Unity Biotechnology, Inc., a clinical-stage biopharmaceutical company focused on developing therapeutics for age-related diseases, announced its Form 10-Q report for the quarter ended September 30, 2024, highlighting positive clinical data for UBX1325 and significant financial improvements. The company is focused on creating senolytic medicines to selectively eliminate senescent cells.
The report indicates a substantial decrease in net loss, from $14.8 million in Q3 2023 to $6.5 million in Q3 2024, and from $35.5 million to $17.6 million for the nine-month periods, reflecting the impact of restructuring efforts. These efforts included reductions in headcount and operational costs to align resources with clinical programs.
UBX1325 Clinical Trial Updates
UBX1325 (foselutoclax) remains Unity Biotechnology's lead candidate, with ongoing clinical trials evaluating its efficacy in diabetic macular edema (DME) and neovascular age-related macular degeneration (nAMD). The Phase 1 study demonstrated acceptable safety and tolerability, alongside significant improvements in Best Corrected Visual Acuity (BCVA) in patients with DME and nAMD.
Positive results from the Phase 2 BEHOLD study in DME patients showed statistically significant and clinically meaningful improvements in BCVA and central subfield thickness (CST) at 24 weeks, with a favorable safety profile. The company also initiated and completed enrollment for the Phase 2b ASPIRE study, comparing UBX1325 head-to-head against aflibercept in previously treated DME patients. This study has been extended to 36 weeks to assess safety, efficacy, and durability.
Regulatory and Strategic Developments
Unity Biotechnology engaged in a Type C interaction with the FDA regarding the development of UBX1325 for DME. The FDA provided input on the design of the pivotal trial and the primary endpoint for regulatory approval, anticipated to be a non-inferiority trial comparing UBX1325 to an approved anti-VEGF agent.
The Phase 2 ENVISION study for UBX1325 in nAMD patients demonstrated maintenance of visual acuity and a favorable safety profile. This study included both combination treatment and monotherapy arms, with positive results in maintaining vision gains and reducing the need for anti-VEGF rescue treatments.
Financial Position and Future Outlook
In November 2023, Unity Biotechnology entered into an Inducement Offer with certain warrant holders, resulting in the exercise of warrants and issuance of new warrants, generating approximately $4.4 million in gross proceeds. These funds will support working capital, clinical trial progression, and general corporate purposes.
Despite these positive developments, Unity Biotechnology anticipates continued operating losses and negative cash flows as it advances its drug candidates through clinical development and regulatory approval processes. The company expects to require substantial additional funding to continue its research and development activities, and plans to seek additional capital through equity offerings, debt financing, and strategic collaborations. The company's financial condition raises substantial doubt about its ability to continue as a going concern, with existing capital resources expected to fund operations only into the third quarter of 2025.
