Regulatory approval to initiate
first-in-human study with a miniature, ultra long-acting GLP-1
(exenatide) implant in obese or overweight individuals in
Australia
Miniature, ultra long-acting GLP-1 implant
produced sham-implant adjusted liver fat reduction of 82% in an
obese mouse model from a single administration with expected
twice-yearly dosing
Announces $5M equity financing which secures
solid financial position into late 2025, supporting projected
completion of first-in-human study and data read-out
Vivani Medical, Inc. (Nasdaq: VANI) (“Vivani” or the “Company”),
a biopharmaceutical company developing miniaturized, long-acting
drug implants, today reported financial results for the third
quarter ended September 30, 2024, and provided a business
update.
Vivani’s Chief Executive Officer Adam Mendelsohn, Ph.D., stated,
“We made significant progress advancing our proprietary GLP-1
implants for obesity and chronic weight management in the third
quarter, and we anticipate the initiation of our first-in-human
clinical study, named LIBERATE-1, in the fourth quarter of this
year. After choosing to conduct our initial first-in-human study in
Australia, in part to take advantage of potentially significant
rebates from the Australian government, we were excited to receive
the regulatory approvals to initiate LIBERATE-1, as a key element
of our NPM-115 clinical program in overweight and obese
individuals. Today’s $5 million common stock financing announcement
puts us in an excellent position to complete LIBERATE-1 and
continue development of our pipeline programs in 2025.”
Dr. Mendelsohn added, “Our NanoPortal drug delivery technology
has the potential to directly address medication non-adherence
which is responsible for approximately 125,000 avoidable deaths
each year in the US alone, more than caused by breast, colorectal
and liver cancer combined. In addition, approximately 50% of
patients with chronic diseases, including patients with obesity and
type 2 diabetes, do not take their medicine as prescribed in the
real world, a statistic which holds for both daily orals as well as
weekly injectables. GLP-1 drugs have already improved the health of
millions of people with obesity and type 2 diabetes, but the future
potential impact of these medicines to improve global health across
a variety of new indications is even more remarkable. At Vivani, we
are addressing the tremendous opportunity to revolutionize the
treatment of chronic diseases, including obesity, with our emerging
pipeline of miniature, ultra long-acting drug implants specifically
designed to ensure medication adherence with twice-yearly, and
potentially once-yearly, administration that will allow patients to
achieve the full potential benefits of their medicine.”
Recent Business Highlights
In July 2024, the Company announced that it expects to initiate
the first clinical study in the NPM-115 program in the fourth
quarter of 2024 in Australia, pending regulatory clearance in that
country. The NPM-115 clinical program will evaluate the
investigational 6-month GLP-1 implant for chronic weight management
in patients who are either obese or overweight with a related
comorbidity.
In September 2024, the Company announced that the Bellberry
Human Research Ethics Committee approved, and the Therapeutic Goods
Administration in Australia formally acknowledged a first-in-human
clinical trial of the Company’s miniature, subdermal GLP-1
(exenatide) implant in obese and overweight subjects.
Also in September 2024, the Company reported that its exenatide
implant produced sham-implant adjusted liver fat reduction of 82%
in an obese mouse model from a single administration with expected
twice-yearly dosing. The Company previously announced sham-implant
adjusted preclinical weight loss of 20%, which is comparable to the
weight loss produced from the semaglutide (active ingredient in
Ozempic®/Wegovy®) injection control arm in the same study.
On November 8, 2024, the Company entered into a private sale
transaction with one of its independent directors whereby the
Company sold an aggregate of 3,968,253 shares of the Company’s
common stock to the director at a price of $1.26 per share. The
gross proceeds from this private sale transaction were $5.0 million
which secures Vivani’s financial position into late 2025 and
supports projected completion of the first-in-human study and data
read-out.
Upcoming Anticipated Milestones
- Vivani plans to initiate LIBERATE-1, a Phase 1, first-in-human
study of a miniature, ultra long-acting GLP-1 (exenatide) implant
to investigate the safety, tolerability and full pharmacokinetic
profile in obese or overweight subjects. The trial will enroll
participants who will be titrated on weekly semaglutide injections
for 8 weeks (0.25 mg/week for 4 weeks followed by 0.5 mg/week for 4
weeks) before being randomized to receive a single administration
of Vivani’s exenatide implant (n=8), weekly exenatide injections
(n=8), or weekly 1 mg semaglutide injections (n=8) for a 9-week
treatment duration. Changes in weight will be measured. Data is
projected to be available in 2025.
- Vivani will present at the Innovation in Obesity Therapeutics
Summit – West Coast on December 10-12, 2024, in San Diego, CA.
Ozempic® and Wegovy® are registered trademarks of Novo Nordisk
A/S.
Third Quarter 2024 Financial Results
Cash balance: As of September 30, 2024, Vivani had cash,
cash equivalents and restricted cash totaling $21.0 million,
compared to $26.3 million as of June 30, 2024. The decrease of $5.3
million is attributed to a net loss of $6.0 million, a decrease of
$0.3 million changes in operating assets and liabilities, 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 $0.4 million provided by
financing activities.
Research and development expense: Research and
development expense during the three months ended September 30,
2024 was $4.2 million, compared to $4.4 million during the three
months ended September 30, 2023. The decrease of $0.2 million, or
5%, was primarily attributable to staffing reduction in Vivani’s
neurostimulation business and reduced use of outside services,
partially offset by the increase in Alameda site facility
expenses.
General and administrative expense: General and
administrative expense during the three months ended September 30,
2024 was $2.1 million, compared to $2.7 million during the three
months ended September 30, 2023. The decrease of $0.6 million, or
22%, was attributable to staffing reduction in Vivani’s
neurostimulation business along with reduced outside legal and
other professional services.
Other income, net: Other income, net during the three
months ended September 30, 2024 was $0.3 million, compared to $0.4
million during the three months ended September 30, 2023. The
change was not significant.
Net Loss: The net loss during the three months ended
September 30, 2024 was $6.0 million, compared to $6.8 million
during the three months ended September 30, 2023. The decrease in
net loss of $0.8 million was primarily attributable to a decrease
in operating expenses of $0.8 million.
About Vivani Medical, Inc.
Leveraging its proprietary NanoPortalTM 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 patient
tolerance to their medication. Vivani’s lead program, NPM-115,
utilizes a miniature, six-month, subdermal, GLP-1 (exenatide)
implant under development for chronic weight management in obese or
overweight individuals. Vivani’s emerging pipeline also includes
the NPM-139 (semaglutide implant) which is also under development
for chronic weight management in obese and overweight individuals.
The semaglutide implant has the added potential benefit of
once-yearly administration. NPM-119 refers to the Company’s type 2
diabetes development program utilizing a six-month, subdermal
exenatide implant. Both the NPM-115 and NPM-119 programs utilize
exenatide based products with a higher-dose associated with the
NPM-115 program 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 50
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 Vivani’s products, including NPM-115 and
NPM-119; delays and changes in the development of Vivani’s
products, including as a result of applicable laws, regulations and
guidelines, potential delays in submitting and receiving regulatory
clearance or approval to conduct Vivani’s development activities,
including Vivani’s ability to commence clinical development of
NPM-119; risks related to the initiation, enrollment and conduct of
Vivani’s planned clinical trials and the results therefrom;
Vivani’s history of losses and Vivani’s ability to access
additional capital or otherwise fund Vivani’s business; market
conditions and the ability of Cortigent to complete its initial
public offering. There may be additional risks that the Company
considers immaterial, or which are unknown. A further list and
description of risks and uncertainties can be found in the
Company’s most recent Annual Report on Form 10-K filed with the
U.S. Securities and Exchange Commission filed on March 26, 2024, as
updated by the Company’s subsequent Quarterly Reports on Form 10-Q.
Any forward-looking statement made by Vivani in this press release
is based only on information currently available to the Company and
speaks only as of the date on which it is made. The Company
undertakes no obligation to publicly update any forward-looking
statement, whether written or oral, that may be made from time to
time, whether as a result of added information, future developments
or otherwise, except as required by law.
VIVANI MEDICAL, INC.
AND SUBSIDIARIES
Condensed Consolidated Balance
Sheets (unaudited)
(In thousands, except per share
data)
September 30,
December 31,
2024
2023
ASSETS
Current assets:
Cash and cash equivalents
$
19,646
$
20,654
Prepaid expenses and other current
assets
1,753
2,408
Total current assets
21,399
23,062
Property and equipment, net
1,644
1,729
Right-of-use assets
18,383
19,616
Restricted cash
1,338
1,338
Other assets
132
52
Total assets
$
42,896
$
45,797
LIABILITIES AND STOCKHOLDERS’
EQUITY
Current liabilities:
Accounts payable
$
815
$
542
Accrued expenses
2,024
1,727
Litigation accrual
1,675
1,675
Accrued compensation expense
371
396
Current operating lease liabilities
1,385
1,383
Total current liabilities
6,270
5,723
Long-term operating lease liabilities
18,294
19,313
Total liabilities
24,564
25,036
Commitments and contingencies (Note
12)
Stockholders’ equity:
Preferred stock, par value $0.0001
per share; 10,000 shares authorized; none outstanding
-
-
Common stock, par value $0.0001 per
share; 300,000 shares authorized; shares issued and
outstanding: 55,266 and 51,031 at September 30, 2024
and December 31, 2023, respectively
6
5
Additional paid-in capital
134,108
119,054
Accumulated other comprehensive income
92
140
Accumulated deficit
(115,874
)
(98,438
)
Total stockholders’ equity
18,332
20,761
Total liabilities and stockholders’
equity
$
42,896
$
45,797
VIVANI MEDICAL, INC.
AND SUBSIDIARIES
Condensed Consolidated
Statements of Operations (unaudited)
(In thousands, except per share
data)
Three Months Ended September
30,
Nine Months Ended September
30,
2024
2023
2024
2023
Operating expenses:
Research and development, net of
grants
$
4,203
$
4,441
$
11,442
$
12,260
General and administrative, net of
grants
2,106
2,703
6,775
8,488
Total operating expenses
6,309
7,144
18,217
20,748
Loss from operations
(6,309
)
(7,144
)
(18,217
)
(20,748
)
Other income, net
268
362
781
1,122
Net loss
$
(6,041
)
$
(6,782
)
$
(17,436
)
$
(19,626
)
Net loss per common share - basic and
diluted
$
(0.11
)
$
(0.13
)
$
(0.32
)
$
(0.39
)
Weighted average common shares outstanding
- basic and diluted
55,247
50,837
54,161
50,757
View source
version on businesswire.com: https://www.businesswire.com/news/home/20241113827166/en/
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)
過去 株価チャート
から 10 2024 まで 11 2024
Vivani Medical (NASDAQ:VANI)
過去 株価チャート
から 11 2023 まで 11 2024