Full Press Release Details
Vivani Medical Provides
Reports Fourth Quarter
and Full Year 2023 Financial Results
shift prioritizes the development of GLP-1 implants for the treatment of obesity
and chronic weight management
NPM-115 (exenatide implant) preclinical weight loss data comparable to
semaglutide, active ingredient in Ozempic /Wegovy
million financing round enables acceleration of priority development programs and
secures operations into the second half of 2025
Alameda, CA -- (BUSINESS WIRE) -- March 26, 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 fourth quarter and full year ended December 31, 2023, and
provided a business update.
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 Alameda, California, capable of supporting the manufacturing of large-scale clinical trial
materials and, ultimately, commercial supply."
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 U.S. Food and Drug Administration
with the requested NPM-119 Chemistry, Manufacturing and Controls information in the first half of this year, with the goal of obtaining
an Investigational New Drug Application clearance of NPM-119 to initiate clinical development. The considerable work we have done
to prepare NPM-119 for clinical development will be leveraged as we move toward a first-in-human clinical study for NPM-115, which
aligns with our new strategic priority."
Recent Business Highlights
In March 2024, Vivani announced the pricing of 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 provides funding of operations into the second half of 2025.
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 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. Vivani announced the addition
of NPM-115 to its portfolio in November 2023. Adding to Vivani's emerging obesity portfolio, 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.
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, Alameda, California.
Upcoming Anticipated Milestones
Fourth Quarter 2023 Financial Results
Cash Balance: As of December 31, 2023, Vivani had
cash, cash equivalents and restricted cash totaling $22.0 million, compared to $46.4 million as of December 31, 2022. The decrease
of $24.5 million is primarily attributed to a net loss of $25.7 million, $1.3 million used from a net change in operating assets
and liabilities and $0.9 million related to purchase of equipment. The decrease was partially offset by non-cash items totaling
$3.2 million for depreciation and amortization of property and equipment, stock-based compensation, loss on disposal of fixed assets
Research and development expenses: Research and development
expenses during the fourth quarter of 2023 were $4.7 million, compared to $4.4 million during the fourth quarter of 2022. The increase
of $0.3 million, or 6%, was primarily attributable to increased payroll and personnel-related costs, increased rent and related
facilities expense due to the lease agreement in Alameda, California, partially offset by lower spending on drug implants development
General and administrative expenses: General and administrative
expenses during the fourth quarter of 2023 were $1.5 million, compared to $3.4 million during the fourth quarter of 2022. The decrease
of $1.9 million, or 55%, was primarily attributable to a provision for a legal claim of $1.7 million recorded in the fourth quarter
Other income (expense): Other income (expense), net during
the fourth quarter of 2023 was $0.2 million, compared to $0.5 million during the fourth quarter of 2022. The decrease of $0.3 million,
or 62%, was primarily attributed to a decrease in interest income on cash investments.
Net Loss: The net loss during the fourth quarter of 2023
was $6.0 million, compared to $7.3 million during the fourth quarter of 2022. The decrease in net loss of $1.3 million was primarily
attributable to a decrease in operating expenses of $1.6 million, partially offset by a decrease in interest income on cash investments.
Full Year 2023 Financial Results
Research and development expenses: Research and development
expenses during the year ended December 31, 2023 was $17.0 million, compared to $14.2 million during the year ended December 31,
2022. The increase of $2.8 million, or 20%, was primarily attributable to increased payroll and personnel-related costs, increased
rent due to the lease agreement in Alameda, California and related facilities expense and the inclusion of Cortigent (former legacy
company Second Sight), since the merger acquisition date of August 30, 2022, partially offset by drug implant development costs.
General and administrative expenses: General and administrative
expenses during the year ended December 31, 2023 was $10.0 million, compared to $7.1 million during the year ended December 31,
2022. The increase of $2.9 million, or 41%, was primarily attributable to increased payroll and personnel-related expenses, increased
rent and related facilities expense due to the lease agreement in Alameda, California, insurance costs, professional service expense
and the inclusion of Cortigent, since the merger acquisition date of August 30, 2022, partially offset by a provision for a legal
claim of $1.7 million recorded in 2022.
Other income (expense), net: Other income (expense),
net during the year ended December 31, 2023 was $1.3 million, compared to $7.4 million during the year ended December 31, 2022.
Other income consisted of interest income of $1.5 million during the year ended December 31, 2023. Other income during the year
ended December 31, 2022 included $6.9 million related to a gain on bargain purchase from the acquisition of Second Sight and interest
Net Loss: The net loss during the year ended December
31, 2023 was $25.7 million, compared to $13.9 million during the year ended December 31, 2022. The increase in net loss of $11.8
million was primarily attributable to an increase in operating expenses of $5.7 million and the prior year gain on the bargain
purchase from the acquisition of Second Sight of $6.9 million, partially offset by increased interest income due to higher average
investments and rate increases on cash investments.
About Vivani Medical,
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 50%, including those taking
daily pills. Medication non-adherence, which contributes to more than $500 billion in annual avoidable healthcare costs and 125,000