UNITY Biotechnology’s Investor and Analyst Day to Highlight UBX1325 Program in Age-Related Diseases of the Eye

Rhea-AI Summary

UNITY Biotechnology, Inc. (Nasdaq: UBX) announced its Investor and Analyst Day on October 12, 2022, focusing on the UBX1325 program, a novel Bcl-xL inhibitor targeting age-related eye diseases. Presentations will review Phase 2 BEHOLD data for diabetic macular edema (DME) and details of the Phase 2 ENVISION study for wet age-related macular degeneration (wAMD). Key topics include preliminary results showing significant vision improvement and upcoming milestones, such as full 24-week data from BEHOLD expected by year-end 2022 and ENVISION data anticipated in early 2023.

Positive

• Initial findings from the Phase 2 BEHOLD study show significant improvement in vision for DME patients following UBX1325 treatment.
• UNITY raised approximately $41.8 million in net proceeds, extending its cash runway into 2024.
• Upcoming clinical milestones include multiple data releases in 2023 for both DME and wAMD.

Negative

• None.

- Presentations from UNITY’s leadership team and fireside chat with retina expert Robert B. Bhisitkul, M.D., Ph.D., on Wednesday, October 12 from 8:00 a.m. to 9:30 a.m. ET -

SOUTH SAN FRANCISCO, Calif., Oct. 11, 2022 (GLOBE NEWSWIRE) -- UNITY Biotechnology, Inc. (Nasdaq: UBX), a biotechnology company developing therapeutics to slow, halt, or reverse diseases of aging, tomorrow will host an Investor and Analyst Day with presentations highlighting the UBX1325 program, a novel Bcl-xL inhibitor for the treatment of age-related diseases of the eye, followed by a fireside chat with retina expert Robert Bhisitkul, M.D., Ph.D. Presentations include a review of the BEHOLD data in diabetic macular edema (DME), an overview of the recently added long-term extension arms to the Phase 2 ENVISION study in wet age-related macular degeneration (wAMD), as well as clinical development plans, near-term data milestones, and the latest research supporting the therapeutic approach of targeting senescent cells in diseased retinal tissue.

“We’re encouraged by the momentum our ophthalmology program has garnered as UBX1325 advances through the clinic and is emerging as a potentially new class of medicine in DME and wAMD,” said Anirvan Ghosh, Ph.D., chief executive officer of UNITY. “Based on the potential efficacy we’ve already seen in patients with DME up to 18 weeks following a single injection of UBX1325 in our ongoing Phase 2 BEHOLD study, we are exploring additional indications where new treatment options are much needed. We look forward to sharing additional details of our clinical development plan for UBX1325 in patients with wAMD in tomorrow’s presentations, including a Part B extension of our Phase 2 ENVISION study to explore the benefit of a second cycle of UBX1325 treatment at 24 weeks, and the potential benefit of combination treatment with anti-VEGF therapy. We are also excited to be sharing recent mechanism of action work as well as an overview of our product strategy for UBX1325.”

Key Topics of the Investor & Analyst Day

• Review of preclinical research on accumulation of senescent cells and Bcl-xL expression in diseased blood vessels in the retina, as well as evidence that Bcl-xL inhibitors lead to a selective elimination of senescent cells in diseased vasculature, improvement in barrier function, reduction in inflammatory cytokines, and revascularization of ischemic zones
  
  
• Summary of Phase 2 BEHOLD data results at 12 and 18 weeks showing initial evidence of a treatment effect of UBX1325 in patients with DME – a single injection in subjects led to statistically significant and clinically meaningful improvement in vision and structural stability with a favorable safety profile
  
  
• Overview of the Phase 2 ENVISION study design in wAMD, including the addition of the Part B extension arms to evaluate repeat dosing of UBX1325 and combination benefit with anti-VEGF therapy

• Overview of the current therapeutic landscape in DME and wAMD, emerging product profile and strategy for UBX1325, and the opportunity for UBX1325 in the treatment paradigm for DME and wAMD
  
  
• Fireside chat with Dr. Bhisitkul discussing current treatment options for patients with DME and wAMD, the need for novel mechanisms of action to provide efficacy beyond that achieved with anti-VEGF therapies, and the significance of recent UBX1325 Phase 2 clinical data in DME
  

Upcoming Clinical Milestones for UBX1325

• Full 24-week safety and efficacy data from BEHOLD, the Phase 2 DME clinical trial (UBX1325-02 Study), expected before year-end 2022
  
• 48-week long-term extension study data from BEHOLD expected in Q2 2023
  
• Initial 16-week safety and efficacy data from ENVISION, the Phase 2 wAMD clinical trial (UBX1325-03 Study), expected in Q1 2023
  
• Full 24-week safety and efficacy data from ENVISION expected in Q2 2023
  
• 48-week long-term extension study data from ENVISION expected in Q4 2023
  

UNITY completed a follow-on offering in August of this year, raising approximately $41.8 million in net proceeds. Combined with proceeds from its ATM facility, the Company now expects to have cash runway into 2024.

The live webcast can be accessed in the “Investors and Media” section of the website, www.unitybiotechnology.com, under “Events & Presentations” or by clicking here. A replay will be available two hours after the completion of the call and can be accessed in the “Investors & Media” section of our website, under “Events and Presentations.”

About UNITY
UNITY is developing a new class of therapeutics to slow, halt, or reverse diseases of aging. UNITY’s current focus is on creating medicines to selectively eliminate or modulate senescent cells and thereby provide transformative benefit in age-related ophthalmologic and neurologic diseases. More information is available at www.unitybiotechnology.com or follow us on Twitter and LinkedIn.

Forward-Looking Statements

This press release contains forward-looking statements including statements related to UNITY’s understanding of cellular senescence and the role it plays in diseases of aging, the potential for UNITY to develop therapeutics to slow, halt, or reverse diseases of aging, including for ophthalmologic and neurologic diseases, our expectations regarding potential benefits, activity, effectiveness, and safety of UBX1325, the potential for UNITY to successfully commence and complete clinical studies of UBX1325 for DME, AMD, and other ophthalmologic diseases, the expected timing and nature of results of the clinical trials in UBX1325 including BEHOLD and ENVISION, including the risk that interim results of our clinical studies may not be indicative of future results, the timing of the expected commencement, progression, and conclusion of our studies including those of UBX1325, and UNITY’s expectations regarding the sufficiency of its cash runway. 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 COVID-19 worldwide pandemic may continue to negatively impact the development of preclinical and clinical drug candidates, including delaying or disrupting the enrollment of patients in clinical trials, risks relating to the uncertainties inherent in the drug development process, and risks relating to UNITY’s understanding of senescence biology. 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 in this press release represent our views as of the date of this release. We anticipate that subsequent events and developments will cause our views to change. However, while we may elect to update these forward-looking statements at some point in the future, we have no current intention of doing so except to the extent 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 further 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 the business of UNITY in general, see UNITY’s most recent Quarterly Report on Form 10-Q for the quarter ended June 30, 2022, filed with the Securities and Exchange Commission on August 12, 2022, as well as other documents that may be filed by UNITY from time to time with the Securities and Exchange Commission.

Media Contact:
Evoke Canale
Jason Spark
jason.spark@evokegroup.com

Investor Contact:
Joyce Allaire
LifeSci Advisors
212-915-2569
jallaire@lifesciadvisors.com

FAQ

What is the focus of UNITY's Investor and Analyst Day on October 12, 2022?

The event will highlight the UBX1325 program, a Bcl-xL inhibitor for age-related eye diseases, including presentations on clinical data and future plans.

What are the preliminary findings from the Phase 2 BEHOLD study for UBX1325?

The study showed significant and clinically meaningful improvements in vision for diabetic macular edema patients after a single UBX1325 injection.

When can we expect full data from the ongoing clinical trials for UBX1325?

Full 24-week safety and efficacy data from the BEHOLD study is expected by year-end 2022, with additional ENVISION study data anticipated in early 2023.

How much funding did UNITY Biotechnology raise recently?

UNITY completed a follow-on offering in August 2022, raising approximately $41.8 million in net proceeds.

What are the potential benefits of UBX1325 in eye disease treatment?

UBX1325 may provide new treatment options for conditions like diabetic macular edema and wet age-related macular degeneration, aiming to improve vision significantly.