Vivani Medical Updates Business and Reports Q1 2024 Financial Results

Vivani Medical, Inc., a biopharmaceutical company listed on Nasdaq under the ticker symbol VANI, is at the forefront of developing miniaturized, long-term drug implants aimed at managing chronic conditions such as obesity, type 2 diabetes, and other persistent diseases. The company recently disclosed its financial results for Q1 2024 and provided an update on its business activities.

Adam Mendelsohn, Ph.D., CEO of Vivani, highlighted the company's strategic pivot towards prioritizing the development of GLP-1 implants for obesity and chronic weight management. Vivani has embarked on preclinical activities for its high-dose exenatide implant, NPM-115, which supports forthcoming clinical trials. Furthermore, the company is on schedule to submit an Investigational New Drug (IND) application for NPM-115 by the end of the year. Concurrently, Vivani is preparing to provide necessary Chemistry, Manufacturing, and Controls (CMC) information to the FDA related to another IND, NPM-119, within the first half of the year.

Dr. Mendelsohn emphasized the commercial potential for GLP-1 products, noting the significant market growth and the benefits that Vivani's miniature, subdermal implants could offer. These implants, intended to be administered once every six months or longer, aim to enhance medication adherence and prevent weight regain after treatment cessation.

Recent developments include the February 2024 announcement of positive preclinical data for NPM-115, demonstrating comparable weight loss results to semaglutide, the active ingredient in popular diabetes medications like Ozempic® and Wegovy®. In tests on high-fat diet-induced obese mice, NPM-115 led to approximately 20% weight loss over 28 days, matching the results from Ozempic injections. Additionally, Vivani revealed that semaglutide is the active ingredient in NPM-139, another subdermal GLP-1 implant under development, which could potentially be administered once yearly.

In March 2024, Vivani bolstered its financial position through a $15-million registered direct offering of common stock and warrants. This infusion of capital is intended to accelerate priority development programs like NPM-115 and sustain operations through the second half of 2025. Moreover, Daniel Bradbury, former CEO of Amylin Pharmaceuticals, was appointed to Vivani's Board of Directors, bringing valuable expertise in the GLP-1 receptor agonist field.

Looking ahead, Vivani anticipates filing the IND application for NPM-115 in the latter half of 2024 and commencing a first-in-human trial once regulatory clearance is obtained. The company is also focused on addressing the FDA's CMC information requests for NPM-119 within the first half of 2024.

Vivani plans to actively participate in several industry events, including the TIDES USA conference on Oligonucleotide and Peptide Therapeutics in May 2024 and the Annual BIO International Conference in June 2024. These events will provide platforms for presenting new data and engaging with potential partners and investors.

Financially, as of March 31, 2024, Vivani reported cash, cash equivalents, and restricted cash totaling $31.0 million, up from $22.0 million at the end of 2023. The increase is primarily due to the net proceeds from the recent securities offering. The company's research and development expenses for Q1 2024 were $3.7 million, slightly down from $4.0 million in the same period in 2023. General and administrative expenses also saw a minor decrease, totaling $2.5 million compared to $2.6 million in the previous year. Vivani reported a net loss of $6.0 million for Q1 2024, a slight improvement from the $6.3 million loss in Q1 2023.

In summary, Vivani Medical is making significant strides in the development of GLP-1 drug implants with promising preclinical results and a solid financial footing to support its ongoing and future projects. The company's focus on enhancing medication adherence and efficacy through innovative drug delivery systems positions it well for future growth and success.