VANINasdaqElectromedical & Electrotherapeutic ApparatusUS GAAP · USD

Vivani Medical, Inc.

Vivani Medical, Inc. is a U.S.-based biopharmaceutical company focused on miniature, ultra long-acting drug implant programs and related delivery platforms. The company also holds neuromodulation assets through its subsidiary Cortigent, which was formed from legacy Second Sight Medical Products and is being positioned as a separate business.

Kysy yhtiöstä
Liikevaihto0,0milj. USD
Liikevoitto (EBIT)−27,6milj. USD
−11,7 %v/v
Nettotulos−26,6milj. USD
−13,3 %v/v
Vapaa kassavirta−25,5milj. USD
−19,4 %v/v

Tilikausi 2025 · muutos edellisvuodesta

Kehitys 2020–2025

−30−20−100milj. USD2020: EBIT −15 milj. USD20202021: EBIT −8,9 milj. USD20212022: EBIT −21 milj. USD20222023: EBIT −27 milj. USD20232024: 0,00 milj. USD2024: EBIT −25 milj. USD20242025: 0,00 milj. USD2025: EBIT −28 milj. USD20250,00−28
LiikevaihtoLiikevoitto (EBIT)
Kysy Clarifolta: Vivani Medical, Inc.

Liiketoiminta

Osuus liikevaihdosta
Drug implant programs70 %

Preclinical and clinical-stage miniature implants designed to deliver GLP-1 therapies over long durations.

Metabolic disease candidates20 %

Implant-based therapies aimed at obesity, overweight, and type 2 diabetes indications.

Neurostimulation systems10 %

Brain implant and neuromodulation assets intended to help patients recover critical body functions.

Asiakkaat

Vivani does not sell commercial products broadly today; its direct counterparties are primarily clinical investigators, research partners, regulators, and contract development and manufacturing organizations that support product development. The eventual end customers for its implant programs are patients with chronic metabolic diseases, while Cortigent’s technologies are aimed at patients with severe neurological impairment or loss of function.

Clinical development partners

CROs, trial sites, and manufacturers that support preclinical and clinical testing of implant candidates.

Metabolic disease patients

People with obesity, overweight, or type 2 diabetes who are the intended users of GLP-1 implant therapies.

Neuromodulation patients

Patients with severe neurological conditions who may benefit from Cortigent's implantable systems.

Regulatory stakeholders

FDA and other regulators that determine whether programs can advance into and through clinical development.

Strategia

Vivani's strategy centers on advancing its miniature drug implant platform, with NPM-115, NPM-119, and NPM-139 representing the core metabolic pipeline. In parallel, the company is working to separate Cortigent into an independent public company so each business can pursue its own therapeutic focus and capital strategy.

Advance lead metabolic implant programsLyhyt aikaväli

Clinical progress is the main value driver for a development-stage company.

Separate Cortigent into a standalone companyLyhyt aikaväli

A spin-off can create two more focused businesses with distinct capital needs and strategies.

Build a broader long-acting implant portfolioKeskipitkä aikaväli

A platform approach can extend the technology beyond a single lead asset.

Maantiede

Vivani is headquartered in the United States and operates as a development-stage company with U.S.-based corporate and regulatory activity. It also established Vivani Medical Australia Pty Ltd. to support studies of its product candidates, reflecting a small but important international clinical footprint.

Riskit

Vivani faces the typical risks of a development-stage biotech company: heavy dependence on external financing, uncertain clinical outcomes, and regulatory delays. Its dual-track structure also adds execution risk because the company must advance metabolic implants while managing the separation of Cortigent and the associated legal, tax, and listing approvals.

Järjestetty vakavuuden mukaan
MatalaKohtalainenKorkeaMatalaKohtalainenKorkeaVaikutus →Todennäköisyys →Additional financing requirement1Clinical development uncertainty2Regulatory delay or hold3Third-party dependence4Cortigent spin-off execution5
Vaikutus on riskin vakavuus ja todennäköisyys sen toteutumisen todennäköisyys lähivuosina, molemmat arvioitu yhtiön raporttien perusteella. Numerot vastaavat listaa.
  1. Additional financing requirementVaikutus: KorkeaTodennäköisyys: Korkea

    Development programs consume cash before any product revenue exists, so funding access is critical.

    Kohdistuu: Company-wide development operations

  2. Clinical development uncertaintyVaikutus: KorkeaTodennäköisyys: Kohtalainen

    Preclinical and clinical programs can fail on safety, efficacy, or pharmacokinetics.

    KohdistuuNPM-115NPM-119NPM-139
  3. Regulatory delay or holdVaikutus: KorkeaTodennäköisyys: Kohtalainen

    FDA or other regulators can pause, narrow, or delay studies and commercialization.

    Kohdistuu: Clinical-stage implant programs

  4. Third-party dependenceVaikutus: KeskitasoTodennäköisyys: Kohtalainen

    CROs, manufacturers, and study sites affect trial quality, timing, and cost.

    Kohdistuu: Clinical and preclinical operations

  5. Cortigent spin-off executionVaikutus: KeskitasoTodennäköisyys: Matala

    The separation requires SEC, Nasdaq, tax, and board approvals and could be delayed or fail.

    Kohdistuu: Cortigent neuromodulation business

Kysy Clarifolta: Vivani Medical, Inc.

Kirjanpito

Harkinnanvaraiset erät
Research and development expense

Most spending is expensed as incurred, so trial timing directly affects reported results.

Vaikutus: Clinical progress changes quarterly expense levels

Stock-based compensation

Non-cash awards affect operating expense and require valuation assumptions.

Vaikutus: Can materially affect G&A and R&D expense

Grant accounting

NIH or similar grants may be recorded as reductions to operating expense.

Vaikutus: Offsets development spend and affects comparability

Consolidation and spin-off accounting

Cortigent remains consolidated until separation, which affects assets, liabilities, and disclosures.

Vaikutus: Spin-off timing can change reported structure and balances

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Päivitetty: 24.9.2026