Eledon Pharmaceuticals Reports Second Quarter 2021 Operating and Financial Results
Received approval from
Reached agreement with the FDA to conduct a preclinical renal transplant study evaluating AT-1501 monotherapy in four non-human primates; launched academic collaboration to conduct the study with data expected mid-2022
Announces plans to develop AT-1501 as a therapy for IgA nephropathy (IgAN), the fourth potential indication for clinical development of AT-1501; company expects to initiate Phase 2 by year-end 2021
Conference call today at
“We have made significant progress since the announcement in April of our updated development strategy for AT-1501 in renal transplantation,” stated
“In addition to our progress in ALS and renal transplant, we have selected IgA nephropathy as the fourth indication for the clinical development of AT-1501,” said
Second Quarter 2021 and Recent Corporate Developments
- Completion of enrollment in third of four cohorts in the Phase 2 study of AT-1501 in ALS expected shortly with full enrollment of the trial expected to be completed by year end 2021.
- Received clearance from
Health Canadain response to Clinical Trial Application to initiate a clinical trial of AT-1501 for the prevention of kidney transplant rejection.
- Reached agreement on the design of an FDA-requested preclinical renal transplant study in non-human primates (n = 4) evaluating AT-1501 monotherapy and launched academic collaboration to conduct the study.
- Announced selection of IgA nephropathy (IgAN) as fourth indication for clinical development of AT-1501.
- Presented two posters and two oral presentations at the
American Society of Transplantationannual meeting held in June.
- Appointed leading immunology and rheumatology expert Dr.
Jan Hillsonto its Board of Directors.
Upcoming Anticipated Milestones
- Presentation at the
International Pancreas and Islet Transplantation World Congressannual meeting, which is being held virtually October 20-23, 2021.
- Q4 2021: initiation of non-human primate renal transplant study of AT-1501 monotherapy.
- Q4 2021: initiation of clinical trial of AT-1501 for the prevention of kidney transplant rejection.
- Q4 2021: initiation of clinical trial of AT-1501 in IgAN.
- H1 2022: topline data from Phase 2 trial of AT-1501 in ALS.
- H1 2022: initial data from Phase 2 trial of AT-1501 in islet cell transplantation.
- Mid-2022: completion of non-human primate renal transplant study of AT-1501 monotherapy.
- Late 2022: initial data from clinical trial of AT-1501 in kidney transplantation.
Financial Results for the Three Months Ended
- The company reported a net loss of
$7.4 million, or $0.50per share, for the three months ended June 30, 2021, compared to a net loss of $2.6 million, or $2.74per share, for the same period in 2020.
- Research and development expenses were
$4.2 millionfor the three months ended June 30, 2021, compared to $0.8 millionfor the comparable period in 2020, an increase of $3.4 million. The increase in research and development spend primarily reflects clinical and formulation costs associated with increased activity for our lead asset AT-1501.
- General and administrative expenses were
$3.7 millionfor the three months ended June 30, 2021, compared to $1.3 millionfor the comparable period in 2020, an increase of $2.4 million. The increase in general and administrative spend primarily reflects increased personnel and stock-based costs, legal and other professional fees.
- The company had approximately
$101.1 millionin cash and cash equivalents as of June 30, 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 a planned clinical trial in kidney transplant patients, 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
CONDENSED CONSOLIDATED BALANCE SHEETS
(In thousands, except share data)
|Cash and cash equivalents||$||101,133||$||114,195|
|Prepaid expenses and other current assets||1,449||1,435|
|Total current assets||102,582||115,630|
|Operating lease asset, net||267||138|
|In-process research and development||32,386||32,386|
|LIABILITIES AND STOCKHOLDERS’ EQUITY|
|Current operating lease liability||179||144|
|Accrued expenses and other liabilities||1,641||973|
|Total current liabilities||2,677||2,483|
|Deferred tax liabilities||3,017||4,106|
|Non-current operating lease liability||90||—|
|Commitments and contingencies (Note 5)|
|Series X1 non-voting convertible preferred stock,
|authorized; 108,070 shares issued and outstanding at
|Series X preferred stock,
|issued and outstanding at
|Additional paid-in capital||274,783||270,974|
|Total stockholders’ equity||178,521||190,596|
|Total liabilities and stockholders’ equity||$||184,305||$||197,185|
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS
(In thousands, except share and per share data)
|For the Three Months
|For the Six Months
|Research and development||$||4,242||$||832||$||9,895||$||2,480|
|General and administrative||3,729||1,269||7,081||2,999|
|Total operating expenses||7,971||2,591||16,976||5,969|
|Loss from operations||(7,971||)||(2,591||)||(16,976||)||(5,969||)|
|Other income (expense), net||(1||)||5||4||35|
|Warrant inducement expense||—||—||—||(4,829||)|
|Loss before income tax benefit||(7,972||)||(2,586||)||(16,972||)||(10,763||)|
|Income tax benefit||588||—||1,089||—|
|Net loss and comprehensive loss||$||(7,384||)||$||(2,586||)||$||(15,883||)||$||(10,763||)|
|Net loss per share, basic and diluted||$||(0.50||)||$||(2.74||)||$||(1.07||)||$||(11.31||)|
|Weighted-average common shares outstanding,|
|basic and diluted||14,815,731||943,419||14,823,348||951,352|
Source: Eledon Pharmaceuticals, Inc.