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Benitec Biopharma Inc. (BNTC)·Q1 2025 Earnings Summary

Executive Summary

  • Q1 FY2025 (quarter ended September 30, 2024) delivered zero revenue and a narrower net loss of $5.1M versus $6.6M in the prior-year quarter; diluted EPS improved to $(0.48) from $(3.05), primarily reflecting a higher share count after financing and warrant exercises .
  • Operating expenses were $5.8M (R&D $3.6M; G&A $2.2M), down slightly year over year ($5.9M), but up vs the prior quarter’s $4.1M; cash and equivalents rose sharply to $67.8M, strengthening runway to advance BB-301 .
  • Clinical progress in OPMD: Subject 1 showed 35–42% improvements in SSQ scores and 18–33% reductions in VFSS TPR at Day 270; Subject 2 achieved a clinically normal swallowing profile with 89% SSQ reduction and 92% reduction in pathological low‑volume sequential swallows at Day 180 .
  • Versus S&P Global consensus, EPS beat by ~$0.07 (actual $(0.48) vs $(0.55)) on zero revenue in line with estimates (0) .
  • Management plans to treat the fourth low‑dose subject in December and enroll additional subjects at the next, higher dose in 2025, citing adequate funding as a key catalyst for continued execution .

What Went Well and What Went Wrong

What Went Well

  • Robust clinical efficacy signals: “clinically meaningful improvements” for both Subjects at low dose, including Subject 2 achieving a clinically normal swallowing profile at Day 180; management: “We were highly encouraged by the significant, clinically meaningful improvements...” (Jerel A. Banks, M.D., Ph.D.) .
  • Safety: No Serious Adverse Events observed for the three low‑dose subjects; DSMB previously endorsed continued enrollment without modification .
  • Balance sheet strength: Cash and equivalents increased to $67.8M at quarter‑end, supported by April PIPE financing and subsequent warrant exercises; “Benitec is well‑funded to advance the BB‑301 clinical development program” .

What Went Wrong

  • No operating revenue; the business remains pre‑commercial, relying on external financing to fund clinical development .
  • QoQ cost uptick: Total operating expenses increased to $5.8M from $4.1M in the prior quarter, driven by higher G&A and R&D to support program execution .
  • Dilution impact: Weighted average shares rose to 10.6M from 2.16M YoY, materially affecting per‑share metrics and signaling ongoing equity dependence for funding .

Financial Results

Quarterly Trends (oldest → newest)

MetricQ4 FY2023 (Dec 31, 2023)Q3 FY2024 (Mar 31, 2024)Q1 FY2025 (Sep 30, 2024)
Revenue ($USD Millions)$0.00 $0.00 $0.00
R&D Expense ($USD Millions)$5.10 $2.57 $3.59
G&A Expense ($USD Millions)$1.82 $1.58 $2.21
Total Operating Expenses ($USD Millions)$6.93 $4.14 $5.79
Net Loss ($USD Millions)$(6.80) $(4.28) $(5.06)
Diluted EPS ($)$(2.64) $(1.64) $(0.48)
Cash and Equivalents ($USD Millions)$20.37 (as of 12/31/23) $14.14 (as of 3/31/24) $67.84 (as of 9/30/24)

Year-over-Year Comparison (Q1 FY2025 vs Q1 FY2024 – quarter ended Sep 30)

MetricQ1 FY2024 (Sep 30, 2023)Q1 FY2025 (Sep 30, 2024)YoY Δ
Revenue ($USD Millions)$0.00 $0.00 $0.00
R&D Expense ($USD Millions)$4.43 $3.59 −$0.84
G&A Expense ($USD Millions)$1.55 $2.21 +$0.66
Total Operating Expenses ($USD Millions)$5.87 $5.79 −$0.08
Net Loss ($USD Millions)$(6.57) (attributable to common) $(5.06) +$1.51
Diluted EPS ($)$(3.05) $(0.48) +$2.57
Weighted Avg Shares (Millions)2.16 10.64 +8.49

Estimates vs Actuals (S&P Global)

MetricConsensus (Q1 FY2025)Actual (Q1 FY2025)Surprise
EPS ($)$(0.55)*$(0.48) +$0.07 (beat)
Revenue ($USD Millions)$0.00*$0.00 In line

Values marked with * retrieved from S&P Global.

KPIs (Clinical Efficacy – BB-301 Low-Dose Cohort)

KPISubject 1 (Day 270 post-dose)Subject 2 (Day 180 post-dose)
SSQ Total Score change−35% (improvement) −89% (improvement)
SSQ Sub-score Thin Liquid−42% −84% (repeat swallows)
VFSS TPR Thin Liquid−33% N/A (sequential swallows metric improved 92%)
VFSS TPR Solid Food−18% N/A
VFSS TPR Thick Liquids−30% N/A
Pathologic low‑volume sequential swallowsN/A−92%
SafetyNo SAEs observed (low-dose) No SAEs observed (low-dose)

Guidance Changes

MetricPeriodPrevious GuidanceCurrent GuidanceChange
RevenueFY2025Not provided Not provided Maintained (none)
EPSFY2025Not provided Not provided Maintained (none)
OpExFY2025Not provided Not provided Maintained (none)
Cash RunwayThrough 2025“Cash Runway Extended Through 2025” (after April PIPE) “Well-funded to advance BB‑301” and planning higher-dose enrollment in 2025 Maintained qualitatively
Clinical Milestones2H 2024Additional interim safety/efficacy data expected in 2H 2024 Fourth low‑dose subject anticipated Dec 2024; higher-dose enrollment in 2025 Updated timeline details

Earnings Call Themes & Trends

Note: No formal earnings call transcript identified for Q1 FY2025; company hosted an October 14 webcast to discuss interim clinical results .

TopicPrevious Mentions (Q4 FY2023; Q3 FY2024)Current Period (Q1 FY2025)Trend
Clinical efficacy (OPMD)DSMB cleared continued enrollment; interim data expected mid-2024 Strong interim efficacy signals at low dose (SSQ and VFSS improvements; Subject 2 normal profile) Improving efficacy narrative
SafetyNo SAEs reported; transient GERD resolved No SAEs observed in three low‑dose subjects Stable positive safety
Enrollment & dosing23 NH subjects; second subject dosed; third anticipated Third low‑dose subject treated Oct; fourth anticipated Dec; higher dose planned 2025 Execution progressing
Financing & runway$40M PIPE closed; runway through 2025 Cash $67.8M; “well-funded” for program advancement Strengthened balance sheet
Data disseminationInterim data expected 2H 2024 Late‑breaking oral presentation at WMS; webcast held Increased external visibility

Management Commentary

  • “We were highly encouraged by the significant, clinically meaningful improvements observed for both Subjects treated at the low‑dose of BB‑301, with Subject 1 experiencing durable improvements in core dysphagic symptoms of 35% to 40%, and Subject 2 achieving a clinically normal swallowing profile...” — Jerel A. Banks, M.D., Ph.D., Executive Chairman and CEO .
  • “We remain optimistic about the potential for continued benefit... and, including funds from recent exercises of shareholder‑held warrants, Benitec is well‑funded to advance the BB‑301 clinical development program. We look forward to enrolling additional Subjects at the next, higher dose of BB‑301, in 2025.” — Jerel A. Banks, M.D., Ph.D. .

Q&A Highlights

  • No Q1 FY2025 earnings call transcript was available; the company held an October 14 webcast to discuss interim clinical study results, with replay referenced in the press release .
  • No additional guidance clarifications or tone shifts can be assessed without a call transcript .

Estimates Context

  • EPS beat: Actual diluted EPS of $(0.48) vs S&P Global consensus of $(0.55)*, a ~$0.07 beat .
  • Revenue in line: Actual $0.00 vs S&P Global consensus $0.00* .
  • Coverage: 3 estimates for EPS and 3 for revenue in Q1 FY2025*, indicating modest Street coverage for a clinical‑stage biotech.
    Values marked with * retrieved from S&P Global.

Key Takeaways for Investors

  • Clinical momentum: Low‑dose BB‑301 generated meaningful functional improvements with clean safety, de‑risking the program ahead of higher‑dose enrollment in 2025 .
  • Funding runway: The $67.8M cash balance at quarter‑end and prior PIPE financing support continued execution without near‑term revenue, mitigating financing overhang .
  • EPS optics: The EPS “beat” and YoY per‑share improvement reflect dilution effects from a larger share base rather than operating leverage; focus on cash burn and clinical milestones .
  • Near‑term catalysts: Fourth subject dosing (Dec 2024), ongoing interim data flow, and initiation of higher‑dose cohort in 2025 could drive sentiment and liquidity events .
  • Risk factors: Absence of commercial revenue, potential trial enrollment/timing risks, and need for sustained efficacy/safety across larger cohorts remain core considerations .
  • Monitoring priorities: Track quarterly OpEx trends vs cash runway, incremental SSQ/VFSS readouts, and any regulatory interactions or dissemination at medical meetings .
  • Positioning: Program advances with favorable early data and funding support; stock likely sensitive to incremental clinical efficacy signals and dose‑escalation outcomes .