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Calidi Biotherapeutics, Inc. (CLDI)·Q3 2025 Earnings Summary

Executive Summary

  • Q3 showed stable opex and a narrowed YoY loss per share, but EPS missed the single-analyst S&P consensus due to a $5.67M non‑cash deemed dividend on warrants; cash rose sequentially on an underwritten offering and other financings .
  • Scientific momentum continued: RedTail/CLD‑401 SITC data demonstrated protection from immune clearance after systemic dosing and expression of genetic payloads at the tumor site; a new SAB was established to aid development .
  • Balance sheet extended: $6.9M gross underwritten offering in November (total 2025 gross proceeds $23.0M), quarter-end cash $10.4M plus $0.2M restricted; subsequent ATM ($0.4M) and sale of Nova Cell stake for $6.0M consideration (mix of debt cancellation and deferred) .
  • Risk overhang: Q3 10-Q contains a going-concern warning; management expects to raise additional capital to fund operations and clinical progress .

What Went Well and What Went Wrong

What Went Well

  • RedTail platform validation: SITC preclinical data showed systemic dosing with protection from immune clearance and targeted replication at metastatic tumor sites; platform effectively expressed genetic medicines at the tumor site. “RedTail…continues to demonstrate its ability to potently and specifically deliver genetic payloads to metastatic tumor sites.” — CEO Eric Poma .
  • Strategic advisory depth: New Scientific Advisory Board formed, including former Pfizer CMO Mace Rothenberg and leading virotherapy experts, to support CLD‑401 and RedTail .
  • Liquidity progress: $6.9M gross underwritten offering post‑quarter, bringing 2025 gross proceeds to $23.0M; cash increased to ~$10.4M as of 9/30 (plus $0.2M restricted) vs $5.3M cash at 6/30 .

What Went Wrong

  • EPS miss and equity dilution optics: Net loss per share was $(2.21) vs S&P consensus of $(1.68)*, pressured by a $5.67M non‑cash deemed dividend on warrants that increased loss attributable to common stockholders .
  • Going concern: Management concluded substantial doubt about the company’s ability to continue as a going concern without additional financing .
  • Continued operating losses and funding need: No product revenue; ongoing R&D and G&A drive losses, requiring substantial additional capital to advance programs .

Financial Results

MetricQ3 2024Q1 2025Q2 2025Q3 2025
Net Loss ($USD Millions)$(5.07) $(5.06) $(5.76) $(5.18)
Net Loss per Share (GAAP)$(7.75) $(0.18) $(1.99) $(2.21)
Research & Development ($USD Millions)$2.15 $2.43 $2.59 $2.36
General & Administrative ($USD Millions)$3.07 $2.64 $3.07 $2.69
Total Operating Expense ($USD Millions)$5.23 $5.06 $5.66 $5.05
Weighted Avg Shares (Thousands)652 27,086 2,877 4,907
Cash + Restricted Cash (Period End, $USD Millions)$10.8 $5.4 $10.6

Notes: Q3'25 includes a $5.67M non‑cash deemed dividend on warrants that increased net loss attributable to common stockholders . Company reported no product revenue and does not expect product sales until approvals .

Vs. Wall Street (S&P Global) for Q3 2025:

MetricActualConsensusSurprise
EPS (GAAP)$(2.21) $(1.68)*Miss
Revenue ($USD Millions)$0.00 (no product revenue) $0.00*Inline

Values marked with * were retrieved from S&P Global.

Segment breakdown/KPIs: Not applicable; Calidi is pre‑revenue with no segmented reporting in the quarter .

Guidance Changes

MetricPeriodPrevious GuidanceCurrent GuidanceChange
CLD‑401 IND timingDevelopment milestoneIND filing expected by end of 2026 Advancing to clinical trials; no date update provided Maintained (no update)
Financial guidance (revenue/margins/OpEx)FYNone providedNone provided
Liquidity/runwayNext 12 monthsSubstantial doubt language expected until financings are securedSubstantial doubt persists; plan to raise additional capital

Earnings Call Themes & Trends

Note: No Q3’25 earnings call transcript was available as of this analysis; themes reflect Q1–Q3 press releases and the Q3 10‑Q.

TopicPrevious Mentions (Q-2 and Q-1)Current Period (Q3 2025)Trend
RedTail/CLD‑401 platform progressAACR/ASCO data: IL‑15 superagonist payload; CD55 membrane engineering reduces immune clearance; systemic delivery to metastatic sites; IND by end 2026 SITC data: protected from immune clearance after systemic dosing; replicates in tumor cells; expresses genetic medicines at tumor site Positive scientific momentum
Regulatory (CLD‑201)IND opened Q1; FDA Fast Track designation in Q2 for soft tissue sarcoma No new regulatory updates disclosedNeutral
Capital/financingQ1 cash $10.6M; Q2 $4.6M warrant inducement, cash $5.3M $6.9M Nov underwritten offering (2025 total $23.0M), cash ~$10.4M at Q3 end; subsequent ATM ~$0.4M; sale of Nova Cell stake for $6.0M consideration Improved near‑term liquidity; ongoing need
Governance/expertiseCEO transition and CMO advisor added in Q1 New Scientific Advisory Board (Pfizer ex‑CMO, virotherapy leaders) Strengthening bench
Listing/compliance1‑for‑12 reverse stock split effective Aug 4, 2025 Compliance actions taken
Liquidity/going concernSubstantial doubt about going concern; need additional capital Risk persists

Management Commentary

  • “In our preclinical models, the RedTail platform continues to demonstrate its ability to potently and specifically deliver genetic payloads to metastatic tumor sites. CLD‑401…is advancing to clinical trials.” — Eric Poma, CEO (Q3 PR) .
  • “The RedTail technology can now allow for ‘programmable membranes’…Calidi is also exploring additional cell types outside of oncology… and additional payloads.” (Q3 PR) .
  • Prior quarter: “We believe our RedTail platform…will be a substantial breakthrough…We look forward to…building on Calidi’s strong platforms.” (Q2 PR) .

Q&A Highlights

  • No Q3’25 earnings call transcript was available. The company scheduled an investor webinar with live Q&A for Nov 19, 2025, following the earnings release and SITC data update .
  • Key likely focus areas (inferred from filings/PRs): liquidity and financing plans (given going‑concern), RedTail/CLD‑401 development path and timing, and CLD‑201 clinical execution .

Estimates Context

  • Coverage remains limited (1 estimate for EPS and revenue). Q3’25 EPS came in at $(2.21) vs S&P Global consensus of $(1.68), primarily reflecting the $5.67M non‑cash deemed dividend on warrants that increased loss attributable to common stockholders; revenue inline at $0.00 .
  • Expect estimate models to incorporate the quarter’s reverse split (Aug 4, 2025) and warrant‑related non‑cash items going forward .
    Values marked with * were retrieved from S&P Global.

Key Takeaways for Investors

  • Scientific de‑risking continues for RedTail/CLD‑401 with SITC data supporting systemic delivery and targeted expression; SAB formation adds credibility to clinical translation .
  • Liquidity improved sequentially via financings ($6.9M Nov underwritten offering; 2025 total gross proceeds $23.0M) and subsequent actions (ATM ~$0.4M; Nova Cell stake sale $6.0M consideration), but a going‑concern warning underscores continued dependence on external capital .
  • Q3 operating profile was disciplined: R&D $2.36M and G&A $2.69M, with total opex ~$5.05M; YoY G&A down vs Q3’24 $3.07M .
  • EPS miss vs consensus was driven by a non‑cash deemed dividend on warrants ($5.67M), not a deterioration in core operating spend; watch for model adjustments .
  • Near‑term catalysts: further preclinical/IND‑enabling updates for CLD‑401, progression of CLD‑201 (Fast Track), and financing milestones; stock remains highly sensitive to capital markets access and dilution parameters .
  • Execution focus: balancing runway with trial initiation timing; partnership or non‑dilutive funding could materially alter the funding path and valuation .

Sources

  • Q3 2025 8‑K press release and exhibits (financial tables and highlights) .
  • Q3 2025 10‑Q (financial statements; reverse split; liquidity/going concern; financing updates) .
  • Q2 2025 8‑K press release (financials; ASCO data; CLD‑201 Fast Track; financing) .
  • Q1 2025 8‑K press release (financials; CEO transition; AACR RedTail update; CLD‑201 IND) .
  • Company IR/GlobeNewswire press releases (Q3 results; SITC investor day; webinar) .