Eliem Therapeutics, Inc. (Nasdaq: ELYM) (“Eliem” or the
“Company”), a biotechnology company focused on developing novel
therapies for neuronal excitability disorders to address unmet
needs in psychiatry, epilepsy, chronic pain, and other disorders of
the peripheral and central nervous systems, today provided a
strategic business update and announced a leadership transition.
Pipeline Reprioritization
The Company’s Board of Directors has determined that it is in
the best interests of the Company and its stockholders to
re-prioritize Eliem’s pipeline to focus on its high potential
preclinical Kv7.2/3 program (“Kv7 Program”) and the development of
its lead Kv7.2/3 candidate, ETX-123. Kv7.2/3 is a target that has
clinical validation in epilepsy and pain, with further potential in
depression disorders. Eliem has identified multiple Kv7.2/3
modulators in a novel and highly differentiated chemical space, and
its lead candidate, ETX-123, has demonstrated excellent potency,
selectivity, and in vivo anticonvulsant activity. The Company plans
to commence a first-in-human Phase 1 trial in the first half of
2024.
In connection with its focus on the Kv7 Program, the Company
will pause all further development of ETX-155, a novel GABAA
receptor positive allosteric modulator neuroactive steroid (“GABAA
PAM”) that is Phase 2-ready for major depressive disorder (MDD),
with the potential to also pursue development in epilepsy. The
Company has completed Phase 1 clinical trials, which demonstrated
an encouraging pharmacokinetic, safety and tolerability profile for
the 60-milligram dose of ETX-155. A Phase 2a clinical trial in
subjects with MDD was ready to initiate in the current
quarter. However, the Board determined that, given
current capital market conditions and investor sentiment around the
GABAA PAM opportunity in MDD, it is not in the best interests of
the Company or its stockholders to invest in the Phase 2a MDD trial
at this time. Eliem would like to thank employees, investigators
and vendors who were operationalizing the Phase 2a clinical
trial.
Corporate Reorganization and Leadership
Transition
As a result of the decision to pause the development of ETX-155
and focus on the Kv7 Program, the Board has approved a corporate
reorganization plan to conserve financial resources. As part of the
reorganization, the Company will reduce its workforce by
approximately 55% in the first half of 2023.
The Company will continue its focus on treatments for neuronal
excitability disorders, and is retaining its core R&D team, led
by Dr. Valerie Morisset, EVP R&D and Chief Scientific Officer.
This team will carry on driving ETX-123 development forward and
executing on other pipeline opportunities, including other
opportunities for the Kv7 Program.
Eliem has also announced today that, in connection with this
reorganization, Bob Azelby, president and chief executive officer,
and a member of the Eliem Board, will be departing the Company and
the Board imminently, and Andrew Levin, current Chairman of the
Board, has been appointed as Executive Chairman overseeing the
day-to-day operations of the Company, effective upon Mr. Azelby’s
departure.
In addition, Erin Lavelle, executive vice president, chief
operating officer and chief financial officer, and Jim Bucher,
executive vice president and general counsel, will depart the
Company following a short transition period.
“We are excited about this next chapter for Eliem with our
encouraging Kv7 Program, utilizing a proven mechanism of action,
which we believe has the potential to improve the lives of patients
suffering from a variety of CNS disorders. We believe the Company
is well positioned to execute on ETX-123 and the overall Kv7
Program, and our current balance sheet provides us significant
runway to see the program through compelling data catalysts,” said
Dr. Levin. “On behalf of the full Board, I extend my deepest
gratitude to Bob, Erin, and Jim for their leadership and
contributions to Eliem, and to our departing employees for all
their efforts on behalf of the Company.”
The Company preliminarily estimates that its cash, cash
equivalents and marketable securities were $123.6 million as of
December 31, 2022. This preliminary estimate is not a comprehensive
statement of the Company’s financial results for the year ended
December 31, 2022 and has not been audited, reviewed, or compiled
by its independent registered public accounting firm. The Company’s
current cash, cash equivalents and marketable securities are
expected to fund operations into 2027, with further guidance to be
provided as clinical data is available for the Kv7 Program.
Overview of Eliem’s Kv7.2/3 Channel Opener
Program
The Company’s preclinical program targets the Kv7.2/3 potassium
channel (Kv7), a target that has clinical validation in pain and
epilepsy.
- The Company has
initiated the scaling up synthesis of its lead candidate ETX-123,
to enable the initiation of IND-enabling safety studies, with Phase
1 studies planned to initiate in the first half of 2024.
- The Company’s
novel Kv7 compounds, including additional pre-candidates, have
demonstrated high potency and differentiated selectivity in
electrophysiology assays, and in vivo anticonvulsant activity in
the maximal electroshock seizure (MES) rat model.
- The Company has
filed foundational intellectual property claims on its novel Kv7
compounds.
About Eliem Therapeutics, Inc.
Eliem Therapeutics, Inc. is a biotechnology company focused on
developing novel therapies for neuronal excitability disorders to
address unmet needs in psychiatry, epilepsy, chronic pain, and
other disorders of the peripheral and central nervous systems.
These disorders often occur when neurons are overly excited or
inhibited, leading to an imbalance, and our focus is on restoring
homeostasis. We are developing a pipeline of clinically
differentiated product candidates focused on validated mechanisms
of action with broad therapeutic potential to deliver improved
therapeutics for patients with these disorders. Eliem channels its
experience, energy, and passion for improving patients’ quality of
life to fuel our efforts to develop life-changing novel therapies.
At its core, the Eliem team is motivated by the promise of helping
patients live happier, more fulfilling lives.
https://eliemtx.com/
Forward-Looking Statements
This press release contains forward-looking statements,
including, without limitation, statements relating to: the
advancement of Eliem’s pipeline; the continued development and
clinical and therapeutic potential of Eliem’s Kv7 channel opener
program; Eliem’s planned activities and expectations for the Kv7
channel opener program, including the initiation of IND-enabling
safety studies and Phase 1 studies, and the timing thereof; Eliem’s
belief that it is well financed and that its current cash, cash
equivalents and marketable securities will fund operations into
2027; Eliem’s commitment to developing therapies targeting neuronal
excitability disorders; and certain of Eliem’s preliminary
financial results as of December 31, 2022. Words such as
“advanced,” “believe,” “encouraging,” “excited,” “expected,”
“focus,” “initiate,” “planned,” “positioned,” “potential,”
“progressing,” “remain,” “reported,” “would,” or other similar
expressions, identify forward-looking statements, but the absence
of these words does not necessarily mean that a statement is not
forward-looking. In addition, any statements that refer to
expectations, projections or other characterizations of future
events or circumstances are forward-looking statements. The
forward-looking statements in this press release are based upon
Eliem’s current plans, assumptions, beliefs, expectations,
estimates and projections, and involve substantial risks and
uncertainties. Actual results and the timing of events could differ
materially from those anticipated in the forward-looking statements
due to these risks and uncertainties as well as other factors,
which include, without limitation: the clinical, therapeutic and
commercial value of the Kv7 program; risks related to the potential
failure of the Kv7 program to demonstrate safety and efficacy in
clinical testing; Eliem’s ability to initiate and conduct clinical
trials and studies of Kv7 program sufficient to achieve a positive
completion; Eliem’s ability to obtain and protect intellectual
property rights, and operate without infringing on the intellectual
property rights of others; the uncertain timing and level of
expenses associated with Eliem’s preclinical and clinical
development activities; the sufficiency of Eliem’s capital and
other resources; risks and uncertainties related to regulatory
application, review and approval processes and Eliem’s compliance
with applicable legal and regulatory requirements; market
competition; changes in economic and business conditions; impacts
on Eliem’s business due to external events, including health
pandemics or other contagious outbreaks, such as the COVID-19
pandemic; and other factors discussed under the caption “Risk
Factors” in Eliem’s Quarterly Report on Form 10-Q for the quarterly
period ended September 30, 2022. This filing is available on the
SEC’s website at www.sec.gov. Additional information will also be
set forth in Eliem’s other reports and filings it will make with
the SEC from time to time. The forward-looking statements made in
this press release speak only as of the date of this press release.
Eliem expressly disclaims any duty, obligation or undertaking to
release publicly any updates or revisions to any forward-looking
statements contained herein to reflect any change in Eliem’s
expectations with regard thereto or any change in events,
conditions or circumstances on which any such statements are
based.
InvestorsChris Brinzey ICR
Westwickechris.brinzey@westwicke.com339-970-2843
MediaAndy Brimmer / Jamie Moser / Aura
Reinhard Joele Frank, Wilkinson Brimmer
Katcher 212-355-4449
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