Eliem Therapeutics Reports Fourth Quarter and Year-End Financial Results and Business Highlights
07 March 2023 - 8:10AM
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 and year ended December 31, 2022.
“We are excited to advance our Kv7 program forward
with ETX-123 as the lead candidate,” said Andrew Levin, M.D.,
Ph.D., Executive Chairman of Eliem Therapeutics. “Our Kv7 program
utilizes 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 look forward to presenting preclinical data at
the 7th RSC-BMCS / SCI Symposium on Ion Channels as Therapeutic
Targets being held later this month. With a strong balance sheet
funding operations into 2027, we are in an optimal position to
execute on ETX-123 and the Kv7 program.”
Recent Highlights
- Announced Corporate Reorganization and Pipeline
Reprioritization to Focus on Advancing High Potential Kv7
Program: In February, the Company’s Board of Directors
determined that it is in the best interests of the Company and its
stockholders to reprioritize 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. The Company
paused 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. As part of this
reprioritization, the Company is retaining its core R&D team
under the continued leadership of Dr. Valerie Morisset, EVP R&D
and Chief Scientific Officer, to carry on driving forward the Kv7
Program and exploring other pipeline opportunities, and will reduce
its workforce by approximately 55% in the first half of 2023.
- Appointed Andrew Levin as Executive Chairman:
Following the corporate reorganization and departure of Bob Azelby,
Eliem’s former President and Chief Executive Officer, Andrew Levin,
current Chairman of the Board, was appointed as Executive Chairman
overseeing the day-to-day operations of the Company.
- Cash Runway Extended into 2027: As a result of
the corporate reorganization and pipeline reprioritization, the
Company’s current cash, cash equivalents and marketable securities
is expected to fund operations into 2027.
Program Updates and Anticipated Key
Milestones
- The Company has initiated the scaling up synthesis of the lead
Kv7 candidate, ETX-123, to enable the initiation of investigational
new drug (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.
- Initial ETX-123 preclinical data will be presented at the 7th
RSC-BMCS / SCI Symposium on Ion Channels as Therapeutic Targets
being held March 27-28, 2023 at the Wellcome Genome Campus in
Cambridge, UK.
Fourth Quarter and Year-End 2022 Financial
Results
- Cash Position: Cash, cash equivalents and marketable securities
were $123.6 million as of December 31, 2022, compared to $161.4
million as of December 31, 2021.
- Research and Development (R&D) expenses: R&D expenses
were $4.9 million for the three months ended December 31, 2022, and
$26.2 million for the full year 2022, compared to $6.9 million and
$23.3 million for comparable periods in 2021, respectively.
- General and Administrative (G&A) expenses: G&A expenses
were $4.6 million for the three months ended December 31, 2022, and
$18.9 million for the full year 2022, compared to $3.8 million and
$12.4 million for comparable periods in 2021, respectively.
- Net loss: Net loss was $7.8 million for the three months ended
December 31, 2022, and $45.2 million for the full year 2022,
compared to $10.5 million and $47.5 million for comparable periods
in 2021, respectively.
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 safety studies and planned initiation of Phase 1
studies in the first half of 2024; the exploration of future
pipeline opportunities; Eliem’s reorganization and pipeline
reprioritization, and the anticipated results thereof; 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,” “opportunities,” “planned,” “runway,”
“initiate,” “anticipated,” “milestones,” 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 Annual Report on Form 10-K
for the year ended December 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.
Investors Chris Brinzey ICR
Westwicke chris.brinzey@westwicke.com 339-970-2843
Media Marites Coulter Verge
Scientific Mcoulter@vergescientific.com 415.819.2214
|
Eliem
Therapeutics, Inc.Consolidated Balance
Sheets(In thousands, except share and per share
amounts) |
|
|
|
|
|
|
As of December 31, |
|
|
|
2022 |
|
|
2021 |
|
Assets |
|
|
|
|
|
|
Cash and cash equivalents |
|
$ |
43,585 |
|
|
$ |
46,922 |
|
Short-term marketable securities |
|
|
79,981 |
|
|
|
89,558 |
|
Prepaid expenses and other current assets |
|
|
10,827 |
|
|
|
11,772 |
|
Total current assets |
|
$ |
134,393 |
|
|
$ |
148,252 |
|
Operating lease right-of-use assets |
|
|
471 |
|
|
|
— |
|
Long-term marketable securities |
|
|
— |
|
|
|
24,919 |
|
Other long-term assets |
|
|
128 |
|
|
|
70 |
|
Total assets |
|
$ |
134,992 |
|
|
$ |
173,241 |
|
Liabilities and stockholders’ equity |
|
|
|
|
|
|
Current
liabilities: |
|
|
|
|
|
|
Accounts payable |
|
$ |
750 |
|
|
$ |
1,404 |
|
Accrued expenses |
|
|
5,047 |
|
|
|
4,627 |
|
Operating lease liabilities |
|
|
300 |
|
|
|
— |
|
Total current liabilities |
|
$ |
6,097 |
|
|
$ |
6,031 |
|
Other long-term liabilities |
|
|
— |
|
|
|
7 |
|
Operating lease liabilities, net of current portion |
|
|
180 |
|
|
|
— |
|
Total liabilities |
|
$ |
6,277 |
|
|
$ |
6,038 |
|
Commitments
and contingencies |
|
|
|
|
|
|
Stockholders’ equity |
|
|
|
|
|
|
Common stock, $0.0001 par value per share, 250,000,000 shares
authorized; 26,567,681 shares issued and outstanding at December
31, 2022 and December 31, 2021 |
|
|
3 |
|
|
|
3 |
|
Additional paid-in capital |
|
|
249,930 |
|
|
|
242,939 |
|
Accumulated other comprehensive loss |
|
|
(358 |
) |
|
|
(123 |
) |
Accumulated deficit |
|
|
(120,860 |
) |
|
|
(75,616 |
) |
Total
stockholders’ equity |
|
$ |
128,715 |
|
|
$ |
167,203 |
|
Total
liabilities and stockholders’ equity |
|
$ |
134,992 |
|
|
$ |
173,241 |
|
|
|
|
|
|
|
|
|
|
|
Eliem
Therapeutics, Inc.Consolidated Statements of
Operations(In thousands, except share and per share
amounts)(unaudited) |
|
|
|
|
|
|
|
|
|
Three Months Ended December 31, |
|
|
Year Ended December 31, |
|
|
|
2022 |
|
|
2021 |
|
|
2022 |
|
|
2021 |
|
Operating
expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
Research and development |
|
$ |
4,927 |
|
|
$ |
6,879 |
|
|
$ |
26,214 |
|
|
$ |
23,322 |
|
General and administrative |
|
|
4,627 |
|
|
|
3,824 |
|
|
|
18,921 |
|
|
|
12,350 |
|
Total operating expenses |
|
|
9,554 |
|
|
|
10,703 |
|
|
|
45,135 |
|
|
|
35,672 |
|
Loss from
operations |
|
|
(9,554 |
) |
|
|
(10,703 |
) |
|
|
(45,135 |
) |
|
|
(35,672 |
) |
Other income
(expense): |
|
|
|
|
|
|
|
|
|
|
|
|
Change in fair value of redeemable convertible preferred stock
tranche liability |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
(11,718 |
) |
Foreign currency gain (loss) |
|
|
1,032 |
|
|
|
98 |
|
|
|
(1,484 |
) |
|
|
(170 |
) |
Interest income, net |
|
|
760 |
|
|
|
60 |
|
|
|
1,375 |
|
|
|
80 |
|
Total other income (expense) |
|
|
1,792 |
|
|
|
158 |
|
|
|
(109 |
) |
|
|
(11,808 |
) |
Net
loss |
|
$ |
(7,762 |
) |
|
$ |
(10,545 |
) |
|
$ |
(45,244 |
) |
|
$ |
(47,480 |
) |
Accretion of
redeemable convertible preferred stock to redemption value and
cumulative preferred stock dividends |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
(4,548 |
) |
Net loss
attributable to common stockholders |
|
$ |
(7,762 |
) |
|
$ |
(10,545 |
) |
|
$ |
(45,244 |
) |
|
$ |
(52,028 |
) |
Net loss per
share attributable to common stockholders, basic and diluted |
|
$ |
(0.29 |
) |
|
$ |
(0.40 |
) |
|
$ |
(1.72 |
) |
|
$ |
(4.24 |
) |
Weighted-average number of shares outstanding used to compute net
loss per share attributable to common stockholders, basic and
diluted |
|
|
26,372,935 |
|
|
|
26,225,842 |
|
|
|
26,311,554 |
|
|
|
12,260,551 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Eliem Therapeutics (NASDAQ:ELYM)
Historical Stock Chart
From Mar 2024 to Apr 2024
Eliem Therapeutics (NASDAQ:ELYM)
Historical Stock Chart
From Apr 2023 to Apr 2024