Eledon Pharmaceuticals Reports Third Quarter 2021 Operating and Financial Results
Nearing full enrollment in ALS Phase 2 Study; topline data expected 1H 2022
Received Investigational New Drug (“IND”) clearance from the FDA for AT-1501 in islet cell transplantation in the
Announced renal transplantation research collaboration with CareDx, Inc.
Initiated AT-1501 monotherapy non-human primate renal transplant study; topline data expected 1H 2022
Conference call today at
“We made significant progress across our three therapeutic areas: transplantation focusing on kidney and islet cell transplantation, autoimmunity focused on IgA Nephropathy (IgAN), and neurodegeneration focusing on ALS,” stated
“In addition, we recently announced our research collaboration with CareDx, the leader in precision medicine for transplant patients and caregivers,” said
Third Quarter 2021 and Recent Corporate Developments
- Received a “No Objection” Letter from
Health Canada, allowing Eledon to initiate a Canadian clinical trial of AT-1501 for the prevention of kidney transplant rejection.
- Announced selection of IgAN as next indication for clinical development of AT-1501; initiation of Phase 2 study expected by year-end.
- Completed enrollment of the first three cohorts of a Phase 2 study of AT-1501 in ALS; fourth and final cohort enrollment is nearing completion with full enrollment expected by year-end.
- Initiated preclinical renal transplant study evaluating AT-1501 monotherapy in at least four non-human primates.
- Announced renal transplant research collaboration with CareDx providing Eledon access to CareDx’s best-in-class biomarker and predictive algorithm technologies.
- Received IND clearance from the
U.S. Food & Drug Administrationfor AT-1501 in islet cell transplantation in the United States.
- Presented data at the 2021
Northeast Amyotrophic Lateral Sclerosis Consortiumand the International Pancreas and Islet Transplantation World Congress.
Upcoming Anticipated Milestones
- Q4 2021: initiation of Phase 1b clinical trial of AT-1501 in kidney transplantation.
- Q4 2021: initiation of Phase 2 clinical trial of AT-1501 in IgAN.
- 1H 2022: topline data from Phase 2 trial of AT-1501 in ALS.
- 1H 2022: completion of non-human primate study with AT-1501.
- 2H 2022: initial data from Phase 1b trial of AT-1501 in kidney transplantation.
- 2H 2022: initial data from Phase 2 trial of AT-1501 in IgAN.
- 2022: initial data from Phase 2 trial of AT-1501 in islet cell transplantation.
Financial Results for the Three Months Ended
- The company reported a net loss of
$9.8 million, or $0.66per share, for the three months ended September 30, 2021, compared to a net loss of $6.1 million, or $5.51per share, for the same period in 2020.
- Research and development expenses were
$7.7 millionfor the three months ended September 30, 2021, compared to $0.6 millionfor the comparable period in 2020, an increase of $7.1 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
$2.8 millionfor the three months ended September 30, 2021, compared to $3.7 millionfor the comparable period in 2020, a decrease of $0.9 million.
- The company had approximately
$94.0 millionin cash and cash equivalents as of September 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 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
CONDENSED CONSOLIDATED BALANCE SHEETS
(In thousands, except share data)
|Cash and cash equivalents||$||94,041||$||114,195|
|Prepaid expenses and other current assets||1,517||1,435|
|Total current assets||95,558||115,630|
|Operating lease asset, net||222||138|
|In-process research and development||32,386||32,386|
|LIABILITIES AND STOCKHOLDERS’ EQUITY|
|Current operating lease liability||177||144|
|Accrued expenses and other liabilities||2,271||973|
|Total current liabilities||4,046||2,483|
|Deferred tax liabilities||2,331||4,106|
|Non-current operating lease liability||45||—|
|Commitments and contingencies (Note 5)|
|Series X1 non-voting convertible preferred stock,
|Series X preferred stock,
|Additional paid-in capital||276,827||270,974|
|Total stockholders’ equity||170,748||190,596|
|Total liabilities and stockholders’ equity||$||177,170||$||197,185|
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS
(In thousands, except share and per share data)
|For the Three Months
|For the Nine Months
|Research and development||$||7,658||$||615||$||17,553||$||3,095|
|General and administrative||2,848||3,731||9,929||6,730|
|Total operating expenses||10,506||6,148||27,482||12,117|
|Loss from operations||(10,506||)||(6,148||)||(27,482||)||(12,117||)|
|Other income, net||3||4||7||39|
|Warrant inducement expense||—||—||—||(4,829||)|
|Loss before income tax benefit||(10,503||)||(6,144||)||(27,475||)||(16,907||)|
|Income tax benefit||686||—||1,775||—|
|Net loss and comprehensive loss||$||(9,817||)||$||(6,144||)||$||(25,700||)||$||(16,907||)|
|Net loss per share, basic and diluted||$||(0.66||)||$||(5.51||)||$||(1.73||)||$||(16.81||)|
|Weighted-average common shares outstanding, basic and diluted||14,815,852||1,114,133||14,820,822||1,006,008|
Source: Eledon Pharmaceuticals, Inc.