Full Press Release Details
Medical Provides Business Update and
First Quarter 2024 Financial Results
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
financial position supports operations into the second half of 2025 and potential delivery of key portfolio milestones
CA -- (BUSINESS WIRE) - May 13, 2024 - Vivani Medical, Inc. (Nasdaq: VANI) ("Vivani" or the
"Company"), a biopharmaceutical company developing miniaturized, long-term drug implants including its lead asset
NPM-115 for chronic weight management in obese or overweight patients with one or more risk factors, today reported financial
results for the first quarter ended March 31, 2024, and provided a business update.
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 U.S. Food and Drug Administration ("FDA") with the requested
Chemistry, Manufacturing and Controls ("CMC") information related to our NPM-119 IND in the first half of this year."
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."
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 20% compared to a sham implant control after a 28-day treatment duration, comparable to weight loss observed
in mice treated with injections of Ozempic in the same study. The Company 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.
March 2024, Vivani completed a $15-million registered direct offering of common stock and warrants. Proceeds from the financing
will enable acceleration of priority development programs, including NPM-115 for obesity, and fund operations into the second
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 .
Anticipated Milestones
Quarter 2024 Financial Results
balance: As of March 31, 2024, Vivani had cash, cash equivalents and restricted cash totaling $31.0 million, compared to $22.0
million as of December 31, 2023. The increase of $9.0 million is attributed to the net cash provided by issuance of common stock
and warrants in connection with securities purchase agreement of $13.7 million, $1.0 million provided by a net change in operating
assets and liabilities and non-cash items totaling $0.5 million for depreciation and amortization of property and equipment, stock-based
compensation and lease expense, partially offset by a net loss of $6.0 million and $0.2 million used for purchase of property
and development expense: Research and development expense during the three months ended March 31, 2024 was $3.7 million,
compared to $4.0 million during the three months ended March 31, 2023. The decrease of $0.3 million, or 6%, was primarily
attributable to a decrease in costs from the Company's wholly owned subsidiary Cortigent and drug implant development
costs, partially offset by increased payroll and personnel-related costs and increased rent due to the lease agreement in
Alameda, California and related facilities expense.
and administrative expense: General and administrative expense during the three months ended March 31, 2024 was $2.5 million,
compared to $2.6 million during the three months ended March 31, 2023. The decrease of $0.1 million, or 5%, was attributable to
a decrease in costs from Cortigent, partially offset by increased payroll and personnel-related costs, increased rent due to the
lease agreement in Alameda, California and professional service expense.
income, net: Other income, net during the three months ended March 31, 2024 was $0.2 million, compared to $0.3 million during
the three months ended March 31, 2023. The change was not significant.
Loss: The net loss during the three months ended March 31, 2024 was $6.0 million, compared to $6.3 million during the three
months ended March 31, 2023. The decrease in net loss of $0.3 million was primarily attributable to a decrease in operating expenses
is a registered trademark of the AstraZeneca group of companies.
and Wegovy are registered trademarks of Novo Nordisk A/S.
is a registered trademark of Eli Lilly and Company.
Vivani Medical, Inc.
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
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 medications face significant challenges in
achieving positive real-world effectiveness.
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.
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 U.S. Securities Exchange Commission ("SEC") on March 26, 2024, and any subsequent filings filed with
the SEC. 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.
Chief Business Officer
Chief Financial Officer