Equillium Reports $8.1 Million Net Loss and $41.1 Million Revenue for 2024

Equillium, Inc., a clinical-stage biotechnology company, reported a net loss of $8.1 million for the year ended December 31, 2024, compared to a net loss of $13.3 million in 2023. Revenue for 2024 totaled $41.1 million, primarily from an asset purchase agreement with Ono Pharmaceutical Co., Ltd., including $28.3 million in development funding and $12.8 million from the amortization of an upfront payment. This represents a $5.0 million increase compared to 2023 revenue of $36.1 million. Research and development expenses increased slightly by $0.4 million to $37.4 million in 2024, while general and administrative expenses decreased by $1.6 million to $11.9 million.

Significant changes in 2024 included the expiration of the asset purchase agreement with Ono on October 30, 2024, ending Ono's funding of itolizumab (EQ001) development expenses. The company also announced topline results from its Phase 3 EQUATOR study of itolizumab in acute graft-versus-host disease (aGVHD), which did not meet primary endpoints but showed statistically significant improvements in secondary endpoints. In March 2025, Equillium submitted data from the EQUATOR study and a request for Breakthrough Therapy Designation to the FDA. Development of EQ302 and EQ101 was paused due to financial constraints, with the company exploring partnering opportunities for both.

Equillium acquired Ariagen, Inc. in October 2024, gaining a preclinical-stage therapeutic drug product. The company also maintains a collaboration and license agreement with Biocon Limited for itolizumab, including an exclusive supply agreement for clinical and commercial drug product. As of December 31, 2024, Equillium employed 35 full-time employees. The company's cash, cash equivalents, and short-term investments totaled $22.6 million as of December 31, 2024, projected to fund operations into the third quarter of 2025 based on certain assumptions.

Key operational developments included the completion of a Phase 2 study of itolizumab in ulcerative colitis, showing positive topline data. The company also completed a Phase 1b study of itolizumab in systemic lupus erythematosus and lupus nephritis, reporting positive topline data from the Type B lupus nephritis portion of the study. Equillium's strategy focuses on advancing preclinical and clinical development of its product candidates, pursuing additional indications, and potentially acquiring new products. The company intends to commercialize its product candidates independently or through partnerships.

Equillium's outlook is contingent upon securing additional funding and receiving positive feedback from the FDA regarding its BLA submission for itolizumab, anticipated in the first half of 2026. The company acknowledges substantial doubt about its ability to continue as a going concern due to its current liquidity position and recurring losses. Further cost-cutting measures may be necessary if additional funding is not secured.