Form 8-K - Current report

 

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): May 13, 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		94502
(Address of principal executive offices)		(Zip Code)

 

Registrant’s telephone number, including area code: [phone]

 

(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, par value $0.0001		VANI		The 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 2.02 Results of Operations and Financial Condition.

 

On May 13, 2024, Vivani Medical, Inc. (the “Company”) issued a press release entitled “Vivani Medical Provides Business Update and Reports First Quarter 2024 Financial Results”, which is attached to this Current Report as Exhibit 99.1.

 

The information contained in this Item 2.02 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, whether made before or after the date hereof, except as shall be expressly set forth by reference in such a filing.

 

Item 7.01. Regulation FD Disclosure

 

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 contained in this Item 7.01 and Exhibit 99.2 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, whether made before or after the date hereof, 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) Exhibits.

 

Exhibit No.		Description
99.1		Press Release dated May 13, 2024 entitled “Vivani Medical Provides Business Update and Reports First Quarter 2024 Financial Results”.
99.2		Corporate Slides, as of May 13, 2024.
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.
Date: May 13, 2024	By:	/s/ Brigid Makes
		Brigid Makes
		Chief Financial Officer

 

 

 

Exhibit 99.1

 

 

 

Vivani Medical Provides Business Update and

Reports First Quarter 2024 Financial Results

 

Company continues advancing the development of miniature, long-term GLP-1 implants for the treatment of chronic weight management in obese or overweight patients, type 2 diabetes, and other chronic diseases

 

Stable financial position supports operations into the second half of 2025 and potential delivery of key portfolio milestones

 

Alameda, CA -- (BUSINESS WIRE) – May 13, 2024 – Vivani Medical, Inc. (Nasdaq: VANI) (“Vivani” or the “Company”), a biopharmaceutical company developing miniaturized, long-term drug implants including its lead asset NPM-115 for chronic weight management in obese or overweight patients with one or more risk factors, today reported financial results for the first quarter ended March 31, 2024, and provided a business update.

 

Adam Mendelsohn, Ph.D., Vivani’s Chief Executive Officer, stated, “Since pivoting to prioritize the development of our GLP-1 implants for obesity and chronic weight management, we have initiated preclinical activities for NPM-115, our high-dose exenatide implant to support clinical investigations. An Investigational New Drug (“IND”) application for NPM-115 remains on track for submission before the end of this year. In addition, we remain on track to provide the U.S. Food and Drug Administration (“FDA”) with the requested Chemistry, Manufacturing and Controls (“CMC”) information related to our NPM-119 IND in the first half of this year.”

 

Dr. Mendelsohn added, “The commercial opportunity for GLP-1 products remains robust with remarkable growth and significant potential for differentiated products including our miniature, subdermal implants with a target frequency of administration of six months or longer. We believe that the largest positive real-world impact in the GLP-1 category will be realized by addressing medication adherence and avoiding the weight regain which occurs upon treatment discontinuation, both of which are directly addressed by our miniature GLP-1 implants in development. As a result, we believe that our pipeline assets continue to hold significant potential opportunity for patients, caregivers, prescribers and payers.”

 

Recent Business Highlights

 

In February 2024, Vivani announced positive NPM-115 preclinical weight loss data comparable to semaglutide, the active ingredient in Ozempic^® and Wegovy^®. In a study of 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 injections of Ozempic in the same study. The Company also disclosed semaglutide as 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.

 

In March 2024, Vivani completed a $15-million registered direct offering of common stock and warrants. Proceeds from the financing will enable acceleration of priority development programs, including NPM-115 for obesity, and fund operations into the second half of 2025.

 

 

 

 

In March 2024, Vivani also announced the appointment of Daniel Bradbury to its Board of Directors. Under Bradbury’s leadership as Chief Executive Officer, Amylin Pharmaceuticals, Inc., with partner Alkermes plc, secured the 2012 approval of Bydureon^® (exenatide injection), the world’s first once-weekly GLP-1 receptor agonist, a class of drugs that now includes blockbusters Ozempic^®, Trulicity^® and Wegovy^®.

 

Upcoming Anticipated Milestones

 

●

Vivani anticipates filing the NPM-115 IND application in the second half of 2024 and initiating a first-in-human trial after receiving regulatory clearance to proceed.

 

●

Vivani remains on track to provide the FDA with the requested CMC information associated with the current Clinical Hold on NPM-119 during the first half of 2024.

 

●

Vivani plans to participate in multiple external events, including the TIDES USA conference on Oligonucleotide and Peptide Therapeutics on May 17, 2024 in Boston, MA, where Dr. Mendelsohn will present new NPM-115 data, as well as the Annual BIO International Conference in San Diego, CA on June 3-5, 2024, where Dr. Mendelsohn and Vivani’s Chief Business Officer Don Dwyer will meet with potential partners, investors and other industry representatives.

 

First Quarter 2024 Financial Results

 

Cash balance: As of March 31, 2024, Vivani had cash, cash equivalents and restricted cash totaling $31.0 million, compared to $22.0 million as of December 31, 2023. The increase of $9.0 million is attributed to the net cash provided by issuance of common stock and warrants in connection with securities purchase agreement of $13.7 million, $1.0 million provided by a net change in operating assets and liabilities and non-cash items totaling $0.5 million for depreciation and amortization of property and equipment, stock-based compensation and lease expense, partially offset by a net loss of $6.0 million and $0.2 million used for purchase of property and equipment.

 

Research and development expense: Research and development expense during the three months ended March 31, 2024 was $3.7 million, compared to $4.0 million during the three months ended March 31, 2023. The decrease of $0.3 million, or 6%, was primarily attributable to a decrease in costs from the Company’s wholly owned subsidiary Cortigent and drug implant development costs, partially offset by increased payroll and personnel-related costs and increased rent due to the lease agreement in Alameda, California and related facilities expense.

 

General and administrative expense: General and administrative expense during the three months ended March 31, 2024 was $2.5 million, compared to $2.6 million during the three months ended March 31, 2023. The decrease of $0.1 million, or 5%, was attributable to a decrease in costs from Cortigent, partially offset by increased payroll and personnel-related costs, increased rent due to the lease agreement in Alameda, California and professional service expense.

 

Other income, net: Other income, net during the three months ended March 31, 2024 was $0.2 million, compared to $0.3 million during the three months ended March 31, 2023. The change was not significant.

 

 

 

 

Net Loss: The net loss during the three months ended March 31, 2024 was $6.0 million, compared to $6.3 million during the three months ended March 31, 2023. The decrease in net loss of $0.3 million was primarily attributable to a decrease in operating expenses of $0.4 million.

 

Bydureon^® is a registered trademark of the AstraZeneca group of companies.

 

Ozempic® and Wegovy^® are registered trademarks of Novo Nordisk A/S.

 

Trulicity^® is a registered trademark of Eli Lilly and Company.

 

About Vivani Medical, Inc.

 

Leveraging its proprietary NanoPortal™ platform, Vivani 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 lead programs 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. These NanoPortal 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.

 

About Cortigent, Inc.

 

Vivani’s wholly owned subsidiary, Cortigent, is developing precision 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. The company has developed, manufactured, and marketed an implantable visual prosthetic device, Argus II^®, that delivered meaningful visual perception to blind individuals. 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, 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-115 and NPM-119; delays and changes in applicable laws, regulations and guidelines including potential delays in submitting required regulatory applications to the 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 for the year ended December 31, 2023 filed with the U.S. Securities Exchange Commission (“SEC”) on March 26, 2024, and any subsequent filings filed with the SEC. 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:
Don Dwyer
Chief Business Officer
[e-mail]
[phone]

 

Investor Relations Contact:
Brigid Makes
Chief Financial Officer
[e-mail]
[phone]

 

Media Contact:
Sean Leous
ICR Westwicke
[e-mail]

[phone]

 

 

 

 

VIVANI MEDICAL, INC.

AND SUBSIDIARIES

 

Condensed Consolidated Balance Sheets (unaudited)

(in thousands, except per share data)

 

		March 31,				December 31,
		2024				2023
ASSETS
Current assets:
Cash and cash equivalents		$	29,648			$	20,654
Prepaid expenses and other current assets			1,854				2,408
Total current assets			31,502				23,062
Property and equipment, net			1,689				1,729
Right-of-use assets			19,212				19,616
Restricted cash			1,338				1,338
Other assets			47				52
Total assets		$	53,788			$	45,797
LIABILITIES AND STOCKHOLDERS’ EQUITY
Current liabilities:
Accounts payable		$	570			$	542
Accrued expenses			1,953				1,727
Litigation accrual			1,675				1,675
Accrued compensation expense			506				396
Current operating lease liabilities			1,434				1,383
Total current liabilities			6,138				5,723
Long-term operating lease liabilities			18,940				19,313
Total liabilities			25,078				25,036
Commitments and contingencies
Stockholders’ equity:
Preferred stock, par value $0.0001 per share; 10,000 shares authorized; none outstanding			—				—
Common stock, par value $0.0001 per share; 300,000 shares authorized; shares issued and outstanding: 54,978 and 51,031 at March 31, 2024 and December 31, 2023, respectively			5				5
Additional paid-in capital			133,094				119,054
Accumulated other comprehensive income			88				140
Accumulated deficit			(104,477	)			(98,438	)
Total stockholders’ equity			28,710				20,761
Total liabilities and stockholders’ equity		$	53,788			$	45,797

 

 

 

 

VIVANI MEDICAL, INC.

AND SUBSIDIARIES

 

Condensed Consolidated Statements of Operations (unaudited)

(in thousands, except per share data)

 

		Three Months Ended March 31,
		2024				2023
Operating expenses:
Research and development, net of grants		$	3,726			$	3,955
General and administrative, net of grants			2,501				2,646
Total operating expenses			6,227				6,601
Loss from operations			(6,227	)			(6,601	)
Other income, net			188				283
Net loss		$	(6,039	)		$	(6,318	)
Net loss per common share - basic and diluted		$	(0.12	)		$	(0.12	)
Weighted average common shares outstanding - basic and diluted			52,202				50,755

 

 

Exhibit 99.2

 

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

 

 

Disclaimers The following slides and any accompanying oral presentation contain forward-looking statements within the meaning of Section 27Aof 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 thataddress operating performance or events or developments that Vivani Medical, Inc. (“Vivani”, the “Company”, “we” or “us) expects or anticipates will occur in thefuture, such as stated objectives or goals, our products and their therapeutic potential and planned development, the indications that we intend to target, ourtechnology, 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 expectationswere 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-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 approvals 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 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 inour Annual Report on Form 10-K for the year ended December 31, 2023, and our subsequent filings with the SEC. We urge you to consider those risks and uncertaintiesin evaluating our forward-looking statements. We caution readers not to place undue reliance upon any such forward-looking statements, which speak only asof 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 anyforward-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

 

 

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 Elutia, Inc. •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 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. 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. Vivani is well-positioned to advance NPM-115 and NPM-119 towards potentially transformational milestones in 2024 and 2025.

 

 

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 estimates 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 high-dose exenatide semaglutide

 

 

Drug Implants Proprietary Platform Technology

 

 

Potential application with many molecular types Designed to assure adherence Minimally-fluctuating and tunable delivery profiles NanoPortalTM: 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 NanoPortalTM: 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 1sthour 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 NanoPortalTMis 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 Obesity1: •764M people living with obesity •15M (2%) taking an anti-obesity medication •GLP-1 monotherapy may provide adequate weight loss for the majority of patients2 •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 nmol/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. 16Year(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 Diabetes1: •537M people living with diabetes •~ 15% in good control •Non-adherence is the primary reason for low, real-world effectiveness2,3 •Guaranteed adherence will produce significant healthcare cost savings4 •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’s1ITCA 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 CRL2(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 1i2o Therapeutics acquired Intarcia Therapeutic’s assets including ITCA-650 2CRL: 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 releaseprofile observed in pre-clinical studies •SmallerDevice (2.2mm x 21.5mm) •Insertion using smaller 11-gauge needle NPM-119 well-positioned to avoid ITCA 650’s device technology challenges NanoPortalTM 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

 

 

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 configuration to 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; SU: 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 -Communications with the FDA to resolve the NPM-119 clinical hold are ongoing. Vivani currently expects to submit the requested CMC information to the FDA in the first half of 2024. 28Year(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.Q1 2024: P&L Statement 31In Thousands, except per Share DataMar. 31, 2024Mar. 31, 2023Operating expenses:Research and development, net of grants3,726$ 3,955$ General and administrative, net of grants2,5012,646Total operating expenses6,2276,601Loss from operations(6,227)(6,601)Other income, net188283Net loss(6,039)$ (6,318)$ Net loss per common share – basic and diluted(0.12)$ (0.12)$ Weighted average common shares outstanding – basic and diluted52,20250,755Three Months EndedCondensed Consolidated Statements of Operations (unaudited)

 

 

Vivani Medical, Inc. Vivani Medical, Inc.Q1 2024: Balance Sheet 32In ThousandsMar. 31, 2024Dec. 31, 2023ASSETSCash and cash equivalents29,648$ 20,654$ Prepaid expenses and other current assets1,8542,408Total current assets31,50223,062Property and equipment, net1,6891,729Right-of-use assets19,21219,616Restricted cash1,3381,338Other assets4752Total assets53,788$ 45,797$ LIABILITIES AND STOCKHOLDERS’ EQUITYCurrent liabilities6,138$ 5,723$ Long-term operating lease liabilities18,94019,313Total liabilities25,07825,036Stockholders’ equity:Total common stock, APIC & other comprehensive income133,187119,199Accumulated deficit(104,477)(98,438)Total liabilities and stockholders’ equity53,788$ 45,797$ Condensed Consolidated Balance Sheets (unaudited)

 

 

Vivani Medical, Inc.Q1 2024: Cap Table 33As of March 31, 2024 Equity WAEP* Number of Shares Common Stock 54,978,465 Stock Options $2.67 5,880,343 RSUs - 402,500 Warrants $3.38 10,961,248 Fully Diluted Shares 72,222,556

 

 

Vivani Medical, Inc. 34 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. 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. Vivani is well-positioned to advance NPM-115 and NPM-119 towards potentially transformational milestones in 2024 and 2025.

 

Cover	May 13, 2024
Cover [Abstract]
Document Type	8-K
Amendment Flag	false
Document Period End Date	May 13, 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, par value $0.0001
Trading Symbol	VANI
Security Exchange Name	NASDAQ
Entity Emerging Growth Company	false

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