VANIW Vivani Medical Inc (PK)

 

 

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 Earliest Event Reported): February 28, 2024

 

Vivani Medical, Inc.

(Exact name of registrant as specified in its charter)

 

Delaware	001-36747	02-0692322
(State or Other Jurisdiction of Incorporation)	(Commission File Number)	(IRS Employer Identification No.)

 

1350 S. Loop Road Alameda, California (Address of Principal Executive Offices)		94502 (Zip Code)

 

(415) 506-8462 

(Registrant’s telephone number, including area code)

 

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.

 

On February 28, 2024, Vivani Medical, Inc. (the “Company”) issued a press release announcing positive preclinical data on weight loss effects for NPM-115, the Company’s miniature, twice-yearly, exenatide implant under development for the treatment of chronic weight management. A copy of the press release is furnished hereto as Exhibit 99.1.

 

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 99.2 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 in this report (including Exhibits 99. 1 and 99.2, is being furnished pursuant to Item 7.01 and shall not be deemed to be “filed” for the purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended, or the Exchange Act, except as expressly set forth by specific reference in such filing. This report will not be deemed an admission as to the materiality of any information in this Item 7.01 (including Exhibits 99.1 and 99.2).

 

Item 9.01 Financial Statements and Exhibits.

 

(d) Exhibits

 

Exhibit No.		Description
99.1		Press Release titled “Vivani Medical Announces Positive NPM-115 Preclinical Weight Loss Data Comparable to Ozempic®/Wegovy® and Discloses NPM-139 as Semaglutide as Strategy Shifts to Prioritize Obesity Portfolio”issued by the Company on February 28, 2024.
99.2		Corporate Presentation as of February 28, 2024.
104		Cover Page Interactive Data File (embedded within the Inline XBRL document)

SIGNATURES

 

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

 

			VIVANI MEDICAL, INC.
Date:	February 28, 2024	By:	/s/ Brigid Makes
			Brigid Makes Chief Financial Officer (Principal Financial and Accounting Officer)

 

Exhibit 99.1

 

FOR IMMEDIATE RELEASE

 

Vivani Medical Announces Positive NPM-115 Preclinical Weight Loss Data Comparable to Ozempic®/Wegovy® and Discloses NPM-139 as Semaglutide as Strategy Shifts to Prioritize Obesity Portfolio

 

NPM-115 (exenatide implant) generated significant weight loss comparable to injectable semaglutide (Ozempic^®/Wegovy^®) from a single administration with expected twice-yearly dosing

 

Vivani discloses semaglutide as the active pharmaceutical ingredient in NPM-139, with the added potential benefit of once-yearly dosing

 

NPM-115 and NPM-139 are miniature, subdermal implants in development for chronic weight management designed to guarantee medication adherence and potentially improve treatment tolerability by providing smooth and steady delivery of GLP-1 therapy

 

ALAMEDA, Calif., February 28, 2024 -- (BUSINESS WIRE) -- Vivani Medical, Inc. (Nasdaq: VANI) (“Vivani” or the “Company”), an innovative, preclinical-stage biopharmaceutical company developing novel, long-term drug implants, today announced positive preclinical data on weight loss effects for NPM-115, the Company’s miniature, twice-yearly, exenatide implant under development for the treatment of chronic weight management. The Company also disclosed that semaglutide is the active pharmaceutical ingredient in NPM-139, a miniature, subdermal GLP-1 implant in development for chronic weight management, with the added potential benefit of once-yearly administration. These developments are part of a strategic shift to prioritize the Company’s obesity implants based on emerging data regarding the potential for high-dose GLP-1 products to improve health outcomes for obese and overweight patients.

 

“In response to tremendous medical need and unprecedented market demand, we are prioritizing the development of our GLP-1 implants for the treatment of obesity and chronic weight management. Since a high-dose GLP-1 implant for obesity would likely also be able to address our previous type 2 diabetes focus, the recently generated compelling weight loss data from NPM-115 naturally supports a shift in focus towards an indication with even broader potential. We believe the primary expected advantages of our proprietary NanoPortal™ implant technology, improving medication adherence and medication tolerability, have the potential to transform and advance the adoption of GLP-1 therapy in the future.” said Adam Mendelsohn, Ph.D., Vivani President and Chief Executive Officer. “The potential for long-term GLP-1 implants becomes even more compelling when you consider that the improved adherence and persistence of Ozempic and Wegovy over prior obesity medications is still only 40% as recently reported in a large retrospective cohort study published in the research journal Obesity. Collectively, the potential for improvement in medication adherence, tolerability and real-world patient outcomes motivates us to rapidly advance the development of NPM-115, NPM-139 and the balance of our portfolio.”

 

In a study in high-fat diet-induced obese mice, NPM-115 generated weight loss of approximately 20% compared to a sham implant control after a 28-day treatment duration, comparable to weight loss observed in mice treated with semaglutide injections (Ozempic/Wegovy) in the same study. The supratherapeutic doses provided for both NPM-115 (single administration delivering exenatide at ~530 nmol/kg/day), and semaglutide (weekly injections of ~2,700 nmol/kg/week), were selected to maximize the weight-loss potential of both exenatide and semaglutide.

 

Weight loss in high fat diet-induced obese mice. % weight change from baseline for NPM-115 (exenatide) vs Ozempic^® (semaglutide), corrected to control (sham implant). Values are mean ± SE.

 

 

 

In a second study in healthy rats, a single administration of the Company’s exenatide implant NPM-119, in development for the treatment of type 2 diabetes, resulted in body weights that were approximately 25% lower than a vehicle implant control after 15 weeks of treatment with an expected duration of effect of six months. NPM-119 delivered exenatide at a rate of approximately 320 nmol/kg/day and has demonstrated smooth, non-fluctuating release of exenatide in both in vitro and in vivo studies. NPM-119 has previously demonstrated pharmacokinetic data exhibiting continuous and therapeutic exenatide exposure levels over a six-month duration in healthy rats. Since NPM-115 is a higher-dose version of an otherwise similar product as NPM-119, the durability of the effect on weight demonstrated in this study is expected to translate to future studies utilizing NPM-115.

 

Weight difference from control in healthy Sprague-Dawley Rats. % weight change from baseline for NPM-119 (exenatide) corrected to control (vehicle implant). Values are mean ± SE.

 

 

These preclinical data provide further evidence that the weight loss potential of exenatide treatment in humans may be comparable to other GLP-1 molecules such as semaglutide assuming adequate exposure levels are achieved and maintained. The weight loss potential of exenatide in humans has not been fully evaluated in the currently marketed exenatide products Byetta® (twice-daily injection) and Bydureon® (weekly injection) potentially due to limitations associated with adherence and dosing. NPM-115 directly addresses these limitations. It is designed to improve adherence by enabling patients to receive continuous dosing over a six-month interval from a single administration. NPM-115 is planned to maximize exenatide’s weight loss effect in humans, pending further development and regulatory clearance, by evaluating exenatide exposure levels higher than previously explored.

 

Dr. Mendelsohn will present study results on May 17 at the TIDES USA 2024 conference in Boston.

 

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 adherence, and potentially to improve medication tolerability. Vivani’s NPM-115 and NPM-119 are miniature, six-month, GLP-1 implants in development for the treatment of chronic weight management in obese or overweight patients and type 2 diabetes, respectively. Both NPM-115 and NPM-119 are exenatide based products with a higher-dose associated with NPM-115 for the treatment of chronic weight management in obese or overweight patients. An IND for NPM-119’s first-in-human study LIBERATE-1 has been submitted and is on clinical hold pending requests by the FDA for additional chemistry, manufacturing, and controls (CMC) information. Vivani anticipates submitting the requested CMC information to the FDA in the first half of 2024. LIBERATE-1 is a randomized, 12-week investigation of the safety, tolerability, and full pharmacokinetic profile of NPM-119 in patients with type 2 diabetes. Vivani is also preparing to submit an IND for a first-in-human study with NPM-115 for the treatment of chronic weight management later this year. These NanoPortal^TM implants are designed to provide patients with the opportunity to realize the full potential benefit of their medication by avoiding the challenges associated with the daily or weekly administration of orals and injectables. 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, which contributes to more than $500 billion in annual avoidable healthcare costs and 125,000 potentially preventable deaths annually in the U.S. alone, is a primary and daunting reason why obese or overweight patients, and patients taking type 2 diabetes or other chronic disease medications face significant challenges in achieving positive real-world effectiveness.

 

Vivani’s wholly owned subsidiary Cortigent is developing targeted neurostimulation systems intended to help patients recover critical body functions. Investigational devices include Orion®, designed to provide artificial vision to people who are profoundly blind, and a new system intended to accelerate the recovery of arm and hand function in patients who are partially paralyzed due to stroke. Vivani continues to assess strategic options for advancing Cortigent’s pioneering technology.

 

Forward-Looking Statements

 

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, products in development, including the therapeutic potential thereof, plans to address any requests from the FDA related to the agency’s current clinical hold on NPM-119, the initiation of the LIBERATE-1 trial and reporting of trial results, the planned development therefor, our emerging development plans for NPM-115, NPM-139, or our plans with respect to Cortigent and its proposed initial public offering, technology, strategy, cash position and financial runway. 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 products, including NPM-115 and NPM-119; delays and changes in the development of our products, including our ability to address any requests from the FDA related to LIBERATE-1 and to commence clinical development of NPM-119, including as a result of applicable laws, regulations and guidelines, potential delays in submitting and receiving regulatory clearance or approval to conduct our development activities, 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 access additional capital or otherwise fund our business; market conditions and the ability of Cortigent to complete its initial public offering. 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 filed with the SEC filed on March 31, 2023, as updated by our subsequent Quarterly Reports on Form 10-Q. 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.

 

Company Contact:
Donald Dwyer
Chief Business Officer
info@vivani.com
(415) 506-8462

 

Investor Relations Contact:
Brigid A. Makes
Chief Financial Officer
investors@vivani.com
(415) 506-8462

 

Media Contact:
Sean Leous
ICR Westwicke
Sean.Leous@westwicke.com

(646) 866-4012

 

 

Exhibit 99.2

 

Vivani Medical, Inc. Guaranteed Adherence. Better Outcomes. Nasdaq: VANI www.vivani.com February 2024

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 products and their therapeutic potential and planned development, the indications that we intend to target, our te chnology, our business and strategy, milestones, addressable markets, or that are not otherwise historical facts, are forward - looking statements. While man agement 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 t hose 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 - 115. NPM - 119 or otherwise commence our planned clinical trials for these products under development; conduct any pre - clinical activities of our other products; our products may not demonstrate safety or efficacy in clinical trials; we may fail to secure marketing a ppr ovals for our products; 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 products may be inaccurate; we may fail to timely raise additional required funding; more efficient competitors or more effective competing t rea tment 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 a nd retain key employees and qualified personnel; earlier study results may not be predictive of later stage study outcomes; and we are dependent on third - pa rties for some or all aspects of our product manufacturing, research and preclinical and clinical testing. Additional risks and uncertainties are described in ou r Annual Report on Form 10 - K filed on March 31, 2023, and our subsequent filings with the SEC. We urge you to consider those risks and uncertainties in ev alu ating 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 fo rward - looking statement contained herein (or elsewhere) to reflect any change in our expectations with regard thereto, or any change in eve nts , 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, a ccu racy or completeness of, any information obtained from third - party sources. Finally, while we believe our own internal research is reliable, such research ha s not been verified by any independent source. All of our therapies are still investigational and have not been approved by any regulatory authority for an y use. 2

Vivani Executive Leadership Team • Co - founder/Co - inventor of Vivani 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: • CTO 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: Quantum - Si and Aziyo Biologics • Involved in/Directed 2 IPOs, 2 reverse mergers and 1 SPAC Brigid A. Makes, MBA – Chief Financial Officer • Former Executive Director at AstraZeneca with leadership roles in regulatory affairs, drug development, commercial and business development • Former Vivani Board observer for AZ • Former PhaseBio Board observer for AZ (prior to IPO) • Former Director at Cephalon and Rhone Poulenc Rorer Donald Dwyer, MBA – Chief Business Officer 3

Vivani Medical, Inc. 4 Lead programs NPM - 115 and NPM - 119 are miniature, six - month, GLP - 1 (exenatide) implants under development for the treatment of chronic weight management in obese or overweight patients and type 2 diabetes, respectively. NPM - 139 (semaglutide implant) is also under development for chronic weight management with the added potential benefit of once - yearly administration. An innovative, biopharmaceutical company developing a portfolio of miniature, long - term, drug implants to treat chronic diseases. Our NanoPortal ™ platform technology enables the design of implants aimed at improving medication non - adherence and tolerability. Vivani is well - positioned to advance NPM - 115 and NPM - 119 towards potentially transformational milestones in 2024.

Feline Pre - Diabetes & Diabetes >$0.5B Human Obesity >$50B 5 Company Pipeline If Approved, Vivani Products will Compete in Markets with Large Potential Indication Feasibility Pre - Clinical Clinical Market Size* Human Type II Diabetes Human Obesity NPM - 119 exenatide >$20B >$50B NPM - 139 Vivani * Estimated Market Sizes where Vivani products would compete, if approved. Does not represent future sales or revenue estimat es of Vivani pipeline products JP Morgan analyst Richard Vosser estimates GLP - 1 Market reaches $71 billion by 2032 (9/11/2023). We assume >$20B for type 2 diabetes and >$50B for chronic weight management in obese or overweight patients ** In Partnership with Okava Pharmaceuticals, Inc. OKV - 119** exenatide NPM - 115 h igh - dose exenatide semaglutide

Drug Implants Proprietary Platform Technology

Potential application with many molecular types Designed to assure adherence Minimally - fluctuating and tunable delivery profiles NanoPortal TM : 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 TM : How it Works... Pore too small: No release Pore target size: Near constant release 8 Pore too large: Burst release

Near - constant and minimally - fluctuating release 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. Values are mean ± SD. Fluctuations during each 2.5 - hour interval are within measurement error 9 Minimal Fluctuations with 2.5 - hour interval sampling Individual Release Profiles (n=6) *Release - rates include exenatide and related substances.

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

Targeting the Rapidly Growing GLP - 1 RA Market Vivani Lead Program NPM - 115 High - Dose Exenatide Implant for Chronic Weight Management

• Tremendous unmet medical need in Obesity 1 : • 764M people living with obesity • 15M (2%) taking an anti - obesity medication • GLP - 1 monotherapy may provide adequate weight loss for the majority of patients 2 • Preliminary preclinical data with NPM - 115 has demonstrated similar magnitude of weight loss for exenatide and semaglutide • NPM - 115 target profile may provide an attractive alternative to life - long injections or pills for long - term maintenance of GLP - 1 therapy for weight management 6 - Month Exenatide (Glucagon - like Peptide 1 Receptor Agonist) Implant for Chronic Weight Management in Obese or Overweight Patients Lead Product NPM - 115: 12 1, 2 Novo Nordisk 2023 Annual Report

100% 75% 50% 25% 0% • The remaining opportunity for an additional 60% improvement in persistence is significant and will translate to improved patient outcomes • NPM - 115 (exenatide implant) is designed to guarantee adherence for 6 months / implant Recent retrospective cohort study (n=1,911) reported improved medication persistence with semaglutide of 40% after one year Weight Loss Medicines Associated With Adherence Challenges Large Retrospective Cohort Study* (N=1,911) 13 * Published in Obesity, December 8, 2023 ** NPM - 115 (exenatide implant) was not included in the published study, assumes one implant replaced after six months. Currently under development, designed to enable 100% adherence, not approved in any market. Percent Remaining on Therapy

NPM - 115 is associated with comparable weight loss to semaglutide in preclinical studies 14 Weight loss in high fat diet - induced obese mice. (A) % weight change from baseline for a single administration of NPM - 115 (exenatide, ~530 nmol/kg/day) vs weekly Ozempic injections (semaglutide, 2,700 nmol/kg/week), corrected to control (sham implant) at 28 days; (B) % weight change from baseline over time from a single administration of NPM - 115 (exenatide, ~530 nmol/kg/day) vs. weekly Ozempic injections (semaglutide, 2,700 nmo l/kg/week), corrected to control (sham implant). Values are mean ± SE. A B

Exenatide delivered with NanoPortal™ technology is associated with durable body weight effects 15 Weight difference from control in healthy Sprague - Dawley Rats. % weight change from baseline for a single administration of NPM - 119 (exenatide, ~320 nmol/kg/day) corrected to control (vehicle implant). (A) All animals measured through 105 days of treatment; (B) 5 animals measured in each group through 112 days of treatment followed by a 28 - day recovery period. Values are mean ± SE. A B

NPM - 115 Clinical + Regulatory Development Near - Term Plan November 2023 – Vivani announced the designation of NPM - 115 (high - dose exenatide implant) and initiation of the development program for chronic weight management. February 2024 – Company reported positive preclinical study results demonstrating comparable weight loss between NPM - 115 implant and Ozempic/Wegovy (semaglutide injection). 2024 – Planned submission of an Investigational New Drug Application to support the initiation of a First - in - Human trial of NPM - 115 for the treatment of chronic weight management in obese or overweight patients. 16 Year(s) Milestone Status 2023 Announced Designation of NPM - 115 (high dose exenatide) November 2023 2024 Reported Positive Weight Loss in Preclinical studies February 2024 2024 Submit IND filing to FDA for First - In - Human study Expected 2024

Targeting the Rapidly Growing GLP - 1 RA Market Vivani Lead Program NPM - 119 Exenatide Implant for Type 2 Diabetes

1 2023 Novo Nordisk Annual Report 2 Guo 2016 2,3 Carls et al., 2017 4 IMS 2013 Report • Significant unmet need in Diabetes 1 : • 537M people living with diabetes • ~ 15% in good control • Non - adherence is the primary reason for low, real - world effectiveness 2,3 • Guaranteed adherence will produce significant healthcare cost savings 4 • FDA indicated 505(b)(2) streamlined approval pathway may be available 6 - Month Exenatide (Glucagon - like Peptide 1 Receptor Agonist) Implant for Type 2 Diabetes Lead Product (NPM - 119): 18

NPM - 119 Implant and Applicator 19

Ozempic Januvia Invokana NPM - 119* 100% 75% 50% 25% 0% GLP - 1 agonist, weekly injection Mody et al., 2022 DPP - 4 inhibitors, daily pills Polonsky et al.,2016 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 nonadherence 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 – under development, designed to enable 100% adherence, not approved in any market Real - World Adherence of Select Drugs 20

Intarcia’s 1 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 2 (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 dispute resolutions, FDA’s CDER proposes to deny Intarcia’s public hearing request 2023 – FDA Advisory Board unanimously recommends against the approvability of ITCA 650 due to concerns about safety risks linked to irregular and uncontrolled exenatide release Value of long - term GLP - 1 (exenatide) implant externally validated previously 1 i2o Therapeutics acquired Intarcia Therapeutic’s assets including ITCA - 650 2 CRL: Complete Response Letter – issued by FDA to identify NDA deficiencies 21

(Intarcia) • FDA alleges that daily variations in drug release may be responsible for clinical safety signals • Larger Device (4mm x 45mm) • Insertion using larger 6 - gauge needle • Minimally fluctuating drug 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 ITCA 650’s device technology challenges NanoPortal TM Osmotic Pump (NPM - 119) 22

Never taken a GLP - 1 RA Patient market research indicates strong market adoption potential for a miniature, 6 - month exenatide implant dQ&A insights reported market research during FDA Advisory Board to review ITCA 650 (exenatide implant) on September 21, 2023 23 56% of patients responded “likely” or “definitely” to get an exenatide implant if FDA approved, prescriber recommended, and covered by insurance

0 2 4 6 8 10 Likely to Prescribe (1=not likely, 10=extremely likely) Primary Care Physicians (n=10) Prescribing Rating, Average 8.3 out of 10 Prescriber and Payer research also provide strong support for a miniature, 6 - month exenatide implant Rating : Overall, using a scale of 1 to 10, where 1 is not at all likely and 10 is extremely likely, how likely are you to prescribe NPM - 119? Vivani sponsored qualitative market research, March 2020. ~90% of patients receive treatment in primary care Total : ~$5,500 (annual, per patient) Adherence = Lower Acute Care & Outpatient Costs Curtis et al., 2017 24

6 - Month NPM - 119 preclinical proof - of - concept achieved Implants removed * 25 Pharmacokinetics of 6 - month NPM - 119 in male Sprague - Dawley rats Exenatide antibody - positive animals are not included in this data set. Values are mean ± SD. *2 of 6 implants are responsible for higher Day 1 exenatide concentrations which is not expected to occur in the configuratio n t o be used in the clinic. ** The estimated exenatide EC50 is 51.4 pg /mL when exenatide antibody titers are < 125 and 84 pg /mL when exenatide antibody titers are >= 125. These exenatide EC50 estimates are consistent with the exenatide EC50 estimate, 83.5 pg /mL, from the FDA Clinical Pharmacology review of BYDUREON **

NPM - 119 Clinical and Regulatory Pathway

Proposed First - in - Human Trial: LIBERATE - 1 Primary Objectives: Safety/tolerability assessment and full PK characterization Glycemic control (HbA1c) and weight will also be assessed Randomize 12 Weeks Key Inclusion/Exclusion Criteria • T2DM and HbA1c <8.5% • 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=8) Bydureon BCise 2mg/week (N=8) T2DM: Type 2 Diabetes Mellitus; TZD: Thiazolidinedione; SGLT - 2: Sodium - glucose cotransporter - 2; DPP - 4: Dipeptidyl peptidase 4; S U: Sulfonylurea 27

NPM - 119 Clinical + Regulatory Development Near - Term Plan July 14, 2023 – Vivani submitted an Investigational New Drug to support a proposed First in Human study also know as LIBERATE - 1 to explore the full pharmacokinetic profile of NPM - 119 in patients with type 2 diabetes. August 18, 2023 – FDA provided a Clinical Hold on the proposed LIBERATE - 1 study primarily due to insufficient Chemistry, Manufacturing and Controls (CMC) information. 2024 - Vivani continues to generate the requested CMC information and remains actively engaged in discussions as part of its efforts to lift the Clinical Hold and enable the expeditious initiation of LIBERATE - 1. Discussions with FDA to resolve the clinical hold are ongoing. Vivani currently expects to submit the requested CMC information to the FDA in the first half of 2024. 28 Year(s) Milestone Status 2023 IND filed to support First - in - Human (LIBERATE - 1) clinical study July 14, 2023 2023 FDA provided Clinical Hold letter August 18, 2023 2024 Generate/Submit New CMC data to Lift Clinical Hold 2024

12 - Week NPM - 119 PK in Rats Intended for explant at 12 weeks in LIBERATE - 1, implants left in place for this study 29 Pharmacokinetics of 3 - month NPM - 119 in male Sprague - Dawley rats Exenatide antibody - positive animals are not included in this data set. Values are mean ± SD. * The estimated exenatide EC50 is 51.4 pg /mL when exenatide antibody titers are < 125 and 84 pg /mL when exenatide antibody titers are >= 125. *

Vivani Medical, Inc. Financial Information

Vivani Medical, Inc. Q3 2023: P&L Statement 31 In Thousands, except per Share Data Sep. 30, 2023 Sep. 30, 2022 Sep. 30, 2023 Sep. 30, 2023 Operating expenses: Research and development, net of grants 4,441$ 3,859$ 12,260$ 9,742$ General and administrative 2,703 1,585 8,488 3,709 Total operating expenses 7,144 5,444 20,748 13,451 Loss from operations (7,144) (5,444) (20,748) (13,451) Other income (expense), net 362 6,867 1,122 6,846 Net income/(loss) (6,782)$ 1,423$ (19,626)$ (6,605)$ Net income/(loss) per common share – basic (0.13)$ 0.04$ (0.39)$ (0.18)$ Net income/(loss) per common share – diluted (0.13)$ 0.04$ (0.39)$ (0.18)$ Weighted average common shares outstanding – basic 50,837 37,965 50,757 37,712 Weighted average common shares outstanding – diluted 50,837 38,477 50,757 37,712 3 Months Ended 9 Months Ended Condensed Consolidated Statements of Operations (unaudited)

Vivani Medical, Inc. Vivani Medical, Inc. Q3 2023: Balance Sheet 32

Vivani Medical, Inc. Q3 2023: Cap Table 33 As of September 30, 2023 Equity WAEP* Number of Shares Common Stock 51,025,060 Stock Options $2.82 6,043,164 RSUs $3.15 402,500 Warrants** $11.13 10,310,543 Fully Diluted Shares 67,781,267 *Weighted Average Exercise Price **Actual warrants total 15,437,918 including 7,684,313 for Second Sight which when exercised 3 for 1, convert to 2,563,688 common shares

Vivani Medical, Inc. 34 Lead programs NPM - 115 and NPM - 119 are miniature, six - month, GLP - 1 (exenatide) implants under development for the treatment of chronic weight management in obese or overweight patients and type 2 diabetes, respectively. NPM - 139 (semaglutide implant) is also under development for chronic weight management with the added potential benefit of once - yearly administration. An innovative, biopharmaceutical company developing a portfolio of miniature, long - term, drug implants to treat chronic disease. Our NanoPortal ™ platform technology enables the design of implants aimed at improving medication non - adherence and tolerability. Vivani is well - positioned to advance NPM - 115 and NPM - 119 towards potentially transformational milestones in 2024.

 

v3.24.0.1

Cover	Feb. 28, 2024
Cover [Abstract]
Document Type	8-K
Amendment Flag	false
Document Period End Date	Feb. 28, 2024
Entity File Number	001-36747
Entity Registrant Name	Vivani Medical, Inc.
Entity Central Index Key	0001266806
Entity Tax Identification Number	02-0692322
Entity Incorporation, State or Country Code	DE
Entity Address, Address Line One	1350 S. Loop Road
Entity Address, City or Town	Alameda
Entity Address, State or Province	CA
Entity Address, Postal Zip Code	94502
City Area Code	(415)
Local Phone Number	506-8462
Written Communications	false
Soliciting Material	false
Pre-commencement Tender Offer	false
Pre-commencement Issuer Tender Offer	false
Title of 12(b) Security	Common stock
Trading Symbol	VANI
Security Exchange Name	NASDAQ
Entity Emerging Growth Company	false

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