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QB

Q32 Bio Inc. (QTTB)·Q4 2024 Earnings Summary

Executive Summary

  • Q4 2024 delivered clean financials with zero collaboration revenue, a narrower net loss of $14.2M and EPS of $-1.16; cash and equivalents were $78.0M, extending runway into 2H 2026 .
  • Bempikibart AA program advanced: late-breaking AAD oral presentation, durable post-treatment responses, and favorable safety; Part B to dose in 1H 2025 with topline in 1H 2026 .
  • SIGNAL-AD Part B did not meet its primary endpoint; management is reviewing results; safety remained favorable across trials. Bold negative surprise: SIGNAL-AD miss .
  • Near-term catalysts: AA Part B initiation (1H 2025), AAD visibility, AA Part B topline (1H 2026), ADX-097 renal basket initial data (1H 2025) and topline (2H 2025) .
  • No Q4 earnings call transcript was found; Wall Street consensus estimates via S&P Global were unavailable at time of writing, limiting beat/miss analysis [Search: none] [GetEstimates error].

What Went Well and What Went Wrong

What Went Well

  • AAD late-breaking oral presentation underscored AA clinical activity and durable responses, with robust pharmacology and a favorable safety profile (“encouraging clinical activity… durable responses… well-tolerated safety profile”) .
  • AA trial showed post-hoc signals: mean SALT reduction 16% for bempikibart vs 2% for placebo (p=0.045), SALT-20 achieved in 9% at week 24 and 13% at week 26; no Grade 3+ related AEs .
  • Cash runway extended into 2H 2026, supporting AA OLE and AA Part B topline; strengthens funding visibility across milestones .

What Went Wrong

  • SIGNAL-AD Part B failed to meet the primary endpoint (EASI change 74% bempikibart vs 76% placebo; p=NS), prompting an internal review; high placebo rates cited .
  • Elevated operating costs YoY as R&D rose to $10.5M (vs $8.3M) and G&A to $4.0M (vs $2.8M), reflecting Phase 2 trial and public-company costs .
  • Plans to initiate ADX-097 in AAV were deferred to focus resources on AA and renal basket programs, narrowing near-term program breadth .

Financial Results

MetricQ4 2023Q3 2024Q4 2024
Revenue (Collaboration arrangement) ($USD Millions)$(14.662) $0.000 $0.000
Net Loss ($USD Millions)$27.067 $17.595 $14.189
Diluted EPS ($USD)$-76.39 $-1.46 $-1.16
R&D Expense ($USD Millions)$8.339 $14.346 $10.545
G&A Expense ($USD Millions)$2.808 $4.468 $3.981
Cash and Equivalents ($USD Millions)$25.617 $89.078 $78.0

Notes:

  • Margins are not meaningful given zero quarterly collaboration revenue in Q4 2024 and Q3 2024 .

Segment breakdown and commercial KPIs: Not applicable; the company reported no product revenues .

Guidance Changes

MetricPeriodPrevious GuidanceCurrent GuidanceChange
Cash RunwayThrough milestonesInto mid-2026 Into 2H 2026 Raised/Extended
SIGNAL-AA Part B – Initiation1H 2025Expansion contemplated following AA signals On track to dose patients in 1H 2025 Maintained/Confirmed
SIGNAL-AA Part B – Topline1H 2026Not previously specifiedOn-track for 1H 2026 New specific timing
ADX-097 Renal Basket – Initial Data1H 20251H 2025 1H 2025 Maintained
ADX-097 Renal Basket – Topline2H 20252H 2025 2H 2025 Maintained
ADX-097 AAV Phase 2 – Initiation1H 2025Expected to commence in 1H 2025 Deferred to focus on AA and renal basket Lowered/Delayed

Earnings Call Themes & Trends

No Q4 2024 earnings call transcript was available; themes below reflect press releases across quarters.

TopicPrevious Mentions (Q1 2024)Previous Mentions (Q3 2024)Current Period (Q4 2024)Trend
IL-7Rα strategy and bempikibartPhase 2 AA enrollment completed; AD trial on-track Both AD and AA toplines expected in Dec 2024 AAD late-breaking AA data; durable responses; Part B initiation 1H 2025, topline 1H 2026 Strengthening AA focus
AA clinical outcomesEnrollment completed; topline planned Topline expected in Dec Post-hoc efficacy (SALT improvement, SALT-20), favorable safety Positive signal, advancing
AD clinical outcomesAD on-track AD topline expected in Dec Part B miss; safety favorable; internal review Negative surprise
Complement program ADX-097Phase 2 renal basket planned 1H 2024; AAV 1H 2025 Enrollment underway; initial/open-label data 1H 2025; topline 2H 2025 Renal basket timelines maintained; AAV deferred Focused on renal basket
Cash runway and financing$135.3M; mid-2026 runway $89.1M; mid-2026 runway $78.0M; runway into 2H 2026 Extended despite spend

Management Commentary

  • “We are pleased to have been selected to present our bempikibart Phase 2a Part A data at AAD… highlighting the encouraging clinical activity… robust pharmacologic data, and a well-tolerated safety profile.” – Jodie Morrison, CEO .
  • “We are disappointed that the SIGNAL-AD trial did not achieve its primary endpoint… we plan to conduct a review to better understand the results.” – Jodie Morrison, CEO .
  • “Results from our analysis of SIGNAL-AA showed clinically meaningful activity and a safety profile… we look forward to advancing bempikibart as a potential treatment for AA.” – Jason Campagna, M.D., Ph.D., CMO .

Q&A Highlights

  • No Q4 2024 earnings call transcript was available; therefore, Q&A details and any real-time guidance clarifications are not accessible [ListDocuments: none; SearchDocuments: none].

Estimates Context

  • S&P Global Wall Street consensus estimates for Q4 2024 could not be retrieved during this session due to API limit restrictions; as a result, beat/miss vs consensus cannot be determined at this time [GetEstimates error].
  • Given QTTB’s stage and zero reported collaboration revenue in Q4 2024, many brokers may not publish quarterly revenue EPS targets; if needed, we can re-attempt S&P Global pull later to anchor any estimate comparisons .

KPIs (Clinical Signals)

KPIWeek 24Week 26
SALT mean reduction – bempikibart vs placebo (%)16% vs 2% 18% vs 2%
SALT-20 achievement – bempikibart vs placebo (%)9% vs 0% 13% vs 0%

Additional AD efficacy snapshot: EASI improvement at Week 14 was 74% bempikibart vs 76% placebo (p=NS) .

Why Results Moved

  • The narrower net loss vs prior year primarily reflects the absence of a large negative collaboration revenue reversal seen in Q4 2023 (collaboration arrangement revenue $(14.662)M in Q4 2023 vs $0.0M in Q4 2024) and modest other income improvements; operating expenses increased YoY due to Phase 2 trial activity and public-company costs .
  • The SIGNAL-AD miss likely stems from high placebo response rates and trial design nuances; management flagged a formal review to diagnose drivers while reaffirming the favorable safety and PK/PD target engagement .
  • AA program momentum and durable post-treatment responses bolster the narrative of IL‑7/TSLP pathway modulation potentially enabling remittive effects, supporting the decision to proceed to Part B with loading regimen and longer follow-up .

Key Takeaways for Investors

  • AA is now the lead value driver: advancing to Part B with defined dosing and timelines; clinical signals and safety profile are constructive. Bold: AA focus intensifies .
  • AD disappointment is contained by safety strength and pharmacology; expect a data review rather than immediate program expansion .
  • Runway into 2H 2026 provides funding capacity through AA Part B topline and ADX‑097 renal basket topline, reducing near-term financing overhang .
  • Watch for AAD-driven awareness and KOL engagement as near-term sentiment catalysts; clinical durability narrative may differentiate vs JAK class .
  • Program prioritization (AAV deferral) aligns resources to AA and renal basket execution—clarity on focus should aid operational efficiency .
  • With no transcript and estimates unavailable, stock reactions will be driven by upcoming clinical milestones and any future guidance updates; revisit estimates when accessible to frame consensus risk/reward [GetEstimates error].