8-K
Vivani Medical, Inc. (VANI)
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): October 22, 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, including zip code)
(415) 506-8462
(Telephone number, including area code, of agent for service)
(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<br>Symbol(s) | Name of each exchange on which registered |
|---|---|---|
| Common Stock, par value $0.0001 per share | 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 8.01 Other Events.
On October 22, 2024, Vivani Medical, Inc. announced it will be presenting at the Partnership Opportunities in Drug Delivery (PODD) Event on October 29, 2024 and at the ThinkEquity Conference on October 30, 2024. A copy of the press release issued in connection with this announcement is being furnished as Exhibit 99.1 to this Current Report on Form 8-K.
| Item 9.01 | Financial Statements and Exhibits. |
|---|
(d) Exhibits.
| Exhibit<br>No. | Description |
|---|---|
| 99.1 | Press release issued by Vivani Medical, Inc. on October 22, 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, the registrant has duly caused this report to be signed on its behalf by the undersigned thereunto duly authorized.
| VIVANI MEDICAL, INC. | ||
|---|---|---|
| Date: October 22, 2024 | By: | /s/ Donald Dwyer |
| Name: | Donald Dwyer | |
| Title: | Chief Business Officer |
Exhibit****99.1
FOR IMMEDIATE RELEASE
Vivani Medical to Present at the Partnership Opportunities in Drug Delivery (PODD) Event and ThinkEquity Conference in October 2024
ALAMEDA, Calif. – (BUSINESS NEWSWIRE) – October 22, 2024 – Vivani Medical, Inc. (NASDAQ: VANI) (the “Company” or “Vivani”), an innovative biopharmaceutical company developing miniaturized, ultra long-acting drug implants, announced today that it will present at two upcoming events in October: (1) Partnership Opportunities in Drug Delivery (PODD), taking place in Boston on October 28 and 29, 2024 and (2) the ThinkEquity Conference, taking place in New York on October 30, 2024.
Event details are as follows:
Partnership Opportunities in Drug Delivery (PODD) Event
Panel (Track 1): Targeted and Long Acting Delivery; Sustained Release Innovations to Reduce Patient Burden
Date: Tuesday, October 29, 2024
Time: 3:35 p.m. - 4:05 p.m. Eastern Time
Location: Westin Boston Seaport, 425 Summer Street, Boston, MA 02210
Dr. Adam Mendelsohn, Vivani’s Chief Executive Officer and other industry representatives will participate on the panel discussion which will be moderated by Stephen Buckley, Ph.D., Vice President, Advanced Drug Delivery at Novo Nordisk. More information about the panel and PODD event can be found at https://poddconference.com/.
ThinkEquity Conference
Presentation Date: Wednesday, October 30, 2024
Presentation Time: 2:30 p.m. Eastern Time
Location: The Mandarin Oriental Hotel, 80 Columbus Circle, New York, 10023
Dr. Mendelsohn will provide a Company related update. A webcast of the Vivani ThinkEquity Conference presentation will be available on the Investors page of the Vivani corporate website and at the following link: https://wsw.com/webcast/tep25/vani/1677024.
More information about the ThinkEquity Conference, including registration information, can be found at https://www.think-equity.com/thinkequity-conference.
About Vivani Medical, Inc.
Leveraging its proprietary NanoPortalTM 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 patient tolerance to their medication. Vivani’s lead program, NPM-115, utilizes a miniature, six-month, subdermal, GLP-1 (exenatide) implant under development for chronic weight management in obese or overweight individuals. Vivani’s emerging pipeline also includes the NPM-139 (semaglutide) implant which is also under development for chronic weight management in obese and overweight individuals. The semaglutide implant has the added potential benefit of once-yearly administration. NPM-119 refers to the Company’s Type 2 Diabetes development program utilizing a six-month, subdermal exenatide implant. Both the NPM-115 and NPM-119 programs utilize exenatide based products with a higher-dose associated with the NPM-115 program for 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 obese or overweight patients, and patients taking type 2 diabetes or other chronic disease treatments, face significant challenges in achieving positive real-world effectiveness. While the current GLP-1 landscape includes over 50 new molecular entities under clinical stage development, Vivani remains confident that its highly differentiated portfolio of miniature long-acting GLP-1 implants have the potential to provide an attractive therapeutic option for patients, prescribers and payers.
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 Vivani’s business, products in development, including the therapeutic potential thereof, the planned development therefor, the initiation of the LIBERATE-1 trial and reporting of trial results, Vivani’s emerging development plans for NPM-115, NPM-139, or Vivani’s plans with respect to Vivani’s 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 Vivani’s 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 Vivani’s 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 Vivani’s products, including NPM-115 and NPM-119; delays and changes in the development of Vivani’s products, including as a result of applicable laws, regulations and guidelines, potential delays in submitting and receiving regulatory clearance or approval to conduct Vivani’s development activities, risks related to the initiation, enrollment and conduct of Vivani’s planned clinical trials and the results therefrom; Vivani’s history of losses and Vivani’s ability to access additional capital or otherwise fund Vivani’s 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 filed with the U.S. Securities and Exchange Commission filed on March 26, 2024, as updated by the Company’s subsequent Quarterly Reports on Form 10-Q. Any forward-looking statement made by Vivani 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: Jami Taylor Investor Relations Advisor investors@vivani.com (415) 506-8462
Media Contact: Sean Leous ICR Westwicke sean.leous@westwicke.com (646) 866-4012