0001753926-26-000548
SEC filingVivani Medical, Inc. (VANI), a clinical-stage biopharmaceutical company, reported a net loss of $26.6 million for FY 2025, widening from $23.5 million in FY 2024, driven by increased research and development expenses of $18.1 million (up from $15.7 million) and general and administrative costs of $9.4 million (up from $8.9 million). Total operating expenses rose 12% to $27.6 million, reflecting accelerated clinical development of NanoPortal™ GLP-1 implant candidates like NPM-139 for obesity and NPM-133 for type 2 diabetes. No revenue was generated as the company remains pre-commercial. Cash and equivalents stood at $16.2 million with total assets of $39.4 million and stockholders' equity of $15.7 million as of December 31, 2025. Net cash used in operations was $24.3 million, offset by $23.3 million from equity financings including private placements and registered offerings netting $37.0 million. The company raised funds via multiple director-affiliated transactions and sales agreements. With $17.6 million in cash, equivalents, and restricted cash, Vivani projects runway into mid-2027, prioritizing NPM-139 Phase 1 trials in mid-2026 pending FDA clearance. Accumulated deficit reached $148.5 million, underscoring ongoing funding needs amid promising preclinical data showing 20% weight loss sustained over a year.
Vivani Medical reported FY2025 net loss of $26.6M, up 13% from $23.5M in FY2024, with basic/diluted EPS steady at -$0.43 on 62.4M weighted shares. Operating loss widened to $27.6M from $24.7M due to R&D escalation to $18.1M (15% YoY increase) tied to LIBERATE-1 Phase 1 completion and NPM-139 preclinical advancement, plus G&A at $9.4M (6% rise). Other income fell to $0.9M from $1.2M. No revenue as pre-commercial. Balance sheet shows $39.4M assets, $16.2M cash, $15.7M equity; accumulated deficit $148.5M. Operations consumed $24.3M cash, mitigated by $23.3M financing.
No revenue generated in FY2025 or FY2024. Vivani is clinical-stage, focusing on NanoPortal implants (NPM-139 semaglutide for obesity, NPM-133 for T2D, NPM-115 exenatide). LIBERATE-1 met safety/PK objectives; NPM-139 preclinical showed 20% weight loss sustained >6 months. Okava partnership advances OKV-119 veterinary GLP-1. Grants offset $0.04M R&D.
Pre-revenue, no gross margins. Operating margin N/A; loss from operations -$27.6M (100% of expenses). R&D 66% of opex (up from 64%), G&A 34%. Non-cash items: $1.5M stock comp, $0.4M depreciation, $0.3M lease expense. Cash burn intensified by clinical ramp-up.
Operating cash use $24.3M (vs $20.8M FY2024), investing $1.2M capex. Financing $23.3M from $8.7M registered direct, $8.5M private sales, $6.0M placement. Net cash decline $2.1M to $17.6M (incl. restricted). Current assets $17.9M (cash dominant), liabilities $23.7M (leases $18.9M). Equity $15.7M; 76.4M shares outstanding (up from 59.2M). Runway to mid-2027.
Management projects cash sufficiency to mid-2027, prioritizing NPM-139 Phase 1 (mid-2026, safety/PK vs. semaglutide injections) and Phase 2 prep. LIBERATE-1 de-risks platform for semaglutide/exenatide. Cortigent spin-off/IPO advances. Risks: funding needs, clinical delays, regulatory hurdles (505(b)(2) pathway), competition in GLP-1 space. $12.6M committed private capital through July 2026.