Financial Performance - Vivani Medical reported a net loss of $26.6 million for the full year 2025, an increase of 13.2% compared to a net loss of $23.5 million in 2024[18]. - Net loss for 2025 was $26,609 thousand, compared to a net loss of $23,486 thousand in 2024, indicating a worsening of approximately 13.0%[27]. - Net loss per common share remained at $0.43 for both 2024 and 2025, indicating consistent performance in terms of loss per share[27]. Expenses - Research and development expenses for the year ended December 31, 2025, were $18.1 million, reflecting a 15% increase from $15.7 million in 2024[15]. - General and administrative expenses for the full year 2025 were $9.4 million, a 6% increase from $8.9 million in 2024[16]. - Total operating expenses increased from $24,677 thousand in 2024 to $27,556 thousand in 2025, representing an increase of about 11.5%[27]. - Research and development expenses rose from $15,745 thousand in 2024 to $18,126 thousand in 2025, an increase of about 15.1%[27]. - General and administrative expenses increased from $8,932 thousand in 2024 to $9,430 thousand in 2025, reflecting a rise of approximately 5.6%[27]. Cash and Assets - As of December 31, 2025, Vivani had cash and cash equivalents of $16.2 million, down from $18.4 million at the end of 2024[11]. - Total current assets decreased from $20,442 thousand in 2024 to $17,898 thousand in 2025, a decline of approximately 12.5%[25]. - Cash and cash equivalents decreased from $18,352 thousand in 2024 to $16,232 thousand in 2025, a decline of approximately 11.6%[25]. Liabilities and Equity - Total liabilities decreased slightly from $23,951 thousand in 2024 to $23,663 thousand in 2025, a reduction of about 1.2%[25]. - Total stockholders' equity decreased from $17,610 thousand in 2024 to $15,730 thousand in 2025, a decline of approximately 10.7%[25]. Financing and Future Plans - The company raised $41.5 million in gross proceeds through multiple financing activities in 2025 and 2026, supporting operations into mid-2027[8]. - The company plans to transition Cortigent into an independent publicly traded company, exploring both a spin-off and an IPO[20]. Clinical Studies and Product Development - The Phase 1 clinical study for NPM-139, a semaglutide implant for chronic weight management, is projected to begin in mid-2026, with results expected by the end of 2026[4]. - The LIBERATE-1 study demonstrated over 20% sham-adjusted weight loss sustained for a full year with a single administration of the semaglutide implant[2]. - Significant progress has been made in manufacturing capabilities to prepare for commercial-scale production of the semaglutide implant[4].

Product Development - Vivani Medical is developing miniature, ultra long-acting subdermal drug implants using its proprietary NanoPortal™ technology, aimed at improving medication adherence for chronic diseases [453]. - Vivani's lead program, NPM-139, a six-month GLP-1 (semaglutide) implant, demonstrated approximately 20% weight loss in preclinical studies, maintained for over six months after a single administration [456]. - The NPM-115 exenatide implant showed comparable weight loss results of approximately 20% in preclinical studies with obese mice, indicating potential for effective chronic weight management [459]. - The FDA lifted the clinical hold on NPM-119, allowing for the initiation of a first-in-human study for the treatment of type 2 diabetes [465]. - Vivani plans to initiate a Phase 1 clinical study for NPM-139 in the first half of 2026, pending regulatory clearance [472]. - The LIBERATE-1 clinical trial for NPM-115 demonstrated a positive safety and tolerability profile, with top-line data released in August 2025 [463]. Financial Performance - The company has experienced recurring operating losses and negative cash flows since inception, with expectations to continue this trend for the foreseeable future [492]. - Net loss for the year ended December 31, 2025 was $26.6 million, an increase of $3.1 million compared to a net loss of $23.5 million in 2024 [512]. - Cash used in operating activities during 2025 was $24.3 million, compared to $20.8 million in 2024 [514][515]. - Net cash used in investing activities was $1.2 million in 2025, up from $0.6 million in 2024 [516]. - Financing activities provided $23.3 million of cash in 2025, primarily from a registered direct offering and securities purchase agreements [516]. Capital and Funding - On March 1, 2024, the company raised $15 million through a registered direct offering of 3,947,368 shares at $3.80 per share, resulting in net proceeds of $13.7 million after issuance costs [478]. - On April 22, 2024, the company entered into an Open Market Sale Agreement to offer up to $75 million in common stock through Jefferies LLC [479]. - In 2025, the company issued 7,480,158 shares under private sales transactions, generating gross proceeds of $8.6 million, with an expected additional $12.6 million from remaining shares in 2026 [486]. - On October 26, 2025, the company completed a private placement of 3,703,703 shares at $1.62 per share, resulting in gross proceeds of $6 million [487]. - Concurrently, the company raised approximately $9.7 million from a registered direct offering of 6,000,000 shares, netting $8.7 million after fees [489]. - The company received $35,000 in grants during the twelve months ended December 31, 2025, compared to $200,000 in the previous year, reflecting a decrease in grant funding [491]. Research and Development - Research and development expense for the year ended December 31, 2025 was $18.1 million, an increase of $2.4 million or 15% compared to $15.7 million in 2024 [509]. - The company expects research and development expenses to increase in the future as it pursues enhancements of existing products and develops new technologies [513]. Strategic Initiatives - Vivani is exploring strategic options for its neurostimulation technology through its subsidiary Cortigent, including a potential spin-off or IPO [474]. - If Cortigent successfully completes an IPO, it will repay Vivani $1.5 million from the proceeds and issue a promissory note for $2 million [475]. - The strategic goal of the potential spin-off or IPO is to create two focused companies to enhance value in their respective therapeutic areas [476]. - On April 12, 2025, Okava Pharmaceuticals expanded its collaboration with Vivani to include the development of a long-acting GLP-1 therapy for dogs, adding $5 million in regulatory milestone payments for obesity treatment [477]. Operational Outlook - The company estimates that available cash will meet its obligations into mid-2027, but additional capital will be necessary for ongoing operations [493]. - The company is subject to risks associated with developing pharmaceutical products, including significant increases in operating expenses as clinical trials and research activities expand [496]. - General and administrative expense for the year ended December 31, 2025 was $9.4 million, up $0.5 million or 6% from $8.9 million in 2024 [510]. - The company has not declared or paid dividends and has no plans to do so in the foreseeable future [507]. - As of December 31, 2025, the company had no off-balance sheet arrangements [518]. - The majority of operating expenses were denominated in U.S. dollars, with no foreign currency forward contracts currently in place [520].

Core Insights - Vivani Medical, Inc. has successfully completed its first-in-human study LIBERATE-1 for the NPM-139 semaglutide implant, which is aimed at chronic weight management, with results expected by the end of 2026 [1][4][16] - The company has demonstrated over 20% sham-adjusted weight loss sustained for a full year with a single preclinical administration of the semaglutide implant [1][4][5] - Vivani's financial position is solid, with $41.5 million raised in gross proceeds from various financings, expected to support operations into mid-2027 [2][8] Company Developments - The company is advancing its NPM-139 semaglutide implant based on positive results from LIBERATE-1 and preclinical studies, with plans to initiate a Phase 1 clinical study in mid-2026 [5][6] - Vivani's CEO highlighted the unique features of their GLP-1 implant candidates, including the potential for annual dosing and the ability to quickly cease treatment if necessary [4] - Significant progress has been made in manufacturing capabilities, preparing for commercial-scale production [4] Financial Performance - As of December 31, 2025, Vivani reported cash and cash equivalents of $16.2 million, down from $18.4 million in 2024, primarily due to a net loss of $26.6 million [11][19] - Research and development expenses for Q4 2025 were $4.6 million, a 7% increase from $4.3 million in Q4 2024, attributed to staffing reductions and decreased use of outside services [12] - The net loss for the full year 2025 was $26.6 million, compared to $23.5 million in 2024, reflecting increased clinical trial and development expenses [19] Upcoming Milestones - The company anticipates the initiation of the Phase 1 feasibility study for NPM-139 in mid-2026, with data potentially available by the end of the year [4][6][16] - Plans are in place for a Phase 2 clinical study of NPM-139, pending results from the Phase 1 study and regulatory feedback [6]

Core Insights - Cortigent is a leading developer of brain implant devices utilizing precision neurostimulation technology, and it is the only company with FDA approval for a device providing artificial vision for the profoundly blind [1][7] - The Orion Visual Cortical Prosthesis System, developed by Cortigent, aims to deliver meaningful visual perception to blind individuals and has shown promising results in a 6-year Early Feasibility Study [1][3] - The company is also working on a new medical device to enhance recovery of arm and hand motion in patients with paralysis due to stroke [1][7] Study Results - The Early Feasibility Study involved six subjects implanted between January 2018 and January 2019, concluding in March 2025 [6] - All subjects demonstrated improvement in visual function tests with the Orion system activated, achieving positive or mild positive scores on the Functional Low-vision Observer Rated Assessment (FLORA) [6] - The study reported a loss of functionality in fewer than 4% of electrodes, with only one serious adverse event (a seizure) occurring early in the study [6] Future Plans - Cortigent plans to conduct a larger pivotal clinical trial to seek marketing approval for the Orion system, pending discussions with the U.S. Food and Drug Administration [3][5] - The company aims to advance the Orion cortical stimulation system in 2026, collaborating with leading experts and regulatory bodies [5] Technology Overview - The Orion system features a wirelessly powered implantable pulse generator connected to an array of 60 micro-electrodes for implantation on the visual cortex of blind patients [2] - A small processing unit worn on the belt converts real-time video from specialized glasses into wireless commands to stimulate neurons, creating visual perception through phosphenes [2] Company Background - Cortigent is a wholly-owned subsidiary of Vivani Medical, Inc., which is focused on developing advanced medical devices through its proprietary neurostimulation technology platform [1][7] - The Orion system has received FDA Breakthrough Device designation and is protected by an extensive intellectual property estate [7]

Core Insights - Cortigent is a leading developer of brain interface devices utilizing precision neurostimulation technology, with a focus on treating blindness and improving motor recovery in stroke patients [1][3] Group 1: Orion Cortical Stimulation System - The Orion cortical stimulation system is designed to treat common forms of blindness and has successfully completed a six-year Early Feasibility Study, showing promising safety and efficacy results [1][3] - The investigational Orion system features a compact design with one of the smallest and highest-count micro-electrode neurostimulators, implanted on the visual cortex to deliver controlled electrical charges that create visual perception [2][3] - The system includes an implantable pulse generator with 60 outputs and a 60-electrode cortical surface array, demonstrating safety and functionality for over 17 years in previous devices [2] Group 2: Company Background and Technology - Cortigent, a subsidiary of Vivani Medical, is focused on developing brain implant devices to restore critical body functions, leveraging a patent-protected precision neurostimulation technology platform [3] - The company’s predecessor, Second Sight Medical Products, previously marketed the Argus II, the first FDA-approved device for treating a rare form of blindness, which has helped hundreds of patients achieve meaningful visual perception [3] - Cortigent is also applying its technology to enhance recovery of arm and hand motion in patients with paralysis due to stroke [3] Group 3: Upcoming Presentation - Cortigent will present an award-winning poster on the Orion Visual Cortical Prosthesis System at the North American Neuromodulation Society annual meeting in Las Vegas on January 23, 2026 [1]

Product Development - Vivani Medical is developing a portfolio of miniature, ultra long-acting subdermal drug implants using its proprietary NanoPortal™ technology, aimed at improving medication adherence and drug tolerability for chronic diseases [128]. - The lead program, NPM-139, a six-month GLP-1 (semaglutide) implant, demonstrated approximately 20% weight loss in preclinical studies, maintained for over seven months [131]. - NPM-115, an exenatide implant, showed comparable weight loss results of approximately 20% in obese mice, indicating potential for similar outcomes in human trials [135]. - The FDA lifted the clinical hold on NPM-119, allowing the initiation of a first-in-human study for the exenatide implant in type 2 diabetes patients [140]. - Vivani plans to initiate a Phase 1 clinical study for NPM-139 in the first half of 2026, pending regulatory clearance [146]. - The company established Vivani Medical Australia Pty Ltd. to support studies of its product candidates in the fourth quarter of 2023 [134]. - The NPM-139 program is expected to provide annual dosing potential, enhancing its commercial viability [145]. - Vivani's GLP-1 implant technology aims to deliver therapeutic drug levels for up to six months or longer, addressing the issue of medication non-adherence [130]. Financial Performance - Vivani's cash, cash equivalents, and restricted cash decreased by $15.7 million from $19.7 million as of December 31, 2024, to $4.0 million as of September 30, 2025 [164]. - Working capital decreased by $17.1 million from $14.5 million as of December 31, 2024, to negative $2.7 million as of September 30, 2025 [164]. - Research and development expense for the three months ended September 30, 2025, was $4.5 million, an increase of $0.3 million or 8% compared to the same period in 2024 [168]. - General and administrative expense for the three months ended September 30, 2025, was $2.2 million, an increase of $0.1 million or 5% compared to the same period in 2024 [169]. - Research and development expense for the nine months ended September 30, 2025, was $13.5 million, an increase of $2.1 million or 18% compared to the same period in 2024 [171]. - General and administrative expense for the nine months ended September 30, 2025, was $7.3 million, an increase of $0.5 million or 7% compared to the same period in 2024 [172]. - The company incurred a net loss of $20.0 million during the nine months ended September 30, 2025 [174]. - Other income, net during the three months ended September 30, 2025, was $0.2 million, a decrease of $0.1 million compared to the same period in 2024 [170]. - The company expects to continue incurring operating losses and negative operating cash flows for the foreseeable future [159]. - The company estimates that currently available cash will provide sufficient funds to meet its planned obligations into 2027 [160]. - For the nine months ended September 30, 2024, the company reported a net loss of $17.4 million, with cash used in operating activities amounting to $15.0 million [175]. - Cash used for investing activities during the nine months ended September 30, 2025 and 2024 was $0.9 million and $0.3 million respectively, primarily for the purchase of property and equipment [176]. - Cash provided by financing activities was $2.7 million during the nine months ended September 30, 2025, mainly from the issuance of common stocks in private financing agreements [177]. - Cash provided by financing activities was $14.2 million during the nine months ended September 30, 2024, primarily due to a securities purchase agreement with an institutional investor [178]. - As of September 30, 2025, the company had no off-balance sheet arrangements [179]. - The company invests excess cash in money market funds and short-term certificates of deposits to maintain liquidity and safety of principal [180]. - The majority of the company's operating expenses are denominated in U.S. dollars, with no current foreign currency hedging strategies in place [181]. Corporate Structure - Vivani's merger with Second Sight Medical Products and Nano Precision Medical was completed on August 30, 2022, creating a focused biopharmaceutical entity [132]. - The company is pursuing a spin-off of its neurostimulation assets into Cortigent, with a Form 10 registration statement filed with the SEC on May 29, 2025 [149].

Financial Performance - The company reported a net loss of $6.5 million for Q3 2025, compared to a net loss of $6.0 million in Q3 2024, reflecting an increase in operating expenses[13] - Vivani's accumulated deficit increased to $141.9 million as of September 30, 2025, compared to $121.9 million at the end of 2024[19] - The net loss for Q3 2025 was $6,530 million, compared to a net loss of $6,041 million in Q3 2024, indicating an 8.1% increase in losses[21] - The net loss per common share for Q3 2025 remained at $0.11, consistent with Q3 2024[21] - The net loss for the nine months ended September 30, 2025, was $19,976 million, up from $17,436 million in the prior year, reflecting a 14.0% increase[21] - The company reported a total net loss of $19,976 million for the nine months ended September 30, 2025, compared to $17,436 million for the same period in 2024, indicating a worsening financial position[21] Cash and Assets - As of September 30, 2025, Vivani had cash and cash equivalents totaling $2.6 million, a decrease of $15.7 million from $18.4 million as of December 31, 2024[9] - Vivani's total assets decreased to $25.0 million as of September 30, 2025, down from $41.6 million as of December 31, 2024[19] Operating Expenses - Research and development expenses for Q3 2025 were $4.5 million, up from $4.2 million in Q3 2024, indicating increased investment in R&D[10] - General and administrative expenses for Q3 2025 were $2,206 million, compared to $2,106 million in Q3 2024, reflecting a 4.8% increase[21] - Total operating expenses for Q3 2025 reached $6,725 million, an increase of 6.6% from $6,309 million in Q3 2024[21] - For the nine months ended September 30, 2025, total operating expenses were $20,746 million, compared to $18,217 million for the same period in 2024, a 13.9% increase[21] Funding and Development - The company completed a private placement generating approximately $25.7 million in cash and commitments to support the accelerated development of NPM-139[1] - Gross proceeds from a recent offering of 6,000,000 shares were approximately $15.7 million, before fees and expenses[3] - Vivani Medical plans to initiate a Phase 1 clinical study of the semaglutide implant for chronic weight management in the first half of 2026, pending regulatory feedback[1] - The company is developing a portfolio of GLP-1 based implants aimed at improving medication adherence and tolerability for obesity and type 2 diabetes[14] Other Income and Spin-off - Other income for Q3 2025 was $195 million, down from $268 million in Q3 2024, a decrease of 27.2%[21] - The company anticipates completing the spin-off of its subsidiary Cortigent shortly after the SEC resumes operations[8]

Core Insights - Vivani Medical is progressing towards initiating a Phase 1 clinical study of its semaglutide implant for chronic weight management in the first half of 2026, with plans for a Phase 2 study contingent on Phase 1 results and regulatory feedback [1][5][9] - The company reported a cash position of approximately $4.0 million as of September 30, 2025, down from $19.7 million at the end of 2024, primarily due to a net loss of $20.0 million [10][14] - Vivani's proprietary NanoPortal™ technology differentiates its ultra long-acting miniature GLP-1 implants from over 50 other candidates in the market, addressing issues of medication adherence and tolerability [2][15] Financial Highlights - The company generated approximately $25.7 million in cash and cash commitments from a private placement and October financings to support the accelerated development of NPM-139 [1][3] - Research and development expenses for Q3 2025 were $4.5 million, an increase from $4.2 million in Q3 2024, reflecting ongoing investment in product development [11] - The net loss for Q3 2025 was $6.5 million, compared to $6.0 million in Q3 2024, attributed to increased operating expenses [14][23] Business Developments - Vivani successfully completed the LIBERATE-1 clinical study, marking a significant milestone for its NanoPortal™ technology [2][8] - The company temporarily withdrew the record date for the planned spin-off of its subsidiary, Cortigent, due to the U.S. federal government shutdown, with plans to establish a new date once operations resume [4][9] - The company is also developing NPM-133, a semaglutide-based implant for the treatment of type 2 diabetes, alongside NPM-139 for weight management [2][15]

Summary of Vivani Medical Conference Call Company Overview - **Company**: Vivani Medical (NasdaqCM: VANI) - **Focus**: Addressing medication adherence in chronic disease treatments, particularly in the GLP-1 receptor agonists space [2][12] Industry Context - **Chronic Disease Treatment**: Over 50% of patients do not adhere to their medication regimens, leading to an estimated $500 billion in avoidable costs to the U.S. healthcare system annually [2] - **GLP-1 Receptor Agonists**: This class of drugs has shown significant effectiveness in treating obesity and related conditions, with three approved injectables: Wegovy, Zepbound, and Saxenda [3] Core Product and Technology - **Product**: A six-month semaglutide implant aimed at improving patient outcomes through better adherence, tolerability, and convenience [12] - **Technology**: NanoPortal drug delivery system, allowing for sustained release of medication without the complications of traditional delivery methods [18] Key Differentiators - **Adherence**: The implant aims to reduce missed doses, which is a significant issue with current GLP-1 therapies, where over 50% of patients miss doses [9][21] - **Tolerability**: The implant is designed to minimize gastrointestinal side effects commonly associated with GLP-1 drugs by stabilizing drug levels [7][9] - **Cost-Effectiveness**: The implant could potentially lower manufacturing costs and improve pricing flexibility compared to current injectable therapies [11] Clinical Development and Market Potential - **Clinical Trials**: Anticipated initiation of clinical development for the semaglutide implant in the first half of next year [13][29] - **Market Growth**: GLP-1 products are expected to see a 32% compounded annual growth rate, indicating strong market potential [21] - **Patient Persistence**: Current persistence rates for semaglutide are low, with only 40% remaining on treatment after one year and 25% after two years [22][23] Competitive Landscape - **Market Activity**: Over 50 companies are developing new GLP-1 injectables, but many are likely to fail due to lack of differentiation [4] - **Unique Offering**: Vivani Medical's implant is the only GLP-1 implant in development for obesity, with a unique dosing schedule of once or twice a year [33] Future Directions - **Expansion Plans**: Potential to explore the use of the implant in other chronic diseases and patient populations, including type 2 diabetes and psychiatric conditions [12][14] - **Animal Health**: Collaboration with a small animal health company to develop similar implants for pets, tapping into a growing market [14] Conclusion - Vivani Medical is positioned to address significant unmet needs in chronic disease management through its innovative implant technology, targeting improved medication adherence and patient outcomes in the growing GLP-1 market [33]

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