Executive Summary

Q2 2025 EPS was $(0.40) versus consensus of $(0.50), a beat of $0.10; revenue was $0 versus $0 consensus (in line). Sequentially, EPS improved from $(0.59) in Q1, driven by lower SG&A and modestly lower R&D . Consensus values marked with * were retrieved from S&P Global.
Management highlighted near-term regulatory catalysts: Helix De Novo 510(k) submission targeted for Q3 2025, and CardiAMP HF clinical consultation with Japan PMDA mid‑Q4 2025; an FDA meeting request on CardiAMP is also planned for Q4 2025 .
Cash was $0.98M at quarter-end; $0.77M raised via ATM post-quarter, bringing cash to ~$1.1M and runway into October 2025; management also “anticipates a financing in September” .
Operational momentum: CardiAMP HF II confirmatory trial now has four sites actively enrolling with a fifth coming; Henry Ford Health initiated enrollment in July .
Business development: Exclusive Heart3D Fusion Imaging partnership with CART‑Tech announced on Aug 13, expected to enhance image-guided cardiac biotherapeutic delivery; Helix positioned as potentially the first approved transendocardial biotherapeutic delivery system in the U.S. .

What Went Well and What Went Wrong

What Went Well

EPS beat vs consensus: $(0.40) actual vs $(0.50)* expected, aided by lower SG&A and slightly lower R&D sequentially; Q2 SG&A $0.683M vs $1.196M in Q1, R&D $1.368M vs $1.530M in Q1 .
Clinical/regulatory progress: PMDA consultation expected mid Q4, FDA meeting request in Q4, and Helix De Novo 510(k) submission targeted for Q3; CEO: “Our Helix has potential to be the first approved transendocardial biotherapeutic delivery system in the United States” .
Trial execution: CardiAMP HF II actively enrolling at four sites with a fifth imminent; Henry Ford Health initiated enrollment, reinforcing site momentum .

What Went Wrong

Year-over-year net loss widened: $(2.049)M in Q2 2025 vs $(1.646)M in Q2 2024, reflecting higher R&D (CardiAMP HF closeout and HF II start-up) .
Cash remains constrained: $0.98M at 6/30; despite ATM proceeds, runway extends only into October and management signaled need for a September financing .
No formal numeric revenue or margin guidance; company remains pre‑revenue with limited revenue visibility, and margins are not meaningful given zero collaboration revenue in Q2 .

Financial Results

Core P&L and Cash Metrics

Metric	Q2 2024	Q1 2025	Q2 2025
Revenue ($USD Thousands)	$3	$0	$0
Research & Development ($USD Thousands)	$800	$1,530	$1,368
SG&A ($USD Thousands)	$852	$1,196	$683
Total Costs & Expenses ($USD Thousands)	$1,652	$2,726	$2,051
Operating Loss ($USD Thousands)	$(1,649)	$(2,726)	$(2,051)
Other Income, net ($USD Thousands)	$3	$14	$2
Net Loss ($USD Thousands)	$(1,646)	$(2,712)	$(2,049)
EPS (Basic & Diluted, $USD)	$(0.88)	$(0.59)	$(0.40)
Weighted-Average Shares (Basic & Diluted)	1,877,069	4,635,764	5,059,736
Net Cash Used in Operations ($USD Thousands)	$1,300	$1,600	$1,600
Cash & Equivalents ($USD Thousands)	$1,421	$949	$980

Notes: Margins are not meaningful given de minimis revenue and pre‑commercial stage .

Actuals vs Consensus

Metric	Q1 2025 Actual	Q1 2025 Consensus*	Surprise	Q2 2025 Actual	Q2 2025 Consensus*	Surprise
EPS ($USD)	$(0.59)	$(0.39)*	Miss $(0.20)	$(0.40)	$(0.50)*	Beat $0.10
Revenue ($USD)	$0	N/A*	N/A	$0	$0.0*	In line

Values with * retrieved from S&P Global. Surprises computed from cited actuals and S&P Global consensus.

Guidance Changes

Metric	Period	Previous Guidance	Current Guidance	Change
R&D Expense (YoY trajectory)	FY 2025	“Increase modestly in 2025”	“Increase modestly in 2025”	Maintained
SG&A Expense (YoY trajectory)	FY 2025	“Track close to 2024 levels”	“Track close to 2024 levels”	Maintained
Helix De Novo 510(k) submission (FDA)	Q3 2025	“Anticipated this quarter” (Q2 timing)	“Submit in Q3 2025”	Slight delay/pushed
CardiAMP HF FDA meeting request	Q4 2025	“Meeting request/submission anticipated this quarter”	“Complete submission and meeting request in Q4 2025”	Clarified timing
CardiAMP HF PMDA clinical consultation	Q4 2025	“Next consultation invited after 2‑yr data”	“In‑person consultation mid‑Q4 2025”	Scheduled
Financing	Sep 2025	Not previously stated	“Anticipate a financing in September”	New
CardiAMP HF II Enrollment	2025	“3 sites actively enrolling”	“4 sites enrolling; 5th imminent”	Raised

Earnings Call Themes & Trends

Topic	Previous Mentions (Q4 2024, Q1 2025)	Current Period (Q2 2025)	Trend
Regulatory path (PMDA, FDA)	PMDA invited next consult post 2‑yr data; FDA engagement planned; pathway may involve subgroup approval and post‑marketing studies	PMDA consult mid‑Q4; FDA meeting request Q4; Helix De Novo submission Q3; CEO detailed timeline and expectations	Visibility improving
Helix delivery platform	Highlighted safety/performance history; potential partnering; Morph DNA usage	“Potential to be the first approved transendocardial delivery system”; De Novo 510(k) in Q3	Advancing toward submission
CardiAMP HF II enrollment	Activation/consenting; plan to accelerate post data	Four sites enrolling; fifth imminent; Medicare reimbursement supports cost	Building momentum
Partnerships/business development	Active dialogues across Helix/Morph; non‑dilutive funding for CardiALLO discussed	Partnerships not “on hold”; active discussions across platforms; Heart3D Fusion Imaging partnership announced	Expanding
Financing and liquidity	Annual cash burn reduced in 2024; modest increase expected in 2025	ATM proceeds; runway into October; anticipate September financing	Near-term raise flagged
IP portfolio	Robust portfolio; new JP patent; pending allowances	New U.S. patent No. 12,311,127 granted in June	Strengthened
CardiALLO (BCDA‑03)	Low-dose cohort completed; DSMB review planned	DSMB recommended proceed; pursuing non‑dilutive funding in Q1 2026	Stable, funding clarity

Management Commentary

CEO on strategic inflection: “Our Helix has potential to be the first approved transendocardial biotherapeutic delivery system in The United States… We remain interested in partnering this technology” .
CEO on regulatory timelines: “If [PMDA] accept our positioning… meeting minutes could potentially end with ‘address the following questions in your application for approval’… process would take as much as a year” .
CFO on runway and efficiency: “Sold $769,000 under our ATM facility… current cash balance approximately $1,100,000… runway into October… We will work hard to continue our track record of efficient use of resources” .
CEO on financing: “We also anticipate a financing in September that we are working to have be a success for current shareholders” .
Press release highlight: “Our active discussions on the approvability of the CardiAMP Cell Therapy System, as well the anticipated submission for approval of its dedicated Helix… have potential to be transformative” .

Q&A Highlights

PMDA pathway and device vs biologic framework: Management emphasized autologous, point‑of‑care device path aligns with Japanese cultural and regulatory context; conditional approvals and post‑marketing studies possible .
FDA interaction type and sequencing: Considering Breakthrough “Sprint” discussion; Helix De Novo submitted ahead of CardiAMP to streamline risk considerations .
HF II trial logistics: Four centers enrolling; longer lead‑in to mitigate Hawthorne effect; all patients will have NT‑proBNP ≥500 pg/mL; potential to modify trial should FDA support therapy .
Partnerships: Not on hold; active across Helix, Morph, and CardiALLO; CardiAMP distribution interest in Japan contingent on regulatory clarity .
CMI (BCDA‑02) readout: Roll‑in cohort top‑line targeted for Q4; partnering interest may hinge on PMDA/FDA clarity .

Estimates Context

Q2 2025: EPS $(0.40) vs $(0.50)* consensus (beat $0.10); revenue $0 vs $0.0* consensus (in line). Q1 2025: EPS $(0.59) vs $(0.39)* consensus (miss $0.20); revenue not estimated*/N/A .
Implication: Sequential expense discipline improved EPS in Q2; estimate revisions likely to focus on operating expense run-rate and timing of financing and regulatory milestones.

Values with * retrieved from S&P Global.

Key Takeaways for Investors

Near-term catalysts: Helix De Novo 510(k) submission (Q3), PMDA clinical consultation (mid‑Q4), FDA meeting request for CardiAMP (Q4), and a September financing; each can move the stock .
Clinical momentum: HF II trial enrollment is ramping; Medicare reimbursement ($17,500 per procedure) offsets R&D study costs, aiding capital efficiency .
Liquidity watch: Post‑ATM cash of ~$1.1M extends runway into October, but a financing is expected; size/terms will be critical for dilution and execution capacity .
Platform leverage: Heart3D Fusion Imaging partnership and Helix/Morph platforms create optionality via partnering and potential future revenue streams independent of CardiAMP timelines .
Regulatory narrative: Autologous, device‑regulated approach may align well with PMDA; subgroup significance (elevated NT‑proBNP) and confirmatory HF II design support potential U.S. pathway .
Expense trajectory: R&D to rise modestly in 2025; SG&A to track 2024 levels—model operating burn accordingly .
Trading lens: EPS beat and clearer regulatory timelines are positives; financing overhang and cash constraints are key risks—monitor September raise and Q3/Q4 milestones for catalysts .

Appendices

Selected Program and Milestone Disclosures

Anticipated milestones: HF manuscript (Q4 2025); PMDA clinical review (Q4 2025); FDA meetings (Q4 2025); HF II enrollment ongoing; CMI roll‑in top line (Q4 2025); CardiALLO non‑dilutive funding (Q1 2026); Helix FDA submission (Q3 2025) .
CardiALLO Phase 1/2 low-dose cohort completed with DSMB recommending proceed; no treatment‑emergent adverse events observed in low dose cohort .
IP: U.S. Patent No. 12,311,127 granted for “Radial and Trans‑endocardial Delivery Catheter” .

BioCardia, Inc. (BCDA)·Q2 2025 Earnings Summary