Company announces addition of NPM-115
(high-dose exenatide implant) to its emerging pipeline, a potential
alternative to life-long injections or pills for long-term GLP-1
therapy for the treatment of chronic weight management in obese or
overweight patients
Vivani is actively engaged in discussions with
the US FDA to enable the expeditious initiation of LIBERATE-1,
proposed FIH study of NPM-119 in patients with type 2 diabetes; in
parallel the Company also plans to submit application to support
initiation of the FIH study in Australia
Vivani Medical, Inc. (Nasdaq: VANI) (“Vivani” or the “Company”),
an innovative, preclinical-stage biopharmaceutical company
developing novel, long-term drug implants, today reported financial
results for the third quarter of 2023 and provided a business
update.
Vivani™ continues to advance its emerging pipeline 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.
“At Vivani, we continue to make progress in the development of
our pipeline of miniature, long-term drug implants designed to
improve the treatment of chronic diseases including obesity and
type 2 diabetes.” said Adam Mendelsohn, Ph.D., Vivani President and
Chief Executive Officer. “We are excited to announce the addition
of NPM-115 (high-dose exenatide implant) under development for the
treatment of chronic weight management in obese or overweight
patients to our emerging portfolio. Although the initial focus of
our exenatide implant has been for the treatment of type 2
diabetes, the implant was associated with ~16.6% lower weight than
a vehicle control implant and the weight loss was substantially
maintained throughout the full 16-week treatment period in
non-obese Sprague-Dawley rats. This result is consistent with the
magnitude of weight loss reported in the literature from a separate
study that administered semaglutide, the drug substance in
blockbuster products Ozempic®, Wegovy®, and Rybelsus®, in the same
animal model. We believe that NanoPortal has the potential to both
address the medication adherence challenges associated with the
currently marketed exenatide products and provide higher, more
efficacious dosing, thereby enabling patients to receive
exenatide’s maximum potential benefits in both clinical and
real-world settings. Given the extraordinary adoption of GLP-1
products for the treatment of obesity, Vivani intends to emphasize
NPM-115 and advance the program towards human testing.”
Dr. Mendelsohn continued: “Regarding NPM-119 (6-month exenatide
implant) under development for the treatment of type 2 diabetes,
Vivani remains actively engaged in discussions with the FDA as part
of our efforts to lift the clinical hold, which is exclusively
related to outstanding CMC information requests, and enable the
expeditious initiation of LIBERATE-1, our First-In-Human (“FIH”)
study in patients with type 2 diabetes. In addition, we are
announcing parallel plans to pursue the initiation of the FIH study
in Australia. Lastly, we continue to make steady progress with
NPM-139, another promising treatment for obesity with the added
potential for a once-yearly treatment duration.”
Third Quarter Business Highlights
Vivani is announcing the addition of NPM-115 (high-dose
exenatide implant) under development for chronic weight management
in obese or overweight patients to its emerging pipeline.
Preliminary evidence suggests NPM-115, if successful, may provide
another competitive GLP-1 monotherapy treatment option with
potential advantages associated with improved medication adherence
and tolerability. In addition, NPM-115 may provide an attractive
alternative to life-long injections or pills for long-term
maintenance of GLP-1 therapy for chronic weight management.
On July 14, 2023, the Company submitted an Investigational New
Drug application to the U.S. Food and Drug Administration (FDA) for
the proposed NPM-119 FIH study LIBERATE-1 in patients with type 2
diabetes.
On August 18, 2023, the FDA provided written notification that
the LIBERATE-1 study was on full clinical hold exclusively because
of insufficient Chemistry, Manufacturing, and Controls (“CMC”)
information to assess the risk to human subjects. Vivani remains
actively engaged in discussions with the FDA as part of its efforts
to lift the clinical hold and enable the expeditious initiation of
LIBERATE-1.
In parallel, Vivani plans to submit an application to a Human
Research Ethics Committee in Australia to support the initiation of
the Company’s FIH study in that country. If available, Vivani
intends to utilize research and development incentives and rebates
from the Australian government in order to defray a portion of the
costs from the trial. Since clinical studies conducted in Australia
comply with the International Conference on Harmonization
guidelines and data generated in Australia are acceptable to the
FDA and other regulatory authorities, Vivani plans to use relevant
clinical data generated in Australia to support regulatory
submissions in other geographies including the US. Additional
guidance will be provided as new information becomes available.
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 the active
comparator Bydureon BCise® (exenatide extended-release injectable
suspension 2mg).
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.
Moving forward, Vivani will focus on the further development of
NPM-119, NPM-115 and its emerging pipeline of innovative,
miniature, long-term drug implants to treat patients with chronic
diseases. Vivani has grown to 36 full-time employees, which does
not include the 14 Cortigent employees of whom some have been
furloughed, and Vivani’s new headquarters are in Alameda,
California.
Third Quarter ended September 30, 2023, Financial
Results
Cash Balance: As of September 30, 2023, Vivani had cash, cash
equivalents and restricted cash totaling $26.2 million compared to
$46.4 million as of December 31, 2022. The decrease of $20.2
million is attributed to the $19.6 million operating loss plus a
net increase in net operating assets of $3.0 million, offset
partially by $2.4 million of non-cash charges. The Company believes
its cash and cash equivalents as of September 30, 2023, are
estimated to be sufficient to fund operations into early 2025.
Research and development expense. Research and development
expense increased by $0.5 million, or 15%, to $4.4 million in the
third quarter of 2023 from $3.9 million in the third 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 $0.3 million. The remainder of the increase was
primarily due to drug implant development costs.
General and administrative expense. General and administrative
expense increased $1.1 million, or 71%, to $2.7 million in the
third quarter of 2023 from $1.6 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 increased
$0.6 million in the third quarter of 2023 versus the partial
quarter of 2022 which only included one month from the merger date,
higher costs associated with being a public company for D&O
insurance and professional fees, and higher payroll related
expenses.
Other income (expense). Other income was impacted by the merger
acquisition of cash which increased our interest income to $0.4
million for the three months ended September 30, 2023. The quarter
ended September 30, 2022 was impacted by the gain on bargain
purchase of $6.9 million recorded on the purchase of Second Sight
at the time of the merger.
Net Loss: The net loss was $6.8 million as compared to net
income of $1.4 million for the three-months ended September 30,
2023, and 2022, respectively. The $8.2 million change in net
loss/income was primarily attributable to the bargain purchase gain
of $6.9 million recorded on the purchase of Second Sight and by a
$1.0 million increase from the inclusion of Cortigent expenses
which were not included in 2022 prior to the merger, and increased
salaries and costs of being a public company.
Year to Date September 30, 2023, Financial Results
Research and development expense. Research and development
expense increased by $2.6 million, or 26%, to $12.3 million in the
first nine months of 2023 from $9.7 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 $1.4 million. The remainder of the increase was primarily
due to drug implants development costs and increased payroll
related costs.
General and administrative expense. General and administrative
expense increased $4.8 million, or 129%, to $8.5 million in the
first nine months of 2023 from $3.7 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
increased $2.7 million in the first nine months of 2023 versus the
partial inclusion of one month in 2022 after the merger date,
higher public company costs and higher payroll related
expenses.
Other income (expense). Other income was impacted by the merger
acquisition of cash which increased our interest income to $1.1
million for the nine months ended September 30, 2023. The income
for the nine months ended September 30, 2022 included $6.9 million
for the gain on bargain purchase from the acquisition of Second
Sight.
Net Loss: The net loss was $19.6 million as compared to $6.6
million for the nine-months ended September 30, 2023, and 2022,
respectively. The $13.0 million increase in net loss was primarily
attributable to the bargain purchase gain of $6.9 million recorded
on the purchase of Second Sight and a $4.3 million increase from
the inclusion of Cortigent expenses, which were not included in
2022 prior to the merger, and increased salaries and costs of being
a public company.
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 programs, NPM-119 and NPM-115, are
miniature, six-month, GLP-1 implants in development for the
treatment of type 2 diabetes and chronic weight management in obese
or overweight patients, respectively. Both NPM-119 and NPM-115 are
exenatide based products with a higher-dose associated with NPM-115
for the treatment of 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 why obese or overweight patients, and
patients taking type 2 diabetes or other chronic disease treatments
face significant challenges in achieving positive real-world
effectiveness.
Vivani’s wholly owned subsidiary Cortigent is developing
targeted 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. The company 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 our business,
products in development, including the therapeutic potential
thereof, the planned development therefor, plans to address any
requests from the FDA related to the agency’s current clinical hold
on NPM-119, the initiation of the LIBERATE-1 trial and reporting of
trial results, our emerging development plans for NPM-115, NPM-139,
or 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 and
NPM-115; delays and changes in the development of our 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 address any requests from the FDA related
to LIBERATE-1 and to commence clinical development of NPM-119;
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 SEC filed on March 31, 2023, as updated by our subsequent
Quarterly Reports on Form 10-Q. 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, except per share
data)
September 30,
December 31,
2023
2022
ASSETS
Current assets:
Cash and cash equivalents
$
24,821
$
45,076
Prepaid expenses and other current
assets
5,861
2,452
Total current assets
30,682
47,528
Property and equipment, net
1,134
1,182
Right-of-use assets
20,050
779
Restricted cash
1,366
1,366
Deposits and other assets
87
275
Total assets
$
53,319
$
51,130
LIABILITIES AND STOCKHOLDERS’
EQUITY
Current liabilities:
Accounts payable
$
1,891
$
1,177
Accrued expenses
1,815
2,358
Litigation accrual
1,675
1,675
Accrued compensation expense
676
657
Current operating lease liabilities
1,376
955
Total current liabilities
7,433
6,822
Long term operating lease liabilities
19,679
—
Total liabilities
27,112
6,822
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: 51,025 as
of September 30, 2023 and 50,736 as of December 31, 2022,
respectively
5
5
Additional paid-in capital
118,568
117,054
Accumulated other comprehensive loss
46
35
Accumulated deficit
(92,412
)
(72,786
)
Total stockholders’ equity
26,207
44,308
Total liabilities and stockholders’
equity
$
53,319
$
51,130
VIVANI MEDICAL, INC.
AND SUBSIDIARIES
Condensed Consolidated
Statements of Operations (unaudited)
(in thousands, except per share
data)
For the Three Months
ended
For the Nine Months
ended
September 30,
September 30,
2023
2022
2023
2022
Operating expenses:
Research and development, net of
grants
$
4,441
$
3,859
$
12,260
$
9,742
General and administrative
2,703
1,585
8,488
3,709
Total operating expenses
7,144
5,444
20,748
13,451
Loss from operations
(7,144
)
(5,444
)
(20,748
)
(13,451
)
Other income (expense), net
362
6,867
1,122
6,846
Net income/(loss)
$
(6,782
)
$
1,423
$
(19,626
)
$
(6,605
)
Net income/(loss) per common share –
basic
$
(0.13
)
$
0.04
$
(0.39
)
$
(0.18
)
Net income/(loss) per common share –
diluted
$
(0.13
)
$
0.04
$
(0.39
)
$
(0.18
)
Weighted average common shares outstanding
– basic
50,837
37,965
50,757
37,712
Weighted average common shares outstanding
– diluted
50,837
38,477
50,757
37,712
View source
version on businesswire.com: https://www.businesswire.com/news/home/20231114578356/en/
Donald Dwyer Chief Business Officer info@vivani.com (415)
506-8462
Investor Relations Contact: Brigid A. Makes Chief Financial
Officer investors@vivani.com (415) 506-8462
Media Contact: Sean Leous ICR Westwicke Sean.Leous@westwicke.com
(646) 866-4012
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