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Item 7.01. Regulation FD Disclosure
Vivani Medical, Inc. (the “Company”), will make presentations at the ThinkEquity Investor Conference described in item 8.01 below (the “Conference”). A copy of a slide presentation that Adam Mendelsohn, Chief Executive Officer and Brigid Makes, Chief Financial Officer intend to use (the “Presentation Materials”) during the Conference 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 the Company 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, 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 8.01 Other Events
The Company will present at the upcoming ThinkEquity investor conference at 11:00 am EDT at the Mandarin Oriental in New York on October 26, 2022. Dr. Adam Mendelsohn, CEO, will present a company overview and Brigid Makes, CFO, will join in hosting one-on-one meetings with investors during the conference. The presentation can be accessed live here: https://wsw.com/webcast/tep23/vani/1674436. A replay of the presentation will be available at www.vivani.com.
The Company issued a press release entitled Vivani Medical to Present at the ThinkEquity Investor Conference, which is attached to this Current Report as Exhibit 99.2.
Item 9.01 Financial Statements and Exhibits.
|99.1||Presentation Materials Dated October 17, 2022|
|99.2||Press Release entitled Vivani Medical to Present at the ThinkEquity Investor Conference dated October 17, 2022.|
|104||The cover page of this Current Report on Form 8-K, formatted in Inline XBRL.|
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: October 17, 2022||By:||/s/ Donald Dwyer|
|Chief Business Officer|
Vivani Medical, Inc. combination of Nano Precision Medical and Second Sight Medical Products Nasdaq: VANI October 17, 2022 www.vivani.com
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 "safe harbor" created by those sections. All statements in this release that are not based on historical fact are "forward looking statements." These statements may be identified by words such as "estimates," "anticipates," "projects," "plans" or "planned," "strategy," “goal," "seeks," "may," "will," "expects," "intends," "believes," "should," and similar expressions, or the negative versions thereof, and which also may be identified by their context. All statements that address 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 target, our technology, our business and strategy, milestones, addressable markets, or that are not otherwise historical facts, are forward-looking statements. While management has based any forward-looking statements included in this presentation on its current expectations, the information on which such expectations were based may change. Forward-looking statements involve inherent risks and uncertainties which could cause actual results to differ materially 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 activities of our other product candidates; our product candidates may not demonstrate safety or efficacy in clinical trials; we may fail to secure marketing approvals for our product candidates; there may be delays in regulatory approval or changes in regulatory framework that are out of our control; our estimation of addressable markets of our product candidates may be inaccurate; we may fail to timely raise additional required funding; more efficient competitors 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 updates or revisions to any forward-looking statement contained herein (or elsewhere) to reflect any change in our expectations with regard thereto, or any change in 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 these third-party sources to be reliable as of the date of this presentation, we have not independently verified, and make no representation as to the adequacy, fairness, accuracy or completeness of, any information obtained from third-party sources. Finally, while we believe our own internal research is reliable, such research has not been verified by any independent source. All of our therapies are still investigational and have not been approved by any regulatory 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 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.
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 estimates 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 NanoPortalTM 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 effectiveness1,2 •Guaranteed adherence will produce significant healthcare cost savings3 •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 NanoPortalTM Osmotic Pump (NPM) 16
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. 17 ** 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)
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) 19 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 20 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. Progress towards IND-enabling activities: •Development of both low dose and high dose versions 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 •GMP production of LIBERATE-1 clinical supplies is underway
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 22 •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 24 HistoricalPro formaPro forma($ in 000s)Second SightNPMadjustmentscombinedFor 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)
Vivani Medical, Inc. Vivani Medical, Inc. Pro-forma Balance Sheet 25 ($ in 000s)CombinedSecond SightNPM Merger pro formaFor the Period ending June 30, 2022HistoricalHistorical adjustmentsas adjustedAssetsCash and cash equivalents $ 56,377 $ 3,450 $ (1,624) $ 58,203 Other assets9,272 2,967 (8,000) 4,239 Total assets $ 65,649 $ 6,417 $ (9,624) $ 62,442 Liabilities and Stockholders' equityCurrent liabilities $ 2,591 $ 2,905 $ (984) $ 4,512 SAFE- 8,000 (8,000) - Long-term liabilities- 328 - 328 Total liabilities2,591 11,233 (8,984) 4,840 Stockholders' EquityCommon stock and APIC397,355 62,109 (340,080) 119,384 Other comprehensive income(424) - 424 - Accumulated deficit(333,873) (66,925) 339,016 (61,782) Total equity63,058 (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 (Lockedup 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 26
Vivani Medical, Inc. 27 Biopharm 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.
FOR IMMEDIATE RELEASE
Vivani Medical to Present at the ThinkEquity Investor Conference
EMERYVILLE, Calif. – (BUSINESS NEWSWIRE) – Oct. 17, 2022 – Vivani Medical, Inc. (NASDAQ: VANI) (the “Company” or “Vivani”), an innovative, clinical-stage biopharmaceutical company that develops novel, long-term therapeutic implants, announced today that it will present at the upcoming ThinkEquity investor conference at 11:00 am EDT at the Mandarin Oriental in New York on October 26, 2022.
Dr. Adam Mendelsohn, CEO, will present a company overview and Brigid Makes, CFO, will join in hosting one-on-one meetings with investors during the conference.
The presentation can be accessed live here: https://wsw.com/webcast/tep23/vani/1674436. A replay of the presentation will be available at www.vivani.com.
About Vivani Medical, Inc.
Leveraging its proprietary NanoPortal platform, Vivani Medical develops biopharmaceutical implants designed to deliver drug molecules steadily over extended periods of time, with the goal of guaranteeing patient adherence to their medication. Vivani’s lead program, NPM-119, is a tiny, 6-month GLP-1 implant under investigation for the treatment of patients with Type 2 diabetes. NPM-119 can provide patients the opportunity to realize the full potential benefit of their medication while avoiding the hassles associated with the daily or weekly administration of oral and injectable products. Medication non-adherence occurs when patients do not take their medication as prescribed. This affects an alarming number of patients, approximately 50%, including those taking daily pills. Medication non-adherence is a primary reason why Type 2 diabetes treatments face significant challenges in achieving positive real-world effectiveness.
Vivani represents the August 2022 merger of Second Sight Medical Products, Inc., and Nano Precision Medical, Inc. NPM-119 is being developed within Vivani’s Biopharm Division (formerly Nano Precision Medical, Inc.). An IND for NPM-119 remains on track for filing around the end of this year to support initiation of a Phase 2 clinical study called LIBERATE-1. Vivani is also developing a portfolio of innovative, highly differentiated, new drug product candidates leveraging its proprietary NanoPortal implant technology, which has potential application across a broad range of compounds.
Vivani’s Neuromodulation Division (formerly Second Sight Medical Products) has developed, manufactured, and marketed implantable visual prosthetics that are intended to deliver useful artificial vision to blind individuals. Vivani is currently assessing strategic options for advancing Orion II, a visual prosthetic device designed to treat profound blindness.
This press release contains certain “forward-looking statements” within the meaning of the “safe harbor” provisions of the US Private Securities Litigation Reform Act of 1995. Forward-looking statements can be identified by words such as: “target,” “believe,” “expect,” “will,” “may,” “anticipate,” “estimate,” “would,” “positioned,” “future,” and other similar expressions that in this press release, including statements regarding our business, product candidates, including the therapeutic potential thereof and the planned development therefor, technology and strategy. Forward-looking statements are neither historical facts nor assurances of future performance. Instead, they are based only on our current beliefs, expectations, and assumptions. Because forward-looking statements relate to the future, they are subject to inherent uncertainties, risks and changes in circumstances that are difficult to predict and many of which are outside of our control. Actual results and outcomes may differ materially from those indicated in the forward-looking statements. Therefore, you should not rely on any of these forward-looking statements. Important factors that could cause actual results and outcomes to differ materially from those indicated in the forward-looking statements include, among others, risks related to the development and commercialization of our product candidates, including NPM-119; delays and changes in applicable laws, regulations and guidelines including potential delays in submitting required regulatory applications to the U.S. Food and Drug Administration (“FDA”); risks related to the initiation, enrollment and conduct of our planned clinical trials and the results therefrom; our history of losses and our ability to achieve or sustain profitability in the future; and the impact of COVID-19 on our business. There may be additional risks that the Company considers immaterial, or which are unknown. A further list and description of risks and uncertainties can be found in the Company’s most recent Annual Report on Form 10-K, and any subsequent quarterly filings on Form 10-Q filed with the Securities and Exchange Commission (the “Commission”), and the Company’s final proxy statement/prospectus filed with the Commission on June 24, 2022. Any forward-looking statement made by us in this press release is based only on information currently available to the Company and speaks only as of the date on which it is made. The Company undertakes no obligation to publicly update any forward-looking statement, whether written or oral, that may be made from time to time, whether as a result of added information, future developments or otherwise, except as required by law.
Chief Business Officer
Chief Financial Officer