Eledon Pharmaceuticals Reports Second Quarter 2023 Operating and Financial Results
August 10 2023 - 6:00AM
Eledon Pharmaceuticals, Inc. (“Eledon”) (NASDAQ: ELDN) today
reported its second quarter operating and financial results and
reviewed recent business highlights.
“We have now transplanted nine patients in our ongoing Phase 1b
kidney transplantation trial and remain highly encouraged by the
results to date,” said David-Alexandre C. Gros, M.D., Chief
Executive Officer. “We believe that tegoprubart could represent a
significant advancement in immunosuppressive therapy following
kidney transplantation and look forward to presenting updated data
from our Phase 1b at a medical conference next quarter. In
addition, we have started activating sites in our BESTOW Phase 2
kidney transplantation trial and are progressing towards dosing the
first patient.”
Second Quarter 2023 and Recent Corporate
Developments
- Announced the closing of a financing
worth up to $185 million, with $35 million in upfront funding and
additional aggregate financing of up to $105 million, subject to
achieving clinical development milestones, volume weighted share
price levels, and trading volume conditions, as well as up to an
additional $45 million upon exercise of warrants. If all
commitments are met, 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.
- Dosed the ninth patient in the
ongoing Phase 1b trial evaluating tegoprubart in patients
undergoing kidney transplantation. This trial will be conducted in
parallel with the Phase 2 BESTOW trial. The Company anticipates
reporting updated interim clinical data from the Phase 1b study in
the fourth quarter of 2023.
- Successfully completed a
preclinical, non-human primate study comparing subcutaneous and
intravenous tegoprubart formulations. The study results
demonstrated in an animal model that tegoprubart may be safely
delivered subcutaneously and that similar blood levels of drug may
be achieved by both routes of administration.
Upcoming Anticipated 2023 Milestones
- 3Q 2023: Begin enrollment in the
Phase 2 BESTOW trial of tegoprubart in kidney transplantation.
- 4Q 2023: Report updated interim
clinical data from the ongoing Phase 1b trial of tegoprubart in
kidney transplantation.
Second Quarter Financial Results
The company reported a net loss of $9.6 million,
or $0.40 per share, for the three months ended June
30, 2023, compared to a net loss of $9.2 million,
or $0.65 per share, for the same period in 2022.
Research and development expenses were $7.2
million for the three months ended June 30, 2023,
compared to $5.7 million for the comparable period in
2022, an increase of $1.5 million. The increase in research
and development spend primarily reflects an increase in clinical
development costs, personnel costs and costs related to the
production of clinical trial materials.
General and administrative expenses were $3.2
million for the three months ended June 30, 2023,
compared to $3.5 million for the comparable period in
2022, a decrease of $0.3 million. The decrease was primarily
related to lower professional service costs.
The company had approximately $71.4 million in cash
and cash equivalents and short-term investments as of June 30,
2023, compared to $56.4 million in cash and cash
equivalents as of December 31, 2022. Cash and cash equivalents
and short-term investments at June 30, 2023 included net cash
proceeds received from the Securities Purchase Agreement entered
into on April 28, 2023.
About Eledon Pharmaceuticals and
tegoprubart
Eledon Pharmaceuticals is a clinical stage biotechnology
company with immunology expertise that is developing therapies to
protect and prevent rejection of transplanted organs, as well as to
treat amyotrophic lateral sclerosis (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
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) |
|
|
|
June 30,2023 |
|
|
December 31,2022 |
|
ASSETS |
|
|
|
|
|
|
Current
assets: |
|
|
|
|
|
|
Cash and cash equivalents |
|
$ |
40,947 |
|
|
$ |
56,409 |
|
Short-term investments |
|
|
30,431 |
|
|
|
— |
|
Prepaid expenses and other current assets |
|
|
2,244 |
|
|
|
3,109 |
|
Total
current assets |
|
|
73,622 |
|
|
|
59,518 |
|
Operating lease asset, net |
|
|
553 |
|
|
|
739 |
|
In-process research and development |
|
|
32,386 |
|
|
|
32,386 |
|
Other
assets |
|
|
224 |
|
|
|
150 |
|
Total
assets |
|
$ |
106,785 |
|
|
$ |
92,793 |
|
LIABILITIES AND STOCKHOLDERS’ EQUITY |
|
|
|
|
|
|
Current
liabilities: |
|
|
|
|
|
|
Accounts payable |
|
$ |
2,197 |
|
|
$ |
2,200 |
|
Current operating lease liabilities |
|
|
390 |
|
|
|
363 |
|
Accrued expenses and other liabilities |
|
|
2,313 |
|
|
|
3,912 |
|
Total
current liabilities |
|
|
4,900 |
|
|
|
6,475 |
|
Deferred
tax liabilities |
|
|
1,752 |
|
|
|
1,752 |
|
Non-current operating lease liabilities |
|
|
184 |
|
|
|
383 |
|
Total
liabilities |
|
|
6,836 |
|
|
|
8,610 |
|
|
|
|
|
|
|
|
Commitments and contingencies |
|
|
|
|
|
|
|
|
|
|
|
|
|
Stockholders’ equity: |
|
|
|
|
|
|
Preferred stock, $0.001 par value, 5,000,000 shares authorized at
June 30, 2023 and December 31, 2022: |
|
|
|
|
|
|
Series X1 non-voting convertible preferred stock, $0.001 par value,
515,000 shares designated; 110,086 and 117,970 shares issued and
outstanding at June 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 and
outstanding at June 30, 2023 and December 31, 2022,
respectively |
|
|
— |
|
|
|
— |
|
Common
stock, $0.001 par value, 200,000,000 shares authorized at June 30,
2023 and December 31, 2022; 23,043,933 and
13,776,788 shares issued and outstanding at June 30, 2023 and
December 31, 2022, respectively |
|
|
23 |
|
|
|
14 |
|
Additional paid-in capital |
|
|
323,142 |
|
|
|
287,034 |
|
Accumulated deficit |
|
|
(223,216 |
) |
|
|
(202,865 |
) |
Total
stockholders’ equity |
|
|
99,949 |
|
|
|
84,183 |
|
Total
liabilities and stockholders’ equity |
|
$ |
106,785 |
|
|
$ |
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
June 30, |
|
|
For the Six MonthsEnded
June 30, |
|
|
|
2023 |
|
|
2022 |
|
|
2023 |
|
|
2022 |
|
Operating expenses |
|
|
|
|
|
|
|
|
|
|
|
|
Research and development |
|
$ |
7,201 |
|
|
$ |
5,743 |
|
|
$ |
15,314 |
|
|
$ |
12,378 |
|
General
and administrative |
|
|
3,153 |
|
|
|
3,540 |
|
|
|
6,150 |
|
|
|
6,764 |
|
Total operating expenses |
|
|
10,354 |
|
|
|
9,283 |
|
|
|
21,464 |
|
|
|
19,142 |
|
Loss
from operations |
|
|
(10,354 |
) |
|
|
(9,283 |
) |
|
|
(21,464 |
) |
|
|
(19,142 |
) |
Other
income, net |
|
|
775 |
|
|
|
36 |
|
|
|
1,113 |
|
|
|
31 |
|
Net loss
and comprehensive loss |
|
$ |
(9,579 |
) |
|
$ |
(9,247 |
) |
|
$ |
(20,351 |
) |
|
$ |
(19,111 |
) |
Net loss
per share, basic and diluted |
|
$ |
(0.40 |
) |
|
$ |
(0.65 |
) |
|
$ |
(1.06 |
) |
|
$ |
(1.34 |
) |
Weighted-average common shares outstanding, basic and diluted |
|
|
24,006,549 |
|
|
|
14,265,905 |
|
|
|
19,173,080 |
|
|
|
14,299,969 |
|
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