Unity Biotechnology Reports $25.99 Million Net Loss for 2024, Improved from $39.86 Million in 2023

Unity Biotechnology, Inc. reported a net loss of $25.99 million for the year ended December 31, 2024, a significant improvement compared to the $39.86 million net loss in 2023. This improvement is largely attributed to a decrease in operating expenses, primarily driven by reductions in research and development ($7.1 million) and general and administrative expenses ($3.5 million). These decreases stemmed from a reduction in force, resulting in lower personnel costs, and cost-saving measures such as subleasing of office space. The company also reported interest income of $1.73 million, down from $2.87 million in 2023.

Significant changes compared to the previous fiscal year include a decrease in research and development expenses, primarily due to the completion of the UBX1325 BEHOLD and ENVISION studies. General and administrative expenses also decreased due to reduced headcount and lower facilities costs. The company's interest income decreased due to lower market yields and the total interest-bearing instruments held. A key development was the completion of enrollment in the Phase 2b ASPIRE study of UBX1325 for diabetic macular edema (DME), comparing it to aflibercept. This study has been extended to 36 weeks to assess long-term efficacy and durability.

The company's most advanced drug candidate, UBX1325, showed positive results in the Phase 2 BEHOLD study for DME, with statistically significant improvements in best-corrected visual acuity (BCVA) at 18, 24, and 48 weeks compared to sham treatment. Positive, though not statistically significant, results were also observed in the Phase 2 ENVISION study for neovascular age-related macular degeneration (nAMD). A Type C meeting with the FDA in August and September 2024 provided guidance for the design of a pivotal non-inferiority trial for UBX1325 in DME, comparing it to an approved anti-VEGF agent. The company anticipates receiving topline data from the ASPIRE study in the first and second quarters of 2025.

As of December 31, 2024, Unity Biotechnology had 16 full-time employees, a decrease from previous years due to restructuring efforts. The company's cash, cash equivalents, and marketable securities totaled $23.2 million at the end of 2024. The company's financial condition raises substantial doubt about its ability to continue as a going concern, as existing capital resources are projected to fund operations only into the fourth quarter of 2025. The company intends to raise additional funds through collaborations, equity offerings, or debt financing. The company's aggregate market value of common equity held by non-affiliates was $22,509,406 as of June 30, 2024.

The company's outlook is contingent upon the successful development and commercialization of UBX1325 and the securing of additional funding. The company acknowledges significant risks related to its limited operating history, financial condition, dependence on third-party suppliers, competition, and the inherent uncertainties of clinical-stage drug development and regulatory approval. The company's financial statements include a going concern qualification due to the projected shortfall in funding to sustain operations beyond the fourth quarter of 2025.