Eledon Pharmaceuticals Reports Second Quarter 2022 Operating and Financial Results
Received FDA clearance of IND application for Phase 2 trial evaluating tegoprubart for the prevention of rejection in kidney transplant recipients
First patient dosed in Phase 1b trial evaluating tegoprubart for the prevention of rejection in kidney transplant recipients in
Reported positive topline results from Phase 2a trial of tegoprubart demonstrating safety, target engagement, and biomarker response in patients living with amyotrophic lateral sclerosis (ALS)
Tegoprubart received Orphan Drug Designation from the
Conference call today at
“This quarter was marked by significant clinical and regulatory progress across all four tegoprubart development programs, reinforcing our confidence in tegoprubart’s broad therapeutic potential and setting the stage for the next 12 months,” said
Second Quarter 2022 and Recent Corporate Developments
- Received Investigational New Drug (IND) application clearance from the
U.S. Food and Drug Administration(FDA) for a larger, controlled, Phase 2 trial of tegoprubart for the prevention of organ rejection in persons receiving a kidney transplant. This study will run in parallel to the ongoing Phase 1b clinical trial of tegoprubart in kidney transplantation.
- Dosed the first patient in a Phase 1b, open-label study of tegoprubart in
Canada, the United Kingdomand Australiato treat patients undergoing kidney transplantation.
- Announced positive topline results from a Phase 2a clinical trial of tegoprubart in patients with ALS. Tegoprubart successfully met the primary endpoints of safety and tolerability, with no drug-related serious adverse events. Additionally, dose dependent target engagement was demonstrated, and pro-inflammatory biomarker reduction was associated with a trend in the slowing of disease progression as measured by ALSFRS slope when compared to a cohort from the ALS PRO-ACT database.
- Dosed multiple patients in a Phase 2a clinical trial evaluating tegoprubart for the treatment of IgA Nephropathy (IgAN). The ongoing trial has received regulatory clearances in 9 countries, and the company plans to expand the study in up to 3 additional countries. Eledon expects to complete enrollment in the high dose cohort in the first half of 2023.
- Announced that the FDA granted orphan drug designation to tegoprubart to prevent allograft rejections in pancreatic islet cell transplantation. A site for the company’s Phase 2a trial is expected to open in
the United Statesin the third quarter of 2022.
Upcoming Anticipated Milestones
- 1Q 2023: initial three and six-month open label data from the Phase 1b trial of tegoprubart in kidney transplantation.
- 1Q 2023: initial six-month open label data from the Phase 2a trial of tegoprubart in IgAN with the completion of enrollment in the first half of 2023.
- 1Q 2023: initial three-month open label data from the Phase 1/2 trial of tegoprubart in islet cell transplantation.
Financial Results for the Three Months Ended
The company reported a net loss of
- Research and development expenses were
$5.7 millionfor the three months ended June 30, 2022, compared to $4.2 millionfor the comparable period in 2021, an increase of $1.5 million. The increase in research and development spend primarily reflects an increase in clinical development costs and costs related to the production of clinical trial materials as we advance tegoprubart into global phase 1 and 2 clinical trials.
- General and administrative expenses were
$3.5 millionfor the three months ended June 30, 2022, compared to $3.7 millionfor the comparable period in 2021, a decrease of $0.2 million.
- The company had approximately
$70.5 millionin cash and cash equivalents as of June 30, 2022, compared to $84.8 millionin cash and cash equivalents as of December 31, 2021. The company believes that it has sufficient financial resources to fund operating activities into 2024.
Eledon will hold a conference call today, August 11, 2022, at 4:30 pm Eastern Time to discuss second quarter 2022 results. The dial-in numbers are 877-300-8521 for domestic callers and 412-317-6026 for international callers. The conference ID is 10169199. A live webcast of the conference call will be available on the Investor Relations section of the Company's website at www.eledon.com. The webcast will be archived on the website following the completion of the call.
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 sites, 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
(858) 525 2047
CONDENSED CONSOLIDATED BALANCE SHEETS
(In thousands, except share data)
|Cash and cash equivalents||$||70,460||$||84,833|
|Prepaid expenses and other current assets||2,328||3,513|
|Total current assets||72,788||88,346|
|Operating lease asset, net||581||768|
|In-process research and development||32,386||32,386|
|LIABILITIES AND STOCKHOLDERS’ EQUITY|
|Current operating lease liability||287||369|
|Accrued expenses and other liabilities||1,671||2,219|
|Total current liabilities||3,276||4,401|
|Deferred tax liability||1,752||1,752|
|Non-current operating lease liability||299||400|
|Commitments and contingencies|
|Series X1 non-voting convertible preferred stock,
|Series X non-voting convertible preferred stock,
|Additional paid-in capital||283,375||278,880|
|Total stockholders’ equity||149,379||163,995|
|Total liabilities and stockholders’ equity||$||154,706||$||170,548|
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS
(In thousands, except share and per share data)
|For the Three Months
|For the Six Months
|Research and development||$||5,743||$||4,242||$||12,378||$||9,895|
|General and administrative||3,540||3,729||6,764||7,081|
|Total operating expenses||9,283||7,971||19,142||16,976|
|Loss from operations||(9,283||)||(7,971||)||(19,142||)||(16,976||)|
|Other income/(expense), net||36||(1||)||31||4|
|Loss before income tax benefit||(9,247||)||(7,972||)||(19,111||)||(16,972||)|
|Income tax benefit||—||588||—||1,089|
|Net loss and comprehensive loss||$||(9,247||)||$||(7,384||)||$||(19,111||)||$||(15,883||)|
|Net loss per share, basic and diluted||$||(0.65||)||$||(0.50||)||$||(1.34||)||$||(1.07||)|
|Weighted-average common shares outstanding, basic and diluted||14,265,905||14,815,731||14,299,969||14,823,348|
Source: Eledon Pharmaceuticals, Inc.