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Carisma Therapeutics Inc. (CARM)·Q2 2024 Earnings Summary

Executive Summary

  • Q2 2024 delivered a materially narrower net loss and higher collaboration revenue, reflecting increased revenue recognition and lower R&D/G&A vs the prior year; cash of $40.4M with a $2.0M Moderna milestone received in July supports runway into Q3 2025 .
  • Clinical execution advanced: first patient dosed in the CT-0525 Phase 1 (HER2), FDA Fast Track granted, CT-0508+pembrolizumab RL2 data updated, and Moderna in vivo CAR-M GPC3 candidate nominated (triggering $2.0M milestone) .
  • Management reiterated timing: initial CT-0525 data by year-end 2024 and liver fibrosis development candidate nomination in Q1 2025, reinforcing near-term and 2025 catalyst visibility .
  • Street estimates were unavailable via S&P Global at the time of this analysis; no beat/miss assessment versus consensus can be made (S&P Global data unavailable due to request limit).

What Went Well and What Went Wrong

  • What Went Well

    • CT-0525 execution and regulatory momentum: first patient dosed in Phase 1 and FDA Fast Track designation; initial data targeted by year-end 2024 .
    • Strategic pipeline progress with Moderna: in vivo CAR-M GPC3 development candidate nominated, unlocking a $2.0M milestone; plan to present preclinical data at an upcoming meeting .
    • Cost discipline and operating leverage: YoY reductions in R&D and G&A drove a sharply narrower operating loss and net loss versus Q2 2023 .
    • Quote: “We’ve achieved considerable clinical and research advancements this year… dedicating our efforts to our lead asset, CT-0525… multiple potential value drivers in both the near and long term.” — Steven Kelly, CEO .
  • What Went Wrong

    • Limited efficacy signal in CT-0508+pembrolizumab sub-study: best overall response was stable disease (1/6), with corticosteroid use and/or HLA loss limiting efficacy in some PD patients, despite immunologic activation suggesting synergy .
    • Cash declined QoQ to $40.4M from $56.5M, highlighting ongoing burn; runway maintained into Q3 2025 but dependent on execution and assumptions .
    • Development reprioritization and prior workforce reduction (announced earlier in 2024) underscore resource constraints and the need for focused execution on CT-0525 and partnered programs .

Financial Results

Income statement and cash metrics (USD Millions, except per-share and shares). Periods ordered oldest → newest.

MetricQ2 2023Q4 2023Q1 2024Q2 2024
Collaboration Revenues$3.56 $4.29 $3.40 $9.20
R&D Expense$18.52 $19.42 $17.46 $15.31
G&A Expense$6.01 $7.32 $5.45 $5.56
Total Operating Expenses$24.53 $26.74 $22.91 $20.87
Operating Loss$(20.97) $(22.45) $(19.51) $(11.67)
Net Loss$(19.88) $(20.96) $(18.98) $(11.16)
Net Loss/Share (Basic & Diluted)$(0.49) $(0.52) $(0.46) $(0.27)
Weighted Avg Shares (Basic & Diluted)40,258,107 40,391,608 40,938,464 41,543,553
Cash & Cash Equivalents (Period-End)$77.61 $56.52 $40.36

Observations and drivers

  • Collaboration revenue rose sharply QoQ and YoY; management did not provide a detailed driver breakdown in the Q2 release, though deferred revenue balances stepped down QoQ (see KPIs) .
  • YoY R&D decreased primarily due to lower facilities/other expenses (sponsored research) and lower CT-0508 costs, partly offset by increased CT-0525 preclinical costs and severance-related personnel costs; G&A decreased YoY due to lower professional fees and insurance following prior-year merger costs, partly offset by higher facilities and personnel .

KPIs and balance sheet indicators

KPIQ4 2023Q1 2024Q2 2024
Deferred Revenue – Current$1.41 $1.19 $0.66
Deferred Revenue – Long-term$45.00 $45.00 $41.25
Total Liabilities$63.02 $62.90 $58.98
Total Stockholders’ Equity$26.53 $10.90 $0.36

Segment breakdown

  • The company reports collaboration revenue and does not present a commercial segment breakdown; no segment detail is provided in the earnings materials reviewed .

Guidance Changes

MetricPeriodPrevious GuidanceCurrent GuidanceChange
Cash runwayThrough Q3 2025Runway into Q3 2025 (as of Q1 with $56.5M cash) Runway into Q3 2025 (as of Q2 with $40.4M cash; $2.0M milestone received in July) Maintained
CT-0525 initial data2024Initial Phase 1 data by year-end 2024 Initial Phase 1 data by year-end 2024 Maintained
CT-0508+pembrolizumab RL2 data2Q24Expected RL2 data in 2Q24 RL2 data updated Aug 8, 2024 (n=6 combined RL1/RL2) Delivered
Liver fibrosis dev. candidate nomination1Q25Nomination expected 1Q25 Nomination expected 1Q25 Maintained
Moderna in vivo CAR-M GPC3 candidate2Q24N/A (target nomination anticipated under collaboration) Nominated in 2Q24; $2.0M milestone received 7/3 Delivered

Earnings Call Themes & Trends

Note: No Q2 2024 earnings call transcript was available in our document set; themes reflect press releases and the 8-K.

TopicPrevious Mentions (Q4’23, Q1’24)Current Period (Q2’24)Trend
Anti‑HER2 strategy (CT‑0525 lead)Reprioritized to CT‑0525 with goal to identify registrational profile in 2025; stop new CT‑0508 recruitment; maintain enrolled operations First patient dosed; FDA Fast Track; initial data by YE’24 Positive execution; regulatory momentum
CT‑0508 + pembrolizumabRL1 data at AACR (n=3) well‑tolerated; plan RL2 data in 2Q24 RL2 data updated; well‑tolerated, best OR = SD (1/6); translational immune activation suggests potential synergy Mixed clinical efficacy; supportive translational signals
In vivo CAR‑M (Moderna)Collaboration emphasized; preclinical in vivo feasibility shown (Nov 2023) GPC3 in vivo CAR‑M candidate nominated; $2.0M milestone; preclinical data presentation expected Executing to plan; external validation
Fibrosis programPreclinical PoC demonstrated in liver and lung models; 1Q25 nomination target AASLD 2024 poster accepted; 1Q25 nomination reiterated; SAB expanded with fibrosis KOLs Building credibility; timeline intact
Cost discipline / restructuringWorkforce reduction (~37%) and reprioritization announced YoY R&D and G&A down; runway maintained to 3Q25 Improved P&L trajectory

Management Commentary

  • “We’ve achieved considerable clinical and research advancements this year… dedicating our efforts to our lead asset, CT‑0525… [and] robust development pipeline offers multiple potential value drivers in both the near and long term.” — Steven Kelly, CEO .
  • “Receiving Fast Track designation for CT‑0525… marks a significant milestone… we are enrolling patients in the Phase 1 clinical trial and remain on track to report initial clinical data by the end of 2024.” — Eugene P. Kennedy, M.D., CMO .
  • “The nomination of the first Development Candidate underscores our productive collaboration with Moderna to develop mRNA‑based in vivo CAR‑M cell therapies… targets GPC3… significant step forward…” — Michael Klichinsky, PharmD, PhD, Co‑Founder & CSO .

Q&A Highlights

  • No Q2 2024 earnings call transcript was available in our document set; therefore, Q&A highlights and guidance clarifications from a call are not provided.

Estimates Context

  • S&P Global consensus estimates for Q2 2024 revenue and EPS were unavailable at the time of query due to a data access limit; as a result, we cannot assess beats/misses versus consensus or quantify estimate deltas today (S&P Global data unavailable).
  • Company-issued guidance was limited to operational milestones and cash runway (maintained into Q3 2025), rather than revenue/EPS guidance, consistent with clinical-stage biopharma norms .

Key Takeaways for Investors

  • CT‑0525 is the central near‑term value driver: first patient dosed, FDA Fast Track, and initial data due by YE’24 — a potential stock-moving catalyst .
  • Translation from CT‑0508 to CT‑0525 continues to be the clinical narrative: while efficacy in the CT‑0508+pembro sub‑study was limited (OR = SD in 1/6), immune activation signals justify combinations and a move to monocytes (CT‑0525) for higher exposure .
  • Partner validation persists: Moderna’s nomination of an in vivo CAR‑M GPC3 candidate and the $2.0M milestone add external confidence and non-dilutive funding .
  • Cash runway into Q3 2025 provides execution window, but cash declined QoQ; watch burn and potential BD/financing to sustain momentum into 2025 milestones .
  • 2H24/1H25 catalyst map: CT‑0525 initial data (YE’24), AASLD fibrosis poster (Nov 2024), and fibrosis development candidate nomination (1Q25) .
  • With Street estimates unavailable today, focus on absolute progress/milestones and any incremental collaboration revenue recognition as near-term drivers (deferred revenue stepped down QoQ) .

Appendix: Additional Detail on Expenses (Why they moved)

  • R&D YoY decreased $3.2M primarily from lower facilities/other (sponsored research) and lower CT‑0508 costs, partially offset by higher CT‑0525 preclinical and personnel (severance) costs .
  • G&A YoY decreased $0.4M due to lower professional fees (non‑recurring 2023 merger costs) and insurance, partially offset by higher facilities and personnel costs (salary, headcount, SBC, severance) .