Vivani Medical, Inc. (Nasdaq: VANI) (“Vivani” or the “Company”),
a biopharmaceutical company developing miniaturized, long-term drug
implants, including lead product NPM-119 for the treatment of
patients with type 2 diabetes and/or obesity, today reported
financial results for the first quarter and provided a business
update. NPM-119 is a preclinical stage, 6-month, GLP-1 implant
using Vivani’s proprietary NanoPortal™ implant technology.
Vivani continues to advance the development of its emerging
portfolio of innovative, highly differentiated drug implants
leveraging its proprietary NanoPortal™ subdermal implant technology
designed to guarantee medication adherence and improve patient
outcomes in the treatment of chronic diseases.
Adam Mendelsohn, Chief Executive Officer said, “Vivani remains
on schedule with the planned submission of an Investigational New
Drug (IND) application for NPM-119 (GLP-1 implant) and the
subsequent initiation of the proposed first-in-human Phase 2
clinical study of NPM-119, 'LIBERATE-1, in mid-2023.” Dr.
Mendelsohn further commented, “We believe that NPM-119 has the
potential to significantly improve real-world outcomes for the
approximately half of patients with type 2 diabetes who are
non-adherent with their medication. We further believe that NPM-119
may also provide an improved gastrointestinal side-effect profile
compared to other available GLP-1 treatment options because of
NPM-119’s steady drug delivery profile.” The LIBERATE-1 trial will
be the first clinical study of the company’s platform NanoPortal
implant technology.
First Quarter Business Highlights
In January 2023, Vivani successfully completed the IND-enabling,
non-clinical toxicology, and biocompatibility studies to support
the planned IND submission for NPM-119 (exenatide implant) under
development for the treatment of patients with type 2 diabetes. By
mid-2023, we plan to file an IND with the U.S. Food and Drug
Administration (the “FDA”) and, if clearance is obtained, initiate
LIBERATE-1. LIBERATE-1 is a randomized, 12-week investigation of
the safety, tolerability, and full pharmacokinetic profile of
NPM-119 (GLP-1) implant in patients with type 2 diabetes.
LIBERATE-1 will enroll patients who have been on a GLP-1 therapy
which will be discontinued prior to receiving either NPM-119 or an
active comparator Bydureon BCise® (exenatide extended-release
injectable suspension 2mg). LIBERATE-1 will also evaluate the
treatment effects on glycemic control and weight, and the inclusion
of the active comparator is intended to explore the feasibility of
an abbreviated 505(b)(2) approval pathway for NPM-119.
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, Inc. (“Cortigent”). Cortigent was formed for the purpose
of advancing Vivani’s neuromodulation division and is expected to
continue to be controlled by Vivani after the initial public
offering.
Moving forward, Vivani will focus on its Biopharm Division and
the further development of NPM-119 and its emerging pipeline of
innovative, miniature, long-term drug implants to treat patients
with chronic diseases and high unmet medical need. Vivani’s
Biopharm Division has grown to nearly 40 full-time employees. Its
headquarters are located at 5858 Horton Street, Emeryville,
California.
Upcoming Anticipated Milestones and Events
We expect to file the NPM-119 (GLP-1 implant) IND with the FDA
and, subject to IND clearance, we intend to initiate LIBERATE-1 in
Q3-2023 and expect to report top-line results in the first half of
2024.
In addition, we are seeking to complete the Initial Public
Offering for our Cortigent business in the third quarter of 2023
enabling us to continue advancing our neuromodulation
technology.
We will also be participating in several investor conferences
and attending key industry conferences including the 2023 BIO
International Convention June 5-8, 2023, in Boston MA and the
American Diabetes Association 83rd Scientific Sessions June 23-26,
2023, in San Diego, CA.
First Quarter 2023 Financial Results
Cash Balance: As of March 31, 2023, Vivani had cash and cash
equivalents totaling $38.1 million compared to $45.1 million as of
December 31, 2022. The decrease is attributed to the $6.3 million
operating loss plus a reduction of working capital of $1.1 million,
offset partially by $0.4 million of non-cash expenses. We believe
our cash and cash equivalents as of March 31, 2023, are sufficient
to fund operations into the second half of 2024.
Research and Development Expense: Research and development
expense increased by $1.3 million, or 48%, to $4.0 million in the
first quarter of 2023 from $2.7 million in the first 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 costs for the quarter by
$0.6 million. The remainder of the increase was primarily due to
subdermal drug implants development costs.
General and Administrative Expense: General and administrative
expenses increased $1.4 million, or 115%, to $2.6 million in the
first quarter of 2023 from $1.2 million in the same period of 2022.
This increase is primarily attributable to increased costs
associated with the inclusion of our acquired company Second Sight
which totaled $1.1 million in the first quarter of 2023.
Operating Expense: Operating expenses were $6.6 million for the
three months ended March 31, 2023, compared to $3.9 million for the
three months ended March 31, 2022, representing an increase of $2.7
million, or 69%. The inclusion of Second Sight costs for the first
quarter of 2023 totaled $1.7 million.
Net Loss: The net loss was $6.3 million as compared to $3.9
million for the three-months ended March 31, 2023, and 2022,
respectively. The $2.4 million increase in net loss was primarily
attributable to a $2.7 million increase in operating expenses, as
noted above, partially offset by an increase of $0.3 million in
interest income due to our higher cash balance.
About Vivani Medical, Inc.
Leveraging its proprietary NanoPortal™ platform, Vivani Medical
develops biopharmaceutical implants designed to deliver drug
molecules steadily over extended periods of time with the goal of
guaranteeing adherence, and potentially to improve tolerance to
their medication. Vivani’s lead program NPM-119 is a miniaturized,
6-month GLP-1 implant under investigation for the treatment of
patients with type 2 diabetes and/or obesity. NPM-119 is designed
to provide patients with the opportunity to realize the full
potential benefit of their medication by avoiding the challenges
associated with the daily or weekly administration of orals and
injectables. Medication non-adherence occurs when patients do not
take their medication as prescribed. This affects an alarming
number of patients, approximately 50%, including those taking daily
pills. Medication non-adherence, which contributes to more than
$500 billion in annual avoidable healthcare costs and 125,000
potentially preventable deaths annually in the US alone, is a
primary and daunting reason why type 2 diabetes treatments face
significant challenges in achieving positive real-world
effectiveness.
Vivani’s wholly owned subsidiary Cortigent, Inc., has developed,
manufactured, and marketed implantable visual prosthetics that are
intended to deliver useful artificial vision to blind individuals.
Cortigent continues to assess strategic options for advancing its
pioneering neuromodulation technology including the Orion® Visual
Cortical Prosthesis System for providing artificial vision to
profoundly blind individuals and a new medical device system to
improve the recovery of hand and arm movement in partially
paralyzed stroke patients undergoing rehabilitation.
Forward-Looking Statements
This press release contains certain “forward-looking statements”
within the meaning of the “safe harbor” provisions of the US
Private Securities Litigation Reform Act of 1995. Forward-looking
statements can be identified by words such as: “target,” “believe,”
“expect,” “will,” “may,” “anticipate,” “estimate,” “would,”
“positioned,” “future,” and other similar expressions that in this
press release, including statements regarding our business,
products in development, including the therapeutic potential
thereof and the planned development therefor, our plans with
respect to Cortigent and its proposed initial public offering,
technology, strategy, cash position and financial runway.
Forward-looking statements are neither historical facts nor
assurances of future performance. Instead, they are based only on
our current beliefs, expectations, and assumptions. Because
forward-looking statements relate to the future, they are subject
to inherent uncertainties, risks and changes in circumstances that
are difficult to predict and many of which are outside of our
control. Actual results and outcomes may differ materially from
those indicated in the forward-looking statements. Therefore, you
should not rely on any of these forward-looking statements.
Important factors that could cause actual results and outcomes to
differ materially from those indicated in the forward-looking
statements include, among others, risks related to the development
and commercialization of our products, including NPM-119; delays
and changes in applicable laws, regulations and guidelines
including potential delays in submitting required regulatory
applications to the U.S. Food and Drug Administration (“FDA”);
risks related to the initiation, enrollment and conduct of our
planned clinical trials and the results therefrom; our history of
losses and our ability to access additional capital or otherwise
fund our business; market conditions and the ability of Cortigent
to complete its initial public offering. There may be additional
risks that the Company considers immaterial, or which are unknown.
A further list and description of risks and uncertainties can be
found in the Company’s most recent Annual Report on Form 10-K filed
with the Securities and Exchange Commission (the “Commission”)
filed on March 31, 2023. Any forward-looking statement made by us
in this press release is based only on information currently
available to the Company and speaks only as of the date on which it
is made. The Company undertakes no obligation to publicly update
any forward-looking statement, whether written or oral, that may be
made from time to time, whether as a result of added information,
future developments or otherwise, except as required by law.
VIVANI MEDICAL, INC.
AND SUBSIDIARIES
Condensed Consolidated Balance
Sheets (unaudited)
(in thousands)
March 31,
December 31,
2023
2022
ASSETS
Current assets:
Cash and cash equivalents
$
38,073
$
45,076
Prepaid expenses and other current
assets
2,611
2,452
Total current assets
40,684
47,528
Property and equipment, net
1,111
1,182
Right-of-use assets
1,148
779
Restricted cash
1,366
1,366
Deposits and other assets
271
275
Total assets
$
44,580
$
51,130
LIABILITIES AND STOCKHOLDERS’
EQUITY
Current liabilities:
Accounts payable
$
746
$
1,177
Accrued expenses
2,114
2,358
Litigation accrual
1,675
1,675
Accrued compensation expense
415
657
Current operating lease liabilities
913
955
Total current liabilities
5,863
6,822
Long term operating lease liabilities
349
—
Total liabilities
6,212
6,822
Commitments and contingencies
Stockholders’ equity:
Preferred stock, no par value, 10,000
shares authorized; none outstanding
—
—
Common stock, no par value; 300,000 shares
authorized; shares issued and outstanding: 50,789 as of March 31,
2023 and 50,736 as of December 31, 2022, respectively
109,050
109,050
Additional paid-in capital
8,378
8,009
Accumulated other comprehensive loss
44
35
Accumulated deficit
(79,104
)
(72,786
)
Total stockholders’ equity
38,368
44,308
Total liabilities and stockholders’
equity
$
44,580
$
51,130
VIVANI MEDICAL, INC.
AND SUBSIDIARIES
Condensed Consolidated
Statements of Operations (unaudited)
(in thousands, except per share
data)
Three Months Ended March
31,
2023
2022
Operating expenses:
Research and development, net of
grants
$
3,955
$
2,679
General and administrative, net of
grants
2,646
1,228
Total operating expenses
6,601
3,907
Loss from operations
(6,601
)
(3,907
)
Other income (expense), net
283
(17
)
Net loss
$
(6,318
)
$
(3,924
)
Net loss per common share – basic and
diluted
$
(0.12
)
$
(0.11
)
Weighted average common shares outstanding
– basic and diluted
50,755
36,806
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version on businesswire.com: https://www.businesswire.com/news/home/20230515005301/en/
Company Contact: Donald Dwyer Chief Business Officer
info@vivani.com (415) 506-8462
Investor Relations Contact: Brigid Makes Chief Financial Officer
investors@vivani.com (415) 506-8462
Media Contact: Sean Leous ICR Westwicke
Sean.Leous@westwicke.com
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