Full Press Release Details
Vivani Medical Provides Business Update and
Reports Fourth Quarter and Full Year 2024 Financial Results
Successful initial administration and full enrollment in first-in-human LIBERATE-1
(exenatide implant) in obese and
overweight subjects with top-line data expected in mid-2025
Positive NPM-139 (semaglutide implant)
preclinical weight loss data comparable to
injections of semaglutide, active
ingredient in Ozempic /Wegovy , with potential for once-yearly dosing
Additional $8.25M equity financing which
secures solid financial position into the second quarter of 2026,
further development of NPM-139 and NPM-115 programs in chronic weight management
Alameda, CA -- (GLOBE NEWSWIRE) -- March 31, 2025 -
Vivani Medical, Inc. (Nasdaq: VANI) ("Vivani" or the
"Company"), a biopharmaceutical company developing miniaturized, ultra long-acting drug
implants including its lead assets NPM-115 (exenatide
management in obese or overweight patients with one or more risk factors, today
reported financial results for the fourth quarter and full year ended December 31, 2024, and provided a business update.
transitioned Vivani to a clinical-stage biotechnology company and achieved significant milestones in both our NPM-115 and
NPM-139 programs, both focused on transforming the treatment of chronic weight
management targeting once or twice-yearly dosing," said Adam Mendelsohn, Ph.D.,
Vivani's Chief Executive Officer, "Our first-in-human LIBERATE-1 study
continues to progress as planned with each implantation to date having been
successful and we remain on track for top-line data in mid-2025. By providing
key performance data on drug release, the value of LIBERATE-1 extends beyond
the NPM-115 program by also informing the NPM-139 program as it advances in
Dr. Mendelsohn added, "In March, we raised funding
to support operations into the second quarter of 2026. Additionally, we continue
to equip our dedicated facility in Alameda, California, to support the
manufacturing of large-scale clinical trial materials and, ultimately,
recent positive preclinical weight loss data with NPM-139, Vivani is now
planning to advance NPM-139 towards clinical phase development in addition to
the ongoing NPM-115 program.
Recent Business Highlights
On March 27, 2025, Vivani announced an $8.25 million equity financing which secures solid financial position into the second quarter of 2026 and enables acceleration of priority development programs, including NPM-115 and NPM-139 for the treatment of obesity and chronic weight management.
On March 26, 2025, Vivani announced promising preclinical data for NPM-139, its subdermal semaglutide implant that is under development for chronic weight management in obese and overweight individuals. These results reinforce Vivani's commitment to addressing chronic weight management and other chronic diseases by leveraging its proprietary NanoPortal implant technology which is designed to enable smooth and steady delivery of therapeutic molecules including GLP-1 therapy. This development marks a significant advancement in improving medication adherence and patient convenience, addressing a critical gap in the treatment of chronic diseases including obesity and type 2 diabetes.
2025, Vivani also announced the successful administration of its first GLP-1
(exenatide) implant in the LIBERATE-1 clinical trial. This milestone marks a
critical step toward addressing one of healthcare's most pressing challenges:
medication adherence in metabolic diseases involving 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
GLP-1 implant and reaffirming previous estimates that top-line results should
be available in mid-2025.
On March 12, 2025, the Company announced that it intends to spin off Cortigent, Inc. ("Cortigent"), a Delaware corporation and its wholly owned subsidiary, that develops brain implant devices to help people recover critical body functions, as an independent publicly traded company. The strategic goal of this transaction is to create two focused companies dedicated to driving current and future value in their respective therapeutic areas of expertise.
forward, Vivani will focus on developing NPM-115, NPM-139 and its emerging
pipeline of innovative miniature, ultra long-acting drug implants to treat
patients with chronic diseases and high unmet medical need. The recent
preclinical demonstration of NPM-139 comes on the heels of having rapidly
enrolled and successfully administered the initial implants in LIBERATE-1, a
first-in-human study with NPM-115, which is expected to pave the road for
NPM-139 as development continues for both programs. Today, the Biopharm Division has
grown to 35 full-time employees and its headquarters and operations are
located at 1350 S. Loop Road, Alameda, California 94502.
Upcoming Anticipated Milestones
Fourth Quarter 2024 Financial Results
Note: Vivani (or the "Company")
refers to the consolidated company including the Biopharm Division and
Cortigent. The Biopharm Division refers to the drug implant business, the main
focus of the consolidated company.
Cash Balance: As of December 31, 2024, Vivani had cash, cash equivalents and restricted cash totaling $19.7 million, compared to $22.0 million as of December 31, 2023. The decrease of $2.3 million is primarily attributed to a net loss of $23.5 million, and $0.6 million related to purchase of equipment, which was mostly offset by net proceeds of $19.1 million provided by the financing activities, non-cash items totaling $2.3 million which includes stock-based compensation, depreciation and amortization of property and equipment, and lease expense.
Research and development expenses: Research and development expenses during the fourth quarter of 2024 were $4.3 million, compared to $4.7 million during the fourth quarter of 2023. The decrease of $0.4 million, or 9%, was primarily attributable to
staffing reduction and
reduced use of outside services.
General and administrative expenses: General and administrative expenses during the fourth quarter of 2024 were $2.1 million, compared to $1.5 million during the fourth quarter of 2023. The increase of $0.6 million, or 43%, was primarily attributable to increased professional services and stock-based compensation expense from the Biopharm Division.
Other income (expense): Other income (expense), net during the fourth quarter of 2024 was $0.4 million, compared to $0.2 million during the fourth quarter of 2023. The increase of $0.2 million, or 124%, was primarily attributed to the tax credit earned on our Australian clinical trial investment.
Net Loss: The net loss during the fourth quarter of 2024 was $6.1 million, compared to $6.0 million during the fourth quarter of 2023. The change was insignificant.
Full Year 2024 Financial Results
Research and development expenses: Research and development expenses during the year ended December 31, 2024 was $15.7 million, compared to $17.0 million during the year ended December 31, 2023. The decrease of $1.2 million, or 7%, was primarily attributable to
staffing reduction and
reduced use of outside services from Cortigent, partially offset by the increase in
our Biopharm Division's clinical trial related expenses.
General and administrative expenses: General and administrative expenses during the year ended December 31, 2024 was $8.9 million, compared to $10.0 million during the year ended December 31, 2023. The decrease of $1.1 million, or 11%, was primarily attributable to
staffing reductions along
with reduced outside legal services from Cortigent,
partially offset by the increase in the professional services of our Biopharm Division.
Other income (expense), net: Other income (expense), net during the year ended December 31, 2024 was $1.2 million, compared to $1.3 million during the year ended December 31, 2023.
The change was insignificant.
Net Loss: The net loss during the year ended December 31, 2024 was $23.5 million, compared to $25.7 million during the year ended December 31, 2023. The decrease in net loss of $2.2 million, or approximately 8%, was primarily attributable to
staffing reduction and
reduced use of outside services from
partially offset by increased clinical trial related expenses and professional
services from our Biopharm Division.
About Vivani Medical, Inc.
Leveraging its proprietary
NanoPortal platform, Vivani develops therapeutic 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 programs, NPM-139 (semaglutide implant) and NPM-115 (exenatide
implant), are miniature, subdermal GLP-1 implants under development for chronic
weight management in obese or overweight individuals designed for once or
twice-yearly administration. Vivani's emerging pipeline also includes NPM-119, which
refers to the Company's six-month, subdermal, GLP-1 (exenatide implant) under
development for the treatment of type 2 diabetes. Development of a semaglutide
implant for the treatment of type 2 diabetes is also under consideration. These
NanoPortal implants are designed to provide patients with the opportunity to experience
the full potential benefit of their medication by avoiding the challenges
associated with the daily or weekly administration of oral and injectable
non-adherence occurs when patients do not take their medication as prescribed.