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UNITED
STATES
SECURITIES
AND EXCHANGE COMMISSION
Washington,
DC 20549
FORM
10-Q
(Mark
One)
☒ |
QUARTERLY
REPORT PURSUANT TO SECTION 13 OR 15 (d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
For
the quarterly period ended June 30, 2023
or
☐ |
TRANSITION
REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
For
the transition period from ________ to ________
Commission
File Number: 001-36747
Vivani
Medical, Inc.
(Exact
name of registrant as specified in its charter)
Delaware |
|
02-0692322 |
(State or other
jurisdiction of
incorporation or organization) |
|
(I.R.S. Employer
Identification No.) |
5858
Horton Street, Suite 280 Emeryville, CA 94608
(Address
of principal executive offices, including zip code)
(415) 506-8462
(Registrant’s
telephone number, including area code)
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 |
|
VANI |
|
NASDAQ |
Indicate
by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15 (d) of the Securities
Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such
reports), and (2) has been subject to such filing requirements for the past 90 days. Yes ☒ No ☐
Indicate
by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant
to Rule 405 of Regulation S-T (§232.405 of this chapter) during the preceding 12 months (or for such shorter period that
the registrant was required to submit such files). Yes ☒ No ☐
Indicate
by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, a smaller reporting
company, or an emerging growth company. See the definitions of “large accelerated filer,” “accelerated filer,”
“smaller reporting company,” and “emerging growth company” in Rule 12b-2 of the Exchange Act.
Large accelerated filer |
☐ |
|
Accelerated filer |
☐ |
Non-accelerated filer |
☒ |
|
Smaller reporting company |
☒ |
|
|
|
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. ☐
Indicate
by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act).
Yes ☐ No ☒
As
of August 10, 2023, the registrant had 50,818,799
shares of common stock, par value $0.0001 per share and 7,680,938 warrants, outstanding.
VIVANI
MEDICAL, INC.
AND
SUBSIDIARIES
FORM
10-Q
TABLE
OF CONTENTS
PART
I. FINANCIAL STATEMENTS
Item
1. Financial Statements
VIVANI
MEDICAL, INC.
AND
SUBSIDIARIES
Condensed
Consolidated Balance Sheets (unaudited)
(in
thousands except per share data)
|
|
June
30, |
|
|
December
31, |
|
|
|
2023 |
|
|
2022 |
|
|
|
|
|
|
|
|
ASSETS |
|
|
|
|
|
|
|
|
Current
assets: |
|
|
|
|
|
|
|
|
Cash
and cash equivalents |
|
$ |
32,486 |
|
|
$ |
45,076 |
|
Prepaid
expenses and other current assets |
|
|
3,736 |
|
|
|
2,452 |
|
Total
current assets |
|
|
36,222 |
|
|
|
47,528 |
|
Property
and equipment, net |
|
|
1,075 |
|
|
|
1,182 |
|
Right-of-use
assets |
|
|
20,684 |
|
|
|
779 |
|
Restricted
cash |
|
|
1,366 |
|
|
|
1,366 |
|
Deposits
and other assets |
|
|
260 |
|
|
|
275 |
|
Total
assets |
|
$ |
59,607 |
|
|
$ |
51,130 |
|
LIABILITIES
AND STOCKHOLDERS’ EQUITY |
|
|
|
|
|
|
|
|
Current
liabilities: |
|
|
|
|
|
|
|
|
Accounts
payable |
|
$ |
1,989 |
|
|
$ |
1,177 |
|
Accrued
expenses |
|
|
1,994 |
|
|
|
2,358 |
|
Litigation
accrual |
|
|
1,675 |
|
|
|
1,675 |
|
Accrued
compensation expense |
|
|
567 |
|
|
|
657 |
|
Current
operating lease liabilities |
|
|
861 |
|
|
|
955 |
|
Total
current liabilities |
|
|
7,086 |
|
|
|
6,822 |
|
Long
term operating lease liabilities |
|
|
20,127 |
|
|
|
— |
|
Total
liabilities |
|
|
27,213 |
|
|
|
6,822 |
|
Commitments
and contingencies (Note 10) |
|
|
|
|
|
|
|
|
Stockholders’
equity: |
|
|
|
|
|
|
|
|
Preferred
stock, no par value, 10,000 shares authorized; none outstanding |
|
|
— |
|
|
|
— |
|
Common
stock, par value $0.0001 per share; 300,000 shares authorized; shares issued and outstanding: 50,799 as of June 30, 2023 and
50,736 as of December 31, 2022, respectively |
|
|
5 |
|
|
|
5 |
|
Additional
paid-in capital |
|
|
117,954 |
|
|
|
117,054 |
|
Accumulated
other comprehensive loss |
|
|
65 |
|
|
|
35 |
|
Accumulated
deficit |
|
|
(85,630 |
) |
|
|
(72,786 |
) |
Total
stockholders’ equity |
|
|
32,394 |
|
|
|
44,308 |
|
Total
liabilities and stockholders’ equity |
|
$ |
59,607 |
|
|
$ |
51,130 |
|
The
accompanying notes are an integral part of these condensed consolidated financial statements.
VIVANI
MEDICAL, INC.
AND
SUBSIDIARIES
Condensed
Consolidated Statements of Operations (unaudited)
(in
thousands, except per share data)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
For the Three Months ended |
|
|
For the Six Months ended |
|
|
|
June 30, |
|
|
June 30, |
|
|
|
2023 |
|
|
2022 |
|
|
2023 |
|
|
2022 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and development, net of grants |
|
$ |
3,864 |
|
|
$ |
3,203 |
|
|
$ |
7,819 |
|
|
$ |
5,883 |
|
General and administrative |
|
|
3,139 |
|
|
|
884 |
|
|
|
5,785 |
|
|
|
2,112 |
|
Total operating expenses |
|
|
7,003 |
|
|
|
4,087 |
|
|
|
13,604 |
|
|
|
7,995 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Loss from operations |
|
|
(7,003 |
) |
|
|
(4,087 |
) |
|
|
(13,604 |
) |
|
|
(7,995 |
) |
Other income (expense), net |
|
|
477 |
|
|
|
(16 |
) |
|
|
760 |
|
|
|
(33 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net income/(loss) |
|
$ |
(6,526 |
) |
|
$ |
(4,103 |
) |
|
$ |
(12,844 |
) |
|
$ |
(8,028 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net income/(loss) per common share – basic |
|
$ |
(0.13 |
) |
|
$ |
(0.11 |
) |
|
$ |
(0.25 |
) |
|
$ |
(0.22 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted average common shares outstanding – basic |
|
|
50,795 |
|
|
|
36,880 |
|
|
|
50,748 |
|
|
|
36,819 |
|
The
accompanying notes are an integral part of these condensed consolidated financial statements.
VIVANI
MEDICAL, INC.
AND
SUBSIDIARIES
Condensed Consolidated Statements
of Comprehensive Loss (unaudited)
(in thousands)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended |
|
|
Six Months Ended |
|
|
|
June 30, |
|
|
June 30, |
|
|
|
2023 |
|
|
2022 |
|
|
2023 |
|
|
2022 |
|
Net loss |
|
$ |
(6,526 |
) |
|
$ |
(4,103 |
) |
|
$ |
(12,844 |
) |
|
$ |
(8,028 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Other comprehensive income (loss): |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Foreign currency translation adjustments |
|
|
21 |
|
|
|
— |
|
|
|
30 |
|
|
|
— |
|
Comprehensive loss |
|
$ |
(6,505 |
) |
|
$ |
(4,103 |
) |
|
$ |
(12,814 |
) |
|
$ |
(8,028 |
) |
The
accompanying notes are an integral part of these condensed consolidated financial statements.
VIVANI
MEDICAL, INC.
AND
SUBSIDIARIES
Condensed
Consolidated Statements of Stockholders’ Equity (Deficit) (unaudited)
(in thousands)
|
|
|
|
|
|
|
|
|
|
|
Accumulated |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Additional |
|
|
Other |
|
|
|
|
|
Total |
|
|
|
Common
Stock |
|
|
Paid-in |
|
|
Comprehensive |
|
|
Accumulated |
|
|
Stockholders’ |
|
|
|
Shares |
|
|
Amount |
|
|
Capital |
|
|
Loss |
|
|
Deficit |
|
|
Equity
(Deficit) |
|
Balance,
January 1, 2022 |
|
|
36,803 |
|
|
$ |
4 |
|
|
$ |
61,358 |
|
|
$ |
— |
|
|
$ |
(58,897 |
) |
|
$ |
2,465 |
|
Repurchase
of common stock |
|
|
4 |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
Options
exercised |
|
|
24 |
|
|
|
— |
|
|
|
1 |
|
|
|
— |
|
|
|
— |
|
|
|
1 |
|
Stock-based
compensation expense |
|
|
— |
|
|
|
— |
|
|
|
340 |
|
|
|
— |
|
|
|
— |
|
|
|
340 |
|
Net
loss |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
(3,924 |
) |
|
|
(3,924 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance,
March 31, 2022 |
|
|
36,831 |
|
|
$ |
4 |
|
|
$ |
61,699 |
|
|
$ |
— |
|
|
$ |
(62,821 |
) |
|
$ |
(1,118 |
) |
Options
exercised |
|
|
6 |
|
|
|
— |
|
|
|
12 |
|
|
|
— |
|
|
|
— |
|
|
|
12 |
|
Stock-based
compensation expense |
|
|
— |
|
|
|
— |
|
|
|
394 |
|
|
|
— |
|
|
|
— |
|
|
|
394 |
|
Net
loss |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
(4,103 |
) |
|
|
(4,103 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance,
June 30, 2022 |
|
|
36,837 |
|
|
$ |
4 |
|
|
$ |
62,105 |
|
|
$ |
— |
|
|
$ |
(66,924 |
) |
|
$ |
(4,815 |
) |
|
|
|
|
|
|
|
|
|
|
|
Accumulated |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Additional |
|
|
Other |
|
|
|
|
|
Total |
|
|
|
Common
Stock |
|
|
Paid-in |
|
|
Comprehensive |
|
|
Accumulated |
|
|
Stockholders’ |
|
|
|
Shares |
|
|
Amount |
|
|
Capital |
|
|
Loss |
|
|
Deficit |
|
|
Equity |
|
Balance,
January 1, 2023 |
|
|
50,736 |
|
|
$ |
5 |
|
|
$ |
117,054 |
|
|
$ |
35 |
|
|
$ |
(72,786 |
) |
|
$ |
44,308 |
|
Options
exercised |
|
|
53 |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
Stock-based
compensation expense |
|
|
— |
|
|
|
— |
|
|
|
369 |
|
|
|
— |
|
|
|
— |
|
|
|
369 |
|
Foreign
currency adjustment |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
9 |
|
|
|
— |
|
|
|
9 |
|
Net
loss |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
(6,318 |
) |
|
|
(6,318 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance,
March 31, 2023 |
|
|
50,789 |
|
|
$ |
5 |
|
|
$ |
117,423 |
|
|
$ |
44 |
|
|
$ |
(79,104 |
) |
|
$ |
38,368 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Options
exercised |
|
|
10 |
|
|
|
— |
|
|
|
7 |
|
|
|
— |
|
|
|
— |
|
|
|
7 |
|
Stock-based
compensation expense |
|
|
— |
|
|
|
— |
|
|
|
524 |
|
|
|
— |
|
|
|
— |
|
|
|
524 |
|
Foreign
currency adjustment |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
21 |
|
|
|
— |
|
|
|
21 |
|
Net
loss |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
(6,526 |
) |
|
|
(6,526 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance,
June 30, 2023 |
|
|
50,799 |
|
|
$ |
5 |
|
|
$ |
117,954 |
|
|
$ |
65 |
|
|
$ |
(85,630 |
) |
|
$ |
32,394 |
|
The
accompanying notes are an integral part of these condensed consolidated financial statements.
VIVANI
MEDICAL, INC.
AND
SUBSIDIARIES
Condensed
Consolidated Statements of Cash Flows (unaudited)
(in
thousands)
|
|
|
|
|
|
|
|
|
|
|
Six
Months Ended June 30, |
|
|
|
2023 |
|
|
2022 |
|
Cash
flows from operating activities: |
|
|
|
|
|
|
|
|
Net
loss |
|
$ |
(12,844 |
) |
|
$ |
(8,028 |
) |
Adjustments
to reconcile net loss to net cash used in operating activities: |
|
|
|
|
|
|
|
|
Depreciation
and amortization |
|
|
188 |
|
|
|
170 |
|
Stock-based
compensation |
|
|
893 |
|
|
|
734 |
|
Non-cash
lease expense |
|
|
128 |
|
|
|
54 |
|
Changes
in operating assets and liabilities: |
|
|
|
|
|
|
|
|
Prepaid
expenses and other assets |
|
|
(1,270 |
) |
|
|
(181 |
) |
Accounts
payable |
|
|
822 |
|
|
|
363 |
|
Accrued
compensation expenses |
|
|
(90 |
) |
|
|
— |
|
Accrued
expenses |
|
|
(343 |
) |
|
|
263 |
|
Net
cash used in operating activities |
|
|
(12,516 |
) |
|
|
(6,625 |
) |
Cash
flows from investing activities: |
|
|
|
|
|
|
|
|
Purchases
of property and equipment |
|
|
(81 |
) |
|
|
(116 |
) |
Net
cash used in investing activities |
|
|
(81 |
) |
|
|
(116 |
) |
Cash
flows from financing activities: |
|
|
|
|
|
|
|
|
Proceeds
from SAFE note |
|
|
— |
|
|
|
8,000 |
|
Net
proceeds from sale of common stock and exercise of warrants |
|
|
7 |
|
|
|
13 |
|
Net
cash provided by financing activities |
|
|
7 |
|
|
|
8,013 |
|
Effect
of exchange rate changes on cash and cash equivalents |
|
|
0 |
|
|
|
— |
|
Cash,
cash equivalents and restricted cash: |
|
|
|
|
|
|
|
|
Net
increase (decrease) |
|
|
(12,590 |
) |
|
|
1,272 |
|
Balance
at beginning of period |
|
|
46,442 |
|
|
|
2,178 |
|
Balance
at end of period |
|
$ |
33,852 |
|
|
$ |
3,450 |
|
Non-cash
investing and financing activities: |
|
|
|
|
|
|
|
|
Establishment
of operating right-of-use assets through operating lease obligations |
|
$ |
20,755 |
|
|
$ |
— |
|
The
accompanying notes are an integral part of these condensed consolidated financial statements.
VIVANI
MEDICAL, INC.
AND
SUBSIDIARY
Notes
to Condensed Consolidated Financial Statements (unaudited)
|
1. |
Organization and Business Operations |
Vivani Medical, Inc. (“Vivani,”
the “Company,” “we,” “us,” “our” or similar terms) is a preclinical stage biopharmaceutical
company which develops miniaturized, subdermal implants utilizing its proprietary NanoPortal™ technology to enable long-term,
near constant-rate delivery of a broad range of medicines to treat chronic diseases. Vivani uses this platform technology to develop
and potentially commercialize drug implants, alone or in collaboration with pharmaceutical company partners to address a leading
cause of poor clinical outcomes in the treatment of chronic disease, medication non-adherence. For example, approximately 50% of
patients treated for type 2 diabetes are non-adherent to their medicines which can lead to poor clinical outcomes. We are developing
a portfolio of miniature, sub-dermal drug implants that, unlike most oral and injectable medicines, are designed with the goal
of guaranteeing adherence by delivering therapeutic drug levels for up to 6 months or the life of the implant. In addition, by
leveraging our proprietary NanoPortal implant technology we can design implants that deliver minimally fluctuating drug levels
that may improve the tolerability profiles for certain medicines for which side effects are associated with fluctuating drug levels
such as GLP-1 receptor agonists (GLP-1s).
In February 2022, we announced the signing
of a definitive merger agreement between Nano Precision Medical, Inc. (“NPM”) and Second Sight Medical Products, Inc.
(“Second Sight”), pursuant to which NPM became a wholly owned subsidiary of Second Sight. On August 30, 2022, the merger
closed and the combined company of NPM and Second Sight was renamed Vivani Medical, Inc.
In December 2022, we contributed our neuromodulation
assets and certain liabilities to Cortigent, Inc. a newly formed corporation in Delaware, and wholly owned subsidiary of Vivani,
in exchange for 20 million shares of common stock of Cortigent. While the primary focus of Vivani is to develop and ultimately
commercialize our drug implant business from legacy company NPM, Vivani’s new management team remains committed to identifying
and exploring strategic options for the further advancement of the neuromodulation business of Cortigent which includes the development
of its pioneering neurostimulation systems to help patients recover critical body functions. In March 2023, Vivani announced the
filing of a Registration Statement on Form S-1 with the U.S. Securities and Exchange Commission (“SEC”) for the proposed
initial public offering of Cortigent. Cortigent will continue to be majority-owned by Vivani immediately following its initial
public offering.
Subject to completion of Cortigent’s
initial public offering, Vivani intends to focus exclusively on further development of the drug implant business.
On July 6, 2023, Vivani changed its state
of incorporation from the State of California to the State of Delaware by means of a plan of conversion, effective July 5, 2023.
The reincorporation, including the principal terms of the plan of conversion, was submitted to a vote of, and approved by, Vivani’s
stockholders at its 2023 Annual Meeting of Stockholders held on June 15, 2023.
As part of this change of incorporation the Company established
a par value of $0.0001 per share and all periods have been retroactively adjusted to reflect this change.
In
early July 2023, Vivani successfully completed the manufacture of clinical supplies to support a proposed first-in-human (“FIH”)
investigation of NPM-119 (exenatide implant) in patients with type 2 diabetes mellitus. On July 14, 2023, the Company submitted
an Investigational New Drug (“IND”) application to the U.S. Food and Drug Administration (“FDA)” for the
proposed NPM-119 FIH study also named LIBERATE-1™. On August 11, 2023, FDA verbally notified Vivani that the agency
was placing a clinical hold on Vivani’s IND application for the proposed clinical investigation and indicated its intention
to subsequently provide an official clinical hold letter stating the reasons for the clinical hold. Vivani plans to engage with
the FDA in order to lift the clinical hold and commence its planned clinical development of NPM-119. The Company expects to commence
enrollment in LIBERATE-1 in the second half of 2023 subject to regulatory clearance. Assuming LIBERATE-1 commences as planned,
the Company would anticipate the availability of interim LIBERATE-1 data in the first half of 2024 and full top-line results in
the second half of 2024.
Agreement
and Plan of Merger with Nano Precision Medical, Inc.
On
February 4, 2022, Second Sight entered into an agreement and plan of merger
(the “Merger Agreement”) with NPM. The Merger was approved by the shareholders
of Second Sight on July 27, 2022, and closed on August 30, 2022. Upon consummation of the Merger, NPM became a wholly owned subsidiary
of Second Sight. Concurrent with to the Merger, Second Sight changed its name to Vivani Medical, Inc., and changed its trading
symbol from EYES to VANI, and trades under the ticker VANI on the NASDAQ market. Certain investors and members of the NPM board
of directors are also investors and members of the board of directors of Second Sight.
Under
the terms and conditions of the Merger Agreement, the securities of NPM converted into the right to receive shares of Second Sight’s
common stock representing 77.32% of the total issued and outstanding shares of common stock of Second Sight on a fully converted
basis, including, without limitation, giving effect to the conversion of all options, warrants, and any and all other convertible
securities assuming net settlement. Second Sight filed a Registration Statement on Form S-4 on May 13, 2022, in connection with
the Merger to register the merger shares effective June 24, 2022.
On
February 4, 2022, in connection with the Merger, Second Sight and NPM also entered into a Simple Agreement for Future Equity (“SAFE”)
whereby Second Sight provided to NPM an investment advance of $8 million. The Merger Agreement provided that the SAFE would terminate
if the Merger were to be successfully completed. Under the terms of the SAFE, upon successfully completion of the Merger on August
30, 2022, the investment advance was eliminated. Under the accounting for a business combination, the $8 million adjusted the
purchase consideration.
The
Merger involved a change of control and was accounted for as a reverse merger in accordance with accounting principles generally
accepted in the United States of America (“GAAP”). Under this method of accounting, Second Sight was treated as the
“acquired” company for financial reporting purposes with NPM as the acquirer. The assets acquired and liabilities
assumed by NPM were recorded at fair value under Accounting Codification Standard (“ASC”), Business Combinations.
Accordingly, on August 30, 2022 (the “Acquisition Date”), NPM (a calendar year-end entity) was deemed to have acquired
100% of the outstanding common shares and voting interest of Second Sight. The results of Second Sight’s operations
have been included in the consolidated financial statements since that date.
The
acquisition-date fair value of consideration transferred totaled $54.4 million, which consisted of the fair value of the 13,136
common shares deemed issued to Second Sight shareholders, was determined based on the per share closing price of the Company’s
common shares on the acquisition date of $4.14.
The
following table summarizes the fair values of the assets acquired and liabilities assumed at the acquisition date (in thousands):
At August 30, 2022 |
|
|
|
|
|
|
|
Cash |
|
$ |
55,374 |
|
Property and equipment |
|
|
99 |
|
Prepaid expenses |
|
|
1,657 |
|
Right of use assets |
|
|
140 |
|
Other assets |
|
|
56 |
|
Total identifiable assets acquired |
|
|
57,326 |
|
Current liabilities |
|
|
(3,913 |
) |
Right of use liabilities |
|
|
(151 |
) |
Total liabilities assumed |
|
|
4,064 |
|
Net identifiable assets acquired |
|
$ |
53,262 |
|
The
SAFE loan of $8.0 million was cancelled in the Merger which adjusted the fair value of net assets acquired.
The
following table summarizes the calculation of the gain on bargain purchase (in thousands):
|
|
|
|
|
Total consideration |
|
$ |
54,385 |
|
SAFE loan forgiven |
|
|
(8,000 |
) |
Less net identifiable assets acquired |
|
|
(53,262 |
) |
Gain on bargain purchase |
|
$ |
6,877 |
|
Because
NPM purchased 100% of Second Sight and the fair value of identifiable assets acquired and liabilities assumed exceeded the fair
value of the consideration, we reassessed the recognition and measurement of identifiable assets acquired and liabilities assumed
and concluded that all acquired assets and assumed liabilities were properly recognized and that the valuation procedures and
resulting measures were appropriate. As a result, we recognized a gain of $6.9 million.
We
recognized $0.7 million of acquisition related costs that were expensed in the twelve months ended December 31, 2022. These costs
are included in the consolidated income statement in the line item entitled “General and administrative costs.”
Pro
forma consolidated net loss as if Second Sight had been included in the consolidated results was $13.3 million for the six months
ended June 30, 2022.
Liquidity
From
inception, our operations have been funded primarily through the sales of our common stock and warrants. The completion of our
reverse merger with Second Sight Medical Products, Inc. provided $53.3 million in net assets including approximately $55.4 million
in cash.
Our
financial statements have been presented on the basis that our business is a going concern, which contemplates the realization
of assets and the satisfaction of liabilities in the normal course of business. We are subject to the risks and uncertainties
associated with a business with no revenue that is developing novel medical devices, including limitations on our operating capital
resources. We have incurred recurring operating losses and negative operating cash flows since inception, and we expect to continue
to incur operating losses and negative operating cash flows for the foreseeable future. We estimate that currently available cash
will provide sufficient funds to enable the Company to meet its planned obligations through September 2024.
2.
Basis of Presentation, Significant Accounting Policies and Recent Accounting Pronouncements
Basis
of Presentation
These
unaudited interim financial statements have been prepared in accordance with United States generally accepted accounting principles
(“GAAP”) and following the requirements of the SEC for interim reporting. As permitted under those rules, certain footnotes or other financial information that are normally required
by GAAP can be condensed or omitted. In our opinion, the unaudited interim financial statements have been prepared on the same
basis as the audited financial statements and include all adjustments, which include only normal recurring adjustments, necessary
for the fair presentation of our financial position and our results of operations and cash flows for periods presented. These
statements do not include all disclosures required by GAAP and should be read in conjunction with our financial statements and
accompanying notes for the fiscal year ended December 31, 2022, included within our Annual Report on Form 10-K filed with the
SEC on March 31, 2023. The results of the interim periods are not necessarily indicative of the results expected for the full
fiscal year or any other interim period or any future year or period.
Income
taxes - interim periods
In
calculating the provision for interim income taxes, in accordance with ASC 740, Income Taxes, an estimated annual effective
tax rate is applied to year-to-date ordinary income. At the end of each interim period, we estimate the effective tax rate expected
to be applicable for the full fiscal year. This differs from the method utilized at the end of an annual period.
Use
of estimates
The
preparation of financial statements requires management to make a number of estimates and assumptions related to the
reported amount of assets and liabilities and the disclosure of contingent assets and liabilities at the date of the
financial statements, and the reported amounts of expenses during the period. Estimates are based on historical experience
and on various other assumptions that are believed to be reasonable under the circumstances. Some of the more significant
estimates include the purchase price of net assets acquired in the Merger, useful lives of long-lived assets, the fair value
of equity-based compensation, and the estimated incremental borrowing rate used in calculating lease assets and liabilities
and evaluation of going concern. Actual results could differ materially from those estimates.
Net
income/loss per share
Basic
net income/loss per share is computed using net income/loss from operations divided by the weighted-average number of shares of
common stock outstanding during the period.
Diluted
net income/loss per share represents net income/loss from operations divided by the weighted- average number of common shares
outstanding during the period, including all potentially dilutive common stock equivalents. Common stock equivalents consist of
shares subject to warrants and share-based awards with exercise prices less than the average market price of common stock for
the period, to the extent their inclusion would be dilutive.
The
computation of the weighted-average shares of common stock outstanding for diluted EPS excludes the following potential common
shares as of June 30, 2023, and 2022 (in thousands):
Schedule of net loss per share
|
|
June
30,
2023 |
|
|
June
30,
2022 |
|
Shares underlying warrants
outstanding |
|
|
10,311 |
|
|
|
9,074 |
|
Shares underlying stock options outstanding |
|
|
6,139 |
|
|
|
4,630 |
|
Shares underlying RSU’s |
|
|
403 |
|
|
|
— |
|
The
shares underlying the SAFE obligation were issuable only if the Merger were to be terminated. These contingently issuable shares
were excluded from the dilutive computation because conversion was not “probable” as defined in the accounting literature.
However, if the evaluation met the probability threshold, the shares would be excluded from diluted EPS since their inclusion
would have an anti-dilutive effect.
Significant
Accounting Policies
Our
significant accounting policies are set forth in our financial statements for the year ended December 31, 2022, included within
our Annual Report on Form 10-K filed with the SEC on March 31, 2023.
Recently
Issued Accounting Pronouncements
We
do not believe that any recently issued, but not yet effective, accounting standards, if adopted, will have a material effect
on the financial statements.
3.
Concentration of Risk
Credit
Risk
Financial
instruments that subject us to concentrations of credit risk consist primarily of cash and money market funds. We maintain cash
and money market funds with financial institutions that we deem reputable.
Foreign
Operations
The
accompanying condensed consolidated financial statements as of June 30, 2023, include gross assets amounting to $0.1 million relating
to operations of our subsidiary based in Switzerland.
4.
Fair Value Measurements
The
authoritative guidance with respect to fair value establishes a fair value hierarchy that prioritizes the inputs to valuation
techniques used to measure fair value into three levels and requires that assets and liabilities carried at fair value be classified
and disclosed in one of three categories, as presented below. Disclosure as to transfers in and out of Levels 1 and 2, and activity
in Level 3 fair value measurements, is also required.
Level
1. Observable inputs such as quoted prices in active markets for an identical asset or liability that we have the ability to access
as of the measurement date. Financial assets and liabilities utilizing Level 1 inputs include active-exchange traded securities
and exchange-based derivatives.
Level
2. Inputs, other than quoted prices included within Level 1, which are directly observable for the asset or liability or indirectly
observable through corroboration with observable market data. Financial assets and liabilities utilizing Level 2 inputs include
fixed income securities, non-exchange-based derivatives, mutual funds, and fair-value hedges.
Level
3. Unobservable inputs in which there is little or no market data for the asset or liability which requires the reporting entity
to develop its own assumptions. Financial assets and liabilities utilizing Level 3 inputs include infrequently-traded non-exchange-based
derivatives and commingled investment funds, and are measured using present value pricing models.
Cash
equivalents, which includes money market funds, are the only financial instrument measured and recorded at fair value on our consolidated
balance sheet, and they are valued using Level 1 inputs.
Assets
measured at fair value on a recurring basis are as follows (in thousands):
Schedule of Money Market Funds at their Level within the Fair Value Hierarchy
|
|
Total |
|
|
Level
1 |
|
|
Level
2 |
|
|
Level
3 |
|
June 30, 2023 (unaudited): |
|
|
|
|
|
|
|
|
|
|
|
|
Money
market funds |
|
$ |
31,561 |
|
|
$ |
31,561 |
|
|
$ |
— |
|
|
$ |
— |
|
December 31, 2022: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Money market funds |
|
$ |
44,417 |
|
|
$ |
44,417 |
|
|
$ |
— |
|
|
$ |
— |
|
5.
Selected Balance Sheet Detail
Property
and equipment
Property
and equipment consisted of the following (in thousands):
|
|
June
30,
2023 |
|
|
December
31,
2022 |
|
Equipment |
|
$ |
3,598 |
|
|
$ |
3,520 |
|
Furniture and fixtures |
|
|
10 |
|
|
|
10 |
|
Software |
|
|
54 |
|
|
|
51 |
|
Leasehold improvements |
|
|
12 |
|
|
|
12 |
|
|
|
|
3,674 |
|
|
|
3,593 |
|
Accumulated depreciation
and amortization |
|
|
(2,599 |
) |
|
|
(2,411 |
) |
Property and equipment,
net |
|
$ |
1,075 |
|
|
$ |
1,182 |
|
Right-of-use
assets and operating lease liabilities
We
lease certain office space and equipment for our use. Leases with an initial term of 12 months or less are not recorded on the
balance sheet. Lease costs are recognized in the income statement over the lease term on a straight-line basis. Depreciation is
computed using the straight-line method over the estimated useful life of the respective assets. The depreciable life of assets
and leasehold improvements are limited by the expected lease term. Our lease agreements do not contain any material residual value
guarantees or restrictive covenants. As most of our leases do not provide an implicit rate, we used our estimated incremental
borrowing rate based on the information available at commencement date in determining the present value of lease payments.
Schedule of right of use assets and operating lease liabilties
Assets |
|
Classification |
|
June
30,
2023 (in thousands) |
|
|
December
31,
2022 (in thousands) |
|
Non-current
assets |
|
Right-of-use assets |
|
$ |
20,684 |
|
|
$ |
779 |
|
Liabilities |
|
|
|
|
|
|
|
|
|
|
Current |
|
Current operating lease liabilities |
|
$ |
861 |
|
|
$ |
955 |
|
Long term |
|
Long term operating lease liabilities |
|
$ |
20,127 |
|
|
$ |
— |
|
Schedule of lease liabilities
| |
For the three months ended June 30, 2023 | | |
For the three months ended June 30, 2022 | | |
For the six months ended June 30, 2023 | | |
For the six months ended June 30, 2022 | |
Cash paid for operating lease liabilities (in thousands) | |
$ | 382 | | |
$ | 211 | | |
| 759 | | |
| 422 | |
Rent
expense, including common area maintenance charges, was $0.6 million and $0.2 million and was $0.9 and $0.5 during the three-month
and six-month periods ended June 30, 2023 and 2022, respectively.
On
February 1, 2023, we entered into a lease agreement, effective March 1, 2023, to sublease office space to replace Cortigent’s
existing headquarters. Our rental payments amount to $22,158 per month plus operating expenses, to lease 14,823 square feet of
office space at 27200 Tourney Road, Valencia, California 91355. The sub-lease has a term of two years and two months. We also
entered into a lease for storage space on January 25, 2023, in the same building at a cost of $6,775 per month for a term of two
years and one month.
Vivani
entered into a triple net lease agreement for a single building with 43,645 square feet of space in Alameda, California on November
21, 2022. The stated term of the lease commences on June 1, 2023 and terminates on September 30, 2033, ten years and 4 months.
Payments increase annually from $2,676,311 to $3,596,784, or 124 payments less the first four which are abated, totaling approximately
$31 million. Vivani will be responsible for insurance, property taxes and CAM charges. Vivani was required to deposit $1.4 million
to guarantee a letter of credit to secure the lease and this amount is included in long-term assets on the balance sheet at June
30, 2023. The current lease expires on September 30, 2023.
The
Company evaluated the lease under the provisions of ASC 842, Leases. Information related to the right-of-use assets and related lease
liabilities under this lease are as follows (in thousands):
Year Ending December 31, | | |
| |
2023 | | |
$ | 669 | |
2024 | | |
| 2,723 | |
2025 | | |
| 2,805 | |
2026 | | |
| 2,889 | |
2027 | | |
| 2,976 | |
Thereafter | | |
| 18,926 | |
Total lease payments | | |
$ | 30,988 | |
| | |
| | |
Less imputed interest | | |
| (10,900 | ) |
| | |
| | |
Total lease liabilities | | |
$ | 20,088 | |
| | |
| | |
Discount rate | | |
| 8.38 | % |
6.
Equity Securities
We
are authorized to issue 300,000,000 shares of common stock with 50,798,799 issued as of June 30, 2023. In addition, we are authorized
to issue 10,000,000 shares of preferred stock with none issued. On August 19, 2022, the Company initiated a reverse stock split
of one share for every three shares. All share numbers have been retroactively adjusted for the split. On August 30, 2022, 13,136,362
shares were deemed issued for the merger acquisition.
7.
Warrants
NPM,
prior to the Merger, issued common stock and warrants (collectively, the “unit” or “units”) in 2019, 2020
and 2021 for $3.15 per unit. Outstanding warrants of 7,746,855 to purchase common stock are shown in the table below and generally
expire 5 years from the date of issuance at $3.15 per share, are transferable into one share of common stock and may be exercised
on a cashless basis. The warrants qualified for an exception to derivative accounting and, accordingly, their value was not bifurcated
from the total purchase price.
Second
Sight warrants of 7,691,063 were outstanding and are convertible into 2,563,688 shares in the table below and converted as part
of the Merger for Vivani warrants on a like for-like basis. The weighted average exercise price of these warrants is $35.24. Of
this total 7,680,938 warrants are convertible into 2,560,313 shares and are tradeable on the open market. Under accounting standards
in a business combination, these warrants were measured at fair value as of the Merger date; however, the warrants were substantially
out-of-the-money and were assigned no value.
A
summary of warrant activity for the six months ended June 30, 2023 is presented below (in thousands, except per share and contractual
life data).
Summary of Warrant Activity
|
|
Number
of
Shares |
|
|
Weighted
Average
Exercise
Price
Per Share |
|
|
Weighted
Average
Remaining
Contractual
Life (in Years) |
|
Warrants outstanding as of
December 31, 2022 |
|
|
10,311 |
|
|
$ |
11.13 |
|
|
|
2.31 |
|
Issued |
|
|
— |
|
|
|
|
|
|
|
|
|
Exercised |
|
|
— |
|
|
|
|
|
|
|
|
|
Forfeited or expired |
|
|
— |
|
|
|
|
|
|
|
|
|
Warrants outstanding as of June 30, 2023 |
|
|
10,311 |
|
|
$ |
11.13 |
|
|
|
1.81 |
|
Warrants exercisable as of June 30, 2023 |
|
|
10,311 |
|
|
$ |
11.13 |
|
|
|
1.81 |
|
The
warrants outstanding as of June 30, 2023, had no intrinsic value.
8.
Stock-Based Compensation
A
summary of stock option activity for the six months ended June 30, 2023, is presented below (in thousands, except per share and
contractual life data).
Summary of Stock Option Activity
|
|
Number
of
Shares |
|
|
Weighted
Average
Exercise
Price
Per Share |
|
|
Weighted
Average
Remaining
Contractual
Life (in Years) |
|
Options outstanding as of
December 31, 2022 |
|
|
5,272 |
|
|
$ |
3.07 |
|
|
|
7.15 |
|
Granted |
|
|
1,122 |
|
|
$ |
1.25 |
|
|
|
|
|
Exercised |
|
|
(101 |
) |
|
$ |
0.44 |
|
|
|
|
|
Forfeited or expired |
|
|
(154 |
) |
|
$ |
2.78 |
|
|
|
|
|
Options outstanding, vested and expected to
vest as of June 30, 2023 |
|
|
6,139 |
|
|
$ |
2.79 |
|
|
|
7.03 |
|
Options exercisable as of June 30, 2023 |
|
|
3,941 |
|
|
$ |
3.29 |
|
|
|
5.94 |
|
The
estimated aggregate intrinsic value of stock options exercisable as of June 30, 2023, was $0.3 million. As of June 30, 2023, there
was $2.4 million of total unrecognized compensation cost related to outstanding stock options that will be recognized over a weighted
average period of 1.2 years.
During
the six months ended June 30, 2023, we granted stock options to purchase 1,121,817
shares of common stock to certain employees and board members. The options are exercisable for a period of ten
years from the date of grant at a weighted average price of $1.25
per share, which was calculated at the fair value of our common stock on the respective grant date. The options
generally vest over a period of four
years. The fair value of options subject to only service conditions are valued using the Black-Scholes option pricing
model, while those subject to performance or market conditions are valued using the Monte-Carlo Simulation model. During the
six-months ended June 30, 2023, 200,000
options were issued and valued at $0.1
million using the Monte-Carlo model using the following assumptions:
| ● | Beginning Stock Price. We utilized the Company's
publicly traded share price as of the Valuation Date as the beginning stock value. At the Valuation Date, the publicly traded
common share price was $1.09 per share. |
| ● | Drift Rate. In determining the value of the instrument
in the risk-neutral framework, riskfree rates were estimated based on the applicable treasury rate for the projection period.
For each simulation, the term of the risk-free rate was based on the term from the Valuation Date through the latest date on which
the award could vest (i.e., two years following the Performance Period End Date). Please note that, for the purposes of calculating
the service period associated with the Subject Interest, the Company’s cost of equity was utilized as the drift rate. |
| ● | Volatility. The total equity volatility (standard
deviation) was based on a total equity volatility analysis. |
| ● | Period. The period was measured as the number
of years from the Valuation Date through the PSO expiration date (10 years following the date of grant). |
| ● | Dividends. The Company has not historically paid
dividends. In addition, the Company does not expect to pay dividends going forward. As such, no dividends were considered in our
analysis. |
During
the six-months ended June 30, 2023, 921,817 options were issued and valued at $0.9 million using the Black-Scholes
option-pricing model using the following assumptions: expected term of 4.00
to 6.20
years, volatility of 100%,
risk-free interest rate of 3.99%
to 4.45%,
and expected dividend rate of 0.0%.
We also granted 402,500 RSU’s (as defined below) during
the quarter. These RSUs had market conditions which required our stock price to exceed $3.15 per share for three consecutive days
in the four years from grant date for the RSUs to vest.
The
following table summarizes restricted stock unit (“RSU”) activity for the six months ended June 30, 2023 (in thousands,
except per share data):
Summary of Restricted Stock Unit
|
|
Number
of
Shares
|
|
|
Weighted
Average
Grant
Date
Fair Value
Per
Share
|
|
Outstanding as of
December 31, 2022 |
|
|
— |
|
|
$ |
— |
|
Awarded |
|
|
403 |
|
|
|
0.93 |
|
Vested and released |
|
|
— |
|
|
|
— |
|
Forfeited/canceled |
|
|
— |
|
|
|
— |
|
Outstanding
as of June 30, 2023 |
|
|
403 |
|
|
$ |
0.93 |
|
As
of June 30, 2023, there was $0.2 million of total unrecognized compensation cost related to the outstanding RSUs that will be
recognized over a weighted average period of 1.2 years.
Stock-based
compensation expense recognized for stock-based awards in the condensed consolidated statements of operations for the three and
six months ended June 30, 2023, and 2022 was as follows (in thousands):
Stock-based Compensation Expense
| |
Three Months Ended June 30, | | |
Six Months Ended June 30, | |
| |
2023 | | |
2022 | | |
2023 | | |
2022 | |
Research and development | |
$ | 284 | | |
$ | 324 | | |
$ | 532 | | |
$ | 514 | |
General and administrative | |
| 240 | | |
| 70 | | |
| 361 | | |
| 220 | |
Total | |
$ | 524 | | |
$ | 394 | | |
$ | 893 | | |
$ | 734 | |
9. |
Risk and Uncertainties |
We
continue to monitor the ongoing COVID-19 global pandemic which has resulted in travel and other restrictions to reduce the spread
of the disease. We presently are not experiencing any significant disruptions from the ongoing COVID-19 pandemic. All clinical
and chemistry, manufacturing and control activities are currently active.
The
safety, health and well-being of all patients, medical staff and internal and external teams is the paramount and primary focus.
As the pandemic and its resulting restrictions evolve in jurisdictions across the country, the potential exists for further disruptions
to projected timelines. We are in close communication with clinical teams and key vendors and are prepared to take action should
the pandemic worsen and impact the business in the future.
10.
Commitments and Contingencies
Clinical
Trial Agreements
Based
upon FDA approval of Argus II, which was obtained in February 2013, we were required to collect follow-up data from subjects enrolled
in our pre-approval trial for a period of up to ten years post-implant, which was extended through the year 2019. This requirement
to collect follow-up data was halted in 2020 with FDA approval. In addition, we conducted three post-market studies to comply
with U.S. FDA, French, and European post-market surveillance regulations and requirements and are conducting an early feasibility
clinical study of Orion. We have contracted with various universities, hospitals, and medical practices to provide these services.
Payments are based on procedures performed for each subject and are charged to clinical and regulatory expense as incurred. Total
amounts charged to expense for the three and six months ended June 30, 2023 were $88,000 and $115,000, respectively.
Litigation,
Claims and Assessments
Three
oppositions filed by Pixium Vision SA (“Pixium”) are pending in the European Patent Office, each challenging the validity
of a European patent owned by us. The outcomes of the challenges are not certain, however, if successful, they may affect our
ability to block competitors from utilizing our patented technology. We do not believe a successful challenge will have a material
effect on our ability to manufacture and sell our products, or otherwise have a material effect on our operations.
As
described in the Company’s 10-K for the year ended December 31, 2020, the Company had entered into a Memorandum of
Understanding (“MOU”) for a proposed business combination with Pixium. In response to a press release by Pixium
dated March 24, 2021, and subsequent communications between us and Pixium, our Board of Directors determined that the
business combination with Pixium was not in the best interest of our shareholders. On April 1, 2021, we gave notice to Pixium
that we were terminating the MOU between the parties and seeking an amicable resolution of termination amounts that may be
due, however no assurance can be given that an amicable resolution will be reached. We accrued $1,000,000
of liquidated damages as contemplated by the MOU in accounts payable as of March 31, 2021, and remitted that amount to Pixium
in April 2021. Pixium
indicated that it considered this termination wrongful, rejected the Company’s offers, but retained the $1,000,000
payment. On May 19, 2021, Pixium filed suit in the Paris Commercial Court, and currently claim damages of approximately
€5.1 million or about $5.6
million. We believe we have fulfilled our obligations to Pixium with the liquidated damages payment of $1,000,000. On
December 9, 2022, the Company received notice that the Paris Commercial Court has rendered its judgement, including finding
that the Company’s termination of the MOU was not valid. In the judgement, the Company was ordered to pay to Pixium the
amount of €2,500,000 minus a €947,780 credit for the $1,000,000 already paid for, a net amount payable of
approximately €1,552,220. The Company filed an appeal with the Appeals Court of Paris on May 24, 2023. The Company recorded a charge of
$1,675,000 for the year ended December 31, 2022, related to this matter but plans to raise any and all legal challenges to
this preliminary judgement.
We
are party to litigation arising in the ordinary course of business. It is our opinion that the outcome of such matters will not
have a material effect on our results of operations, however, the results of litigation and claims are inherently unpredictable.
Regardless of the outcome, litigation can have an adverse impact on us because of defense and settlement costs, diversion of management
resources and other factors.
11. Subsequent Events
In
early July 2023, Vivani successfully completed the manufacture of clinical supplies to support a proposed first-in-human (“FIH”)
investigation of NPM-119 (exenatide implant) in patients with type 2 diabetes mellitus. On July 14, 2023, the Company submitted
an Investigational New Drug (“IND”) application to the U.S. Food and Drug Administration (“FDA)” for the
proposed NPM-119 FIH study also named LIBERATE-1. On August 11, 2023, FDA verbally notified Vivani that the agency
was placing a clinical hold on Vivani’s IND application for the proposed clinical investigation and indicated its intention
to subsequently provide an official clinical hold letter stating the reasons for the clinical hold. Vivani plans to engage with
the FDA in order to lift the clinical hold and commence its planned clinical development of NPM-119. The Company expects to commence
enrollment in LIBERATE-1 in the second half of 2023 subject to regulatory clearance. Assuming LIBERATE-1 commences as planned,
the Company would anticipate the availability of interim LIBERATE-1 data in the first half of 2024 and full top-line results in
the second half of 2024.
Item 2. |
Management’s Discussion and Analysis
of Financial Condition and Results of Operations |
The
following discussion and analysis of our financial condition and results of operations should be read together with our
unaudited condensed financial statements and related notes included elsewhere in this Quarterly Report on Form 10-Q. Some of
the information contained in this discussion and analysis or set forth elsewhere in this Quarterly Report, including
information with respect to our products, plans and strategy for our business and related financing, contains forward-looking
statements that involve risks and uncertainties, including statements regarding our expected financial results in future
periods. The words “anticipates,” “believes,” “could,” “estimates,”
“expects,” “intends,” “may,” “might,” “plans,”
“projects,” “will,” “would,” “strategy” and similar expressions are intended
to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Examples
of forward-looking statements include, among others, statements we make regarding expectations for revenues, liquidity, cash
flows and financial performance, the anticipated results of our development efforts and the timing for receipt of required
regulatory approvals, including those required to commence clinical development of our product candidates, insurance
reimbursements and product launches, our financing plans and future capital requirements, and statements regarding the
anticipated or projected impact of our merger on our business, results of operations, financial condition or prospects, the
materially adverse impact of the recent COVID-19 coronavirus pandemic and related public health measures on our business. We
may not actually achieve the plans, intentions or expectations disclosed in our forward-looking statements and you should not
place undue reliance on our forward-looking statements. Actual results or events could differ materially from the
plans, intentions and expectations disclosed in the forward-looking statements that we make. We assume no obligations to
update these forward-looking statements to reflect events or circumstances after the date of this Quarterly Report or to
reflect actual outcomes.
Overview
Vivani
Medical, Inc. (“Vivani,” the “Company,” “we,” “us,” “our” or similar
terms) is a preclinical stage biopharmaceutical company which develops miniaturized, subdermal implants utilizing its proprietary
NanoPortal™ technology to enable long-term, near constant-rate delivery of a broad range of medicines to treat chronic diseases.
Vivani uses this platform technology to develop and potentially commercialize drug implants, alone or in collaboration with pharmaceutical
company partners to address a leading cause of poor clinical outcomes in the treatment of chronic disease, medication non-adherence.
For example, approximately 50% of patients treated for type 2 diabetes are non-adherent to their medicines which can lead to poor
clinical outcomes. We are developing a portfolio of miniature, sub-dermal drug implants that, unlike most oral and injectable
medicines, are designed with the goal of guaranteeing adherence by delivering therapeutic drug levels for up to 6 months or the
life of the implant. In addition, by leveraging our proprietary NanoPortal implant technology we can design implants that deliver
minimally fluctuating drug levels that may improve the tolerability profiles for certain medicines for which side effects are
associated with fluctuating drug levels such as GLP-1 receptor agonists (GLP-1s).
In
February 2022, we announced the signing of a definitive merger agreement between Nano Precision Medical, Inc.(“NPM”)
and Second Sight Medical Products, Inc. (“Second Sight”) pursuant to which NPM became a wholly owned subsidiary of
Second Sight. On August 30, 2022, the merger closed and the combined company of NPM and Second Sight was renamed Vivani Medical,
Inc.
In
December 2022, we contributed our neuromodulation assets and certain liabilities to Cortigent, Inc., a newly formed wholly owned
subsidiary of Vivani, in exchange for 20 million shares of common stock of Cortigent. While the primary focus of Vivani is to
develop and ultimately commercialize our drug implant business from legacy company NPM, Vivani’s new management team remains
committed to identifying and exploring strategic options for the further advancement of the neuromodulation business of Cortigent
which includes the development of its pioneering neurostimulation systems to help patients recover critical body functions. In
March 2023, Vivani announced the filing of a Registration Statement on Form S-1 with the U.S. Securities and Exchange Commission
(“SEC”) for the proposed initial public offering of Cortigent. Cortigent is expected to continue to be majority-owned
by Vivani immediately following the initial public offering.
On
July 6, 2023, Vivani changed its state of incorporation from the State of California to the State of Delaware by means of a plan
of conversion, effective July 5, 2023. The reincorporation, including the principal terms of the plan of conversion, was submitted
to a vote of, and approved by, Vivani’s stockholders at its 2023 Annual Meeting of Stockholders held on June 15, 2023.
Subject
to completion of Cortigent’s initial public offering, Vivani intends to focus exclusively on further development of the
drug implant business.
In
early July 2023, Vivani successfully completed the manufacture of clinical supplies to support a proposed first-in-human (“FIH”)
investigation of NPM-119 (exenatide implant) in patients with type 2 diabetes mellitus. On July 14, 2023, the Company submitted
an Investigational New Drug (“IND”) application to the U.S. Food and Drug Administration (“FDA)” for the
proposed NPM-119 FIH study also named LIBERATE-1. On August 11, 2023, FDA verbally notified Vivani that the agency
was placing a clinical hold on Vivani’s IND application for the proposed clinical investigation and indicated its intention
to subsequently provide an official clinical hold letter stating the reasons for the clinical hold. Vivani plans to engage with
the FDA in order to lift the clinical hold and commence its planned clinical development of NPM-119. The Company expects to commence
enrollment in LIBERATE-1 in the second half of 2023 subject to regulatory clearance. Assuming LIBERATE-1 commences as planned,
the Company would anticipate the availability of interim LIBERATE-1 data in the first half of 2024 and full top-line results in
the second half of 2024.
Liquidity
From
inception, our operations have been funded primarily through the sales of our common stock and warrants. The completion of our
reverse merger with Second Sight Medical Products, Inc. provided $53.3 million in net assets including approximately $55.4 million
in cash.
Second
Sight was awarded a $6.4 million National Institutes of Health (“NIH”) five-year grant (with annual reviews)
from NIH to fund the “Early Feasibility Clinical Trial of a Visual Cortical
Prosthesis.” The fifth and final year grant of $1.0 million was approved in March 2023.
We
are subject to the risks and uncertainties associated with a business with no revenue that is developing novel pharmaceutical
product candidates and medical devices candidates. We have incurred recurring operating losses and negative operating cash
flows since inception, and we expect to continue to incur operating losses and negative operating cash flows for the
foreseeable future. We expect our operating expenses to increase significantly as we continue our business operations,
particularly as we prepare to and initiate our planned clinical trial of NPM-119 and conduct our other research and
development activities.
On August 11, 2023, the FDA notified us that the agency was placing a clinical hold on our IND for
the proposed FIH study of NPM-119. The FDA indicated its intention to subsequently provide an official clinical hold letter
stating the reasons for the clinical hold. If we are required to conduct additional IND-enabling activities such as
additional pre-clinical studies, our overall expenditures relating to our NPM-119 program would increase. Our financial
statements have been presented on the basis that our business is a going concern, which contemplates the realization of
assets and satisfaction of liabilities in the normal course of business. To finance our operations, we will need to raise
additional capital, which cannot be assured. Our operating plan may change as a result of many factors currently unknown to
us, and we will need to seek additional funds through public or private equity offerings or debt financings, grants,
collaborations, strategic partnerships or other sources. However, we may be unable to raise additional capital or enter into
such other arrangements when needed on favorable terms or at all. If we are unable to obtain funding on a timely basis, we
may be required to significantly curtail, delay or discontinue one or more of our research or development programs, or we may
be unable to expand or maintain our operations, maintain our current organization and employee base or otherwise capitalize
on our business opportunities, as desired, which could materially and adversely affect our business, financial condition and
results of operations. We estimate that currently available cash will provide sufficient funds to enable the Company to meet
its planned obligations through September 2024.
Merger
Agreement
As
discussed in the Notes to Condensed Consolidated Financial Statements of the Company, on February 4, 2022, the Company
entered the Merger Agreement with Second Sight. On May 13, 2022, the Company filed a Registration Statement on Form S-4 (the
“Registration Statement”) with the SEC in connection with the contemplated Merger, which is currently effective.
Shareholders of the Company approved the Merger on July 27, 2022, and the merger was completed in August 2022.
Safe
Agreement
On
February 4, 2022, in connection with the Merger, Second Sight and NPM also entered into a Simple Agreement for Future Equity (“SAFE”)
whereby Second Sight provided to NPM an investment advance of $8 million. If the Merger were to be terminated without completion,
NPM would issue to Second Sight that number of shares of NPM common stock equal to not less than 2.133% of the issued and outstanding
shares of NPM common stock assuming exercise or conversion of all outstanding vested and unvested options, warrants, and convertible
securities. The agreement provided that the SAFE would terminate if the Merger were to be successfully completed.
Under
the terms of the SAFE, upon successfully completion of the Merger on August 30, 2022, the investment advance was eliminated. Under
the accounting for a business combination, the $8 million adjusted the purchase consideration.
Critical
Accounting Policies and Estimates
The
preparation of our condensed consolidated financial statements in conformity with generally accepted accounting principles in
the United States (“GAAP”) and the requirements of the United States Securities and Exchange Commission require management
to make estimates, assumptions and judgments that affect the amounts, liabilities, revenue and expenses reported in the financial
statements and the notes to the financial statements. On an ongoing basis, we evaluate our critical accounting policies and estimates.
We base our estimates on historical experience and on various other assumptions that we believe to be reasonable under the circumstances,
the results of which form the basis for making judgments about the carrying values of assets and liabilities that are not readily
apparent from other sources. Some of those judgments can be subjective and complex, and therefore, actual results could differ
materially from those estimates under different assumptions or conditions.
There
have been no material changes to our critical accounting policies during the six months ended June 30, 2023.
Results
of Operations
Operating
Expenses. We generally recognize our operating expenses as incurred in two general operational categories: research and development
and general and administrative. Our operating expenses also include a non-cash component related to the amortization of stock-based
compensation for research and development and general and administrative personnel. We have received grants from institutions
or agencies, such as the National Institutes of Health, to help fund the some of the cost of our development efforts. We have
recorded the amount of funding received from these grants as reductions to operating expenses.
● |
Research and development
expenses consist primarily of employee compensation and consulting costs related to the design, development, and enhancements
of our current and potential future products, and clinical as well as internal and external costs associated with conducting
clinical trials and maintaining relationships with regulatory agencies offset by grant revenue received in support of specific
research projects. We expense our research and development costs as they are incurred. |
● |
General and administrative
expenses consist primarily of salaries and related expenses for executive, legal, finance, human resources, information technology
and administrative personnel, as well as recruiting and professional fees, patent filing and annuity costs, insurance costs
and other general corporate expenses, including rent. |
Comparison
of the Three Months Ended June 30, 2023 and 2022
Research
and development expense. Research and development expense increased by $0.7 million, or 21%, to $3.9 million in the second
quarter of 2023 from $3.2 million in the second quarter of 2022. The costs increased due to costs of our acquired company Second
Sight being included from the merger acquisition date of August 30, 2022. This inclusion increased these costs for the quarter
by $0.5 million. The remainder of the increase was primarily due to drug implants development costs.
General
and administrative expense. General and administrative expense increased $2.2 million, or 255%, to $3.1 million in
the second quarter of 2023 from $0.9 million in the same period of 2022. This increase was attributable to increased costs
associated with the inclusion of our acquired company Second Sight which totaled $1.0 million in the second quarter of 2023,
higher costs associated with being a public company of $0.9 million for D&O insurance and professional fees, and payroll
related expenses. Approximately $0.2 million of costs were incurred related to the Cortigent IPO in the quarter.
Other
income. Other income was impacted by the merger acquisition of cash which increased our interest income by $0.5 million
for the three months ended June 30, 2023 as compared to the same period in 2022 before the merger.
Comparison
of the Six Months Ended June 30, 2023 and 2022
Research
and development expense. Research and development expense increased by $1.9 million, or 33%, to $7.8 million in the first six
months of 2023 from $5.9 million in the same period of 2022. The costs increased due to costs of our acquired company Second Sight
being included from the merger acquisition date of August 30, 2022. This inclusion increased these costs for the period by $1.2
million. The remainder of the increase was primarily due to drug implants development costs.
General
and administrative expense. General and administrative expense increased $3.7 million, or 174%, to $5.8 million in the
first six months of 2023 from $2.1 million in the same period of 2022. This increase was attributable to increased
costs associated with the inclusion of our acquired company Second Sight which totaled $2.1 million in the first six months
of 2023, higher public company costs of $1.0 million, and higher payroll related expenses. Approximately $0.3 million of costs were
incurred related to the Cortigent IPO in the period.
Other
income. Other income was impacted by the merger acquisition of cash which increased our interest income to $0.7 million
for the six months ended June 30, 2023 as compared to the same period in 2022 before the merger.
Liquidity
and Capital Resources
Our
financial statements have been presented on the basis that our business is a going concern, which contemplates the realization
of assets and the satisfaction of liabilities in the normal course of business. We are subject to the risks and uncertainties
associated with a business with no revenue that is developing a novel pharmaceutical product candidates and medical device candidates,
including limitations on our operating capital resources and uncertain demand for our products. We have incurred recurring operating
losses and negative operating cash flows since inception, and we expect to continue to incur operating losses and negative operating
cash flows for the foreseeable future.
Conducting
clinical trials is a time-consuming, expensive and uncertain process that takes many years to complete and we may
never generate the necessary data or results required to obtain marketing approval. We do not expect revenues until we
are successful in completing the development and obtaining marketing approval for our products. We expect expenses to
increase in connection with our ongoing activities, particularly as we initiate clinical trials, initiate new research and
development projects and seek marketing approval for any product candidates that we successfully develop. In particular, we
expect to incur increased expenses as we initiate our planned Phase 2 clinical trial of NPM-119. On August 11, 2023, the FDA
notified us that the agency was placing a clinical hold on our IND for the proposed FIH study of NPM-119. The FDA indicated
its intention to subsequently provide an official clinical hold letter stating the reasons for the clinical hold. If we
are required to conduct additional IND-enabling activities such as additional pre-clinical studies, our overall expenditures
relating to our NPM-119 program would increase. In addition, if we obtain marketing approval we expect to incur significant
additional expenses related to sales, marketing, distribution and other commercial infrastructure to commercialize such
product. In addition, our product candidates, if approved, may not achieve commercial success. We incur significant costs
associated with operating as a public company in a regulated industry.
Until
such time, if ever, we can generate product revenues, we anticipate that we will seek to fund our operations through public or
private equity or debt financings, grants, collaborations, strategic partnerships or other sources. However, we may be unable
to raise additional capital or enter into such other arrangements when needed on favorable terms or at all. To the extent that
we raise additional capital through the sale of equity, convertible debt or other equity-linked securities, the ownership interests
of some or all of our common stockholders will be diluted, the holders of new equity securities may have priority rights over
our existing stockholders and the terms of these securities may include liquidation or other preferences that adversely affect
the rights of our existing common stockholders. Debt financing, if available, may involve agreements that include covenants limiting
or restricting our ability to take specific actions, such as incurring additional debt, making capital expenditures or declaring
dividends. If adequate funds are not available, we may be required to curtail operations significantly or to obtain funds by entering
into agreements on unattractive terms. If, for example, we raise funds through additional collaborations, strategic alliances
or licensing arrangements with third parties, we may have to relinquish valuable rights to our technologies, future revenue streams,
research programs or product candidates, or to grant licenses on terms that may not be favorable to us. Our inability to raise
capital could have a material adverse effect on our business, financial condition and results of operations.
Cash,
cash equivalents and restricted cash decreased by $12.6 million from $46.4 million as of December 31, 2022 to $33.9 million as
of June 30, 2023. Working capital was $29.1 million as of June 30, 2023 compared to $40.7 million as of December 31, 2022, a decrease
of $11.6 million. We use our cash and cash equivalents and working capital to fund our operating activities.
Cash
Flows from Operating Activities
During
the six months ended June 30, 2023, we used $12.5 million of cash in operating activities, consisting primarily of a net loss
of $12.8 million and a net increase in net operating assets of $0.9 million, partially offset by non-cash charges of $1.2 million
for depreciation and amortization of property and equipment, stock-based compensation and change in right of use assets. During
the six months ended June 30, 2022, we used $6.6 million of cash in operating activities, consisting primarily of a net loss of
$8.0 million, offset by non-cash charges which provided cash of $1.0 million for depreciation and amortization of property and
equipment, stock-based compensation, change in right of use and partially offset by a net decrease in net operating assets of
$0.4 million.
Cash
Flows from Investing Activities
Cash
used for investing activities in the six months ended June 30, 2023 and 2022 was minimal for both periods. In 2023 $81,000 was
used for the purchase of property and equipment. In 2022, $116,000 was used for the purchase of property and equipment.
Cash
Flows from Financing Activities
Financing
activities was $7,000 in the six months ended June 30, 2023. Financing activities provided $8.0 million of cash in the six months
ended June 30, 2022 from the funding of the SAFE agreement.
Off-Balance
Sheet Arrangements
As
of June 30, 2023, we did not have any transactions, obligations or relationships that constitute off-balance sheet arrangements.
Item 3. |
Quantitative and Qualitative Disclosures
about Market Risk |
Interest
Rate Sensitivity
The
primary objective of our investment activities is to maintain the safety of principal and preserve liquidity without incurring
significant risk. We invest cash in excess of our current needs in money market funds. As of June 30, 2023, our investments consisted
solely of money market funds.
Exchange
Rate Sensitivity
The
majority of our operating expenses were denominated in U.S. dollars. We have not entered into foreign currency forward contracts
to hedge our operating expense exposure to foreign currencies, but we may do so in the future.
Item 4. |
Controls and
Procedures |
Evaluation
of Disclosure Controls and Procedures
Our
management, including our Chief Executive Officer (“CEO”) and our Chief Financial Officer (“CFO”), evaluated
the effectiveness of our disclosure controls and procedures as of the end of the period covered by this report. The term “disclosure
controls and procedures,” as defined in Rules 13a-15(e) and 15d-15(e) under the Exchange Act, means controls and other procedures
of a company that are designed to ensure that information required to be disclosed by a company in the reports that it files or
submits under the Exchange Act is recorded, processed, summarized and reported, within the time periods specified in the SEC’s
rules and forms. Disclosure controls and procedures include, without limitation, controls and procedures designed to ensure that
information required to be disclosed by a company in the reports that it files or submits under the Exchange Act is accumulated
and communicated to the company’s management, including its principal executive and principal financial officers, as appropriate
to allow timely decisions regarding required disclosure. As of June 30, 2023, based on the evaluation of these disclosure controls
and procedures, our CEO and CFO have concluded that our disclosure controls and procedures were effective at the reasonable assurance
level.
Changes
in Internal Control over Financial Reporting
There
has been no change in our internal control over financial reporting during the six months ended June 30, 2023, that materially
affected, or are reasonably likely to materially affect, our internal control over financial reporting. We are updating our internal
control environment to address changes in our risks in financial reporting to accommodate our operating activities, staffing levels,
and segregation of duties. Such changes may result in new or reduced controls.
Inherent
Limitations on Effectiveness of Controls
Because
of the inherent limitations of internal control over financial reporting, including the possibility of collusion or improper management
override of controls, material misstatements due to error or fraud may not be prevented or detected on a timely basis. Also, projections
of any evaluation of the effectiveness of the internal control over financial reporting to future periods are subject to the risk
that the controls may become inadequate because of changes in conditions, or that the degree of compliance with the policies or
procedures may deteriorate. A control system, no matter how well conceived and operated, can provide only reasonable, not absolute,
assurance that the objectives of the control system are met. Further, the design of a control system must reflect the fact that
there are resource constraints, and the benefits of controls must be considered relative to their costs. These inherent limitations
include the realities that judgments in decision-making can be faulty, and that breakdowns can occur because of a simple error
or mistake. Additionally, controls can be circumvented by the individual acts of some persons, by collusion of two or more people
or by management override of the controls. The design of any system of controls also is based in part upon certain assumptions
about the likelihood of future events, and there can be no assurance that any design will succeed in achieving its stated goals
under all potential future conditions; over time, controls may become inadequate because of changes in conditions, or the degree
of compliance with policies or procedures may deteriorate. Because of the inherent limitations in a cost-effective control system,
misstatements due to error or fraud may occur and not be detected.
PART
II-OTHER INFORMATION
Item 1. |
Legal Proceedings |
Three
oppositions filed by Pixium Vision SA (“Pixium”) are pending in the European Patent Office, each challenging the validity
of a European patent owned by Second Sight. The outcomes of the challenges are not certain, however, if successful, they may affect
our ability to block competitors from utilizing our patented technology. We believe a successful challenge will not have a material
effect on our ability to manufacture and sell our products, or otherwise have a material effect on our operations.
As
described in the Company’s 10-K for the year ended December 31, 2020, the Company had entered into a Memorandum of
Understanding (“MOU”) for a proposed business combination with Pixium Vision SA (“Pixium”). In
response to a press release by Pixium dated March 24, 2021, and subsequent communications between us and Pixium, our Board of
Directors determined that the business combination with Pixium was not in the best interest of our shareholders. On April 1,
2021, we gave notice to Pixium that we were terminating the MOU between the parties and seeking an amicable resolution of
termination amounts that may be due, however no assurance can be given that an amicable resolution will be reached. We
accrued $1,000,000 of liquidated damages as contemplated by the MOU in accounts payable as of March 31, 2021 and remitted
that amount to Pixium in April 2021. Pixium indicated that it considered this termination wrongful, rejected the
Company’s offers, but retained the $1,000,000 payment. On May 19, 2021, Pixium filed suit in the Paris Commercial
Court, and currently claim damages of approximately €5.1 million or about $5.6 million. We believe we have fulfilled
our obligations to Pixium with the liquidated damages payment of $1,000,000. On December 9, 2022, the Company received notice
that the Paris Commercial Court has rendered its judgement, including finding that the Company’s termination of the MOU
was not valid. In the judgement, the Company was ordered to pay to Pixium the amount of €2,500,000 minus a
€947,780 credit for the $1,000,000 already paid for, a net amount payable of approximately €1,552,220. The
Company filed an appeal with the Appeals Court of Paris on May 24, 2023. The Company recorded a charge of $1,675,000 for the
year ended December 31, 2022 related to this matter but plans to raise any and all legal challenges to this preliminary
judgement.
From
time to time, we may be involved in a variety of legal proceedings and claims relating to securities laws, product liability,
patent infringement, contract disputes, employment matters and other matters relating to various claims that arise in the normal
course of our business in addition to governmental and other regulatory investigations and proceedings. It is our opinion that
the outcome of such matters will not have a material adverse effect on our results of operations, however, the results of litigation,
proceedings, disputes and claims are inherently unpredictable. Regardless of the outcome, litigation can have an adverse impact
on us because of defense and settlement costs, diversion of management resources and other factors.
Our
business is subject to numerous material and other risks. You should carefully consider the risks and uncertainties described
below together with all of the other information contained in this Form 10-Q, including our consolidated financial statements
and the related notes, and in our other filings with the SEC. If any of the stated risks actually occur, our business, prospects,
operating results, and financial condition could suffer materially. In such event, the trading price of our common stock could
decline and you might lose all or part of your investment. The material risks associated with our business were most recently
discussed in our Form 10-K that we filed on March 31, 2023. There have been no material changes from the risk factors previously
disclosed in such filing, other than those as discussed below.
We
could experience delays in the commencement or completion of clinical trials, which could result in increased costs or otherwise
impair our research and development efforts.
Delays
in the commencement or completion of clinical trials could significantly impact our drug development costs and otherwise impair
our research and development efforts. We do not know whether planned clinical trials will begin on time or be completed on schedule,
if at all. The commencement of clinical trials can be delayed for a variety of reasons, including, but not limited to, delays
related to:
|
● |
obtaining regulatory
approval to commence one or more clinical trials; |
|
● |
reaching agreement on
acceptable terms with prospective third-party contract research organizations (CROs) and clinical trial sites; |
|
● |
manufacturing sufficient
quantities of a product candidate or other materials necessary to conduct clinical trials; |
|
● |
obtaining institutional
review board approval to conduct one or more clinical trials at a prospective site; |
|
● |
recruiting and enrolling
patients to participate in one or more clinical trials; and |
|
● |
the failure of our collaborators
to adequately resource our product candidates. |
For
example, on August 11, 2023, the U.S. Food and Drug Administration (FDA) notified Vivani that the agency was placing a clinical
hold on Vivani’s Investigational New Drug (IND) application for the proposed first in human (FIH) study of NPM-119. The
FDA indicated its intention to subsequently provide an official clinical hold letter stating the reasons for the clinical hold.
Vivani plans to engage with the FDA in order to lift the clinical hold and commence its planned clinical development of NPM-119.
However, there can be no assurance that we can address the issues that the FDA may identify in its letter in a timely manner or
at all, and we may incur additional expenses in connection with our efforts to advance NPM-119 into the clinic.
In
addition, once a clinical trial has begun, it may be suspended or terminated by us or our collaborators, institutional review
boards, or, if applicable, data safety monitoring boards charged with overseeing our clinical trials, the FDA, the EMA, or comparable
foreign authorities due to a number of factors, including:
|
● |
failure to conduct the
clinical trial in accordance with regulatory requirements or clinical protocols; |
|
● |
inspection of the clinical
trial operations or clinical trial site by the FDA, the EMA or comparable foreign authorities resulting in the imposition
of a clinical hold; |
|
● |
unforeseen safety issues;
or |
|
● |
lack of adequate funding
to continue the clinical trial. |
If
we experience delays in the completion or termination of any clinical trial of our product candidates, the development of product
candidates will be impaired. In addition, any delays in completing our clinical trials will increase our costs and slow down our
product candidate development process and our anticipated timelines for seeking marketing approval. Such delays could also allow
our competitors to obtain marketing approval for their own product candidates before we do or may shorten the patent protection
period during which we may have the exclusive right to commercialize our product, if approved. Any of these occurrences may harm
our business, financial condition, and prospects significantly. In addition, many of the factors that cause, or lead to, a delay
in the commencement or completion of clinical trials may also ultimately lead to the denial of regulatory approval of our product
candidates.
Clinical
development involves a lengthy and expensive process with uncertain outcomes. We may incur additional costs and experience delays
in developing our product candidates, and our clinical development efforts may not yield favorable results.
To
receive regulatory approval for our product candidates, adequate and well-controlled clinical trials must be conducted to demonstrate
safety and efficacy in humans to the satisfaction of the FDA, the EMA, and comparable foreign authorities. We have not yet conducted
clinical trials for our current product candidates and clinical testing of such product candidates may not yield results to support
continued development or seeking regulatory approval. The development process is expensive, can take many years and has an uncertain
outcome. Failure can occur at any stage of the process. We may experience numerous unforeseen events during, or as a result of,
the development process that could delay or prevent development and approval of our product candidates, including the following:
|
● |
we may be unable to
initiate or conduct planned clinical trials on our anticipated timelines, including as a result of failing to obtain any clearances
necessary to conduct clinical trials or being subject to clinical holds that prevent continuation of such trials; |
|
● |
clinical trials may
produce negative or inconclusive results; |
|
● |
preclinical studies
conducted with product candidates during clinical development to, among other things, evaluate their safety, tolerability
and pharmacokinetics and optimize their formulation may produce unfavorable results; |
|
● |
patient recruitment
and enrollment in clinical trials may be slower than anticipated; |
|
● |
costs of development
may be greater than anticipated; |
|
● |
our product candidates
may cause undesirable side effects that delay or preclude regulatory approval or limit their commercial use or market acceptance,
if approved; |
|
● |
if one or more product
candidates are developed in collaboration with third parties, such parties may not devote sufficient resources to these clinical
trials or other preclinical studies of these candidates or conduct them in a timely manner; |
|
● |
we may face delays or
other challenges associated with the availability and sourcing key raw materials and/or key components; and |
|
● |
we may encounter difficulties
in developing product candidates related to our proprietary NanoPortal implant technology or difficulties associated with
the long-term purity, potency, safety, or stability of our product candidates. |
For
example, on August 11, 2023, the FDA notified us that the agency was placing a clinical hold on IND application for the proposed
FIH study of NPM-119. The FDA indicated its intention to subsequently provide an official clinical hold letter stating the reasons
for the clinical hold. We plan to engage with the FDA in order to lift the clinical hold and commence our planned clinical development
of NPM-119. However, there can be no assurance that we can address the issues that the FDA may identify in its letter in a timely
manner or at all, and we may incur additional expenses in connection with our efforts to advance NPM-119 into the clinic.
Even
if we experience success in early development for any product candidate, that experience may not be replicated in later development
or with respect to any other product candidates. For example, in our industry, product candidates in later-stage clinical trials
routinely fail to demonstrate adequate safety and efficacy despite having progressed through initial clinical trials or preclinical
testing.
Even
if our clinical trials generate data that we believe are promising, such data may not be sufficient to support seeking marketing
approval by the FDA, the EMA, or comparable foreign authorities. Further, data generated during development can be interpreted
in different ways, and the FDA, the EMA or comparable foreign authorities may interpret such data in different ways than we do.
If we fail to generate data that adequately demonstrate the safety and efficacy of our product candidates to support marketing
approval from regulatory authorities, we will not be able to market and commercialize these product candidates.
From
time to time, in addition to or as an alternative to raising capital through equity or debt offerings, we may seek to selectively
and opportunistically enter into collaborations with third parties to assist in the development and potential future commercialization
of some or all of our product candidates. However, there can be no assurance that we will be able to establish such collaborations
on acceptable terms, if at all, or it may take longer than expected to establish new collaborations. Even if we enter into one
or more of such collaborations, the risks associated with the development of product candidates still remain, and there can be
no assurance that our potential collaborators will successfully develop, seek approval for and commercialize any of our product
candidates.
We
will require substantial additional financing to pursue our business objectives, which may not be available on acceptable terms,
or at all. A failure to obtain this necessary capital when needed could force us to delay, limit, reduce or terminate our product
development, commercialization efforts or other operations.
Developing
pharmaceutical products, including conducting preclinical studies and clinical trials, is a very time-consuming, expensive, and
uncertain process that takes years to complete. Our operations have consumed substantial amounts of cash, and we expect our expenses
to increase in connection with our ongoing activities, particularly as we conduct clinical trials of our product candidates. Even
if one or more of our product candidates is approved for commercial sale, we will incur significant costs associated with sales,
marketing, manufacturing, and distribution activities. Our expenses could increase beyond expectations if required by the FDA,
the European Medicines Agency (EMA) or other regulatory agencies to perform clinical trials or preclinical studies in addition
to those that we currently anticipate. For example, on August 11, 2023, the FDA notified us that the agency was placing a clinical
hold on our IND for the proposed FIH study of NPM-119. The FDA indicated its intention to subsequently provide an official clinical
hold letter stating the reasons for the clinical hold. If we are required to conduct additional IND-enabling activities such as
additional pre-clinical studies, our overall expenditures relating to our NPM-119 program would increase. Other unanticipated
costs may also arise. Because the design and outcome of our planned and anticipated clinical trials are highly uncertain, we cannot
reasonably estimate the actual amount of resources and funding that will be necessary to successfully complete the development
and commercialization of any product candidate. We are not permitted to market or promote any product candidate before it receives
marketing approval from the regulatory authorities. Accordingly, we will need to obtain substantial additional funding in order
to continue our operations and pursue our business objectives.
There
can be no assurance that we will be able to raise sufficient additional capital on acceptable terms or at all. If such additional
financing is not available on satisfactory terms, or is not available in sufficient amounts, we may be required to delay, limit,
or eliminate one or more of our business objectives, and our competitiveness, and business, financial condition and results of
operations may be materially adversely affected. If we are unable to continue our business, including due to inadequate funding,
you could lose your investment.
Vivani’s
future capital requirements will depend on many factors, including, but not limited to:
|
● |
the scope, rate of progress,
results and cost of its clinical trials, preclinical studies, and other related activities; |
|
● |
its ability to establish
and maintain strategic collaborations, licensing or other arrangements and the financial terms of such arrangements; |
|
● |
the timing of, and the
costs involved in, obtaining regulatory approvals for any of its current or future product candidates; |
| ● | the
number and characteristics of the product candidates it seeks to develop or commercialize; |
| ● | the
cost of manufacturing clinical supplies, and establishing commercial supplies, of its product candidates; |
|
● |
the cost of commercialization
activities if any of its current or future product candidates are approved for sale, including marketing, sales, and distribution
costs; |
|
● |
the expenses needed
to attract and retain skilled personnel; |
|
● |
the costs associated
with being a public company; |
|
● |
the amount of revenue,
if any, received from commercial sales of its product candidates, should any of its product candidates receive marketing approval;
and |
|
● |
the costs involved in
preparing, filing, prosecuting, maintaining, defending, and enforcing possible patent claims, including litigation costs and
the outcome of any such litigation. |
We
may raise capital in the form of equity or debt financing, partnerships, collaborations, licensing, spin-offs or other strategic
transactions. If we raise additional capital by issuing equity securities, the ownership of our existing shareholders may be reduced,
and accordingly these shareholders may experience substantial dilution. We may also issue equity securities that provide for rights,
preferences, and privileges senior to those of its common stock. If we raise funding through debt instruments or facilities, lenders
may require us to pledge some or all of our assets as collateral. We may also be required to observe financial, operational and
other covenants that constrain our business and operations. If we enter into partnerships, collaborations, licensing or other
strategic transactions, we may be required to grant rights to third parties, including rights to develop and market product candidates,
that we would otherwise have retained.
Item 2. |
Unregistered Sales of Equity Securities and
Use of Proceeds |
None.
Item 3. |
Defaults upon
Senior Securities |
None.
Item 4. |
Mine Safety Disclosures |
Not
applicable.
Item 5. |
Other Information |
None.
EXHIBIT
INDEX
Exhibit No. |
Exhibit Description |
101.INS |
XBRL
Instant Document.* |
101.SCH |
XBRL
Taxonomy Extension Schema Document.* |
101.CAL |
XBRL
Taxonomy Extension Calculation Linkbase Document.* |
101.DEF |
XBRL
Taxonomy Extension Definition Linkbase Document.* |
101.LAB |
XBRL
Taxonomy Extension Label Linkbase Document.* |
101.PRE |
XBRL
Taxonomy Extension Presentation Linkbase Document.* |
|
|
104 |
Cover
Page Interactive Data File (formatted as Inline XBRL and contained in Exhibit 101)* |
* |
Indicates
the exhibit is being furnished, not filed, with this report. |
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.
Name |
|
Title |
|
Date |
|
|
|
|
|
/s/ Adam
Mendelsohn |
|
Chief Executive Officer |
|
August 14, 2023 |
Adam Mendelsohn |
|
(Principal Executive Officer) |
|
|
|
|
|
|
|
/s/ Brigid
A. Makes |
|
Chief Financial Officer |
|
August 14,
2023 |
Brigid A. Makes |
|
(Principal Financial and Accounting Officer) |
|
|
Exhibit
31.1
CERTIFICATION
OF THE CHIEF EXECUTIVE OFFICER PURSUANT TO RULE 13a14(a) AND 15d-14(a) OF THE
SECURITIES EXCHANGE ACT, AS ADOPTED PURSUANT TO SECTION 302 OF THE SARBANES-OXLEY ACT OF 2002
I,
Adam Mendelsohn, certify that:
1. |
I have reviewed
this Quarterly Report on Form 10-Q of Vivani Medical, Inc.; |
2. |
Based on my knowledge,
this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the
statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period
covered by this report; |
3. |
Based on my knowledge,
the financial statements, and other financial information included in this report, fairly present in all material respects
the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this
report; |
4. |
The registrant’s
other certifying officer(s) and I are responsible for establishing and maintaining disclosure controls and procedures (as
defined in Exchange Act Rules 13a15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange
Act Rules 13a-15(f) and 15d-15(f)) for the registrant and have: |
(a)
designed such disclosure controls and procedures, or caused such disclosure
controls and procedures to be designed under our supervision, to ensure that material information relating to the registrant,
including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in
which this report is being prepared;
(b)
designed such internal control over financial reporting, or caused such
internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the
reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally
accepted accounting principles;
(c)
evaluated the effectiveness of the registrant’s disclosure controls
and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures,
as of the end of the period covered by this report based on such evaluation; and
(d)
disclosed in this report any change in the registrant’s internal
control over financial reporting that occurred during the registrant’s most recent fiscal quarter (the registrant’s
fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect,
the registrant’s internal control over financial reporting; and
5. The
registrant’s other certifying officer(s) and I have disclosed, based on our most recent evaluation of internal control over
financial reporting, to the registrant’s auditors and the audit committee of the registrant’s board of directors (or
persons performing the equivalent functions):
(a) |
all significant
deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably
likely to adversely affect the registrant’s ability to record, process, summarize and report financial information;
and |
(b) |
any fraud, whether
or not material, that involves management or other employees who have a significant role in the registrant’s internal
control over financial reporting. |
Date: August 14, 2023 |
/s/ Adam Mendelsohn |
|
|
|
Adam Mendelsohn |
|
Chief Executive Officer |
|
(Principal Executive Officer) |
Exhibit
31.2
CERTIFICATION
OF THE CHIEF FINANCIAL OFFICER PURSUANT TO RULE 13a-14(a) AND 15d-14(a) OF THE
SECURITIES EXCHANGE ACT, AS ADOPTED PURSUANT TO SECTION 302 OF THE SARBANES-OXLEY ACT OF 2002
I,
Brigid A. Makes, certify that:
1. |
I have reviewed
this Quarterly Report on Form 10-Q of Vivani Medical, Inc.; |
2. |
Based on my knowledge,
this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the
statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period
covered by this report; |
3. |
Based on my knowledge,
the financial statements, and other financial information included in this report, fairly present in all material respects
the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this
report; |
4. |
The registrant’s
other certifying officer(s) and I are responsible for establishing and maintaining disclosure controls and procedures (as
defined in Exchange Act Rules 13a15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange
Act Rules 13a-15(f) and 15d-15(f)) for the registrant and have: |
(a)
designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision,
to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by
others within those entities, particularly during the period in which this report is being prepared;
(b)
designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed
under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of
financial statements for external purposes in accordance with generally accepted accounting principles;
(c)
evaluated the effectiveness of the registrant’s disclosure controls and procedures and presented in this report our conclusions
about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on
such evaluation; and
(d)
disclosed in this report any change in the registrant’s internal control over financial reporting that occurred during the
registrant’s most recent fiscal quarter (the registrant’s fourth fiscal quarter in the case of an annual report) that
has materially affected, or is reasonably likely to materially affect, the registrant’s internal control over financial
reporting; and
5.
The registrant’s other certifying officer(s) and I have disclosed, based on our most recent evaluation of internal
control over financial reporting, to the registrant’s auditors and the audit committee of the registrant’s board of
directors (or persons performing the equivalent functions):
(a) |
all significant
deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably
likely to adversely affect the registrant’s ability to record, process, summarize and report financial information;
and |
(b) |
any fraud, whether
or not material, that involves management or other employees who have a significant role in the registrant’s internal
control over financial reporting. |
Date: August 14, 2023 |
/s/ Brigid A. Makes |
|
|
|
Brigid A. Makes |
|
Chief Financial Officer |
|
(Principal Financial and Accounting Officer) |
Exhibit
32.1
Certifications
of Principal Executive Officer and Principal Financial Officer Pursuant to 18 U.S.C. Section 1350, As Adopted
Pursuant To Section 906 of the Sarbanes-Oxley Act of 2002
Pursuant
to Section 906 of the Sarbanes-Oxley Act of 2002 (18 U.S.C. 1350), Adam Mendelsohn, Chief Executive Officer (Principal Executive
Officer) and Brigid Makes, Chief Financial Officer (Principal Financial and Accounting Officer) of Vivani Medical, Inc. (the “Company”),
each hereby certifies that, to the best of his or her knowledge:
|
1. |
The Quarterly Report
of the Company on Form 10-Q (the “Report”) for the six months ended June 30, 2023, to which this Certification
is attached as Exhibit 32.1, fully complies with the requirements of Section 13(a) or 15(d) of the Securities Exchange Act
of 1934; and |
|
2. |
The information
contained in the Report fairly presents, in all material respects, the financial condition and results of operations of the
Company. |
Date: August 14, 2023 |
/s/ Adam Mendelsohn |
|
|
|
Adam Mendelsohn |
|
Chief Executive Officer |
|
(Principal Executive Officer) |
|
/s/ Brigid A. Makes |
|
|
|
Brigid A. Makes |
|
Chief Financial Officer |
|
(Principal Financial and Accounting Officer) |
This
certification accompanies the Form 10-Q to which it relates, is not deemed filed with the Securities and Exchange Commission and
is not to be incorporated by reference into any filing of Vivani Medical, Inc. under the Securities Act of 1933, as amended, or
the Securities Exchange Act of 1934, as amended (whether made before or after the date of the Form 10-Q), irrespective of any
general incorporation language contained in such filing.
v3.23.2
Cover - shares
|
6 Months Ended |
|
Jun. 30, 2023 |
Aug. 10, 2023 |
Cover [Abstract] |
|
|
Document Type |
10-Q
|
|
Amendment Flag |
false
|
|
Document Quarterly Report |
true
|
|
Document Transition Report |
false
|
|
Document Period End Date |
Jun. 30, 2023
|
|
Document Fiscal Period Focus |
Q2
|
|
Document Fiscal Year Focus |
2023
|
|
Current Fiscal Year End Date |
--12-31
|
|
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 |
5858
Horton Street
|
|
Entity Address, Address Line Two |
Suite 280
|
|
Entity Address, City or Town |
Emeryville
|
|
Entity Address, State or Province |
CA
|
|
Entity Address, Postal Zip Code |
94608
|
|
City Area Code |
415
|
|
Local Phone Number |
506-8462
|
|
Title of 12(b) Security |
Common Stock
|
|
Trading Symbol |
VANI
|
|
Security Exchange Name |
NASDAQ
|
|
Entity Current Reporting Status |
Yes
|
|
Entity Interactive Data Current |
Yes
|
|
Entity Filer Category |
Non-accelerated Filer
|
|
Entity Small Business |
true
|
|
Entity Emerging Growth Company |
false
|
|
Entity Shell Company |
false
|
|
Entity Common Stock, Shares Outstanding |
|
50,818,799
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v3.23.2
Condensed Consolidated Balance Sheets (unaudited) - USD ($) $ in Thousands |
Jun. 30, 2023 |
Dec. 31, 2022 |
Current assets: |
|
|
Cash and cash equivalents |
$ 32,486
|
$ 45,076
|
Prepaid expenses and other current assets |
3,736
|
2,452
|
Total current assets |
36,222
|
47,528
|
Property and equipment, net |
1,075
|
1,182
|
Right-of-use assets |
20,684
|
779
|
Restricted cash |
1,366
|
1,366
|
Deposits and other assets |
260
|
275
|
Total assets |
59,607
|
51,130
|
Current liabilities: |
|
|
Accounts payable |
1,989
|
1,177
|
Accrued expenses |
1,994
|
2,358
|
Litigation accrual |
1,675
|
1,675
|
Accrued compensation expense |
567
|
657
|
Current operating lease liabilities |
861
|
955
|
Total current liabilities |
7,086
|
6,822
|
Long term operating lease liabilities |
20,127
|
|
Total liabilities |
27,213
|
6,822
|
Stockholders’ equity: |
|
|
Preferred stock, no par value, 10,000 shares authorized; none outstanding |
|
|
Common stock, par value $0.0001 per share; 300,000 shares authorized; shares issued and outstanding: 50,799 as of June 30, 2023 and 50,736 as of December 31, 2022, respectively |
5
|
5
|
Additional paid-in capital |
117,954
|
117,054
|
Accumulated other comprehensive loss |
65
|
35
|
Accumulated deficit |
(85,630)
|
(72,786)
|
Total stockholders’ equity |
32,394
|
44,308
|
Total liabilities and stockholders’ equity |
$ 59,607
|
$ 51,130
|
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v3.23.2
Condensed Consolidated Balance Sheets (unaudited) (Parenthetical) - $ / shares
|
Jun. 30, 2023 |
Dec. 31, 2022 |
Statement of Financial Position [Abstract] |
|
|
Preferred stock, no par value (in dollars per share) |
$ 0
|
$ 0
|
Preferred stock, shares authorized |
10,000
|
10,000
|
Preferred stock, shares outstanding |
0
|
0
|
Common stock, par value (in dollars per share) |
$ 0.0001
|
$ 0.0001
|
Common stock, shares authorized |
300,000
|
300,000
|
Common stock, shares issued |
50,799
|
50,736
|
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50,799
|
50,736
|
X |
- DefinitionFace amount per share of no-par value common stock.
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v3.23.2
Condensed Consolidated Statements of Operations (unaudited) - USD ($) $ in Thousands |
3 Months Ended |
6 Months Ended |
Jun. 30, 2023 |
Jun. 30, 2022 |
Jun. 30, 2023 |
Jun. 30, 2022 |
Operating expenses: |
|
|
|
|
Research and development, net of grants |
$ 3,864
|
$ 3,203
|
$ 7,819
|
$ 5,883
|
General and administrative |
3,139
|
884
|
5,785
|
2,112
|
Total operating expenses |
7,003
|
4,087
|
13,604
|
7,995
|
Loss from operations |
(7,003)
|
(4,087)
|
(13,604)
|
(7,995)
|
Other income (expense), net |
477
|
(16)
|
760
|
(33)
|
Net income/(loss) |
$ (6,526)
|
$ (4,103)
|
$ (12,844)
|
$ (8,028)
|
Net income/(loss) per common share – basic |
$ (0.13)
|
$ (0.11)
|
$ (0.25)
|
$ (0.22)
|
Weighted average common shares outstanding – basic |
50,795
|
36,880
|
50,748
|
36,819
|
X |
- DefinitionThe amount of net income (loss) for the period per each share of common stock or unit outstanding during the reporting period.
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v3.23.2
Condensed Consolidated Statements of Comprehensive Income (unaudited) - USD ($) $ in Thousands |
3 Months Ended |
6 Months Ended |
Jun. 30, 2023 |
Jun. 30, 2022 |
Jun. 30, 2023 |
Jun. 30, 2022 |
Income Statement [Abstract] |
|
|
|
|
Net loss |
$ (6,526)
|
$ (4,103)
|
$ (12,844)
|
$ (8,028)
|
Other comprehensive income (loss): |
|
|
|
|
Foreign currency translation adjustments |
21
|
|
30
|
|
Comprehensive loss |
$ (6,505)
|
$ (4,103)
|
$ (12,814)
|
$ (8,028)
|
X |
- DefinitionAmount after tax of increase (decrease) in equity from transactions and other events and circumstances from net income and other comprehensive income, attributable to parent entity. Excludes changes in equity resulting from investments by owners and distributions to owners.
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v3.23.2
Condensed Consolidated Statements of Stockholders' Equity (Deficit) (unaudited) - USD ($) $ in Thousands |
Common Stock [Member] |
Additional Paid-in Capital [Member] |
AOCI Attributable to Parent [Member] |
Retained Earnings [Member] |
Total |
Beginning balance, value at Dec. 31, 2021 |
$ 4
|
$ 61,358
|
|
$ (58,897)
|
$ 2,465
|
Balance at the beginning (in shares) at Dec. 31, 2021 |
36,803
|
|
|
|
|
Repurchase of common stock |
|
|
|
|
|
Repurchase of common stock (in shares) |
4
|
|
|
|
|
Options exercised |
|
1
|
|
|
1
|
Options exercised (in shares) |
24
|
|
|
|
|
Stock-based compensation expense |
|
340
|
|
|
340
|
Net loss |
|
|
|
(3,924)
|
(3,924)
|
Ending balance, value at Mar. 31, 2022 |
$ 4
|
61,699
|
|
(62,821)
|
(1,118)
|
Ending balance (in shares) at Mar. 31, 2022 |
36,831
|
|
|
|
|
Beginning balance, value at Dec. 31, 2021 |
$ 4
|
61,358
|
|
(58,897)
|
2,465
|
Balance at the beginning (in shares) at Dec. 31, 2021 |
36,803
|
|
|
|
|
Net loss |
|
|
|
|
(8,028)
|
Foreign currency adjustment |
|
|
|
|
|
Ending balance, value at Jun. 30, 2022 |
$ 4
|
62,105
|
|
(66,924)
|
(4,815)
|
Ending balance (in shares) at Jun. 30, 2022 |
36,837
|
|
|
|
|
Beginning balance, value at Mar. 31, 2022 |
$ 4
|
61,699
|
|
(62,821)
|
(1,118)
|
Balance at the beginning (in shares) at Mar. 31, 2022 |
36,831
|
|
|
|
|
Options exercised |
|
12
|
|
|
12
|
Options exercised (in shares) |
6
|
|
|
|
|
Stock-based compensation expense |
|
394
|
|
|
394
|
Net loss |
|
|
|
(4,103)
|
(4,103)
|
Foreign currency adjustment |
|
|
|
|
|
Ending balance, value at Jun. 30, 2022 |
$ 4
|
62,105
|
|
(66,924)
|
(4,815)
|
Ending balance (in shares) at Jun. 30, 2022 |
36,837
|
|
|
|
|
Beginning balance, value at Dec. 31, 2022 |
$ 5
|
117,054
|
35
|
(72,786)
|
$ 44,308
|
Balance at the beginning (in shares) at Dec. 31, 2022 |
50,736
|
|
|
|
50,736
|
Options exercised |
|
|
|
|
|
Options exercised (in shares) |
53
|
|
|
|
|
Stock-based compensation expense |
|
369
|
|
|
369
|
Net loss |
|
|
|
(6,318)
|
(6,318)
|
Foreign currency adjustment |
|
|
9
|
|
9
|
Ending balance, value at Mar. 31, 2023 |
$ 5
|
117,423
|
44
|
(79,104)
|
38,368
|
Ending balance (in shares) at Mar. 31, 2023 |
50,789
|
|
|
|
|
Beginning balance, value at Dec. 31, 2022 |
$ 5
|
117,054
|
35
|
(72,786)
|
$ 44,308
|
Balance at the beginning (in shares) at Dec. 31, 2022 |
50,736
|
|
|
|
50,736
|
Net loss |
|
|
|
|
$ (12,844)
|
Foreign currency adjustment |
|
|
|
|
30
|
Ending balance, value at Jun. 30, 2023 |
$ 5
|
117,954
|
65
|
(85,630)
|
$ 32,394
|
Ending balance (in shares) at Jun. 30, 2023 |
50,799
|
|
|
|
50,799
|
Beginning balance, value at Mar. 31, 2023 |
$ 5
|
117,423
|
44
|
(79,104)
|
$ 38,368
|
Balance at the beginning (in shares) at Mar. 31, 2023 |
50,789
|
|
|
|
|
Options exercised |
|
7
|
|
|
7
|
Options exercised (in shares) |
10
|
|
|
|
|
Stock-based compensation expense |
|
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|
|
|
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|
Net loss |
|
|
|
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|
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|
|
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|
|
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|
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|
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|
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|
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|
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|
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|
|
|
|
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v3.23.2
Condensed Consolidated Statements of Cash Flows (unaudited) - USD ($) $ in Thousands |
6 Months Ended |
Jun. 30, 2023 |
Jun. 30, 2022 |
Cash flows from operating activities: |
|
|
Net loss |
$ (12,844)
|
$ (8,028)
|
Adjustments to reconcile net loss to net cash used in operating activities: |
|
|
Depreciation and amortization |
188
|
170
|
Stock-based compensation |
893
|
734
|
Non-cash lease expense |
128
|
54
|
Changes in operating assets and liabilities: |
|
|
Prepaid expenses and other assets |
(1,270)
|
(181)
|
Accounts payable |
822
|
363
|
Accrued compensation expenses |
(90)
|
|
Accrued expenses |
(343)
|
263
|
Net cash used in operating activities |
(12,516)
|
(6,625)
|
Cash flows from investing activities: |
|
|
Purchases of property and equipment |
(81)
|
(116)
|
Net cash used in investing activities |
(81)
|
(116)
|
Cash flows from financing activities: |
|
|
Proceeds from SAFE note |
|
8,000
|
Net proceeds from sale of common stock and exercise of warrants |
7
|
13
|
Net cash provided by financing activities |
7
|
8,013
|
Effect of exchange rate changes on cash and cash equivalents |
0
|
|
Cash, cash equivalents and restricted cash: |
|
|
Net increase (decrease) |
(12,590)
|
1,272
|
Balance at beginning of period |
46,442
|
2,178
|
Balance at end of period |
33,852
|
3,450
|
Non-cash investing and financing activities: |
|
|
Establishment of operating right-of-use assets through operating lease obligations |
$ 20,755
|
|
X |
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v3.23.2
Organization and Business Operations
|
6 Months Ended |
Jun. 30, 2023 |
Organization, Consolidation and Presentation of Financial Statements [Abstract] |
|
Organization and Business Operations |
|
1. |
Organization and Business Operations |
Vivani Medical, Inc. (“Vivani,”
the “Company,” “we,” “us,” “our” or similar terms) is a preclinical stage biopharmaceutical
company which develops miniaturized, subdermal implants utilizing its proprietary NanoPortal™ technology to enable long-term,
near constant-rate delivery of a broad range of medicines to treat chronic diseases. Vivani uses this platform technology to develop
and potentially commercialize drug implants, alone or in collaboration with pharmaceutical company partners to address a leading
cause of poor clinical outcomes in the treatment of chronic disease, medication non-adherence. For example, approximately 50% of
patients treated for type 2 diabetes are non-adherent to their medicines which can lead to poor clinical outcomes. We are developing
a portfolio of miniature, sub-dermal drug implants that, unlike most oral and injectable medicines, are designed with the goal
of guaranteeing adherence by delivering therapeutic drug levels for up to 6 months or the life of the implant. In addition, by
leveraging our proprietary NanoPortal implant technology we can design implants that deliver minimally fluctuating drug levels
that may improve the tolerability profiles for certain medicines for which side effects are associated with fluctuating drug levels
such as GLP-1 receptor agonists (GLP-1s).
In February 2022, we announced the signing
of a definitive merger agreement between Nano Precision Medical, Inc. (“NPM”) and Second Sight Medical Products, Inc.
(“Second Sight”), pursuant to which NPM became a wholly owned subsidiary of Second Sight. On August 30, 2022, the merger
closed and the combined company of NPM and Second Sight was renamed Vivani Medical, Inc.
In December 2022, we contributed our neuromodulation
assets and certain liabilities to Cortigent, Inc. a newly formed corporation in Delaware, and wholly owned subsidiary of Vivani,
in exchange for 20 million shares of common stock of Cortigent. While the primary focus of Vivani is to develop and ultimately
commercialize our drug implant business from legacy company NPM, Vivani’s new management team remains committed to identifying
and exploring strategic options for the further advancement of the neuromodulation business of Cortigent which includes the development
of its pioneering neurostimulation systems to help patients recover critical body functions. In March 2023, Vivani announced the
filing of a Registration Statement on Form S-1 with the U.S. Securities and Exchange Commission (“SEC”) for the proposed
initial public offering of Cortigent. Cortigent will continue to be majority-owned by Vivani immediately following its initial
public offering.
Subject to completion of Cortigent’s
initial public offering, Vivani intends to focus exclusively on further development of the drug implant business.
On July 6, 2023, Vivani changed its state
of incorporation from the State of California to the State of Delaware by means of a plan of conversion, effective July 5, 2023.
The reincorporation, including the principal terms of the plan of conversion, was submitted to a vote of, and approved by, Vivani’s
stockholders at its 2023 Annual Meeting of Stockholders held on June 15, 2023.
As part of this change of incorporation the Company established
a par value of $0.0001 per share and all periods have been retroactively adjusted to reflect this change.
In
early July 2023, Vivani successfully completed the manufacture of clinical supplies to support a proposed first-in-human (“FIH”)
investigation of NPM-119 (exenatide implant) in patients with type 2 diabetes mellitus. On July 14, 2023, the Company submitted
an Investigational New Drug (“IND”) application to the U.S. Food and Drug Administration (“FDA)” for the
proposed NPM-119 FIH study also named LIBERATE-1™. On August 11, 2023, FDA verbally notified Vivani that the agency
was placing a clinical hold on Vivani’s IND application for the proposed clinical investigation and indicated its intention
to subsequently provide an official clinical hold letter stating the reasons for the clinical hold. Vivani plans to engage with
the FDA in order to lift the clinical hold and commence its planned clinical development of NPM-119. The Company expects to commence
enrollment in LIBERATE-1 in the second half of 2023 subject to regulatory clearance. Assuming LIBERATE-1 commences as planned,
the Company would anticipate the availability of interim LIBERATE-1 data in the first half of 2024 and full top-line results in
the second half of 2024.
Agreement
and Plan of Merger with Nano Precision Medical, Inc.
On
February 4, 2022, Second Sight entered into an agreement and plan of merger
(the “Merger Agreement”) with NPM. The Merger was approved by the shareholders
of Second Sight on July 27, 2022, and closed on August 30, 2022. Upon consummation of the Merger, NPM became a wholly owned subsidiary
of Second Sight. Concurrent with to the Merger, Second Sight changed its name to Vivani Medical, Inc., and changed its trading
symbol from EYES to VANI, and trades under the ticker VANI on the NASDAQ market. Certain investors and members of the NPM board
of directors are also investors and members of the board of directors of Second Sight.
Under
the terms and conditions of the Merger Agreement, the securities of NPM converted into the right to receive shares of Second Sight’s
common stock representing 77.32% of the total issued and outstanding shares of common stock of Second Sight on a fully converted
basis, including, without limitation, giving effect to the conversion of all options, warrants, and any and all other convertible
securities assuming net settlement. Second Sight filed a Registration Statement on Form S-4 on May 13, 2022, in connection with
the Merger to register the merger shares effective June 24, 2022.
On
February 4, 2022, in connection with the Merger, Second Sight and NPM also entered into a Simple Agreement for Future Equity (“SAFE”)
whereby Second Sight provided to NPM an investment advance of $8 million. The Merger Agreement provided that the SAFE would terminate
if the Merger were to be successfully completed. Under the terms of the SAFE, upon successfully completion of the Merger on August
30, 2022, the investment advance was eliminated. Under the accounting for a business combination, the $8 million adjusted the
purchase consideration.
The
Merger involved a change of control and was accounted for as a reverse merger in accordance with accounting principles generally
accepted in the United States of America (“GAAP”). Under this method of accounting, Second Sight was treated as the
“acquired” company for financial reporting purposes with NPM as the acquirer. The assets acquired and liabilities
assumed by NPM were recorded at fair value under Accounting Codification Standard (“ASC”), Business Combinations.
Accordingly, on August 30, 2022 (the “Acquisition Date”), NPM (a calendar year-end entity) was deemed to have acquired
100% of the outstanding common shares and voting interest of Second Sight. The results of Second Sight’s operations
have been included in the consolidated financial statements since that date.
The
acquisition-date fair value of consideration transferred totaled $54.4 million, which consisted of the fair value of the 13,136
common shares deemed issued to Second Sight shareholders, was determined based on the per share closing price of the Company’s
common shares on the acquisition date of $4.14.
The
following table summarizes the fair values of the assets acquired and liabilities assumed at the acquisition date (in thousands):
At August 30, 2022 |
|
|
|
|
|
|
|
Cash |
|
$ |
55,374 |
|
Property and equipment |
|
|
99 |
|
Prepaid expenses |
|
|
1,657 |
|
Right of use assets |
|
|
140 |
|
Other assets |
|
|
56 |
|
Total identifiable assets acquired |
|
|
57,326 |
|
Current liabilities |
|
|
(3,913 |
) |
Right of use liabilities |
|
|
(151 |
) |
Total liabilities assumed |
|
|
4,064 |
|
Net identifiable assets acquired |
|
$ |
53,262 |
|
The
SAFE loan of $8.0 million was cancelled in the Merger which adjusted the fair value of net assets acquired.
The
following table summarizes the calculation of the gain on bargain purchase (in thousands):
|
|
|
|
|
Total consideration |
|
$ |
54,385 |
|
SAFE loan forgiven |
|
|
(8,000 |
) |
Less net identifiable assets acquired |
|
|
(53,262 |
) |
Gain on bargain purchase |
|
$ |
6,877 |
|
Because
NPM purchased 100% of Second Sight and the fair value of identifiable assets acquired and liabilities assumed exceeded the fair
value of the consideration, we reassessed the recognition and measurement of identifiable assets acquired and liabilities assumed
and concluded that all acquired assets and assumed liabilities were properly recognized and that the valuation procedures and
resulting measures were appropriate. As a result, we recognized a gain of $6.9 million.
We
recognized $0.7 million of acquisition related costs that were expensed in the twelve months ended December 31, 2022. These costs
are included in the consolidated income statement in the line item entitled “General and administrative costs.”
Pro
forma consolidated net loss as if Second Sight had been included in the consolidated results was $13.3 million for the six months
ended June 30, 2022.
Liquidity
From
inception, our operations have been funded primarily through the sales of our common stock and warrants. The completion of our
reverse merger with Second Sight Medical Products, Inc. provided $53.3 million in net assets including approximately $55.4 million
in cash.
Our
financial statements have been presented on the basis that our business is a going concern, which contemplates the realization
of assets and the satisfaction of liabilities in the normal course of business. We are subject to the risks and uncertainties
associated with a business with no revenue that is developing novel medical devices, including limitations on our operating capital
resources. We have incurred recurring operating losses and negative operating cash flows since inception, and we expect to continue
to incur operating losses and negative operating cash flows for the foreseeable future. We estimate that currently available cash
will provide sufficient funds to enable the Company to meet its planned obligations through September 2024.
|
X |
- DefinitionThe entire disclosure for the nature of an entity's business, major products or services, principal markets including location, and the relative importance of its operations in each business and the basis for the determination, including but not limited to, assets, revenues, or earnings. For an entity that has not commenced principal operations, disclosures about the risks and uncertainties related to the activities in which the entity is currently engaged and an understanding of what those activities are being directed toward.
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v3.23.2
Basis of Presentation, Significant Accounting Policies and Recent Accounting Pronouncements
|
6 Months Ended |
Jun. 30, 2023 |
Accounting Policies [Abstract] |
|
Basis of Presentation, Significant Accounting Policies and Recent Accounting Pronouncements |
2.
Basis of Presentation, Significant Accounting Policies and Recent Accounting Pronouncements
Basis
of Presentation
These
unaudited interim financial statements have been prepared in accordance with United States generally accepted accounting principles
(“GAAP”) and following the requirements of the SEC for interim reporting. As permitted under those rules, certain footnotes or other financial information that are normally required
by GAAP can be condensed or omitted. In our opinion, the unaudited interim financial statements have been prepared on the same
basis as the audited financial statements and include all adjustments, which include only normal recurring adjustments, necessary
for the fair presentation of our financial position and our results of operations and cash flows for periods presented. These
statements do not include all disclosures required by GAAP and should be read in conjunction with our financial statements and
accompanying notes for the fiscal year ended December 31, 2022, included within our Annual Report on Form 10-K filed with the
SEC on March 31, 2023. The results of the interim periods are not necessarily indicative of the results expected for the full
fiscal year or any other interim period or any future year or period.
Income
taxes - interim periods
In
calculating the provision for interim income taxes, in accordance with ASC 740, Income Taxes, an estimated annual effective
tax rate is applied to year-to-date ordinary income. At the end of each interim period, we estimate the effective tax rate expected
to be applicable for the full fiscal year. This differs from the method utilized at the end of an annual period.
Use
of estimates
The
preparation of financial statements requires management to make a number of estimates and assumptions related to the
reported amount of assets and liabilities and the disclosure of contingent assets and liabilities at the date of the
financial statements, and the reported amounts of expenses during the period. Estimates are based on historical experience
and on various other assumptions that are believed to be reasonable under the circumstances. Some of the more significant
estimates include the purchase price of net assets acquired in the Merger, useful lives of long-lived assets, the fair value
of equity-based compensation, and the estimated incremental borrowing rate used in calculating lease assets and liabilities
and evaluation of going concern. Actual results could differ materially from those estimates.
Net
income/loss per share
Basic
net income/loss per share is computed using net income/loss from operations divided by the weighted-average number of shares of
common stock outstanding during the period.
Diluted
net income/loss per share represents net income/loss from operations divided by the weighted- average number of common shares
outstanding during the period, including all potentially dilutive common stock equivalents. Common stock equivalents consist of
shares subject to warrants and share-based awards with exercise prices less than the average market price of common stock for
the period, to the extent their inclusion would be dilutive.
The
computation of the weighted-average shares of common stock outstanding for diluted EPS excludes the following potential common
shares as of June 30, 2023, and 2022 (in thousands):
Schedule of net loss per share
|
|
June
30,
2023 |
|
|
June
30,
2022 |
|
Shares underlying warrants
outstanding |
|
|
10,311 |
|
|
|
9,074 |
|
Shares underlying stock options outstanding |
|
|
6,139 |
|
|
|
4,630 |
|
Shares underlying RSU’s |
|
|
403 |
|
|
|
— |
|
The
shares underlying the SAFE obligation were issuable only if the Merger were to be terminated. These contingently issuable shares
were excluded from the dilutive computation because conversion was not “probable” as defined in the accounting literature.
However, if the evaluation met the probability threshold, the shares would be excluded from diluted EPS since their inclusion
would have an anti-dilutive effect.
Significant
Accounting Policies
Our
significant accounting policies are set forth in our financial statements for the year ended December 31, 2022, included within
our Annual Report on Form 10-K filed with the SEC on March 31, 2023.
Recently
Issued Accounting Pronouncements
We
do not believe that any recently issued, but not yet effective, accounting standards, if adopted, will have a material effect
on the financial statements.
|
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v3.23.2
Concentration of Risk
|
6 Months Ended |
Jun. 30, 2023 |
Cash and Cash Equivalents [Abstract] |
|
Concentration of Risk |
3.
Concentration of Risk
Credit
Risk
Financial
instruments that subject us to concentrations of credit risk consist primarily of cash and money market funds. We maintain cash
and money market funds with financial institutions that we deem reputable.
Foreign
Operations
The
accompanying condensed consolidated financial statements as of June 30, 2023, include gross assets amounting to $0.1 million relating
to operations of our subsidiary based in Switzerland.
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- DefinitionThe entire disclosure for cash and cash equivalent footnotes, which may include the types of deposits and money market instruments, applicable carrying amounts, restricted amounts and compensating balance arrangements. Cash and equivalents include: (1) currency on hand (2) demand deposits with banks or financial institutions (3) other kinds of accounts that have the general characteristics of demand deposits (4) short-term, highly liquid investments that are both readily convertible to known amounts of cash and so near their maturity that they present insignificant risk of changes in value because of changes in interest rates. Generally, only investments maturing within three months from the date of acquisition qualify.
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v3.23.2
Fair Value Measurements
|
6 Months Ended |
Jun. 30, 2023 |
Fair Value Disclosures [Abstract] |
|
Fair Value Measurements |
4.
Fair Value Measurements
The
authoritative guidance with respect to fair value establishes a fair value hierarchy that prioritizes the inputs to valuation
techniques used to measure fair value into three levels and requires that assets and liabilities carried at fair value be classified
and disclosed in one of three categories, as presented below. Disclosure as to transfers in and out of Levels 1 and 2, and activity
in Level 3 fair value measurements, is also required.
Level
1. Observable inputs such as quoted prices in active markets for an identical asset or liability that we have the ability to access
as of the measurement date. Financial assets and liabilities utilizing Level 1 inputs include active-exchange traded securities
and exchange-based derivatives.
Level
2. Inputs, other than quoted prices included within Level 1, which are directly observable for the asset or liability or indirectly
observable through corroboration with observable market data. Financial assets and liabilities utilizing Level 2 inputs include
fixed income securities, non-exchange-based derivatives, mutual funds, and fair-value hedges.
Level
3. Unobservable inputs in which there is little or no market data for the asset or liability which requires the reporting entity
to develop its own assumptions. Financial assets and liabilities utilizing Level 3 inputs include infrequently-traded non-exchange-based
derivatives and commingled investment funds, and are measured using present value pricing models.
Cash
equivalents, which includes money market funds, are the only financial instrument measured and recorded at fair value on our consolidated
balance sheet, and they are valued using Level 1 inputs.
Assets
measured at fair value on a recurring basis are as follows (in thousands):
Schedule of Money Market Funds at their Level within the Fair Value Hierarchy
|
|
Total |
|
|
Level
1 |
|
|
Level
2 |
|
|
Level
3 |
|
June 30, 2023 (unaudited): |
|
|
|
|
|
|
|
|
|
|
|
|
Money
market funds |
|
$ |
31,561 |
|
|
$ |
31,561 |
|
|
$ |
— |
|
|
$ |
— |
|
December 31, 2022: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Money market funds |
|
$ |
44,417 |
|
|
$ |
44,417 |
|
|
$ |
— |
|
|
$ |
— |
|
|
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v3.23.2
Selected Balance Sheet Detail
|
6 Months Ended |
Jun. 30, 2023 |
Organization, Consolidation and Presentation of Financial Statements [Abstract] |
|
Selected Balance Sheet Detail |
5.
Selected Balance Sheet Detail
Property
and equipment
Property
and equipment consisted of the following (in thousands):
|
|
June
30,
2023 |
|
|
December
31,
2022 |
|
Equipment |
|
$ |
3,598 |
|
|
$ |
3,520 |
|
Furniture and fixtures |
|
|
10 |
|
|
|
10 |
|
Software |
|
|
54 |
|
|
|
51 |
|
Leasehold improvements |
|
|
12 |
|
|
|
12 |
|
|
|
|
3,674 |
|
|
|
3,593 |
|
Accumulated depreciation
and amortization |
|
|
(2,599 |
) |
|
|
(2,411 |
) |
Property and equipment,
net |
|
$ |
1,075 |
|
|
$ |
1,182 |
|
Right-of-use
assets and operating lease liabilities
We
lease certain office space and equipment for our use. Leases with an initial term of 12 months or less are not recorded on the
balance sheet. Lease costs are recognized in the income statement over the lease term on a straight-line basis. Depreciation is
computed using the straight-line method over the estimated useful life of the respective assets. The depreciable life of assets
and leasehold improvements are limited by the expected lease term. Our lease agreements do not contain any material residual value
guarantees or restrictive covenants. As most of our leases do not provide an implicit rate, we used our estimated incremental
borrowing rate based on the information available at commencement date in determining the present value of lease payments.
Schedule of right of use assets and operating lease liabilties
Assets |
|
Classification |
|
June
30,
2023 (in thousands) |
|
|
December
31,
2022 (in thousands) |
|
Non-current
assets |
|
Right-of-use assets |
|
$ |
20,684 |
|
|
$ |
779 |
|
Liabilities |
|
|
|
|
|
|
|
|
|
|
Current |
|
Current operating lease liabilities |
|
$ |
861 |
|
|
$ |
955 |
|
Long term |
|
Long term operating lease liabilities |
|
$ |
20,127 |
|
|
$ |
— |
|
Schedule of lease liabilities
| |
For the three months ended June 30, 2023 | | |
For the three months ended June 30, 2022 | | |
For the six months ended June 30, 2023 | | |
For the six months ended June 30, 2022 | |
Cash paid for operating lease liabilities (in thousands) | |
$ | 382 | | |
$ | 211 | | |
| 759 | | |
| 422 | |
Rent
expense, including common area maintenance charges, was $0.6 million and $0.2 million and was $0.9 and $0.5 during the three-month
and six-month periods ended June 30, 2023 and 2022, respectively.
On
February 1, 2023, we entered into a lease agreement, effective March 1, 2023, to sublease office space to replace Cortigent’s
existing headquarters. Our rental payments amount to $22,158 per month plus operating expenses, to lease 14,823 square feet of
office space at 27200 Tourney Road, Valencia, California 91355. The sub-lease has a term of two years and two months. We also
entered into a lease for storage space on January 25, 2023, in the same building at a cost of $6,775 per month for a term of two
years and one month.
Vivani
entered into a triple net lease agreement for a single building with 43,645 square feet of space in Alameda, California on November
21, 2022. The stated term of the lease commences on June 1, 2023 and terminates on September 30, 2033, ten years and 4 months.
Payments increase annually from $2,676,311 to $3,596,784, or 124 payments less the first four which are abated, totaling approximately
$31 million. Vivani will be responsible for insurance, property taxes and CAM charges. Vivani was required to deposit $1.4 million
to guarantee a letter of credit to secure the lease and this amount is included in long-term assets on the balance sheet at June
30, 2023. The current lease expires on September 30, 2023.
The
Company evaluated the lease under the provisions of ASC 842, Leases. Information related to the right-of-use assets and related lease
liabilities under this lease are as follows (in thousands):
Year Ending December 31, | | |
| |
2023 | | |
$ | 669 | |
2024 | | |
| 2,723 | |
2025 | | |
| 2,805 | |
2026 | | |
| 2,889 | |
2027 | | |
| 2,976 | |
Thereafter | | |
| 18,926 | |
Total lease payments | | |
$ | 30,988 | |
| | |
| | |
Less imputed interest | | |
| (10,900 | ) |
| | |
| | |
Total lease liabilities | | |
$ | 20,088 | |
| | |
| | |
Discount rate | | |
| 8.38 | % |
|
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v3.23.2
Equity Securities
|
6 Months Ended |
Jun. 30, 2023 |
Equity [Abstract] |
|
Equity Securities |
6.
Equity Securities
We
are authorized to issue 300,000,000 shares of common stock with 50,798,799 issued as of June 30, 2023. In addition, we are authorized
to issue 10,000,000 shares of preferred stock with none issued. On August 19, 2022, the Company initiated a reverse stock split
of one share for every three shares. All share numbers have been retroactively adjusted for the split. On August 30, 2022, 13,136,362
shares were deemed issued for the merger acquisition.
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v3.23.2
Warrants
|
6 Months Ended |
Jun. 30, 2023 |
Warrants |
|
Warrants |
7.
Warrants
NPM,
prior to the Merger, issued common stock and warrants (collectively, the “unit” or “units”) in 2019, 2020
and 2021 for $3.15 per unit. Outstanding warrants of 7,746,855 to purchase common stock are shown in the table below and generally
expire 5 years from the date of issuance at $3.15 per share, are transferable into one share of common stock and may be exercised
on a cashless basis. The warrants qualified for an exception to derivative accounting and, accordingly, their value was not bifurcated
from the total purchase price.
Second
Sight warrants of 7,691,063 were outstanding and are convertible into 2,563,688 shares in the table below and converted as part
of the Merger for Vivani warrants on a like for-like basis. The weighted average exercise price of these warrants is $35.24. Of
this total 7,680,938 warrants are convertible into 2,560,313 shares and are tradeable on the open market. Under accounting standards
in a business combination, these warrants were measured at fair value as of the Merger date; however, the warrants were substantially
out-of-the-money and were assigned no value.
A
summary of warrant activity for the six months ended June 30, 2023 is presented below (in thousands, except per share and contractual
life data).
Summary of Warrant Activity
|
|
Number
of
Shares |
|
|
Weighted
Average
Exercise
Price
Per Share |
|
|
Weighted
Average
Remaining
Contractual
Life (in Years) |
|
Warrants outstanding as of
December 31, 2022 |
|
|
10,311 |
|
|
$ |
11.13 |
|
|
|
2.31 |
|
Issued |
|
|
— |
|
|
|
|
|
|
|
|
|
Exercised |
|
|
— |
|
|
|
|
|
|
|
|
|
Forfeited or expired |
|
|
— |
|
|
|
|
|
|
|
|
|
Warrants outstanding as of June 30, 2023 |
|
|
10,311 |
|
|
$ |
11.13 |
|
|
|
1.81 |
|
Warrants exercisable as of June 30, 2023 |
|
|
10,311 |
|
|
$ |
11.13 |
|
|
|
1.81 |
|
The
warrants outstanding as of June 30, 2023, had no intrinsic value.
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v3.23.2
Stock-Based Compensation
|
6 Months Ended |
Jun. 30, 2023 |
Retirement Benefits [Abstract] |
|
Stock-Based Compensation |
8.
Stock-Based Compensation
A
summary of stock option activity for the six months ended June 30, 2023, is presented below (in thousands, except per share and
contractual life data).
Summary of Stock Option Activity
|
|
Number
of
Shares |
|
|
Weighted
Average
Exercise
Price
Per Share |
|
|
Weighted
Average
Remaining
Contractual
Life (in Years) |
|
Options outstanding as of
December 31, 2022 |
|
|
5,272 |
|
|
$ |
3.07 |
|
|
|
7.15 |
|
Granted |
|
|
1,122 |
|
|
$ |
1.25 |
|
|
|
|
|
Exercised |
|
|
(101 |
) |
|
$ |
0.44 |
|
|
|
|
|
Forfeited or expired |
|
|
(154 |
) |
|
$ |
2.78 |
|
|
|
|
|
Options outstanding, vested and expected to
vest as of June 30, 2023 |
|
|
6,139 |
|
|
$ |
2.79 |
|
|
|
7.03 |
|
Options exercisable as of June 30, 2023 |
|
|
3,941 |
|
|
$ |
3.29 |
|
|
|
5.94 |
|
The
estimated aggregate intrinsic value of stock options exercisable as of June 30, 2023, was $0.3 million. As of June 30, 2023, there
was $2.4 million of total unrecognized compensation cost related to outstanding stock options that will be recognized over a weighted
average period of 1.2 years.
During
the six months ended June 30, 2023, we granted stock options to purchase 1,121,817
shares of common stock to certain employees and board members. The options are exercisable for a period of ten
years from the date of grant at a weighted average price of $1.25
per share, which was calculated at the fair value of our common stock on the respective grant date. The options
generally vest over a period of four
years. The fair value of options subject to only service conditions are valued using the Black-Scholes option pricing
model, while those subject to performance or market conditions are valued using the Monte-Carlo Simulation model. During the
six-months ended June 30, 2023, 200,000
options were issued and valued at $0.1
million using the Monte-Carlo model using the following assumptions:
| ● | Beginning Stock Price. We utilized the Company's
publicly traded share price as of the Valuation Date as the beginning stock value. At the Valuation Date, the publicly traded
common share price was $1.09 per share. |
| ● | Drift Rate. In determining the value of the instrument
in the risk-neutral framework, riskfree rates were estimated based on the applicable treasury rate for the projection period.
For each simulation, the term of the risk-free rate was based on the term from the Valuation Date through the latest date on which
the award could vest (i.e., two years following the Performance Period End Date). Please note that, for the purposes of calculating
the service period associated with the Subject Interest, the Company’s cost of equity was utilized as the drift rate. |
| ● | Volatility. The total equity volatility (standard
deviation) was based on a total equity volatility analysis. |
| ● | Period. The period was measured as the number
of years from the Valuation Date through the PSO expiration date (10 years following the date of grant). |
| ● | Dividends. The Company has not historically paid
dividends. In addition, the Company does not expect to pay dividends going forward. As such, no dividends were considered in our
analysis. |
During
the six-months ended June 30, 2023, 921,817 options were issued and valued at $0.9 million using the Black-Scholes
option-pricing model using the following assumptions: expected term of 4.00
to 6.20
years, volatility of 100%,
risk-free interest rate of 3.99%
to 4.45%,
and expected dividend rate of 0.0%.
We also granted 402,500 RSU’s (as defined below) during
the quarter. These RSUs had market conditions which required our stock price to exceed $3.15 per share for three consecutive days
in the four years from grant date for the RSUs to vest.
The
following table summarizes restricted stock unit (“RSU”) activity for the six months ended June 30, 2023 (in thousands,
except per share data):
Summary of Restricted Stock Unit
|
|
Number
of
Shares
|
|
|
Weighted
Average
Grant
Date
Fair Value
Per
Share
|
|
Outstanding as of
December 31, 2022 |
|
|
— |
|
|
$ |
— |
|
Awarded |
|
|
403 |
|
|
|
0.93 |
|
Vested and released |
|
|
— |
|
|
|
— |
|
Forfeited/canceled |
|
|
— |
|
|
|
— |
|
Outstanding
as of June 30, 2023 |
|
|
403 |
|
|
$ |
0.93 |
|
As
of June 30, 2023, there was $0.2 million of total unrecognized compensation cost related to the outstanding RSUs that will be
recognized over a weighted average period of 1.2 years.
Stock-based
compensation expense recognized for stock-based awards in the condensed consolidated statements of operations for the three and
six months ended June 30, 2023, and 2022 was as follows (in thousands):
Stock-based Compensation Expense
| |
Three Months Ended June 30, | | |
Six Months Ended June 30, | |
| |
2023 | | |
2022 | | |
2023 | | |
2022 | |
Research and development | |
$ | 284 | | |
$ | 324 | | |
$ | 532 | | |
$ | 514 | |
General and administrative | |
| 240 | | |
| 70 | | |
| 361 | | |
| 220 | |
Total | |
$ | 524 | | |
$ | 394 | | |
$ | 893 | | |
$ | 734 | |
|
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v3.23.2
Risk and Uncertainties
|
6 Months Ended |
Jun. 30, 2023 |
Risk And Uncertainties |
|
Risk and Uncertainties |
9. |
Risk and Uncertainties |
We
continue to monitor the ongoing COVID-19 global pandemic which has resulted in travel and other restrictions to reduce the spread
of the disease. We presently are not experiencing any significant disruptions from the ongoing COVID-19 pandemic. All clinical
and chemistry, manufacturing and control activities are currently active.
The
safety, health and well-being of all patients, medical staff and internal and external teams is the paramount and primary focus.
As the pandemic and its resulting restrictions evolve in jurisdictions across the country, the potential exists for further disruptions
to projected timelines. We are in close communication with clinical teams and key vendors and are prepared to take action should
the pandemic worsen and impact the business in the future.
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v3.23.2
Commitments and Contingencies
|
6 Months Ended |
Jun. 30, 2023 |
Commitments and Contingencies Disclosure [Abstract] |
|
Commitments and Contingencies |
10.
Commitments and Contingencies
Clinical
Trial Agreements
Based
upon FDA approval of Argus II, which was obtained in February 2013, we were required to collect follow-up data from subjects enrolled
in our pre-approval trial for a period of up to ten years post-implant, which was extended through the year 2019. This requirement
to collect follow-up data was halted in 2020 with FDA approval. In addition, we conducted three post-market studies to comply
with U.S. FDA, French, and European post-market surveillance regulations and requirements and are conducting an early feasibility
clinical study of Orion. We have contracted with various universities, hospitals, and medical practices to provide these services.
Payments are based on procedures performed for each subject and are charged to clinical and regulatory expense as incurred. Total
amounts charged to expense for the three and six months ended June 30, 2023 were $88,000 and $115,000, respectively.
Litigation,
Claims and Assessments
Three
oppositions filed by Pixium Vision SA (“Pixium”) are pending in the European Patent Office, each challenging the validity
of a European patent owned by us. The outcomes of the challenges are not certain, however, if successful, they may affect our
ability to block competitors from utilizing our patented technology. We do not believe a successful challenge will have a material
effect on our ability to manufacture and sell our products, or otherwise have a material effect on our operations.
As
described in the Company’s 10-K for the year ended December 31, 2020, the Company had entered into a Memorandum of
Understanding (“MOU”) for a proposed business combination with Pixium. In response to a press release by Pixium
dated March 24, 2021, and subsequent communications between us and Pixium, our Board of Directors determined that the
business combination with Pixium was not in the best interest of our shareholders. On April 1, 2021, we gave notice to Pixium
that we were terminating the MOU between the parties and seeking an amicable resolution of termination amounts that may be
due, however no assurance can be given that an amicable resolution will be reached. We accrued $1,000,000
of liquidated damages as contemplated by the MOU in accounts payable as of March 31, 2021, and remitted that amount to Pixium
in April 2021. Pixium
indicated that it considered this termination wrongful, rejected the Company’s offers, but retained the $1,000,000
payment. On May 19, 2021, Pixium filed suit in the Paris Commercial Court, and currently claim damages of approximately
€5.1 million or about $5.6
million. We believe we have fulfilled our obligations to Pixium with the liquidated damages payment of $1,000,000. On
December 9, 2022, the Company received notice that the Paris Commercial Court has rendered its judgement, including finding
that the Company’s termination of the MOU was not valid. In the judgement, the Company was ordered to pay to Pixium the
amount of €2,500,000 minus a €947,780 credit for the $1,000,000 already paid for, a net amount payable of
approximately €1,552,220. The Company filed an appeal with the Appeals Court of Paris on May 24, 2023. The Company recorded a charge of
$1,675,000 for the year ended December 31, 2022, related to this matter but plans to raise any and all legal challenges to
this preliminary judgement.
We
are party to litigation arising in the ordinary course of business. It is our opinion that the outcome of such matters will not
have a material effect on our results of operations, however, the results of litigation and claims are inherently unpredictable.
Regardless of the outcome, litigation can have an adverse impact on us because of defense and settlement costs, diversion of management
resources and other factors.
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v3.23.2
Subsequent Events
|
6 Months Ended |
Jun. 30, 2023 |
Subsequent Events [Abstract] |
|
Subsequent Events |
11. Subsequent Events
In
early July 2023, Vivani successfully completed the manufacture of clinical supplies to support a proposed first-in-human (“FIH”)
investigation of NPM-119 (exenatide implant) in patients with type 2 diabetes mellitus. On July 14, 2023, the Company submitted
an Investigational New Drug (“IND”) application to the U.S. Food and Drug Administration (“FDA)” for the
proposed NPM-119 FIH study also named LIBERATE-1. On August 11, 2023, FDA verbally notified Vivani that the agency
was placing a clinical hold on Vivani’s IND application for the proposed clinical investigation and indicated its intention
to subsequently provide an official clinical hold letter stating the reasons for the clinical hold. Vivani plans to engage with
the FDA in order to lift the clinical hold and commence its planned clinical development of NPM-119. The Company expects to commence
enrollment in LIBERATE-1 in the second half of 2023 subject to regulatory clearance. Assuming LIBERATE-1 commences as planned,
the Company would anticipate the availability of interim LIBERATE-1 data in the first half of 2024 and full top-line results in
the second half of 2024.
|
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- DefinitionThe entire disclosure for significant events or transactions that occurred after the balance sheet date through the date the financial statements were issued or the date the financial statements were available to be issued. Examples include: the sale of a capital stock issue, purchase of a business, settlement of litigation, catastrophic loss, significant foreign exchange rate changes, loans to insiders or affiliates, and transactions not in the ordinary course of business.
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v3.23.2
Basis of Presentation, Significant Accounting Policies and Recent Accounting Pronouncements (Policies)
|
6 Months Ended |
Jun. 30, 2023 |
Accounting Policies [Abstract] |
|
Basis of Presentation |
Basis
of Presentation
These
unaudited interim financial statements have been prepared in accordance with United States generally accepted accounting principles
(“GAAP”) and following the requirements of the SEC for interim reporting. As permitted under those rules, certain footnotes or other financial information that are normally required
by GAAP can be condensed or omitted. In our opinion, the unaudited interim financial statements have been prepared on the same
basis as the audited financial statements and include all adjustments, which include only normal recurring adjustments, necessary
for the fair presentation of our financial position and our results of operations and cash flows for periods presented. These
statements do not include all disclosures required by GAAP and should be read in conjunction with our financial statements and
accompanying notes for the fiscal year ended December 31, 2022, included within our Annual Report on Form 10-K filed with the
SEC on March 31, 2023. The results of the interim periods are not necessarily indicative of the results expected for the full
fiscal year or any other interim period or any future year or period.
|
Income taxes - interim periods |
Income
taxes - interim periods
In
calculating the provision for interim income taxes, in accordance with ASC 740, Income Taxes, an estimated annual effective
tax rate is applied to year-to-date ordinary income. At the end of each interim period, we estimate the effective tax rate expected
to be applicable for the full fiscal year. This differs from the method utilized at the end of an annual period.
|
Use of estimates |
Use
of estimates
The
preparation of financial statements requires management to make a number of estimates and assumptions related to the
reported amount of assets and liabilities and the disclosure of contingent assets and liabilities at the date of the
financial statements, and the reported amounts of expenses during the period. Estimates are based on historical experience
and on various other assumptions that are believed to be reasonable under the circumstances. Some of the more significant
estimates include the purchase price of net assets acquired in the Merger, useful lives of long-lived assets, the fair value
of equity-based compensation, and the estimated incremental borrowing rate used in calculating lease assets and liabilities
and evaluation of going concern. Actual results could differ materially from those estimates.
|
Net income/loss per share |
Net
income/loss per share
Basic
net income/loss per share is computed using net income/loss from operations divided by the weighted-average number of shares of
common stock outstanding during the period.
Diluted
net income/loss per share represents net income/loss from operations divided by the weighted- average number of common shares
outstanding during the period, including all potentially dilutive common stock equivalents. Common stock equivalents consist of
shares subject to warrants and share-based awards with exercise prices less than the average market price of common stock for
the period, to the extent their inclusion would be dilutive.
The
computation of the weighted-average shares of common stock outstanding for diluted EPS excludes the following potential common
shares as of June 30, 2023, and 2022 (in thousands):
Schedule of net loss per share
|
|
June
30,
2023 |
|
|
June
30,
2022 |
|
Shares underlying warrants
outstanding |
|
|
10,311 |
|
|
|
9,074 |
|
Shares underlying stock options outstanding |
|
|
6,139 |
|
|
|
4,630 |
|
Shares underlying RSU’s |
|
|
403 |
|
|
|
— |
|
The
shares underlying the SAFE obligation were issuable only if the Merger were to be terminated. These contingently issuable shares
were excluded from the dilutive computation because conversion was not “probable” as defined in the accounting literature.
However, if the evaluation met the probability threshold, the shares would be excluded from diluted EPS since their inclusion
would have an anti-dilutive effect.
|
Significant Accounting Policies |
Significant
Accounting Policies
Our
significant accounting policies are set forth in our financial statements for the year ended December 31, 2022, included within
our Annual Report on Form 10-K filed with the SEC on March 31, 2023.
|
Recently Issued Accounting Pronouncements |
Recently
Issued Accounting Pronouncements
We
do not believe that any recently issued, but not yet effective, accounting standards, if adopted, will have a material effect
on the financial statements.
|
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v3.23.2
Organization and Business Operations (Tables)
|
6 Months Ended |
Jun. 30, 2023 |
Organization, Consolidation and Presentation of Financial Statements [Abstract] |
|
The following table summarizes the fair values of the assets acquired and liabilities assumed at the acquisition date (in thousands): |
The
following table summarizes the fair values of the assets acquired and liabilities assumed at the acquisition date (in thousands):
At August 30, 2022 |
|
|
|
|
|
|
|
Cash |
|
$ |
55,374 |
|
Property and equipment |
|
|
99 |
|
Prepaid expenses |
|
|
1,657 |
|
Right of use assets |
|
|
140 |
|
Other assets |
|
|
56 |
|
Total identifiable assets acquired |
|
|
57,326 |
|
Current liabilities |
|
|
(3,913 |
) |
Right of use liabilities |
|
|
(151 |
) |
Total liabilities assumed |
|
|
4,064 |
|
Net identifiable assets acquired |
|
$ |
53,262 |
|
|
The following table summarizes the calculation of the gain on bargain purchase (in thousands): |
The
following table summarizes the calculation of the gain on bargain purchase (in thousands):
|
|
|
|
|
Total consideration |
|
$ |
54,385 |
|
SAFE loan forgiven |
|
|
(8,000 |
) |
Less net identifiable assets acquired |
|
|
(53,262 |
) |
Gain on bargain purchase |
|
$ |
6,877 |
|
|
X |
- DefinitionTabular disclosure of realized and unrealized gain (loss) on investment in security.
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v3.23.2
Basis of Presentation, Significant Accounting Policies and Recent Accounting Pronouncements (Tables)
|
6 Months Ended |
Jun. 30, 2023 |
Accounting Policies [Abstract] |
|
Schedule of net loss per share |
The
computation of the weighted-average shares of common stock outstanding for diluted EPS excludes the following potential common
shares as of June 30, 2023, and 2022 (in thousands):
Schedule of net loss per share
|
|
June
30,
2023 |
|
|
June
30,
2022 |
|
Shares underlying warrants
outstanding |
|
|
10,311 |
|
|
|
9,074 |
|
Shares underlying stock options outstanding |
|
|
6,139 |
|
|
|
4,630 |
|
Shares underlying RSU’s |
|
|
403 |
|
|
|
— |
|
|
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v3.23.2
Selected Balance Sheet Detail (Tables)
|
6 Months Ended |
Jun. 30, 2023 |
Organization, Consolidation and Presentation of Financial Statements [Abstract] |
|
Property and equipment consisted of the following (in thousands): |
Property
and equipment consisted of the following (in thousands):
|
|
June
30,
2023 |
|
|
December
31,
2022 |
|
Equipment |
|
$ |
3,598 |
|
|
$ |
3,520 |
|
Furniture and fixtures |
|
|
10 |
|
|
|
10 |
|
Software |
|
|
54 |
|
|
|
51 |
|
Leasehold improvements |
|
|
12 |
|
|
|
12 |
|
|
|
|
3,674 |
|
|
|
3,593 |
|
Accumulated depreciation
and amortization |
|
|
(2,599 |
) |
|
|
(2,411 |
) |
Property and equipment,
net |
|
$ |
1,075 |
|
|
$ |
1,182 |
|
|
Schedule of right of use assets and operating lease liabilties |
Schedule of right of use assets and operating lease liabilties
Assets |
|
Classification |
|
June
30,
2023 (in thousands) |
|
|
December
31,
2022 (in thousands) |
|
Non-current
assets |
|
Right-of-use assets |
|
$ |
20,684 |
|
|
$ |
779 |
|
Liabilities |
|
|
|
|
|
|
|
|
|
|
Current |
|
Current operating lease liabilities |
|
$ |
861 |
|
|
$ |
955 |
|
Long term |
|
Long term operating lease liabilities |
|
$ |
20,127 |
|
|
$ |
— |
|
|
Schedule of lease liabilities |
Schedule of lease liabilities
| |
For the three months ended June 30, 2023 | | |
For the three months ended June 30, 2022 | | |
For the six months ended June 30, 2023 | | |
For the six months ended June 30, 2022 | |
Cash paid for operating lease liabilities (in thousands) | |
$ | 382 | | |
$ | 211 | | |
| 759 | | |
| 422 | |
|
The Company evaluated the lease under the provisions of ASC 842, Leases. Information related to the right-of-use assets and related lease liabilities under this lease are as follows (in thousands): |
The
Company evaluated the lease under the provisions of ASC 842, Leases. Information related to the right-of-use assets and related lease
liabilities under this lease are as follows (in thousands):
Year Ending December 31, | | |
| |
2023 | | |
$ | 669 | |
2024 | | |
| 2,723 | |
2025 | | |
| 2,805 | |
2026 | | |
| 2,889 | |
2027 | | |
| 2,976 | |
Thereafter | | |
| 18,926 | |
Total lease payments | | |
$ | 30,988 | |
| | |
| | |
Less imputed interest | | |
| (10,900 | ) |
| | |
| | |
Total lease liabilities | | |
$ | 20,088 | |
| | |
| | |
Discount rate | | |
| 8.38 | % |
|
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v3.23.2
Warrants (Tables)
|
6 Months Ended |
Jun. 30, 2023 |
Warrants |
|
Summary of Warrant Activity |
A
summary of warrant activity for the six months ended June 30, 2023 is presented below (in thousands, except per share and contractual
life data).
Summary of Warrant Activity
|
|
Number
of
Shares |
|
|
Weighted
Average
Exercise
Price
Per Share |
|
|
Weighted
Average
Remaining
Contractual
Life (in Years) |
|
Warrants outstanding as of
December 31, 2022 |
|
|
10,311 |
|
|
$ |
11.13 |
|
|
|
2.31 |
|
Issued |
|
|
— |
|
|
|
|
|
|
|
|
|
Exercised |
|
|
— |
|
|
|
|
|
|
|
|
|
Forfeited or expired |
|
|
— |
|
|
|
|
|
|
|
|
|
Warrants outstanding as of June 30, 2023 |
|
|
10,311 |
|
|
$ |
11.13 |
|
|
|
1.81 |
|
Warrants exercisable as of June 30, 2023 |
|
|
10,311 |
|
|
$ |
11.13 |
|
|
|
1.81 |
|
|
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v3.23.2
Stock-Based Compensation (Tables)
|
6 Months Ended |
Jun. 30, 2023 |
Retirement Benefits [Abstract] |
|
Summary of Stock Option Activity |
A
summary of stock option activity for the six months ended June 30, 2023, is presented below (in thousands, except per share and
contractual life data).
Summary of Stock Option Activity
|
|
Number
of
Shares |
|
|
Weighted
Average
Exercise
Price
Per Share |
|
|
Weighted
Average
Remaining
Contractual
Life (in Years) |
|
Options outstanding as of
December 31, 2022 |
|
|
5,272 |
|
|
$ |
3.07 |
|
|
|
7.15 |
|
Granted |
|
|
1,122 |
|
|
$ |
1.25 |
|
|
|
|
|
Exercised |
|
|
(101 |
) |
|
$ |
0.44 |
|
|
|
|
|
Forfeited or expired |
|
|
(154 |
) |
|
$ |
2.78 |
|
|
|
|
|
Options outstanding, vested and expected to
vest as of June 30, 2023 |
|
|
6,139 |
|
|
$ |
2.79 |
|
|
|
7.03 |
|
Options exercisable as of June 30, 2023 |
|
|
3,941 |
|
|
$ |
3.29 |
|
|
|
5.94 |
|
|
Summary of Restricted Stock Unit |
The
following table summarizes restricted stock unit (“RSU”) activity for the six months ended June 30, 2023 (in thousands,
except per share data):
Summary of Restricted Stock Unit
|
|
Number
of
Shares
|
|
|
Weighted
Average
Grant
Date
Fair Value
Per
Share
|
|
Outstanding as of
December 31, 2022 |
|
|
— |
|
|
$ |
— |
|
Awarded |
|
|
403 |
|
|
|
0.93 |
|
Vested and released |
|
|
— |
|
|
|
— |
|
Forfeited/canceled |
|
|
— |
|
|
|
— |
|
Outstanding
as of June 30, 2023 |
|
|
403 |
|
|
$ |
0.93 |
|
|
Stock-based Compensation Expense |
Stock-based
compensation expense recognized for stock-based awards in the condensed consolidated statements of operations for the three and
six months ended June 30, 2023, and 2022 was as follows (in thousands):
Stock-based Compensation Expense
| |
Three Months Ended June 30, | | |
Six Months Ended June 30, | |
| |
2023 | | |
2022 | | |
2023 | | |
2022 | |
Research and development | |
$ | 284 | | |
$ | 324 | | |
$ | 532 | | |
$ | 514 | |
General and administrative | |
| 240 | | |
| 70 | | |
| 361 | | |
| 220 | |
Total | |
$ | 524 | | |
$ | 394 | | |
$ | 893 | | |
$ | 734 | |
|
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- DefinitionThe element represents Cash and cash equivalents fair value.
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- DefinitionThe element represents gain on bargain purchase.
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v3.23.2
Organization and Business Operations (Details Narrative) - USD ($)
|
|
6 Months Ended |
12 Months Ended |
Aug. 30, 2022 |
Jun. 30, 2023 |
Dec. 31, 2022 |
Consolidation, Less than Wholly Owned Subsidiary, Parent Ownership Interest, Effects of Changes, Net [Line Items] |
|
|
|
Purchase consideration |
|
$ 8,000,000
|
|
Common stock, voting rights |
on August 30, 2022 (the “Acquisition Date”), NPM (a calendar year-end entity) was deemed to have acquired
100% of the outstanding common shares and voting interest of Second Sight.
|
|
|
Common stock issued |
13,136
|
50,799
|
50,736
|
Common stock, par or stated value per share |
$ 4.14
|
|
|
Assets, fair value adjustment |
$ 8,000,000.0
|
|
|
Fair value of identifiable assets acquired and liabilities |
|
|
100.00%
|
Gain of other income expenses |
|
|
$ 6,900,000
|
Business combination, acquisition related costs |
|
|
$ 700,000
|
Net Assets |
|
$ 53,300,000
|
|
Cash Available for Distributions |
|
55,400,000
|
|
Pro Forma [Member] |
|
|
|
Consolidation, Less than Wholly Owned Subsidiary, Parent Ownership Interest, Effects of Changes, Net [Line Items] |
|
|
|
Business combination, pro forma |
|
$ 13,300,000
|
|
Series of Individually Immaterial Business Acquisitions [Member] |
|
|
|
Consolidation, Less than Wholly Owned Subsidiary, Parent Ownership Interest, Effects of Changes, Net [Line Items] |
|
|
|
Fair value of the consideration transferred |
$ 54,400,000
|
|
|
Second Sight Switzerland and Sarl [Member] |
|
|
|
Consolidation, Less than Wholly Owned Subsidiary, Parent Ownership Interest, Effects of Changes, Net [Line Items] |
|
|
|
Subsidiary, Ownership Percentage, Parent |
|
77.32%
|
|
X |
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v3.23.2
Schedule of Money Market Funds at their Level within the Fair Value Hierarchy (Details) - USD ($) $ in Thousands |
Jun. 30, 2023 |
Dec. 31, 2022 |
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] |
|
|
Money market funds |
$ 31,561
|
$ 44,417
|
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|
|
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] |
|
|
Money market funds |
31,561
|
44,417
|
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|
|
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] |
|
|
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0
|
0
|
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|
|
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|
|
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$ 0
|
$ 0
|
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v3.23.2
Property and equipment consisted of the following (in thousands): (Details) - USD ($) $ in Thousands |
Jun. 30, 2023 |
Dec. 31, 2022 |
Property, Plant and Equipment [Line Items] |
|
|
Property and equipment, gross |
$ 3,674
|
$ 3,593
|
Accumulated depreciation and amortization |
(2,599)
|
(2,411)
|
Property and equipment, net |
1,075
|
1,182
|
Equipment [Member] |
|
|
Property, Plant and Equipment [Line Items] |
|
|
Property and equipment, gross |
3,598
|
3,520
|
Furniture and Fixtures [Member] |
|
|
Property, Plant and Equipment [Line Items] |
|
|
Property and equipment, gross |
10
|
10
|
Computer Hardware and Software [Member] |
|
|
Property, Plant and Equipment [Line Items] |
|
|
Property and equipment, gross |
54
|
51
|
Leasehold Improvements [Member] |
|
|
Property, Plant and Equipment [Line Items] |
|
|
Property and equipment, gross |
$ 12
|
$ 12
|
X |
- DefinitionAmount of accumulated depreciation, depletion and amortization for physical assets used in the normal conduct of business to produce goods and services.
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The Company evaluated the lease under the provisions of ASC 842, Leases. Information related to the right-of-use assets and related lease liabilities under this lease are as follows (in thousands): (Details) $ in Thousands |
6 Months Ended |
Jun. 30, 2023
USD ($)
|
Organization, Consolidation and Presentation of Financial Statements [Abstract] |
|
2023 |
$ 669
|
2024 |
2,723
|
2025 |
2,805
|
2026 |
2,889
|
2027 |
2,976
|
2028 |
18,926
|
Total lease payments |
30,988
|
Imputed interest |
(10,900)
|
Total lease liabilities |
$ 20,088
|
Discount rate |
8.38%
|
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v3.23.2
Selected Balance Sheet Detail (Details Narrative) - USD ($)
|
|
3 Months Ended |
6 Months Ended |
Feb. 01, 2023 |
Jun. 30, 2023 |
Jun. 30, 2022 |
Jun. 30, 2023 |
Jun. 30, 2022 |
Lessee, Lease, Description [Line Items] |
|
|
|
|
|
Rent expense manintenance charges |
|
$ 600,000
|
$ 200,000
|
$ 900,000
|
$ 500,000
|
Description of lease |
lease 14,823 square feet of
office space at 27200 Tourney Road, Valencia, California 91355.
|
|
|
|
|
Description of sub lease terms |
The sub-lease has a term of two years and two months. We also
entered into a lease for storage space on January 25, 2023, in the same building at a cost of $6,775 per month for a term of two
years and one month.
|
|
|
|
|
Lease Agreement [Member] |
|
|
|
|
|
Lessee, Lease, Description [Line Items] |
|
|
|
|
|
Description of lease agreement |
|
|
|
a triple net lease agreement for a single building with 43,645 square feet of space in Alameda, California on November
21, 2022. The stated term of the lease commences on June 1, 2023 and terminates on September 30, 2033, ten years and 4 months.
Payments increase annually from $2,676,311 to $3,596,784, or 124 payments less the first four which are abated, totaling approximately
$31 million. Vivani will be responsible for insurance, property taxes and CAM charges. Vivani was required to deposit $1.4 million
to guarantee a letter of credit to secure the lease and this amount is included in long-term assets on the balance sheet at June
30, 2023. The current lease expires on September 30, 2023.
|
|
Lessor [Member] |
|
|
|
|
|
Lessee, Lease, Description [Line Items] |
|
|
|
|
|
Termination date of the lease |
Mar. 01, 2023
|
|
|
|
|
Non-cash lease expense |
$ 22,158
|
|
|
|
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v3.23.2
Equity Securities (Details Narrative) - shares
|
Jun. 30, 2023 |
Dec. 31, 2022 |
Aug. 30, 2022 |
Accumulated Other Comprehensive Income (Loss) [Line Items] |
|
|
|
Common stock, shares authorized |
300,000
|
300,000
|
|
Common stock, shares issued |
50,799
|
50,736
|
13,136
|
Preferred stock, shares authorized |
10,000
|
10,000
|
|
Stock issued during period shares merger acquisitions |
|
|
13,136,362
|
Common Stock [Member] |
|
|
|
Accumulated Other Comprehensive Income (Loss) [Line Items] |
|
|
|
Common stock, shares authorized |
300,000,000
|
|
|
Common stock, shares issued |
50,798,799
|
|
|
Preferred Stock [Member] |
|
|
|
Accumulated Other Comprehensive Income (Loss) [Line Items] |
|
|
|
Preferred stock, shares authorized |
10,000,000
|
|
|
Preferred stock, shares issued |
0
|
|
|
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v3.23.2
Warrants (Details Narrative) - USD ($)
|
6 Months Ended |
|
|
|
|
Jun. 30, 2023 |
Dec. 31, 2022 |
Dec. 31, 2021 |
Dec. 31, 2020 |
Dec. 31, 2019 |
Second Sight Warrant Member |
|
|
|
|
|
Subsidiary, Sale of Stock [Line Items] |
|
|
|
|
|
Outstanding warrants |
7,691,063
|
|
|
|
|
Number of warrants convertible |
2,563,688
|
|
|
|
|
Weighted average exercise price |
$ 35.24
|
|
|
|
|
Warrant [Member] |
|
|
|
|
|
Subsidiary, Sale of Stock [Line Items] |
|
|
|
|
|
Outstanding warrants |
10,311,000
|
10,311,000
|
|
|
|
Exercise price per share |
$ 11.13
|
$ 11.13
|
|
|
|
Number of warrants convertible |
2,560,313
|
|
|
|
|
Outstanding warrants |
7,680,938
|
|
|
|
|
Intrinsic value |
$ 0
|
|
|
|
|
Right Offering [Member] |
|
|
|
|
|
Subsidiary, Sale of Stock [Line Items] |
|
|
|
|
|
Share price (in dollars per share) |
|
|
$ 3.15
|
$ 3.15
|
$ 3.15
|
Outstanding warrants |
7,746,855
|
|
|
|
|
Term of warrants |
5 years
|
|
|
|
|
Exercise price per share |
$ 3.15
|
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v3.23.2
Summary of Stock Option Activity (Details) shares in Thousands |
6 Months Ended |
Jun. 30, 2023
$ / shares
shares
|
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] |
|
Options outstanding at beginning (in years) |
4 years
|
Options exercisable period (in years) |
10 years
|
Share-Based Payment Arrangement, Option [Member] |
|
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] |
|
Options outstanding at beginning, number of shares (in shares) | shares |
5,272
|
Options outstanding at beginning, weighted average exercise price (in dollars per share) | $ / shares |
$ 3.07
|
Options outstanding at beginning (in years) |
7 years 1 month 24 days
|
Granted | shares |
1,122
|
Granted, weighted average exercise price (in dollars per share) | $ / shares |
$ 1.25
|
Exercised | shares |
(101)
|
Exercised, weighted average exercise price (in dollars per share) | $ / shares |
$ 0.44
|
Forfeited or expired | shares |
(154)
|
Forfeited or expired, weighted average exercise price (in dollars per share) | $ / shares |
$ 2.78
|
Options outstanding at ending, number of shares (in shares) | shares |
6,139
|
Options outstanding at ending, vested and expected to vest (in dollars per share) | $ / shares |
$ 2.79
|
Options outstanding at ending, vested and expected to vest (in years) |
7 years 11 days
|
Options exercisable, number of shares (in shares) | shares |
3,941
|
Options exercisable, weighted average exercise price (in dollars per share) | $ / shares |
$ 3.29
|
Options exercisable period (in years) |
5 years 11 months 8 days
|
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v3.23.2
Stock-Based Compensation (Details Narrative)
|
6 Months Ended |
Jun. 30, 2023
USD ($)
shares
|
Defined Benefit Plan Disclosure [Line Items] |
|
Stock options exercisable |
$ 300,000
|
Unrecognized compensation cost |
$ 2,400,000
|
Weighted average period (in years) |
1 year 2 months 12 days
|
Number of shares that may be issued | shares |
1,121,817
|
Options exercisable period (in years) |
10 years
|
Options exercisable (in dollars per share) | shares |
1.25
|
Vest period (in years) |
4 years
|
Restricted Stock Units (RSUs) [Member] |
|
Defined Benefit Plan Disclosure [Line Items] |
|
Unrecognized compensation cost |
$ 200,000
|
Weighted average period (in years) |
1 year 2 months 12 days
|
Share based compensation granted | shares |
402,500
|
Restricted Stock Units (RSUs) [Member] | Share-Based Payment Arrangement, Option [Member] |
|
Defined Benefit Plan Disclosure [Line Items] |
|
Description of share-based payment arrangement |
These RSUs had market conditions which required our stock price to exceed $3.15 per share for three consecutive days
in the four years from grant date for the RSUs to vest.
|
Valuation Technique, Option Pricing Model [Member] |
|
Defined Benefit Plan Disclosure [Line Items] |
|
Option shares were issued | shares |
200,000
|
Option value |
$ 100,000
|
Amount of pricing model option |
$ 0
|
Valuation Technique, Option Pricing Model [Member] | Measurement Input, Option Volatility [Member] |
|
Defined Benefit Plan Disclosure [Line Items] |
|
Expected volatility |
100.00%
|
Valuation Technique, Option Pricing Model [Member] | Measurement Input, Expected Dividend Rate [Member] |
|
Defined Benefit Plan Disclosure [Line Items] |
|
Expected dividend |
0.00%
|
Valuation Technique, Option Pricing Model [Member] | Minimum [Member] | Measurement Input, Expected Term [Member] |
|
Defined Benefit Plan Disclosure [Line Items] |
|
Expected term (in years) |
4 years
|
Valuation Technique, Option Pricing Model [Member] | Minimum [Member] | Measurement Input, Risk Free Interest Rate [Member] |
|
Defined Benefit Plan Disclosure [Line Items] |
|
Risk free interest rate |
3.99%
|
Valuation Technique, Option Pricing Model [Member] | Maximum [Member] | Measurement Input, Expected Term [Member] |
|
Defined Benefit Plan Disclosure [Line Items] |
|
Expected term (in years) |
6 years 2 months 12 days
|
Valuation Technique, Option Pricing Model [Member] | Maximum [Member] | Measurement Input, Risk Free Interest Rate [Member] |
|
Defined Benefit Plan Disclosure [Line Items] |
|
Risk free interest rate |
4.45%
|
X |
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v3.23.2
Commitments and Contingencies (Details Narrative) - USD ($)
|
|
2 Months Ended |
3 Months Ended |
6 Months Ended |
|
May 19, 2021 |
Sep. 12, 2022 |
Jun. 30, 2023 |
Jun. 30, 2023 |
Mar. 31, 2021 |
Commitments and Contingencies Disclosure [Abstract] |
|
|
|
|
|
Clinical and regulatory expense |
|
|
$ 88,000
|
$ 115,000
|
|
Liquidated damage |
|
|
|
|
$ 1,000,000
|
Description of contract termination and claims |
|
|
|
Pixium
indicated that it considered this termination wrongful, rejected the Company’s offers, but retained the $1,000,000
payment. On May 19, 2021, Pixium filed suit in the Paris Commercial Court, and currently claim damages of approximately
€5.1 million or about $5.6
million. We believe we have fulfilled our obligations to Pixium with the liquidated damages payment of $1,000,000.
|
|
Loss contingency, damages paid, value |
$ 1,000,000
|
|
|
|
|
Demanded damages, value |
$ 5,600,000
|
|
|
|
|
Description of legal settlement |
|
On
December 9, 2022, the Company received notice that the Paris Commercial Court has rendered its judgement, including finding
that the Company’s termination of the MOU was not valid. In the judgement, the Company was ordered to pay to Pixium the
amount of €2,500,000 minus a €947,780 credit for the $1,000,000 already paid for, a net amount payable of
approximately €1,552,220. The Company filed an appeal with the Appeals Court of Paris on May 24, 2023. The Company recorded a charge of
$1,675,000 for the year ended December 31, 2022, related to this matter but plans to raise any and all legal challenges to
this preliminary judgement.
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