Unity Biotechnology, Inc. (UBX)·Q1 2025 Earnings Summary

Executive Summary

• Q1 2025 was defined by ASPIRE Phase 2b topline: UBX1325 delivered ~+5.2 letters at 24 weeks and ~+5.5 letters at 36 weeks, generally comparable to aflibercept; however, the study did not meet the primary endpoint of non-inferiority at the average of weeks 20 and 24 .
• Financially, net loss widened to $7.30M and EPS was $(0.43); cash, cash equivalents and marketable securities declined to $16.9M, with cash runway guided into Q4 2025 .
• Management highlighted favorable safety, non-inferiority at 9 of 10 time points, and stronger performance in subgroups with CST <400 microns; full 36-week data expected in Q2 2025, a near-term catalyst .
• Estimate comparison is unavailable: S&P Global consensus mapping for UBX was not found, so beats/misses vs Street cannot be assessed (values unavailable; S&P Global data) .

What Went Well and What Went Wrong

What Went Well

• UBX1325 achieved non-inferiority vs aflibercept at most time points through 36 weeks, with mean BCVA gains of +5.2 letters at 24 weeks and +5.5 letters at 36 weeks, and a favorable safety profile without intraocular inflammation or severe ocular AEs .
• Subgroup strength: UBX1325 generally outperformed aflibercept in patients with moderately aggressive disease (baseline CST <400 microns) and in patients who switched from aflibercept prior to enrollment, showing consistent and durable vision gains .
• CEO tone supportive of next steps: “The 24-week data indicates that UBX1325… can lead to vision improvement in patients with inadequate response to standard of care… The full 36-week data will be instrumental in shaping our plans for subsequent studies” .

What Went Wrong

• Primary endpoint miss: ASPIRE did not meet statistical non-inferiority at the average of weeks 20 and 24 (achieved only at 88% CI vs 90% threshold), which will require design and patient selection refinements for pivotal planning .
• CST increases at weeks 16 and 20 led to supplemental anti-VEGF treatment for some patients; faricimab-pretreated patients drove much of the CST gain and week-20 vision dip, highlighting rescue criteria sensitivity and subgroup heterogeneity .
• Financials: Net loss widened to $7.30M and cash decreased to $16.9M from $23.2M in Q4, reflecting operating burn as the ASPIRE study nears completion; warrant liability loss also pressured reported results .

Financial Results

Notes:

• Revenue not presented in company statements; Loss from operations equals total operating expenses, implying no reported product revenue .
• Cash runway: Company states runway into Q4 2025 .

KPIs (Clinical)

Segment breakdown: Not applicable—single clinical program focus (UBX1325 in DME).

Margins: Not applicable given no product revenue reported.

Guidance Changes

Earnings Call Themes & Trends

Management Commentary

• “The 24-week data indicates that UBX1325… can lead to vision improvement in patients with inadequate response to standard of care… The full 36-week data will be instrumental in shaping our plans for subsequent studies” — Anirvan Ghosh, CEO .
• “UBX1325 generally outperformed aflibercept in patients who had moderate disease severity (baseline CST <400 microns)… Patients who switched from aflibercept… to UBX1325 had the most consistent and durable vision gains” — Company summary of topline .
• Physician view: “Achieving durable improvements in visual acuity via an entirely new mechanism of action… would be invaluable for patients receiving sub‑optimal response from current treatment options… UBX1325… would be a welcome treatment alternative” — Dr. David S. Boyer .

Q&A Highlights

• Go-forward design: Focus on CST <400 micron subgroup for pivotal to maximize probability of success; aligns with majority of current DME patients under treatment and observed robust gains .
• Prior therapy subgroups: Faricimab-pretreated patients drove CST gain and week‑20 dip; aflibercept‑pretreated subgroup showed consistent improvement (~6+ letter gain by week 36) .
• Rescue criteria: FDA advised AND rescue (CST and vision drop); retrospective analysis suggests ~90% of ASPIRE patients would not trigger rescue under AND, supporting lower rescue rates in pivotal .
• Control arm expectations: With per‑label aflibercept run‑in (more than 3 injections), control curve likely stabilizes earlier, improving comparative interpretability .
• Durability and dosing: Mechanism suggests durable PD‑driven effect; most gain after first injection; second provides limited incremental benefit; continued dosing beyond two injections not indicated by data .

Estimates Context

• Street consensus via S&P Global for Q1 2025 EPS and revenue is unavailable due to missing company mapping, preventing beat/miss analysis (values unavailable; S&P Global data).
• Implication: Near-term estimate revisions likely to focus on clinical probability of success and cash runway rather than revenue/EPS for a pre-commercial biotech.

Key Takeaways for Investors

• Clinical signal present despite primary endpoint miss: UBX1325 achieved non-inferiority at most timepoints and showed stronger gains in CST<400 subgroup; clean safety/tolerability is a positive for future development .
• Pivotal path clarity: FDA guidance (per‑label aflibercept dosing; AND rescue criteria) plus subgroup learnings can reduce rescues and sharpen study power; expect refined inclusion criteria around CST thresholds .
• Cash runway into Q4 2025 provides time to secure full 36‑week dataset and align pivotal design; cash/marketable securities were $16.9M at quarter-end, net loss $7.30M .
• Near-term catalyst: Full 36‑week ASPIRE dataset in Q2 2025—watch for confirmation of non‑inferiority and subgroup advantage; a stronger dataset could be a stock driver .
• Risk factors: Week‑20 average miss, rescue sensitivity to CST dynamics (especially faricimab‑pretreated patients), and funding needs beyond runway remain central risks .
• Strategy: Expect management to focus on moderately controlled fluid (CST<400) and prior aflibercept‑treated patients to highlight differentiation; limited dosing beyond two injections consistent with durable mechanism .
• Trading lens: Stock likely reacts to clarity on pivotal design and subgroup confirmation in full 36‑week readout; clean safety and defined responder profile can support sentiment into pivotal planning .