Unity Biotechnology

• Chardan Capital initiates a Buy rating for Unity Biotechnology, citing the potential of UBX1325 in treating diabetic macular edema (DME). • UBX1325, a senolytic candidate, targets cellular senescence and SASP, which contribute to retinal diseases like DME. • A Phase 2b ASPIRE trial is underway, with topline data expected in Q1 2025, evaluating UBX1325 in previously treated DME patients. • UBX1325's unique mechanism could offer a novel treatment option for DME patients unresponsive to current anti-VEGF or steroid therapies.

• UNITY Biotechnology appointed Federico Grossi as Chief Medical Officer, enhancing its leadership with his extensive experience in ophthalmology and drug development. • Dr. Grossi previously led the development of SYFOVRE for geographic atrophy at Apellis Pharmaceuticals, bringing a proven track record to UNITY. • His appointment is timely as UNITY anticipates Phase 2b ASPIRE trial results for UBX1325 in diabetic macular edema (DME). • UNITY aims to leverage Dr. Grossi's expertise to advance its pipeline of senolytic treatments for age-related retinal diseases.

Unity Biotechnology's UBX1325, a senolytic therapy, targets diabetic macular edema (DME) by addressing treatment burdens and suboptimal responses.

• Unity Biotechnology's Q3 2024 financial results show a reduced net loss of $6.5 million, compared to $14.8 million in Q3 2023, driven by strategic restructuring. • Clinical trials of UBX1325 (foselutoclax) demonstrate significant improvements in visual acuity for diabetic macular edema (DME) and neovascular age-related macular degeneration (nAMD). • A Phase 2b ASPIRE study evaluating UBX1325 against aflibercept in DME patients has been extended to 36 weeks to assess long-term safety and efficacy. • Unity Biotechnology secured $4.4 million through an inducement offer, supporting ongoing clinical trials and extending the company's operational runway.

• UNITY Biotechnology's UBX1325 (foselutoclax) targets senescent cells in diabetic macular edema (DME), offering a novel approach to address limitations of current anti-VEGF therapies. • A Phase 2b ASPIRE study is underway, comparing UBX1325 to aflibercept, with topline 24-week primary endpoint data expected in Q1 2025 and 36-week data in Q2 2025. • FDA interaction suggests a pivotal trial for UBX1325 would need to demonstrate non-inferiority to an approved anti-VEGF agent, using best-corrected visual acuity (BCVA) as the primary endpoint. • UNITY Biotechnology's current funds are expected to sustain operations into the third quarter of 2025, supporting the continued development of UBX1325.

• UNITY Biotechnology received FDA guidance suggesting a non-inferiority trial design for UBX1325 (foselutoclax) compared to aflibercept in treating diabetic macular edema (DME). • The pivotal study's primary endpoint is expected to be best-corrected visual acuity (BCVA) assessed by the ETDRS scale, with a non-inferiority margin of 4 letters. • Topline data from the Phase 2b ASPIRE study, comparing UBX1325 to aflibercept, is expected in Q1 and Q2 2025, informing the potential pivotal study design. • UNITY's cash, cash equivalents, and marketable securities totaled $29.0 million as of September 30, 2024, expected to fund operations into Q3 2025.

• UNITY Biotechnology's UBX1325 (foselutoclax) is under development as a novel senolytic therapeutic for diabetic macular edema (DME). • A pivotal study design, based on FDA interaction, will compare UBX1325 to aflibercept, focusing on non-inferiority in best-corrected visual acuity (BCVA). • Topline data from the Phase 2b ASPIRE study, comparing UBX1325 to aflibercept, is expected in Q1 and Q2 2025. • UNITY's cash, cash equivalents, and marketable securities are projected to fund operations into the third quarter of 2025.

• UNITY Biotechnology will host an Ophthalmology Day on October 15, 2024, focusing on its ASPIRE study. • The ASPIRE study evaluates foselutoclax (UBX1325) against aflibercept for diabetic macular edema (DME). • Twenty-four-week safety and efficacy data from the ASPIRE study are expected in Q1 2025. • Key opinion leaders will discuss UBX1325's potential in addressing unmet needs in DME.