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Adicet Bio, Inc. (ACET)·Q2 2024 Earnings Summary

Executive Summary

  • Q2 2024 focused on pipeline execution: ADI-001 autoimmune program expanded beyond lupus nephritis (LN) to include SLE, SSc, and AAV; ADI-270 IND cleared in RCC with Fast Track status, positioning first gamma delta 1 CAR T for solid tumors .
  • Operating discipline continued: R&D expense fell year over year (–$2.5M YoY), G&A was modestly higher on stock-based comp; net loss improved YoY but was flat QoQ; cash and equivalents stood at $224,069K at quarter-end with runway into 2H 2026 .
  • Guidance/timeline changes: LN Phase 1 enrollment slipped to Q3 2024 (previously “initiate in Q2 2024”), while ADI-270 advanced from expected IND filing to full IND clearance with Phase 1 start guided for Q4 2024 and preliminary data in 1H 2025 .
  • Potential stock reaction catalysts: near-term initiation of ADI-001 in LN (Q3 2024), expansion into SLE/SSc/AAV (2H 2024), and ADI-270 Phase 1 start in RCC (Q4 2024), with multiple preliminary readouts guided for 1H 2025 .

What Went Well and What Went Wrong

What Went Well

  • Regulatory momentum: FDA Fast Track Designation granted for ADI-001 in LN and ADI-270 in RCC, de-risking clinical path and potentially expediting review .
  • Platform expansion: Autoimmune program broadened beyond LN to SLE, SSc, and AAV, indicating confidence in ADI-001’s biology and clinical potential; “We believe ADI-001 has best-in-class potential for autoimmune diseases…” – CEO Chen Schor .
  • IND clearance: ADI-270 IND cleared, enabling first-in-solid tumor gamma delta 1 CAR T clinical study; “ADI-270 is the first ever gamma delta 1 CAR T cell therapy candidate to enter clinical trials for the treatment of solid tumors” .

What Went Wrong

  • Timeline slip: LN Phase 1 enrollment moved to Q3 2024 from prior Q2 2024 expectation, reflecting site initiation/enrollment dependencies .
  • Operating burn persisted: Net loss remained sizable at $(29,901)K, and cash declined from Q1 to Q2 as the company invests in pipeline across autoimmune and oncology .
  • R&D mix shift: While R&D declined YoY, G&A ticked up due to stock-based comp; analysts may scrutinize cost trajectory as programs scale .

Financial Results

Income Statement Snapshot (USD Thousands)

MetricQ4 2023Q1 2024Q2 2024
Research & Development24,759 23,897 25,901
General & Administrative6,807 6,974 6,948
Total Operating Expenses31,566 30,871 32,849
Net Loss29,489 28,016 29,901
Diluted EPS ($)(0.69) (0.35) (0.33)

Notes:

  • YoY Q2 improvements driven by lower CDMO/external R&D and reduced headcount; G&A increased primarily on stock-based compensation .

Balance Sheet Highlights (USD Thousands)

MetricQ4 2023Q1 2024Q2 2024
Cash & Cash Equivalents159,711 247,589 224,069
Working Capital142,985 232,889 210,449
Total Assets207,295 293,095 268,842
Total Stockholders’ Equity170,175 258,804 235,111

Consensus vs. Actual (Q2 2024):

  • S&P Global consensus for EPS and revenue was unavailable at time of analysis; comparisons to estimates cannot be provided.

KPIs (Operational)

KPIQ4 2023Q1 2024Q2 2024
Cash runway guidanceInto 2H 2026 Into 2H 2026 Into 2H 2026
ADI-001 LN timelineInitiation 2Q 2024 (planned) Initiation 2Q 2024 (on track) Enrollment in Q3 2024
ADI-001 autoimmune expansionPlan to expand indications Planning broader indications IND cleared for SLE/SSc/AAV; enroll 2H 2024
ADI-270 RCC timelineFile IND 2Q 2024 (on track) Expect IND submission 2Q 2024 IND cleared; Phase 1 start Q4 2024; prelim data 1H 2025

Guidance Changes

Metric/ProgramPeriodPrevious GuidanceCurrent GuidanceChange
Cash runwayMulti-yearFund ops into 2H 2026 Fund ops into 2H 2026 Maintained
ADI-001 LN Phase 12024Initiate in 2Q 2024 Begin enrollment in Q3 2024 Lowered (timing slip)
ADI-001 LN prelim data2024/2025Q4 2024 or Q1 2025 1H 2025 (subject to sites/enrollment) Lowered (shift to 1H 2025)
ADI-001 SLE/SSc/AAV2024/2025Planning expansion IND cleared; enrollment in 2H 2024; data 1H 2025 Raised/clarified
ADI-270 RCC2024/2025IND filing in 2Q 2024 IND cleared; Phase 1 start Q4 2024; prelim data 1H 2025 Raised (milestone achieved + timelines set)

Earnings Call Themes & Trends

Note: No Q2 2024 earnings call transcript was found; themes compiled from Q4 2023, Q1 2024, and Q2 2024 earnings press releases.

TopicPrevious Mentions (Q4 2023 & Q1 2024)Current Period (Q2 2024)Trend
Autoimmune program (ADI-001)IND cleared for LN; initiate Phase 1 in 2Q 2024; expand to additional autoimmune indications Enrollment in LN to begin Q3 2024; IND expanded to SLE/SSc/AAV; enrollment 2H 2024 Mixed: broader scope, slight timing slip
Solid tumors (ADI-270 RCC)Expect IND submission in 2Q 2024 IND cleared; Fast Track; Phase 1 start Q4 2024; prelim data 1H 2025 Accelerating/regulatory progress
Hematologic malignancies (MCL)Continue enrolling; update in 2H 2024 Enrollment ongoing; clinical update planned for Q4 2024 Steady execution
Regulatory/legalIND clearance (ADI-001 LN); expected IND (ADI-270) Fast Track for ADI-001 and ADI-270; ADI-270 IND clearance Strengthening
R&D execution/costsElevated R&D in 2023; planned execution in 2024 R&D down YoY in Q2; G&A up on stock-based comp Improving efficiency YoY
Liquidity/runwayRunway into 2H 2026 Runway into 2H 2026; cash $224,069K Maintained

Management Commentary

  • “We believe ADI-001 has best-in-class potential for autoimmune diseases and we are excited about the opportunity to expand ADI-001 clinical development beyond LN to include patients with SLE, SSc and AAV… This progress underscores the unique potential of our gamma delta 1 CAR T cell platform in both autoimmune diseases and solid tumors.” – Chen Schor, President & CEO .
  • “ADI-270 is the first ever gamma delta 1 CAR T cell therapy candidate to enter clinical trials for the treatment of solid tumors… We believe that ADI-270 has the potential to become an important therapeutic option for patients with RCC and other CD70+ tumors.” – Chen Schor .
  • “We are pleased that ADI-270… has been granted Fast Track Designation by the FDA… this significant milestone underscores our commitment to advancing innovative treatments…” – Chen Schor .

Q&A Highlights

  • No Q2 2024 earnings call transcript was available; therefore, no Q&A highlights or clarifications can be provided for this quarter.

Estimates Context

  • S&P Global (Capital IQ) consensus EPS and revenue estimates for Q2 2024 were unavailable at the time of analysis due to data access limitations; as a result, we cannot assess beats/misses vs. consensus for ACET this quarter.
  • Implication: Investor focus should center on qualitative catalysts (regulatory progress, trial timelines) and liquidity rather than near-term revenue/EPS comparisons, given ACET’s clinical-stage status .

Key Takeaways for Investors

  • Regulatory tailwinds: Fast Track designations for both ADI-001 (LN) and ADI-270 (RCC) and ADI-270 IND clearance materially de-risk early development and can accelerate timelines .
  • Autoimmune expansion is a core thesis: IND cleared to include SLE, SSc, and AAV, with enrollment beginning 2H 2024; broadening opportunity set beyond LN enhances optionality .
  • Near-term catalysts: LN Phase 1 enrollment in Q3 2024; ADI-270 Phase 1 initiation in Q4 2024; preliminary clinical data for multiple programs in 1H 2025 – key stock-moving events to monitor .
  • Operating discipline: YoY R&D down and net loss improved, aligning with more focused external spend; watch QoQ spend as programs scale and additional sites come online .
  • Liquidity runway intact: Cash of $224,069K supports operations into 2H 2026, providing a long runway to reach several value-inflecting data readouts .
  • Execution risk remains: LN enrollment shifted to Q3 2024 and data pushed toward 1H 2025; timelines remain subject to site initiation and patient recruitment, warranting close tracking .
  • Oncology optionality: ADI-270’s entry into RCC with a differentiated armored gamma delta CAR T profile and Fast Track status could broaden investor interest beyond autoimmune, pending Phase 1 data .