Vivani's wholly owned subsidiary, Cortigent, Inc. ("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. Cortigent 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 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 Cortigent and its proposed initial public offering, technology, strategy, cash position and financial runway. Forward-looking statements are neither historical facts nor assurances of future performance. Instead, they are based only on 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, including Vivani's ability to commence clinical development of NPM-119; 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; market conditions and the ability of Cortigent to complete its initial public offering. There may be additional risks that the Company considers immaterial, or which are unknown. A further list and description of risks and uncertainties can be found in the Company's most recent Annual Report on Form 10-K filed with the 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.
VIVANI MEDICAL, INC.
AND SUBSIDIARIES
Condensed Consolidated Balance Sheets (unaudited)
(In thousands, except per share data)
September 30, December 31,
2024 2023
--------------- ------------------
ASSETS
Current assets:
Cash and cash equivalents $ 19,646 $ 20,654
Prepaid expenses and other
current assets 1,753 2,408
----------- --------------
Total current assets 21,399 23,062
Property and equipment, net 1,644 1,729
Right-of-use assets 18,383 19,616
Restricted cash 1,338 1,338
Other assets 132 52
----------- --------------
Total assets $ 42,896 $ 45,797
=========== ==============
LIABILITIES AND STOCKHOLDERS'
EQUITY
Current liabilities:
Accounts payable $ 815 $ 542
Accrued expenses 2,024 1,727
Litigation accrual 1,675 1,675
Accrued compensation
expense 371 396
Current operating lease
liabilities 1,385 1,383
----------- --------------
Total current liabilities 6,270 5,723
Long-term operating lease
liabilities 18,294 19,313
----------- --------------
Total liabilities 24,564 25,036
----------- --------------
Commitments and contingencies
(Note 12)
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:
55,266 and 51,031 at
September 30, 2024 and
December 31, 2023,
respectively 6 5
Additional paid-in capital 134,108 119,054
Accumulated other
comprehensive income 92 140
Accumulated deficit (115,874) (98,438)
----------- --------------
Total stockholders' equity 18,332 20,761
----------- --------------
Total liabilities and
stockholders' equity $ 42,896 $ 45,797
=========== ==============
VIVANI MEDICAL, INC.
AND SUBSIDIARIES
Condensed Consolidated Statements of Operations (unaudited)
(In thousands, except per share data)
Three Months Ended Nine Months Ended
September 30, September 30,
------------------ -------------------
2024 2023 2024 2023
------- -------- -------- --------
Operating
expenses:
Research and
development, net
of grants $ 4,203 $ 4,441 $ 11,442 $ 12,260
General and
administrative,
net of grants 2,106 2,703 6,775 8,488
------ ------- ------- -------
Total operating
expenses 6,309 7,144 18,217 20,748
------ ------- ------- -------
Loss from
operations (6,309) (7,144) (18,217) (20,748)
Other income, net 268 362 781 1,122
------ ------- ------- -------
Net loss $(6,041) $ (6,782) $(17,436) $(19,626)
====== ======= ======= =======
Net loss per
common share -
basic and
diluted $ (0.11) $ (0.13) $ (0.32) $ (0.39)
------ ------- ------- -------
Weighted average
common shares
outstanding -
basic and
diluted 55,247 50,837 54,161 50,757
====== ======= ======= =======
View source version on businesswire.com: https://www.businesswire.com/news/home/20241113827166/en/
CONTACT: 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
(END) Dow Jones Newswires
November 13, 2024 08:30 ET (13:30 GMT)
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