Financial Performance - Research and development expenses for the years ended December 31, 2025, and 2024 were approximately $18.3 million and $15.1 million, respectively, indicating a year-over-year increase of 15.5%[151]. - The company may face increased competition that could lead to price reductions and revenue shortfalls, impacting its financial condition and operating results[168]. - Legislative changes, such as the Budget Control Act of 2011, have reduced Medicare payments to providers, which may adversely affect revenue and commercial prospects[208]. - The overall escalating cost of medical products has led to increased pressures on the healthcare industry to reduce costs, impacting demand for products[204]. Supply Chain Management - The company has established long-term relationships with key suppliers, including Largan for lens modules (over 17 years), Toshiba for CMOS image sensors (over 11 years), and Moai/Speedbridge for ASICs (over 6 years), ensuring favorable terms and reasonable lead times[152]. - The company is actively planning mitigation measures to address supply chain risks, including qualifying backup suppliers and building reserve supplies of critical components[158]. - The company has entered into multiple memorandums of understanding and agreements with suppliers to secure critical components for its products, ensuring a stable supply chain[153][155][156]. Product Development and Innovation - CapsoCam Plus captures a full 360° panoramic video, providing superior diagnostic yield compared to competitor systems that offer limited views and require wired data recorders[162]. - CapsoCam Colon, once FDA cleared, is expected to outperform existing colorectal cancer detection methods, which suffer from poor sensitivity and high costs, with colonoscopy having only a 74% detection rate for cancer[164]. - The CapsoCloud platform allows providers to remotely access data and stream in vivo videos, enhancing workflow efficiency and patient data management[166]. - The company has developed a comprehensive intellectual property portfolio related to its capsule camera products, including over 140 issued patents worldwide as of December 31, 2025[220]. - The company is focusing on enhancing image quality with patents for image enhancement methods for dark areas of capsule images, with Patent No. 8150123 expiring on September 3, 2030[222]. - The company is actively pursuing advancements in endoscopic imaging, with multiple patents related to structured light and physiological feature size measurement, all expiring in 2035[223]. Regulatory Compliance - The FDA regulates the company's products as medical devices, requiring either 510(k) clearance or PMA approval for commercial distribution in the U.S.[171]. - The FDA's 510(k) clearance process allows devices to be marketed if deemed substantially equivalent to existing devices, while non-equivalent devices require a more rigorous PMA process[176]. - Clinical trials for medical devices must comply with FDA regulations, and significant risk devices require an IDE application before human trials can commence[181]. - Post-market regulations include stringent quality management system requirements and mandatory reporting of device-related adverse events to the FDA[186]. - Manufacturers are subject to periodic inspections by the FDA, and non-compliance with QMSR requirements can lead to production shutdowns or product recalls[187]. - The FDA has broad enforcement powers, including the ability to impose fines, withdraw approvals, or initiate criminal prosecutions for regulatory violations[188]. Competition and Market Landscape - Competitors in the market include well-established companies like Medtronic, which have significant resources and brand recognition, posing challenges for market share[161]. - Future healthcare reform measures could limit government payments for healthcare products and services, resulting in reduced demand and pricing pressure[209]. Employee Relations - As of December 31, 2025, the company had approximately 99 full-time employees, with no employees represented by a labor union[228]. - The company maintains a good relationship with its employees and focuses on recruiting, retaining, and incentivizing talent[229]. Legal and Corporate Governance - The company is not currently involved in any litigation or legal proceedings that are likely to have a material adverse effect on its business[230]. - The corporate headquarters is located at 18805 Cox Avenue, Suite 250, Saratoga, California 95070[231]. - The company provides access to its Annual Report, Quarterly Reports, and Current Reports on its website, free of charge[232]. - The SEC maintains a website that contains reports and information filed by the company electronically[232]. - The company encourages investors and the media to follow its disclosure channels for material information[233]. - The company is classified as a smaller reporting company and is not required to provide certain market risk disclosures[570].

Financial Performance and Funding - The company has not yet generated any revenue from sales of a commercial product and does not have any products approved for sale[25]. - In October 2025, the company entered into a collaboration agreement with Chugai Pharmaceutical, receiving a $10.0 million upfront payment and potential milestones totaling up to $175.0 million[27]. - The company sold approximately 42.6 million shares of Class A common stock and warrants for a total gross proceeds of approximately $60.3 million in October 2025[29]. - The company has received a total of $1.2 million under the Chugai Research Agreement for evaluation services of certain compounds[137]. Product Development and Clinical Trials - The company initiated a Phase 1 clinical trial for RT-114, a GLP-1/GLP-2 dual agonist for obesity, in December 2025[44]. - RT-114 demonstrated a relative bioavailability of 111% compared to subcutaneously administered PG-102 in preclinical studies[39]. - In February 2025, preclinical studies showed successful oral delivery of semaglutide via the RaniPill HC, with a relative bioavailability of 107% compared to subcutaneous administration[51][53]. - The study demonstrated comparable weight loss and decreased food intake in both oral and subcutaneous groups, indicating a pharmacodynamic effect[53]. - RT-105, an oral formulation of adalimumab, has a mean bioavailability of 49%, compared to 46% for subcutaneous injection[62]. - A Phase 1 study of RT-111 showed high bioavailability of 84% for the 0.5 mg dose relative to subcutaneous STELARA, with no serious adverse events reported[68][72]. - The Phase 1 study of RT-111 involved 55 participants, with no participants reporting difficulty swallowing the capsule[70]. - The company has tested over 350 RaniPill HC devices in vivo, including a clinical trial initiated in December 2025 for a GLP-1/GLP-2 dual agonist for obesity treatment[103]. - A recent study showed the RaniPill HC achieved a 100% oral delivery success rate for antibodies adalimumab and dupilumab in canine models[108]. - The company conducts extensive preclinical and clinical development for each product candidate, including laboratory tests and human clinical trials, which require FDA and IRB approval[168]. - Human clinical trials are typically conducted in three phases, with Phase 1 involving 20 to 80 subjects, Phase 2 involving several hundred subjects, and Phase 3 involving several hundred to several thousand subjects[177]. Market Potential and Strategy - The global market for anti-obesity treatments is estimated to reach $100 billion by 2030, with over 100 million adults in the U.S. classified as obese[37]. - The global biologics market was valued at $511.0 billion in 2024 and is projected to reach $1.4 trillion by 2033[82]. - The company aims to disrupt the injectable biologics market by developing oral biologics therapies, targeting chronic disease patients who currently rely on injections[86]. - The key markets for the company's products, once approved, will be in the United States, Europe, and Asia[144]. Manufacturing and Technology - The RaniPill capsule technology is designed to deliver a wide variety of drug substances, including antibodies and peptides, with high bioavailability[23]. - The company has invested in automated manufacturing production lines for the RaniPill capsule, which will result in significant future capital outlays[26]. - The RaniPill capsule is designed to deliver drug payloads up to 200µL with high bioavailability, and the RaniPill GO can deliver up to a 3 mg dose in microtablet form[89]. - The RaniPill capsule's proprietary coating allows it to withstand stomach acid and deploy in the small intestine, ensuring high bioavailability[95]. - The company plans to expand in-house manufacturing and optimize processes through automation, considering third-party contract manufacturers for commercial scale[91]. - The manufacturing process for RaniPill capsules involves a series of integrated and optimized steps to ensure high reliability[140]. - The company is pursuing a vertically integrated manufacturing strategy for RaniPill capsules, which allows for rapid product iteration and control over product quality[139]. Regulatory and Compliance - The company is navigating regulatory pathways for product approval, adhering to FDA regulations for biologic products[117]. - The company expects most product candidates to follow the BLA path for regulatory approval, leveraging FDA's prior conclusions of safety, purity, and potency for already-approved products[122][123]. - The company completed a pre-IND meeting with the FDA regarding RT-102, determining that a 505(b)(2) pathway is suitable for its development in the U.S.[124]. - The company must navigate various preclinical, clinical, and commercial approval requirements from regulatory authorities to obtain marketing approval for its product candidates[166]. - The FDA must grant authorization for clinical trials through an IND or IDE application, which becomes effective 30 days after receipt unless safety concerns arise[179]. - The NDA or BLA submission must include proof of safety and efficacy, and the FDA has ten months for standard review or six months for priority review after acceptance for filing[186]. - The FDA may require post-marketing clinical trials as a condition of approval for products receiving accelerated approval[190]. - Regulatory agencies require extensive monitoring and auditing of clinical activities, and progress reports must be submitted at least annually to the FDA[174]. - The FDA conducts pre-approval inspections of manufacturing facilities to ensure compliance with cGMP requirements before approving an NDA or BLA[187]. - The company must adhere to FDA regulations governing investigational product labeling, informed consent, and human subject protections throughout the clinical trial process[181]. - The FDA imposes ongoing regulations on products post-approval, including cGMP compliance and user fee requirements[192]. - Non-compliance with FDA regulations can lead to severe consequences, including product recalls and fines[193]. Strategic Partnerships and Collaborations - The company intends to enter into licenses and collaborations with biopharmaceutical companies to develop and commercialize oral versions of their biologics and drugs[34]. - The company has entered into a License and Supply Agreement with Celltrion for the development of RT-105 and RT-111, enhancing its product pipeline[61][67]. - Under the ProGen Collaboration Agreement, development costs and operating profits from the commercialization of RT-114 will be equally shared between the company and ProGen[132]. - The company is actively pursuing strategic partnerships to enhance the oral delivery of biologics and strengthen its intellectual property portfolio[91]. - The company has built a patent portfolio globally, with its initial patent family expected to extend into at least 2030 if all fees are paid[161]. Organizational Structure and Employment - As of December 31, 2025, the company had 69 full-time employees and two part-time employees, primarily based in San Jose and Fremont, California[215]. - The company underwent significant organizational transactions in connection with its IPO, including the establishment of a holding company structure with Rani Holdings as the parent company[216]. - The Tax Receivable Agreement was terminated on December 31, 2025, releasing the company from any further obligations under the agreement[217][219]. - The company amended and restated its operating agreement to appoint Rani Holdings as the sole managing member of Rani LLC and exchanged all outstanding interests into Class A Units and Class B units[218]. - The company filed an Amended and Restated Certificate of Incorporation on December 31, 2025, which became effective upon filing[220]. - The company adopted Amended and Restated Bylaws on December 31, 2025, to reflect changes resulting from the adoption of the Restated Charter[221].

Financial Performance - Fourth quarter 2025 total revenues were $27.0 million, a decrease of 3.5% year-over-year, while full year 2025 total revenues were $103.5 million, down 16.5% from 2024[7] - The net loss for Q4 2025 was $(32.7) million, or $(0.28) per share, an improvement from a net loss of $(76.7) million, or $(0.76) per share in Q4 2024[18] - The net loss for the year ended December 31, 2025, was $83.39 million, compared to a net loss of $201.32 million in 2024, showing an improvement of approximately 58.6%[33] - Adjusted EBITDA for Q4 2025 was a loss of $(10.3) million, an improvement from a loss of $(14.8) million in Q4 2024[20] - Adjusted EBITDA for the year ended December 31, 2025, was $(58.115) million, an increase in loss compared to $(52.675) million for the year ended December 31, 2024[35] Revenue Breakdown - Service revenues in Q4 2025 increased by 62% year-over-year to $14.7 million, representing 54% of total revenue, compared to 32% in Q4 2024[12] - Product revenues in Q4 2025 were $11.0 million, down 35.7% from $17.2 million in Q4 2024[4] - Total revenues for the year ended December 31, 2025, were $103.52 million, a decrease from $124.04 million in 2024, representing a decline of approximately 16.6%[29] - Product sales for the three months ended December 31, 2025, were $11.04 million, down from $17.17 million in the same period of 2024, indicating a decrease of about 35.7%[29] Expenses and Liabilities - Operating expenses in Q4 2025 decreased by 54% to $37.0 million, compared to $81.2 million in Q4 2024[16] - Operating expenses for the year ended December 31, 2025, totaled $109.60 million, down from $240.84 million in 2024, indicating a reduction of approximately 54.5%[29] - Total liabilities decreased to $82.96 million in 2025 from $99.51 million in 2024, a reduction of approximately 16.7%[31] Cash Position - Cash and cash equivalents as of December 31, 2025, totaled $39.6 million, with no debt[24] - Cash and cash equivalents at the end of 2025 were $39.57 million, a decrease from $41.85 million at the end of 2024[34] Future Outlook - For full year 2026, the company expects revenue in the range of $105 million to $115 million, with gross margins of approximately 35%[10] - The company anticipates continued growth in repeatable charging services and network recurring revenue, supported by improving utilization trends[9] Strategic Initiatives - The company completed a $20 million public equity offering in December 2025 to strengthen liquidity and support investment in DC fast charging infrastructure[8] - Blink Charging's principal line of products includes the Blink EV charging network, which utilizes proprietary cloud-based software to operate and maintain charging stations[40] - The company has established strategic partnerships for EV charging solutions across various locations, including parking facilities, healthcare facilities, and retail locations[40] Accounting and Reporting - The company reported a gross profit of $25.50 million for the year ended December 31, 2025, compared to $37.65 million in 2024, a decrease of about 32%[29] - The company reported a provision for credit losses of $3.89 million for the year ended December 31, 2025, compared to $1.72 million in 2024, representing an increase of approximately 126%[33] - Blink Charging's management believes that EBITDA is a key measure for evaluating the economic productivity of its operations[37] - The company emphasizes that Adjusted EBITDA excludes significant non-cash or non-recurring expenses, providing a clearer view of core operating results[38] Forward-Looking Statements - Forward-looking statements indicate that actual results may differ materially from projected revenue and adjusted EBITDA targets due to inherent risks and uncertainties[41] - Blink Charging has no obligation to update forward-looking statements unless required by federal securities law[41]

Financial Performance - Alpha Cognition generated fourth quarter 2025 net product revenue of $2.5 million, contributing to full year 2025 total revenue of $10.2 million[1] - Total revenues for the year ended December 31, 2025, reached $10,220,275, compared to $0 in 2024[36] - Product sales generated $6,792,024, while licensing contributed $3,428,251 to total revenues[36] - The company reported a net loss of $20,669,875 for 2025, an increase from a net loss of $14,788,727 in 2024[36] - The company reported an operating loss of $22.7 million for 2025, compared to $12.0 million in 2024[8] Growth Indicators - Bottles dispensed in Q4 increased 62% quarter-over-quarter to 4,941, with December being the strongest month since launch, selling 1,859 bottles[5] - The number of prescribers increased by 50% in Q4, indicating growing adoption of ZUNVEYL in long-term care settings[5] - The company executed a second national PBM contract, now having agreements with two of the four major PBMs relevant to long-term care[4] Expenses and Investments - Research and Development expenses decreased to $1.9 million in 2025 from $3.9 million in 2024 as the company transitioned to a commercial stage[8] - Selling, General & Administrative expenses rose to $29.1 million in 2025 from $8.0 million in 2024, reflecting increased commercial investment[8] - Selling, general and administrative expenses surged to $29,076,123 in 2025, compared to $8,012,230 in 2024, reflecting a significant increase of 263%[36] - Research and development expenses decreased to $1,867,972 in 2025 from $3,920,412 in 2024, a reduction of 52.3%[36] Cash and Assets - Cash and cash equivalents totaled $66 million at year-end 2025, supporting the target of operating profitability in 2027[1] - Cash and cash equivalents rose to $66,046,789, compared to $48,546,210 in the previous year, marking a 36% increase[34] - Total current assets increased to $79,010,272 in 2025, up from $50,251,178 in 2024, reflecting a growth of 57.3%[34] - Total liabilities increased to $17,200,060 in 2025, up from $11,642,111 in 2024, representing a 47.5% rise[34] - Stockholders' equity grew to $62,530,175 in 2025, compared to $39,094,827 in 2024, indicating a 60% increase[34] Future Plans - The company plans to initiate multiple studies, including the CONVERGE study and RESOLVE study, to further evaluate ZUNVEYL's effectiveness in long-term care[8] - Alpha Cognition expects two product approvals outside the U.S. via its partner, CMS, in Asia[8] Share Information - The weighted-average shares used to compute net loss per share increased to 17,680,597 in 2025 from 7,247,864 in 2024[36]

Financial Performance - Q4 2025 preliminary revenue is estimated to be between $18.1 million and $30.0 million, with a GAAP net loss from continuing operations of $37.0 million to $25.1 million[1][6]. - For the three months ended December 31, 2025, Veritone reported total revenue of $18.1 million, a decrease from $22.4 million in the same period of 2024, representing a decline of approximately 19.3%[26]. - The operating loss for the same period was $23.3 million, compared to an operating loss of $11.4 million in Q4 2024, indicating a deterioration of 104.4%[26]. - The net loss from continuing operations for the three months ended December 31, 2025, was $37.0 million, compared to a net loss of $25.1 million in Q4 2024, reflecting a 47.5% increase in losses[27]. - For the year ended December 31, 2025, Veritone, Inc. reported a GAAP net loss of $(110.5) million, compared to a loss of $(98.6) million for the year ended December 31, 2024[29]. - The non-GAAP net loss from continuing operations for 2025 was $(39.5) million, while the non-GAAP net loss for 2024 was $(27.6) million[29]. - The company expects a GAAP net loss range of $(53.8) million to $(43.3) million for the year ended December 31, 2026, with a corresponding non-GAAP net loss range of $(22.5) million to $(13.5) million[34]. Revenue Outlook - FY 2026 revenue outlook is projected to be between $130 million and $145 million, with a Non-GAAP net loss expected to range from $22.5 million to $13.5 million[1][5][13]. Bookings and Contracts - Total new bookings for Veritone Data Refinery exceeded $50.0 million in Q4 2025, representing a 25% increase from November 2025 estimates and a 250% increase from Q4 2024[1][8]. - The company closed 257 enterprise software and licensing contracts, including significant agreements with major clients such as Google and NBC Universal[1][8]. - The company has secured major contract wins to deploy its VDR product solution with leading hyperscalers, enhancing its market presence[1][8]. Debt and Expenses - The company ended fiscal year 2025 with $27.4 million in cash and cash equivalents, and $45.6 million in convertible debt, having paid down 100% of its senior secured term loan[1][5]. - The company has reduced its overall debt by approximately $77.5 million, resulting in annualized debt carrying cost savings of about $13.0 million[1][9]. - Total operating expenses for Q4 2025 were $41.9 million, slightly down from $43.5 million in Q4 2024, showing a decrease of 3.7%[26]. - Interest expense for the year ended December 31, 2025, was $10.2 million, down from $12.1 million in 2024[29]. - Depreciation and amortization expenses for 2025 were $27.2 million, compared to $28.5 million in 2024[29]. - Stock-based compensation expense for 2025 was $6.7 million, slightly lower than $7.7 million in 2024[29]. - Acquisition and due diligence costs for 2025 were $3.1 million, down from $4.1 million in 2024[29]. Strategic Initiatives - A strategic agreement with Oracle was announced to enhance the deployment of enterprise AI and generative AI solutions, positioning Oracle Cloud Infrastructure as a key component of Veritone's offerings[1][3][8]. - Veritone launched a strategic partnership with Armada to improve public safety intelligence through AI capabilities[1][12]. - The company anticipates continued momentum in the public sector and increased demand for its AiWARE platform and Veritone Data Refinery solutions[22]. - Veritone is focusing on expanding its aiWARE SaaS business and enhancing existing products while introducing new products to achieve market acceptance[22]. - The company is also addressing existing material weaknesses in its internal control over financial reporting and has plans for remediation[22]. Data Processing - More than 22.2 trillion tokens were processed in the second half of 2025, indicating a tripling of data volume compared to the first half of the year[1][8]. - The change in fair value of earnout receivable for 2025 was $7.7 million, compared to a loss of $(1.4) million in 2024[29].

FDA Approval Process - On March 25, 2026, the FDA indicated that a single Phase 3 study may be sufficient for marketing approval of QRX003 in the U.S.[72] - The FDA approval process requires rigorous pre-clinical and clinical testing to demonstrate safety and effectiveness[92][98]. - The FDA requires two adequate and well-controlled Phase 3 clinical trials for prevalent diseases to demonstrate safety and efficacy[99]. - An NDA submission must include results from all pre-clinical and clinical testing, along with a substantial application user fee, which typically increases annually[101]. - The FDA's goal for acting on an NDA for a new molecular entity is ten months, but the preliminary review can extend this to twelve months[102]. - The FDA may issue a complete response letter (CRL) if the NDA has deficiencies, requiring the applicant to address these before resubmission[104]. - The FDA may require post-marketing studies to gather additional safety and efficacy data after NDA approval[122]. - The FDA may expedite the review of applications for products intended to treat serious or life-threatening conditions that show substantial improvement over existing therapies[112]. - Orphan drug designation provides a seven-year market exclusivity period for drugs treating rare diseases affecting fewer than 200,000 individuals in the U.S.[113]. Clinical Development - The first clinical site for QRX003 in pediatric patients with Peeling Skin Syndrome opened in December 2024, with significant improvements observed after 12 weeks of treatment[75][76]. - Quoin plans to submit a pre-IND meeting request for QRX009 by the end of Q2 2026 and initiate clinical testing in Proof of Concept studies before the end of 2026[77]. - QRX003 has the potential to be the first approved treatment for NS globally, with plans for self-commercialization in the U.S., Western Europe, and Japan[78][79]. Market and Competition - The company has established nine marketing partnerships for QRX003 covering 61 countries, including Australia, New Zealand, and major Latin American countries[79]. - The company faces competition from other biotechnology firms and research institutions, with several candidates for NS treatment currently in development[84]. - Direct or indirect governmental price regulation may affect the prices charged for product candidates, with ongoing legislative proposals that could significantly impact the pharmaceutical industry[128]. - The Inflation Reduction Act requires the U.S. Department of Health and Human Services to negotiate prices for certain drugs, with the first negotiated prices taking effect in 2026 for 10 high-cost Medicare Part D products[130]. Financial and Regulatory Considerations - A formal pricing analysis for QRX003 has not been concluded, with anticipated influences from FDA negotiations and pharmacoeconomic data[83]. - The ability to commercialize product candidates depends significantly on adequate financial coverage and reimbursement from third-party payors, with significant uncertainty regarding insurance coverage for newly approved products[127]. - The company anticipates ongoing legislative and regulatory interest in drug pricing practices, which may lead to further reductions in coverage and reimbursement levels for pharmaceutical products[129]. - The company is subject to various global privacy and data protection laws, which could result in significant penalties and reputational harm if not complied with[126]. Company Structure and Operations - The company had four full-time employees and two part-time employees as of December 31, 2025, with no collective bargaining agreements in place[136]. - The company is classified as a "smaller reporting company," allowing it to take advantage of reduced disclosure obligations under the Securities Exchange Act[146]. - The company completed a business combination with Quoin Pharmaceuticals, Inc. on October 28, 2021, and subsequently changed its name to Quoin Pharmaceuticals Ltd.[142]. - The company is obligated to file reports with the SEC as a U.S. domestic issuer since January 1, 2023, which requires more detailed disclosures than those for foreign private issuers[142]. - The company’s operations do not produce hazardous waste, and it is not subject to hazardous materials regulations[134]. - The company is classified as a smaller reporting company under Rule 12b-2 of the Exchange Act and is not obligated to provide the disclosures typically required under Item 7A[369]. Intellectual Property and Confidentiality - The company entered into a License Agreement with Skinvisible Pharmaceuticals, paying a one-time fee of $1 million and agreeing to a royalty percentage on net sales[89]. - Quoin relies on trade secret protection and confidentiality agreements to safeguard proprietary know-how not covered by patents[90].

Product Development and Innovation - In December 2025, the company launched the SOLIS™ truck-mounted folding solar array and COR™ portable battery system, marking its entry into the clean-energy market[25]. - The AetherLux Pro heat pump technology received attention from multi-billion dollar corporations and U.S. government entities, indicating strong market interest[25]. - The company has initiated early production of its first hard folding tonneau cover, the Worksport AL3 Pro, which is now in active production for most major light truck models in North America[39]. - The company is developing advanced heat pump technology through its subsidiary, TerraVis Energy, aimed at residential, commercial, and industrial applications[61]. - The introduction of new product lines in 2025 contributed to increased production volume and improved overhead allocation efficiencies[201]. Financial Performance - For the fiscal year ended December 31, 2025, net sales increased by 89.8% to $16,101,738 compared to $8,484,379 in 2024[195]. - Gross profit for 2025 was $4,474,907, representing a 394.1% increase from $905,650 in 2024[195]. - The company experienced a net loss of $19,352,297 in 2025, compared to a net loss of $16,163,789 in 2024, reflecting a 19.7% increase in losses[195]. - The company reported net losses of $19,352,297 in 2025, compared to $16,163,789 in 2024, indicating a worsening financial position[205]. - Cash and cash equivalents increased by $1,062,795 (22%) from $4,883,099 in 2024 to $5,945,894 in 2025[214]. Market Expansion and Partnerships - The company reported a 42% increase in national dealer partnerships over the preceding quarter, expanding its distribution network significantly[25]. - The company announced a strategic partnership with Patriot Automotive Technologies to accelerate nationwide expansion through a network of over 200 dealer locations[25]. - The company is actively pursuing relationships with additional distributors and dealers to expand its market presence in the U.S. and Canada[200]. - The company plans to continue enhancing its business-to-consumer and business-to-business channels while focusing on cost efficiencies and brand awareness[197]. Capital and Funding - The company raised approximately $521,835 through its at-the-market offering program in 2025, with net proceeds of $504,372 after expenses[20]. - A warrant exercise inducement agreement resulted in gross proceeds of approximately $6.4 million from the exercise of 2,194,526 shares at a reduced price of $2.90 per share[21]. - The company conducted a Regulation A offering, generating approximately $10.0 million in gross proceeds between June and October 2025[22]. - The company raised approximately $21.8 million from public and private offerings during the fiscal year[208]. Operational Challenges - The company expects to continue incurring operating losses as it scales operations and invests in product development, manufacturing, and commercialization[75]. - The company relies on one supplier for the production of its outsourced soft tonneau covers, which may hinder growth if there are delays or loss of this supplier[90]. - The company faces risks from tariffs and supply chain issues, which have increased input costs but were offset by higher production volumes and operational efficiencies[175]. - The company has expressed substantial doubt about its ability to continue as a going concern due to a history of operating losses and reliance on equity and debt financings[74]. Intellectual Property and Legal Risks - The company faces challenges in protecting its intellectual property rights globally, which could negatively impact its business operations[93]. - Legal systems in certain countries may not favor the enforcement of patents, making it difficult to stop infringement and protect proprietary rights[94]. - The company’s ability to maintain a strong patent position is crucial for its commercial success, as inadequate protection could harm its profitability[96]. - Much of the company's intellectual property is protected as trade secrets, which must be diligently safeguarded to maintain competitive advantage[99]. Cybersecurity and Risk Management - The company has cybersecurity insurance coverage in the aggregate amount of $1,000,000 per annual policy period to mitigate risks associated with cybersecurity attacks[87]. - The company currently lacks enhanced cybersecurity measures, a dedicated team, and robust protocols to manage cybersecurity risks[142]. - The company plans to invest in cybersecurity improvements, including engaging external experts and developing an incident response strategy[144]. Employee and Operational Structure - The company employs 103 full-time employees and 5 part-time employees in the U.S., with plans to hire additional staff as operations grow[67]. - As of December 31, 2025, the company operates three facilities, with one owned and two leased, totaling 166,339 sq ft[149]. Market Trends and Projections - The U.S. pickup truck market is expected to grow at a compound annual growth rate (CAGR) of 5.3% from 2025 to 2030, with approximately 61 million pickup trucks in operation as of Q3 2024[48]. - The tonneau cover market in the U.S. was estimated to be $2.56 billion in 2024 and is projected to grow at a CAGR of 7.1% from 2025 to 2030[50]. - The electric pickup truck market is expected to grow at a CAGR of 29.86% from 2025 to 2029 in North America, presenting opportunities for partnerships with electric truck manufacturers[49]. - The global Portable Power Station Market is projected to grow at a CAGR of 5.3% between 2025 and 2035[53].

Fleet and Operations - The company has 22 contracted/committed rigs as of December 31, 2023, with an increase to 29 rigs following the acquisition of five new rigs in January 2026[52]. - There are currently 11 newbuild jack-up rigs under construction, which may lead to increased competition and potential oversupply in the market[54]. - The recent acquisition of five new rigs increases the size of the fleet and the associated risks due to industry cyclicality[49]. - The recent acquisition of five rigs increased the fleet from 24 to 29, raising the risk exposure related to the market value of these rigs[70]. - Only three of the five newly acquired rigs are currently contracted, heightening risks related to contracting uncontracted rigs[142]. - The acquisition of the five rigs through a joint venture is valued at $287 million, which may involve significant leverage and operational risks[146]. - Integration activities for the newly acquired rigs may disrupt existing operations and divert management's attention, potentially impacting financial performance[145]. Market Conditions and Risks - The offshore drilling industry is highly cyclical, with periods of low demand and oversupply impacting business operations and financial results[51]. - Oil prices have shown significant volatility, ranging from approximately $70.31 to $93.12 in 2024 and between $58.92 to $80.79 in 2025, affecting drilling activity levels[56]. - The company faces risks related to geopolitical tensions, inflation, and competition in the offshore drilling market, which could adversely affect dayrates and contract renewals[49]. - The company may experience reduced demand if long-term oil prices decline or if rig supply increases above current levels, impacting financial performance[57]. - Advances in onshore exploration and development technologies may lead customers to allocate more capital expenditure to onshore activities, potentially reducing offshore spending[60]. - Global geopolitical tensions, supply chain disruptions, and inflation have created volatility in oil and gas prices, which could adversely affect the company's business and financial condition[63]. - The volatility in oil prices and potential down-cycles in the offshore drilling industry could negatively impact customer demand and the fair market value of the company's rigs[69]. Financial Condition and Debt - The company’s financial condition may be affected by significant debt maturities and liquidity risks in the coming years[50]. - As of December 31, 2025, the company had $2,210.0 million in principal amount of debt outstanding, representing 61.0% of its assets[198]. - The company has scheduled final maturity dates for all its debt between 2028 and 2030, with annual amortization of $101.0 million for the 2028 Notes and $42.6 million for the 2030 Notes[195]. - The company issued $165 million in additional 2030 Notes and incurred $150 million in Seller Financing to partially fund the acquisition of the new rigs, increasing overall indebtedness[143]. - Future cash flows may be insufficient to meet obligations under existing bonds and loans, impacting the company's ability to operate[209]. - The company expects a significant portion of cash flow from operations to be dedicated to debt interest and principal payments, limiting availability for other purposes[211]. - The company has significant debt maturities in 2028 and 2030, which may require raising additional financing[215]. - The company may need to raise funds through additional debt or equity issuance, which could dilute existing shareholders[216]. - The company is subject to restrictive debt covenants that may limit its ability to finance future operations and capital needs[218]. Operational Risks - The company faces risks related to international operations, including political uncertainties and compliance with various laws and regulations, which could impact its ability to operate effectively[71]. - The company is exposed to risks related to contract renewals and potential cancellations by customers, particularly in unfavorable market conditions[49]. - The company has experienced contract terminations and suspensions due to unfavorable market conditions, which may lead to significant revenue loss[84]. - The company may face challenges in securing favorable contracts for its jack-up rigs as existing contracts expire, potentially leading to idle rigs and associated costs[85]. - The company incurs significant activation and reactivation costs for its rigs, which may not be fully recouped from customers, affecting cash flow[100]. - The company may incur liabilities exceeding contractual agreements due to enforceability issues of indemnities in certain jurisdictions[126]. - The company may face significant operational hazards, including blow-outs and equipment defects, which could lead to liability claims and financial losses[124]. - The company’s insurance policies may not adequately cover all risks, potentially resulting in substantial costs from uncovered incidents[130]. - Severe weather conditions, particularly in the Gulf of America and the North Sea, could materially affect the company's operations and financial performance[131]. - The company is exposed to risks associated with public health crises, which could disrupt operations and impact demand for services[113]. Compliance and Regulatory Risks - Compliance with evolving regulations related to low or zero carbon alternatives may result in increased operational costs and impact the company's reputation[67]. - The company is subject to complex and evolving tax laws, which may lead to increased tax liabilities and affect financial results[177]. - Global tax reforms, including a 15% global minimum tax effective January 1, 2024, could significantly impact the company's effective tax rate and cash flow[178]. - Future government regulations related to climate change may increase operational costs and require significant financial expenditures for compliance[184]. - Growing public concern about climate change may adversely affect demand for the company's services and restrict access to capital[185]. - Compliance with complex cybersecurity laws and regulations poses significant challenges and potential penalties for the company[139]. - The company faces risks related to compliance with anti-bribery and anti-corruption laws, which could result in substantial fines and operational curtailments[190]. Shareholder and Governance Issues - The company has 307,701,075 common shares outstanding, with Related Parties owning approximately 24.7% of total shares[238]. - Future sales of equity securities may dilute ownership and negatively impact the market price of common shares[237]. - The company has commercial relationships with Drew Holdings Ltd, including ongoing advisory arrangements[240]. - Directors Mr. Thiago Mordehachvili and Mr. Tor Olav Trøim also serve as directors of related parties, potentially leading to conflicts of interest[241]. - The resolution of conflicts of interest may not always align with the best interests of the company or its shareholders[241]. - The company maintains fiduciary duties to both itself and the related parties, which may complicate decision-making[241]. - Additional details on related party transactions can be found in the section "Item 7.B. Related Party Transactions"[242]. Labor and Cost Pressures - Inflation and the limited availability of qualified personnel may lead to higher operating costs, impacting overall profitability[50]. - The limited availability of qualified personnel in operational regions may lead to higher operating costs and impact the company's ability to staff rigs effectively[102]. - Inflationary pressures, including increases in labor and material costs, may adversely affect the company's operating results and overall demand for drilling services[101]. - Local content requirements in various jurisdictions may increase operational costs and affect the ability to hire experienced personnel[152].

Revenue and Profitability - Revenue for Q4 2025 decreased by 4.5% to $2.85 million compared to $2.99 million in Q4 2024, driven by lower shipments of force-sensing products [4]. - Gross profit for Q4 2025 was $905,000, down 23.5% from $1.18 million in the same quarter last year, resulting in a gross margin of 31.7% compared to 39.6% [5]. - Net loss for Q4 2025 increased to $574,000 from a net loss of $413,000 in Q4 2024, attributed to lower revenue and gross margin [6]. - Adjusted EBITDA for Q4 2025 was $(511,000), worsening from $(233,000) in the prior-year period [8]. - For the three months ended December 31, 2025, the net loss was $574,000 compared to a net loss of $413,000 for the same period in 2024 [24]. - The EBITDA for the three months ended December 31, 2025, was $(519,000), an increase in loss from $(240,000) in the same period of 2024 [24]. - Adjusted EBITDA for the year ended December 31, 2025, was $(885,000), compared to $(1,072,000) for the year ended December 31, 2024 [24]. - The company reported a total net loss of $1,615,000 for the year ended December 31, 2025, compared to a net loss of $1,984,000 for the year ended December 31, 2024 [24]. Expenses - Engineering, research and development expenses for Q4 2025 were $353,000, down from $480,000 in Q4 2024 [21]. - The company incurred a depreciation expense of $49,000 for the three months ended December 31, 2025, up from $32,000 in the same period of 2024 [24]. - Amortization expense for the year ended December 31, 2025, was $717,000, slightly down from $753,000 in 2024 [24]. - Stock-based compensation expense for the three months ended December 31, 2025, was $8,000, compared to $7,000 in the same period of 2024 [24]. - The income tax expense for the three months ended December 31, 2025, was $169,000, compared to a benefit of $33,000 in the same period of 2024 [24]. - Interest income for the three months ended December 31, 2025, was $(2,000), down from $(8,000) in the same period of 2024 [24]. - The total adjustments to arrive at EBITDA included a depreciation expense of $190,000 for the year ended December 31, 2025, compared to $143,000 in 2024 [24]. Assets and Liabilities - Total assets decreased to $11.74 million in 2025 from $13.12 million in 2024, with total liabilities slightly reduced to $2.52 million [19]. Business Development and Strategy - The company began volume production of a custom piezoelectric sensor solution for the autonomous vehicle market and is shipping a second-generation custom FSR solution for robotic-assisted surgery [7]. - The company successfully converted preferred stock into common stock, eliminating $400,000 in annual preferred stock dividends [7]. - The company is actively pursuing acquisitions and is optimistic about organic growth in 2026 and 2027 [4]. - The company added two Senior Business Development Directors in January 2026 to enhance growth in North America and Europe [7].

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].