Nucor earnings beat by $0.08, revenue fell short of estimates
SOUTH SAN FRANCISCO - UNITY Biotechnology, Inc. [NASDAQ: UBX], a small-cap biotechnology company with a market capitalization of approximately $31 million, announced today that its Phase 2b ASPIRE clinical trial has yielded positive topline results for UBX1325, a therapeutic candidate for the treatment of diabetic macular edema (DME). The trial compared UBX1325 with aflibercept, a standard anti-VEGF therapy, and found that UBX1325 was generally non-inferior in improving vision.
Patients treated with UBX1325 experienced gains in visual acuity, with an average improvement of +5.2 letters at 24 weeks and +5.5 letters at 36 weeks. The treatment met the non-inferiority criteria at 9 out of 10 time points through 36 weeks, except for the average of weeks 20 and 24, where it fell slightly short of the predefined 90% confidence interval, achieving 88%.
The study also highlighted that UBX1325 was numerically superior to aflibercept at seven out of ten time points in a subgroup of patients with moderately aggressive disease. These results suggest potential benefits for a significant portion of the DME patient population. The positive trial results have contributed to UNITY’s strong market performance, with the stock showing an impressive year-to-date return of nearly 87%, according to InvestingPro data.
UNITY’s CEO, Anirvan Ghosh, Ph.D., expressed optimism about the findings and the prospect of advancing UBX1325 to late-stage studies. The company aims to provide an alternative for patients who have not responded adequately to existing anti-VEGF therapies. While UNITY maintains a healthy liquidity position with a current ratio of 2.62, InvestingPro analysis indicates the company is currently trading near its Fair Value. Investors can access 8 additional exclusive ProTips and comprehensive financial metrics through an InvestingPro subscription.
Approximately 750,000 patients in the U.S. are diagnosed and treated for DME, with many not achieving optimal results from current treatments. UBX1325 offers a new mechanism of action, potentially helping patients who do not respond to standard therapies.
David S. Boyer, MD, emphasized the importance of having an additional treatment option for patients with sub-optimal responses to current treatments. UBX1325, if approved, could change the treatment landscape for such patients.
UBX1325 is a BCL-xL inhibitor designed to selectively target senescent cells in the diabetic retina. The favorable safety and tolerability profile of UBX1325 has been demonstrated in multiple clinical studies, with no significant adverse events reported.
UNITY expects to release the complete 36-week data for the remaining patients in the second quarter of 2025, with the next earnings announcement scheduled for April 3, 2025. The company’s EBITDA currently stands at -$27.6 million, reflecting its development-stage status. The information in this article is based on a press release statement from UNITY Biotechnology, Inc.
In other recent news, Unity Biotechnology has been highlighted by Chardan Capital Markets with a Buy rating and a $6.00 price target, emphasizing the potential of its lead candidate, UBX1325, for treating diabetic macular edema (DME). UBX1325 is currently in a Phase 2b ASPIRE trial, with topline data expected in the first quarter of 2025. The company also appointed Federico Grossi, M.D., Ph.D., as its new chief medical officer, bringing significant experience in clinical development and regulatory strategy, particularly in ophthalmology. Dr. Grossi’s leadership is expected to advance Unity’s strategic initiatives, especially as the company approaches critical milestones in its DME treatment trials. Piper Sandler has included Unity Biotechnology in its report on companies with key Phase 2b readouts expected in 2025, indicating potential catalysts for the company’s future developments. These recent developments position Unity Biotechnology as a company to watch in the biotech sector, particularly in the field of senolytic treatments for retinal diseases.
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