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Cullinan Therapeutics, Inc. (CGEM)·Q4 2024 Earnings Summary

Executive Summary

  • Clinical momentum continued with key pipeline updates: the pivotal Phase 2b REZILIENT1 study for zipalertinib met its primary endpoint; full results are planned mid-2025 and an NDA submission is targeted for H2 2025, pending FDA discussions . Cash runway into 2028 was reaffirmed, with cash and investments of $606.9M at 12/31/24 .
  • Q4 operating expenses rose year over year (R&D $40.5M vs $34.8M; G&A $14.6M vs $10.6M), widening net loss attributable to Cullinan to $47.6M (vs $23.8M in Q4’23); basic/diluted net loss per common share was $(0.73) . Sequential cash declined to $606.9M from $639.0M (Q3) and $664.9M (Q2), consistent with pipeline investment .
  • Immunology expansion advanced: the global Phase 1 SLE study for CLN-978 is ongoing with site expansion; initial clinical data expected in Q4 2025; RA Phase 1 remains on track to start in Q2 2025 .
  • CEO tone constructive on 2025 catalysts: “we are positioned to again deliver meaningful catalysts in 2025 … [CLN-978] remains the first and only development-stage CD19 T cell engager with FDA IND clearance in autoimmune diseases” .

What Went Well and What Went Wrong

What Went Well

  • Zipalertinib pivotal study met its primary endpoint in previously treated EGFR ex20ins NSCLC; company plans mid-2025 data disclosure and, pending discussions, an NDA in H2 2025, adding a tangible regulatory catalyst to the 2025 calendar .
  • Immunology strategy execution: CLN-978 SLE Phase 1 is enrolling globally with site expansion; initial data guided for Q4 2025; RA trial initiation remains slated for Q2 2025, broadening the autoimmune footprint .
  • Management signaled confidence in near-term catalysts and competitive positioning: “we are positioned to again deliver meaningful catalysts in 2025… [and] established an important competitive advantage in the immunology space” .

What Went Wrong

  • Expenses and losses increased: Q4 R&D rose to $40.5M (from $34.8M YoY), G&A to $14.6M (from $10.6M), driving Q4 net loss attributable to Cullinan to $47.6M (from $23.8M) and $(0.73) per common share (from $(0.48)) .
  • Sequential operating expense step-up (total OpEx $55.0M vs $48.9M in Q3 and $50.0M in Q2) as programs progressed, while interest income declined sequentially ($7.5M vs $8.4M in Q3), pressuring P&L leverage .
  • Cash declined sequentially to $606.9M at 12/31/24 (from $639.0M at 9/30/24 and $664.9M at 6/30/24), reflecting ongoing investment across immunology and oncology pipelines (runway still into 2028) .

Financial Results

Key P&L and cash metrics (USD Thousands)

MetricQ2 2024Q3 2024Q4 2024
Research & Development$36,259 $35,506 $40,492
General & Administrative$13,768 $13,349 $14,556
Total Operating Expenses$50,027 $48,855 $55,048
Interest Income$8,071 $8,384 $7,512
Net Loss (Attributable to Cullinan)$(42,028) $(40,560) $(47,647)
Net Loss per Common Share (Basic/Diluted)$(0.75) $(0.69) $(0.73)
Cash & Investments (Period-End)$664,943 $638,996 $606,917

Q4 year-over-year comparison (USD Thousands, except per-share)

MetricQ4 2023Q4 2024
Research & Development$34,848 $40,492
General & Administrative$10,637 $14,556
Total Operating Expenses$45,485 $55,048
Interest Income$5,917 $7,512
Net Loss (Attributable to Cullinan)$(23,803) $(47,647)
Net Loss per Common Share (Basic/Diluted)$(0.48) $(0.73)
Weighted-Average Common Shares42,794 58,580

Consensus vs. Reported (Q4 2024)

  • S&P Global consensus for EPS and revenue was unavailable at time of analysis; beats/misses cannot be assessed.

Guidance Changes

MetricPeriodPrevious GuidanceCurrent GuidanceChange
Cash RunwayMulti-year“Runway into 2028” (Q2’24, Q3’24) “Runway into 2028” (Q4’24) Maintained
CLN-978 SLE initial dataQ4 2025“Initial clinical data in Q4 2025” (Q3’24) “Initial clinical data in Q4 2025” (Q4’24) Maintained
CLN-978 RA Phase 1 startQ2 2025“Initiate Phase 1 in Q2 2025” (Q3’24) “Remain on track for Q2 2025 start” (Q4’24) Maintained
Zipalertinib pivotal readoutMid-2025“Results expected mid-year 2025” (Q3’24) “Full results mid-year 2025” (Q4’24) Maintained (specificity added)
Zipalertinib regulatoryH2 2025Not previously stated“Plan to submit NDA in H2 2025, pending FDA discussions” New/Added
CLN-619 initial expansion cohort data (endometrial/cervical)1H/Q2 2025“1H 2025” (Q2’24) “Q2 2025” (Q3’24, Q4’24) Tightened in Q3; maintained in Q4

Earnings Call Themes & Trends

TopicPrevious Mentions (Q-2 and Q-1)Current Period (Q4 2024)Trend
Immunology expansion (CLN-978)Q2: IND on track for SLE; RA as second indication . Q3: SLE IND cleared (US/AU); initial SLE data in Q4 2025; RA trial planned Q2 2025 .Global SLE Phase 1 ongoing with site expansion; initial SLE data Q4 2025; RA Phase 1 on track Q2 2025 .Execution progressing; timelines maintained
Zipalertinib (EGFR ex20ins)Q2: Positive initial Phase 2b data; enrollment to complete by YE’24 . Q3: Pivotal Phase 2b completed enrollment ahead of schedule; mid-2025 results anticipated .Pivotal Phase 2b met primary endpoint; full results mid-2025; NDA planned H2 2025 (pending FDA) .Momentum improved; added regulatory clarity
CLN-619 (anti-MICA/MICB)Q2: Combination/mono data at ASCO; expansion cohorts; initial expansion data 1H 2025 .Q3: MM Phase 1 initiated; initial data in endometrial/cervical cancers Q2 2025 .Q4: Expansion ongoing; initial data in Q2 2025 reiterated .
Cash/CapitalQ2: $664.9M cash; runway into 2028 . Q3: $639.0M; runway into 2028 .Q4: $606.9M; runway into 2028 .Cash trending down with investment; runway intact
Oncology breadth (CLN-049/617)Q2: CLN-049 IV escalation; CLN-617 enrolling .Q3: Continued enrollment across programs .Q4: Continued enrollment in AML/MDS (CLN-049) and advanced solid tumors (CLN-617) .

Management Commentary

  • CEO (Nadim Ahmed): “Building on our execution throughout 2024, we are positioned to again deliver meaningful catalysts in 2025, starting with key updates for CLN-978 and zipalertinib.” He highlighted CLN-978’s competitive edge as “the first and only development-stage CD19 T cell engager with … FDA IND clearance in autoimmune diseases,” and cited the plan to deliver SLE data in Q4 2025 and pursue an NDA for zipalertinib in H2 2025, pending FDA discussions .

Q&A Highlights

  • No Q4 2024 earnings call transcript was available in the filing set; Q&A details were not provided in the company’s official materials. Analysis relies on the 8-K/press release content .

Estimates Context

  • We attempted to retrieve S&P Global consensus EPS and revenue estimates for Q4 2024, Q3 2024, and Q2 2024, but data were unavailable at time of analysis; consequently, we cannot assess beats/misses versus consensus.

Key Takeaways for Investors

  • 2025 catalyst density increased: zipalertinib pivotal met primary endpoint with mid-2025 full results and a planned H2 2025 NDA, adding a clear regulatory path in EGFR ex20ins NSCLC (pending FDA discussions) .
  • Immunology thesis intact: CLN-978 SLE Phase 1 is underway globally with site expansion; initial data expected Q4 2025; RA Phase 1 remains on track for Q2 2025, reinforcing the platform’s optionality .
  • Operating spend rising with execution: Q4 total OpEx of $55.0M (vs $48.9M in Q3) and net loss of $47.6M reflect program ramp; monitor spend discipline as multiple readouts approach .
  • Balance sheet supports execution: $606.9M at year-end with runway into 2028 provides funding through key clinical and potential regulatory milestones .
  • Near-term data flow: CLN-619 initial expansion data (endometrial/cervical) expected in Q2 2025; zipalertinib full pivotal results mid-2025; both are potential stock-moving events .
  • Estimate benchmarking unavailable: With S&P Global consensus data unavailable, trading may hinge more on pipeline milestones and qualitative updates than on quarterly EPS prints near term.
  • Watch regulatory cadence: FDA interactions on zipalertinib and continued global site expansion/enrollment for CLN-978 are pivotal to sustaining momentum and de-risking timelines .

Additional data and sources:

  • Q4 2024 8-K and attached press release (financials, pipeline updates) .
  • Q4 2024 standalone press release (duplicate of EX-99.1 content) .
  • Q3 2024 8-K/press release (prior quarter benchmarks, pipeline) .
  • Q2 2024 8-K/press release (prior two quarters, drivers of R&D/G&A) .
  • Additional Q4 2024 period press releases: CLN-978 FDA IND clearance (Oct 16, 2024) and ACR preclinical data updates (Nov 2024) .