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UNITY BIOTECHNOLOGY UNITY Biotechnology , Inc. Reports First Quarter 2021 Financial Results and Business Updates May 11 , 2021 - UBX1325 demonstrates favorable tolerability in Phase 1 safety study with initial evidence of relevant biological activity - - Phase 2a proof - of - concept study initiated in patients with diabetic macular edema ; data expected first half of 2022 Cash balance sufficient to fund operations into second half of 2022 SOUTH SAN FRANCISCO , Calif . , May 11 , 2021 ( GLOBE NEWSWIRE ) -- UNITY Biotechnology , Inc. ( UNITY ) [ NASDAQ : UBX ] , a biotechnology company developing therapeutics to slow , halt , or reverse diseases of aging , today reported financial results for the first quarter ended March 31 , 2021 . " The highlight of the quarter was the completion of the initial assessment of patients in our Phase 1 safety study of UBX1325 , a senolytic molecule that has the potential to promote reparative vascular remodeling in the retina in various age - related eye diseases such as diabetic macular edema and age - related macular degeneration and could provide a disease - modifying alternative to current VEGF - targeting therapies , " said Anirvan Ghosh , Ph.D. , chief executive officer of UNITY . " We are excited by this safety and tolerability data as well as initial evidence of relevant biological activity , and are very pleased to have initiated a Phase 2a proof - of - concept study of UBX1325 . " Key Business Highlights Ophthalmology - UBX1325 In October 2020 , UNITY began its Phase 1 study of UBX1325 in patients with diabetic macular edema ( DME ) and wet age - related macular degeneration ( AMD ) . The ongoing Phase 1 study includes patients with a diagnosis of DME or AMD with significant visual impairment and who are no longer candidates for anti - vascular endothelial growth factor ( VEGF ) therapy . UBX1325 , the first senolytic agent to be administered to these patient populations , has been well tolerated with no significant treatment - associated adverse events in either disease population . The initial assessment of the Phase 1 , first - in - human , open - label , single - ascending dose study included 12 patients with advanced DME or wet AMD . The primary outcome measure is ocular and systemic safety and tolerability of a single intravitreal injection of UBX1325 evaluated by the incidence of dose limiting toxicities ( DLTs ) and treatment emergent adverse events ( TEAEs ) reported up to 24 weeks after administration . The single intravitreal injection of UBX1325 was well tolerated and had no adverse findings that would limit advancement of UBX1325 into further clinical investigation . Based on prospectively determined safety criteria , the Phase 1 study was able to dose - escalate beyond the originally planned 5 mcg dose up to 10 mcg , which will inform the final dose for the Phase 2a study in DME which is expected to read out in 2022. In addition , based on encouraging early data , UNITY intends to recruit additional patients with wet AMD into the Phase 1 study to potentially support an additional , independent Phase 2a study in wet AMD , which could also read out in 2022. The company intends to share details of the activity profile of UBX1325 from this Phase 1 study , including data on best - corrected visual acuity ( BCVA ) , central subfield thickness ( CST ) , and sub - retinal fluid ( SRF ) , in the coming months . Based on this initial data , UNITY has initiated a Phase 2a proof - of - concept study to evaluate the safety , efficacy , and durability of a single intravitreal injection of UBX1325 in a broader population of patients with DME . Approximately 60 patients will be enrolled in the study , randomized evenly between UBX1325 and sham - injected patients , and followed for 24 weeks post - injection . Endpoints being explored in the study include safety and tolerability , improvements in BCVA , CST , SRF , and durability of effect . UNITY anticipates receiving initial results from the Phase 2a proof - of - concept study in patients with DME in the first of half of 2022 . " Mounting evidence shows an accumulation of senescent cells in diseased retinal and choroidal tissue associated with the vasculature - hallmarks of diabetic eye disease and other age - related eye diseases , " said Jamie Dananberg , M.D. , chief medical officer of UNITY . " Senolytics represent a potential new class of medicine designed to selectively target diseased blood vessels to reduce vascular leakage , allow healthy vascular remodeling , and restore retinal function . We find the data we have seen to date very promising and look forward to evaluating both the safety and efficacy of UBX1325 in advanced clinical studies . " Operational Highlights First Quarter Financial Results Cash , cash equivalents , and marketable securities totaled $ 110.2 million as of March 31 , 2021 compared with $ 115.6 million as of December 31 , 2020 . UNITY believes that current cash , cash equivalents , and marketable securities are sufficient to fund operations into the second half of 2022 . Operating loss for the three months ended March 31 , 2021 was $ 14.9 million compared to $ 27.2 million for the three months ended March 31 , 2020 . Cash used in operations during the first quarter of 2021 was $ 15.1 million compared to $ 25.1 million for the first quarter of 2020 . Research and development expenses decreased by $ 10.6 million , to $ 8.7 million for the three months ended March 31 , 2021 , from $ 19.3 million for the three months ended March 31 , 2020. The decrease was primarily due to decreases of $ 6.0 million in direct research and development expenses due to termination of osteoarthritis studies , $ 2.8 million in personnel costs due to reduction in force , $ 0.9 million in laboratory supplies , and $ 0.9 million