Eledon Pharmaceuticals Reports Third Quarter 2023 Operating and Financial Results
09 Novembre 2023 - 10:01PM
Eledon Pharmaceuticals, Inc. (“Eledon”) (NASDAQ: ELDN) today
reported its third quarter operating and financial results and
reviewed recent business highlights.
“We were thrilled recently to report updated results from our
ongoing Phase 1b study that continue to validate tegoprubart’s
potential as an immunosuppressive agent that can prevent the
rejection of transplanted kidneys,” said David-Alexandre C. Gros,
M.D., Chief Executive Officer. “Tegoprubart demonstrated not only
the potential to preserve, but also to improve graft function in
comparison to the current standard of care treatment. Additionally,
during the quarter we initiated our Phase 2 BESTOW trial and had
the historic opportunity to support the second ever transplant of a
genetically modified heart from a pig to a human. We continue to
make significant progress toward our mission of bringing a
much-needed, new treatment option to the growing number of patients
undergoing kidney transplantation,” Dr. Gros continued.
Recent Corporate Developments
- Reported data from the ongoing Phase
1b open-label trial evaluating tegoprubart for the prevention of
rejection in patients undergoing kidney transplantation at the
American Society of Nephrology Kidney Week 2023 Annual Meeting that
took place in Philadelphia, PA from November 2-5, 2023. Data from
11 participants demonstrated that tegoprubart successfully
prevented kidney transplant rejection and was generally safe and
well-tolerated. Aggregate mean eGFR was above 70 mL/min/1.73m2 at
all reported time points after day 90 supporting tegoprubart’s
potential to protect organ function in patients undergoing kidney
transplantation.
- Announced that tegoprubart was used
as a cornerstone component of the chronic immunosuppressive regimen
administered following the second-ever transplant of a genetically
modified heart from a pig to a human. The procedure was completed
on September 20th at University of Maryland Medical Center on a
58-year-old male suffering from heart failure.
- Dosed the first participant in the
Phase 2 BESTOW trial evaluating tegoprubart for the prevention of
organ rejection in patients receiving a kidney transplant.
- Enrolled the first participant in
the Phase 2 open-label extension (OLE) study which will evaluate
the long-term safety, pharmacokinetics, and efficacy of tegoprubart
in participants who have completed one year of treatment in the
ongoing Phase 1b study, or the Phase 2 BESTOW study.
- Announced the publication of results
from a study evaluating tegoprubart as an immunomodulatory
monotherapy in nonhuman primate kidney and islet allotransplants in
Science Translational Medicine. Results from the study showed that
treatment with tegoprubart as a monotherapy promoted long-term
kidney and islet allograft survival and function in nonhuman
primates, indicating its potential as an immunomodulatory agent for
organ transplantation.
- Strengthened leadership team with
appointment of Eliezer Katz, M.D., FACS as Chief Medical
Officer.
- Appointed industry veteran James
Robinson and renowned transplant surgeon Allan Kirk, M.D., Ph.D.,
to its Board of Directors.
Upcoming Anticipated 2024 Milestones
- First Half 2024: Report updated
interim clinical data from the ongoing Phase 1b trial of
tegoprubart in kidney transplantation.
- End of 2024: Complete enrollment in
the Phase 2 BESTOW trial of tegoprubart in kidney
transplantation.
Third Quarter Financial Results
The company reported a net loss of $10.3 million,
or $0.35 per share, for the three months
ended September 30, 2023, compared to a net loss of $10.5
million, or $0.73 per share, for the same period in 2022.
Research and development expenses were $7.9
million for the three months ended September 30, 2023,
compared to $7.5 million for the comparable period in
2022, an increase of $0.4 million. The increase in research
and development expenses was primarily driven by an increase in
expenses related to the production of clinical trial materials of
$0.8 million. The increase was partially offset by a decrease in
employee compensation and benefits primarily driven by lower
non-cash stock-based compensation expenses and a decrease in
clinical development expenses with external contract research
organizations.
General and administrative expenses were $3.3
million for the three months ended September 30, 2023,
compared to $3.1 million for the comparable period in
2022, a decrease of $0.2 million. The increase in general and
administrative expenses was primarily driven by an increase in
employee compensation and benefits primarily driven by higher
non-cash stock-based compensation expenses.
The company had approximately $59.6 million in cash
and cash equivalents and short-term investments as
of September 30, 2023, compared to $56.4 million in
cash and cash equivalents as of December 31, 2022.
About Eledon Pharmaceuticals and
tegoprubart
Eledon Pharmaceuticals, Inc. is a clinical stage biotechnology
company that is developing immune-modulating therapies for the
management and treatment of life-threatening conditions. The
Company’s lead investigational product is tegoprubart, an
anti-CD40L antibody with high affinity for CD40 Ligand, a
well-validated biological target within the costimulatory
CD40/CD40L cellular pathway. The central role of CD40L
signaling in both adaptive and innate immune cell activation
and function positions it as an attractive target for
non-lymphocyte depleting, immunomodulatory therapeutic
intervention. The Company is building upon a deep historical
knowledge of anti-CD40 Ligand biology to conduct preclinical and
clinical studies in kidney allograft transplantation,
xenotransplantation, and amyotrophic lateral sclerosis (ALS).
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
Media Contact:
Jenna UrbanBerry & Company Public Relations(212) 253
8881jurban@berrypr.com
Source: Eledon Pharmaceuticals
ELEDON PHARMACEUTICALS, INC.
CONDENSED CONSOLIDATED BALANCE SHEETS (In
thousands, except share data)
(Unaudited)
|
|
September 30,2023 |
|
|
December 31,2022 |
|
ASSETS |
|
|
|
|
|
|
Current
assets: |
|
|
|
|
|
|
Cash and cash equivalents |
|
$ |
3,667 |
|
|
$ |
56,409 |
|
Short-term investments |
|
|
55,942 |
|
|
|
— |
|
Prepaid expenses and other current assets |
|
|
3,382 |
|
|
|
3,109 |
|
Total
current assets |
|
|
62,991 |
|
|
|
59,518 |
|
Operating lease asset, net |
|
|
459 |
|
|
|
739 |
|
In-process research and development |
|
|
32,386 |
|
|
|
32,386 |
|
Other
assets |
|
|
233 |
|
|
|
150 |
|
Total
assets |
|
$ |
96,069 |
|
|
$ |
92,793 |
|
LIABILITIES AND STOCKHOLDERS’ EQUITY |
|
|
|
|
|
|
Current
liabilities: |
|
|
|
|
|
|
Accounts payable |
|
$ |
465 |
|
|
$ |
2,200 |
|
Current operating lease liabilities |
|
|
396 |
|
|
|
363 |
|
Accrued expenses and other liabilities |
|
|
2,038 |
|
|
|
3,912 |
|
Total
current liabilities |
|
|
2,899 |
|
|
|
6,475 |
|
Deferred
tax liabilities |
|
|
1,752 |
|
|
|
1,752 |
|
Non-current operating lease liabilities |
|
|
83 |
|
|
|
383 |
|
Total
liabilities |
|
|
4,734 |
|
|
|
8,610 |
|
|
|
|
|
|
|
|
Commitments and contingencies |
|
|
|
|
|
|
|
|
|
|
|
|
|
Stockholders’ equity: |
|
|
|
|
|
|
Preferred stock, $0.001 par value, 5,000,000 shares authorized at
September 30, 2023 and December 31, 2022: |
|
|
|
|
|
|
Series X1non-voting convertible preferred stock, $0.001 par
value,515,000 shares designated; 110,086 and 117,970 shares issued
andoutstanding at September 30, 2023 and December 31, 2022,
respectively |
|
|
— |
|
|
|
— |
|
Series X non-voting convertible preferred stock, $0.001 par
value,10,000 shares designated; 4,422 and 6,204 shares issued
andoutstanding at September 30, 2023 and December 31, 2022,
respectively |
|
|
— |
|
|
|
— |
|
Common
stock, $0.001 par value, 200,000,000 shares authorized at September
30, 2023 and December 31, 2022; 23,545,130 and 13,776,788 shares
issued and outstanding at September 30, 2023 and December 31, 2022,
respectively |
|
|
24 |
|
|
|
14 |
|
Additional paid-in capital |
|
|
324,876 |
|
|
|
287,034 |
|
Accumulated deficit |
|
|
(233,565 |
) |
|
|
(202,865 |
) |
Total
stockholders’ equity |
|
|
91,335 |
|
|
|
84,183 |
|
Total
liabilities and stockholders’ equity |
|
$ |
96,069 |
|
|
$ |
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 MonthsEnded
September 30, |
|
|
For the Nine MonthsEnded
September 30, |
|
|
|
2023 |
|
|
2022 |
|
|
2023 |
|
|
2022 |
|
Operating expenses |
|
|
|
|
|
|
|
|
|
|
|
|
Research and development |
|
$ |
7,931 |
|
|
$ |
7,452 |
|
|
$ |
23,245 |
|
|
$ |
19,830 |
|
General
and administrative |
|
|
3,267 |
|
|
|
3,146 |
|
|
|
9,417 |
|
|
|
9,910 |
|
Total operating expenses |
|
|
11,198 |
|
|
|
10,598 |
|
|
|
32,662 |
|
|
|
29,740 |
|
Loss
from operations |
|
|
(11,198 |
) |
|
|
(10,598 |
) |
|
|
(32,662 |
) |
|
|
(29,740 |
) |
Other
income, net |
|
|
849 |
|
|
|
127 |
|
|
|
1,962 |
|
|
|
158 |
|
Net loss
and comprehensive loss |
|
$ |
(10,349 |
) |
|
$ |
(10,471 |
) |
|
$ |
(30,700 |
) |
|
$ |
(29,582 |
) |
Net loss
per share, basic and diluted |
|
$ |
(0.35 |
) |
|
$ |
(0.73 |
) |
|
$ |
(1.35 |
) |
|
$ |
(2.07 |
) |
Weighted-average common shares outstanding, basic and diluted |
|
|
29,974,400 |
|
|
|
14,265,905 |
|
|
|
22,813,085 |
|
|
|
14,289,729 |
|
Eledon Pharmaceuticals (NASDAQ:ELDN)
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