UNITY Biotechnology announces restructuring to advance corporate strategy and focus on core ophthalmology programs
Strategic realignment to focus capital resources on clinical programs and extend cash trail through Q1 2023
12-week data from Phase 2a study of UBX1325 in diabetic macular edema (DME) expected mid-2022
16-week data from Phase 2 study in wet age-related macular degeneration (wet AMD) expected in Q4 2022
SOUTH SAN FRANCISCO, Calif., Feb. 03 2022 (GLOBE NEWSWIRE) — UNITY Biotechnology, Inc. (“UNITY”) [NASDAQ: UBX]a biotechnology company developing therapies to slow, halt or reverse the diseases of aging, today announced that it has launched a restructuring program to align its resources with late-stage ophthalmology programs while further extending its capital operating until the first quarter of 2023.
Strategic Focus Areas
UNITY has aligned its resources to focus on its clinical programs in ophthalmology and achieve key development milestones:
Safety and efficacy data of UBX1325 over 12 weeks from the Phase 2a study in DME (study UBX1325-02) by mid-2022, as well as data from safety and efficacy over 24 weeks of this study before the end of 2022
UBX1325 16-Week Safety and Efficacy Data from Phase 2 Wet AMD Study (Study UBX1325-03) by Year-End 2022
24-Week Safety and Efficacy Data of UBX1325 from the Additional Phase 1 Study Wet AMD Cohort (Study UBX1325-01) in H1 2022
Bispecific Tie2/VEGF preclinical data to support the selection of an advanced candidate by mid-2022
Revised Financial Guidelines
Actions to prioritize ophthalmology programs and implement cost reduction measures are expected to extend the cash trail through Q1 2023, enabling UNITY to obtain several key clinical data reads for UBX1325 and support the bi-specific Tie2/VEGF program through the nomination of advanced candidates with current cash and liquidity. equivalents. All other pipeline programs will be suspended to focus resources on these advanced programs. UNITY will reduce its workforce, primarily in Discovery Research, by approximately 50% to optimize capital allocation and align with key strategic priorities, reducing its headcount to 34 full-time employees by mid-2020. the year.
“I am incredibly proud of the progress made by our team, highlighted by the impressive Phase 1 data from our lead program, UBX1325, and we are now fully focused on completing our Phase 2 studies in patients with AD. macular edema and age-related macular degeneration,” said Anirvan Ghosh, Ph.D., CEO of UNITY. “It was a difficult but prudent decision to align our resources around our ophthalmology programs and I believe this increased focus will propel us towards key milestones, including the Phase 2 data inflection points this year. . These datasets could represent a transformative therapeutic option for patients based on UBX1325’s novel mechanism of action. I would like to express my sincere appreciation and gratitude to all our colleagues for the fundamental work that has brought us to this point, and for their dedication and service to UNITY while striving to develop new treatments for patients with diseases of aging.
UNITY is developing a new class of therapies to slow, stop or reverse the diseases of aging. UNITY’s current goal is to create drugs to selectively eliminate or modulate senescent cells and thereby provide transformative benefits in age-related ophthalmological and neurological diseases. More information is available at www.unitybiotechnology.com or follow us on Twitter and LinkedIn.
This press release contains forward-looking statements, including statements relating to UNITY’s understanding of cellular senescence and the role it plays in diseases of aging, the potential for UNITY to develop therapies to slow, stop or reverse diseases of aging, including for ophthalmological and neurological diseases, our expectations regarding the potential benefits, activity, efficacy and safety of UBX1325, the ability of UNITY to successfully commence and complete studies UBX1325 clinical trials for DME, AMD and other eye diseases, the expected timing of the results of our UBX1325 studies, the timing of the expected start, progression and completion of our studies, including including those of UBX1325, and UNITY’s expectations regarding the adequacy of its cash trail. These statements involve substantial known and unknown risks, uncertainties and other factors that may cause our actual results, levels of activity, performance or achievements to be materially different from the information expressed or implied by these forward-looking statements. including the risk that the global COVID-19 pandemic could continue to adversely impact the development of preclinical and clinical drug candidates, including by delaying or disrupting the recruitment of patients into clinical trials, risks related to uncertainties inherent in the drug development process and the risks associated with UNITY’s understanding of the biology of senescence. We may not actually achieve the plans, intentions or expectations disclosed in our forward-looking statements, and you should not place undue reliance on our forward-looking statements. Actual results or events could differ materially from the plans, intentions and expectations disclosed in the forward-looking statements we make. The forward-looking statements contained in this press release represent our opinions as of the date of this release. We anticipate that subsequent events and developments will cause our views to change. However, while we may choose to update these forward-looking statements at some time in the future, we currently have no intention of doing so except as required by applicable law. You should therefore not rely on these forward-looking statements as representing our views as of any date subsequent to the date of this release. For a more detailed description of the risks and uncertainties that could cause actual results to differ from those expressed in these forward-looking statements, as well as risks relating to UNITY’s business generally, see UNITY’s most recent Quarterly Report on Form 10. -Q for the quarter ended September 30, 2021, filed with the Securities and Exchange Commission on November 10, 2021, together with such other documents as may be filed by UNITY from time to time with the Securities and Exchange Commission.
LifeSci Advisors, LLC