Eledon Pharmaceuticals, Inc.

For the fourth quarter of 2022, Eledon reported a net loss of $58.4 million, or $4.09 per share, versus a net loss of $8.8 million, or $0.59 per share, in the same period of 2021. The quarter included a non-cash goodwill impairment charge of $48.6 million; excluding that charge, net loss would have been $9.7 million, or $0.68 per share. Q4 R&D was $7.3 million, up from $6.2 million a year ago, and G&A was $2.8 million, down from $3.2 million. For the full year, net loss was $88 million, or $6.16 per share, versus $34.5 million, or $2.33 per share in 2021; excluding the impairment charge, full-year net loss would have been $39.3 million, or $2.75 per share. Full-year R&D was $27.1 million versus $23.7 million in 2021, and G&A was $12.7 million versus $13.1 million. Eledon ended 2022 with approximately $56.4 million in cash and cash equivalents, and management said it has less than one year of cash runway under the current operating plan. No formal revenue or operating guidance was given; management said BESTOW is planned to initiate in the middle of the year, Phase Ib enrollment is expected to finish by year-end, and BESTOW enrollment is expected to take about a year and a half from first patient in, with another year to final data.

DA Gros framed 2023 as a strategic pivot toward kidney transplantation, arguing the market is large, the regulatory path is clearer, and the hospital concentration makes it a tractable commercial opportunity for a smaller biotech. He highlighted the early tegoprubart kidney data as evidence that the drug may prevent rejection while improving graft function, and said the program now has momentum heading into BESTOW and the eGenesis xeno collaboration. His tone was constructive and optimistic, but grounded in the need to focus resources and secure financing.

Paul Little focused on the financial losses, the goodwill impairment, and the company’s liquidity position. He said the quarterly and annual net losses were heavily affected by a $48.6 million non-cash goodwill write-down, while R&D rose mainly due to higher manufacturing and clinical development costs and G&A declined modestly. He also emphasized that cash was approximately $56.4 million at year-end and that the company has less than one year of cash runway, making study execution and timing subject to financing.

Analysts pressed management on what additional efficacy data would be shown from the next-day presentation, whether biomarker or inflammatory readouts would be included, and what KOL feedback had been. Management said the presentation would focus on eGFR at various time points for the three patients, not additional biomarker work, because eGFR is already a predictable kidney function measure. Questions also centered on why the design includes a new-onset diabetes endpoint; management explained that CNIs and steroids can damage pancreatic beta cells, and said BESTOW will also attempt to taper steroids off quickly over a few months. On enrollment, management said Phase Ib should finish by year-end and BESTOW enrollment should take about 18 months, with data a year after the last patient finishes.