Financial Proceeds and Capital - The company issued four series of warrants in May 2023, which could generate gross proceeds of $71.4 million if fully exercised[183]. - In July 2024, the company received approximately $17.9 million from the full exercise of Series H Warrants, and another $17.9 million from Series I Warrants in July 2025[183]. - A private placement completed in July 2025 generated approximately $40.1 million in gross proceeds[183]. Product Development and Commercialization - The company launched CGuard Prime in the U.S. in July 2025 following FDA approval in June 2025, marking its transition to a commercial stage medical device company[189]. - The establishment of a global headquarters in Miami, Florida, was completed in October 2024 to support the U.S. commercialization of CGuard Prime[190]. - The company is expanding its manufacturing and operational capabilities, including engaging a contract manufacturer to support production growth[190]. - Significant resources are being expended to build a direct sales organization and distribution capabilities for CGuard Prime, with risks associated with recruiting and retaining qualified personnel[198]. - The company derives most of its revenue from CGuard EPS sales in CE marked countries and has not yet received FDA approval for SwitchGuard[202]. - Market acceptance of CGuard Prime is uncertain, and the company may face challenges in achieving sufficient adoption by physicians and patients[195]. - The company may incur substantial costs if the commercialization of CGuard Prime is unsuccessful, impacting its financial condition and results of operations[198]. Competitive Landscape and Market Risks - The company operates in a highly competitive medical device market, facing significant risks of product obsolescence and competition from larger firms with greater resources[206]. - Price competition in the medical device sector may impact the company's ability to maintain satisfactory pricing and margins, potentially leading to decreased gross margins and investment capacity[207]. - The company is at risk of patent infringement claims from larger competitors, which could divert resources and hinder product commercialization[208]. - Ongoing patent litigation in the stent industry poses a threat to the company's market position and could delay product introductions[209]. Clinical Trials and Regulatory Compliance - The company has completed patient enrollment for the C-GUARDIANS II trial, evaluating the CGuard Prime 80 cm stent system, with 50 patients enrolled by Q1 2026[210]. - The FDA approved the IDE for the C-GUARDIANS III trial, which will evaluate the SwitchGuard NPS, expected to begin patient enrollment in Q2 2026[210]. - The company faces challenges in clinical trials, including patient enrollment and adherence, which could delay product development timelines[213]. - Regulatory compliance is critical, as failure to meet FDA IDE regulations could materially harm the company's business[210]. - The company must demonstrate safety and effectiveness in clinical trials to obtain regulatory approval for new products, with risks of delays or failures impacting commercial opportunities[215]. - Post-approval, the company's products will be subject to ongoing regulatory review, which could result in recalls or market withdrawals if compliance issues arise[225]. - The company has limited experience in regulatory affairs, which may affect its ability to navigate complex regulatory requirements and obtain necessary approvals, potentially leading to increased costs and lost revenue[229]. - Regulatory approvals for the company's products are subject to complex requirements, and there is no assurance that such approvals will be granted on a timely basis, if at all[230]. - The company may face significant delays in obtaining regulatory approvals due to limited personnel in clinical, regulatory, and quality assurance roles, currently consisting of only ten employees[229]. - If the company fails to comply with ongoing regulatory requirements, its products could be subject to restrictions or withdrawal from the market[231]. - The company must obtain separate regulatory approvals for marketing its products in foreign jurisdictions, which may involve additional testing and time[237]. Legal and Compliance Risks - The company is subject to various federal and state healthcare laws, and violations could result in significant penalties, including exclusion from federal healthcare programs[238]. - The company may face product liability claims, and its insurance coverage may not be sufficient to cover these claims, potentially leading to material adverse effects on its financial condition[246]. - Any adverse events involving the company's products could result in recalls or enforcement actions, harming its reputation and financial results[228]. - The company may be subject to enforcement actions if its marketing and promotional materials violate applicable regulatory restrictions, which could harm its business and reputation[235]. - Changes in healthcare laws and regulations could adversely affect the company's business and results of operations, increasing the risk of non-compliance[238]. Reimbursement and Market Dynamics - The company may face challenges in obtaining adequate reimbursement levels for its products from third-party payors, potentially leading to smaller than expected market sizes[247]. - Future reimbursement may be subject to increased restrictions in both the U.S. and international markets, adversely affecting product demand and profitability[248]. - Healthcare reform initiatives and legislative changes in the U.S. could significantly impact the company's business, including potential slowdowns in FDA reviews and approvals due to reduced staffing[249]. - The Affordable Care Act has faced challenges that may lead to modifications affecting the company's regulatory burdens and operating costs[250]. - Medicare payment reductions of up to 2% per fiscal year are set to remain in effect through 2031, which could impact the company's financial condition and cash flows[251]. - The implementation of the EU HTA Regulation may increase compliance costs and adversely affect product pricing and reimbursement decisions in the European market[255]. - Disruptions at the FDA due to funding shortages or government shutdowns could delay product approvals and negatively impact the company's business[256][257]. Intellectual Property and Supply Chain Risks - The company faces risks related to intellectual property protection, including challenges to patent validity and enforceability that could adversely affect revenue[258][262]. - The evolving legal standards regarding patentability and enforcement may limit the company's ability to protect its proprietary technologies effectively[264]. - The company relies on external suppliers for key materials, with some components sourced from single suppliers, which poses risks to manufacturing continuity[281]. - In 2022, the mesh supplier notified the company of an inability to supply polymer fiber, leading to inventory purchases to support production needs through early 2028[282]. - The company is validating an alternative PET resin for its MicroNet mesh, but there are no assurances that this validation will be successful or that regulatory approvals will be obtained[282]. - Changes to suppliers or components for CGuard Prime require FDA approval, which can be time-consuming and may delay supply chain adjustments[283]. - The company depends on a third-party sterilization vendor, and any disruptions could lead to delays in product release and distribution[284]. - Any interruption in the supply chain could impair the company's ability to meet demand and maintain inventory levels, adversely affecting financial performance[285]. Market Opportunity and Adoption Challenges - The company's growth is dependent on the total market opportunity for CAS, which is inherently imprecise and relies on physician adoption[286]. - The annual total addressable market for CAS products is based on internal and third-party estimates, which may prove to be incorrect, impacting sales growth[286]. - Physicians may be slow to adopt new products, affecting the company's ability to penetrate the market opportunity for CAS[286]. - The adoption of CAS (Carotid Artery Stenting) is heavily influenced by physician training and experience, with inadequate training potentially leading to adverse patient outcomes and negatively affecting adoption rates[291]. Manufacturing and Operational Risks - The company has engaged Aptyx, a contract manufacturer, to expand manufacturing capacity for CGuard Prime, which is critical for meeting customer demand and maintaining product quality standards[292]. - Manufacturing risks include the ability to produce products in sufficient quantities and on time, which is essential for fulfilling customer orders and maintaining operating margins[293]. - The company faces challenges in accurately forecasting customer demand, which could lead to inventory issues and affect the ability to meet customer needs[296]. - Excess inventory may result in obsolescence or write-downs, while underestimating demand could lead to supply interruptions and damage to customer relationships[298]. Liability and Insurance Concerns - The medical device industry is subject to significant product liability risks, particularly due to the critical nature of the procedures involved, which could lead to litigation and harm market acceptance[301]. - Product liability insurance is costly and may not provide adequate coverage, exposing the company to significant liabilities in case of claims[303]. - The company is required to file adverse event reports with the FDA, which could result in negative publicity and harm its reputation if significant adverse events are reported[304]. - The success of CAS depends on broad market acceptance among physicians and hospitals, which is currently uncertain due to various factors including competition and perceived risks[288]. Financial Performance and Market Volatility - Fluctuations in quarterly and annual results may not fully reflect the underlying performance of the business, making it difficult to assess future performance accurately[299]. - The CGuard Prime carotid stent system has received FDA approval for carotid revascularization, but off-label use may lead to product liability claims[305]. - Product liability claims are prevalent in the medical device industry and could significantly increase expenses and harm the company's reputation[306]. - The company faces risks from litigation and claims that could negatively impact business operations and financial condition[307]. Cybersecurity and Operational Challenges - Cybersecurity risks could compromise sensitive data, leading to legal claims and operational disruptions[308]. - Anticipated growth may strain the company's operational infrastructure, requiring effective management of resources and personnel[309]. - The company must scale capacity and enhance quality assurance to meet increasing demand for products[310]. - Loss of key management or inability to attract skilled personnel could adversely affect product development and business strategies[311]. Global Operations and Geopolitical Risks - Global operations expose the company to various risks, including regulatory challenges and geopolitical events[312]. - Economic conditions, including inflation and market volatility, may adversely affect sales cycles and financial performance[315]. - Increased scrutiny of ESG practices could lead to higher costs and impact the company's reputation and access to capital[321]. Stock Market and Compliance Risks - The company launched CGuard Prime in July 2025 following FDA approval, and is expanding manufacturing capacity in North Carolina to support anticipated production growth[327]. - In 2025, approximately 39% of the company's revenues were denominated in U.S. dollars, while 61% were in other currencies, primarily Euros[332]. - A 10% appreciation of the New Israeli Shekel (NIS) against the U.S. dollar would have decreased the company's net income by approximately $1.1 million based on 2025 expense levels[332]. - The NIS appreciated by an average of 12.5% relative to the U.S. dollar in 2025, increasing the U.S. dollar cost of shekel-denominated expenses[334]. - The U.S. government imposed a new 10% global tariff effective February 24, 2026, which was subsequently increased to 15% on February 21, 2026[328]. - Changes in tax laws, including the One Big Beautiful Bill Act (OBBBA) signed into law in July 2025, could adversely affect the company's effective tax rate and operating results[331]. - The company is exposed to risks from fluctuations in currency exchange rates, particularly between the NIS and U.S. dollar or Euro, which could impact financial performance[333]. - Military service call-ups in Israel may affect the company's operations, as several employees were drafted for military service during recent conflicts[339]. - The company currently has 66 full-time employees in Israel, and any disruption to manufacturing or supply chain due to ongoing conflicts could harm operations[340]. - Political instability and hostilities in the region could adversely affect the company's operations and market price of its shares[342]. Corporate Governance and Listing Risks - A significant portion of the company's intellectual property has been developed by Israeli employees, and under Israeli Patent Law, employees may claim remuneration for service inventions, potentially leading to litigation[344]. - The company's common stock is listed on the Nasdaq Capital Market and must comply with minimum listing requirements, including minimum bid price and stockholders' equity[347]. - Failure to maintain compliance with Nasdaq's continued listing standards could result in delisting, adversely affecting the company's ability to raise financing and the liquidity of its common stock[348]. - Delisting from Nasdaq may negatively impact investor confidence and the value of the company's common stock[349]. - The market prices of the company's common stock are subject to significant volatility, influenced by various external factors beyond the company's control[346]. - The company has a staggered board of directors, which could impede takeover attempts and management changes[353]. - As a former shell company, the company’s securities are subject to Rule 144(i), limiting the liquidity of unregistered securities unless compliance with reporting requirements is maintained[354]. - The trading market for the company's common stock may decline if analysts cease coverage or if operating results fall below expectations[355]. - The tax treatment of the company's preferred stock and warrants is uncertain and may vary for different investors[356]. - The company may face challenges in enforcing judgments against its directors or officers due to the location of assets and personnel outside the U.S.[345].

Revenue Performance - Lifeward reported a revenue of $5.1 million in Q4 2025, a decrease of approximately 33% from $7.5 million in Q4 2024[11]. - Revenue for the full year 2025 was $22.0 million, down 14% from $25.7 million in 2024[16]. - Lifeward reported revenue of $5,081,000 for Q4 2025, a decrease of 32.6% compared to $7,545,000 in Q4 2024[32]. - Total revenues for Q4 2025 were $5,081 million, a decrease of 32.6% from $7,545 million in Q4 2024[38]. - The company reported a total revenue of $22,034 million for the year ended December 31, 2025, down from $25,663 million in 2024[38]. Profitability and Loss - Lifeward's net loss narrowed by 65% to $5.3 million, or $3.60 per share, in Q4 2025, compared to a net loss of $15.3 million, or $20.82 per share, in Q4 2024[15]. - The company's net loss for Q4 2025 was $5,348,000, compared to a net loss of $15,278,000 in Q4 2024, representing a 65.0% improvement[32]. - GAAP net loss for Q4 2025 was $(5,348) million compared to $(15,278) million in Q4 2024, showing an improvement[38]. - Non-GAAP net loss per share for Q4 2025 was $(2.85), a decrease from $(4.54) in Q4 2024[38]. Operating Expenses - Total operating expenses in Q4 2025 declined by 64% to $6.2 million from $17.1 million in Q4 2024[13]. - Lifeward's total operating expenses for the full year 2025 decreased by 25% to $28.1 million from $37.6 million in 2024[18]. - Total operating expenses for Q4 2025 were $6,206,000, down from $17,072,000 in Q4 2024, indicating a reduction of 63.6%[32]. Cash and Assets - As of December 31, 2025, Lifeward had $2.2 million in unrestricted cash and cash equivalents[21]. - Cash and cash equivalents at the end of Q4 2025 were $2,169,000, down from $6,746,000 at the end of Q4 2024, a decline of 67.7%[34]. - Lifeward's total assets decreased to $22,900,000 as of December 31, 2025, from $30,487,000 in 2024, a decline of 25.0%[34]. - The company experienced a net cash used in operating activities of $16,826,000 for the year ended December 31, 2025, compared to $21,718,000 in 2024, a reduction of 22.6%[36]. Research and Development - Research and development expenses for the year ended December 31, 2025, were $3,249,000, a decrease of 29.8% from $4,625,000 in 2024[32]. - Research and development expenses for Q4 2025 were $843 million, which is 16.6% of revenue, compared to 15.0% in Q4 2024[40]. Strategic Initiatives - The company expects to close a strategic transaction with Oramed, which includes up to $47 million in additional funding, positioning Lifeward towards cash flow positive[4]. - Lifeward's acquisition of powered upper-body exoskeleton technology is expected to be ready for commercial launch within 18 to 24 months[5]. - The company expanded reimbursement coverage for the ReWalk Personal Exoskeleton, providing access to approximately 16 million covered lives in the U.S.[6]. Liabilities - Lifeward's total current liabilities increased to $12,039,000 as of December 31, 2025, from $10,225,000 in 2024, an increase of 17.8%[34]. Financial Guidance - The company did not provide GAAP reconciliation for its non-GAAP financial guidance due to uncertainties in predicting certain expenses[29].

Market Potential - The ADHD treatment market in the US is estimated to have approximately 100 million annual prescriptions, with a potential 1% market share representing $250 to $300 million in annual revenue[17]. - CTx-2103, targeting the anxiety market, is designed for once-daily administration and is part of a market that generated over $1 billion in sales in 2025[19]. - Total prescriptions of extended-release stimulants in the U.S. grew by 10.2% annually for the 12 months ended September 2025, with approximately 96 million stimulant prescriptions written[38][46]. - Approximately 90% of all ADHD medication prescriptions are stimulants, with four main medications dominating 92% of the extended-release stimulant market[46]. - Recent stimulant medications have captured only about 2.0% of total ADHD prescriptions in the U.S. in 2025, indicating a significant unmet need for effective treatments[54]. Product Development - CTx-1301 and CTx-1302 are designed to provide a near immediate onset of action within 30 minutes and eliminate the need for booster doses, addressing key shortcomings of current therapies[18]. - The NDA for CTx-1301 was submitted to the FDA on July 31, 2025, with a PDUFA target action date of May 31, 2026[23]. - A Phase 3 study of CTx-1301 in adults showed significant improvements in secondary endpoints, although the primary efficacy endpoint did not achieve statistical significance[22]. - The company plans to initiate the clinical plan for CTx-1302 pending additional capital resources[28]. - CTx-2103's formulation study demonstrated a triple release of buspirone, which is critical for the design of clinical studies for filing an IND[29]. - The clinical development program includes two Phase 1/2 studies and a Phase 3 trial, with the latter completed in June 2023[86]. - CTx-1301 is designed to provide onset-of-action within 30 minutes and entire active-day efficacy, with a release profile of 35%-45%-20% for the total daily dose[70]. - CTx-1301's unique trimodal release profile is engineered to provide rapid symptom relief and maintain efficacy throughout the day, addressing common issues with current ADHD treatments[73]. - CTx-1301 demonstrated consistent dose-dependent efficacy in improving ADHD symptoms, with the 37.5mg dose showing the largest effect size and symptom reduction in a Phase 3 study involving 103 subjects aged 6-17[103]. - CTx-1302 is expected to be the first true once-daily dextroamphetamine tablet for ADHD, with a release profile designed to provide therapeutic efficacy within 30 minutes[110]. - The clinical development program for CTx-1302 includes approximately 100 patients in Phase 1/2 studies and around 500 patients in Phase 3 trials[111]. - CTx-2103 aims to be the first once-daily formulation of buspirone for anxiety treatment, addressing the challenges of multiple daily dosing associated with current treatments[118]. Regulatory and Compliance - The FDA has assigned a PDUFA target action date of May 31, 2026, for the review of CTx-1301's NDA[35]. - The FDA has provided guidance on the regulatory pathway for CTx-2103, indicating potential approval under the 505(b)(2) pathway, which typically requires fewer resources[122]. - The FDA requires that sponsors of clinical trials register and disclose certain clinical trial information on www.clinicaltrials.gov, including results after completion[182]. - Following drug approval, manufacturers are subject to ongoing FDA regulation, including monitoring and record-keeping activities, and must comply with cGMP requirements[183]. - The FDA may issue a complete response letter (CRL) if the NDA is not approved in its current form, detailing deficiencies that need to be addressed[162]. - The FDA may impose restrictions on product distribution and prescribing through a risk evaluation and mitigation strategy (REMS) plan[164]. - The submission of an IND must become effective within 30 days unless the FDA raises concerns, which could delay the start of clinical trials[147]. - The FDA may not approve an ANDA or 505(b)(2) NDA until any applicable period of non-patent exclusivity for the referenced RLD has expired, which includes a five-year period of non-patent marketing exclusivity for the first applicant to gain NDA approval for a new chemical entity[174]. - The FDCA provides three years of marketing exclusivity for a NDA if new clinical investigations are deemed essential for approval, covering only the conditions of use associated with those investigations[175]. - The FDA will conduct a pre-approval inspection of manufacturing facilities to ensure compliance with cGMPs before approving an NDA[159]. - Changes to the manufacturing process are strictly regulated and often require prior FDA approval or notification[186]. - The FDA may withdraw drug approval if compliance with regulatory requirements is not maintained or if new problems arise post-market[187]. Intellectual Property - The company has received a first European patent for CTx-1301, providing patent protection until 2042[24]. - The company holds six patents and two patent applications in the United States, with additional patents and applications in various countries, expiring between 2031 and 2043[130]. - The patent for the "Delayed Prolonged Drug Delivery" formulation is set to expire in March 2031, while other patents related to sustained release formulations extend to November 2035 and beyond[131][132]. - The company intends to strengthen its intellectual property portfolio to protect its PTR platform and product candidates from competitors[35]. - The company is focused on building its intellectual property portfolio, including trade secrets and proprietary know-how, to maintain a competitive edge in the ADHD market[133]. Financial Considerations - The cost of preparing and submitting an NDA is substantial, with application user fees currently over $3.24 million and an annual program fee of approximately $394,000[156]. - The company expects that some product candidates may require black box warnings as part of their labeling during the NDA review process[164]. - The Medicare program may reimburse self-administered drugs under Medicare Part D, which is administered by private plans[200]. - The Inflation Reduction Act of 2022 has reduced US government reimbursement for some drugs, indicating ongoing downward pressure on pharmaceutical reimbursements[202]. - Compliance with healthcare laws and regulations involves substantial costs, and violations may lead to significant penalties, including loss of eligibility for FDA approvals[206]. Market Strategy - The company aims to leverage its PTR platform to develop additional assets with the potential for $1 billion or more in peak annual sales[30]. - The company is evaluating opportunities to acquire or in-license additional assets to complement its portfolio and enhance value[35]. - The company intends to submit NDAs under the 505(b)(2) regulatory approval pathway, which may reduce some development burdens by referencing existing studies[143]. - The company must negotiate coverage and reimbursement decisions for its product candidates, which are influenced by existing branded drugs and clinical need[199]. - The company plans to enter into commercial supply agreements with additional manufacturers for its APIs in the future[128]. Safety and Efficacy - CTx-1301 patients experienced a 28.6% reduction in treatment emergent adverse events compared to Focalin XR[79]. - No serious treatment-emergent adverse events (TEAEs) were reported in the Phase 3 trials, indicating a favorable safety profile for CTx-1301[102]. - The Phase 1 food effect studies confirmed that CTx-1301 can be taken with or without food, with no serious treatment emergent adverse events reported[83]. - The Phase 3 study showed significant improvements in CGI-S scores for CTx-1301 compared to placebo, indicating notable treatment effects[86]. - The proprietary PTR drug delivery platform technology aims to eliminate the need for additional stimulant boosters, enhancing patient compliance[64].

Financial Performance - Cingulate reported a net loss of $6.3 million for Q4 2025, compared to a net loss of $6.2 million in Q4 2024, and a total net loss of $22.4 million for the full year 2025, up from $16.6 million in 2024[12]. - As of December 31, 2025, Cingulate had approximately $11.0 million in cash and cash equivalents, a decrease of $1.3 million from the previous year, with expectations to meet capital needs into late Q4 2026[9]. - Research and development expenses for Q4 2025 were $2.0 million, down from $4.3 million in Q4 2024, while total R&D expenses for the year were $9.8 million, slightly up from $9.4 million in 2024[10]. - General and administrative expenses increased to $3.6 million in Q4 2025 from $1.9 million in Q4 2024, totaling $10.2 million for the year compared to $6.2 million in 2024[11]. Intellectual Property - Cingulate received a U.S. Patent Notice of Allowance for CTx-1301, expected to provide protection through May 2042, strengthening its intellectual property portfolio[3]. - A European patent for CTx-1301 was granted, extending protection through May 2042 and expected to be validated in over 30 European territories[4]. Regulatory Developments - The FDA accepted the New Drug Application (NDA) for CTx-1301 in October 2025, with a target action date of May 31, 2026[7]. Financing and Investment - Cingulate closed a $12 million private investment in public equity (PIPE) financing in February 2026, with insider participation and a 180-day lock-up agreement[8]. Commercial Strategy - The company is advancing its commercial readiness, including scaling manufacturing and preparing distribution capabilities[6]. - Cingulate aims to build long-term value for patients and shareholders through its proprietary Precision Timed Release™ (PTR™) platform technology[2].

Competition and Market Challenges - The company experienced significant competition in the marketplace, with challenges from AI technology enabling faster replication of products by competitors[30] - The market for small to medium-sized communication service providers has contracted, which may diminish demand for the company's billing and customer care software[79] - The telecommunications market is experiencing consolidation and increased competition, leading to a loss of customers and expected negative revenue impacts in 2026[219] Customer Acquisition and Retention - The company was unable to recruit any new customers in 2024 or 2025, which may adversely affect future financial performance[33] - A significant portion of revenues is derived from existing customers, and loss of these customers could lead to decreased revenues and profitability[80] - The company has not acquired new customers in 2024 or 2025 due to a reluctance among telcos to invest in comprehensive solutions[217] Financial Performance and Revenue Trends - In 2025, total revenues amounted to $19,457,000, a decrease from $21,446,000 in 2024 and $21,612,000 in 2023, indicating a downward trend in revenue[145] - Total revenues decreased by $2.0 million, or 9.3%, from $21.4 million in 2024 to $19.4 million in 2025, primarily due to declines in the messaging and billing segments[181] - Revenues from services decreased by $2.0 million from $20.7 million in 2024 to $18.7 million in 2025, attributed to a decline in customer usage[182] Operational Risks and Compliance - The company faces risks related to cybersecurity, with potential impacts on customer confidence and revenue if security measures are compromised[49] - The company’s products and services must comply with various international laws and regulations regarding data protection and privacy, which could impact operations[51] - Noncompliance with GDPR could result in fines of up to €20 million or 4% of global annual revenues, adversely impacting the company's operations in the EU[53] - The company faces increased compliance costs and potential sanctions due to evolving privacy and data protection laws across multiple jurisdictions[55] Strategic Acquisitions and Investments - The company acquired Aurenz GmbH in January 2025, a provider of unified communications analytics solutions, and is evaluating further acquisition opportunities[42] - The company has made strategic acquisitions, including Message Mobile and GTX, to enhance its messaging capabilities and expand market presence[159][160] - The company’s strategy includes targeting acquisitions to enhance growth and expand its market presence in convergent billing and customer care software[131] Research and Development - Research and development expenses primarily consist of payroll and overhead costs, with ongoing investments expected[174] - Research and development investment increased to $4.1 million in 2025, representing 20.8% of total revenues, up from $3.4 million or 15.8% in 2024[215] - The company is developing new AI-enabled tools to improve operational efficiency, although these tools are still under development[216] Financial Management and Capital Expenditures - Capital expenditures for 2023 amounted to $64 thousand, with projections for an increase if acquisitions or asset purchases occur[116] - The total cash amount of capital expenditures for 2024 is projected to be $10 thousand, indicating a strategic focus on cost management[116] - Capital expenditures were $27 thousand in 2025, with expectations for an increase if the company pursues acquisitions or asset purchases[212] Customer Dependency and Revenue Composition - One customer accounted for approximately 15% of total revenues in 2025, highlighting reliance on a small number of customers[163] - In 2025, 50% of total revenues were derived from billing and customer care software, 35% from enterprise messaging, and 15% from enterprise software[162] - Services represented 96% of total revenues in 2025, while license fees accounted for 4%[162] Operational Efficiency and Product Development - The company emphasizes the need to enhance existing products and introduce new technologies, including AI, to meet customer expectations[46] - The introduction of an IoT solution enables centralized management and monitoring of IoT devices, expanding service offerings for enterprise customers[137] - The AI platform under development includes a chatbot to assist with customer inquiries, enhancing customer service capabilities[137] Economic and Regulatory Environment - The company is exposed to global economic conditions that may negatively impact customer spending decisions and revenue generation[35] - The company benefits from Israeli tax incentives under the "Preferred Technological Enterprise" program, valid until the end of 2026, but risks losing these benefits if conditions are not met[62] - Political and military conditions in Israel may influence operational results, although the business has not been materially affected to date[106] Operational Challenges - The company has encountered difficulties in retaining qualified personnel, which may hinder its ability to implement business strategies effectively[37] - The company relies on key personnel, and loss of these individuals could negatively impact business operations[67] - The company has experienced system outages in the past, which could harm customer satisfaction and lead to reputational damage[78]

Exhibit 10.1 SECURITIES PURCHASE AGREEMENT This SECURITIES PURCHASE AGREEMENT (this "Agreement") is dated as of March 17, 2026, by and among Ovid Therapeutics Inc., a Delaware corporation (the "Company"), and each of the entities listed on Exhibit A attached to this Agreement (each, an "Investor" and together, the "Investors"). WHEREAS, the Company and the Investors are executing and delivering this Agreement in reliance upon the exemption from securities registration afforded by Section 4(a)(2) of the Secu ...

Financial Performance - Jabil reported net revenue of $8.3 billion for the second quarter of fiscal year 2026, with a core operating margin of 5.7%[7][3] - U.S. GAAP diluted earnings per share for the second quarter was $2.08, while core diluted earnings per share (Non-GAAP) was $2.69[7][6] - Net revenue for the three months ended February 28, 2026, was $8,282 million, a 23% increase from $6,728 million in the same period last year[20] - Operating income for the three months ended February 28, 2026, was $374 million, representing a 52% increase compared to $245 million in the same period last year[20] - Net income attributable to Jabil Inc. for the six months ended February 28, 2026, was $369 million, a 70% increase from $217 million in the same period last year[20] - Diluted earnings per share for the three months ended February 28, 2026, was $2.08, up 96% from $1.06 in the same period last year[23] Revenue Outlook - The company raised its fiscal 2026 outlook, projecting net revenue between $34 billion and $34.8 billion, and core diluted earnings per share between $2.83 and $3.23[5][6] Cash Flow and Assets - Jabil's adjusted free cash flow (Non-GAAP) exceeded $1.3 billion, indicating strong cash generation capabilities[8] - Adjusted free cash flow for the six months ended February 28, 2026, was $632 million, compared to $487 million in the prior year, reflecting a 30% increase[25] - Cash flows provided by operating activities for the six months ended February 28, 2026, totaled $734 million, an increase from $646 million in the same period last year[22] - Total cash and cash equivalents at the end of the period was $1,830 million, compared to $1,592 million at the end of the same period last year[22] Operational Highlights - The company experienced robust demand in Intelligent Infrastructure, particularly in cloud and data center infrastructure, networking, and communications[3] - Jabil's total assets increased to $20.628 billion as of February 28, 2026, up from $18.543 billion at the end of August 2025[18] - Current liabilities rose to $14.811 billion, compared to $13.714 billion in the previous period, reflecting increased operational activities[18] Profitability and Growth - Jabil's retained earnings increased to $6.733 billion, up from $6.382 billion, demonstrating improved profitability[18] - The company is focused on profitable growth, disciplined execution, and margin expansion to deliver long-term value for shareholders[3] - Gross profit for the six months ended February 28, 2026, reached $1,488 million, up 26% from $1,182 million in the prior year[20] Adjustments and Acquisitions - The company incurred $848 million in cash paid for business and intangible asset acquisitions during the six months ended February 28, 2026[22] - The company recorded $62 million in adjustments to operating income for the three months ended February 28, 2026, primarily related to restructuring and acquisition charges[23]

Financial Performance - Fourth quarter 2025 revenue was $15.8 million, down 27% year-over-year, but up 44% excluding the maritime business; sequentially, revenue increased 25%[6] - Net loss for the fourth quarter 2025 was $25.1 million, reflecting a 49% year-over-year improvement, and adjusted EBITDA was ($9.7) million, an 8% year-over-year improvement[7] - For the full year 2025, total revenue was $71.6 million, meeting the mid-point of Spire's financial outlook[7] - Revenue for Q4 2025 was $15,825,000, a decrease of 27.1% compared to $21,659,000 in Q4 2024[29] - Net loss for Q4 2025 was $25,094,000, compared to a net loss of $48,783,000 in Q4 2024, showing an improvement[30] - The company reported a net cash used in operating activities of $59,829,000 for the year 2025, compared to $18,453,000 in 2024[32] - The company achieved a gain on the sale of a business amounting to $154,305,000 during the year 2025[29] - For FY 2026, the company projects revenue between $75,000,000 and $85,000,000, with revenue excluding maritime expected to be between $71,300,000 and $81,300,000[37] Cash Flow and Assets - Cash flows used in operations for the fourth quarter 2025 were $4.3 million, representing a 78% year-over-year improvement[8] - Spire's cash, cash equivalents, and marketable securities as of December 31, 2025, were $81.8 million, maintaining a debt-free balance sheet[8] - Cash and cash equivalents rose to $24,813,000 in 2025, compared to $19,206,000 in 2024[31] - Total assets increased to $210,992,000 as of December 31, 2025, up from $193,575,000 in 2024[31] Expenses and Margins - Operating expenses totaled $125,144,000 for the year 2025, an increase of 14.7% from $109,150,000 in 2024[29] - Gross profit for the year ended December 31, 2025, was $29,163,000, down from $39,875,000 in 2024, reflecting a gross margin decline[29] - The fourth quarter 2025 GAAP gross margin improved 8 percentage points year-over-year to 41%[7] - Gross profit (GAAP) for Q4 2025 was $6,432,000, down from $7,010,000 in Q4 2024, representing a decrease of 8.2%[33] - Non-GAAP gross profit for Q4 2025 was $6,867,000, compared to $8,264,000 in Q4 2024, a decline of 17.0%[33] - Research and development expenses were $36,672,000 for the year 2025, an increase of 25.5% from $29,237,000 in 2024[29] - Research and development expenses (GAAP) for Q4 2025 were $8,702,000, down from $10,052,000 in Q4 2024, a decrease of 13.4%[33] - Sales and marketing expenses (GAAP) for Q4 2025 were $2,575,000, down from $6,755,000 in Q4 2024, a significant decrease of 61.9%[33] Future Projections - Spire expects 2026 revenue, excluding maritime revenue, to grow over 50% from 2025, with guidance for Q1 2026 revenue ranging from $14.5 million to $15.5 million[10] - Revenue excluding maritime business for Q1 2026 is expected to change year-over-year by 4% to 12%, and for FY 2026 by 41% to 61%[10] - The projected loss from operations for FY 2026 is between $55,900,000 and $50,700,000, with a non-GAAP loss from operations expected to be between $37,800,000 and $32,600,000[37] - The company anticipates a net loss per share (GAAP) for FY 2026 between $1.65 and $1.49, with a non-GAAP net loss per share projected between $1.11 and $0.96[37] - For Q1 2026, revenue is expected to range from $14,500,000 to $15,500,000, with revenue excluding maritime projected between $12,800,000 and $13,800,000[36] Contracts and Developments - In Q4 2025, Spire launched 12 satellites and shipped 9 satellites for a launch completed in January 2026, enhancing its capabilities in space reconnaissance and weather forecasting[11] - Spire was awarded a contract with a shared ceiling of $151 billion for the Missile Defense Agency's SHIELD program, allowing for rapid delivery of innovative capabilities[11]

Revenue Growth - Annual Recurring Revenue (ARR) grew 28% year-over-year to $1.125 billion, with SaaS ARR increasing 38% year-over-year to $746 million[7]. - Total revenue for fiscal year 2026 was $1.071 billion, reflecting a 24% year-over-year increase, while subscription revenue rose 27% year-over-year to $1.010 billion[8]. - For Q1 FY 2027, SailPoint expects total ARR guidance of $1,153 to $1,157 million, representing a year-over-year growth of 25%[9]. - Total revenue guidance for FY 2027 is projected to be between $1,260 to $1,270 million, with a year-over-year growth of 18% to 19%[9]. - Total revenue for the three months ended January 31, 2026, was $294,647,000, representing a 23% increase from $240,121,000 in the same period of 2025[44]. - Subscription revenue for the three months ended January 31, 2026, reached $280,778,000, a 25% increase compared to $224,379,000 in the prior year[44]. - The company’s total subscription revenue for the year ended January 31, 2026, was $1,010,198,000, a 27% increase from $793,919,000 in 2025[44]. Profitability and Loss - Operating loss for fiscal Q4 2026 was $(40) million, or (14)% of revenue, compared to $(30) million, or (13)% of revenue in fiscal Q4 2025[8]. - Adjusted income from operations for fiscal Q4 2026 was $61 million, or 21% of revenue, up from $46 million, or 19% of revenue in fiscal Q4 2025[8]. - The net loss for the year ended January 31, 2026, was $270,054,000, a decrease from a net loss of $315,830,000 in 2025[37]. - The company reported a net loss of $36,215,000 for the three months ended January 31, 2026, an improvement from a net loss of $80,104,000 in the same period of 2025[42]. - GAAP net loss for the three months ended January 31, 2026, was $36,215,000, compared to a loss of $270,054,000 for the year[50]. - Adjusted net income for the year ended January 31, 2026, was $132,685,000, with an adjusted EPS of $0.24[50]. Cash Flow and Financial Position - Cash flows from operating activities in fiscal Q4 2026 were $64 million, with free cash flow of $57 million[7]. - Cash, cash equivalents, and restricted cash at the end of the period totaled $361,386,000, significantly up from $124,390,000 at the end of the previous year[42]. - Cash and cash equivalents as of January 31, 2026, were $358,144,000, significantly higher than $121,293,000 as of January 31, 2025[40]. - Net cash provided by operating activities for the three months ended January 31, 2026, was $63,864,000, compared to $13,794,000 in the same period of 2025[42]. - The company’s cash flows from investing activities for the three months ended January 31, 2026, were a net outflow of $6,894,000, compared to a net outflow of $12,663,000 in the same period of 2025[42]. Expenses - Research and development expenses increased to $56,366,000 for the three months ended January 31, 2026, up from $45,456,000 in the prior year[37]. - GAAP research and development expense for the three months ended January 31, 2026, was $56,366,000, up from $45,456,000 in 2025[47]. - GAAP sales and marketing expense for the three months ended January 31, 2026, was $140,692,000, an increase from $116,865,000 in 2025[48]. - GAAP general and administrative expense for the three months ended January 31, 2026, was $41,325,000, up from $27,665,000 in 2025[48]. - Adjusted research and development expense for the three months ended January 31, 2026, was $46,327,000, compared to $39,505,000 in 2025[47]. - Adjusted sales and marketing expense for the three months ended January 31, 2026, was $104,234,000, compared to $87,368,000 in 2025[48]. Future Outlook - The company aims to secure every type of identity, positioning itself as a foundational identity control plane for AI-powered enterprises[4]. - The company anticipates continued growth in the identity security solutions market, with expectations for future revenue growth and operational improvements[34]. - SailPoint's adjusted operating margin for FY 2027 is projected to be between 18.2% to 18.8%[9].

Revenue Performance - Total revenue for Q4 2025 was $3.1 million, a 62% increase compared to $1.9 million in Q4 2024, and a sequential increase of 25% from Q3 2025[5] - U.S. revenue for Q4 2025 was $0.9 million, reflecting a sequential growth of 74% during the second quarter of CGuard Prime's launch, while international revenue was $2.3 million, a 17% increase over Q4 2024[6] - For the full year 2025, total revenue was $9.0 million, a 28% increase from $7.0 million in 2024, with U.S. revenue at $1.4 million and international revenue at $7.6 million, an 8% increase over 2024[13] - The company expects full year 2026 revenue to be in the range of $13 million to $15 million, reflecting a growth of approximately 45% to 65% over 2025[19] Profit and Loss - Gross profit for Q4 2025 was $1.2 million, or 37.5% of revenue, up from $0.5 million, or 24.1% of revenue, in Q4 2024, driven by a favorable sales mix[7] - Net loss for Q4 2025 was $11.8 million, or $0.14 per share, compared to a net loss of $9.2 million, or $0.19 per share, in Q4 2024[12] Operating Expenses - Total operating expenses for Q4 2025 were $13.3 million, an increase of $3.5 million compared to $9.8 million in Q4 2024, primarily due to increased headcount-related expenses[10] Cash and Securities - As of December 31, 2025, cash and cash equivalents and marketable securities totaled $54.2 million, up from $34.6 million as of December 31, 2024[17] Liabilities and Equity - Total liabilities increased to $14,203 million in 2025 from $10,721 million in 2024, representing a growth of 32.7%[31] - Total equity rose to $55,201 million in 2025, up from $36,086 million in 2024, marking a significant increase of 53.0%[31] - Current liabilities reached $10,712 million in 2025, compared to $7,678 million in 2024, reflecting a 39.4% increase[31] - Long-term liabilities grew to $3,491 million in 2025, up from $3,043 million in 2024, indicating a rise of 14.7%[31] - Additional paid-in capital increased to $357,489 million in 2025 from $289,589 million in 2024, a growth of 23.5%[31] - The accumulated deficit widened to $(302,292) million in 2025 from $(253,506) million in 2024, an increase of 19.2%[31] - The number of common shares issued and outstanding increased to 43,532,281 in 2025 from 26,611,033 in 2024, a rise of 63.5%[31] - The total assets, as indicated by total liabilities and equity, reached $69,404 million in 2025, up from $46,807 million in 2024, representing a growth of 48.2%[31] - Operating lease liabilities net of current maturities increased to $2,224 million in 2025 from $1,796 million in 2024, a rise of 23.8%[31] - The liability for employee rights upon retirement and others slightly increased to $1,267 million in 2025 from $1,247 million in 2024, a growth of 1.6%[31] Clinical and Regulatory Updates - The company supported over 500 cumulative carotid procedures utilizing CGuard Prime since its launch[8] - The company completed enrollment in the CGUARDIANS II pivotal trial for CGuard Prime designed for TCAR procedures and submitted a PMA-S to the FDA for approval[8]