Eledon Pharmaceuticals Reports Fourth Quarter and Full-Year 2020 Operating and Financial Results
Continued enrollment in Phase 2 clinical trial of AT-1501 in amyotrophic lateral sclerosis (ALS)
First patient to be enrolled in Phase 2 clinical trial of AT-1501 in islet cell transplantation for type 1 diabetes expected in Q2’21
Cash Balance of
“2020 was a transformational year highlighted by our acquisition of Anelixis Therapeutics and recent name change to
Fourth Quarter 2020 and Recent Corporate Developments
- Commenced enrollment in an open-label Phase 2a clinical trial of AT-1501 in ALS.
- Received clearance from
Health Canada to proceed with the initiation of a Phase 2 clinical trial of AT-1501 in islet cell transplantation for type 1 diabetes. - Appointed
June Lee , MD to Board of Directors.Dr. Lee brings extensive clinical and development expertise as the former Chief Development and Chief Operating Officer of MyoKardia, Inc. - Announced name change to
Eledon Pharmaceuticals, Inc. (Nasdaq: ELDN), from Novus Therapeutics, to reflect the company’s new focus on autoimmune diseases, transplantation, and ALS. - Expanded management team to include
Paul Little as Chief Financial Officer, andJeffrey Bornstein , M.D., as Chief Medical Officer.
Upcoming Anticipated Milestones
- Continue patient enrollment in ongoing Phase 2 trial in ALS with top line data readout expected in first half 2022.
- Enroll first patient in Phase 2 trial of AT-1501 in islet cell transplantation for type 1 diabetics in Q2’21, with interim data readout expected in first half 2022.
- Initiate Phase 2 trial of AT-1501 in renal transplantation in late 2Q/mid-2021.
- 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
$3.0 million for the three months endedDecember 31, 2020 , compared to$1.3 million for the comparable period in 2019, an increase of$1.7 million . The increase in research and development spend primarily reflects clinical and formulation costs associated with increased activity for lead asset AT-1501. - General and administrative expenses were
$3.3 million for the three months endedDecember 31, 2020 , compared to$1.0 million for the comparable period in 2019, an increase of$2.3 million . The increase in general and administrative spend primarily reflects merger and integration related expenses associated with the Anelixis acquisition and stock-based compensation expense of$0.8 million .
Financial Results for the Year Ended
The company reported a net loss of
- Research and development expenses were
$6.1 million for the year endedDecember 31, 2020 , compared to$8.1 million for the year endedDecember 31, 2019 , a decrease of$2.0 million . The decrease in research and development spend primarily reflects a decrease in clinical and development costs related to completion of our legacy lead Phase 2a study for acute otitis media, partially offset by an increase in stock-based compensation expense. - General and administrative expenses were
$10.1 million for the year endedDecember 31, 2020 , compared to$6.1 million for the year endedDecember 31, 2019 , an increase of$4.0 million . The increase in general and administrative spend primarily reflects merger and integration related expenses associated with the Anelixis acquisition and stock-based compensation expense of$1.0 million .
Financial Liquidity at
Concurrent with the acquisition of Anelixis Therapeutics in
The company had approximately
Conference Call
Eledon will hold a conference call today,
About
Follow
Forward-Looking Statements
This press release contains forward-looking statements that involves 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
Investor Contact:
cdavis@lifesciadvisors.com
212.915.2577
Source:
CONSOLIDATED BALANCE SHEETS
(In thousands, except share data)
2020 | 2019 | |||||||
ASSETS | ||||||||
Current assets: | ||||||||
Cash and cash equivalents | $ | 114,195 | $ | 8,791 | ||||
Prepaid expenses and other current assets | 1,435 | 1,180 | ||||||
Total current assets | 115,630 | 9,971 | ||||||
Property and equipment, net | — | 5 | ||||||
Operating lease asset, net | 138 | 316 | ||||||
48,648 | — | |||||||
In-process research and development | 32,386 | — | ||||||
Other assets | 383 | 639 | ||||||
Total assets | $ | 197,185 | $ | 10,931 | ||||
LIABILITIES AND STOCKHOLDERS’ EQUITY | ||||||||
Current liabilities: | ||||||||
Accounts payable | $ | 1,366 | $ | 329 | ||||
Current operating lease liability | 144 | 180 | ||||||
Accrued severance | 12 | — | ||||||
Accrued expenses and other liabilities | 961 | 813 | ||||||
Total current liabilities | 2,483 | 1,322 | ||||||
Deferred tax liability | 4,106 | — | ||||||
Non-current operating lease liability | — | 144 | ||||||
Total liabilities | 6,589 | 1,466 | ||||||
Commitments and contingencies | ||||||||
Stockholders’ equity: | ||||||||
Series X1 non-voting convertible preferred stock, |
||||||||
515,000 shares authorized; 108,070 and no shares issued and | ||||||||
outstanding at |
— | — | ||||||
Series X preferred stock, |
||||||||
issued and outstanding at |
— | — | ||||||
Common stock, |
||||||||
and outstanding at |
15 | 1 | ||||||
Additional paid-in capital | 270,974 | 67,046 | ||||||
Accumulated deficit | (80,393 | ) | (57,582 | ) | ||||
Total stockholders’ equity | 190,596 | 9,465 | ||||||
Total liabilities and stockholders’ equity | $ | 197,185 | $ | 10,931 |
CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS
(In thousands, except share and per share data)
Year Ended |
||||||||
2020 | 2019 | |||||||
Operating expenses | ||||||||
Research and development | $ | 6,131 | $ | 8,128 | ||||
General and administrative | 10,052 | 6,056 | ||||||
Restructuring expense | 2,282 | — | ||||||
— | 1,867 | |||||||
Total operating expenses | 18,465 | 16,051 | ||||||
Loss from operations | (18,465 | ) | (16,051 | ) | ||||
Other income, net | 79 | 40 | ||||||
Warrant inducement expense | (4,829 | ) | — | |||||
Loss before income tax benefit | (23,215 | ) | (16,011 | ) | ||||
Income tax benefit | 404 | — | ||||||
Net loss and other comprehensive loss | $ | (22,811 | ) | $ | (16,011 | ) | ||
Net loss per share, basic and diluted | $ | (15.72 | ) | $ | (24.42 | ) | ||
Weighted-average common shares outstanding, basic and diluted | 1,451,432 | 655,526 |
Source: Eledon Pharmaceuticals, Inc.