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UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, DC 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): September 23, 2022

 

VIVANI MEDICAL, INC. 

(Exact name of registrant as specified in its charter)

 

California   001-36747   02-0692322

(State or other jurisdiction of

incorporation)

 

(Commission

File Number)

 

(IRS Employer

Identification No.)

 

 

5858 Horton Street, Suite 280

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

Warrants

 

VANI

VANIW

  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 7.01REGULATION FD DISCLOSURE

 

Vivani Medical, Inc. (“Vivani” or the “Company”), will make presentations at investment conferences (“Conferences”). A copy of a slide presentation that Adam Mendelsohn, Chief Executive Officer, Brigid Makes, Chief Financial Officer, and Don Dwyer, Chief Business Officer, intend to use (the “Presentation Materials”) during the Conferences is attached to this Current Report on Form 8-K as Exhibit 99.1, and is incorporated by reference herein.  The Presentation Materials speak as of the date of this Current Report on Form 8-K. While Vivani may elect to update the Presentation Materials in the future or reflect events and circumstances occurring or existing after the date of this Current Report on Form 8-K, Vivani 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

 

Exhibit No. Description

 

99.1 Presentation Materials dated September 23, 2022.

 

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.
     
Date: September 23, 2022 By:  /s/ Donald Dwyer
    Donald Dwyer
    Chief Business Officer

 

 

 

 

Exhibit 99.1

 

Vivani Medical, Inc. combination of Nano Precision Medical and Second Sight Medical Products Nasdaq: VANI September 22, 2022

 

 

Disclaimers The following slides and any accompanying oral presentation contain forward - looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, which are intended to be covered by the “s afe harbor” created by those sections. All statements in this release that are not based on historical fact are “forward looking statements.” These sta tements may be identified by words such as “estimates,” “anticipates,” “projects,” “plans” or “planned,” “strategy,” “goal,” “seeks,” “may,” “will,” “expe cts ,” “intends,” “believes,” “should,” and similar expressions, or the negative versions thereof, and which also may be identified by their context. All statements that ad dress operating performance or events or developments that Vivani Medical, Inc. (“Vivani”, the “Company”, “we” or “us) expects or anticipates will occur in the future, such as stated objectives or goals, our product candidates and their therapeutic potential and planned development, the indications that we intend to t arg et, our technology, our business and strategy, milestones, addressable markets, or that are not otherwise historical facts, are forward - looking statemen ts. While management has based any forward - looking statements included in this presentation on its current expectations, the information on which such ex pectations were based may change. Forward - looking statements involve inherent risks and uncertainties which could cause actual results to differ materiall y from those in the forward - looking statements as a result of various factors. These risks and uncertainties include, but are not limited to, that we may fail to complete any required pre - clinical activities for NPM - 119 or otherwise commence our planned Phase 2 trial for this candidate; conduct any pre - clinical act ivities of our other product candidates; our product candidates may not demonstrate safety or efficacy in clinical trials; we may fail to secure marketing ap provals for our product candidates; there may be delays in regulatory approval or changes in regulatory framework that are out of our control; our es tim ation of addressable markets of our product candidates may be inaccurate; we may fail to timely raise additional required funding; more efficient competit ors or more effective competing treatment may emerge; we may be involved in disputes surrounding the use of our intellectual property crucial to our success; we may not be able to attract and retain key employees and qualified personnel; earlier study results may not be predictive of later stage study outcomes; and we are dependent on third - parties for some or all aspects of our product manufacturing, research and preclinical and clinical testing. Additional risks and uncertainties are described in our Annual Report on Form 10 - K filed on March 29, 2022, and in the Company’s Forms 10 - K/A filed on May 2, 2022, S - 4 filed on May 13, 2022, 10 - Q filed on May 16, 2022, and 10 - Q filed on August 12, 2022, and as thereafter amended. We urge you to consider those risks and uncertainties in evaluating our forward - looking statements. We caution readers not to place undue reliance upon any such forward - looking statements, which speak only as of the date made. Except as otherwise required by the federal securities laws, we disclaim any obligation or undertaking to publicly release any updat es or revisions to any forward - looking statement contained herein (or elsewhere) to reflect any change in our expectations with regard thereto, or any chang e i n events, conditions, or circumstances on which any such statement is based. Certain information contained in this presentation relates to or is based on studies, publications, surveys and other data obtained from third party sources and the Company’s own internal estimates and research. While we believe thes e t hird - party sources to be reliable as of the date of this presentation, we have not independently verified, and make no representation as to the adequa cy, fairness, accuracy or completeness of, any information obtained from third - party sources. Finally, while we believe our own internal research is relia ble, such research has not been verified by any independent source. All of our therapies are still investigational and have not been approved by any regulato ry authority for any use. 2

 

 

3 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 NPM 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

 

 

Vivani Medical, Inc. 4 BioPharm Division (formerly Nano Precision Medical) develops drug implant candidates to address medication non - adherence, a leading cause of poor clinical outcomes, leveraging its proprietary NanoPortal technology. NPM - 119 (GLP - 1 implant) is the priority focus of Vivani. Neuromodulation Division (formerly Second Sight Medical Products) develops highly innovative medical implant candidates to treat blindness. Vivani is assessing strategic options for the development of an improved, follow - on device candidate, Orion II. Combination of two operating companies developing drug and device implant candidates intended to treat conditions with high unmet medical need. Vivani is well - positioned with new leadership and sufficient capital to support multiple milestones for NPM - 119 while assessing strategic options for Orion II.

 

 

Combined 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 >$1B SSMP NPM - 159*** proprietary compound NPM - 139*** proprietary compound ORION visual prosthesis 5 Nano Precision Medical OKV - 119** exenatide

 

 

Biopharm Division Drug Implants Proprietary Platform Technology

 

 

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

 

 

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

 

 

Minimized Implant Size Extendable Implant Duration Tunable Delivery Rate Tunable Delivery Profile 9 NanoPortal TM is a Platform Technology Broad Potential Application Can Support Portfolio of New Drug Implants

 

 

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

 

 

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 • 5 months of in vivo pre - clinical verification; 6 - month product candidate in development • 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): 11

 

 

2013 2014 2015 2016 2017 2018 2019 2020 2021 2022 2023 2024 2025 2026 25 20 15 10 5 0 12 Expected 2026 ~$23B GLP - 1 Market Opportunity* World - wide Sales ($Billions) * Evaluate Pharma 08 June 2021

 

 

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 13 * NPM - 119 - investigational candidate, not approved in any market * NPM - 119 designed to enable 100% adherence. Real - World Adherence of Select Drugs

 

 

• 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* 14 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

 

 

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 resolution actions, FDA denied Intarcia’s request for public hearing Value of long - term GLP - 1 (exenatide) implant externally validated previously 15 * CRL: Complete Response Letter – issued by FDA to identify NDA deficiencies

 

 

(Intarcia) • FDA has concerns about daily variations in release • 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) 16

 

 

NPM - 119 Clinical and Regulatory Pathway

 

 

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 Low Dose (N=20) NPM - 119 High Dose (N=20) Bydureon BCise 2mg/week (N=20) 18 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

 

 

NPM - 119 Clinical + Regulatory Development Near - Term Plan 19 Year(s) Milestone Status 2020 FDA Pre - IND Meeting Completed 4Q2022 / 1Q2023 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 more expeditious pathway to FDA approval. Next Expected Milestones: File NPM - 119 Investigational New Drug (IND) application in 4Q2022 / 1Q2023 Deliver top - line LIBERATE - 1 data in 2H2023

 

 

Neuromodulation Division ORION II Neurostimulation Implant Technology to Treat Blindness

 

 

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 21 • Patient Preference Study – Part two – defines safety endpoints for approval; in preparation • New Leadership Team is developing strategic options for advancing Orion II

 

 

Vivani Medical, Inc. Financial Information

 

 

Vivani Medical, Inc. Pro - Forma P&L Statement 23 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, 2022 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)

 

 

Vivani Medical, Inc. Vivani Medical, Inc. Pro - forma Balance Sheet 24 ($ 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)

 

 

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 25

 

 

Vivani Medical, Inc. 26 BioPharm Division (formerly Nano Precision Medical) develops drug implant candidates to address medication non - adherence, a leading cause of poor clinical outcomes, leveraging its proprietary NanoPortal technology. NPM - 119 (GLP - 1 implant) is the priority focus of Vivani. Neuromodulation Division (formerly Second Sight Medical Products) develops highly innovative medical implant candidates to treat blindness. Vivani is assessing strategic options for the development of an improved, follow - on device candidate, Orion II. Combination of two operating companies developing drug and device implant candidates intended to treat conditions with high unmet medical need. Vivani is well - positioned with new leadership and sufficient capital to support multiple milestones for NPM - 119 while assessing strategic options for Orion II.