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Candel Therapeutics, Inc. (CADL)·Q3 2024 Earnings Summary

Executive Summary

  • Q3 2024 showed disciplined OpEx with total operating expenses of $8.76M, but GAAP net loss widened to $10.65M due to a $1.64M non‑cash warrant liability revaluation and higher net other expense; EPS was $(0.33), compared to $(0.29) in Q3 2023 .
  • Cash and cash equivalents declined to $16.56M, and management reiterated runway “to the end of Q1 2025,” consistent with Q2 guidance and improved versus Q1’s “into Q4 2024” .
  • Clinical catalysts remain the stock’s key driver: phase 2b and phase 3 CAN‑2409 prostate topline data guided for Q4 2024; additional NSCLC and pancreatic CAN‑2409 OS updates targeted for Q1 2025 .
  • No Q3 earnings call transcript was available; the quarter’s narrative was communicated via the 8‑K press release and additional R&D updates (CAN‑3110 melanoma preclinical, enLIGHTEN IL‑12/IL‑15 asset) .

What Went Well and What Went Wrong

What Went Well

  • Management affirmed on‑track timelines for two prostate studies (phase 2b PFS and phase 3 DFS) in Q4 2024, sustaining near‑term clinical catalyst visibility: “We remain on track for phase 2b and phase 3 topline data…in the fourth quarter of 2024” (Paul Peter Tak) .
  • Pipeline momentum: CAN‑3110 first‑in‑class HSV oncolytic candidate showed preclinical antitumor activity in melanoma with dose‑dependent tumor growth inhibition and regression in a subset (3/8 high‑dose), accompanied by systemic immune activation .
  • R&D efficiency YoY: Q3 R&D of $5.42M was down vs $5.85M in Q3 2023, driven by lower payroll and depreciation/impairment, indicating continued cost discipline post‑restructuring .

What Went Wrong

  • GAAP P&L volatility from warrant liability: other income (expense), net swung to $(1.89)M from $0.43M YoY due to $(1.64)M change in fair value of warrant liability, widening net loss to $(10.65)M vs $(8.44)M YoY .
  • Cash burn: cash fell to $16.56M from $21.45M in Q2 and $25.70M in Q1, reinforcing financing risk into 2025 despite runway guidance .
  • G&A creep YoY: Q3 G&A rose to $3.34M from $3.02M in Q3 2023, primarily reflecting higher professional and consulting fees, partially offset by lower insurance costs .

Financial Results

Quarter-over-Quarter (Q2 2024 → Q3 2024)

MetricQ2 2024Q3 2024
R&D Expense ($USD Millions)$4.98 $5.42
G&A Expense ($USD Millions)$3.59 $3.34
Total Operating Expenses ($USD Millions)$8.57 $8.76
Loss from Operations ($USD Millions)$(8.57) $(8.76)
Interest Income ($USD Millions)$0.24 $0.24
Interest Expense ($USD Millions)$(0.57) $(0.49)
Change in FV of Warrant Liability ($USD Millions)$(13.34) $(1.64)
Other Income (Expense), Net ($USD Millions)$(13.67) $(1.89)
Net Loss ($USD Millions)$(22.24) $(10.65)
Diluted EPS ($USD)$(0.74) $(0.33)
Weighted-Average Shares (Basic/Diluted)29,878,210 32,013,569
Cash & Cash Equivalents ($USD Millions)$21.45 $16.56
Working Capital ($USD Millions)$8.74 $2.82

Notes:

  • Revenue not reported; statements present operating expenses and losses without a revenue line .

Year-over-Year (Q3 2023 → Q3 2024)

MetricQ3 2023Q3 2024
R&D Expense ($USD Millions)$5.85 $5.42
G&A Expense ($USD Millions)$3.02 $3.34
Total Operating Expenses ($USD Millions)$8.86 $8.76
Loss from Operations ($USD Millions)$(8.86) $(8.76)
Other Income (Expense), Net ($USD Millions)$0.43 $(1.89)
Net Loss ($USD Millions)$(8.44) $(10.65)
Diluted EPS ($USD)$(0.29) $(0.33)
Weighted-Average Shares (Basic/Diluted)28,919,810 32,013,569

Cash Trend (Q1 → Q3 2024)

MetricQ1 2024Q2 2024Q3 2024
Cash & Cash Equivalents ($USD Millions)$25.70 $21.45 $16.56

Segment breakdown: Not applicable; CADL does not report commercial revenue or segments in the quarter .

KPIs: Primary operational KPIs are pipeline milestones and cash runway; management guided to CAN‑2409 prostate topline data in Q4 2024 and OS updates in NSCLC and PDAC in Q1 2025 .

Guidance Changes

MetricPeriodPrevious GuidanceCurrent GuidanceChange
Cash RunwayCorporate“Into Q4 2024” (Q1 release) “Into/To end of Q1 2025” (Q2/Q3 releases) Raised vs Q1; Maintained vs Q2
CAN‑2409 Prostate (Phase 2b PFS topline)Q4 2024Q4 2024 (Q1/Q2) Q4 2024 (Q3) Maintained
CAN‑2409 Prostate (Phase 3 DFS topline)Q4 2024Q4 2024 (Q1/Q2) Q4 2024 (Q3) Maintained
CAN‑2409 NSCLC (OS update)Q1 2025Not previously dated in Q1/Q2 Q1 2025 (Q3) New
CAN‑2409 Pancreatic (OS update)Q1 2025Not previously dated in Q1/Q2 Q1 2025 (Q3) New

No revenue, margin, OpEx, OI&E, tax rate, dividends guidance was provided .

Earnings Call Themes & Trends

No Q3 earnings call transcript was available in our search; themes tracked from Q1–Q3 earnings press releases and R&D communications.

TopicPrevious Mentions (Q2 2024, Q1 2024)Current Period (Q3 2024)Trend
R&D Execution (CAN‑2409)NSCLC OS topline at ASCO; PDAC mOS 28.8m vs 12.5m; prostate readouts guided Q4 2024 Prostate phase 2b/phase 3 topline confirmed for Q4 2024; NSCLC/Pancreatic OS updates guided Q1 2025 Strengthening
Regulatory/DesignationsOrphan designations for CAN‑2409 (PDAC) and CAN‑3110 (rHGG) FDA orphan designation for CAN‑3110 reiterated Stable
Cash RunwayInto Q4 2024 (Q1); into Q1 2025 (Q2) To end of Q1 2025 (Q3) Improving vs Q1; Flat vs Q2
Platform Innovation (enLIGHTEN)Second TLS candidate unveiled at AACR IL‑12/IL‑15 asset with NK/CD8 activation; tumor regression in models Advancing
CAN‑3110 ExpansionrHGG multiple‑injection cohort safety/feasibility; Nature publication (single injection) background Melanoma preclinical activity (Nestin/CDKN2A alterations) with systemic immune activation Broadening indications

Management Commentary

  • “We remain on track for phase 2b and phase 3 topline data in non‑metastatic, localized prostate cancer for CAN‑2409 in the fourth quarter of 2024… We continue to advance our clinical and pre‑clinical candidates… leveraging our robust enLIGHTEN Discovery Platform” — Paul Peter Tak, MD, PhD, FMedSci, President & CEO .
  • “We are encouraged by the first clinical and biomarker activity data after repeated injection of CAN‑3110… which suggests a long tail of survival… excited about the data that supports potential expansion of CAN‑3110… into melanoma” — Paul Peter Tak .
  • “Data showed notable improvements in estimated median overall survival of 28.8 months… vs 12.5 months… No new safety signals were observed” — CAN‑2409 PDAC update (Q2 release) .
  • “Presented topline overall survival data… mOS of 20.6 months… compared to published results of <12 months with SoC docetaxel‑based chemotherapy…” — CAN‑2409 NSCLC (Q2 release) .

Q&A Highlights

  • No Q3 earnings call transcript or Q&A session was available in our document catalog; investor communications occurred via press releases and event presentations .

Estimates Context

  • Wall Street consensus EPS and revenue estimates for Q3 2024 via S&P Global were unavailable at time of query due to API limit; therefore, results vs consensus could not be compared. Values retrieved from S&P Global were unavailable at the time of query.
  • Implication: Estimate updates will likely focus on timing and probability of CAN‑2409 prostate readouts and potential financing runway extension; GAAP EPS volatility from warrant liability suggests limited utility of near‑term EPS comparisons absent non‑GAAP normalization .

Key Takeaways for Investors

  • Balance sheet runway “to end of Q1 2025” places emphasis on near‑term clinical readouts (CAN‑2409 prostate in Q4 2024) as primary stock catalysts and potential financing inflection points .
  • GAAP P&L remains sensitive to non‑cash warrant liability revaluations; Q3’s $(1.64)M change reduced other income and widened net loss—monitor for continued EPS volatility unrelated to operating execution .
  • R&D spending is controlled YoY post‑restructuring, supporting focused execution into readouts; however, G&A creep and cash decline emphasize prudent cost management and capital planning .
  • Positive external validation persists (ASCO presentations, orphan designations), and platform innovation (IL‑12/IL‑15 asset) expands optionality beyond current indications, aiding medium‑term pipeline value creation .
  • CAN‑3110 expansion into melanoma is supported by mechanistic alignment (Nestin/CDKN2A) and preclinical activity; continued rHGG multi‑injection data could strengthen the efficacy narrative .
  • Absent an earnings call, investors should rely on press releases and conference updates; watch for the Q4 2024 prostate readouts and Q1 2025 OS updates in NSCLC/PDAC as pivotal de‑risking events .
  • Consider near‑term trading around catalyst dates and potential capital raises; medium‑term thesis hinges on clinical success in prostate and supportive survival benefits in NSCLC/PDAC translating to regulatory pathways .