Full Press Release Details
Vivani Medical Provides Business Update and
Reports Second Quarter 2024 Financial Results
of the NPM-115 clinical program expected in the fourth quarter of 2024 with a first-in-human
study evaluating a miniature, subdermal GLP-1 (exenatide) implant in obese or
FDA provided clearance of the
Investigational New Drug Application for NPM-119, providing further confidence to
advance the Company's emerging portfolio of GLP-1 implants into clinical phase development
Solid financial position supports
operations into the second half of 2025 and potential delivery of key portfolio
Alameda, CA -- (BUSINESS WIRE) - August 13, 2024 -
Vivani Medical, Inc. (Nasdaq: VANI) ("Vivani" or the "Company"), a biopharmaceutical
company developing miniaturized, long-acting drug implants, today reported
financial results for the second quarter ended June 30, 2024, and provided a
Chief Executive Officer Adam Mendelsohn, Ph.D., stated, "During the second quarter
we achieved significant progress toward advancing the development of our proprietary,
GLP-1 implants for obesity and chronic weight management, and anticipate the
initiation of our first-in-human clinical study in the fourth quarter of this
year. After successfully addressing the FDA's requests for additional Chemistry,
Manufacturing and Controls information and securing clearance on our NPM-119 Investigational
New Drug Application in the first half of this year, Vivani is now on the cusp
of transitioning to a clinical-stage development phase biotechnology company, now
in position to initiate clinical testing in the fourth quarter of this year."
Mendelsohn added, "Our highly differentiated portfolio of miniature, ultra long-acting
GLP-1 implants have the potential to directly address medication non-adherence and
tolerability, two significant barriers to achieving optimal therapy for chronic
weight management and other chronic diseases. An alarmingly high proportion of chronic
disease patients, approximately 50%, do not take their medicine as prescribed
in the real world, a statistic which holds for both daily orals as well as
weekly injectables. In addition, a recent study has shown that 64% of patients
taking the popular GLP-1 therapy Wegovy (semaglutide for weight management)
discontinue therapy within the first year, a number which increases to 76% by
year two. Importantly, GLP-1 therapy discontinuation is associated with a quick
reversal of the GLP-1 health benefits for most patients. Vivani's pipeline offers
the potential to significantly improve the adherence and persistence challenges
these patients currently face."
May 2024, Vivani and development partner Okava Pharmaceuticals Inc. announced publication
of positive weight loss data supporting the potential veterinary use of
OKV-119, a miniature, long-term GLP-1 implant under development for the treatment
of pre-diabetes, diabetes and obesity in companion cats. Data published in BMC
Veterinary Research provided further evidence that Vivani's NanoPortal
implant technology holds promise in reducing obesity in cats where an estimated
40% of the domestic cat population needs help managing their weight.
June 2024, the Company announced that the U.S. Food and Drug Administration ("FDA")
cleared the Investigational New Drug Application ("IND") for NPM-119, a
miniature, six-month, subdermal GLP-1 implant designed to address medication
non-adherence and potentially improve tolerability in patients with type 2
diabetes. The proposed first-in-human clinical study was designed to evaluate
the safety, tolerability and pharmacokinetic profile of the exenatide implant
versus marketed exenatide injectable, Bydureon BCise .
In July 2024, Vivani
provided an update on the clinical development plans for the miniature, long-acting
GLP-1 obesity implant program for NPM-115. In support of the recent strategic
shift to prioritize the development of its obesity and chronic weight
management portfolio, the Company announced revised plans to evaluate its GLP-1
implant as part of the NPM-115 program in patients who are obese or overweight
in the company's first-in-human study, LIBERATE-1. This study will enroll
patients who will be titrated on weekly semaglutide (Wegovy ) for eight weeks before
subsequently being randomized to receive a single exenatide implant, weekly exenatide
injections (Bydureon BCise) or weekly semaglutide injections for a nine-week
treatment duration. The Company expects the study to be initiated in the fourth
quarter of 2024 in Australia, pending regulatory approval, with data from the
study anticipated in 2025.
Upcoming Anticipated Milestones
Second Quarter 2024 Financial Results
Cash balance: As of June 30, 2024, Vivani had cash, cash equivalents and restricted cash totaling $26.3 million, compared to $31.0 million as of March 31, 2024. The decrease of $4.7 million is attributed to a net loss of $5.4 million, partially offset by $0.6 million in non-cash items for depreciation and amortization of property and equipment, stock-based compensation and lease expense, and a net cash of $0.1 million provided by financing activities.
Research and development expense: Research and development expense during the three months ended June 30, 2024 was $3.5 million, compared to $3.9 million during the three months ended June 30, 2023. The decrease of $0.4 million, or 9%, was primarily attributable to staffing reduction and reduced use of outside services.
General and administrative expense: General and administrative expense during the three months ended June 30, 2024 was $2.2 million, compared to $3.1 million during the three months ended June 30, 2023. The decrease of $1.0 million, or 31%, was attributable to staffing reduction along with reduced outside legal and other professional services.
Other income, net: Other income, net during the three months ended June 30, 2024 was $0.3 million, compared to $0.5 million during the three months ended June 30, 2023. The change was not significant.
Net Loss: The net loss during the three months ended June 30, 2024 was $5.3 million, compared to $6.5 million during the three months ended June 30, 2023. The decrease in net loss of $1.2 million was primarily attributable to a decrease in operating expenses of $1.3 million.
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Vivani Medical, Inc.
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 tolerance to
their medication. Vivani's lead program, NPM-115, is a miniature, six-month, subdermal,
GLP-1 (exenatide) implant under development for the treatment of chronic weight
management in obese or overweight patients. Vivani's emerging pipeline also includes
NPM-139 (semaglutide implant) which is also under development for chronic
weight management in obese and overweight patients. NPM-139 has the added
potential benefit of once-yearly administration. NPM-119 refers to the Company's
six-month, subdermal exenatide implant under development for the treatment of
type 2 diabetes. Both NPM-115 and NPM-119 are exenatide based products with a
higher-dose associated with NPM-115 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 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 obese or overweight patients, and
patients taking type 2 diabetes or other chronic disease treatments face
significant challenges in achieving positive real-world effectiveness. While
the current GLP-1 landscape includes over 100 new molecular entities under
clinical stage development, Vivani remains confident that its highly
differentiated portfolio of miniature long-acting GLP-1 implants have the
potential to provide an attractive therapeutic option for patients, prescribers
About Cortigent, Inc.