Eliem Therapeutics, Inc. (Nasdaq: ELYM), a clinical-stage
biotechnology company focused on developing novel therapies for
neuronal excitability disorders to address unmet needs in chronic
pain, psychiatry, epilepsy 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, 2022.
“We are excited about the potential of our pipeline in multiple
neuronal excitability disorders,” said Bob Azelby, president and
chief executive officer of Eliem Therapeutics. “While disappointed
by the negative outcome of ETX-810 in diabetic peripheral
neuropathic pain, we look forward to providing the topline Phase 2a
data for ETX-810 in lumbosacral radicular pain, the chronic pain
indication with the most robust precedent clinical validation for
this mechanism, in the third quarter of 2022. In addition to
ETX-810, we remain committed to the development of our ETX-155
program in depression and epilepsy and will provide an update on
our path forward once we complete our previously reported root
cause analysis relating to the interim results from our Phase 1b
photosensitive epilepsy trial. Due to our strong balance sheet, we
also intend to advance our novel Kv7 channel opener program into
IND-enabling studies this year and we continue to believe this
program has potential to be best-in-class.”
Program Updates and Anticipated Key
Milestones
ETX-810 in chronic pain: ETX-810 is a novel,
new chemical entity prodrug of the bioactive lipid
palmitoylethanolamide (PEA) that is currently being evaluated in a
Phase 2a clinical trial in subjects with lumbosacral radicular pain
(LSRP), commonly referred to as sciatica. The Company announced the
completion of enrollment of the LSRP Phase 2a trial in April 2022,
with topline data expected in the third quarter of 2022.
In addition, in April 2022, the Company reported topline data from
its Phase 2a trial in diabetic peripheral neuropathic pain (DPNP),
which did not meet the primary endpoint.
ETX-155 in depression and epilepsy: ETX-155 is
a novel GABAA receptor positive allosteric modulator that the
Company plans to evaluate in subjects with major depressive
disorder (MDD), perimenopausal depression (PMD), and epilepsy. In
March 2022, the Company received clearance from the U.S. Food and
Drug Administration (FDA) of the investigational new drug
application (IND) for two Phase 2a clinical trials for ETX-155 in
patients with MDD and PMD. In April 2022, the Company reported that
interim results from the first three subjects in its Phase 1b
proof-of-concept trial for ETX-155 in photosensitive epilepsy were
inconclusive, and that this was attributed to a lower-than-expected
drug exposure in these subjects relative to exposures observed in
Phase 1. The Company is in the process of investigating the root
cause of this reduced exposure and has elected to delay enrollment
of the Phase 2a MDD and PMD trials pending further information from
this root cause investigation.
Kv7.2/3 channel opener program: The Company’s
preclinical program targets the Kv7.2/3 potassium channel, a target
that has been shown to control neuronal excitability and that has
clinical validation in pain and epilepsy. The Company remains on
track to initiate IND-enabling studies in 2022.
Anxiolytic for generalized anxiety disorder
(GAD): The Company is in early preclinical development of
a novel, rapid-acting, non-sedating, non-addictive anxiolytic for
the potential treatment of GAD. The Company is continuing the
preclinical development of this program with the intent to provide
a development plan update later in 2022.
First Quarter 2022 Financial Results
- Cash Position: Cash, cash equivalents and short- and long-term
marketable securities was $149.9 million as of March 31, 2022, as
compared to $47.9 million as of March 31, 2021. This includes net
proceeds from the Company’s August 2021 initial public offering.
The Company’s current cash, cash equivalents and short- and
long-term marketable securities are expected to fund operations
through at least 2023.
- Research and Development (R&D) expenses: R&D expenses
were $8.3 million for the three months ended March 31, 2022,
compared to $4.7 million for the same period in 2021.
- General and Administrative (G&A) expenses: G&A expenses
were $4.9 million for the three months ended March 31, 2022,
compared to $2.2 million for the same period in 2021.
- Net loss: Net loss was $13.2 million for the three months ended
March 31, 2022, compared to $18.6 million for the same period in
2021. The same period in 2021 included a non-recurring $11.7
million expense related to a change in fair value of redeemable
convertible preferred stock.
About Eliem Therapeutics,
Inc.
Eliem Therapeutics, Inc. is a clinical-stage biotechnology
company focused on developing novel therapies for neuronal
excitability disorders to address unmet needs in chronic pain,
psychiatry, epilepsy 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
Eliem’s pipeline; Eliem’s plans for clinical trials of ETX-155 and
the timing thereof; the anticipated topline data readout of ETX-810
in LSRP and the timing thereof; the progression of the Kv7.2/3 and
next-generation anxiolytic preclinical programs; the expectation
that Eliem’s current cash, cash equivalents and short- and
long-term marketable securities will fund operations through at
least 2023; and Eliem’s commitment to developing therapies
targeting debilitating disorders. Words such as “advance,”
“believe,” “committed,” “continue,” “excited,” “expected,”
“initiate,” “intend,” “intent,” “investigation,” “look forward,”
“on track,” “plans,” “potential,” “remain,” “update,” “will,” 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-810, ETX-155 and Eliem’s preclinical
programs; risks related to the potential failure of ETX-810 and
ETX-155 to demonstrate safety and efficacy in clinical testing;
Eliem’s ability to initiate and conduct clinical trials and studies
of ETX-810 and ETX-155 sufficient to achieve a positive completion;
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, 2022. 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 BrinzeyICR
Westwickechris.brinzey@westwicke.com 339-970-2843
MediaMarites CoulterVerge
ScientificMcoulter@vergescientific.com 415.819.2214
|
Eliem Therapeutics, Inc. Consolidated
Balance Sheets (In thousands, except share and per share
amounts) |
|
|
|
|
|
|
|
|
|
Assets |
|
March 31, 2022 |
|
|
December 31, 2021 |
|
Current assets: |
|
|
|
|
|
|
Cash and cash equivalents |
|
$ |
31,931 |
|
|
$ |
46,922 |
|
Short-term marketable securities |
|
|
92,010 |
|
|
|
89,558 |
|
Prepaid expenses and other current assets |
|
|
9,342 |
|
|
|
11,772 |
|
Total current assets |
|
$ |
133,283 |
|
|
$ |
148,252 |
|
Operating lease right-of-use assets |
|
|
807 |
|
|
|
— |
|
Long-term marketable securities |
|
|
25,911 |
|
|
|
24,919 |
|
Other long-term assets |
|
|
2,418 |
|
|
|
70 |
|
Total assets |
|
$ |
162,419 |
|
|
$ |
173,241 |
|
Liabilities and stockholders’ equity |
|
|
|
|
|
|
Current
liabilities: |
|
|
|
|
|
|
Accounts payable |
|
|
847 |
|
|
|
1,404 |
|
Accrued expenses |
|
|
5,481 |
|
|
|
4,588 |
|
Accrued expenses, related party |
|
|
109 |
|
|
|
39 |
|
Operating lease liabilities, current |
|
|
459 |
|
|
|
|
Total current liabilities |
|
$ |
6,896 |
|
|
$ |
6,031 |
|
Other long-term liabilities |
|
|
— |
|
|
|
7 |
|
Operating lease liabilities, net of current portion |
|
|
381 |
|
|
|
— |
|
Total liabilities |
|
$ |
7,277 |
|
|
$ |
6,038 |
|
Commitments and contingencies (Note 6) |
|
|
|
|
|
|
Stockholders’ equity |
|
|
|
|
|
|
Common stock, $0.0001 par value per share, 250,000,000 shares
authorized; 26,567,681 shares issued and outstanding at March 31,
2022 and December 31, 2021, respectively |
|
|
3 |
|
|
|
3 |
|
Additional paid-in capital |
|
|
244,480 |
|
|
|
242,939 |
|
Accumulated other comprehensive loss |
|
|
(521 |
) |
|
|
(123 |
) |
Accumulated deficit |
|
|
(88,820 |
) |
|
|
(75,616 |
) |
Total stockholders’ equity |
|
$ |
155,142 |
|
|
$ |
167,203 |
|
Total liabilities and stockholders’ equity |
|
$ |
162,419 |
|
|
$ |
173,241 |
|
|
|
|
|
|
|
|
|
|
Eliem Therapeutics, Inc.Consolidated
Statements of Operations and Comprehensive Loss(In
thousands, except share and per share amounts)(unaudited) |
|
|
|
|
|
|
Three Months Ended March 31, |
|
|
|
2022 |
|
|
2021 |
|
Operating expenses: |
|
|
|
|
|
|
Research and development |
|
$ |
8,111 |
|
|
$ |
4,273 |
|
Research and development, related party |
|
|
149 |
|
|
|
388 |
|
General and administrative |
|
|
4,872 |
|
|
|
2,218 |
|
Total operating expenses |
|
|
13,132 |
|
|
|
6,879 |
|
Loss
from operations |
|
|
(13,132 |
) |
|
|
(6,879 |
) |
Other
income (expense): |
|
|
|
|
|
|
Change in fair value of redeemable convertible preferred stock
tranche liability |
|
|
— |
|
|
|
(11,718 |
) |
Foreign currency loss |
|
|
(157 |
) |
|
|
(4 |
) |
Other income, net |
|
|
85 |
|
|
|
— |
|
Total other income (expense) |
|
|
(72 |
) |
|
|
(11,722 |
) |
Net
loss |
|
$ |
(13,204 |
) |
|
$ |
(18,601 |
) |
Accretion of redeemable convertible preferred stock to redemption
value and cumulative preferred stock dividends |
|
|
— |
|
|
|
(1,085 |
) |
Net loss
attributable to common stockholders |
|
$ |
(13,204 |
) |
|
$ |
(19,686 |
) |
Net loss
per share attributable to common stockholders, basic and
diluted |
|
$ |
(0.50 |
) |
|
$ |
(5.70 |
) |
Weighted-average number of shares outstanding used to compute net
loss per share attributable to common stockholders, basic and
diluted |
|
|
26,238,950 |
|
|
|
3,455,979 |
|
|
|
|
|
|
|
|
Comprehensive loss: |
|
|
|
|
|
|
Net
loss |
|
$ |
(13,204 |
) |
|
$ |
(18,601 |
) |
Other
comprehensive loss: |
|
|
|
|
|
|
Unrealized loss on investments, net of tax of $0 |
|
|
(398 |
) |
|
|
— |
|
Comprehensive loss |
|
$ |
(13,602 |
) |
|
$ |
(18,601 |
) |
Eliem Therapeutics (NASDAQ:ELYM)
Historical Stock Chart
From Aug 2024 to Sep 2024
Eliem Therapeutics (NASDAQ:ELYM)
Historical Stock Chart
From Sep 2023 to Sep 2024