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]

Core Insights - Several biotech and healthcare stocks experienced significant after-hours trading gains due to clinical updates, strategic deals, and regulatory milestones [1] Company Summaries - **Genenta Science S.p.A. (GNTA)**: Shares closed at $2.40, down 27.71% during regular trading, but rebounded to $2.45, up 2.08% in after-hours. The volatility was driven by a $15 million registered direct offering and a strategic collaboration announcement [2] - **EDAP TMS S.A. (EDAP)**: Closed at $1.81, down 22.58%, but rose 8.29% to $1.96 in after-hours trading. The recovery appears technical, with no new news, and is supported by upcoming investor meetings at the UBS Global Healthcare Conference [3] - **BridgeBio Pharma Inc. (BBIO)**: Ended regular trading at $64.50, up 1.48%, and climbed 6.71% to $68.83 after hours. The increase reflects anticipation for Phase 3 CALIBRATE trial results for ADH1, with topline data expected on October 29 [4] - **OrthoPediatrics Corp. (KIDS)**: Closed at $16.91, down 0.29%, but surged 6.45% to $18.00 after releasing Q3 financial results, reporting a GAAP loss per share of $(0.50) despite 12% revenue growth [5][6] - The company raised its full-year 2025 revenue guidance to $233.5 million to $234.5 million, indicating projected growth of 14% to 15% compared to the prior year [7] - **Modular Medical Inc. (MODD)**: Dipped 1.30% to $0.5392 but rallied 5.38% to $0.5682 after hours following the successful completion of its Stage 1 ISO 13485:2016 audit, a key step toward CE Mark certification [8] - **Vivani Medical Inc. (VANI)**: Rose 3.09% to $1.67 and added 3.65% to $1.7310 after closing a $15.7 million capital raise, which included a registered direct offering and private placement, indicating insider confidence [9] - **Amarin Corp. plc (AMRN)**: Slipped 1.56% to $18.94 but rebounded 5.07% to $19.90 after the FDA revised fenofibrate drug labeling, which may favor Amarin's Vascepa in the lipid management space [10]

Core Viewpoint - Vivani Medical, Inc. has successfully closed a registered direct offering and a private placement, raising approximately $15.7 million to support its ongoing research and clinical development efforts [1][2]. Group 1: Offering Details - The company completed a registered direct offering of 6,000,000 shares and a private placement of 3,703,703 shares, both priced at $1.62 per share [1]. - The gross proceeds from these transactions are approximately $15.7 million, before deducting fees and offering expenses [1]. - ThinkEquity acted as the sole placement agent for the registered direct offering [2]. Group 2: Use of Proceeds - The net proceeds from the offerings will be utilized for ongoing research and clinical development of the company's product candidates, as well as for working capital and general corporate purposes [2]. Group 3: Company Overview - Vivani Medical, Inc. is a clinical-stage biopharmaceutical company that develops miniature, ultra long-acting drug implants using its proprietary NanoPortal™ platform [5]. - The company is focused on developing GLP-1 based implants aimed at treating metabolic diseases such as obesity and type 2 diabetes [5]. - The implants are designed to enhance patient adherence to medication by addressing challenges associated with daily or weekly administration of oral and injectable medications [5].

Core Viewpoint - Vivani Medical, Inc. has announced a registered direct offering and private placement of common stock, aiming to raise approximately $15.7 million to support ongoing research and clinical development of its product candidates [1][2]. Group 1: Offering Details - The company is offering 6,000,000 shares of common stock at $1.62 per share in a registered direct offering and an additional 3,703,703 shares in a concurrent private placement, also at $1.62 per share [1]. - The gross proceeds from both offerings are expected to be around $15.7 million before deducting fees and expenses [1]. - The offerings are set to close on or about October 28, 2025, pending customary closing conditions [1]. Group 2: Use of Proceeds - The net proceeds from the offerings will be utilized for ongoing research and clinical development of the company's product candidates, as well as for working capital and general corporate purposes [2]. Group 3: Company Overview - Vivani Medical, Inc. specializes in developing miniature, ultra long-acting drug implants using its proprietary NanoPortal™ platform, targeting metabolic diseases such as obesity and type 2 diabetes [5]. - The company's implants aim to improve patient adherence to medication by providing steady drug delivery over extended periods, addressing challenges associated with daily or weekly administration of oral and injectable medications [5]. - Approximately 50% of patients experience medication non-adherence, which Vivani aims to mitigate through its innovative drug delivery solutions [5].

Core Insights - Vivani Medical, Inc. is a clinical-stage biopharmaceutical company focused on developing miniature, ultra long-acting drug implants aimed at improving medication adherence and patient tolerance [1][4]. Group 1: Company Presentation - CEO Adam Mendelsohn, Ph.D., will present at the ThinkEquity Conference on October 30, 2025, at 1:30 p.m. Eastern Time in New York [1][2]. - The presentation will be available via webcast on Vivani's corporate website [2]. Group 2: Company Overview - Vivani utilizes its proprietary NanoPortal™ platform to create biopharmaceutical implants that deliver drug molecules steadily over extended periods [4]. - The company is developing a portfolio of GLP-1 based implants targeting metabolic diseases such as obesity and type 2 diabetes [4]. - Medication non-adherence affects approximately 50% of patients, including those on daily pills, highlighting the need for innovative delivery methods [4].

Core Viewpoint - Vivani Medical, Inc. has announced a temporary withdrawal of the previously set record date for the spin-off of its subsidiary Cortigent, due to delays caused by the U.S. federal government shutdown [1][2]. Group 1: Company Overview - Vivani Medical, Inc. is a clinical-stage biopharmaceutical company focused on developing miniature, ultra long-acting drug implants [1]. - The company utilizes its proprietary NanoPortal™ platform to create biopharmaceutical implants aimed at delivering drug molecules steadily over extended periods, enhancing patient adherence and tolerance [3]. - Vivani is developing a portfolio of GLP-1 based implants targeting metabolic diseases such as obesity and type 2 diabetes [3]. Group 2: Cortigent Overview - Cortigent, a wholly-owned subsidiary of Vivani, is focused on developing brain implant devices that utilize advanced neuromodulation technology to aid patients in recovering critical body functions [2]. - The Orion Visual Cortical Prosthesis System, an investigational system by Cortigent, is designed to treat blindness from common conditions like glaucoma and diabetic retinopathy, and has received FDA Breakthrough Device designation [2]. - Cortigent's technology also aims to improve recovery of arm and hand motion in patients with paralysis due to stroke [2]. Group 3: Financial Advisory - ThinkEquity is serving as the exclusive financial advisor to Cortigent regarding the spin-off transaction [2].

Summary of Vivani Medical Conference Call Company Overview - **Company**: Vivani Medical Inc. (NasdaqCM: VANI) - **Focus**: Development of biopharmaceutical implants using the proprietary NanoPortal platform to deliver drug molecules steadily over extended periods, aiming to improve medication adherence and tolerability [2][3] Industry Insights - **Market Context**: The company is addressing the significant issue of medication non-adherence, with over 50% of patients not taking their medications as prescribed [3][27] - **GLP-1 Market**: The GLP-1 medicines have transformed obesity and diabetes treatment, with three FDA-approved injectable drugs currently available and expectations for oral versions in the future [5][6] - **Revenue Potential**: GLP-1 products generated over $14 billion in sales in 2024, with a projected 32% compound annual growth rate until the early 2030s [26] Core Technology and Product Development - **Implant Technology**: Vivani Medical is developing a unique implant that allows for long-lasting treatment with a single administration, addressing the challenges of poor medication adherence and tolerability associated with existing GLP-1 therapies [7][8][15] - **Lead Program**: The lead program focuses on a semaglutide implant, which has shown promising results in preclinical studies, including a 20% weight loss over seven months [16][30] - **Clinical Studies**: A successful first-in-human study was completed, demonstrating positive safety and tolerability, with plans to initiate further clinical development in the first half of next year [24][32] Key Challenges and Solutions - **Medication Adherence**: The implant aims to provide guaranteed adherence, eliminating missed doses and improving real-world outcomes [12][14] - **Tolerability Issues**: The technology seeks to mitigate gastrointestinal side effects commonly associated with GLP-1 medications by providing stable drug delivery [12][14] - **Cost-Effectiveness**: The implant is expected to reduce costs associated with existing injectable therapies, potentially increasing access and pricing flexibility [15] Future Applications and Market Expansion - **Broader Indications**: Beyond obesity, the semaglutide implant is being evaluated for type 2 diabetes, chronic kidney disease, and potentially Alzheimer's disease and alcohol addiction [27][30] - **Market Reception**: Patient surveys indicate a high likelihood of acceptance for a GLP-1 implant, with a comparison made to the successful contraceptive implant Nexplanon, which generated approximately $1 billion in sales [31] Leadership and Operations - **Experienced Team**: The company boasts a seasoned leadership team with extensive experience in drug-device combination products and clinical development [34] - **Manufacturing Capabilities**: Vivani Medical has a facility in Alameda, California, for GMP manufacturing to support early commercial production [35] Additional Notes - **Spin-off Announcement**: The company plans to spin off a subsidiary, Cortigent, which focuses on brain implant devices, offering shareholders a dividend of shares in this new entity [36] This summary encapsulates the key points discussed during the Vivani Medical conference call, highlighting the company's innovative approach to addressing medication adherence in chronic disease management through its unique implant technology.