# EDGAR Filing Document

**Accession Number:** 0001266806
**File Stem:** 0001753926-23-000173
**Filing Date:** 2023-2
**Character Count:** 20722
**Document Hash:** 7933079c7d26e6eabac5ebc7b88be797
**Contains OCR:** False
**Source Format:** 

## Filing Content

## Filing Summary
**0001753926-23-000173.hdr.sgml**: 20230217

**ACCESSION NUMBER**: 0001753926-23-000173

**CONFORMED SUBMISSION TYPE**: 8-K

**PUBLIC DOCUMENT COUNT**: 41

**CONFORMED PERIOD OF REPORT**: 20230216

**ITEM INFORMATION**: Regulation FD Disclosure

**ITEM INFORMATION**: Financial Statements and Exhibits

**FILED AS OF DATE**: 20230217

**DATE AS OF CHANGE**: 20230217

**FILER**: 

**COMPANY DATA:**
- **COMPANY CONFORMED NAME:** Vivani Medical, Inc.
- **CENTRAL INDEX KEY:** 0001266806
- **STANDARD INDUSTRIAL CLASSIFICATION:** ELECTROMEDICAL & ELECTROTHERAPEUTIC APPARATUS [3845]
- **IRS NUMBER:** 000000000
- **STATE OF INCORPORATION:** CA
- **FISCAL YEAR END:** 1231

**FILING VALUES:**
- **FORM TYPE:** 8-K
- **SEC ACT:** 1934 Act
- **SEC FILE NUMBER:** 001-36747
- **FILM NUMBER:** 23640202

**BUSINESS ADDRESS:**
- **STREET 1:** 5858 HORTON STREET, SUITE 280
- **CITY:** EMERYVILLE
- **STATE:** CA
- **ZIP:** 94608
- **BUSINESS PHONE:** 818-833-5000

**MAIL ADDRESS:**
- **STREET 1:** 5858 HORTON STREET, SUITE 280
- **CITY:** EMERYVILLE
- **STATE:** CA
- **ZIP:** 94608

**FORMER COMPANY:**
- **FORMER CONFORMED NAME:** SECOND SIGHT MEDICAL PRODUCTS INC
- **DATE OF NAME CHANGE:** 20031010

?xml version="1.0" encoding="utf-8"?

**UNITED STATES**

**SECURITIES AND EXCHANGE COMMISSION**

**WASHINGTON, D.C. 20549**

**FORM 8-K**

**CURRENT REPORT**

**Pursuant to Section 13 OR 15(d) of The Securities Exchange Act of 1934**

Date of Report (Date of earliest event reported): February 16, 2023

**VIVANI MEDICAL, INC.** 

(Exact name of registrant as specified in its charter)

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| | | |
|:---|:---|:---|
| **California** | **001-36747** | **02-0692322** |
| (State or other jurisdiction of<br> incorporation) | (Commission<br> File Number) | (IRS Employer<br> Identification No.) |

---

---

| | |
|:---|:---|
| **5858 Horton Street,Suite 280**<br> **Emeryville, California** | **94608** |
| (Address of principal executive offices) | (Zip Code) |

---

Registrant's telephone number, including area code: **(818) 833-5000**

(Former name or former address, if changed since last report.)

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:

☐ Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

☐ Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

☐ Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

☐ Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

Securities registered pursuant to Section 12(b) of the Act:

---

| | | |
|:---|:---|:---|
| Title of each class | Trading Symbol(s) | Name of each exchange on which registered |
| Common Stock | VANI | Nasdaq Capital Market |

---

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).

Emerging growth company ☐

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐

**Item 7.01**. **Regulation FD Disclosure**

Vivani Medical, Inc. (the "Company") from time to time presents and/or distributes to the investment community at various industry and other conferences slide presentations to provide updates and summaries of its business. These slides are attached to this Current Report on Form 8-K as Exhibit 99.1 and are incorporated by reference herein. The Company is also posting to the "Investors" portion of its website a copy of its current corporate slide presentation. The slides speak as of the date of this Current Report on Form 8-K. While the Company may elect to update the slides in the future or reflect events and circumstances occurring or existing after the date of this Current Report on Form 8-K, the Company specifically disclaims any obligation to do so. The information contained in this Item 7.01 and Exhibit 99.1 hereto shall not be deemed "filed" for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the "Exchange Act"), or incorporated by reference in any filing under the Securities Act of 1933, as amended, or the Exchange Act, except as shall be expressly set forth by reference in such a filing.

**Item 9.01 Financial Statements and Exhibits.**

(d) *<u>Exhibits</u>*.

---

| | |
|:---|:---|
| **Exhibit No.** | **Description** |
| [99.1](g083416_ex99-1.htm) | [Corporate Slides, dated February 16, 2023](g083416_ex99-1.htm) |
| 104 | The cover page of this Current Report on Form 8-K, formatted in Inline XBRL. |

---

**SIGNATURE** 

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

---

| | | |
|:---|:---|:---|
|  | **VIVANI MEDICAL, INC.** | **VIVANI MEDICAL, INC.** |
| Date: February 16, 2023 | By: | /s/ Donald Dwyer |
|  |  | Donald Dwyer |
|  |  | Chief Business Officer |

---

## Exhibit 99.1

**Exhibit 99.1**

![](img001.jpg)

Vivani Medical, Inc. Guaranteed Adherence. Better Outcomes. Nasdaq: VANI February 16, 2023 www.vivani.com +

![](img002.jpg)

![](img003.jpg)

Vivani Executive Leadership Team • Co - founder/Co - inventor of Nano Precision Medical technology • PhD Bioengineering (UCSF/UC Berkeley) • Management of Technology Certificate at Haas School of Business • Research focused on diabetes treatment • Formerly at Boston Scientific and Minimed Adam Mendelsohn PhD – CEO/Director • Numerous COO and Executive Positions at Device and Drug - Device Companies, including: • COO at Dance Biopharm , COO at Avid Bio • Exec VP at Prima Biomed, Sr. VP at Nektar Therapeutics (responsible for Exubera approval), and Worldwide VP at Johnson & Johnson Truc Le, MBA – Chief Operations Officer • Former Chief Medical Officer for Eiger BioPharmaceuticals and Dance BioPharm • Former VP of Medical Development for Amylin • Former Director at GSK, Global Head of Clinical Strategy for Avandia • Former Board member of ViaCyte , Inc. Lisa Porter, MD – Chief Medical Officer • Former Sr. VP and CFO Miramar Labs • Former Sr. VP and CFO AGA Medical • Former CFO Nektar Therapeutics, OraVax and Haemonetics • Current Board director: Quantun - Si, Aziyo and Mind Medicine • Involved in/Directed 2 IPOs, 2 reverse mergers and 1 SPAC Brigid Makes MBA – Chief Financial Officer • Former Executive Director at AstraZeneca with leadership roles in drug development, commercial and business development • Former Nano Precision Medical Board observer for AZ • Former PhaseBio Board observer for AZ (prior to IPO) • Former Director at Cephalon and Rhone Poulenc Rorer Don Dwyer, MBA – Chief Business Officer 3

![](img004.jpg)

Vivani Medical, Inc. B iopharm Division (formerly Nano Precision Medical) develops tiny, drug implants that provide therapeutic levels of medicine over extended periods of time, guaranteeing medication adherence. NPM - 119 (6 - month GLP - 1 implant candidate for Type 2 Diabetes) is Vivani's main focus. Neuromodulation Division (formerly Second Sight Medical Products) develops highly innovative medical implant candidates to treat blindness. Vivani is assessing strategic options for advancing Orion II, a cortical visual prosthesis designed to treat profound blindness. An innovative, clinical - stage, biopharmaceutical company that develops and manufactures novel, long - term therapeutic implants to treat chronic diseases. Vivani is well - positioned with new leadership and sufficient capital to support multiple milestones for NPM - 119 while assessing strategic options for Orion II. 4

![](img005.jpg)

Company Pipeline If Approved, Vivani Candidates will Compete in Markets with Large Potential \* Estimated Market Sizes where Vivani candidates would compete, if approved; Does not represent future sales or revenue estim ate s of Vivani candidates \*\* In Partnership with Okava Pharmaceuticals, Inc. \*\*\* Feasibility in progress with a non - exenatide compound in collaboration with a major pharma company Indication Feasibility Pre - Clinical Clinical Market Size\* Human Type II Diabetes Feline Pre - Diabetes & Diabetes NASH (Non - Alcoholic Steatohepatitis) Human Obesity Profound Blindness NPM - 119 exenatide >$20B >$500M >$18B >$19B >$4B Neuro NPM - 159\*\*\* proprietary compound NPM - 139\*\*\* proprietary compound ORION visual prosthesis Biopharm OKV - 119\*\* exenatide 5

![](img006.jpg)

Biopharm Division Drug Implants Proprietary Platform Technology

![](img007.jpg)

Potential application with many molecular types Designed to Assure Adherence Minimally - fluctuating and tunable delivery profiles NanoPortal: Innovative Delivery Technology Drug Reservoir Nanotube Membrane 7

![](img008.jpg)

By precisely adjusting nanotubes to molecule size, interactions between drug and nanotube walls can result in desirable release profiles over time, including near constant release NanoPortal : How it Works... Pore too small: No release Pore target size: Near constant release Pore too large: Burst release 8

![](img009.jpg)

0 20 40 60 80 100 120 98.0 98.5 99.0 99.5 100.0 Release - Rate (ug/Day)\* Time (days) Minimal Fluctuations with 2.5 - hour interval sampling Near - Constant and Minimally - Fluctuating Release \*Release - rates include exenatide and related substances. Day 1 timepoint includes cumulative release over the first day including a separately measured 1 st hour of release, which was ~7 µg for the high - dose and ~4 µg for the low - dose. 9 Fluctuations during each 2.5 - hour interval are within measurement error 2.5 - hour interval 0 20 40 60 80 100 120 0 30 60 90 Release - Rate (µ g/day)\* Time (days) High-Dose (n=6) Low-Dose (n=6)

![](img010.jpg)

Minimized Implant Size Extendable Implant Duration Tunable Delivery Rate Tunable Delivery Profile NanoPortal TM is a Platform Technology Broad Potential Application Can Support Portfolio of New Drug Implants 10

![](img011.jpg)

Targeting the Rapidly Growing GLP - 1 RA Market $13B in 2020 & $23B Expected in 2026 Vivani's Lead Program NPM - 119

![](img012.jpg)

1 Guo 2016 2 Carls et al., 2017 3 IMS 2013 Report • Non - adherence is the primary reason for low, real - world effectiveness 1,2 • Guaranteed adherence will produce significant healthcare cost savings 3 • FDA indicated 505(b)(2) streamlined approval pathway may be available • ~$54M raised pre - merger from investors including AstraZeneca 6 - Month Exenatide (Glucagon - like Peptide 1 Receptor Agonist) Implant for Type 2 Diabetes Lead Product (NPM - 119): 12

![](img013.jpg)

2013 2014 2015 2016 2017 2018 2019 2020 2021 2022 2023 2024 2025 2026 25 20 15 10 5 0 Expected 2026 ~$23B GLP - 1 Market Opportunity\* World - wide Sales ($Billions) \* Evaluate Pharma 08 June 2021 13

![](img014.jpg)

Januvia Trulicity Invokana NPM - 119\* 100% 75% 50% 25% 0% DPP - 4 inhibitors, daily pills Polonsky et al.,2016 GLP - 1 weekly injections Modyet al., 2018 SGLT - 2 daily pills Cai et al., 2017 GLP - 1 implant every 6 months • Orals and injectables do not guarantee adherence • Approximately 50% of patients do not meet glycemic targets primarily due to adherence NPM - 119 Designed to Enable 100% Adherence through Implant Duration Dual Incentive to Adopt Technology that Improves Adherence • Pharmaceutical revenue is increased • Healthcare costs are decreased Current Drug Adherence Challenge " Drugs don't work in people that don't take them" Real - world Adherence \* NPM - 119 - investigational candidate, not approved in any market \* NPM - 119 designed to enable 100% adherence. Real - World Adherence of Select Drugs 14

![](img015.jpg)

• Varying levels of adherence are associated with different health outcomes • Different health outcomes may not be attributable to drug substance alone • The American Diabetes Association (ADA) Standard of Care guidelines encourage treatment options that address adherence Guaranteed adherence is expected to deliver improved health outcomes Drug Substance + Administration = Drug Product NPM - 119\* Drug Substance Drug Product Administration Weekly Injection 6 - Month Implant Weekly Injection Weekly Injection Daily Pill exenatide (GLP - 1 Receptor Agonist) dulaglutide (GLP - 1 Receptor Agonist) semaglutide (GLP - 1 Receptor Agonist) exenatide (GLP - 1 Receptor Agonist) \* NPM - 119 - investigational candidate, not approved in any market 15

![](img016.jpg)

Intarcia's ITCA 650 (6 - month exenatide implant) may be a relevant value analog for NPM - 119 2014 – Intarcia signed ITCA 650 deal with Servier (excluding US + Japan) $171M up - front, $880M milestones, and double - digit royalties Financings valued Intarcia as high as $4.0B (2017) Intarcia's lead program was ITCA 650 2016 – Intarcia filed initial ITCA 650 New Drug Application (NDA) 2017 – FDA issued the first ITCA 650 CRL\* (cited manufacturing concerns) 2019 – Intarcia re - submitted ITCA 650 NDA 2020 – FDA issued second ITCA 650 CRL (cited clinical safety and device constituent concerns) 2022 – After multiple dispute resolutions, FDA proposes to deny Intarcia's public hearing request 2023 – FDA Chief Scientist communicates willingness to grant public hearing to Intarcia Value of long - term GLP - 1 (exenatide) implant externally validated previously \* CRL: Complete Response Letter – issued by FDA to identify NDA deficiencies 16

![](img017.jpg)

(Intarcia) • FDA has concerns about daily variations in release being responsible for clinical safety issues • Larger Device (4mm x 45mm) • Insertion using larger 6 - gauge needle • Minimally fluctuating release profile observed in pre - clinical studies • Smaller Device (2.2mm x 21.5mm) • Insertion using smaller 11 - gauge needle NPM - 119 well - positioned to avoid Intarcia's device technology challenges NanoPortal TM Osmotic Pump (NPM) 17

![](img018.jpg)

6 - Month NPM - 119 Preclinical Proof - of - Concept Achieved EC 50 \* Exenatide antibody - positive animals are not included in this data set. \*\*2 of 6 implants are responsible for higher Day 1 exenatide concentrations. Additional optimization ongoing to yield consis ten t gradual initial PK profiles. Implants removed. \*\* 0 100 200 300 400 500 600 700 0 2 4 6 8 10 12 14 16 0 30 60 90 120 150 Exenatide Plasma Concentration in 85 kg Human (pg /mL) Exenatide Plasma Concentration Normalized to 250g Rats (ng/mL) Time from initial initiation (days) 6-Month NPM-119 Prototype (n=6) 18

![](img019.jpg)

NPM - 119 Clinical and Regulatory Pathway

![](img020.jpg)

Proposed First in Human Trial: LIBERATE - 1 Randomize 12 Weeks Key Inclusion/Exclusion Criteria • T2DM and HbA1c ≥6.5% and <10.0% • On non - exenatide GLP - 1 therapy (discontinued upon enrollment) • May be taking their GLP - 1 in combination with up to 2 of the following: metformin, TZD, SGLT - 2 inhibitor, or DPP - 4 inhibitor • Excluded: SU, insulin NPM - 119 (N=32) Bydureon BCise 2mg/week (N=16) Primary Objectives: Safety/tolerability assessment and full PK characterization Secondary Objective: Evaluate change from baseline in glycemic control (HbA1c) T2DM: Type 2 Diabetes Mellitus; TZD: Thiazolidinedione; SGLT - 2: Sodium - glucose cotransporter - 2; DPP - 4: Dipeptidyl peptidase 4; S U: Sulfonylurea 20

![](img021.jpg)

NPM - 119 Clinical + Regulatory Development Near - Term Plan Year(s) Milestone Status 2020 FDA Pre - IND Meeting Completed 1H2023 File IND to support Ph 2 (LIBERATE - 1) clinical study On - Track 2023 Deliver LIBERATE - 1 top - line results Projected We expect to utilize the 505(b)(2) pathway, which permits submissions to rely, in part, on the safety and effectiveness of a previously approved product, which may potentially result in a significantly more expeditious and cost - effective pathway to FDA approval than is typically required for new diabetes therapeutics. Progress towards IND - enabling activities: • Development of NPM - 119 to be used in LIBERATE - 1 is complete • Recent extensive studies have confirmed excellent biocompatibility of NPM - 119's device constituent • NPM - 119 was well tolerated in a preclinical GLP toxicology study • IND - enabling data is complete • GMP production of LIBERATE - 1 clinical supplies is underway 21

![](img022.jpg)

Neuromodulation Division ORION II Neurostimulation Implant Technology to Treat Blindness

![](img023.jpg)

Orion II Current Activities and Future Considerations • Initial clinical pilot study at UCLA and Baylor College of Medicine; 3 - year data encouraging • Confirming regulatory pathway with FDA • Patient Preference Study – Part one – informs potential adoption; encouraging results obtained • Market Access, Reimbursement and Long - term Support Programs critical for long - term success • Patient Preference Study – Part two – defines safety endpoints for approval; in preparation • New Leadership Team is developing strategic options for advancing Orion II 23

![](img024.jpg)

Vivani Medical, Inc. Financial Information

![](img025.jpg)

Vivani Medical, Inc. Pro - Forma P&L Statement Historical Pro forma Pro forma ($ in 000s) Second Sight NPM adjustments combined For the six months ended June 30, 2022: Net sales $- $- $- $- Cost of sales - - - Gross profit - - - Total operating expenses 5,345 7,995 (1,615) 11,725 Loss from operations $(5,345) $(7,995) $1,615 $(11,725) Loss per share on a pro forma basis (0.23)$ For the year ended December 31, 2021: Net sales $- $- $- $- Gross profit 130 - 130 Total operating expenses 9,063 13,323 2,154 24,540 Loss from operations $(8,933) $(13,323) $(2,154) $(24,410) Loss per share on a pro forma basis (0.55)$(The unaudited pro forma condensed combined financial information was derived from, and should be read in conjunction with, the Exhibit 99.3 included in Form 8-K filed with the SEC on September 2, 2022) 25

![](img026.jpg)

Vivani Medical, Inc. Vivani Medical, Inc. Pro - forma Balance Sheet ($ in 000s) Combined Second Sight NPM Merger pro forma For the Period ending June 30, 2022 Historical Historical adjustments as adjusted Assets Cash and cash equivalents $56,377 $3,450 $(1,624) $58,203 Other assets 9,272 2,967 (8,000) 4,239 Total assets $65,649 $6,417 $(9,624) $62,442 Liabilities and Stockholders' equity Current liabilities $2,591 $2,905 $(984) $4,512 SAFE - 8,000 (8,000) - Long-term liabilities - 328 - 328 Total liabilities 2,591 11,233 (8,984) 4,840 Stockholders' Equity Common stock and APIC 397,355 62,109 (340,080) 119,384 Other comprehensive income (424) - 424 - Accumulated deficit (333,873) (66,925) 339,016 (61,782) Total equity 63,058 (4,816) (640) 57,602 - Total liabilities and equity $65,649 $6,417 $(9,624) $62,442 (The unaudited pro forma condensed combined financial information was derived from, and should be read in conjunction with, the Exhibit 99.3 included in Form 8-K filed with the SEC on September 2, 2022) 26

![](img027.jpg)

As of August 30, 2022 Name Common (CS) Options Outstanding (1) Common Warrants (2) Total Shares, Options & Warrants Total Shares Outstanding 50,726,329 4,609,642 10,310,539 65,646,510 Total Restricted Shares (Locked- up 180 Days) 21,942,231 2,214,791 9,310,573 33,467,595 Unrestricted Shares 28,784,098 2,394,850 999,966 32,178,915 % Total Restricted Shares 43.3% 48.0% 90.3% 51.0% Capitalization Table (1) 795K outstanding stock options unvested (2) 2.564M Common Warrants underwater and expire March 2024. VIVANI MEDICAL,INC Vivani Medical, Inc. Post Merger Cap Table 27

![](img028.jpg)

Vivani Medical, Inc. B iopharm Division (formerly Nano Precision Medical) develops tiny, drug implants that provide therapeutic levels of medicine over extended periods of time, guaranteeing medication adherence. NPM - 119 (6 - month GLP - 1 implant candidate for Type 2 Diabetes) is Vivani's main focus. Neuromodulation Division (formerly Second Sight Medical Products) develops highly innovative medical implant candidates to treat blindness. Vivani is assessing strategic options for advancing Orion II, a cortical visual prosthesis designed to treat profound blindness. An innovative, clinical - stage, biopharmaceutical company that develops and manufactures novel, long - term therapeutic implants to treat chronic diseases. Vivani is well - positioned with new leadership and sufficient capital to support multiple milestones for NPM - 119 while assessing strategic options for Orion II. 28