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Carisma Therapeutics Inc. (CARM)·Q3 2023 Earnings Summary

Executive Summary

  • Q3 2023 was primarily an execution quarter: collaboration revenue increased to $3.83 million, operating expenses rose as CT-0525 advanced, and net loss was $21.4 million with diluted EPS of $(0.53) . Cash, cash equivalents and marketable securities were $94.1 million, with runway “into the first quarter of 2025” .
  • Pipeline progressed: CT-0525 IND was submitted (first patient expected 1H24), CT-1119 clinical candidate was selected (IND in 2025), and positive preclinical in vivo CAR‑M data from the Moderna collaboration were presented at SITC, reinforcing the platform thesis .
  • Guidance timing shifted: CT‑0508+pembrolizumab data presentation moved from H2’23 to 1H’24; liver fibrosis PoC remained 1H’24; runway updated to Q1’25 from Q2’s “through 2024” framing .
  • Management tone remained constructive on CAR‑M differentiation and value‑creation milestones: “value‑driving, next‑generation cell therapies” and progress in HER2 and in vivo programs were emphasized .

What Went Well and What Went Wrong

  • What Went Well

    • CT‑0525 advanced: IND submitted with first‑patient‑in expected 1H24, marking forward clinical momentum in the HER2 franchise .
    • Platform validation: in vivo CAR‑M preclinical proof‑of‑concept presented at SITC showed feasibility/tolerability and endogenous myeloid cell redirection with mRNA/LNP, highlighting the Moderna collaboration breadth .
    • Management conviction: “We continue to progress CT‑0508 and CT‑0525… as we work to validate our first‑in‑class engineered macrophage platform” (Steven Kelly, CEO) .
  • What Went Wrong

    • Operating intensity increased: R&D rose to $19.6M (+$4.0M YoY) on CT‑0525 preclinical costs and higher headcount; G&A rose to $6.6M (+$2.8M YoY), driving a larger YoY operating loss .
    • Data timing push: CT‑0508+pembrolizumab sub‑study data, previously expected in H2’23, moved to 1H’24, modestly extending the clinical readout cadence .
    • No earnings call transcript available: no Q&A clarifications on timelines or OpEx trajectory were accessible; only SEC 8‑K and press materials were located for Q3 [List search showed no transcript: 0 results for earnings‑call‑transcript in Aug–Nov 2023; 0 results for other‑transcript].

Financial Results

  • Q3 results vs prior year and prior quarter (all figures in USD thousands, except per‑share data). Estimates from S&P Global were not retrievable; see Estimates Context.
MetricQ3 2022Q1 2023Q2 2023Q3 2023
Collaboration Revenues$2,578 $3,243 $3,560 $3,827
Research & Development Expense$15,557 $16,641 $18,518 $19,551
General & Administrative Expense$3,772 $9,574 $6,007 $6,620
Total Operating Expenses$19,329 $26,215 $24,525 $26,171
Operating Loss$(16,751) $(22,972) $(20,965) $(22,344)
Net Loss$(18,327) $(24,642) $(19,876) $(21,403)
Diluted EPS$(8.37) $(1.93) $(0.49) $(0.53)
Weighted Avg Shares (diluted)2,189,265 12,783,523 40,258,107 40,285,858

Liquidity and runway:

MetricQ1 2023Q2 2023Q3 2023
Cash, Cash Equivalents and Marketable Securities$139.0M $117.1M $94.1M
Runway Commentary“through the end of 2024” “through the end of 2024” “into the first quarter of 2025”

Notes:

  • No product or segment revenues; collaboration revenue reflects Moderna collaboration accounting .
  • Year‑over‑year EPS comparability is affected by capital structure changes around the Sesen merger (share count increased significantly in 2023) .

Guidance Changes

MetricPeriodPrevious GuidanceCurrent GuidanceChange
Cash RunwayCorporate“through the end of 2024” (Q2’23) “into the first quarter of 2025” (Q3’23) Extended
CT‑0525 (anti‑HER2 CAR‑Monocyte)IND/First PatientIND expected H2’23 IND submitted; first patient 1H’24 Achieved IND; added FPI timing
CT‑0508 + pembrolizumabData timingInitial data expected H2’23 Data presentation 1H’24 Delayed to 1H’24
Liver Fibrosis (non‑oncology)Preclinical PoC1H’24 1H’24 Maintained
CT‑1119 (mesothelin CAR‑Monocyte)Next stepNext‑gen candidate selection 1H’24 Clinical candidate selected; IND in 2025 Advanced/Calendarized to 2025

Earnings Call Themes & Trends

Note: No Q3’23 earnings call transcript was found in our document system (0 results for “earnings‑call‑transcript” or “other‑transcript” in Aug–Nov 2023). The table below synthesizes themes from Q1–Q3 press disclosures.

TopicPrevious Mentions (Q1 and Q2 2023)Current Period (Q3 2023)Trend
HER2 franchise (CT‑0508/CT‑0525)CT‑0508 combo sub‑study initiated; CT‑0525 IND planned H2’23 CT‑0525 IND submitted; first patient 1H’24; CT‑0508+pembro data shifted to 1H’24 Execution with modest data timing push
In vivo CAR‑M (Moderna)Additional oncology target nominated; 5 targets under collaboration Preclinical PoC at SITC: feasibility/tolerability/early efficacy with mRNA/LNP Platform validation momentum
CT‑1119 (mesothelin)Next‑gen candidate selection targeted 1H’24 Clinical candidate selected; IND in 2025; SIRPα KD and next‑gen CAR incorporated Program definition and timeline set
Cash/RunwayQ1/Q2: through YE’24 Into Q1’25 Slightly extended
OpEx/ResourcingRising R&D tied to CT‑0525 and pipeline; higher G&A post‑merger R&D +$4.0M YoY on CT‑0525; G&A +$2.8M YoY Elevated investment continues

Management Commentary

  • “During the third quarter, Carisma made several key advancements across our clinical and pre‑clinical programs... We continue to progress CT‑0508 and CT‑0525... as we work to validate our first‑in‑class engineered macrophage platform.” — Steven Kelly, President & CEO .
  • On in vivo CAR‑M with Moderna: “Presented pre‑clinical proof of concept data demonstrating feasibility, tolerability, and early efficacy... redirecting endogenous myeloid cells... using mRNA/LNP” .
  • Financial outlook: “cash, cash equivalents and marketable securities of $94.1 million… sufficient to sustain planned operations into the first quarter of 2025” .

Q&A Highlights

  • No Q3 2023 earnings call transcript was available; we searched for “earnings‑call‑transcript” and “other‑transcript” for CARM dated Aug–Nov 2023 and found none (0 results). As a result, no Q&A clarifications or tone checks can be provided for this quarter.

Estimates Context

  • Wall Street consensus (S&P Global) for Q3’23 EPS and revenue could not be retrieved due to system limits at the time of request; thus, we are not presenting versus‑consensus comparisons for this quarter. Values retrieved from S&P Global were unavailable for this request.

Key Takeaways for Investors

  • Runway updated to Q1’25 reduces near‑term financing overhang and supports execution into multiple catalysts (CT‑0525 first‑patient‑in and CT‑0508+pembro readout) .
  • CT‑0525 IND submission and defined 1H’24 FPI create a clearer clinical glidepath in HER2 solid tumors, a key value driver for the CAR‑M strategy .
  • In vivo CAR‑M PoC at SITC is strategically significant: it broadens optionality (off‑the‑shelf potential) and underpins the Moderna collaboration’s multi‑program scope .
  • Operating intensity remains elevated (R&D +$4.0M YoY; G&A +$2.8M YoY), keeping net losses sizable; watch for OpEx discipline as programs mature .
  • Timing push of CT‑0508+pembro data to 1H’24 modestly delays a potential catalyst but remains within a constructive 12‑month window .
  • With no consensus comparisons this quarter, near‑term stock reaction likely keys off pipeline cadence (CT‑0525 FPI, CT‑0508 combo data) and any additional in vivo CAR‑M updates .

Appendix: Additional Detail From Prior Quarters (for Trend)

  • Q1 2023: Collaboration revenue $3.24M; R&D $16.64M; G&A $9.57M; Net loss $24.64M; EPS $(1.93); cash, cash equivalents and marketable securities $139.0M; runway “through the end of 2024” .
  • Q2 2023: Collaboration revenue $3.56M; R&D $18.52M; G&A $6.01M; Net loss $19.88M; EPS $(0.49); cash, cash equivalents and marketable securities $117.1M; runway “through the end of 2024” .

Sources: Q3’23 8‑K press release and exhibits ; Q2’23 8‑K press release ; Q1’23 8‑K press release .