Vivani's NPM-119 trial on clinical hold; submits Complete Response to FDA

Vivani Medical, Inc.

FDA placed LIBERATE-1 study on clinical hold Aug 11, citing insufficient CMC information to assess human subject risks.
Vivani submitted Complete Response on Aug 25; FDA has 30 days to respond.
If hold lifted, Phase 2a trial expected to start Oct 2023, interim results 1H2024, top-line 2H2024.
If CR inadequate, timeline delayed by ~one quarter.
Cortigent subsidiary to repay $1.5M and issue $2M promissory note at 5% under amended funding agreement.

item 1.01 item 7.01 item 9.01

Key facts

Extracted from this filing and checked against the source text.

Material Agreements SEC 8-K Item 1.01/1.02 confidence 0.9

Vivani Medical, Inc. amended Amendment with Cortigent, Inc. valued at $1,500,000 (effective 2023-08-25).

Action: amendment
Agreement: credit facility
Counterparty: Cortigent, Inc.
Value: $1,500,000
Effective: 2023-08-25

Exact text from the filing

On August 25, 2023, the Company and Cortigent, Inc. ("Cortigent"), a wholly owned subsidiary of the Company entered into an Amendment 1 (the "Amendment") to the Transition Funding, Support and Services Agreement dated March 19, 2023 (the "TFSSA").

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Vivani Medical, Inc. filing history →

Source: SEC EDGAR

accession 0001753926-23-001153

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