Executive Summary

Reported FY 2024 results with $38.9M total revenue, reduced operating loss to $(43.9)M, and year-end cash and cash equivalents of $212.6M; cash, cash equivalents and restricted cash totaled approximately $214.3M, supporting runway into mid-2027, including completion of the planned Phase 3 AURORA trial in MG .
Regulatory de-risking: FDA Special Protocol Assessment (SPA) agreement for the Phase 3 AURORA trial; trial design finalized with 1:1 randomization (Descartes-08 vs placebo) in ~100 AChR Ab+ MG participants; primary endpoint is ≥3-point MG-ADL improvement at Month 4; initiation on track for 1H25 .
Clinical durability: Updated Phase 2b MG data showed average MG-ADL reduction of 5.5 (±1.1) at Month 4 (n=12) with 80% (4/5) maintaining clinically meaningful responses through Month 12; outpatient administration without lymphodepleting chemotherapy maintained; complements long-term strategy in autoimmunity .
2025 pipeline milestones: SLE Phase 2 preliminary data in 2H25; Phase 2 pediatric basket (juvenile SLE, juvenile MG, JDM, ANCA vasculitis) expected to initiate in 2H25; Descartes-15 first-in-human dosing ongoing (multiple myeloma), with autoimmune indications to follow .
Consensus estimates: S&P Global quarterly consensus for Q4 2024 was not available at the time of this analysis; no beat/miss assessment vs Street can be provided (S&P Global data unavailable due to access limits).*

What Went Well and What Went Wrong

What Went Well

SPA agreement secured for AURORA Phase 3, providing regulatory clarity and de-risking on path to BLA, with design locked and 1H25 start maintained .
Clinical durability strengthened: MG Phase 2b updated results showed deepening responses over time with Month 4 MG-ADL reduction of 5.5 (±1.1) and 80% of evaluable patients maintaining clinically meaningful responses at Month 12 .
Balance sheet strengthened: Year-end cash and equivalents of $212.6M (cash, cash equivalents and restricted cash ≈ $214.3M) support runway into mid-2027 including AURORA completion; management highlighted “a clear path toward potential approval” and that the company is “well-positioned” to execute pipeline milestones .
- Quote (CEO): “Notably, we remain on track to commence our planned Phase 3 AURORA trial ... we are confident that we have a clear path toward potential approval of this promising new therapy.”
- Quote (CEO): “With these anticipated milestones, along with our strong balance sheet, we believe we are well-positioned to deliver on our mission to expand the reach of cell therapy to autoimmunity.”

What Went Wrong

Non-operating volatility persists: Material P&L impact from fair value changes in contingent value right (CVR) and forward contract liabilities (FY 2024 included $(36.9)M CVR fair value loss and $(6.9)M forward contract fair value loss), masking underlying operating improvements .
Revenue timing volatility: Collaboration revenue highly concentrated in prior quarters (e.g., $30M milestone recognized in Q2’24), with minimal Q3 revenue; Q4 release presented FY rather than quarterly figures, limiting visibility into quarter-specific trends .
Continued losses despite lower OpEx: FY net loss $(77.4)M and basic EPS $(4.48), though improved from FY 2023; CVR liability (non-current) increased to $387.7M at year-end, underscoring ongoing non-operating risk overhang .

Financial Results

Note: The Q4 2024 press release presented full-year results; quarter-specific Q4 revenue/EPS were not provided. Quarterly trend shown for Q1–Q3 2024.

FY results (USD Millions, except per-share)

Metric	FY 2023	FY 2024
Total Revenue ($M)	$26.0	$38.9
Research & Development Expense ($M)	$71.3	$45.1
General & Administrative Expense ($M)	$40.5	$30.1
Operating Loss ($M)	$(86.4)	$(43.9)
Net Loss ($M)	$(219.7)	$(77.4)
Basic EPS ($)	$(49.76)	$(4.48)
Cash & Cash Equivalents (Year-End, $M)	$76.9	$212.6
Restricted Cash (Year-End, $M)	$1.4	$1.7

2024 quarterly trend (Q1–Q3 only; USD Millions, except per-share)

Metric	Q1 2024	Q2 2024	Q3 2024
Total Revenue ($M)	$5.84	$33.45	$0.39
R&D Expense ($M)	$9.74	$12.66	$11.40
G&A Expense ($M)	$9.45	$7.03	$6.56
Net Income (Loss) ($M)	$(56.82)	$13.84	$(24.18)
Basic EPS ($)	$(10.50)	$0.58	$(1.13)
Cash, Cash Equivalents & Restricted Cash ($M)	$104.8	$88.9	$220.9

Balance sheet highlights (Year-End)

Metric	Dec 31, 2023	Dec 31, 2024
Total Assets ($M)	$305.1	$435.0
Total Liabilities ($M)	$444.7	$441.8
CVR Liability (Non-Current, $M)	$342.6	$387.7
Warrant Liabilities (Total, $M)	$6.4	$3.8 (non-current)
Common Shares Outstanding (Period-End)	5.40M	25.77M

Segment breakdown: Not applicable (no reportable segments) .

KPIs (Clinical/Operational)

KPI	Q4 2024 (FY release)	Prior References
MG-ADL Mean Reduction at Month 4 (Phase 2b, primary efficacy dataset n=12)	5.5 (±1.1)	Topline positive announced mid-2024
Durable Response Through Month 12	80% (4/5 evaluable) maintained ≥2-point MG-ADL reduction	Durability deepened through Month 9 in prior updates
AURORA Phase 3 Design	1:1 randomized, ~100 AChR Ab+ MG; primary endpoint ≥3-point MG-ADL at Month 4	EoP2 meeting, Phase 3 by 1H25 (prior)
Cash Runway	Into mid-2027 (incl. AURORA completion)	Into mid-2027 (prior)

Guidance Changes

Metric	Period	Previous Guidance	Current Guidance	Change
Descartes-08 (MG) Phase 3 AURORA start	1H 2025	Expected to commence 1H 2025	On track 1H 2025; SPA agreement reached on design	Maintained timeline; de-risked with SPA
SLE Phase 2 preliminary data	2H 2025	Dosing underway; timing not specified	Preliminary data expected 2H 2025	New timing disclosed
Pediatric basket trial (Descartes-08)	2H 2025	IND filing planned by YE 2024	Phase 2 pediatric basket trial expected to initiate 2H 2025	Updated to initiation timing
Descartes-15 Phase 1 (MM)	Ongoing	First patient dosed; dosing underway	Dosing ongoing; autoimmune to follow	Maintained
Cash runway	Through mid-2027	Into mid-2027	Into mid-2027 incl. AURORA completion	Maintained (clarified)

Earnings Call Themes & Trends

Note: A Q4 2024 earnings call transcript could not be located; themes synthesized from company disclosures.

Topic	Previous Mentions (Q2 & Q3 2024)	Current Period (Q4 2024)	Trend
Regulatory (MG Phase 3)	EoP2 meeting by YE 2024; Phase 3 to commence 1H 2025	SPA agreement; design finalized; 1H 2025 start on track	Improved visibility; de-risked
Efficacy durability (MG)	Topline positive Phase 2b; plan to share updated data by YE 2024	Month 4 MG-ADL −5.5; durable responses through Month 12	Strengthening
Manufacturing/cGMP	New HQ and 27–30k sq ft facility to scale	COO promotion; continued cGMP expansion	Scaling operations
Financing/Cash runway	$130M PIPE; cash & RC ≈ $88.9M (Q2)	YE cash & RC ≈ $214.3M; runway mid-2027	Stronger liquidity
Pediatric basket	IND by YE 2024	Phase 2 initiation targeted 2H 2025	Timetable set
Descartes-15	Dose first patient 2H 2024; first patient dosed	Dosing ongoing; autoimmune next	Progressing

Management Commentary

Strategic focus: “we remain on track to commence our planned Phase 3 AURORA trial ... [and] are confident that we have a clear path toward potential approval” (Carsten Brunn, Ph.D., CEO) .
Pipeline breadth: “we remain on track to report preliminary data from our ongoing Phase 2 ... in SLE and expect to initiate our Phase 2 pediatric basket trial ... in the second half of this year” (CEO) .
Operational readiness: promotion of Emily English to COO and leadership in expanding the Frederick, MD cGMP facility underscore manufacturing scale-up into pivotal/commercial readiness .

Q&A Highlights

No Q4 2024 earnings call transcript was available in the document set; accordingly, Q&A highlights and any intra-quarter guidance clarifications are not available for this period (no transcript found in current catalog) [List: earnings-call-transcript none found 2025-01-01 to 2025-04-30].

Estimates Context

Wall Street consensus (S&P Global) for Q4 2024 EPS and revenue was unavailable at the time of analysis due to access limits; therefore, beat/miss vs estimates cannot be assessed at this time.*

Key Takeaways for Investors

Regulatory path de-risked: SPA-backed Phase 3 AURORA design with outpatient mRNA CAR-T regimen (no lymphodepletion) and clear primary endpoint supports a credible route to BLA if results are positive .
Clinical momentum: Durable Phase 2b responses to Month 12 and meaningful MG-ADL improvement at Month 4 bolster probability of technical success heading into Phase 3 .
Sufficient capital: ≈$214.3M in cash, cash equivalents and restricted cash at YE 2024 supports operations into mid-2027, including AURORA completion—limiting near-term financing overhang risk .
Non-operating P&L noise remains: CVR and derivative fair value changes can materially swing reported earnings; focus on OpEx trajectory and clinical milestones to assess core progress .
Near-term catalysts: Phase 3 AURORA initiation (1H25), SLE Phase 2 preliminary data (2H25), pediatric basket initiation (2H25), and ongoing Descartes-15 clinical progress; these events are likely stock drivers .
Manufacturing scalability: In-house cGMP capacity and leadership additions position RNAC for pivotal execution and potential commercialization if Phase 3 succeeds .
Trading setup: With regulatory clarity improving (SPA), incremental efficacy durability, and a defined 2025 catalyst calendar, sentiment should track clinical execution and Phase 3 site start-up pace .

Footnotes:
*Consensus estimates were intended to be sourced from S&P Global but were unavailable at the time due to access limits; no alternative consensus data were cited.

Cartesian Therapeutics, Inc. (RNAC)·Q4 2024 Earnings Summary