Initiation of the NPM-115 clinical program
expected in the fourth quarter of 2024 with a first-in-human study
evaluating a miniature, subdermal GLP-1 (exenatide) implant in
obese or overweight patients
FDA provided clearance of the
Investigational New Drug Application for NPM-119, providing further
confidence to advance the Company’s emerging portfolio of GLP-1
implants into clinical phase development
Solid financial position supports operations
into the second half of 2025 and potential delivery of key
portfolio milestones
Vivani Medical, Inc. (Nasdaq: VANI) (“Vivani” or the “Company”),
a biopharmaceutical company developing miniaturized, long-acting
drug implants, today reported financial results for the second
quarter ended June 30, 2024, and provided a business update.
Vivani’s Chief Executive Officer Adam Mendelsohn, Ph.D., stated,
“During the second quarter we achieved significant progress toward
advancing the development of our proprietary, GLP-1 implants for
obesity and chronic weight management, and anticipate the
initiation of our first-in-human clinical study in the fourth
quarter of this year. After successfully addressing the FDA’s
requests for additional Chemistry, Manufacturing and Controls
information and securing clearance on our NPM-119 Investigational
New Drug Application in the first half of this year, Vivani is now
on the cusp of transitioning to a clinical-stage development phase
biotechnology company, now in position to initiate clinical testing
in the fourth quarter of this year.”
Dr. Mendelsohn added, “Our highly differentiated portfolio of
miniature, ultra long-acting GLP-1 implants have the potential to
directly address medication non-adherence and tolerability, two
significant barriers to achieving optimal therapy for chronic
weight management and other chronic diseases. An alarmingly high
proportion of chronic disease patients, approximately 50%, do not
take their medicine as prescribed in the real world, a statistic
which holds for both daily orals as well as weekly injectables. In
addition, a recent study has shown that 64% of patients taking the
popular GLP-1 therapy Wegovy® (semaglutide for weight management)
discontinue therapy within the first year, a number which increases
to 76% by year two. Importantly, GLP-1 therapy discontinuation is
associated with a quick reversal of the GLP-1 health benefits for
most patients. Vivani’s pipeline offers the potential to
significantly improve the adherence and persistence challenges
these patients currently face.”
Recent Business Highlights
In May 2024, Vivani and development partner Okava
Pharmaceuticals Inc. announced publication of positive weight loss
data supporting the potential veterinary use of OKV-119, a
miniature, long-term GLP-1 implant under development for the
treatment of pre-diabetes, diabetes and obesity in companion cats.
Data published in BMC Veterinary Research provided further evidence
that Vivani’s NanoPortal™ implant technology holds promise in
reducing obesity in cats where an estimated 40% of the domestic cat
population needs help managing their weight.
In June 2024, the Company announced that the U.S. Food and Drug
Administration (“FDA”) cleared the Investigational New Drug
Application (“IND”) for NPM-119, a miniature, six-month, subdermal
GLP-1 implant designed to address medication non-adherence and
potentially improve tolerability in patients with type 2 diabetes.
The proposed first-in-human clinical study was designed to evaluate
the safety, tolerability and pharmacokinetic profile of the
exenatide implant versus marketed exenatide injectable, Bydureon
BCise®.
In July 2024, Vivani provided an update on the clinical
development plans for the miniature, long-acting GLP-1 obesity
implant program for NPM-115. In support of the recent strategic
shift to prioritize the development of its obesity and chronic
weight management portfolio, the Company announced revised plans to
evaluate its GLP-1 implant as part of the NPM-115 program in
patients who are obese or overweight in the company’s
first-in-human study, LIBERATE-1. This study will enroll patients
who will be titrated on weekly semaglutide (Wegovy®) for eight
weeks before subsequently being randomized to receive a single
exenatide implant, weekly exenatide injections (Bydureon BCise) or
weekly semaglutide injections for a nine-week treatment duration.
The Company expects the study to be initiated in the fourth quarter
of 2024 in Australia, pending regulatory approval, with data from
the study anticipated in 2025.
Upcoming Anticipated Milestones
- Vivani anticipates receiving approval from a Human Research
Ethics Committee in Australia to support initiation of the
Company’s first-in-human study, which supports the NPM-115 obesity
implant program, during the fourth quarter of 2024. Study results
are expected in 2025.
- Vivani plans to participate in multiple industry and investor
conferences, including the H.C. Wainwright conference in New York,
NY, taking place September 9-12, 2024. The Company will also
participate in Maxim’s Virtual Healthcare Summit, October 15-17,
2024. Dr. Mendelsohn plans to provide the Company’s slide
presentations at both conferences.
Second Quarter 2024 Financial Results
Cash balance: As of June 30, 2024, Vivani had cash, cash
equivalents and restricted cash totaling $26.3 million, compared to
$31.0 million as of March 31, 2024. The decrease of $4.7 million is
attributed to a net loss of $5.4 million, partially offset by $0.6
million in non-cash items for depreciation and amortization of
property and equipment, stock-based compensation and lease expense,
and a net cash of $0.1 million provided by financing
activities.
Research and development expense: Research and development
expense during the three months ended June 30, 2024 was $3.5
million, compared to $3.9 million during the three months ended
June 30, 2023. The decrease of $0.4 million, or 9%, was primarily
attributable to staffing reduction and reduced use of outside
services.
General and administrative expense: General and administrative
expense during the three months ended June 30, 2024 was $2.2
million, compared to $3.1 million during the three months ended
June 30, 2023. The decrease of $1.0 million, or 31%, was
attributable to staffing reduction along with reduced outside legal
and other professional services.
Other income, net: Other income, net during the three months
ended June 30, 2024 was $0.3 million, compared to $0.5 million
during the three months ended June 30, 2023. The change was not
significant.
Net Loss: The net loss during the three months ended June 30,
2024 was $5.3 million, compared to $6.5 million during the three
months ended June 30, 2023. The decrease in net loss of $1.2
million was primarily attributable to a decrease in operating
expenses of $1.3 million.
Wegovy® is a registered trademark of Novo Nordisk A/S. Bydureon®
is a registered trademark of the AstraZeneca group of
companies.
About Vivani Medical, Inc.
Leveraging its proprietary NanoPortal platform, Vivani develops
biopharmaceutical implants designed to deliver drug molecules
steadily over extended periods of time with the goal of
guaranteeing adherence, and potentially to improve tolerance to
their medication. Vivani’s lead program, NPM-115, is a miniature,
six-month, subdermal, GLP-1 (exenatide) implant under development
for the treatment of chronic weight management in obese or
overweight patients. Vivani’s emerging pipeline also includes
NPM-139 (semaglutide implant) which is also under development for
chronic weight management in obese and overweight patients. NPM-139
has the added potential benefit of once-yearly administration.
NPM-119 refers to the Company’s six-month, subdermal exenatide
implant under development for the treatment of type 2 diabetes.
Both NPM-115 and NPM-119 are exenatide based products with a
higher-dose associated with NPM-115 for chronic weight management
in obese or overweight patients. These NanoPortal implants are
designed to provide patients with the opportunity to realize the
full potential benefit of their medication by avoiding the
challenges associated with the daily or weekly administration of
orals and injectables. Medication non-adherence occurs when
patients do not take their medication as prescribed. This affects
an alarming number of patients, approximately 50%, including those
taking daily pills. Medication non-adherence, which contributes to
more than $500 billion in annual avoidable healthcare costs and
125,000 potentially preventable deaths annually in the U.S. alone,
is a primary and daunting reason obese or overweight patients, and
patients taking type 2 diabetes or other chronic disease treatments
face significant challenges in achieving positive real-world
effectiveness. While the current GLP-1 landscape includes over 100
new molecular entities under clinical stage development, Vivani
remains confident that its highly differentiated portfolio of
miniature long-acting GLP-1 implants have the potential to provide
an attractive therapeutic option for patients, prescribers and
payers.
About Cortigent, Inc.
Vivani’s wholly owned subsidiary, Cortigent, Inc. (“Cortigent”),
is developing precision neurostimulation systems intended to help
patients recover critical body functions. Investigational devices
include Orion®, designed to provide artificial vision to people who
are profoundly blind, and a new system intended to accelerate the
recovery of arm and hand function in patients who are partially
paralyzed due to stroke. Cortigent has developed, manufactured, and
marketed an implantable visual prosthetic device, Argus II®, that
delivered meaningful visual perception to blind individuals. Vivani
continues to assess strategic options for advancing Cortigent’s
pioneering technology.
Forward-Looking Statements
This press release contains certain “forward-looking statements”
within the meaning of the “safe harbor” provisions of the US
Private Securities Litigation Reform Act of 1995. Forward-looking
statements can be identified by words such as: “target,” “believe,”
“expect,” “will,” “may,” “anticipate,” “estimate,” “would,”
“positioned,” “future,” and other similar expressions that in this
press release, including statements regarding Vivani’s business,
products in development, including the therapeutic potential
thereof, the planned development therefor, the initiation of the
LIBERATE-1 trial and reporting of trial results, Vivani’s emerging
development plans for NPM-115, NPM-139, or Vivani’s plans with
respect to Cortigent and its proposed initial public offering,
technology, strategy, cash position and financial runway.
Forward-looking statements are neither historical facts nor
assurances of future performance. Instead, they are based only on
Vivani’s current beliefs, expectations, and assumptions. Because
forward-looking statements relate to the future, they are subject
to inherent uncertainties, risks and changes in circumstances that
are difficult to predict and many of which are outside of Vivani’s
control. Actual results and outcomes may differ materially from
those indicated in the forward-looking statements. Therefore, you
should not rely on any of these forward-looking statements.
Important factors that could cause actual results and outcomes to
differ materially from those indicated in the forward-looking
statements include, among others, risks related to the development
and commercialization of our products, including NPM-115 and
NPM-119; delays and changes in the development of Vivani’s
products, including as a result of applicable laws, regulations and
guidelines, potential delays in submitting and receiving regulatory
clearance or approval to conduct our development activities,
including our ability to commence clinical development of NPM-119;
risks related to the initiation, enrollment and conduct of Vivani’s
planned clinical trials and the results therefrom; our history of
losses and Vivani’s 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 U.S. Securities and Exchange
Commission filed on March 26, 2024, as updated by The Company’s
subsequent Quarterly Reports on Form 10-Q. Any forward-looking
statement made by Vivani in this press release is based only on
information currently available to the Company and speaks only as
of the date on which it is made. The Company undertakes no
obligation to publicly update any forward-looking statement,
whether written or oral, that may be made from time to time,
whether as a result of added information, future developments or
otherwise, except as required by law.
VIVANI MEDICAL, INC.
AND SUBSIDIARIES
Condensed Consolidated Balance
Sheets (unaudited)
(in thousands, except per share
data)
June 30,
December 31,
2024
2023
ASSETS
Current assets:
Cash and cash equivalents
$
24,919
$
20,654
Prepaid expenses and other current
assets
1,418
2,408
Total current assets
26,337
23,062
Property and equipment, net
1,710
1,729
Right-of-use assets
18,801
19,616
Restricted cash
1,338
1,338
Other assets
38
52
Total assets
$
48,224
$
45,797
LIABILITIES AND STOCKHOLDERS’
EQUITY
Current liabilities:
Accounts payable
$
645
$
542
Accrued expenses
1,660
1,727
Litigation accrual
1,675
1,675
Accrued compensation expense
384
396
Current operating lease liabilities
1,420
1,383
Total current liabilities
5,784
5,723
Long-term operating lease liabilities
18,616
19,313
Total liabilities
24,400
25,036
Commitments and contingencies (Note
11)
Stockholders’ equity:
Preferred stock, par value $0.0001
per share; 10,000 shares authorized; none outstanding
-
-
Common stock, par value $0.0001 per
share; 300,000 shares authorized; shares issued and
outstanding: 55,197 and 51,031 at June 30, 2024 and
December 31, 2023, respectively
6
5
Additional paid-in capital
133,588
119,054
Accumulated other comprehensive income
63
140
Accumulated deficit
(109,833
)
(98,438
)
Total stockholders’ equity
23,824
20,761
Total liabilities and stockholders’
equity
$
48,224
$
45,797
VIVANI MEDICAL, INC.
AND SUBSIDIARIES
Condensed Consolidated
Statements of Operations (unaudited)
(in thousands, except per share
data)
Three Months Ended June
30,
Six Months Ended June
30,
2024
2023
2024
2023
Operating expenses:
Research and development, net of
grants
$
3,513
$
3,864
$
7,239
$
7,819
General and administrative, net of
grants
2,168
3,139
4,669
5,785
Total operating expenses
5,681
7,003
11,908
13,604
Loss from operations
(5,681
)
(7,003
)
(11,908
)
(13,604
)
Other income, net
325
477
513
760
Net loss
$
(5,356
)
$
(6,526
)
$
(11,395
)
$
(12,844
)
Net loss per common share - basic and
diluted
$
(0.10
)
$
(0.13
)
$
(0.21
)
$
(0.25
)
Weighted average common shares outstanding
- basic and diluted
55,021
50,795
53,612
50,748
View source
version on businesswire.com: https://www.businesswire.com/news/home/20240813624656/en/
Company Contact: Donald Dwyer Chief Business Officer
info@vivani.com (415) 506-8462
Investor Relations Contact: Jami Taylor Investor Relations
Advisor investors@vivani.com (415) 506-8462
Media Contact: Sean Leous ICR Westwicke Sean.Leous@westwicke.com
(646) 866-4012
Vivani Medical (NASDAQ:VANI)
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