Eledon Pharmaceuticals Reports First Quarter 2022 Operating and Financial Results
Topline data for Phase 2a tegoprubart study in amyotrophic lateral sclerosis (ALS) anticipated in
First patient dosed in Phase 2a trial evaluating tegoprubart in IgA Nephropathy with initial readout expected in late 2022
Successfully completed non-human primate study evaluating tegoprubart monotherapy in the prevention of kidney allograft rejection
Conference call today at
“We are excited to approach the first of four distinct opportunities to highlight tegoprubart’s broad therapeutic potential this year, beginning with our upcoming ALS readout in June. Based on the growing body of evidence validating the CD40/CD40L pathway, we remain more encouraged than ever in the potential of tegoprubart as a best-in-class anti CD40L antibody,” said
First Quarter 2022 and Recent Corporate Developments
- Completed enrollment of all four cohorts in ongoing Phase 2a study with tegoprubart in ALS and remain on track to deliver topline results in
- Dosed the first patient in a Phase 2a clinical trial evaluating tegoprubart for the treatment of IgA Nephropathy. The ongoing trial currently has received regulatory clearances in
Australia, New Zealand, Malaysia, and Spain, and the company plans to expand the study in up to seven additional countries in 2022.
- Successfully completed non-human primate study evaluating tegoprubart monotherapy in the prevention of kidney allograft rejection.
- Continued progress in two other clinical studies evaluating tegoprubart in kidney transplantation and islet cell transplantation with initial readouts anticipated in late 2022.
- Hosted first-ever Company R&D Day highlighting tegoprubart with four leading experts on ALS, renal transplantation, islet cell transplantation, and IgA Nephropathy (IgAN).
- Published meta-analysis comparing the efficacy of historical anti-CD40 and anti-CD40L approaches in the prevention of kidney transplant rejection in nonhuman primates.
Upcoming Anticipated Milestones
- 2Q 2022: topline data from Phase 2a trial of tegoprubart in ALS.
- 2H 2022: initial open label data from Phase 1b trial of tegoprubart in kidney transplantation.
- 2H 2022: initial open label data from Phase 2a trial of tegoprubart in IgAN.
- 2H 2022: initial open label data from Phase 2a 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
$6.6 millionfor the three months ended March 31, 2022, compared to $5.7 millionfor the comparable period in 2021, an increase of $0.9 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
$3.2 millionfor the three months ended March 31, 2022, compared to $3.4 millionfor the comparable period in 2021, a decrease of $0.2 million.
- The company had approximately
$76.7 millionin cash and cash equivalents as of March 31, 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, May 12, 2022, at 4:30 pm Eastern Time to discuss first quarter 2022 results. The dial-in numbers are 877-407-9039 for domestic callers and 201-689-8470 for international callers. The conference ID is 13729260. 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||$||76,677||$||84,833|
|Prepaid expenses and other current assets||2,648||3,513|
|Total current assets||79,325||88,346|
|Operating lease asset, net||675||768|
|In-process research and development||32,386||32,386|
|LIABILITIES AND STOCKHOLDERS’ EQUITY|
|Current operating lease liability||328||369|
|Accrued expenses and other liabilities||1,604||2,219|
|Total current liabilities||2,958||4,401|
|Deferred tax liability||1,752||1,752|
|Non-current operating lease liability||350||400|
|Commitments and contingencies|
|Series X1 non-voting convertible preferred stock||—||—|
|Series X non-voting convertible preferred stock||—||—|
|Additional paid-in capital||281,067||278,880|
|Total stockholders’ equity||156,318||163,995|
|Total liabilities and stockholders’ equity||$||161,378||$||170,548|
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS
(In thousands, except share and per share data)
|For the Three Months
|Research and development||$||6,635||$||5,653|
|General and administrative||3,224||3,352|
|Total operating expenses||9,859||9,005|
|Loss from operations||(9,859||)||(9,005||)|
|Other income/(expense), net||(5||)||5|
|Loss before income tax benefit||(9,864||)||(9,000||)|
|Income tax benefit||—||501|
|Net loss and comprehensive loss||$||(9,864||)||$||(8,499||)|
|Net loss per share, basic and diluted||$||(0.69||)||$||(0.57||)|
|Weighted-average common shares outstanding, basic and diluted||14,330,693||14,831,049|
Source: Eledon Pharmaceuticals, Inc.