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Arcellx, Inc. (ACLX)·Q3 2024 Earnings Summary

Executive Summary

  • Q3 revenue of $26.03M (collaboration) and EPS of $(0.48); OpEx was $59.65M and net loss improved to $(25.87)M YoY, aided by higher collaboration revenue from the expanded Kite agreement .
  • Clinical update remains a key positive: iMMagine-1 preliminary data show 95% ORR and 62% CR/sCR (n=58; median follow-up 10.3 months) with no delayed neurotoxicities to date across >140 patients; Phase 1 median PFS 30.2 months with OS not reached .
  • Cash, cash equivalents and marketable securities were $676.7M, with runway into 2027; first patients dosed in iMMagine-3 with Kite manufacturing at turnaround times in line with Kite’s commercial products, supporting execution and future launch readiness .
  • No earnings call was held for Q3 (no transcript/Q&A), placing greater emphasis on the press release and ASH updates as near-term stock catalysts (Dec ASH oral presentation; iMMagine-3 progress) .
  • Comparison to Wall Street consensus (S&P Global) was unavailable at retrieval time; thus we cannot assess beats/misses versus SPGI consensus at this time (see Estimates Context) [Values retrieved from S&P Global]*.

What Went Well and What Went Wrong

  • What Went Well

    • Strong efficacy and safety profile: iMMagine-1 showed 95% ORR and 62% CR/sCR at 10.3-month median follow-up; zero Grade 3/4 CRS and no delayed neurotoxicities across >140 patients; Phase 1 median PFS 30.2 months, OS not reached .
    • Execution and scale-up: first patients dosed in iMMagine-3 with Kite manufacturing; turnaround times in line with Kite’s commercial products, supporting commercial readiness .
    • CEO emphasized competitive positioning and launch preparation: “We believe we’re well positioned… Our partnership with Kite allows us to leverage their established global commercial capabilities… It’s an exciting time at Arcellx! We are preparing for the commercial launch of anito-cel…” .
  • What Went Wrong

    • Sequential revenue drift this year (Q1→Q2→Q3: $39.26M → $27.38M → $26.03M), reflecting collaboration revenue timing dynamics; G&A continued to rise YoY as the company scales .
    • R&D and G&A spending remain significant; despite YoY net loss improvement to $(25.87)M, loss from operations was $(33.62)M for Q3 .
    • Safety-related adverse events included three deaths in iMMagine-1 (related and unrelated: retroperitoneal hemorrhage, CRS, fungal infection), though no new therapy-related deaths since the abstract cut and no Grade ≥3 CRS/ICANS to date .

Financial Results

Quarterly P&L and cash (USD Millions except per-share)

MetricQ1 2024Q2 2024Q3 2024
Revenue (Collaboration)$39.256 $27.384 $26.030
Total Operating Expenses$55.066 $62.377 $59.646
Loss from Operations$(15.810) $(34.993) $(33.616)
Net Loss$(7.198) $(27.202) $(25.867)
EPS (basic & diluted)$(0.14) $(0.51) $(0.48)
Cash & Mkt. Securities (period-end)$691.021 $646.816 $676.682

Year-over-year (YoY) comparison (USD Millions except per-share)

MetricQ3 2023Q3 2024
Revenue (Collaboration)$14.957 $26.030
R&D Expense$43.807 $39.173
G&A Expense$16.012 $20.473
Net Loss$(39.336) $(25.867)
EPS (basic & diluted)$(0.81) $(0.48)

KPI – Clinical efficacy/safety (selected)

KPIPeriod/StudyValue
ORRiMMagine-1 Phase 2 (n=58; median FU 10.3m)95% (55/58)
CR/sCRiMMagine-1 Phase 262% (36/58)
MRD negativityiMMagine-1 (evaluable n=39)92% at ≥10^-5
6-mo PFS/OS ratesiMMagine-190% / 95%
Any Grade CRS (Gr3/4)iMMagine-184% (0% Gr3/4)
Any Grade ICANS (Gr3)iMMagine-19% (2% Gr3)
Deaths (AEs)iMMagine-13 (mixed related/unrelated)
Median PFSPhase 1 (median FU 38.1m)30.2 months
Median OSPhase 1Not reached
Delayed neurotoxicityPhase 1 + iMMagine-1 (>140 pts)None observed to date

Notes: Management attributed the YoY revenue increase to the December 2023 expansion of the Kite collaboration; YoY R&D decline was partly due to a 2023 Lonza manufacturing services expense, partially offset by preclinical and personnel costs .

Guidance Changes

MetricPeriodPrevious Guidance (Q2 2024)Current Guidance (Q3 2024)Change
Cash runwayMulti-yearFund operations into 2027 Fund operations into 2027 Maintained
iMMagine-1 data disclosureCY2024Present iMMagine-1 data by year-end (ASH abstract submitted) Oral presentation at ASH Dec 9, 2024 (updated cut) Clarified timing/details
iMMagine-3 trial status2H 2024Trial initiated by Kite First patients dosed; Kite manufacturing; turnaround time in line with commercial products Progressed
Revenue/OpEx/Tax rateQ3/FYNot providedNot providedNo change (no numeric guidance)

Earnings Call Themes & Trends

TopicPrevious Mentions (Q1–Q2 2024)Current Period (Q3 2024)Trend
Clinical efficacy & safetyReiterated best-in-class potential; Q2: preparing to share iMMagine-1 data iMMagine-1 ORR 95%, CR/sCR 62%; no delayed neurotoxicities; Phase 1 mPFS 30.2m, OS NR Strengthening
Manufacturing & supply chainPartnership with Kite; iMMagine-3 initiated by Kite First patients dosed in iMMagine-3; turnaround time aligned with Kite commercial Positive execution
Commercial readinessPlatform momentum; D-Domain story; launch prep implied Explicit: “preparing for the commercial launch of anito-cel” More explicit
Financial runwayInto 2027 Into 2027 reaffirmed Stable
Regulatory/medical meetingsASH abstract submitted ASH oral presentation scheduled; webcast event planned Advancing
Non-oncology expansionFDA cleared anito-cel IND in myasthenia gravis (Q2) No Q3 update in PR; focus on MM programs Neutral

Note: No Q3 earnings call or transcript available .

Management Commentary

  • “We believe the data from the recently published ASH abstracts continues to differentiate anito-cel’s clinical profile as a potentially best-in-class treatment option for multiple myeloma patients… Our partnership with Kite allows us to leverage their established global commercial capabilities… It’s an exciting time at Arcellx! We are preparing for the commercial launch of anito-cel…” — Rami Elghandour, Chairman & CEO .
  • “No delayed neurotoxicities… have been observed to date with anito-cel… across the Phase 1 and iMMagine-1 studies in the more than 140 patients dosed” .

Q&A Highlights

  • No earnings call or Q&A session was held for Q3 2024; no transcript available .

Estimates Context

  • SPGI/Capital IQ consensus for Q3 2024 EPS and revenue was unavailable due to data retrieval limits at the time of analysis, so we cannot provide a definitive beat/miss versus S&P Global consensus for this quarter [Values retrieved from S&P Global]*.
  • The company provided no numerical guidance on revenue, margins, or tax rate; focus remains on clinical milestones and the Kite collaboration’s operational ramp .

Key Takeaways for Investors

  • Clinical risk/reward improving: Strong iMMagine-1 efficacy (95% ORR; 62% CR/sCR) and clean delayed neurotox profile differentiate anito-cel and underpin a favorable regulatory/commercial setup if durability is confirmed at ASH .
  • Execution confidence rising: iMMagine-3 dosing started with Kite manufacturing at commercial-like turnaround times—an important de-risking step for scalability and future launch logistics .
  • Financial runway intact: ~$676.7M cash/securities and runway into 2027 provide capacity to fund pivotal/Phase 3 programs and pre-launch build-out without near-term financing pressure .
  • Revenue cadence remains collaboration-driven: Sequential moderation from Q1 to Q3 highlights non-linearity; investors should anchor on clinical/regulatory catalysts rather than quarterly revenue prints .
  • Watch ASH and further data updates: Dec 9 oral presentation for iMMagine-1 could be a near-term stock catalyst; look for updated response depth, durability, and safety consistency .
  • No Q3 call: Absence of a call limits color on timelines and launch planning; monitor upcoming webcasts/IR events for incremental detail .
  • Medium-term thesis: If efficacy/safety remain favorable and Kite manufacturing/turnaround continues to perform, launch execution risk decreases and could support valuation re-rating as iMMagine-1/iMMagine-3 mature .

References:

  • Q3 2024 financial results press release and tables .
  • Form 8-K including Item 2.02 and Exhibit 99.1 .
  • Q2 2024 press release and financial tables .
  • Q1 2024 8-K and press release tables .
  • ASH presentation PR (Nov 5, 2024) .
  • No conference call indicator .

Disclaimers:

  • Estimates: S&P Global (Capital IQ) consensus data was unavailable during retrieval; comparisons to consensus are therefore not provided. Values retrieved from S&P Global*.