Vivani Medical Provides Business Update and Reports First Quarter 2024 Financial Results
Vivani Medical (Nasdaq: VANI) has provided a business update and first quarter 2024 financial results. The company is advancing the development of GLP-1 implants for chronic weight management and type 2 diabetes. Key highlights include the initiation of preclinical activities for NPM-115 and the expected IND submission by year-end. A $15-million stock offering in March will fund operations until the second half of 2025. Vivani reported a cash balance of $31.0 million as of March 31, 2024, a net loss of $6.0 million, and a slight reduction in R&D and administrative expenses compared to the previous year.
- Initiated preclinical activities for NPM-115, targeting IND submission by end of 2024.
- Announced positive preclinical weight loss data for NPM-115, comparable to semaglutide.
- Completed a $15-million stock offering, extending operational runway to the second half of 2025.
- Cash balance increased to $31.0 million as of March 31, 2024.
- Decreased R&D and administrative expenses, signaling cost management improvements.
- Appointed Daniel Bradbury to the Board, bringing significant industry experience.
- Reported a net loss of $6.0 million for Q1 2024.
- NPM-119 remains under Clinical Hold, pending FDA clearance.
- Research and development expenses remain high at $3.7 million for Q1 2024.
Insights
The first quarter financial results of Vivani Medical present a mixed picture. On the one hand, the company reported an increase in cash balance from
From an investor's perspective, a stable financial position supporting operations into the second half of 2025 is reassuring. However, the ongoing operational losses necessitate careful scrutiny. The R&D expenses have slightly decreased, but at
The company’s financial health hinges on its ability to reach key milestones, particularly the submission of the IND application for NPM-115 and addressing the FDA’s CMC requirements for NPM-119. Meeting these targets would likely bolster investor confidence. However, the R&D intensity and current losses suggest that revenue generation and profitability are not immediate prospects, making it a speculative investment in the near term.
Vivani Medical’s progress in developing miniature, long-term GLP-1 implants presents a compelling clinical advancement, especially in the treatment of obesity and chronic weight management. GLP-1 receptor agonists, including exenatide and semaglutide, are well-established in clinical practice for these conditions. The potential for a miniature implant offering a six-month or longer administration frequency addresses a critical issue in chronic disease management: patient adherence.
Preclinical data showing weight loss in high-fat diet-induced obese mice comparable to injections of Ozempic indicate promising efficacy. However, it is essential to remember that preclinical results do not always translate directly to human outcomes. The forthcoming IND application and first-in-human trials will be pivotal in determining whether the initial promise translates into clinical success.
Furthermore, the announcement of semaglutide as the active ingredient in NPM-139, with the potential for annual administration, could be a game-changer. Innovations like these can significantly enhance patient compliance and long-term outcomes. The focus on long-term administration also positions Vivani’s products uniquely in a competitive market dominated by weekly or monthly injections.
The market for GLP-1 products is experiencing robust growth, driven by an increasing prevalence of obesity and type 2 diabetes. Vivani's focus on developing miniature, long-term implants taps into this trend, offering a differentiated product that could capture significant market share if proven effective and safe.
The commercial potential of Vivani's GLP-1 implants lies in their ability to address common issues with medication adherence and the weight regain seen upon discontinuation of traditional therapies. By providing a longer-term solution, Vivani can appeal to both patients and healthcare providers seeking more convenient and effective treatment options.
However, market penetration will depend not only on clinical efficacy but also on pricing strategy, insurance coverage and the company’s ability to scale production. Competitors like Novo Nordisk and Eli Lilly already have established brands and market presence, which could pose significant hurdles. The upcoming conferences and meetings with potential partners and investors are strategic moves to build alliances and drive awareness, which could support market entry and expansion.
Company continues advancing the development of miniature, long-term GLP-1 implants for the treatment of chronic weight management in obese or overweight patients, type 2 diabetes, and other chronic diseases
Stable financial position supports operations into the second half of 2025 and potential delivery of key portfolio milestones
Adam Mendelsohn, Ph.D., Vivani’s Chief Executive Officer, stated, “Since pivoting to prioritize the development of our GLP-1 implants for obesity and chronic weight management, we have initiated preclinical activities for NPM-115, our high-dose exenatide implant to support clinical investigations. An Investigational New Drug (“IND”) application for NPM-115 remains on track for submission before the end of this year. In addition, we remain on track to provide the
Dr. Mendelsohn added, “The commercial opportunity for GLP-1 products remains robust with remarkable growth and significant potential for differentiated products including our miniature, subdermal implants with a target frequency of administration of six months or longer. We believe that the largest positive real-world impact in the GLP-1 category will be realized by addressing medication adherence and avoiding the weight regain which occurs upon treatment discontinuation, both of which are directly addressed by our miniature GLP-1 implants in development. As a result, we believe that our pipeline assets continue to hold significant potential opportunity for patients, caregivers, prescribers and payers.”
Recent Business Highlights
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 of high-fat diet-induced obese mice, NPM-115 generated weight loss of approximately
In March 2024, Vivani completed a
In March 2024, Vivani also announced the appointment of Daniel Bradbury to its Board of Directors. Under Bradbury’s leadership as Chief Executive Officer, Amylin Pharmaceuticals, Inc., with partner Alkermes plc, 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®.
Upcoming Anticipated Milestones
- Vivani anticipates filing the NPM-115 IND application in the second half of 2024 and initiating a first-in-human trial after receiving regulatory clearance to proceed.
- Vivani remains on track to provide the FDA with the requested CMC information associated with the current Clinical Hold on NPM-119 during the first half of 2024.
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Vivani plans to participate in multiple external events, including the TIDES
USA conference on Oligonucleotide and Peptide Therapeutics on May 17, 2024 inBoston, MA , where Dr. Mendelsohn will present new NPM-115 data, as well as the Annual BIO International Conference inSan Diego, CA on June 3-5, 2024, where Dr. Mendelsohn and Vivani’s Chief Business Officer Don Dwyer will meet with potential partners, investors and other industry representatives.
First Quarter 2024 Financial Results
Cash balance: As of March 31, 2024, Vivani had cash, cash equivalents and restricted cash totaling
Research and development expense: Research and development expense during the three months ended March 31, 2024 was
General and administrative expense: General and administrative expense during the three months ended March 31, 2024 was
Other income, net: Other income, net during the three months ended March 31, 2024 was
Net Loss: The net loss during the three months ended March 31, 2024 was
Bydureon® is a registered trademark of the AstraZeneca group of companies.
Ozempic® and Wegovy® are registered trademarks of Novo Nordisk A/S.
Trulicity® is a registered trademark of Eli Lilly and 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 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, Inc.
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 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 achieve or sustain profitability in the future; and the impact of COVID-19 on our business. 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 for the year ended December 31, 2023 filed with the
VIVANI MEDICAL, INC. |
||||||||
AND SUBSIDIARIES |
||||||||
Condensed Consolidated Balance Sheets (unaudited) |
||||||||
(in thousands, except per share data) |
||||||||
March 31, |
December 31, |
|||||||
|
2024 |
|
|
2023 |
|
|||
| ASSETS | ||||||||
| Current assets: | ||||||||
| Cash and cash equivalents | $ |
29,648 |
|
$ |
20,654 |
|
||
| Prepaid expenses and other current assets |
|
1,854 |
|
|
2,408 |
|
||
| Total current assets |
|
31,502 |
|
|
23,062 |
|
||
| Property and equipment, net |
|
1,689 |
|
|
1,729 |
|
||
| Right-of-use assets |
|
19,212 |
|
|
19,616 |
|
||
| Restricted cash |
|
1,338 |
|
|
1,338 |
|
||
| Other assets |
|
47 |
|
|
52 |
|
||
| Total assets | $ |
53,788 |
|
$ |
45,797 |
|
||
| LIABILITIES AND STOCKHOLDERS’ EQUITY | ||||||||
| Current liabilities: | ||||||||
| Accounts payable | $ |
570 |
|
$ |
542 |
|
||
| Accrued expenses |
|
1,953 |
|
|
1,727 |
|
||
| Litigation accrual |
|
1,675 |
|
|
1,675 |
|
||
| Accrued compensation expense |
|
506 |
|
|
396 |
|
||
| Current operating lease liabilities |
|
1,434 |
|
|
1,383 |
|
||
| Total current liabilities |
|
6,138 |
|
|
5,723 |
|
||
| Long-term operating lease liabilities |
|
18,940 |
|
|
19,313 |
|
||
| Total liabilities |
|
25,078 |
|
|
25,036 |
|
||
| Commitments and contingencies | ||||||||
| Stockholders’ equity: | ||||||||
| Preferred stock, par value |
|
- |
|
|
- |
|
||
| Common stock, par value |
|
5 |
|
|
5 |
|
||
| Additional paid-in capital |
|
133,094 |
|
|
119,054 |
|
||
| Accumulated other comprehensive income |
|
88 |
|
|
140 |
|
||
| Accumulated deficit |
|
(104,477 |
) |
|
(98,438 |
) |
||
| Total stockholders’ equity |
|
28,710 |
|
|
20,761 |
|
||
| Total liabilities and stockholders’ equity | $ |
53,788 |
|
$ |
45,797 |
|
||
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) |
||||||||
| Three Months Ended March 31, | ||||||||
|
2024 |
|
|
2023 |
|
|||
| Operating expenses: | ||||||||
| Research and development, net of grants | $ |
3,726 |
|
$ |
3,955 |
|
||
| General and administrative, net of grants |
|
2,501 |
|
|
2,646 |
|
||
| Total operating expenses |
|
6,227 |
|
|
6,601 |
|
||
| Loss from operations |
|
(6,227 |
) |
|
(6,601 |
) |
||
| Other income, net |
|
188 |
|
|
283 |
|
||
| Net loss | $ |
(6,039 |
) |
$ |
(6,318 |
) |
||
| Net loss per common share - basic and diluted | $ |
(0.12 |
) |
$ |
(0.12 |
) |
||
| Weighted average common shares outstanding - basic and diluted |
|
52,202 |
|
|
50,755 |
|
||
View source version on businesswire.com: https://www.businesswire.com/news/home/20240513555972/en/
Company:
Don Dwyer
Chief Business Officer
info@vivani.com
(415) 506-8462
Investor Relations:
Brigid Makes
Chief Financial Officer
investors@vivani.com
(415) 506-8462
Media:
Sean Leous
ICR Westwicke
Sean.Leous@westwicke.com
(646) 866-4012
Source: Vivani Medical, Inc.
FAQ
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