enVVeno Medical | 10-K: FY2025 Revenue: USD 0

Revenue: As of FY2025, the actual value is USD 0.

EPS: As of FY2025, the actual value is USD -33.06.

EBIT: As of FY2025, the actual value is USD -21.59 M.

enVVeno Medical Corporation operates as a single segment focused on Medical Device development in the United States, and therefore, segment-specific revenue is not applicable as the company is not currently generating revenue and does not expect significant revenue until its product candidates receive FDA approval.

Net Loss

Net loss was - $19.5 million for the year ended December 31, 2025, representing an 11% decrease from - $21.8 million for the year ended December 31, 2024.

Operating Expenses

Loss from operations was - $20.9 million for the year ended December 31, 2025, compared to - $23.8 million for the year ended December 31, 2024.

Research and Development Expenses

Research and development expenses decreased by $2.2 million, or 19%, to $10.0 million for the year ended December 31, 2025, from $12.2 million for the year ended December 31, 2024. Employee expense: $5,339 thousand in 2025, $4,984 thousand in 2024. Clinical costs: $3,216 thousand in 2025, $5,345 thousand in 2024. Product costs: $840 thousand in 2025, $1,147 thousand in 2024. Other R&D costs: $586 thousand in 2025, $773 thousand in 2024.

Selling, General and Administrative Expenses

Selling, general and administrative expenses decreased by $0.7 million, or 6%, to $10.9 million for the year ended December 31, 2025, from $11.6 million for the year ended December 31, 2024. Employee expense: $6,147 thousand in 2025, $6,285 thousand in 2024. Professional fees: $1,558 thousand in 2025, $2,451 thousand in 2024. Occupancy: $597 thousand in 2025, $626 thousand in 2024. Insurance: $610 thousand in 2025, $655 thousand in 2024. Other SG&A costs: $2,006 thousand in 2025, $1,560 thousand in 2024.

Other Income

Total other income decreased by $0.6 million to $1.4 million for the year ended December 31, 2025, from $2.0 million for the year ended December 31, 2024. Realized gain from sales of trading securities: $1,126 thousand in 2025, $1,640 thousand in 2024. Unrealized loss from trading securities: - $391 thousand in 2025, - $22 thousand in 2024. Interest income: $692 thousand in 2025, $389 thousand in 2024.

Cash Flow

Net cash used in operating activities was - $15.6 million for the year ended December 31, 2025, a decrease of $1.2 million from - $16.8 million for the year ended December 31, 2024. Net cash provided by investing activities was $15.9 million for the year ended December 31, 2025, compared to $1.3 million for the year ended December 31, 2024. Maturities of investments: $61,879 thousand in 2025, $56,939 thousand in 2024. Purchase of investments: - $46,018 thousand in 2025, - $55,567 thousand in 2024. Purchases of property and equipment: - $5 thousand in 2025, - $37 thousand in 2024. Net cash provided by financing activities was $1.0 million for the year ended December 31, 2025, compared to $13.6 million for the year ended December 31, 2024. Proceeds from sale of common stock in At-the-Market offering, net of fees: $782 thousand in 2025, - $0 thousand in 2024. Proceeds from the sale of common stock and pre-funded warrants in public offering, net of fees: - $0 thousand in 2025, $13,591 thousand in 2024. Proceeds from exercise of warrants: $241 thousand in 2025, - $0 thousand in 2024. Proceeds from exercise of stock options: - $0 thousand in 2025, $46 thousand in 2024. Cash and cash equivalents were $3.1 million as of December 31, 2025, compared to $1.8 million as of December 31, 2024.

Other Key Metrics

Total cash and investments were $28.2 million as of December 31, 2025. Working capital was $26.7 million as of December 31, 2025. Unrecognized stock-based compensation expense was $3.2 million as of December 31, 2025, to be recognized over a weighted average remaining vesting period of 1.6 years. Federal net operating loss (NOL) carryforwards were approximately $95.6 million as of December 31, 2025, with $12.0 million pre-2018 NOLs expiring in 2029 and $83.6 million post-2018 NOLs carrying forward indefinitely. State NOL carryforwards were approximately $114.0 million as of December 31, 2025, which begin to expire in 2029. Federal research and development tax credit carryforwards were approximately $0.2 million, beginning to expire in 2027.

Outlook / Guidance

enVVeno Medical Corporation anticipates its cash burn rate may increase from approximately $4 million per quarter to between $4 million and $5 million per quarter in 2026. Despite this increase, the company expects to have sufficient cash to fund operations through mid-2027. The company will need to raise additional capital in the future to support its product development and market penetration initiatives.