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Calidi Biotherapeutics, Inc. (CLDI)·Q2 2025 Earnings Summary

Executive Summary

  • Q2 2025 net loss attributable to common stockholders was $5.7M and diluted EPS was $1.99 loss, improving year-over-year from $7.4M and $16.75 loss, respectively, while sequentially widening vs Q1 ($5.0M loss, $0.18 loss EPS) .
  • R&D rose to $2.6M (+$0.4M y/y) and G&A fell to $3.1M (-$0.5M y/y), with total operating expenses at $5.7M; cash was $5.3M with $0.1M restricted as of June 30, 2025 .
  • Strategic/regulatory momentum: FDA Fast Track Designation for CLD-201; preclinical RedTail/CLD-401 data (IL‑15 superagonist payload, CD55 immune-evasion) presented at ASCO; $4.6M raised via warrant inducement, bringing 2025 gross proceeds to $15.7M .
  • Versus S&P Global consensus: Q2 EPS (-$1.99) modestly missed (-$1.92 estimate; 1 estimate); revenue consensus was $0.00 with no reported revenue .
  • Near-term catalysts include CLD‑201 Phase 1 progression (IND opened Q1) and RedTail lead candidate timeline (CLD‑401 IND by end of 2026) .

What Went Well and What Went Wrong

What Went Well

  • FDA Fast Track Designation for CLD-201 (stem-cell loaded intratumoral viral therapy) in soft tissue sarcoma, supporting expedited regulatory interactions .
  • Compelling RedTail preclinical at ASCO: IL‑15 superagonist payload delivery to metastatic tumors and engineered CD55 expression enabling systemic administration (immune evasion) .
  • Balance sheet support: $4.6M warrant inducement, total $15.7M gross proceeds in 2025, extending runway despite challenging biotech financing environment .
  • CEO tone on platform potential: “We believe our RedTail platform…will be a substantial breakthrough…deliver potent therapeutic genetic medicines to metastatic sites through systemic administration” .

What Went Wrong

  • Cash declined to $5.3M at quarter-end, highlighting continued financing needs to fund R&D through long IND timelines .
  • No commercial revenues reported; operating loss persisted with total operating expenses of $5.7M in Q2 and net loss attributable to common stockholders of $5.7M .
  • Sequentially, net loss widened vs Q1 ($4.99M), reflecting higher R&D and G&A; limited analyst coverage (one EPS estimate) reduces external visibility* .

Financial Results

MetricQ4 2024Q1 2025Q2 2025
Net Loss Attributable to Common Stockholders ($USD Millions)$4.1 $5.0 $5.7
Diluted EPS ($USD)$0.27 loss $0.18 loss $1.99 loss
Research & Development ($USD Millions)$1.8 $2.4 $2.6
General & Administrative ($USD Millions)$2.2 $2.6 $3.1
Total Operating Expenses ($USD Millions)N/A$5.1 $5.7
Weighted Avg Shares Outstanding (thousands)8,005 27,086 2,877
Balance Sheet KPIsQ4 2024Q1 2025Q2 2025
Cash ($USD Millions)$9.6 $10.6 $5.3
Restricted Cash ($USD Millions)$0.2 $0.2 $0.1
Total Assets ($USD Millions)$14.2 $15.1 $9.4
Total Liabilities ($USD Millions)$12.2 $7.8 $7.3
Total Equity ($USD Millions)$2.0 $7.3 $2.1

Note: No segment revenue breakdown applicable; company reported no commercial revenues during these periods .

Guidance Changes

MetricPeriodPrevious GuidanceCurrent GuidanceChange
CLD-401 (RedTail lead) IND timelineIND-enabling/filingPayload/lead candidate reveal in Q2 2025; IND timing not previously specified IND filing expected by end of 2026 Introduced timeline (newly specified)
CLD-201 Phase 12025IND filed March 2025; first patient dosing targeted Q3 2025 IND successfully opened Q1 2025; received FDA Fast Track; dosing timing not updated Regulatory status upgraded (Fast Track); dosing timing maintained/unclear
CLD-101 (high-grade glioma)2025Q2 2025 first patient dosed at Northwestern; 14 patients in City of Hope trial No explicit Q2 update provided Maintained/No update in Q2 release

Earnings Call Themes & Trends

Note: No Q2 2025 earnings call transcript was found in the document set.

TopicPrevious Mentions (Q4 2024, Q1 2025)Current Period (Q2 2025)Trend
RedTail systemic virotherapy (immune evasion, payload delivery)Demonstrated transient gene therapy payload delivery to tumors; planned payload/lead reveal Q2 2025 ASCO data on IL‑15 superagonist delivery and CD55 expression enabling systemic administration Advancing from concept to preclinical validation
Regulatory designationsIND filed for CLD‑201; CLD‑101 trials progressing CLD‑201 granted FDA Fast Track; CLD‑201 IND opened Q1 Strengthening regulatory posture
Financing/runwayYE cash $9.6M; raising capital via offerings $4.6M warrant inducement; 2025 gross proceeds $15.7M; cash $5.3M at Q2 Active capital raising; cash drawdown
Management changes/leadership focusCEO transition to Eric Poma; new CMO appointment CEO reiterates RedTail strategy and capital markets experience New leadership embedding strategy
Clinical execution (CLD‑101, CLD‑201)Q2 2025 first patient dosed planned (CLD‑101); CLD‑201 Phase 1 setup Q2 release highlights CLD‑201 Fast Track; no dosing update Execution milestones pending

Management Commentary

  • “We believe our RedTail platform, with its ability to protect virus from immune clearance and induce tumor lysis and the delivery of potent therapeutic genetic medicines to metastatic sites through systemic administration, will be a substantial breakthrough…” — Eric Poma, PhD, CEO .
  • Q1 strategic framing: RedTail “protect virus from immune clearance and induce tumor lysis and the delivery of potent therapeutic proteins to metastatic sites” .

Q&A Highlights

  • No Q2 2025 earnings call transcript located; no Q&A disclosures available in the filings or press materials for the quarter.

Estimates Context

MetricQ2 2025 ActualQ2 2025 Consensus# of Estimates
EPS ($USD)$1.99 loss $1.92 loss*1*
Revenue ($USD)Not reported (no commercial revenue) $0.00*1*
  • EPS was a modest miss versus consensus (about $0.07 below), amid limited analyst coverage (single estimate)* .
  • With no revenue reported and development-stage status, estimate updates will hinge on capital runway disclosures, regulatory progress (Fast Track), and clarity on Phase 1 initiation timelines .

Values retrieved from S&P Global.*

Key Takeaways for Investors

  • Preclinical validation at ASCO for RedTail/CLD‑401 (IL‑15 superagonist delivery, CD55 immune evasion) strengthens the systemic virotherapy narrative and future IND prospects .
  • FDA Fast Track for CLD‑201 is a material regulatory accelerant; watch for Phase 1 initiation/dosing updates as a potential catalyst .
  • Cash fell to $5.3M at Q2 end; continued external financing likely near term given IND timelines (CLD‑401 filing by end‑2026) and ongoing R&D .
  • Q2 EPS modestly missed a single estimate, highlighting limited coverage; broadened analyst engagement may follow clinical starts and regulatory events* .
  • Prior guidance flagged Q3 2025 first patient dosing for CLD‑201 and Q2 payload/lead reveal (achieved at ASCO); execution vs these milestones will drive sentiment .
  • Near-term trading could react to financing announcements, trial start PRs, and any incremental regulatory designations; medium-term thesis hinges on translating RedTail preclinical efficacy into human proof‑of‑mechanism .