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Wednesday, November 10, 2021

UNITY Biotechnology update post-Q3 report

 UBX1325 Phase 2 study in DME currently enrolling, with additional Phase 2 study in AMD planned for 1H22

UNITY to present at invitation-only Eyecelerator innovation conference at AAO

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 third quarter ended September 30, 2021.

“In our Phase 1 clinical study, UBX1325, a senolytic small molecule working through an entirely new mechanism of action, has shown a favorable safety profile and very promising evidence of biological activity through six months, demonstrating durability,” said Anirvan Ghosh, Ph.D., chief executive officer of UNITY. “As announced yesterday, we share the excitement of the patient and physician community about the potential for UBX1325 as a possible disease-modifying treatment to fill the large and unmet need for options beyond anti-VEGF therapies. Our team continues to advance the UBX1325 program in a Phase 2 proof of concept study currently enrolling patients with diabetic macular edema (DME), and we are using the promising data from patients with age-related macular degeneration (AMD) in the Phase 1 study to inform design of a Phase 2 study in wet AMD to start in the first half of 2022.”

UNITY yesterday released 24-week data from its Phase 1 study of UBX1325 in DME, along with 24-week and 12-week (AMD-only cohort) data in patients with AMD, and will present information about the UBX1325 program at Eyecelerator@AAO 2021 in New Orleans on November 11, 2021, an invitation-only event featuring ophthalmic innovation put on in partnership between the American Academy of Ophthalmology and ASCRS.

Upcoming Milestones

  • UBX1325 Phase 2a proof of concept study in DME had a first patient dosed in June 2021 and is actively recruiting patients, with information about that trial available here. Twelve-week safety and efficacy data are expected in the first half of 2022.

  • UBX1325 Phase 2 proof of concept study in AMD is expected to initiate in the first half of 2022, with twelve-week safety and efficacy data expected in the second half of 2022.

  • UBX2050 (Tie2 mAb) and UBX2089 (alpha-Klotho) expected to enter IND-enabling studies in 2022.

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