Vivani Medical Provides Business Update and Reports Fourth Quarter and Full Year 2023 Financial Results
- None.
- Cash balance decreased to $22.0 million from $46.4 million in 2022.
- Net loss increased to $25.7 million in 2023 compared to $13.9 million in 2022.
- Research and development expenses increased by 20% in 2023.
- General and administrative expenses rose by 41% in 2023.
- Other income decreased significantly from $7.4 million in 2022 to $1.3 million in 2023.
The recent strategic shift by Vivani Medical, Inc. towards the development of GLP-1 implants for obesity treatment, coupled with positive preclinical data for its NPM-115 product, represents a significant pivot within the biopharmaceutical sector. The ability to compare favorably with semaglutide, a proven weight management compound, suggests potential market competitiveness. Vivani's successful $15 million financing round is pivotal in sustaining operations through mid-2025, allowing the company to focus on advancing its priority development programs.
From a financial standpoint, the reduction in net loss in Q4 2023, compared to the same period in 2022, indicates improved operational efficiency. However, a year-over-year increase in net loss due to heightened R&D and G&A expenses, as well as the absence of a one-time gain from a previous acquisition, raises questions about the sustainability of current expenditure levels without additional financing or revenue streams.
The advancement of NPM-115, a high-dose exenatide implant for chronic weight management, into the investigational new drug (IND) application phase is a critical step for Vivani Medical. The preclinical efficacy, mirroring that of semaglutide, suggests a promising therapeutic alternative in the obesity treatment landscape. The company's strategic focus on obesity, a condition with a rising global prevalence, positions it within a high-demand market.
Further scrutiny of NPM-115's preclinical data and the potential for once-yearly administration of NPM-139 will be essential for understanding the long-term clinical and commercial viability of these products. The scientific community will be looking closely at the translation of preclinical results to human trials, which is a common hurdle in drug development.
Vivani Medical's strategic emphasis on obesity treatments taps into a growing segment of chronic disease management. The GLP-1 receptor agonist market is experiencing rapid growth due to the efficacy of existing drugs like Ozempic and Wegovy. Vivani's positioning of NPM-115 as a comparable, potentially more convenient alternative could capture significant market share if clinical trials confirm preclinical promises.
The anticipated milestones, such as the IND filings and potential initiation of human trials, will be closely watched by investors and competitors alike. Success in these areas could lead to substantial valuation increases and partnership opportunities, while failure could have the opposite effect. The decision to prioritize these programs reflects an astute recognition of market trends and unmet medical needs.
Strategic shift prioritizes the development of GLP-1 implants for the treatment of obesity and chronic weight management
Positive NPM-115 (exenatide implant) preclinical weight loss data comparable to semaglutide, active ingredient in Ozempic®/Wegovy®
Adam Mendelsohn, Ph.D., Vivani’s Chief Executive Officer, stated, “2023 was another remarkable year for Vivani as we shifted our strategic focus to our obesity portfolio and announced that our lead program NPM-115 – a six-month GLP-1 implant for obesity – generated preclinical weight loss data comparable to semaglutide, the active ingredient in Ozempic® and Wegovy®. We also disclosed semaglutide as the active pharmaceutical ingredient in NPM-139, a miniature, subdermal GLP-1 implant in development for chronic weight management, with the added potential benefit of once-yearly administration. In March, we raised funding to support operations into the second half of 2025. Additionally, we moved into a dedicated facility in
Dr. Mendelsohn added, “We are on track to submit a new Investigational New Drug Application for NPM-115, our high-dose exenatide implant for chronic weight management in obese and overweight patients with one or more risk factors, later this year. We also remain on track to provide the
Recent Business Highlights
In March 2024, Vivani announced the pricing of a
In March 2024, Vivani also announced the appointment of Daniel Bradbury to its Board of Directors. Under Bradbury’s leadership as CEO, Amylin Pharmaceuticals, with partner Alkermes, secured the 2012 approval of Bydureon® (exenatide injection), the world’s first once-weekly GLP-1 receptor agonist, a class of drugs that now includes blockbusters Ozempic, Trulicity® and Wegovy.
In February 2024, Vivani announced positive NPM-115 preclinical weight loss data comparable to semaglutide, the active ingredient in Ozempic and Wegovy. In a study in high-fat diet-induced obese mice, NPM-115 generated weight loss of approximately
Moving forward, Vivani will focus on developing NPM-115 and its emerging pipeline of innovative miniature, long-term drug implants to treat patients with chronic diseases and high unmet medical need. Today, the Company has grown to nearly 40 full-time employees and its current headquarters and operations are located at 1350 S. Loop Road,
Upcoming Anticipated Milestones
- Vivani anticipates filing the NPM-115 Investigational New Drug Application in the second half of 2024 and initiating a first-in-human trial after receiving regulatory clearance to proceed.
- The Company anticipates filing a Complete Response to the current Clinical Hold on NPM-119 during the first half of 2024.
-
Vivani is seeking
U.S. Securities and Exchange Commission (the “SEC”) approval to proceed with an initial public offering for wholly owned subsidiary Cortigent, Inc. Assuming successful financing is secured, the Company plans to continue advancing Cortigent’s pioneering precision neurostimulation technology for providing meaningful, visual perception in blind people and motor function in impaired stroke patients.
Fourth Quarter 2023 Financial Results
Cash Balance: As of December 31, 2023, Vivani had cash, cash equivalents and restricted cash totaling
Research and development expenses: Research and development expenses during the fourth quarter of 2023 were
General and administrative expenses: General and administrative expenses during the fourth quarter of 2023 were
Other income (expense): Other income (expense), net during the fourth quarter of 2023 was
Net Loss: The net loss during the fourth quarter of 2023 was
Full Year 2023 Financial Results
Research and development expenses: Research and development expenses during the year ended December 31, 2023 was
General and administrative expenses: General and administrative expenses during the year ended December 31, 2023 was
Other income (expense), net: Other income (expense), net during the year ended December 31, 2023 was
Net Loss: The net loss during the year ended December 31, 2023 was
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 medication tolerability. Vivani’s lead programs NPM-115 and NPM-119 are miniature, six-month, GLP-1 implants in development for the treatment of chronic weight management in obese or overweight patients and type 2 diabetes, respectively. Both NPM-115 and NPM-119 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
About Cortigent
Vivani’s wholly owned subsidiary 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. 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, product candidates, including the therapeutic potential thereof and the planned development therefor, technology and strategy. 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 product candidates, including NPM-115 and NPM-119; delays and changes in applicable laws, regulations and guidelines including potential delays in submitting required regulatory applications to the
VIVANI MEDICAL, INC. |
||||||||
AND SUBSIDIARIES |
||||||||
Condensed Consolidated Balance Sheets (unaudited) |
||||||||
(in thousands, except per share data) |
||||||||
December 31, | ||||||||
2023 |
2022 |
|||||||
ASSETS | ||||||||
Current assets: | ||||||||
Cash and cash equivalents | $ |
20,654 |
|
$ |
45,076 |
|
||
Prepaid expenses and other current assets |
|
2,408 |
|
|
2,452 |
|
||
Total current assets |
|
23,062 |
|
|
47,528 |
|
||
Property and equipment, net |
|
1,729 |
|
|
1,182 |
|
||
Right-of-use assets |
|
19,616 |
|
|
779 |
|
||
Restricted cash |
|
1,338 |
|
|
1,366 |
|
||
Deposits and other assets |
|
52 |
|
|
275 |
|
||
Total assets | $ |
45,797 |
|
$ |
51,130 |
|
||
LIABILITIES AND STOCKHOLDERS’ EQUITY | ||||||||
Current liabilities: | ||||||||
Accounts payable | $ |
542 |
|
$ |
1,177 |
|
||
Accrued expenses |
|
1,727 |
|
|
2,358 |
|
||
Litigation accrual |
|
1,675 |
|
|
1,675 |
|
||
Accrued compensation expense |
|
396 |
|
|
657 |
|
||
Current operating lease liabilities |
|
1,383 |
|
|
955 |
|
||
Total current liabilities |
|
5,723 |
|
|
6,822 |
|
||
Long-term operating lease liabilities |
|
19,313 |
|
|
- |
|
||
Total liabilities |
|
25,036 |
|
|
6,822 |
|
||
Stockholders’ equity: | ||||||||
Preferred stock, par value |
|
- |
|
|
- |
|
||
Common stock, par value |
|
5 |
|
|
5 |
|
||
Additional paid-in capital |
|
119,054 |
|
|
117,054 |
|
||
Accumulated other comprehensive gain |
|
140 |
|
|
35 |
|
||
Accumulated deficit |
|
(98,438 |
) |
|
(72,786 |
) |
||
Total stockholders’ equity |
|
20,761 |
|
|
44,308 |
|
||
Total liabilities and stockholders’ equity | $ |
45,797 |
|
$ |
51,130 |
|
||
VIVANI MEDICAL, INC. |
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AND SUBSIDIARIES |
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Condensed Consolidated Statements of Operations (unaudited) |
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(in thousands, except per share data) |
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Three Months Ended December 31, |
Twelve Months Ended December 31, |
|||||||||||||||
|
2023 |
|
2022 |
|
2023 |
|
2022 |
|||||||||
Operating expenses: | ||||||||||||||||
Research and development, net of grants | $ |
4,708 |
|
$ |
4,427 |
|
$ |
16,968 |
|
$ |
14,169 |
|
||||
General and administrative, net of grants |
|
1,509 |
|
|
3,363 |
|
|
9,997 |
|
|
7,072 |
|
||||
Total operating expenses |
|
6,217 |
|
|
7,790 |
|
|
26,965 |
|
|
21,241 |
|
||||
Loss from operations |
|
(6,217 |
) |
|
(7,790 |
) |
|
(26,965 |
) |
|
(21,241 |
) |
||||
Other income (expense), net |
|
191 |
|
|
506 |
|
|
1,313 |
|
|
7,352 |
|
||||
Net loss | $ |
(6,026 |
) |
$ |
(7,284 |
) |
$ |
(25,652 |
) |
$ |
(13,889 |
) |
||||
Net loss per common share - basic and diluted | $ |
(0.12 |
) |
$ |
(0.14 |
) |
$ |
(0.50 |
) |
$ |
(0.36 |
) |
||||
Weighted average shares outstanding - basic and diluted |
|
51,025 |
|
|
50,736 |
|
|
50,853 |
|
|
38,241 |
|
View source version on businesswire.com: https://www.businesswire.com/news/home/20240326159238/en/
Company Contact:
Don Dwyer
Chief Business Officer
info@vivani.com
(818) 833-5000
Investor Relations Contact:
Brigid Makes
Chief Financial Officer
investors@vivani.com
(818) 833-5000
Media Contact:
Sean Leous
ICR Westwicke
Sean.Leous@westwicke.com
(646) 866-4012
Source: Vivani Medical, Inc.
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