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SOUTH SAN FRANCISCO, Calif. - UNITY Biotechnology, Inc. (NASDAQ: UBX), a biotech firm specializing in anti-aging therapeutics with a market capitalization of $19.28 million, reported on Monday the complete 36-week results from its Phase 2b ASPIRE clinical trial. The company’s stock has shown strong momentum recently, gaining over 14% in the past week according to InvestingPro data. The trial assessed the efficacy of UBX1325, a treatment for diabetic macular edema (DME), and showed comparable vision gains to the current leading treatment, aflibercept.
The results indicated that UBX1325 was statistically non-inferior to aflibercept at week 36, particularly in a subgroup of patients with less severe DME (central subfield thickness less than 400 microns), which constituted 60% of the study participants. The safety profile of UBX1325 was also favorable, with no significant adverse events related to intraocular inflammation or other serious ocular conditions reported across multiple studies.
UNITY’s CEO, Anirvan Ghosh, Ph.D., highlighted the potential of UBX1325 as a novel treatment alternative to anti-VEGF therapy, suggesting that the development of UBX1325 could benefit from a partnership with a company that has an established ophthalmic franchise. The company plans to present the full findings at the upcoming ARVO 2025 Annual Meeting on May 7, 2025.
In a strategic move to reduce operational cash burn, UNITY’s Board of Directors has approved a revised operating plan that includes a workforce reduction. The company will explore strategic alternatives, which may involve the sale, license, or divestiture of its assets, including UBX1325 and other related technologies. This restructuring comes as the company faces financial challenges, with InvestingPro data showing an EBITDA of -$26.94 million and a Financial Health Score rated as FAIR. Despite these challenges, analysts maintain optimistic price targets ranging from $4 to $6 per share. The CEO, CFO, and Chief Legal Officer will transition to consulting roles to assist in this process, and external advisors may be engaged.
UBX1325 is part of UNITY’s portfolio aimed at treating diseases of aging, with a focus on ophthalmologic and neurologic conditions. The ASPIRE study, which enrolled 52 subjects, was designed to evaluate UBX1325 against aflibercept in patients with active DME who had not responded optimally to standard treatments.
This report is based on a press release statement from UNITY Biotechnology, Inc. and does not endorse the company’s claims. The exploration of strategic alternatives by UNITY may not result in any transaction or create value for the company or its shareholders. InvestingPro subscribers have access to additional insights, including 7 more ProTips and comprehensive financial metrics that can help evaluate the company’s potential trajectory.
In other recent news, Unity Biotechnology has reported outcomes from its Phase 2b ASPIRE trial evaluating UBX1325 for diabetic macular edema (DME). The trial, which compared UBX1325 to the standard treatment aflibercept, demonstrated non-inferiority at nine out of ten time points over 36 weeks, despite not meeting the primary endpoint at weeks 20 and 24. Patients receiving UBX1325 saw an improvement in visual acuity, gaining an average of 5.2 letters at 24 weeks and 5.5 letters at 36 weeks. Notably, approximately 40% of patients did not require additional anti-VEGF injections through week 36, a significant finding given their prior treatment history. Analyst firms like H.C. Wainwright and Mizuho Securities have maintained their positive outlooks, with H.C. Wainwright adjusting its price target to $4.00 and Mizuho maintaining a $6.00 target. Both firms continue to express optimism about UBX1325’s potential as a treatment option for patients with inadequate responses to existing therapies. Unity’s CEO, Anirvan Ghosh, expressed optimism about advancing UBX1325 to late-stage studies, emphasizing its potential benefits for a significant portion of the DME patient population. The complete 36-week data is expected in the second quarter of 2025, which will further inform the drug’s development path.
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