Executive Summary

Q2 2025 reflected continued pre-revenue investment: net loss of $3.67M and EPS of -$1.87, missing S&P Global consensus EPS of -$1.78 by ~$0.10; R&D declined sequentially while G&A rose year over year . EPS consensus values from S&P Global*.
Management advanced CMC readiness (API transfer to U.S. CDMO and manufactured clinical drug product) and announced a new study plan in ESKD patients transitioning to dialysis, including those with and without AFib—expanding tecarfarin’s potential path to registration .
Liquidity trended lower: cash and equivalents were $5.57M at 6/30/25 vs $7.34M at 3/31/25 and $10.02M at 12/31/24; shares outstanding were ~2.01M at period-end .
Stock reaction catalysts: the ESKD-dialysis initiation plan, sustained LVAD program momentum (Abbott collaboration), and Russell index additions as of June 30, 2025, which can broaden the shareholder base .

What Went Well and What Went Wrong

What Went Well
- CMC and trial readiness materially advanced: “By successfully completing the technical transfer of tecarfarin to a U.S. site of a leading global CDMO and manufacturing tecarfarin drug product, we have achieved critical steps in CMC readiness” — Quang X. Pham, CEO .
- New clinical path in ESKD transitioning to dialysis: enrollment planned for later this year; addresses an unmet need and is framed as a step toward ESKD+AFib registration strategy .
- Index inclusion: effective June 30, 2025, CVKD was added to Russell 3000E and Russell Microcap indexes, potentially broadening institutional ownership .
What Went Wrong
- EPS missed S&P Global consensus; Q2 2025 EPS was -$1.87 vs -$1.78 consensus (approx. $0.10 miss), reflecting higher G&A and ongoing lack of revenue . EPS consensus values from S&P Global*.
- G&A expenses rose sharply YoY to $2.66M (vs $1.21M in Q2 2024), adding pressure to operating expenses even as R&D moderated .
- Cash burn continued: cash fell to $5.57M at quarter-end from $7.34M in Q1 and $10.02M at year-end, underscoring future financing risk absent near-term revenue .

Metric ($USD Millions, except per-share)	Q2 2024	Q1 2025	Q2 2025
R&D Expense	$1.25	$1.67	$1.08
G&A Expense	$1.21	$2.25	$2.66
Total Operating Expenses	$2.47	$3.93	$3.73
Net Loss	$2.39	$3.85	$3.67
Diluted EPS ($)	-$2.24	-$2.09	-$1.87
Interest & Dividend Income	$0.07	$0.08	$0.07
Weighted Avg Shares (Millions)	1.07	1.84	1.96

Notes: Company reported no revenue; gross/EBITDA margins are not applicable in the pre-revenue stage .

Vs. S&P Global consensus and actuals:

Metric	Period	S&P Global Consensus*	Actual	Surprise
EPS ($)	Q2 2025	-$1.78*	-$1.87	-$0.10 (miss)
EPS ($)	Q1 2025	-$2.15*	-$2.09	+$0.06 (beat)
Revenue ($M)	Q2 2025	$0.00*	— (no revenue reported)	n/a
Revenue ($M)	Q1 2025	$0.00*	— (no revenue reported)	n/a

KPIs and Liquidity:

KPI	Q4 2024	Q1 2025	Q2 2025
Cash & Cash Equivalents ($M)	$10.02	$7.34	$5.57
Period-End Shares Outstanding (Millions)	1.782	1.910	2.007

*Values retrieved from S&P Global.

Metric/Item	Period	Previous Guidance	Current Guidance	Change
Quantitative financial guidance (revenue, margins, OpEx, EPS)	2025	None issued in prior release	None issued in Q2 release	Maintained (no guidance)
ESKD Dialysis Clinical Study	2025 start-up	Not previously guided specifically	Plan to initiate; site activation/screening later in 2025	Introduced
TECH-LVAD (Phase 3 planning)	2025	Abbott collaboration and FDA Type D design feedback disclosed previously	Continued pursuit; no new Q2 change disclosed	Maintained

Topic	Previous Mentions (Q4 2024 and Q1 2025)	Current Period (Q2 2025)	Trend
Clinical path (LVAD/ESKD)	Abbott collaboration for TECH-LVAD; FDA Type D meeting guidance on Phase 3 design	Announces ESKD dialysis-transition study plan; frames as step toward ESKD+AFib registration	Broadening clinical strategy beyond LVAD to ESKD initiation
CMC/Manufacturing	cGMP readiness to supply pivotal trials	Completed tech transfer to U.S. site; manufactured clinical drug product	Execution progressing
Business development	Exploring collaborations and pipeline expansion	Continues to explore partners across ESKD, AFib, LVAD	Ongoing
Market visibility	Investor/medical conferences active	Continued conference participation	Steady
Capital/indices	Raised ~$9.8M in 2024	Added to Russell 3000E and Microcap (6/30/25)	Index inclusion may aid ownership breadth

Note: No Q2 2025 earnings call transcript was available in our document set; themes reflect company 8-Ks and press releases.

“We continue to advance our goal of developing transformative therapeutics… reflected in our strategic plan to initiate a clinical trial for tecarfarin in end-stage kidney disease (ESKD) for patients transitioning to dialysis.” — Quang X. Pham, Chairman & CEO .
“By successfully completing the technical transfer… and manufacturing tecarfarin drug product, we have achieved critical steps in CMC readiness to supply our planned clinical trial.” — Quang X. Pham .
“There is a critical need for safe, effective anticoagulants for use in ESKD patients… we are excited to advance this program.” — Quang X. Pham .
On organizational progress earlier in the year: appointment of a CMO, Type D FDA feedback, and Abbott collaboration supportive of TECH-LVAD design and awareness .

No Q2 2025 earnings call transcript or Q&A detail was found in the company’s filings/press releases; no additional clarifications beyond the press releases were available .

Q2 2025 EPS missed S&P Global consensus by ~$0.10: actual -$1.87 vs -$1.78 consensus; revenue remained at zero as expected for a pre-revenue biotech . EPS/revenue consensus values from S&P Global*.
Q1 2025 EPS beat by ~$0.06 (actual -$2.09 vs -$2.15 consensus), aided by higher weighted average shares and interest income, though operating expenses rose year over year . EPS consensus values from S&P Global*.
Given continued pre-revenue status and a broader ESKD/LVAD development plan, Street models may shift OpEx mix (G&A vs R&D timing) and timing of trial start-up costs.

*Values retrieved from S&P Global.

Near-term catalyst: initiation of the ESKD dialysis-transition study (site activation/screening later 2025) can validate tecarfarin’s renal profile and support an ESKD+AFib registration path .
Manufacturing risk reduced: U.S.-based API/drug product readiness de-risks clinical supply for upcoming studies .
Capital needs remain a watch item: cash declined to $5.57M at Q2-end; without revenue, additional financing or partnerships may be necessary to fund multi-indication development .
Program breadth expanding: continued pursuit of LVAD (with Abbott support) while adding ESKD-transitions study increases optionality but may elevate operating complexity .
Index inclusion may aid liquidity/ownership diversification (Russell additions effective 6/30/25) .
EPS variability likely to persist as G&A ramps and R&D timing shifts; model sensitivity should focus on OpEx cadence rather than revenue in the near term .
Regulatory and design clarity (Type D feedback) and external validation (Abbott collaboration) support the medium-term thesis that tecarfarin can address patient populations underserved by warfarin/DOACs .

Citations: Q2 2025 8-K and press release ; Q1 2025 8-K and press release ; FY 2024 update ; ESKD clinical plan press release (Aug 5, 2025) .