Eledon Pharmaceuticals Reports First Quarter 2023 Operating and Financial Results
11 Mai 2023 - 10:01PM
Eledon Pharmaceuticals, Inc. (“Eledon”) (NASDAQ: ELDN) today
reported its first quarter operating and financial results and
reviewed recent business highlights.
“Eledon made significant progress this year in advancing the
clinical development of tegoprubart as well as securing financing
for its future development. We are now well positioned to make
significant strides in our evaluation of tegoprubart as a potential
and much needed replacement for CNIs in kidney transplant
immunomodulation,” said David-Alexandre C. Gros, M.D., Chief
Executive Officer. “The data we presented from our ongoing Phase 1b
study demonstrating clinical benefit in the prevention of rejection
and the protection of kidneys after transplantation validate our
focus on tegoprubart as a potentially transformational therapeutic
option for patients receiving kidney transplants. Following our
recent financing, we are now well capitalized and are building
strong momentum heading into the initiation of our Phase 2 BESTOW
trial in the middle of this year. We are excited to evaluate
tegoprubart in comparison to the standard of care, while continuing
to generate incremental data from our Phase 1b study which we plan
to report later in the year.”
First Quarter 2023 and Recent Corporate
Developments
- Reported positive results from the
first three participants dosed in the ongoing Phase 1b trial
evaluating tegoprubart in patients undergoing kidney
transplantation at the World Congress of Nephrology 2023 (WCN).
Results indicated no incidence of acute rejection at durations of
56, 154, and 232 days, respectively. In addition, strong graft
function was observed in all three participants with mean eGFRs
above 70 mL/min/1.73m2 at measured timepoints out to 31 weeks. To
date, six patients have been enrolled in the study, which will
continue in parallel with the upcoming Phase 2 BESTOW trial.
- Announced the completion of a
financing worth up to $185 million, with $35 million in upfront
funding and additional aggregate financing up to $105 million,
subject to achieving clinical development milestones, volume
weighted share price levels, and trading volume conditions, plus up
to $45 million upon exercise of warrants. The financing is expected
to be sufficient to fund the Company through the completion of the
Phase 2 BESTOW trial, subject to the achievement of specified
milestones, including clinical development enrollment targets.
- Reported safety data from the
high-dose cohort of the Company’s Phase 2a open-label study
evaluating tegoprubart for the treatment of IgA Nephropathy (IgAN)
demonstrating tegoprubart to be safe and well tolerated with no
serious nor severe adverse events reported and no early
discontinuations. Four participants had completed at least 24 weeks
on treatment and five others completed at least 12 weeks.
- To date, approximately 100 human
subjects have been dosed with tegoprubart across multiple disease
indications.
- Announced clinical collaboration
with eGenesis for the use of tegoprubart in eGenesis’ ongoing
xenograft transplant preclinical research and development studies.
The collaboration has the potential to span multiple eGenesis
programs, including kidney and heart transplant.
Upcoming Anticipated 2023 Milestones
Mid-2023: initiate Phase 2 BESTOW trial of tegoprubart in kidney
transplantation.
Late-2023: report updated clinical data from ongoing Phase 1b
trial of tegoprubart in kidney transplantation.
Financial Results for the Three Months Ended March
31, 2023
The Company reported a net loss of $10.8 million,
or $0.75 per share, for the three months ended March
31, 2023, compared to a net loss of $9.9 million,
or $0.69 per share, for the same period in 2022.
Research and development expenses were $8.1
million for the three months ended March 31, 2023,
compared to $6.6 million for the comparable period in
2022, an increase of $1.5 million. The increase was primarily
due to higher clinical development expenses of $2.1 million
and an increase in personnel costs of $0.4 million, due to
increased headcount. The increase was partially offset by decreases
in stock-based compensation of $0.5 million, manufacturing costs of
$0.3 million, and consulting expenses of $0.2 million.
General and administrative expenses were $3.0
million for the three months ended March 31, 2023,
compared to $3.2 million for the comparable period in
2022, a decrease of $0.2 million. The decrease was primarily
related to lower stock-based compensation costs of $0.3 million,
which was partially offset by an increase in personnel expenses of
$0.1 million.
Eledon ended the first quarter with approximately $46.5 million
in cash and cash equivalents, which excludes the $35.0 million
received in the recent financing during the second quarter.
Conference Call
Eledon will hold a conference call today, May 11,
2023 at 4:30 pm Eastern Time to discuss first
quarter results. The dial-in numbers are 1-888-886-7786 for
domestic callers and 1-416-764-8658 for international callers. The
conference ID is 11107025. A live webcast of the conference call
will be available on the Investor Relations section of the
Company's website at www.eledon.com. The webcast will be
archived on the website following the completion of the call.
About Eledon Pharmaceuticals and tegoprubart
(formerly AT-1501)
Eledon Pharmaceuticals is a clinical stage biotechnology
company using its immunology expertise in targeting the CD40 Ligand
(CD40L, also called CD154) pathway to develop therapies to protect
transplanted organs and prevent rejection, and to treat ALS. The
company’s lead compound in development is tegoprubart, an
anti-CD40L antibody with high affinity for CD40 Ligand, a
well-validated biological target with broad therapeutic potential.
Eledon is headquartered in Irvine, California. For more
information, please visit the company’s website
at www.eledon.com.
Follow Eledon Pharmaceuticals on social
media: LinkedIn; Twitter
Forward-Looking Statements
This press release contains forward-looking statements that
involve substantial risks and uncertainties. Any statements about
the company’s future expectations, plans and prospects, including
statements about planned clinical trials, the development of
product candidates, expected timing for initiation of future
clinical trials, expected timing for receipt of data from clinical
trials, the company’s capital resources and ability to finance
planned clinical trials, as well as other statements containing the
words “believes,” “anticipates,” “plans,” “expects,” “estimates,”
“intends,” “predicts,” “projects,” “targets,” “looks forward,”
“could,” “may,” and similar expressions, constitute forward-looking
statements within the meaning of the Private Securities Litigation
Reform Act of 1995. Forward-looking statements are inherently
uncertain and are subject to numerous risks and uncertainties,
including: risks relating to the safety and efficacy of our drug
candidates; risks relating to clinical development timelines,
including interactions with regulators and clinical sides, as well
as patient enrollment; risks relating to costs of clinical trials
and the sufficiency of the company’s capital resources to fund
planned clinical trials; and risks associated with the impact of
the ongoing coronavirus pandemic. Actual results may differ
materially from those indicated by such forward-looking statements
as a result of various factors. These risks and uncertainties, as
well as other risks and uncertainties that could cause the
company’s actual results to differ significantly from the
forward-looking statements contained herein, are discussed in our
quarterly 10-Q, annual 10-K, and other filings with the U.S.
Securities and Exchange Commission, which can be found
at www.sec.gov. Any forward-looking statements contained in
this press release speak only as of the date hereof and not of any
future date, and the company expressly disclaims any intent to
update any forward-looking statements, whether as a result of new
information, future events or otherwise.
Investor Contact:Stephen JasperGilmartin
Group(858) 525 2047stephen@gilmartinir.com
Source: Eledon Pharmaceuticals
|
ELEDON PHARMACEUTICALS, INC. CONDENSED
CONSOLIDATED BALANCE SHEETS (In thousands, except
share data) (Unaudited) |
|
|
|
March 31,2023 |
|
December 31,2022 |
ASSETS |
|
|
|
|
Current assets: |
|
|
|
|
Cash and cash equivalents |
|
$ |
46,485 |
|
|
$ |
56,409 |
|
Prepaid expenses and other current assets |
|
|
2,419 |
|
|
|
3,109 |
|
Total current assets |
|
|
48,904 |
|
|
|
59,518 |
|
Operating lease asset, net |
|
|
647 |
|
|
|
739 |
|
In-process research and development |
|
|
32,386 |
|
|
|
32,386 |
|
Other assets |
|
|
369 |
|
|
|
150 |
|
Total assets |
|
$ |
82,306 |
|
|
$ |
92,793 |
|
LIABILITIES AND STOCKHOLDERS’ EQUITY |
|
|
|
|
Current liabilities: |
|
|
|
|
Accounts payable |
|
$ |
2,852 |
|
|
$ |
2,200 |
|
Current operating lease liabilities |
|
|
384 |
|
|
|
363 |
|
Accrued expenses and other liabilities |
|
|
2,242 |
|
|
|
3,912 |
|
Total current liabilities |
|
|
5,478 |
|
|
|
6,475 |
|
Deferred tax liabilities |
|
|
1,752 |
|
|
|
1,752 |
|
Non-current operating lease liabilities |
|
|
284 |
|
|
|
383 |
|
Total liabilities |
|
|
7,514 |
|
|
|
8,610 |
|
|
|
|
|
|
Commitments and contingencies (Note 6) |
|
|
|
|
|
|
|
|
|
Stockholders’ equity: |
|
|
|
|
Preferred stock, $0.001 par value, 5,000,000 shares authorized at
March 31, 2023 and December 31, 2022: |
|
|
|
|
Series X1 non-voting convertible preferred stock, $0.001 par value,
515,000 shares designated; 117,970 shares issued and outstanding at
March 31, 2023 and December 31, 2022 |
|
|
— |
|
|
|
— |
|
Series X non-voting convertible preferred stock, $0.001 par value,
10,000 shares designated; 6,204 shares issued and outstanding at
March 31, 2023 and December 31, 2022 |
|
|
— |
|
|
|
— |
|
Common stock, $0.001 par value, 200,000,000 shares authorized at
March 31, 2023 and December, 31, 2022; 13,776,788 shares issued and
outstanding at March 31, 2023 and December 31, 2022 |
|
|
14 |
|
|
|
14 |
|
Additional paid-in capital |
|
|
288,415 |
|
|
|
287,034 |
|
Accumulated deficit |
|
|
(213,637 |
) |
|
|
(202,865 |
) |
Total stockholders’ equity |
|
|
74,792 |
|
|
|
84,183 |
|
Total liabilities and stockholders’ equity |
|
$ |
82,306 |
|
|
$ |
92,793 |
|
|
ELEDON PHARMACEUTICALS, INC. CONDENSED
CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE
LOSS (In thousands, except share and per share
data) (Unaudited) |
|
|
|
For the Three Months Ended March 31, |
|
|
|
2023 |
|
|
|
2022 |
|
Operating expenses |
|
|
|
|
Research and development |
|
$ |
8,113 |
|
|
$ |
6,635 |
|
General and administrative |
|
|
2,997 |
|
|
|
3,224 |
|
Total operating expenses |
|
|
11,110 |
|
|
|
9,859 |
|
Loss from operations |
|
|
(11,110 |
) |
|
|
(9,859 |
) |
Other income (expense), net |
|
|
338 |
|
|
|
(5 |
) |
Net loss and comprehensive loss |
|
$ |
(10,772 |
) |
|
$ |
(9,864 |
) |
Net loss per share, basic and diluted |
|
$ |
(0.75 |
) |
|
$ |
(0.69 |
) |
Weighted-average common shares outstanding, basic and diluted |
|
|
14,285,905 |
|
|
|
14,330,693 |
|
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