Unity Btech - UBX STOCK NEWS

UNITY Biotechnology (NASDAQ:UBX) has released its Q1 2025 financial results and provided updates on its Phase 2b ASPIRE study in diabetic macular edema (DME). The company's lead drug candidate, UBX1325 (foselutoclax), showed vision improvements comparable to aflibercept but did not meet the primary endpoint of statistical non-inferiority at weeks 20 and 24, though it achieved non-inferiority at week 36 based on interim data.

Financial highlights include:

• Cash position of $16.9M as of March 31, 2025 (down from $23.2M in December 2024)
• Net loss of $7.3M in Q1 2025 (increased from $5.8M in Q1 2024)
• Research and development expenses decreased to $2.9M (from $3.7M)
• General and administrative expenses increased to $4.0M (from $3.9M)

The company expects current cash reserves to fund operations into Q4 2025, with full 36-week trial data anticipated in Q2 2025.

UNITY Biotechnology (UBX) announced topline results from its Phase 2b ASPIRE clinical trial of UBX1325 in patients with diabetic macular edema (DME) who had poor vision despite prior anti-VEGF treatment.

Key findings show UBX1325-treated patients achieved vision gains of +5.2 letters at 24 weeks and +5.5 letters at 36 weeks, comparable to aflibercept. The treatment was non-inferior to aflibercept at 9 out of 10 time points but missed the primary endpoint at weeks 20-24 (88% confidence interval vs 90% required).

Notable results include:

• Better performance than aflibercept in patients with moderate disease severity
• Consistent vision gains in patients switching from aflibercept
• Favorable safety profile with no major adverse events

UBX1325, a novel BCL-xL inhibitor, targets senescent cells in diabetic retinal blood vessels. Complete 36-week data expected in Q2 2025.

UNITY Biotechnology (NASDAQ: UBX) has announced a virtual investor event scheduled for March 24, 2025, at 8:00 AM ET to discuss important data from their Phase 2b ASPIRE study. The event will present 24- and 36-week results evaluating UBX1325 in patients with Diabetic Macular Edema (DME).

The presentation will feature Dr. Robert Bhisitkul, a key opinion leader from UCSF School of Medicine, alongside company management. UBX1325, characterized as a potent BCL-xL inhibitor with senolytic mechanism of action, is being developed to potentially improve long-term visual outcomes. The event will conclude with a live Q&A session.

UNITY Biotechnology [NASDAQ: UBX] has appointed Dr. Yehia Hashad to its Board of Directors and science committee. Dr. Hashad, currently executive vice president of R&D and chief medical officer at Bausch + Lomb, brings over 25 years of ophthalmology and drug development expertise.

This strategic appointment comes as UNITY prepares for its Phase 2b ASPIRE 24-week data readout for UBX1325, a potential treatment for diabetic macular edema. Dr. Hashad's extensive experience includes overseeing 40+ pharmaceutical programs at Allergan Aesthetics and serving as global medical director for macular degeneration treatments at Novartis Pharma AG.

UNITY Biotechnology (NASDAQ: UBX) has reported its Q4 and full-year 2024 financial results. The company anticipates receiving 24-week topline data from its Phase 2b ASPIRE study for UBX1325 (foselutoclax) in diabetic macular edema (DME) in Q1 2025, followed by 36-week data in Q2 2025.

Financial highlights include:

• Cash position of $23.2 million as of December 31, 2024 (down from $43.2M in 2023)
• Full-year 2024 net loss of $26.0 million (improved from $39.9M in 2023)
• Q4 2024 net loss of $8.4 million (compared to $4.3M in Q4 2023)
• Research and development expenses decreased to $13.0 million in 2024 (from $20.1M in 2023)
• General and administrative expenses reduced to $15.5 million in 2024 (from $19.0M in 2023)

UNITY Biotechnology [NASDAQ: UBX] announced that its Compensation Committee has granted a stock-based award to its new Chief Medical Officer, Federico Grossi. The award consists of options to purchase 150,000 shares of UNITY common stock, granted on January 6, 2025. The grant was made under the UNITY 2020 Employment Inducement Incentive Plan, amended in March 2020, which aims to provide incentives for new hires in accordance with Nasdaq Stock Market Rule 5635(c)(4).

UNITY Biotechnology [NASDAQ: UBX] has appointed Federico Grossi, M.D., Ph.D., as chief medical officer. Dr. Grossi brings over 20 years of biotech industry experience, most recently serving as CMO at Apellis Pharmaceuticals where he led the development of SYFOVRE for geographic atrophy. His appointment comes at a important time as UNITY approaches the readout of topline 24-week results from its Phase 2b ASPIRE study of UBX1325 in diabetic macular edema (DME).

During his 13-year tenure at Apellis, Dr. Grossi oversaw clinical strategy and development programs across multiple therapeutic areas, leading to the approval and launch of EMPAVELI and SYFOVRE. He managed 10-15 concurrent studies from proof-of-concept through phase 3 clinical trials across global regions and built the medical affairs and safety functions.

UNITY Biotechnology [UBX] reported Q3 2024 financial results, highlighting progress in developing UBX1325 (foselutoclax) for diabetic macular edema (DME). Following FDA interaction, UNITY expects a pivotal study to be a non-inferiority trial comparing UBX1325 to aflibercept. Financial highlights include cash position of $29.0 million as of September 30, 2024, net loss of $6.5 million (down from $14.8 million in Q3 2023), and reduced R&D expenses of $2.8 million (down from $4.6 million). The company expects topline 24-week data in Q1 2025 and 36-week data in Q2 2025.

UNITY Biotechnology (NASDAQ: UBX) has announced an in-person and virtual Ophthalmology Day event for investors and analysts on October 15, 2024, in New York. The event will feature presentations from ophthalmology key opinion leaders and company management, focusing on UNITY's ongoing Phase 2b ASPIRE study evaluating foselutoclax (UBX1325) against aflibercept in diabetic macular edema (DME).

The agenda includes discussions on the senolytic therapeutic hypothesis, UBX1325 clinical development plan, and a retina expert roundtable. Twenty-four-week safety and efficacy data are expected in Q1 2025, with 36-week data in Q2 2025. The event will address the evolving therapeutic landscape and UBX1325's potential to meet unmet needs in DME. Virtual attendees can access the webcast through UNITY's website, with replays available for 90 days.