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QB

Q32 Bio Inc. (QTTB)·Q3 2024 Earnings Summary

Executive Summary

  • Q3 2024 reflected disciplined execution ahead of two Phase 2 topline readouts in December (bempikibart in AD and AA), with cash of $89.1M providing runway into mid-2026 .
  • Operating expenses rose year over year driven by bempikibart clinical spend and a $4.0M BMS milestone; net loss widened to $(17.6)M and $(1.46) diluted loss per share; collaboration revenue was $0 vs $1.86M in Q3 2023 .
  • ADX-097 Phase 2 basket trial enrollment is underway, with initial open-label data expected 1H 2025 and topline in 2H 2025, and AAV Phase 2 expected to start in 1H 2025 .
  • Street consensus (S&P Global) for Q3 2024 EPS/revenue was unavailable due to data access error; estimate comparisons cannot be made this quarter (see Estimates Context) [SPGI error in tool].
  • Near-term stock catalysts are the December topline readouts for AD and AA; management reiterated timelines and confidence in differentiated, disease-modifying potential of bempikibart .

What Went Well and What Went Wrong

What Went Well

  • Completed enrollment in SIGNAL-AD with demand-driven expansion to 121 patients; SIGNAL-AA enrollment previously completed; both topline readouts on track for December. “We believe bempikibart has the potential to bring a differentiated, disease-modifying treatment to patients… and look forward to sharing our results” — CEO Jodie Morrison .
  • ADX-097 Phase 2 basket trial progressing, with initial open-label data in 1H 2025 and topline in 2H 2025; preparations to commence Phase 2 in AAV in 1H 2025 .
  • Liquidity healthy: $89.1M cash at 9/30/24, runway into mid-2026 through four Phase 2 milestones (AD/AA topline in Q4’24; ADX-097 renal basket and AAV topline in 2H’25) .

What Went Wrong

  • No collaboration revenue in Q3 2024 vs $1.86M in Q3 2023; pre-commercial status underscores reliance on financing and disciplined spend .
  • Operating expenses up materially Y/Y; R&D rose to $14.3M vs $7.5M driven by clinical/manufacturing for bempikibart and a $4.0M BMS milestone; G&A increased to $4.5M vs $2.2M on stock-based comp and public company costs .
  • Net loss widened to $(17.6)M vs $(14.0)M in Q3 2023; per-share loss $(1.46) vs unusual prior-year $(40.52) due to historical share count dynamics pre-merger/reverse split, highlighting optical volatility in EPS comparability .

Financial Results

Income Statement Metrics vs Prior Year and Prior Quarter

MetricQ3 2023Q2 2024Q3 2024
Collaboration Revenue ($USD Millions)$1.859 N/A$0.000
Research & Development ($USD Millions)$7.463 $13.411 $14.346
General & Administrative ($USD Millions)$2.194 $4.508 $4.468
Net Loss ($USD Millions)$(14.031) $(16.978) $(17.595)
Diluted EPS ($USD)$(40.52) $(1.42) $(1.46)
Weighted Avg Shares - Diluted346,288 11,964,224 12,076,412

Notes: Collaboration revenue for Q2 2024 not disclosed in cited sources. EPS comparability to Q3 2023 is impacted by the merger/reverse split and share base differences .

Liquidity Progression

MetricQ1 2024 (as of 3/31/24)Q2 2024 (as of 6/30/24)Q3 2024 (as of 9/30/24)
Cash, Cash Equivalents & Short-term Investments ($USD Millions)$135.312 $107.6 $89.078

KPIs (Operating Drivers)

KPIQ1 2024Q2 2024Q3 2024
R&D Expense ($USD Millions)$9.841 $13.411 $14.346
G&A Expense ($USD Millions)$5.002 $4.508 $4.468
Net Income (Loss) ($USD Millions)$1.029 (gain from notes conversion) $(16.978) $(17.595)
Diluted EPS ($USD)$(6.33) $(1.42) $(1.46)

Segment breakdown and traditional margin tables are not applicable given pre-revenue status.

Guidance Changes

MetricPeriodPrevious GuidanceCurrent GuidanceChange
Bempikibart AD Phase 2 toplineQ4 2024On track for Q4 2024 December 2024 Maintained
Bempikibart AA Phase 2 toplineQ4 2024On track for Q4 2024 December 2024 Maintained
ADX-097 renal basket initial open-label data1H 2025Initial data by YE 2024 1H 2025 Revised later (timing shift)
ADX-097 renal basket topline2H 20252H 2025 2H 2025 Maintained
ADX-097 AAV Phase 2 start1H 20251H 2025 1H 2025 Maintained
ADX-097 AAV topline2H 20252H 2025 2H 2025 Maintained
Cash runwayThrough mid-2026Mid-2026 Mid-2026 Maintained

Earnings Call Themes & Trends

No Q3 2024 earnings call transcript was available in the document set (searched and none found). Narrative below draws from Q1, Q2, and Q3 earnings press releases and Q3 10-Q.

TopicPrevious Mentions (Q1 & Q2)Current Period (Q3)Trend
Bempikibart execution (AD/AA)AA enrollment completed; AD enrollment on track; topline in 4Q’24 AD enrollment completed, expanded to 121; AA topline timing reaffirmed (Dec) Positive momentum; increased scale in AD
ADX-097 programPlan to start renal basket in 1H’24; AAV start 1H’25; initial data YE’24; topline 2H’25 Renal basket enrolling; initial open-label 1H’25; topline 2H’25; AAV start 1H’25 Timing refined; still progressing
Liquidity/runway~$135.3M cash as of 3/31; runway to mid-2026 $107.6M at 6/30; $89.1M at 9/30; runway reaffirmed to mid-2026 Cash draw consistent with development pace
Regulatory/licensing (BMS)—$4.0M BMS milestone paid; R&D impact Incurred milestone tied to program progress
Corporate (public co. costs)Merger close and public co. costs G&A up Y/Y due to stock comp and public co. costs Normalizing post-merger overhead

Management Commentary

  • “We believe bempikibart has the potential to bring a differentiated, disease-modifying treatment to patients with AD and AA and look forward to sharing our results” — Jodie Morrison, CEO .
  • “Enrollment is underway in the Phase 2 basket trial of ADX-097… Initial open-label data is expected in the first half of 2025, and topline results expected in the second half of 2025” .
  • “Cash and cash equivalents of $89.1 million as of September 30, 2024 expected to provide financial runway through four Phase 2 clinical milestones and into mid-2026” .

Q&A Highlights

  • No Q3 2024 earnings call transcript found; no Q&A available in the document set (searched for “earnings-call-transcript” and none returned).

Estimates Context

  • Attempted to retrieve S&P Global consensus for Q3 2024 EPS and revenue; access failed due to “Daily Request Limit Exceeded.” As a result, consensus estimates could not be included this quarter [SPGI error in tool].
  • Investor implication: Post-readout, Street models will likely recalibrate for bempikibart’s probability of success, timelines, and cash runway trajectory; absence of Q3 estimate comparison does not alter the near-term catalyst path.

Key Takeaways for Investors

  • December topline readouts in AD and AA are the primary near-term catalysts; narrative emphasizes disease-modifying potential and robust AD enrollment (121 patients), which could drive binary stock outcomes around data .
  • Operating expense profile reflects advancement costs and the BMS milestone; expect spend intensity to remain elevated around readouts and subsequent development steps .
  • Liquidity of $89.1M with runway into mid-2026 lowers near-term financing risk; progression from $135.3M (Q1) to $107.6M (Q2) to $89.1M (Q3) is consistent with program cadence .
  • ADX-097 timelines refined (initial open-label data now 1H 2025), keeping second-half 2025 topline intact; continued diversification benefit if data aligns with the tissue-targeted thesis .
  • No revenue; valuation remains event-driven and sensitive to bempikibart efficacy signals and safety/tolerability at selected dosing regimens discussed in trial design .
  • Watch for any capital markets moves post-readouts to extend runway toward registrational studies; G&A levels reflect public company normalization .
  • In absence of Q3 estimate comparisons, focus on qualitative confidence and operational readiness ahead of December, and be prepared for swift thesis updates once topline lands .

Sources: Q3 2024 8-K and Exhibit 99.1 press release ; Q3 2024 10-Q ; Q1 2024 press release ; Q2 2024 press release (IR site) ; Enrollment completion PR (July 9, 2024) ; ADX-097 ASN poster PR (Oct 14, 2024) .