UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM
CURRENT REPORT
Pursuant to Section 13 OR 15(d) of The Securities Exchange Act of 1934
Date
of Report (Date of earliest event reported):
(Exact name of registrant as specified in its charter)
(State or other jurisdiction of incorporation) |
(Commission File Number) |
(IRS Employer Identification No.) |
(Address of principal executive offices) | (Zip Code) |
Registrant’s
telephone number, including area code:
(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 | ||
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 March 26, 2024, Vivani Medical, Inc. (the “Company”) issued a press release entitled “Vivani Medical Provides Business Update and Reports Fourth Quarter and Full Year 2023 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 March 26, 2024 entitled “Vivani Medical Provides Business Update and Reports Fourth Quarter and Full Year 2023 Financial Results”. | |
99.2 | Corporate Slides, as of March 26, 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: March 26, 2024 | By: | /s/ Brigid Makes |
Brigid Makes | ||
Chief Financial Officer |
Exhibit 99.1
Vivani Medical Provides Business Update and
Reports Fourth Quarter and Full Year 2023 Financial Results
Strategic shift prioritizes the development of GLP-1 implants for the treatment of obesity
and chronic weight management
Positive NPM-115 (exenatide implant) preclinical weight loss data comparable to
semaglutide, active ingredient in Ozempic®/Wegovy®
$15 million financing round enables acceleration of priority development programs and
secures operations into the second half of 2025
Alameda, CA -- (BUSINESS WIRE) -- March 26, 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 fourth quarter and full year ended December 31, 2023, and provided a business update.
Adam Mendelsohn, Ph.D., Vivani’s Chief Executive Officer, stated, “2023 was another remarkable year for Vivani as we shifted our strategic focus to our obesity portfolio and announced that our lead program NPM-115 – a six-month GLP-1 implant for obesity – generated preclinical weight loss data comparable to semaglutide, the active ingredient in Ozempic® and Wegovy®. We 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, we raised funding to support operations into the second half of 2025. Additionally, we moved into a dedicated facility in Alameda, California, capable of supporting the manufacturing of large-scale clinical trial materials and, ultimately, commercial supply.”
Dr. Mendelsohn added, “We are on track to submit a new Investigational New Drug Application for NPM-115, our high-dose exenatide implant for chronic weight management in obese and overweight patients with one or more risk factors, later this year. We also remain on track to provide the U.S. Food and Drug Administration with the requested NPM-119 Chemistry, Manufacturing and Controls information in the first half of this year, with the goal of obtaining an Investigational New Drug Application clearance of NPM-119 to initiate clinical development. The considerable work we have done to prepare NPM-119 for clinical development will be leveraged as we move toward a first-in-human clinical study for NPM-115, which aligns with our new strategic priority.”
Recent Business Highlights
In March 2024, Vivani announced the pricing of 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 provides funding of 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 CEO, Amylin Pharmaceuticals, with partner Alkermes, 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.
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 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 injections of Ozempic in the same study. Vivani announced the addition of NPM-115 to its portfolio in November 2023. Adding to Vivani’s emerging obesity portfolio, 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.
Moving forward, Vivani will focus on developing NPM-115 and its emerging pipeline of innovative miniature, long-term drug implants to treat patients with chronic diseases and high unmet medical need. Today, the Company has grown to nearly 40 full-time employees and its current headquarters and operations are located at 1350 S. Loop Road, Alameda, California.
Upcoming Anticipated Milestones
● | Vivani anticipates filing the NPM-115 Investigational New Drug Application in the second half of 2024 and initiating a first-in-human trial after receiving regulatory clearance to proceed. |
● | The Company anticipates filing a Complete Response to the current Clinical Hold on NPM-119 during the first half of 2024. |
● | Vivani is seeking U.S. Securities and Exchange Commission (the “SEC”) approval to proceed with an initial public offering for wholly owned subsidiary Cortigent, Inc. Assuming successful financing is secured, the Company plans to continue advancing Cortigent’s pioneering precision neurostimulation technology for providing meaningful, visual perception in blind people and motor function in impaired stroke patients. |
Fourth Quarter 2023 Financial Results
Cash Balance: As of December 31, 2023, Vivani had cash, cash equivalents and restricted cash totaling $22.0 million, compared to $46.4 million as of December 31, 2022. The decrease of $24.5 million is primarily attributed to a net loss of $25.7 million, $1.3 million used from a net change in operating assets and liabilities and $0.9 million related to purchase of equipment. The decrease was partially offset by non-cash items totaling $3.2 million for depreciation and amortization of property and equipment, stock-based compensation, loss on disposal of fixed assets and lease expense.
Research and development expenses: Research and development expenses during the fourth quarter of 2023 were $4.7 million, compared to $4.4 million during the fourth quarter of 2022. The increase of $0.3 million, or 6%, was primarily attributable to increased payroll and personnel-related costs, increased rent and related facilities expense due to the lease agreement in Alameda, California, partially offset by lower spending on drug implants development costs.
General and administrative expenses: General and administrative expenses during the fourth quarter of 2023 were $1.5 million, compared to $3.4 million during the fourth quarter of 2022. The decrease of $1.9 million, or 55%, was primarily attributable to a provision for a legal claim of $1.7 million recorded in the fourth quarter of 2022.
Other income (expense): Other income (expense), net during the fourth quarter of 2023 was $0.2 million, compared to $0.5 million during the fourth quarter of 2022. The decrease of $0.3 million, or 62%, was primarily attributed to a decrease in interest income on cash investments.
Net Loss: The net loss during the fourth quarter of 2023 was $6.0 million, compared to $7.3 million during the fourth quarter of 2022. The decrease in net loss of $1.3 million was primarily attributable to a decrease in operating expenses of $1.6 million, partially offset by a decrease in interest income on cash investments.
Full Year 2023 Financial Results
Research and development expenses: Research and development expenses during the year ended December 31, 2023 was $17.0 million, compared to $14.2 million during the year ended December 31, 2022. The increase of $2.8 million, or 20%, was primarily attributable to increased payroll and personnel-related costs, increased rent due to the lease agreement in Alameda, California and related facilities expense and the inclusion of Cortigent (former legacy company Second Sight), since the merger acquisition date of August 30, 2022, partially offset by drug implant development costs.
General and administrative expenses: General and administrative expenses during the year ended December 31, 2023 was $10.0 million, compared to $7.1 million during the year ended December 31, 2022. The increase of $2.9 million, or 41%, was primarily attributable to increased payroll and personnel-related expenses, increased rent and related facilities expense due to the lease agreement in Alameda, California, insurance costs, professional service expense and the inclusion of Cortigent, since the merger acquisition date of August 30, 2022, partially offset by a provision for a legal claim of $1.7 million recorded in 2022.
Other income (expense), net: Other income (expense), net during the year ended December 31, 2023 was $1.3 million, compared to $7.4 million during the year ended December 31, 2022. Other income consisted of interest income of $1.5 million during the year ended December 31, 2023. Other income during the year ended December 31, 2022 included $6.9 million related to a gain on bargain purchase from the acquisition of Second Sight and interest income.
Net Loss: The net loss during the year ended December 31, 2023 was $25.7 million, compared to $13.9 million during the year ended December 31, 2022. The increase in net loss of $11.8 million was primarily attributable to an increase in operating expenses of $5.7 million and the prior year gain on the bargain purchase from the acquisition of Second Sight of $6.9 million, partially offset by increased interest income due to higher average investments and rate increases on cash investments.
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 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
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 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 Quarterly Report on Form 10-Q, 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
info@vivani.com
(818) 833-5000
Investor
Relations Contact:
Brigid Makes
Chief Financial Officer
investors@vivani.com
(818) 833-5000
Media Contact:
Sean Leous
ICR Westwicke
Sean.Leous@westwicke.com
(646) 866-4012
VIVANI MEDICAL, INC.
AND SUBSIDIARIES
Condensed Consolidated Balance Sheets (unaudited)
(in thousands, except per share data)
December 31, | ||||||||
2023 | 2022 | |||||||
ASSETS | ||||||||
Current assets: | ||||||||
Cash and cash equivalents | $ | 20,654 | $ | 45,076 | ||||
Prepaid expenses and other current assets | 2,408 | 2,452 | ||||||
Total current assets | 23,062 | 47,528 | ||||||
Property and equipment, net | 1,729 | 1,182 | ||||||
Right-of-use assets | 19,616 | 779 | ||||||
Restricted cash | 1,338 | 1,366 | ||||||
Deposits and other assets | 52 | 275 | ||||||
Total assets | $ | 45,797 | $ | 51,130 | ||||
LIABILITIES AND STOCKHOLDERS’ EQUITY | ||||||||
Current liabilities: | ||||||||
Accounts payable | $ | 542 | $ | 1,177 | ||||
Accrued expenses | 1,727 | 2,358 | ||||||
Litigation accrual | 1,675 | 1,675 | ||||||
Accrued compensation expense | 396 | 657 | ||||||
Current operating lease liabilities | 1,383 | 955 | ||||||
Total current liabilities | 5,723 | 6,822 | ||||||
Long-term operating lease liabilities | 19,313 | — | ||||||
Total liabilities | 25,036 | 6,822 | ||||||
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: 51,031 and 50,736 as of December 31, 2023 and December 31, 2022, respectively | 5 | 5 | ||||||
Additional paid-in capital | 119,054 | 117,054 | ||||||
Accumulated other comprehensive gain | 140 | 35 | ||||||
Accumulated deficit | (98,438 | ) | (72,786 | ) | ||||
Total stockholders’ equity | 20,761 | 44,308 | ||||||
Total liabilities and stockholders’ equity | $ | 45,797 | $ | 51,130 |
VIVANI MEDICAL, INC.
AND SUBSIDIARIES
Condensed Consolidated Statements of Operations (unaudited)
(in thousands, except per share data)
Three Months Ended December 31, | Twelve Months Ended December 31, | |||||||||||||||
2023 | 2022 | 2023 | 2022 | |||||||||||||
Operating expenses: | ||||||||||||||||
Research and development, net of grants | $ | 4,708 | $ | 4,427 | $ | 16,968 | $ | 14,169 | ||||||||
General and administrative, net of grants | 1,509 | 3,363 | 9,997 | 7,072 | ||||||||||||
Total operating expenses | 6,217 | 7,790 | 26,965 | 21,241 | ||||||||||||
Loss from operations | (6,217 | ) | (7,790 | ) | (26,965 | ) | (21,241 | ) | ||||||||
Other income (expense), net | 191 | 506 | 1,313 | 7,352 | ||||||||||||
Net loss | $ | (6,026 | ) | $ | (7,284 | ) | $ | (25,652 | ) | $ | (13,889 | ) | ||||
Net loss per common share - basic and diluted | $ | (0.12 | ) | $ | (0.14 | ) | $ | (0.50 | ) | $ | (0.36 | ) | ||||
Weighted average shares outstanding - basic and diluted | 51,025 | 50,736 | 50,853 | 38,241 |
Exhibit 99.2
Nasdaq: VANI www.vivani.com March 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 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 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 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. Q4 2023: P&L Statement 31 In Thousands, except per Share Data Dec. 31, 2023 Dec. 31, 2022 Dec. 31, 2023 Dec. 31, 2022 Operating expenses: Research and development, net of grants 4,708$ 4,427$ 16,968$ 14,169$ General and administrative, net of grants 1,509 3,363 9,997 7,072 Total operating expenses 6,217 7,790 26,965 21,241 Loss from operations (6,217) (7,790) (26,965) (21,241) Other income (expense), net 191 506 1,313 7,352 Net loss (6,026)$ (7,284)$ (25,652)$ (13,889)$ Net loss per common share – basic (0.12)$ (0.14)$ (0.50)$ (0.36)$ Net loss per common share – diluted (0.12)$ (0.14)$ (0.50)$ (0.36)$ Weighted average common shares outstanding – basic 51,025 50,736 50,853 38,241 Weighted average common shares outstanding – diluted 51,025 50,736 50,853 38,241 Three Months Ended Twelve Months Ended Condensed Consolidated Statements of Operations (unaudited)
Vivani Medical, Inc. Vivani Medical, Inc. Q4 2023: Balance Sheet 32 In Thousands Dec. 31, 2023 Dec. 31, 2022 ASSETS Cash and cash equivalents 20,654$ 45,076$ Prepaid expenses and other current assets 2,408 2,452 Total current assets 23,062 47,528 Property and equipment, net 1,729 1,182 Right-of-use assets 19,616 779 Restricted cash 1,338 1,366 Deposits and other assets 52 275 Total assets 45,797$ 51,130$ LIABILITIES AND STOCKHOLDERS’ EQUITY Current liabilities 5,723$ 6,822$ Long-term operating lease liabilities 19,313 — Total liabilities 25,036 6,822 Stockholders’ equity: Total Common Stock, APIC & Other Comp Gain 119,199 117,094 Accumulated deficit (98,438) (72,786) Total liabilities and stockholders’ equity 45,797$ 51,130$ Condensed Consolidated Balance Sheets (unaudited) * Note: In March 2024, Vivani received net proceeds of $13.8M from a registered direct offering of common stock and warrants. *
Vivani Medical, Inc. Q4 2023: Cap Table 33 As of December 31, 2023 Equity WAEP* Number of Shares Common Stock 51,031,097 Stock Options $2.60 6,090,617 RSUs - 402,500 Warrants** $11.60 9,733,068 Fully Diluted Shares 67,257,282 *Weighted Average Exercise Price
Vivani Medical, Inc. 34 Lead programs NPM - 115 and NPM - 119 are miniature, six - month, GLP - 1 (exenatide) implants under development for the treatment of chronic weight management in obese or overweight patients and type 2 diabetes, respectively. NPM - 139 (semaglutide implant) is also under development for chronic weight management with the added potential benefit of once - yearly administration. An innovative, biopharmaceutical company developing a portfolio of miniature, long - term, drug implants to treat chronic disease. Our NanoPortal ™ platform technology enables the design of implants aimed at improving medication non - adherence and tolerability. Vivani is well - positioned to advance NPM - 115 and NPM - 119 towards potentially transformational milestones in 2024.
F=UF*VE Q+$Q'PTH0P[M0=50^AR
M0JM%K3I\^'*Y;RM*HR$(:.XE##M'#/.&$^UU=QVU8J28'3.N>8@DY*(^_P <.OQU
MMLP8)GP+.)[&^-M'\N6UMK=;AJ7-S15HU$54=\R)7E5. DRGJWQ#?A]O
MLP].N-IH;K]-?,8V>X*1J%"Q&,&4F$2%7FF-+R0*,)D&(F@/OC(^TO+I45%7
MHT?J];JT_=1>.JDMU:X>8QCBG 8%U.X+-:+D:J9.8&F&<%RUY\3C9M
W (U-E8:[=9%_P@VJXX +*)\T+D1I'QQ+(-FWO$1.:W " 75;8:
MFJV4"RHR !Q:P+,=F 930RL2>(' GMP@+6&_>:E;04?4K "09-.[")Q/)]U;
M.[V]F];53=2WJ:VH#-<21)3B2N<8>0\C$L[/=7+A(30&<@FYY5*DR([6PQGE
M&ULVME:]+5;>[>EF+, \4.G4!(4L,( WN;L7W/;W=5MVQN.Z?B).W5;K3>EM-N$>]_1OL9[(^WG/;W5/0
MGL]T!TAU->]7_O\ Y'T]MMOS3;"^6-X\NW#F\>6&[J(8[<6C!@$"F/2>7WKO
M/<-A<7G 8!HBOS Q$8E2J9&B'K5P*PL?AN
M$R2)!*$D '*N EUVA;)!4:O+YLQP5N%"1
M;_=6]E=:ZJIZ]R5%%)D0"X$^4"*8HZ[&]"KD93 _[X].):4:FN'E/4Y"#BQCDWR ?8,9Q4Y,C.,AZY;3=;>W<"LPMT=5)U22#(BM,)HIMI&0JV1=T@4FO
MF)FM<\B,2U6IW>]I3-+86EMWAN"=%FV34F3<+&-,&9$<1@P*2G'$O?%FR@3;
M:U_,76=GJ&4:H*S^%3GAB9GFX$<$9RTZO-Q$,-4UP"-78O;2\%JRW]27%#F&
M]3\1(/E(X' FQJY^T<:U;0Z6ABLA[I:62M%;M,8I)%0F".YV8FVJOI)\VCRF
M1^(-G%
WNA;Z!]>N9+$!@&A9F@B?AARR=*8KOWC<:222%.=?#5P
M.6&NI/1BMO1J4M( (J"96LR(P-05+6)K\NO*+MRT 71PSD:HU$3108J1GB3M
M5UVE-X0%39V[[-