UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, DC 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15 (d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended September 30, 2025 or ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from ________ to ________ Commission File Number: 001-36747 Vivani Medical, Inc. (Exact name of registrant as specified in its charter) Delaware 02-0692322 (Sta ...

Exhibit 99.1 Recent Business Highlights On October 28, 2025, Vivani closed its previously announced best efforts registered direct offering of 6,000,000 shares of its common stock at an offering price of $1.62 per share, which was the closing market price on Friday, October 26, 2025, along with the closing of a concurrent private placement of 3,703,703 shares of its common stock at the same offering price of $1.62 per share purchased by an entity affiliated with Gregg Williams, the Chairman of the Company's ...

Company plans to initiate Phase 1 clinical study of semaglutide implant for chronic weight management in the first half of 2026 and parallel investments in studies to enable rapid initiation of Phase 2 dose-ranging study, pending Phase 1 results and regulatory feedback 3Q 2025 private placement, together with October financings, generated approximately $25.7M in cash and cash commitments to support accelerated development of NPM-139 while securing financial position into 2027 ALAMEDA, Calif., Nov. 13, 2025 ...

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.