Wed, Apr 30, 9:30 PM (12 days ago)
**enVVeno Medical Corporation (NVNO) Q1 2025 Financial Summary** **Financial Health and Performance:** - **Revenue:** No significant revenue reported, as expected for a developmental-stage company. - **Net Loss:** $4.5 million, a 10% decrease from $5.0 million in Q1 2024. - **Operating Expenses:** Decreased by 10% to $4.95 million, driven by lower R&D and SG&A expenses. - **Cash Position:** $2.9 million in cash and cash equivalents, down from $1.75 million in Q1 2024. - **Cash Flow:** Net cash used in operating activities was $4.0 million, an increase of $0.4 million from Q1 2024. **Profit Margins and Earnings:** - **Gross Margin:** Not applicable due to lack of revenue. - **Operating Margin:** -123% (Operating loss of $4.95 million on no revenue). - **Net Margin:** -100% (Net loss of $4.5 million on no revenue). **Trends and Uncertainties:** - **R&D and SG&A Expenses:** Expected to increase as clinical trials progress and commercialization efforts begin. - **Cash Burn Rate:** Anticipated to rise to $4-5 million per quarter. - **Funding:** Future capital requirements depend on clinical trial success and market entry. - **Regulatory:** VenoValve PMA application submitted; FDA decision expected in H2 2025. enVVe IDE approval expected in Q3 2025. **Future Operations Impact:** - **VenoValve:** Potential first-to-market surgical replacement venous valve; FDA approval expected in H2 2025. - **enVVe:** Next-generation, non-surgical replacement venous valve; IDE approval expected in Q3 2025. - **Market:** Significant unmet need for deep venous CVI treatments; potential market of 2.5 million patients annually in the U.S. **Management's Outlook:** - **Liquidity:** Sufficient capital resources to meet obligations for at least one year. - **Future Financing:** Additional capital raising may be required to sustain operations and commercialization efforts. - **Risk Factors:** Dependence on clinical trial success, regulatory approval, and market acceptance.