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BioCardia, Inc. (BCDA)·Q3 2025 Earnings Summary

Executive Summary

  • Q3 2025 EPS was ($0.24), a slight miss vs Wall Street consensus of ($0.23); revenue was $0 and in line with estimates, while net loss improved year-over-year and sequentially on lower SG&A and reduced R&D vs Q2 . EPS and revenue estimates from S&P Global; values marked with an asterisk are sourced from S&P Global.
  • Liquidity strengthened materially: BioCardia closed a $6.0M financing (net $5.2M), lifting quarter-end cash to $5.3M and extending runway into Q2 2026; management also sold ~304K shares via ATM during the quarter .
  • Clinical execution advanced: first patients were enrolled at University of Wisconsin (Oct 30) and Henry Ford Health (Nov 10) in the CardiAMP HF II Phase 3 trial; four centers are actively enrolling, with additional sites onboarding .
  • Regulatory catalysts near-term: positive preliminary PMDA consultation in Japan for CardiAMP HF and an FDA meeting request on CardiAMP approvability planned for Q4 2025; Helix transendocardial delivery De Novo 510(k) submission timing shifted to Q4 2025 (from Q3) .

What Went Well and What Went Wrong

What Went Well

  • Strengthened balance sheet and runway: cash rose to $5.3M with runway into Q2 2026 following $6.0M gross financing, $5.2M net proceeds; ATM activity added further liquidity .
  • Clinical progress in CardiAMP HF II: four centers actively enrolling; publicized first enrollments at University of Wisconsin and Henry Ford Health, reinforcing momentum and physician engagement .
  • Japanese regulatory engagement positive: “positive preliminary clinical consultation” with PMDA; company anticipates next consultation soon that could enable submission for approval in Japan. CEO: “These next two quarters promise to be truly transformative…” .

What Went Wrong

  • Minor EPS miss and limited P&L scale: Q3 EPS ($0.24) modestly missed consensus by $0.01; revenue remained $0, emphasizing reliance on external financing and grants . EPS estimate from S&P Global; values marked with an asterisk are sourced from S&P Global.
  • Helix device submission timing slipped: Helix De Novo 510(k) submission pushed from Q3 2025 to Q4 2025, modestly delaying a potential enabling device approval .
  • Disclosure discrepancy: press release states Q3 net cash used in operations was $1.7M vs $2.6M prior year, while CFO remarks indicated $1.5M vs $1.7M prior year—flagging inconsistency that may require clarification .

Financial Results

MetricQ1 2025Q2 2025Q3 2025
Revenue ($USD Thousands)$0 $0 $0
Net Loss ($USD Thousands)$(2,712) $(2,049) $(1,483)
Net Loss per Share (EPS, $USD)$(0.59) $(0.40) $(0.24)
R&D Expense ($USD Thousands)$1,530 $1,368 $936
SG&A Expense ($USD Thousands)$1,196 $683 $552
Cash and Equivalents ($USD Thousands)$949 $980 $5,287

YoY comparison (selected items):

MetricQ3 2024Q3 2025
R&D Expense ($USD Thousands)$931 $936
SG&A Expense ($USD Thousands)$825 $552
Net Loss ($USD Thousands)$(1,737) $(1,483)
Net Loss per Share (EPS, $USD)$(0.61) $(0.24)
Net Cash Used in Operations ($USD Millions)$2.6 $1.7

Consensus vs actual (Q3 2025):

MetricEstimateActual
Revenue ($USD Millions)$0.00*$0.00
Primary EPS Consensus Mean ($USD)$(0.23)*$(0.24)

Estimates marked with an asterisk are values retrieved from S&P Global.

KPIs and operating metrics:

KPIQ1 2025Q2 2025Q3 2025
CardiAMP HF II centers actively enrolling3 sites 4 sites 4 centers (world class)
Publicized first patient enrollments——UW first patient (Oct 30) ; Henry Ford first patient (Nov 10)
Financing activity—ATM sales 296,422 shares (July–Aug) $6.0M gross ($5.2M net); ATM 304,000 shares

Guidance Changes

MetricPeriodPrevious GuidanceCurrent GuidanceChange
Helix De Novo 510(k) submission (FDA)2025Q3 2025 Q4 2025 Lowered (timing slipped)
CardiAMP HF manuscript publication2025–26Q4 2025 Q1 2026 Lowered (timing slipped)
CardiAMP HF PMDA clinical review (Japan)Q4 2025Q4 2025 Q4 2025 Maintained
CardiAMP HF FDA meeting request (approvability)Q4 2025Q4 2025 Q4 2025 Maintained
CardiALLO HF non‑dilutive fundingQ1 2026Q1 2026 Q1 2026 Maintained
Cash runwayN/AInto Oct 2025 Into Q2 2026 Raised (extended runway)
CardiAMP CMI roll‑in cohort publicationQ1 2026Q4 2025 top‑line target Q1 2026 publication target Lowered (timing clarified/slipped)

Earnings Call Themes & Trends

TopicPrevious Mentions (Q-2 & Q-1)Current Period (Q3 2025)Trend
Regulatory – PMDA (Japan) & FDA (U.S.)Q1: plan to share two‑year CardiAMP HF data with FDA/PMDA soon ; Q2: PMDA submission and meeting request anticipated in Q4 2025 Positive preliminary PMDA consultation; next consult could enable Japan approval; FDA meeting request on CardiAMP approvability targeted Q4 2025 Progressing; near‑term catalysts
Helix transendocardial delivery (De Novo 510(k))Q1: independent FDA submission pursued, strong safety in CardiAMP HF ; Q2: intent to submit in Q3 2025 Submission planned Q4 2025; master file updated to support programs Slight delay; preparation matured
CardiAMP HF II enrollmentQ1: 3 sites active ; Q2: 4 sites active; onboarding more 4 centers actively enrolling; first patients publicized at UW, Henry Ford Steady progress; growing visibility
CardiAMP CMI roll‑in outcomesQ1/Q2: avg +107s exercise tolerance; 82% reduction in angina Updated: avg +80s exercise; 82% angina reduction; roll‑in cohort total 5 patients; well tolerated Cohort completed; data refined for publication
Funding – non‑dilutive (CardiALLO)Q2: study right‑sized for nondilutive funding discussions NIH grant funding expected with high probability in Q1 2026 (subject to government) Confidence increased
Heart3D fusion imagingNot highlighted previouslyCART-Tech partnership; promising preclinical results; plan to advance to clinic in 2026 New technical initiative underway

Management Commentary

  • “This quarter’s $6 million financing is actively supporting approvability discussions of CardiAMP… and our actively enrolling in our CardiAMP HF II phase 3 confirmatory trial. These next two quarters promise to be truly transformative for our business…” — Peter Altman, CEO .
  • “We anticipate requesting a meeting on the approvability of the FDA Designated Breakthrough CardiAMP System in the fourth quarter of 2025.” — Peter Altman, CEO .
  • “Cash currently on hand is expected to provide runway into the second quarter of 2026 without additional financing.” — David McClung, CFO .
  • “The CardiAMP HF II confirmatory phase III… four centers are actively enrolling, three have randomized their first patients, and additional centers are actively being onboarded.” — Peter Altman, CEO .

Q&A Highlights

  • CardiAMP CMI roll‑in cohort: management confirmed 5 patients at six‑month primary endpoint; results “pretty compelling” vs prior disclosure; preparing for publication .
  • HF II enrollment dynamics: dosing flexibility approved by FDA to include patients with fewer available cells; main constraint is internal bandwidth, not site or patient hurdles; trial designed with delay to mitigate Hawthorne effect .
  • NIH non‑dilutive funding: management expressed high probability of NIH support for BCDA‑03 in Q1 2026, contingent on government operations .
  • Japan PMDA: formal clinical consultation is key hurdle; PMDA fully apprised of Phase I–III data; decision will assess sufficiency of combined datasets for safety/efficacy in Japan .

Estimates Context

  • Q3 2025 EPS missed by $0.01 vs S&P Global consensus (estimate $(0.23)* vs actual $(0.24)); revenue was in line at $0 (estimate $0.00* vs actual $0.00) . Estimates marked with an asterisk are values retrieved from S&P Global.
  • Prior quarters’ consensus EPS tracked deeper losses: Q2 $(0.50)* and Q1 $(0.39)*, while actual EPS improved sequentially to $(0.24) in Q3, suggesting models may need to reflect lower SG&A and moderated R&D spending as HF II ramps and device submission prep continues . Estimates marked with an asterisk are values retrieved from S&P Global.
MetricQ1 2025Q2 2025Q3 2025
Primary EPS Consensus Mean ($USD)$(0.39)*$(0.50)*$(0.23)*
Revenue Consensus Mean ($USD Millions)N/A$0.00*$0.00*

Estimates marked with an asterisk are values retrieved from S&P Global.

Key Takeaways for Investors

  • Liquidity improved and dilution risk moderated near term: $6.0M financing ($5.2M net) and ATM activity boosted cash to $5.3M with runway into Q2 2026, supporting regulatory and trial execution .
  • Near‑term catalysts: PMDA clinical consultation (Q4 2025), FDA meeting request on CardiAMP approvability (Q4 2025), and Helix De Novo 510(k) submission (Q4 2025) provide multiple regulatory event paths that could re‑rate the stock .
  • Clinical narrative strengthening: high‑profile centers (UW, Henry Ford) enrolled first patients in HF II; dosing flexibility and CMS reimbursement support enrollment throughput and cost mitigation .
  • Device pathway could enable therapeutics: Helix device approval would validate and de‑risk the delivery platform underpinning CardiAMP/ALLO programs, potentially facilitating subsequent therapeutic approvals .
  • Watch for NIH non‑dilutive funding for CardiALLO: management’s high confidence in Q1 2026 funding could accelerate parallel development with limited dilution .
  • Model considerations: maintain minimal revenue trajectory; incorporate sequential EPS improvement from lower SG&A and moderated R&D; account for timing shifts in Helix submission and manuscript publication .
  • Risk checklist: regulatory acceptance in Japan/U.S., enrollment pace for 250‑patient HF II trial, funding cadence, and any reconciliation of cash flow disclosure discrepancies between press release and call .