UBX1325 ASPIRE Study Results - UBX1325 showed a BCVA gain of 5.2 letters at week 24 and 5.5 letters at week 36[5] - Approximately 40% of UBX1325 patients did not require supplemental anti-VEGF treatment through week 36[5] - UBX1325 generally outperformed Aflibercept in subjects with less aggressive disease (baseline CST < 400 µm)[39] - Patients switching from Aflibercept to UBX1325 experienced consistent gains in BCVA and less variable CST[5, 39] - UBX1325 was non-inferior to Aflibercept at most time points through 36 weeks, but did not meet non-inferiority at the average of weeks 20 and 24 in the primary analysis[5] Market Opportunity and Unmet Needs in DME - The global Diabetic Macular Edema (DME) market is projected to reach $9.6 billion by 2031, with the US market reaching $5.5 billion[43] - Over 50% of patients discontinue anti-VEGF treatment by 6 months[43] - 58% of patients with DME exhibit suboptimal response to anti-VEGF therapies[43] - 28% of patients require frequent dosing (every 4 weeks) with current anti-VEGF treatments[43]

SOUTH SAN FRANCISCO, Calif., May 01, 2025 (GLOBE NEWSWIRE) -- UNITY Biotechnology, Inc. (“UNITY”) [NASDAQ: UBX], a biotechnology company developing therapeutics to slow, halt or reverse diseases of aging, today announced that the Company will present 36-week data from the ASPIRE Phase 2B study at the Association for Research in Vision and Ophthalmology (ARVO) 2025 Annual Meeting being held on May 4-8, 2025 in Salt Lake City, Utah. ARVO 2025 Presentation Details: Title: Safety and Efficacy of Senolytic Candi ...

Core Insights - UNITY Biotechnology, Inc. announced positive results from the Phase 2 BEHOLD study of UBX1325 for diabetic macular edema (DME), indicating potential for long-lasting vision improvements through selective clearance of senescent cells [1][2] - The BEHOLD study demonstrated that a single injection of UBX1325 led to statistically significant and clinically meaningful improvements in visual acuity for up to 48 weeks in patients with advanced DME [2][4] Company Overview - UNITY is focused on developing therapeutics aimed at slowing, halting, or reversing diseases of aging, particularly through the elimination or modulation of senescent cells [5] - UBX1325 is an investigational compound targeting retinal diseases, specifically designed to inhibit proteins that senescent cells rely on for survival [4] Study Details - The BEHOLD study was a multi-center, randomized, double-masked, sham-controlled trial involving 65 patients with persistent visual acuity deficits despite anti-VEGF treatment [3] - Patients in the study had an average visual acuity of 61.4 ETDRS letters and a central subfield thickness (CST) of approximately 439.6 microns at baseline [3] Future Developments - UNITY is conducting a Phase 2b ASPIRE study to evaluate multiple doses of UBX1325 in comparison to aflibercept, with topline data expected in the second quarter of 2025 [2][4]

Financial Performance - The company reported net losses of $7.3 million and $5.8 million for the three months ended March 31, 2025 and 2024, respectively, with an accumulated deficit of $517.6 million as of March 31, 2025[88]. - The company incurred a net loss of $7.3 million for the three months ended March 31, 2025, compared to a net loss of $5.8 million for the same period in 2024, representing an increase in loss of $1.5 million[100]. - Cash used in operating activities for Q1 2025 was $6.4 million, compared to $5.2 million in Q1 2024, reflecting a net loss of $7.3 million in 2025 and $5.8 million in 2024[123][124]. - The company expects to continue incurring net operating losses for several years as it advances drug candidates through clinical development and seeks regulatory approval[111]. - As of March 31, 2025, the company had an accumulated deficit of $517.6 million and does not expect positive cash flows from operations in the foreseeable future[107]. Research and Development - The Phase 2 BEHOLD study of UBX1325 showed a mean improvement in best corrected visual acuity (BCVA) of +6.2 ETDRS letters from baseline at 24 weeks, compared to +7.6 ETDRS letters compared to sham treatment (p=0.0084)[76]. - In the Phase 2b ASPIRE study, UBX1325 was non-inferior to aflibercept at week 24, with a +5.2 letter gain in visual acuity at 24 weeks and a +5.5 letter gain at 36 weeks[82]. - Approximately 50% of UBX1325-treated patients did not require any additional injections through 48 weeks, compared to only 22% in the sham arm[78]. - The company completed enrollment of 52 participants in the ASPIRE study, which is designed to evaluate UBX1325 against aflibercept in patients with active diabetic macular edema (DME)[79]. - The company anticipates receiving full 36-week topline data from the ASPIRE study in the second quarter of 2025[82]. - The company has maintained a favorable safety and tolerability profile for UBX1325 across multiple clinical studies, with no cases of intraocular inflammation reported[82]. Funding and Capital Resources - The company expects existing capital resources to fund planned operating expenses into the fourth quarter of 2025, raising concerns about its ability to continue as a going concern[89]. - The company received approximately $4.4 million from an inducement offer to exercise existing warrants at a reduced price, which will be used for working capital and clinical trial progression[87]. - The company anticipates needing substantial additional funding to support ongoing operations and development programs[117]. - The company has not sold any shares under its shelf registration statements during the three months ended March 31, 2025, indicating a lack of capital raising activity[115]. Expenses and Cash Flow - Research and development expenses decreased by $0.9 million to $2.8 million for the three months ended March 31, 2025, primarily due to a reduction in direct research expenses and personnel costs[101]. - General and administrative expenses increased by $0.2 million to $4.1 million for the three months ended March 31, 2025, mainly due to higher professional fees and reduced sublease income[102]. - Interest income decreased to $0.3 million for the three months ended March 31, 2025, down from $0.5 million in the same period in 2024, attributed to decreased cash on hand[104]. - The company reported an unrealized loss of $0.6 million on warrant liability for the three months ended March 31, 2025, compared to a gain of $1.4 million for the same period in 2024[105]. - The company incurred non-cash charges of $0.2 million in Q1 2025, primarily from stock-based compensation of $0.6 million and unrealized loss on warrant liability of $0.6 million[123]. - The net increase in cash, cash equivalents, and restricted cash for Q1 2025 was $419,000, contrasting with a decrease of $12.4 million in Q1 2024[121]. - Cash provided by investing activities in Q1 2025 was $6.8 million, primarily from maturities of marketable securities of $7.8 million, while Q1 2024 saw cash used in investing activities of $7.2 million due to purchases of marketable securities of $13.5 million[125]. Market Risks and Operational Strategy - The company is exposed to market risks primarily related to interest rate sensitivities, but believes that a 1% movement in market interest rates would not significantly impact the total value of its portfolio[136]. - The company aims to reduce operating expenses and is focused on the progress and costs of its drug candidates' research and development[122]. - The company has various license agreements that obligate it to make milestone payments related to clinical development and sales milestones, as well as tiered royalties in the low-single digits based on sales[128]. - There were no cash flows from financing activities in both Q1 2025 and Q1 2024[126]. - The company has not entered into any off-balance sheet arrangements[132].

Exhibit 99.1 UNITY Biotechnology, Inc. Reports First Quarter 2025 Financial Results and Business Updates SOUTH SAN FRANCISCO, Calif., April 22, 2025 (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, 2025. UNITY announced 24-week and partial 36-week topline data from our Phase 2b ASPIRE study in diabetic macular edema (DME) in th ...

SOUTH SAN FRANCISCO, Calif., April 22, 2025 (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, 2025. UNITY announced 24-week and partial 36-week topline data from our Phase 2b ASPIRE study in diabetic macular edema (DME) in the first quarter. DME patients treated with UBX1325 (foselutoclax) showed vision improvements generally co ...

Core Viewpoint - Shares of UNITY Biotechnology (UBX) fell by 28.8% following mixed results from a mid-stage study comparing its candidate UBX1325 to Regeneron's Eylea in diabetic macular edema (DME) patients [1] Group 1: Study Results - The phase IIb ASPIRE study aimed to demonstrate non-inferiority of UBX1325 to Eylea, measured by mean change in Best Corrected Visual Acuity from baseline to weeks 20 and 24 [2] - The study included 52 DME patients with poor vision despite prior anti-VEGF treatment, randomized to receive either 10 μg UBX1325 or 2 mg Eylea [2] - At weeks 24 and 36, patients treated with UBX1325 showed a +5.2 letter improvement in visual acuity at 24 weeks and a +5.5 letter gain at 36 weeks, indicating vision gains non-inferior to Eylea [3] Group 2: Statistical Analysis - UBX1325 demonstrated statistically significant non-inferiority to Eylea at all time points up to 36 weeks, except for the average of weeks 20 and 24, where it met non-inferiority at an 88% confidence interval, just below the 90% threshold [4] - Year to date, shares of UNITY Biotechnology have increased by 33.1%, compared to the industry's growth of 5.6% [4] Group 3: Safety and Efficacy - UBX1325 showed a favorable safety and tolerability profile across multiple clinical studies, with no reported cases of intraocular inflammation or other serious adverse events [7] - Patients with moderate disease severity (baseline CST less than 400 microns) showed better performance with UBX1325, comprising about 60% of the study population [6] Group 4: Competitive Landscape - Eylea, developed by Regeneron, is a leading drug for various eye diseases, already approved for multiple conditions including DME and wet age-related macular degeneration [8]

Core Insights - Unity Biotechnology's stock (UBX) experienced a significant decline of 34.8%, closing at $1.19, following the release of results from its Phase 2b ASPIRE clinical trial for UBX1325 [4] Group 1: Clinical Trial Results - The Phase 2b ASPIRE clinical trial involved patients with diabetic macular edema (DME) who had poor vision despite prior anti-VEGF treatment, with data collected through 24 weeks for all patients and most through 36 weeks [1] - UBX1325 treatment resulted in visual acuity gains of over 5 letters from baseline at both 24 and 36 weeks, demonstrating non-inferiority to Regeneron Pharmaceuticals' Eylea (aflibercept) at 9 out of 10 time points through 36 weeks [2][6] - At 24 weeks, UBX1325-treated patients had a mean change in Best Corrected Visual Acuity (BCVA) of +5.2 ETDRS letters, which was +0.4 letters better than the aflibercept arm; at 36 weeks, the mean change was +5.5 ETDRS letters, with a +0.2 letter difference compared to aflibercept [6] Group 2: Safety and Financials - UBX1325 continues to show a favorable safety and tolerability profile, with complete 36-week data results expected in the second quarter of 2025 [4] - As of December 31, 2024, Unity had cash, cash equivalents, and marketable securities totaling $23.2 million, which is projected to fund operations into the fourth quarter of 2025 [4] Group 3: Patient Outcomes - Patients treated with UBX1325 generally outperformed those on aflibercept, particularly those with moderate disease severity (baseline Central Subfield Thickness < 400 microns, representing approximately 60% of study patients) [6] - Patients who switched from aflibercept to UBX1325 before study enrollment exhibited the most consistent and durable vision gains [6]

Unity Biotechnology (UBX) Update / Briefing March 24, 2025 08:00 AM ET Speaker0 Good morning, and welcome to the Unity Biotechnology Conference Call and Webcast. At this time, all attendees are in a listen only mode. A question and answer session will follow the formal presentations. As a reminder, this call is being recorded and a replay will be made available on the Unity website following the conclusion of the event. I'd now like to turn the call over to Lynn Sullivan, Chief Financial Officer of Unity Bi ...

Core Insights - UBX1325 demonstrated vision gains comparable to aflibercept in patients with diabetic macular edema (DME) at weeks 24 and 36, achieving non-inferiority at a >90% confidence interval [1][3] - The treatment resulted in a +5.2 letter gain in visual acuity at 24 weeks and a +5.5 letter gain at 36 weeks [1][3] - UBX1325 was numerically superior to aflibercept at 7 out of 10 time points in patients with moderately aggressive disease [1][2] Company Overview - UNITY Biotechnology, Inc. is focused on developing therapeutics to slow, halt, or reverse diseases of aging, with a current emphasis on retinal diseases [9] - UBX1325 is a novel BCL-xL inhibitor designed to eliminate senescent cells in diabetic retinal blood vessels while preserving healthy cells [4][8] - The company aims to transform real-world outcomes for patients with retinal disease through its investigational compound [8] Clinical Trial Details - The Phase 2b ASPIRE study involved 52 subjects randomized to receive either UBX1325 or aflibercept, with the primary endpoint being non-inferiority in visual acuity [6] - The study showed that UBX1325-treated patients had a mean change in Best-Corrected Visual Acuity (BCVA) of +5.2 ETDRS letters at 24 weeks and +5.5 ETDRS letters at 36 weeks, with a slight numerical advantage over aflibercept [3][6] - The ASPIRE study is designed to evaluate the safety and efficacy of UBX1325 in patients with active DME who are not achieving optimal benefit from standard anti-VEGF treatments [6] Market Context - Approximately 1.7 million people in the U.S. have DME, with around 750,000 diagnosed and treated [2] - The standard of care for DME has been anti-VEGF agents for the past 20 years, but many patients experience sub-optimal responses [2] - UBX1325 could provide a new treatment alternative for patients who do not achieve optimal results from existing therapies [4]