Eliem Therapeutics Reports First Quarter Financial Results and Business Highlights
May 11 2023 - 4:10PM
Eliem Therapeutics, Inc. (Nasdaq: ELYM), 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 business update and reported financial
results for the quarter ended March 31, 2023.
“We were excited to share our initial preclinical data from
ETX-123, our lead candidate in the Kv7 program, during the first
quarter,” said Andrew Levin, M.D., Ph.D., executive chairman of
Eliem Therapeutics. “The initial data demonstrate high potency and
differentiated selectivity. The data also confirm the proposed
mechanism of action on neuronal excitability, which we believe, has
the potential to improve the lives of patients suffering from a
variety of CNS disorders. With a strong balance sheet funding
operations into 2027, we expect to have the financial strength to
fund multiple catalysts and advance this exciting program into the
clinic.”
Recent Highlights
- Presented initial ETX-123
preclinical data at the 7th RSC-BMCS / SCI Symposium on Ion
Channels as Therapeutic Targets in March 2023. The data
presented confirmed ETX-123’s mechanism of action on neuronal
excitability via modulation of Kv7 and demonstrated its high
potency and differentiated selectivity for Kv7.2/3 in
electrophysiology assays. Further screens also confirmed an
encouraging broad selectivity profile, including no GABAA, hERG or
other off-target activities at anticonvulsant doses. Additionally,
in vivo oral administration of ETX-123 dose-dependently inhibited
seizures in the rat maximal electroshock seizures (MES) model, with
an encouraging separation versus doses that impaired performance in
the rotarod, a CNS side-effect profiling model.
- Additional preclinical data on
ETX-123 will be presented at two upcoming scientific and medical
conferences. The Company will present additional data at
the Epilepsy Therapies & Diagnostics Development XVII
Conference being held May 31-June 2, 2023 in Aventura, FL and at
the 2nd International Kv7 Channels Symposium 2023 being held
September 13-15, 2023 in Naples, Italy.
Program Updates and Anticipated Key
Milestones
- The Company has initiated synthesis
scale-up for its lead Kv7 candidate, ETX-123, to enable the
initiation of investigational new drug (IND)-enabling safety
studies, with Phase 1 clinical studies currently 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 MES rat model.
- A comprehensive update can be found in
the Company’s corporate presentation linked here.
First Quarter 2023 Financial Results
- Cash Position: Cash, cash equivalents
and marketable securities was $109.4 million as of March 31, 2023,
as compared to $123.6 million as of December 31, 2022. The
Company’s current cash, cash equivalents and marketable securities
are expected to fund operations into 2027.
- Research and Development (R&D)
expenses: R&D expenses were $5.7 million for the three months
ended March 31, 2023, compared to $8.3 million for the same period
in 2022.
- General and Administrative (G&A)
expenses: G&A expenses were $17.7 million for the three months
ended March 31, 2023, compared to $4.9 million for the same period
in 2022.
- Net loss: Net loss was $22.3 million
for the three months ended March 31, 2023, compared to $13.2
million for the same period in 2022.
- Net loss for the quarter included $15.8
million of one-time costs for termination benefits associated with
the recently announced corporate restructuring, of which $9.0
million related to stock-based compensation. Of these costs, $1.8
million was included in R&D expenses and $14.0 million in
G&A expenses.
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
continued development and clinical and therapeutic potential of
ETX-123; the progression of the Kv7.2/3 and next-generation
anxiolytic preclinical programs, including the initiation of IND
-enabling studies and planned initiation of Phase 1 studies in the
first half of 2024; the expectation that Eliem’s current cash, cash
equivalents and marketable securities will fund operations through
2027; future data presentations; and Eliem’s commitment to
developing therapies targeting debilitating disorders. Words such
as “excited,” “advance,” “look forward,” “believe,” “potential,”
“will,” “on track,” “expects,” “opportunity,” “continues,” “plans,”
“runway,” “initiate,” “anticipated,” “support,” 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 ETX-123 and Eliem’s other preclinical programs;
the availability of data at the expected times; 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 current 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 March 31, 2023. This filing, when
available, 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
MediaMarites CoulterVerge
ScientificMcoulter@vergescientific.com415-819-2214
Eliem Therapeutics, Inc.Condensed
Consolidated Balance Sheets(In thousands, except share and
per share amounts)(unaudited) |
|
|
|
March 31, 2023 |
|
|
December 31, 2022 |
|
Assets |
|
|
|
|
|
|
Cash, cash equivalents, and marketable securities |
|
$ |
109,372 |
|
|
$ |
123,566 |
|
Other assets |
|
|
12,713 |
|
|
|
11,426 |
|
Total assets |
|
$ |
122,085 |
|
|
$ |
134,992 |
|
Liabilities and
stockholders’ equity |
|
|
|
|
|
|
Liabilities |
|
|
5,225 |
|
|
|
6,277 |
|
Total stockholders’ equity |
|
|
116,860 |
|
|
|
128,715 |
|
Total liabilities and stockholders’ equity |
|
$ |
122,085 |
|
|
$ |
134,992 |
|
Condensed Consolidated Statements of Operations(In
thousands, except share and per share
amounts)(unaudited) |
|
|
|
|
|
Three Months Ended March 31, |
|
|
|
2023 |
|
|
2022 |
|
Operating
expenses: |
|
|
|
|
|
|
Research and development |
|
$ |
5,720 |
|
|
$ |
8,260 |
|
General and administrative |
|
|
17,718 |
|
|
|
4,872 |
|
Total operating expenses |
|
|
23,438 |
|
|
|
13,132 |
|
Loss from operations |
|
|
(23,438 |
) |
|
|
(13,132 |
) |
Other income (expense), net |
|
|
1,148 |
|
|
|
(72 |
) |
Net loss |
|
$ |
(22,290 |
) |
|
$ |
(13,204 |
) |
Net loss per share, basic and
diluted |
|
$ |
(0.84 |
) |
|
$ |
(0.50 |
) |
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