Executive Summary

Q4 2024 was operationally steady with continued clinical execution: R&D expense fell both QoQ and YoY on lower CDMO spend, while G&A rose modestly; net loss improved to $28.7M ($0.32) from $29.5M ($0.69) YoY and from $30.5M QoQ .
Pipeline momentum remained the quarter’s key driver: first LN patient dosed with ADI-001; first metastatic/advanced ccRCC patient dosed with ADI-270; and Fast Track Designation received in February 2025 for ADI-001 in refractory SLE (extrarenal) and SSc .
Cash, cash equivalents and short-term investments were $176.3M at 12/31/24; runway reiterated into 2H26 (unchanged from Q2/Q3), with cash trending down as clinical activities ramp .
Key upcoming catalysts in 1H25 include preliminary clinical data from ADI-001 in LN and from ADI-270 in ccRCC; additional cohort data expected in 2H25—likely the main stock drivers near term .

What Went Well and What Went Wrong

What Went Well
- First LN patient dosed in the Phase 1 ADI-001 autoimmune basket study; preliminary LN data expected in 1H25, additional autoimmune cohort data anticipated in 2H25 .
- First patient dosed in the Phase 1 ADI-270 ccRCC trial; preliminary data on track for 1H25—critical for validating the solid tumor thesis .
- Additional regulatory momentum: FDA granted Fast Track Designation (Feb 2025) for ADI-001 in refractory SLE (extrarenal) and SSc; CEO: “The recent FDA Fast Track Designation…highlights the significant unmet need for innovative, off-the-shelf therapies” .
What Went Wrong
- Enrollment timing for SLE/SSc/IIM/SPS shifted from 1Q25 (prior Q3 guide) to 2Q25 in Q4 update—a one-quarter delay that investors will track closely .
- G&A rose YoY in Q4 due to higher professional fees, a reminder that overhead remains elevated even as R&D moderates with lower CDMO spend .
- Cash declined sequentially to $176.3M from $202.1M (Q3) and $224.1M (Q2) as programs advance; runway unchanged into 2H26, but cash burn remains in focus pre-data .

Financial Results

Quarterly P&L and cash (oldest → newest)

Metric	Q2 2024	Q3 2024	Q4 2024
R&D Expense ($USD Millions)	$25.9	$26.3	$23.3
G&A Expense ($USD Millions)	$6.9	$6.9	$7.5
Total Operating Expenses ($USD Millions)	$32.8	$33.2	$30.7
Interest Income ($USD Millions)	$3.0	$2.7	$2.1
Net Loss ($USD Millions)	$29.9	$30.5	$28.7
Net Loss per Share ($)	$(0.33)	$(0.34)	$(0.32)
Cash, Cash Equivalents & ST Investments ($USD Millions)	$224.1	$202.1	$176.3

Year-over-year comparison for the quarter

Metric	Q4 2023	Q4 2024
R&D Expense ($USD Millions)	$24.8	$23.3
G&A Expense ($USD Millions)	$6.8	$7.5
Total Operating Expenses ($USD Millions)	$31.6	$30.7
Interest Income ($USD Millions)	$2.2	$2.1
Net Loss ($USD Millions)	$29.5	$28.7
Net Loss per Share ($)	$(0.69)	$(0.32)

Estimates (Wall Street consensus): Not available from S&P Global at the time of analysis; estimates comparison omitted due to data unavailability.

KPI and balance sheet (oldest → newest)

Metric	Q2 2024	Q3 2024	Q4 2024
Working Capital ($USD Millions)	$210.4	$186.9	$160.7
Total Assets ($USD Millions)	$268.8	$246.0	$220.2
Stockholders’ Equity ($USD Millions)	$235.1	$211.5	$186.6
Cash Runway (Management)	Into 2H26	Into 2H26	Into 2H26

Notes:

R&D decline in Q4 vs Q3 was primarily due to lower CDMO-related expenses; G&A increase YoY driven by higher professional fees .
No revenue line was reported; statements focus on operating expenses and other income/expense .

Guidance Changes

Metric	Period	Previous Guidance (Q3 2024)	Current Guidance (Q4 2024)	Change
ADI-001 preliminary data (LN)	1H25	1H25	1H25	Maintained
ADI-001 additional cohort data (SLE/SSc/IIM/SPS/AAV)	2H25	Other autoimmune in 2H25 (subject to sites/enrollment)	Additional LN and other autoimmune cohorts in 2H25 (subject to sites/enrollment)	Maintained (clarified scope)
Start of enrollment: SLE/SSc/IIM/SPS	2025	1Q25 start	2Q25 start	Lowered/Delayed (slipped ~1 quarter)
Start of enrollment: AAV	2H25	2H25 start	2H25 start	Maintained
ADI-270 preliminary data (ccRCC)	1H25	1H25	1H25	Maintained
Cash runway	As of 9/30/24 vs 12/31/24	Into 2H26	Into 2H26	Maintained

Earnings Call Themes & Trends

(No Q4 2024 earnings call transcript was available in our document corpus; themes below reflect Q2/Q3 PRs and Q4 PR/8-K.)

Topic	Previous Mentions (Q-2 and Q-1)	Current Period (Q4 2024)	Trend
ADI-001 autoimmune program	Q2: INDs cleared to expand beyond LN to SLE/SSc/AAV; Fast Track in LN; plan to begin LN enrollment in Q3’24 . Q3: sites activated; LN enrollment opened 4Q’24; basket includes LN, SLE, SSc, IIM, SPS, AAV .	First LN patient dosed (Nov’24); Fast Track added for refractory SLE (extrarenal) and SSc (Feb’25). Preliminary LN data 1H25; additional cohorts 2H25. SLE/SSc/IIM/SPS enrollment now 2Q25; AAV 2H25 .	Advancing, with a one-quarter enrollment slip
ADI-270 (ccRCC, CD70)	Q2: IND cleared; Fast Track; plan to initiate Phase 1 in 4Q’24; prelim data 1H25 . Q3: reiterated plan to open enrollment in 4Q’24 -.	First patient dosed (Dec’24); prelim data 1H25 reiterated .	On track; execution milestone hit
Regulatory	Q2: Fast Track for ADI-001 (LN) ; Q3: IND amendment for IIM/SPS cleared .	Feb’25 Fast Track for ADI-001 in SLE (extrarenal) and SSc .	Strengthening regulatory profile
R&D execution/costs	Q2: R&D down YoY on lower CDMO and headcount; . Q3: R&D up slightly; moving to multiple autoimmune indications .	Q4: R&D down QoQ/YoY on lower CDMO; G&A up YoY on professional fees .	Cost discipline with pipeline scaling
Balance sheet/runway	Q2/Q3 runway into 2H26 .	Runway into 2H26 reiterated; cash trending down as trials progress .	Runway maintained

Management Commentary

“In 2025 we plan to continue advancing our gamma delta 1 CAR T cell therapy programs, achieving key milestones and reporting preliminary data in autoimmune and oncology indications.” — Chen Schor, President & CEO .
“The recent FDA Fast Track Designation for ADI-001 in refractory SLE with extrarenal involvement and in SSc highlights the significant unmet need for innovative, off-the-shelf therapies to treat autoimmune diseases.” — Chen Schor .
“We are continuing to enroll patients in our Phase 1 trial of ADI-270… and remain on track to announce preliminary clinical data in the first half of 2025.” — Chen Schor .

Q&A Highlights

No earnings call transcript for Q4 2024 was available in our document set; as a result, Q&A themes and management clarifications cannot be provided for this quarter. We will update this section if a transcript becomes available.

Estimates Context

We attempted to retrieve S&P Global consensus estimates (EPS and revenue) for Q4 2024; data were unavailable at the time of analysis, so we cannot present vs-consensus comparisons for this quarter. As a clinical-stage company with no reported revenue line in the quarter, EPS is typically the focus of consensus for ACET, but specific values were not retrievable in this instance .

Key Takeaways for Investors

Near-term catalysts in 1H25 (prelim data for ADI-001 in LN and ADI-270 in ccRCC) are central to the stock’s trajectory; additional autoimmune cohorts in 2H25 extend the catalyst window .
Regulatory momentum (Fast Track in SLE and SSc) strengthens the ADI-001 autoimmune narrative and may support expedited development paths if clinical signals are favorable .
Q4 showed disciplined spend with R&D down QoQ/YoY on lower CDMO costs; watch for potential step-ups as multi-cohort enrollment ramps in 2Q25 and beyond .
Cash runway into 2H26 provides multi-readout visibility, but sequential cash declines underscore the importance of positive data to sustain financing optionality .
A one-quarter slip in SLE/SSc/IIM/SPS enrollment (to 2Q25) is a modest execution risk; monitor site initiations and enrollment pace updates closely .
ADI-270’s first dosing is a meaningful milestone toward validating gamma delta CAR T in solid tumors—any early signs of activity or tolerability could be a major upside driver .
Without consensus comparisons this quarter, trading likely keys to clinical and regulatory milestones rather than earnings constructs; positioning ahead of data windows may be the primary strategy.

Adicet Bio, Inc. (ACET)·Q4 2024 Earnings Summary