Vivani Medical — Third Quarter 2026 Earnings Summary

Financial Performance:

• Cash, cash equivalents, and restricted cash totaled $15.5 million as of September 30, 2026, a decrease from $20.8 million as of June 30, 2026.
• Research and development expense, net of grants, was $5.0 million for the three months ended September 30, 2026, compared to $4.5 million in the same period in 2025, an increase of 11%.
• General and administrative expense, net of grants, was $2.5 million for the three months ended September 30, 2026, compared to $2.2 million in the same period in 2025, an increase of 14%.
• Other income, net, was $0.3 million for the three months ended September 30, 2026, compared to $0.2 million in the same period in 2025.
• Net loss was $7.3 million for the three months ended September 30, 2026, compared to $6.5 million in the same period in 2025.
• For the nine months ended September 30, 2026, total operating expenses were $21.4 million compared to $20.7 million in 2025, and net loss was $20.4 million compared to $20.0 million in 2025.
• Net loss per share (basic and diluted) was $(0.08) for the three months ended September 30, 2026, compared to $(0.11) in 2025.
• Total assets were $35.3 million as of September 30, 2026, down from $39.4 million as of December 31, 2025.
• Total liabilities were $22.1 million as of September 30, 2026, down from $23.7 million as of December 31, 2025.
• Stockholders' equity was $13.2 million as of September 30, 2026, down from $15.7 million as of December 31, 2025.

Guidance and Future Outlook:

• Top-line results for the SLIM-1 Phase 1 trial of NPM-139 are anticipated to be announced in November 2026.
• Preparation and submission of an Investigational New Drug (IND) Application for NPM-139 to support a proposed Phase 2 dose-ranging study is planned for 2027.
• The transition of Cortigent into an independent, publicly traded company is expected to occur shortly after receiving final regulatory approval and completing closing and financing activities.
• ClearOne is pursuing financing to raise between $10 million and $15 million concurrently with the merger's closing.

Business Segments and Product Lines:

• Biopharm Division: Developing NPM-139, a miniature, ultra-long-acting semaglutide implant designed for chronic weight management, utilizing proprietary NanoPortal™ technology to provide six- to twelve-months of continuous drug delivery.
• Neurostimulation Division: Cortigent, a wholly owned subsidiary, is developing brain implant devices, including the Orion® cortical stimulation system with FDA Breakthrough Device designation for treating blindness caused by glaucoma and diabetic retinopathy, and technology to improve arm and hand motion recovery in stroke patients.
• SLIM-1 Trial: Full enrollment and initial dosing of 20 GLP-1 naïve participants in Australia was completed on August 6, 2026. The trial compares low-dose NPM-139 against Wegovy® to assess safety, tolerability, and pharmacokinetics.
• Novo Agreement: Signed a new agreement with Novo (formerly Novo Nordisk) on July 7, 2026, to evaluate NPM-139; the agreement contains no exclusivity provisions for NPM-139 or the NanoPortal technology.

Market and Competitive Landscape:

• Vivani positions its NanoPortal implants as unique in the GLP-1 market due to the ability to provide an "off-ramp" for discontinuation, a feature not offered by monthly or quarterly injectable candidates.
• The company targets the over 20% of current GLP-1 users who are women of child-bearing potential, citing the need for reversibility in therapy.
• Vivani aims to address medication non-adherence, which affects approximately 50% of patients taking daily pills.

Risks and Challenges:

• The Cortigent merger remains subject to final regulatory approvals.
• Forward-looking statements regarding business plans, product development, and financial runway are subject to inherent uncertainties, risks, and changes in circumstances, including unexpected costs, delays, and regulatory hurdles.
• Actual results may differ materially from anticipated plans due to factors described in the company's SEC filings, including the Form 10-Q filed August 13, 2026.

Management Commentary and Tone:

• CEO Adam Mendelsohn, PhD, described the quarter as a period of "strong progress and forward momentum."
• Management highlighted the potential for NPM-139 to improve convenience, medication adherence, and tolerability compared to existing therapies.
• The company emphasized the distinct advantage of its technology in offering reversibility, which they believe is a critical consideration for specific patient demographics.

Other Key Points:

• Vivani filed a Form 8-K on October 30, 2026, clarifying that the Cortigent merger close is expected shortly after final regulatory approval.
• The Cortigent merger involves ClearOne Inc. (Nasdaq: CRGT) and aims to establish Cortigent as a standalone company trading on the Nasdaq.
• Vivani's predecessor, Second Sight Medical Products, previously marketed Argus® II, the first FDA-approved device to treat a rare form of blindness.
• The company has no outstanding revenue as it is a clinical-stage biopharmaceutical company.
• The balance sheet shows a litigation accrual of $1.79 million as of September 30, 2026.