Eledon Pharmaceuticals Reports First Quarter 2021 Operating and Financial Results
Continued enrollment in Phase 2 clinical trial of AT-1501 in amyotrophic lateral sclerosis (ALS)
Strengthens senior leadership team with four key additions
“We have made valuable progress advancing AT-1501 during the first quarter, including with our Phase 2 clinical trial in ALS with top line data readout expected in first half 2022,” stated
First Quarter 2021 and Recent Corporate Developments
- Announced updated development strategy for AT-1501 in renal transplantation based on discussions with the
U.S. Food and Drug Administration(“FDA”). As a result, Eledon plans to initiate an evaluation of AT-1501 in a standard non-human primate model of renal transplantation which is expected to be completed late 2022. In parallel, the company will continue to explore potentially conducting a renal transplantation clinical trial outside the United States.
- Announced appointments of seasoned biopharmaceutical executives -
Jeff Bornstein, M.D. as Chief Medical Officer, Paul Littleas Chief Financial Officer, David Hovland, Ph.D., as Chief Regulatory Officer and Bryan Smith, J.D. as General Counsel, Corporate Secretary, and Chief Compliance Officer.
Upcoming Anticipated Milestones
- Deliver two posters and two oral presentations, including pre-clinical data showing the effectiveness of AT-1501 in preventing islet allograft rejection in nonhuman primate models, at the
American Society of Transplantationannual meeting, which is being held virtually June 4– June 9.
- Enroll first patient in Phase 2 trial of AT-1501 in islet cell transplantation for type 1 diabetes with interim data readout expected in first half 2022.
- Initiate Phase 2 trial of AT-1501 in an autoimmune nephritis indication in late 2021.
Financial Results for the Three Months Ended
The company reported a net loss of
- Research and development expenses were
$5.6 millionfor the three months ended March 31, 2021, compared to $1.6 millionfor the comparable period in 2020, an increase of $4.0 million.
- General and administrative expenses were
$3.3 millionfor the three months ended March 31, 2021, compared to $1.7 millionfor the comparable period in 2020, an increase of $1.6 million.
- The company had approximately
$108.6 millionin cash and cash equivalents as of March 31, 2021, compared to $114.2 millionin cash and cash equivalents as of December 31, 2020. The Company believes that it has sufficient financial resources to fund operations as currently planned well into 2023.
Eledon will hold a conference call today,
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 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
CONSOLIDATED BALANCE SHEETS
(In thousands, except share data)
|Cash and cash equivalents||$||108,579||$||114,195|
|Prepaid expenses and other current assets||1,662||1,435|
|Total current assets||110,241||115,630|
|Operating lease asset, net||92||138|
|In-process research and development||32,386||32,386|
|LIABILITIES AND STOCKHOLDERS’ EQUITY|
|Current operating lease liability||97||144|
|Accrued expenses and other liabilities||2,590||961|
|Total current liabilities||4,206||2,483|
|Deferred tax liabilities||3,605||4,106|
|Commitments and contingencies|
|Series X1 non-voting convertible preferred stock,
authorized; 108,070 shares issued and outstanding at
|Series X preferred stock,
issued and outstanding at
|Additional paid-in capital||272,749||270,974|
|Total stockholders’ equity||183,871||190,596|
|Total liabilities and stockholders’ equity||$||191,682||$||197,185|
CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS
(In thousands, except share and per share data)
|For the Three Months
|Research and development||$||5,653||$||1,648|
|General and administrative||3,352||1,730|
|Total operating expenses||9,005||3,378|
|Loss from operations||(9,005||)||(3,378||)|
|Other income, net||5||30|
|Warrant inducement expense||—||(4,829||)|
|Loss before income tax benefit||(9,000||)||(8,177||)|
|Income tax benefit||501||—|
|Net loss and comprehensive loss||$||(8,499||)||$||(8,177||)|
|Net loss per share, basic and diluted||$||(0.57||)||$||(8.52||)|
|Weighted-average common shares outstanding, basic and diluted||14,831,049||959,285|
Source: Eledon Pharmaceuticals, Inc.