Leveraging its proprietary NanoPortal$(TM)$ 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 $500 billion in annual avoidable healthcare costs and 125,000 potentially preventable deaths annually in the U.S. alone, is a primary and daunting reason why obese or overweight patients, and patients taking type 2 diabetes or other chronic disease medications face significant challenges in achieving positive real-world effectiveness.
About Cortigent
Vivani's wholly owned subsidiary Cortigent is developing precision neurostimulation systems intended to help patients recover critical body functions. Investigational devices include Orion$(R)$ , 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(R) , 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.
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 Twelve Months Ended
December 31, 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
====== ====== ======= =======
View source version on businesswire.com: https://www.businesswire.com/news/home/20240326159238/en/
CONTACT: 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
(END) Dow Jones Newswires
March 26, 2024 08:30 ET (12:30 GMT)
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