dr. Klassen received his medical degree from the University of
Nebraska College of Medicine, completed his residency in internal
medicine, fellowship in nephrology, and Master of Health Sciences
degree at Duke University and holds a B.S. in Chemistry from
Central University of Iowa.
Webcast and Conference Call
Management will host a conference call accompanied by a slide
presentation to discuss the acquisition of Metacrine for analysts
and institutional investors, at 8:30 am ET tomorrow, September 7,
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
https://www.equilliumbio.com/investors/events-and-presentations/default.aspx.
The webcast will be archived for 180 days.
MTS Securities LLC is serving as Metacrine’s financial advisor
for the transaction.
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 will file
a registration statement on Form S-4 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 WHEN THEY BECOME AVAILABLE BECAUSE THEY WILL CONTAIN
IMPORTANT INFORMATION ABOUT EQUILLIUM, METACRINE AND THE PROPOSED
MERGER. Investors may obtain free copies of the joint proxy
statement/prospectus (when available) 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
(when available) and Equillium’s other SEC filings are also
available on Equillium’s website at
http://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 http://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.
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, tri-specific
inhibitor of IL-2, IL-9 and IL-15, and EQ102, a first-in-class,
selective inhibitor of IL-15 and IL-21.
About Metacrine
Metacrine, Inc. is a clinical-stage biopharmaceutical company
building a pipeline of differentiated therapies to treat
gastrointestinal and liver diseases. Metacrine has developed a
proprietary farnesoid X receptor (FXR) platform utilizing a unique
chemical scaffold, which has demonstrated an improved therapeutic
profile in clinical trials.
To learn more, visit www.metacrine.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, a first-in-class
tri-specific cytokine inhibitor that selectively targets IL-2,
IL-9, and IL-15, is Phase 2 ready and expected to begin enrolling
patients in an alopecia areata study in the second half of 2022.
EQ102, a bi-specific cytokine inhibitor that selectively targets
IL-15 and IL-21, is ready for clinical development and expected to
begin enrolling patients in a Phase 1 study anticipated to include
normal healthy volunteers and celiac disease patients, in the
second half of 2022.
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 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 current
expectations, estimates, forecasts and projections of Equillium and
Metacrine; 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, 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: the
lack of assurances that the proposed merger 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; having to use cash in ways or on timing other than
expected and the impact of market volatility on cash reserves; and
economic, business, competitive, and/or regulatory factors
affecting the businesses of Equillium and Metacrine generally.
These and other risks and uncertainties are described more fully
under the caption "Risk Factors" and “Management’s Discussion and
Analysis of financial Condition and Results of Operations” sections
of their respective Annual Report on Form 10-K and Quarterly
Reports on Form 10-Q, their Current Reports on Form 8-K and other
and SEC filings and reports, which may be accessed for free by
visiting EDGAR on the SEC web site at http://www.sec.gov and on
Equillium’s and Metacrine’s respective 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 and Metacrine undertake no obligation to update
such statements to reflect events that occur or circumstances that
exist after the date on which they were made.
View source
version on businesswire.com: https://www.businesswire.com/news/home/20220906005973/en/
Investor Contact Michael Moore Vice President, Investor
Relations & Corporate Communications 619-302-4431
ir@equilliumbio.com
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