Vivani Medical Reports Progress and Financial Outcomes for 2024
Vivani Medical Achieves Key Milestones in 2024
Successful initial administration and full enrollment in the first-in-human LIBERATE-1™ study of NPM-115
(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, supporting further development of NPM-139 and NPM-115 programs in chronic weight management.
ALAMEDA, Calif. — Vivani Medical, Inc. (Nasdaq: VANI) continues its commitment to transforming chronic weight management through innovative drug delivery solutions. The company recently reported financial results for the fourth quarter and full year while providing an update on its business operations.
“In the past year, we have taken significant strides in positioning Vivani as a clinical-stage biotechnology company,” explained Dr. Adam Mendelsohn, CEO of Vivani. “The progress we’ve made in our NPM-115 and NPM-139 programs represents our ongoing dedication to improving treatment options for those facing obesity and weight management challenges. Our LIBERATE-1 study has achieved every milestone effectively, setting the stage for promising results by mid-2025.”
The LIBERATE-1 clinical study marks a crucial step for Vivani, as it focuses on delivering the effectiveness of NPM-115 (exenatide implant) through successful implantation procedures. Each implantation has yielded positive outcomes so far, fueling the company’s anticipation for revealing pivotal data in the near future.
Investment and expanded capabilities play pivotal roles in Vivani’s strategy. In March, the company secured $8.25 million in equity financing, which bolsters its financial foundation through the second quarter of 2026. This funding acts as a catalyst in the ongoing development of its core programs, ensuring a solid trajectory towards clinical trials.
The recent success of preclinical trials on NPM-139 further highlights Vivani’s commitment to addressing the complexities of weight loss. With results indicating effectiveness comparable to traditional injections, NPM-139 is on track to begin clinical phase development shortly.
Highlights of Recent Developments
Several notable events have punctuated Vivani Medical's recent trajectory:
- On March 27, funding of $8.25 million was announced, providing a strong financial baseline suitable for accelerating priority developments like NPM-115 and NPM-139.
- Promising preclinical data unveiled for NPM-139 demonstrates its potential for effective chronic weight management, emphasizing Vivani's innovative NanoPortal™ implant technology.
- Vivani successfully administered its first GLP-1 (exenatide) implant during the LIBERATE-1 clinical trial, effectively enrolling subjects within a four-week timeframe.
- Plans for a strategic spin-off of Cortigent, Inc., Vivani's wholly-owned subsidiary focusing on neurostimulation technology, are underway, where both entities will concentrate on their specific areas of expertise
Financial Overview by the Numbers
As of the end of the fiscal year 2024, Vivani's cash reserves totaled $19.7 million, a decrease primarily due to operational losses and previous investments in essential equipment. The overall corporation has managed research and development expenses amounting to $4.3 million in Q4, and the yearly expenses stand at $15.7 million.
Future Milestones to Watch
Vivani aims to communicate key milestones pertaining to the LIBERATE-1 trial while advancing the NPM-139 program toward regulatory applications and clinical trial initiation. A careful reevaluation of their corporate strategies may lead to a successful transition for Cortigent into an independent entity.
Conclusion
Looking ahead, Vivani Medical is strategically focused on the future of its innovative drug implants designed to provide effective chronic weight management solutions. Together, the journey of NPM-115, NPM-139, and others continues to solidify Vivani’s intent to make a significant mark in the healthcare landscape.
Frequently Asked Questions
What is Vivani Medical’s primary focus?
Vivani Medical specializes in developing miniaturized drug implants aimed at offering long-term solutions for chronic weight management.
What recent financial move did Vivani Medical make?
The company secured $8.25 million in equity financing to support its ongoing development projects, ensuring its operational needs through mid-2026.
When can we expect results from the LIBERATE-1 study?
Top-line data from the LIBERATE-1 study is anticipated in mid-2025.
How does NPM-139 compare to other treatments?
NPM-139 has demonstrated preclinical weight loss data comparable to traditional semaglutide injections, highlighting its effectiveness in chronic weight management.
What are Vivani Medical’s future plans?
Vivani aims to advance its clinical programs, including NPM-115 and NPM-139 while pursuing regulatory approvals and overseeing the strategic spin-off of Cortigent.
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