Vivani Medical Provides Business Update Including $3M Equity Financing and Reports First Quarter 2025 Financial Results
- Secured total $11.25M in equity financing, extending runway into mid-2026
- Successful implant insertions for all subjects in LIBERATE-1 trial
- Promising pre-clinical data for NPM-139 semaglutide implant
- Expanded collaboration with Okava Pharmaceuticals to include dogs
- Fast enrollment in LIBERATE-1 study, completed in just four weeks
- Increased net loss to $6.3M in Q1 2025 from $6.0M in Q1 2024
- Cash balance decreased to $14.3M from $19.7M in December 2024
- R&D expenses increased by 13% to $4.2M
Insights
Vivani's $11.25M financing extends runway to 2026 while advancing promising GLP-1 implant technology amid competitive weight management market.
The secured $11.25 million in equity financing ($3M new plus $8.25M previously announced) significantly strengthens Vivani's financial position, extending their runway into mid-2026. This provides crucial breathing room as they navigate the capital-intensive clinical development process for their novel GLP-1 implant technologies.
The successful enrollment and implantation in the LIBERATE-1 clinical trial represents a critical validation milestone for their NanoPortal™ technology platform. The rapid four-week enrollment period suggests strong interest from both clinicians and patients in this alternative GLP-1 delivery method. With top-line results expected mid-2025, this positions Vivani at an important inflection point that could validate their entire technology approach.
In the highly competitive GLP-1 weight management market dominated by injectable products from pharmaceutical giants, Vivani is wisely pursuing a differentiation strategy focused on adherence and convenience with their once or twice-yearly implantable devices. Their expansion into promising preclinical results for NPM-139 (semaglutide implant) is particularly strategic, as semaglutide has demonstrated superior efficacy compared to exenatide in the broader market.
The company's quarterly cash burn rate of approximately $5.4 million appears well-managed given their development stage. R&D expenses increased 13% year-over-year to $4.2 million, reflecting appropriate investment in their clinical programs. The planned spinoff of Cortigent represents a strategic focus on their core metabolic disease pipeline while potentially unlocking separate value for shareholders in the neuromodulation space.
The collaboration expansion with Okava into the veterinary market provides an interesting secondary validation pathway and potential diversification of revenue streams, though this remains early-stage. With $14.3 million cash on hand post-financing and an estimated quarterly burn around $5-6 million, Vivani appears adequately funded through their near-term clinical milestones, but will likely require additional capital before reaching commercialization.
All subjects in the NPM-115 cohort had successful insertions of a miniature, ultra long-acting GLP-1 (exenatide) implant in the on-going LIBERATE-1™ study in obese or overweight individuals; top-line results are anticipated in mid-2025
Announced new
Promising pre-clinical data released for NPM-139 (semaglutide implant) for chronic weight management in obese and overweight patients
Company plans to spin off Cortigent, Inc., a division that develops brain implant devices to help patients recover critical body functions, as an independent publicly traded company
ALAMEDA, Calif., May 13, 2025 (GLOBE NEWSWIRE) -- Vivani Medical, Inc. (Nasdaq: VANI) (“Vivani” or the “Company”), a biopharmaceutical company developing miniaturized, ultra long-acting drug implants, today reported financial results for the first quarter ended March 31, 2025, and provided a business update including a
Vivani Chief Executive Officer Adam Mendelsohn, Ph.D., stated, “Our ongoing first-in-human study, LIBERATE-1, remains on track to deliver key data in mid-2025 with the aim of validating our proprietary NanoPortal™ implant technology and enabling us to advance our portfolio of exenatide and semaglutide based drug implants in clinical development. The study enrolled ahead of schedule, and all NPM-115 (exenatide implant) insertions were successful.”
Dr. Mendelsohn added, “While the GLP-1 market continues to grow and mature, it is clear that meaningful differentiation will be required for commercial success of new market entrants, in part because of the significant clinical benefits delivered by the currently available GLP-1 therapies. We remain confident that our emerging portfolio of convenient, miniature, subdermal drug implants with once- or twice-yearly dosing will stand out as a highly differentiated and sought-after alternative GLP-1 treatment option for patients and providers, with the potential to substantially improve patient outcomes by addressing poor medication adherence and patient tolerability.”
Recent Business Highlights
On May 12, 2025, Vivani announced that it has entered into a securities purchase agreement to issue and sell an aggregate of 2,912,621 shares, each at a price of
On April 15, 2025, Vivani and Okava Pharmaceuticals, Inc. (“Okava”), a clinical-stage company focused on the treatment of age-related diseases in dogs and cats, announced an expansion of their collaboration focused on cats that was initiated in 2019, to now include dogs in the development of OKV-119, a long-acting GLP-1 therapy that leverages Vivani’s NanoPortal technology for weight management, diabetes and other cardiometabolic conditions
On March 27, 2025, Vivani announced that it has entered into a securities purchase agreement to issue and sell an aggregate of 7,366,071 shares, each at a price of
On March 26, 2025, Vivani announced promising preclinical data for NPM-139, its subdermal semaglutide implant under development for chronic weight management in obese and overweight individuals. These results reinforce the Company’s commitment to addressing chronic weight management and other chronic diseases by leveraging its NanoPortal implant technology designed to enable smooth and steady delivery of therapeutic molecules, including GLP-1 therapy.
On March 13, 2025, Vivani announced the successful administration of its first GLP-1 (exenatide) implant in the LIBERATE-1 clinical trial. This milestone marked a critical step toward addressing one of healthcare’s most pressing challenges: medication adherence in the treatment of metabolic diseases including chronic weight management and type 2 diabetes. The Company also announced full enrollment in the LIBERATE-1 study, which was achieved in just four weeks after enrollment of the first subject, signaling early potential interest for this six-month, subdermal exenatide implant and reaffirming previous estimates that top-line results should be available in mid-2025.
On March 12, 2025, Vivani announced that it intends to spin off Cortigent, Inc., a division of the Company that develops brain implant devices to help patients recover critical body functions, as an independent publicly traded company. The strategic goal of this transaction intends to create two companies that are focused and dedicated to driving current and future value in their respective therapeutic areas of expertise.
Upcoming Anticipated Milestones
- Vivani anticipates top-line data from the LIBERATE-1 study in mid-2025. LIBERATE-1 is a Phase 1 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.
- Vivani plans to participate in the BIO International Convention hosted in Boston, MA from June 16 to 19, 2025. Dr. Mendelson will provide a Company presentation during the Convention, in addition to participating in partnering activities with potential investors and strategic partners alongside Vivani Chief Business Officer Don Dwyer.
First Quarter 2025 Financial Results
Cash balance: As of March 31, 2025, Vivani had cash, cash equivalents and restricted cash totaling
Research and development expense: Research and development expense during the three months ended March 31, 2025 was
General and administrative expense: General and administrative expense during the three months ended March 31, 2025 was
Other income, net: Other income, net during the three months ended March 31, 2025 was
Net Loss: The net loss during the three months ended March 31, 2025 was
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 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 subjects. Vivani’s emerging pipeline also includes 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 dosing. 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
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 31, 2025, 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.
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 Healthcare
Sean.Leous@ICRHealthcare.com
(646) 866-4012
VIVANI MEDICAL, INC.
AND SUBSIDIARIES
Condensed Consolidated Balance Sheets (unaudited)
(in thousands, except per share data)
| March 31, | December 31, | ||||||||
| 2025 | 2024 | ||||||||
| ASSETS | |||||||||
| Current assets: | |||||||||
| Cash and cash equivalents | $ | 13,008 | $ | 18,352 | |||||
| R&D tax credit incentive receivable | 175 | 253 | |||||||
| Prepaid expenses and other current assets | 1,667 | 1,837 | |||||||
| Total current assets | 14,850 | 20,442 | |||||||
| Property and equipment, net | 1,609 | 1,693 | |||||||
| Operating lease right-of-use assets, net | 17,523 | 17,957 | |||||||
| Restricted cash | 1,338 | 1,338 | |||||||
| Other assets | 132 | 131 | |||||||
| Total assets | $ | 35,452 | $ | 41,561 | |||||
| LIABILITIES AND STOCKHOLDERS’ EQUITY | |||||||||
| Current liabilities: | |||||||||
| Accounts payable | $ | 1,004 | $ | 817 | |||||
| Accrued expenses | 1,859 | 1,803 | |||||||
| Litigation accrual | 1,675 | 1,675 | |||||||
| Accrued compensation expense | 350 | 343 | |||||||
| Current operating lease liabilities | 1,311 | 1,348 | |||||||
| Total current liabilities | 6,199 | 5,986 | |||||||
| Long-term operating lease liabilities | 17,629 | 17,965 | |||||||
| Total liabilities | 23,828 | 23,951 | |||||||
| Commitments and contingencies (Note 12) | |||||||||
| Stockholders’ equity: | |||||||||
| Preferred stock, par value | - | - | |||||||
| Common stock, par value | 6 | 6 | |||||||
| Additional paid-in capital | 139,802 | 139,480 | |||||||
| Accumulated other comprehensive income | 42 | 48 | |||||||
| Accumulated deficit | (128,226 | ) | (121,924 | ) | |||||
| Total stockholders’ equity | 11,624 | 17,610 | |||||||
| Total liabilities and stockholders’ equity | $ | 35,452 | $ | 41,561 | |||||
VIVANI MEDICAL, INC.
AND SUBSIDIARIES
Condensed Consolidated Statements of Operations (unaudited)
(in thousands, except per share data)
| Three Months Ended March 31, | |||||||||
| 2025 | 2024 | ||||||||
| Operating expenses: | |||||||||
| Research and development, net of grants | $ | 4,217 | $ | 3,726 | |||||
| General and administrative, net of grants | 2,340 | 2,501 | |||||||
| Total operating expenses | 6,557 | 6,227 | |||||||
| Loss from operations | (6,557 | ) | (6,227 | ) | |||||
| Other income, net | 255 | 188 | |||||||
| Net loss | $ | (6,302 | ) | $ | (6,039 | ) | |||
| Net loss per common share - basic and diluted | $ | (0.11 | ) | $ | (0.12 | ) | |||
| Weighted average common shares outstanding - basic and diluted | 59,236 | 52,202 | |||||||
FAQ
What is the current cash position of Vivani Medical (VANI) after the recent equity financing?
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What was Vivani Medical's (VANI) net loss in Q1 2025?
What is Vivani Medical's (VANI) plan for Cortigent, Inc.?
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