Financial Performance - Net loss attributable to common stockholders for Q4 2025 was $3.8 million, or $0.26 per share, compared to a net loss of $8.2 million, or $6.29 per share, in Q4 2024[6] - Net loss attributable to common stockholders for the full year 2025 was $35.5 million, or $7.13 per share, compared to a net loss of $12.9 million, or $12.52 per share, in 2024[9] Expenses - Research and development expenses for Q4 2025 were $2.3 million, consistent with Q4 2024[4] - Full year 2025 research and development expenses increased to $21.8 million from $3.5 million in 2024, driven by acquired in-process research and development expenses of $12.0 million[7] - General and administrative expenses for Q4 2025 decreased to $1.5 million from $5.2 million in Q4 2024, primarily due to a reduction in nonrecurring transaction costs[5] - Full year 2025 general and administrative expenses were $6.1 million, down from $8.7 million in 2024, mainly due to lower transaction costs[8] Cash Position - As of December 31, 2025, cash and cash equivalents totaled $6.5 million, expected to fund operations through the Phase 2b final data readout[10] Clinical Trials - The Halneuron® Phase 2b trial has enrolled 143 patients, with top-line results expected in Q3 2026[2] Financing - A financing of up to $26.9 million was completed in January 2026, with gross proceeds of $12.5 million received[5] Regulatory Status - Halneuron® has received fast track designation from the FDA for treating chemotherapy-induced neuropathic pain[13]

Financial Performance - The Group reported a net loss after tax of $4,070,000 for the six months ended 31 December 2025, a 57% improvement compared to the loss of $9,554,000 for the year ended 30 June 2025[32]. - Operating cash flows improved by 55%, from a negative $6,805,000 for the year ended 30 June 2025 to a negative $3,069,000 for the six months ended 31 December 2025[34]. - Revenue for the six months ended December 31, 2025, was $328,000, a decrease from $653,000 for the previous twelve months[181]. - Loss before income tax expense for the six months was $4,070,000, compared to a loss of $9,554,000 for the previous twelve months[181]. - Total comprehensive income for the period attributable to the owners was a loss of $3,863,000, compared to a loss of $9,823,000 for the previous twelve months[181]. - Cash and cash equivalents decreased to $17,863,000 from $25,059,000 at the end of the previous period[182]. - Total assets slightly decreased to $232,543,000 from $233,541,000[182]. - Total liabilities decreased to $2,324,000 from $3,243,000, indicating improved financial stability[182]. - Net cash used in operating activities for the six months was $3,069,000, compared to $6,805,000 for the previous twelve months[184]. - Expenditure on exploration and evaluation was $6,629,000 for the six months, down from $14,510,000 for the previous twelve months[184]. - Issued capital increased to $309,498,000 from $302,651,000, reflecting ongoing capital raising efforts[183]. Project Development - Ioneer closed a $996 million loan from the U.S. Department of Energy's Office of Energy Dominance Financing in January 2025 to support the development of the Rhyolite Ridge project[6]. - The project economics improved significantly, with a 64% increase in unlevered NPV to $2.23 billion and an 18.0% unlevered IRR, following a reduction in leach duration from 3 days to 1.5 days[8]. - The estimated all-in sustaining cash cost to produce battery-grade lithium hydroxide is US$4,628 per tonne, positioning Rhyolite Ridge in the lowest cost quartile for lithium production globally[13]. - The strategic partnering process is ongoing, with active discussions to identify strong equity partners for Rhyolite Ridge, expected to conclude in the first half of 2026[4]. - The U.S. Department of Interior added boron to its Final 2025 List of Critical Minerals, enhancing the strategic importance of Rhyolite Ridge[17]. - The current mine plan consists entirely of Reserve material, with approximately 35% classified as Proved Ore Reserve, allowing for potential mine life extension[15]. - Ioneer is developing a commercial-scale refining plant for lithium clay in partnership with EcoPro Innovation, with a commercially feasible process flow sheet completed[21]. - The independent evaluation of the Rhyolite Ridge cost estimate confirmed the quality of the project’s cost estimate and risk management framework[23]. - Ioneer holds all significant Federal and State authorizations required for the construction of Rhyolite Ridge, with ongoing legal proceedings related to environmental approvals[24]. - The company is focused on developing the Rhyolite Ridge Lithium-Boron Project, which is the only permitted, shovel-ready lithium-boron project in the U.S.[36]. - The company has secured a $996 million loan from the U.S. Department of Energy to support the development of an on-site processing facility at the Project[42]. - The company has completed 70% of the detailed engineering design, positioning it to be construction-ready at the Final Investment Decision (FID)[37]. - The company anticipates concluding its Strategic Partnering process in the first half of 2026, which is crucial for project financing and execution[36]. - The company plans to issue a 2026 Sustainability Report in the first half of 2027[64]. Shareholder and Executive Compensation - Ioneer Limited's directors hold a total of 150,648,853 shares and 24,357,658 performance rights as of December 31, 2025[50]. - James D Calaway, the Executive Chair, holds 63,595,869 shares and 7,206,821 performance rights[50]. - Bernard Rowe, a director, holds 78,806,195 shares and 16,198,505 performance rights[50]. - Timothy Woodall, an independent non-executive director, holds 375,000 shares and 388,083 performance rights[50]. - Ian Bucknell resigned as Chief Financial Officer and Company Secretary effective December 4, 2025[49]. - April Hashimoto will assume the role of Chief Financial Officer effective December 4, 2025[49]. - The company has a strong leadership team with extensive experience in finance, engineering, and resource sectors[49]. - The board includes members with significant backgrounds in M&A, finance, and project management[49]. - The company is committed to expanding its market presence and enhancing its operational capabilities through strategic leadership[49]. - The company issued 400,000,000 new fully paid ordinary shares at an issue price of A$0.18 (~US$0.13) per share, raising gross proceeds of A$72 million (~US$50 million) to accelerate the development of Rhyolite Ridge[71]. - The company has experienced low turnover at the executive KMP and senior management levels, with an annual retention rate well above 90% despite challenges in the lithium sector over the last three years[88]. - No changes were made to board fees, which have remained unchanged since 2020[89]. - At the October 2025 Annual General Meeting, 72.7% of shareholders voted for the FY2025 remuneration report, falling 2.3% short of the 75% threshold for avoiding a first strike[90]. - The company plans to continue engaging with shareholders and proxy advisers for feedback, believing that executive KMP remuneration is conservatively configured to meet market standards while conserving cash[92]. - The Board decided to discontinue the practice of allowing employees, including executive KMPs, to receive a 20% uplift in STI payments by deferring payment and converting cash to equity[94]. - The maximum total remuneration quantum for FY2025 was deemed appropriate, as the company must pay North American rates to attract and retain US-based executives[106]. - The company’s compensation framework aligns with U.S. standards, typically involving less cash and more equity compared to Australian market standards[108]. - The performance objectives for STI and equity vesting are designed to accelerate development during the pre-production phase, aligning with shareholder value[108]. - The company has not made any one-off equity grants in FY2025[94]. - The LTIP plan includes a time-based element, with only 25% of the LTIP subject to service, which is less than the market practice for most executive KMPs[91]. - Executive KMP annual base salaries were not increased during TY2025, with the base salary for James D Calaway at A$250,000 and Bernard Rowe at A$585,000[116]. - The maximum short-term incentive (STI) opportunity for the Managing Director is 160%, with a prorated amount of 80% for TY2025[120]. - The STI scorecard for TY2025 includes a target of 40% for strategic partnering, with a stretch goal of announcing deals to the market[123]. - Performance-based PRs comprise 60% of the annual target grant value, with a maximum of 75% based on performance metrics[116]. - The long-term incentive (LTI) performance period for TY2025 is adjusted to 42 months, covering from July 1, 2025, to December 31, 2028[124]. - The STI scorecard includes a financial target of spending levels at or below budget, with a base requirement of spending within 1% of the approved budget[123]. - The Board reserves the right to grant above 200% of target STI for exceptional contributions or exercise negative discretion based on shareholder experience[121]. - Time-based PRs make up 40% of the annual target grant value, contingent upon the employee remaining employed until the vesting date[116]. - The Company benchmarks executive KMP base salaries against resource industry market surveys, aiming to position at the P25-P50 level of the market[115]. - The maximum STI opportunity for the Senior Vice President Engineering & Operations is 100%, with a prorated amount of 50% for TY2025[120]. - The company reported a net loss after tax of US$4,070,000 for the six months ended December 31, 2025, compared to a loss of US$9,553,000 for the previous six months[138]. - Basic loss per share was US(0.169) for the six months ended December 31, 2025, compared to US(0.405) for the previous period[138]. - The closing share price increased to A$0.19 as of December 31, 2025, up from A$0.10 six months prior[138]. - The company aims to increase the Measured and Indicated LCE Resource by 10% by June 30, 2025, as part of its long-term strategy[132]. - The maximum incentive opportunity for the Managing Director is set at 48% of base salary for TY2025, reflecting a longer service period[136]. - The vesting scale for shareholder return components indicates that achieving the bottom quartile results in 0% vesting, while the first quartile results in 200% vesting[131]. - The company has set performance targets that include advancing project funding and enhancing project economics through plant optimization for TY2025[141]. - The Board has established a minimum share ownership requirement of five times base salary for the Managing Director over a five-year period[137]. - The company’s total shareholder return over five years was reported at (33.93%) as of December 31, 2025[138]. - The performance rights (PRs) issued are subject to vesting conditions and may be adjusted pro-rata in case of capital restructuring[128]. - The company achieved a 6% reduction in spending compared to the approved budget, demonstrating fiscal discipline[143]. - The strategic partnering process remains active but was delayed from the original schedule, resulting in a 0% outcome for the strategic partnering measure[145]. - The unlevered Project NPV improved by 38% and 64% due to enhanced mining and process plant optimization, exceeding expectations[143]. - There were no OSHA recordable workplace injuries during the performance period, achieving excellent safety outcomes[143]. - The company obtained modified State Air/Water permits and made significant progress in transferring operational water rights, with beneficial agreements reached[143]. - Employee retention was maintained with only one key staff departure during the period, achieving a 5% outcome for this measure[145]. - The total STI payout for executives was calculated at 70% of target, reflecting mixed performance across various measures[144]. - The company spent 6% below budget, with close attention to funding constraints taken into account[143]. - The anticipated first transplanting and seeding of Tiehm's Buckwheat is expected in March, although delays were caused by the U.S. Government shutdown[143]. - The company reviewed over 40 sites for outplanting suitability, selecting two 40-acre sites for trials[143]. - Total equity vesting for executives amounted to 182,561,362 shares, with a net change of 3,781,102 shares during the period[158]. - James D. Calaway holds 63,595,869 shares after acquiring 4,600,759 shares, while Bernard Rowe has 78,806,195 shares after acquiring 9,197,048 shares[158]. - Ian Bucknell's balance increased to 8,945,076 shares after acquiring 3,144,310 shares, despite a disposal of 500,000 shares[158]. - The total balance of ordinary shares for non-executive directors reached 5,914,149 shares, reflecting an increase of 887,890 shares[158]. - The company reported that all remaining options have lapsed, indicating no outstanding options as of the reporting date[160]. - The fair value of options granted to executives was set at 0.138, with an exercise price of 0.185[161]. - The total number of performance rights granted, vested, or lapsed during the year 2025 is detailed in the remuneration report[162]. - The company appointed April Hashimoto as Interim Chief Financial Officer effective November 6, 2025[159]. - The net change in performance rights for executives was recorded as 652,646 shares, all of which lapsed[161]. - The total balance of shares for executive directors reached 159,113,089 shares, with a net change of 27,106,663 shares[158]. - The total fair value of granted rights for 2025 STI and LTI is approximately $41.54 million, with $25.65 million lapsed and $12.11 million performance-based rights lapsed[164]. - 100% of the 2022 LTI time-based rights have lapsed for several executives, indicating a complete vesting failure for this period[164]. - The performance-based rights for 2022 LTI show an 18% vesting rate, with significant lapses totaling approximately $688,902 across various executives[164]. - The 2025 STI time-based rights granted to executives include a one-off ROD bonus with a vesting period of one day, contingent on achieving a positive Record of Decision in FY2025[164]. - The total number of rights granted for 2025 LTI performance-based is 5,836,000, with no rights vested yet[164]. - The company has a significant number of lapsed rights, with a total of 25,650,020 lapsed rights reported for the current period[164]. - The 2024 STI time-based rights have a 100% lapse rate for multiple executives, indicating a potential issue with performance targets[164]. - The company has implemented a new strategy for executive compensation, focusing on performance-based incentives to align with long-term goals[167]. - The total fair value of rights granted for 2025 STI is approximately $6.2 million, with 100% of certain rights vested[164]. - The company is facing challenges in retaining executive talent, as indicated by the resignation of key executives without pro-rata incentives being paid[165]. - The Executive Chair's base salary is set at US$250,000 per annum, effective January 4, 2025, in addition to the existing non-executive chair remuneration of US$185,000[170]. - The Managing Director's base salary is A$585,000 per annum, with a target bonus of 80% of base salary and a maximum STI of 200% of target (160% of base salary)[171]. - The Executive Chair is eligible for a target bonus of 60% of base salary, with a maximum STI of 200% of target (120% of base salary)[170]. - Performance-based awards for the Executive Chair may range from 0 to 200% of grant based on achievement of pre-established targets, with a maximum performance-based PRs of 72% of base salary[171]. - Non-executive Directors' remuneration is capped at A$1,000,000 per annum, including superannuation and retirement benefits[174]. - The Senior Vice President of Engineering & Operations is eligible for a target bonus of 50% of base salary, with a maximum STI of 200% of target (100% of base salary)[172]. - The Vice President of Human Resources is eligible for a target bonus of 40% of base salary, with a maximum STI of 200% of target (80% of base salary)[172]. - The equity grant for the Managing Director is set at 120% of base salary, with 60% performance-based and 40% time-based[171]. - The total fees for Non-executive Directors include cash and equity components, with the Chair receiving A$150,000 in cash and A$35,000 in equity[177]. - Hedging of Performance Rights by Non-executive Directors is not permitted[180].

Acquisition and Growth Strategy - Giftify acquired CardCash for $26,682,000, consisting of 6,108,007 shares of common stock valued at $4.00 per share, $750,000 in cash, and $1,500,000 in notes payable[19]. - CardCash's operations are projected to contribute significantly to the gift card market, expected to reach $400 billion by 2026, with a focus on expanding its four business channels[26]. - CardCash's growth strategy includes increasing marketing efforts to retailers and consumers to accelerate gift card sales[30]. - The introduction of the CardCash uChoose platform enhances the company's offerings by allowing businesses to provide gift cards from a wide selection of brands[28]. - The acquisition of Takeout7 Inc. on May 29, 2025, expanded the company's technology offerings for independent restaurants[187]. Financial Performance - For the fiscal year ended December 31, 2025, net sales reported were $83,181,716, a decrease of 6.5% from $88,934,036 in 2024[202]. - Gross billings for the same period were $154,707,400, reflecting a 27.1% increase from $121,689,314 in 2024[202]. - The company realized net income of $830,197 for the year ended December 31, 2025[76]. - The company reported significant operating losses and negative cash flows in 2025 and 2024, raising concerns about its ability to continue as a going concern[206][205]. - CardCash has incurred net losses since its inception, with net losses of $2,052,198 and $124,546 for the years ended December 31, 2024 and 2023, respectively[76]. Customer Base and Market Position - Restaurant.com's B2C division accounted for approximately 15% of gross revenue for the fiscal year ended December 31, 2025, with a customer database of 6.2 million[34]. - The B2B division of Restaurant.com represented about 85% of gross revenue for the same fiscal year, selling certificates and Discount Dining Passes to corporations[36]. - As of December 31, 2025, the company had a customer base of 5.4 million and featured deals at over 184,000 restaurants and merchants[58]. - The company has a customer database of 6.2 million, which is considered valuable for future revenue opportunities[198]. Operational Challenges and Risks - There is substantial doubt regarding the company's ability to continue as a going concern for at least 12 months beyond the filing of the Annual Report[75]. - The company faces competition from larger, established companies with greater resources and customer bases, which may impact its market position[59]. - The company is subject to evolving regulations that could adversely affect its business operations, including data protection and online service provider liability laws[60]. - The company must continuously improve fraud detection measures to mitigate losses from counterfeit certificates and unauthorized transactions, as failure to do so could harm business operations[95]. - The company is vulnerable to natural disasters and terrorism, which could disrupt operations and negatively affect financial results[93]. Marketing and Customer Acquisition - Restaurant.com utilizes various marketing channels, including search engines, email, and social media, to promote its offerings and acquire new customers[38]. - The company plans to significantly increase its marketing and branding expenditures, which may adversely affect its financial results[117]. - A decline in customer traffic from email and search engine optimization has been noted, leading to a higher reliance on paid marketing channels[138]. - The company faces potential challenges in delivering emails effectively due to changes in email provider policies, which could restrict customer contact[118]. Compliance and Regulatory Issues - The implementation of the CARD Act and similar state laws may classify the company’s discount certificates as gift cards, potentially increasing liabilities related to unredeemed certificates and adversely affecting net income[80]. - The company may face increased compliance costs if it becomes subject to anti-money laundering laws or regulations, which could reduce net income[98]. - The company is subject to scaled disclosure requirements as a smaller reporting company, which may make it more challenging for investors to analyze its financial prospects[155]. Cybersecurity and Technology - Cybersecurity risks pose a threat to the company, with potential breaches leading to significant legal and financial exposure[113]. - The company has implemented a cybersecurity risk management program to identify, assess, and mitigate risks from cybersecurity threats, integrating it into overall risk management processes[160]. - The company utilizes advanced fraud-prevention technology, FraudFix, to ensure transaction security, contributing to consumer savings of over $100 million since inception[193]. Capital and Funding - The company may need to raise additional capital to meet long-term business requirements, which could dilute current stockholders' ownership interests[130]. - Future capital raising efforts may be limited, and failure to secure necessary funding could hinder growth and response to competitive pressures[103]. Stock and Trading Information - The company's common stock is now trading on the Nasdaq Marketplace, but there is limited trading activity, and no assurance that an active market will develop in the future[146]. - Approximately 20% of the outstanding shares of common stock are beneficially owned by insiders, which may adversely affect the price of the common stock and limit stockholder influence[153].

Acquisition and Market Impact - Giftify acquired CardCash for $26,682,000, consisting of 6,108,007 shares valued at $4.00 per share, $750,000 in cash, and $1,500,000 in notes payable[19]. - CardCash's operations are projected to contribute significantly to the gift card market, expected to reach $400 billion by 2026[26]. - CardCash has saved consumers over $100 million since its inception through its gift card exchange platform[24]. - CardCash's branded exchange partnerships with CVS and Amazon generated revenues of $1,800,000 and $1,900,000 respectively in 2023[31]. - The acquisition of Takeout7 Inc. on May 29, 2025, expanded the company's technology offerings for independent restaurants[187]. Financial Performance - For the fiscal year ended December 31, 2025, the company recorded a net loss of $10,491,658 and used cash in operating activities of $1,590,074[75]. - The company realized net income of $830,197 for the year ended December 31, 2025[76]. - For the fiscal year ended December 31, 2025, net sales reported were $83,181,716, a decrease of 6.5% from $88,934,036 in 2024[202]. - Gross billings for the same period were $154,707,400, reflecting a 27.1% increase from $121,689,314 in 2024[202]. - Gross revenue from principal transactions for the year ended December 31, 2025, was $78,264,149, a decrease from $86,758,876 in 2024[213]. - Net revenue from agent transactions increased by $2,742,407, or 126.1%, to $4,917,567 in 2025 compared to $2,175,160 in 2024[213]. - A significant portion of revenue is derived from discounted merchant gift card sales, where gross billings differ from net sales due to retained fees and commissions[214]. Operational Insights - CardCash's gross margin is currently 16.8%, with an anticipated increase of approximately 8% over the next two years due to improved inventory sourcing and retail sales[30]. - The B2C division of Restaurant.com accounted for approximately 15% of gross revenue for the fiscal year ended December 31, 2025[34]. - Restaurant.com's B2B division generated approximately 85% of gross revenue for the fiscal year ended December 31, 2025[36]. - The average order value for bundled offerings ("Specials") from Restaurant.com is nearly five times that of standard certificate purchases[35]. - As of December 31, 2025, the company had a customer base of 5.4 million and featured deals at over 184,000 restaurants and merchants[58]. Challenges and Risks - There is substantial doubt regarding the company's ability to continue as a going concern for at least 12 months beyond the filing of the Annual Report[75]. - The company faces competition from larger, established companies with greater resources and customer bases, which may impact its market position[59]. - The company is subject to various foreign and domestic laws and regulations that could adversely affect its business operations[60]. - The implementation of the CARD Act and similar state laws may classify the company’s discount certificates as gift cards, potentially increasing liabilities related to unredeemed certificates and adversely affecting net income[80]. - The company’s total customer count may be inflated due to multiple registrations and inactive accounts, making it difficult to accurately assess the number of active customers[89]. - The business is subject to seasonal sales fluctuations, which could lead to volatility in working capital cash flow and affect the market price of its common stock[90]. - The company faces risks associated with internet regulations and compliance, which could impede growth and affect revenue if not adhered to[82]. - Fraudulent transactions and counterfeit certificates pose significant risks, potentially leading to substantial losses and affecting the company’s ability to accept credit card payments[95]. - The evolving landscape of privacy laws and regulations could lead to liabilities and affect customer trust if compliance is not maintained[83]. - The company is subject to payments-related risks, including potential increases in interchange fees that could reduce profitability[96]. - Current economic uncertainty, particularly due to geopolitical conflicts, may adversely affect revenue and business operations[100]. - Global inflation has increased operating costs, particularly in employee wages, which could negatively impact financial results[102]. - Future capital raising may be limited, potentially hindering growth and response to competitive pressures[103]. - The company faces risks from changes in search engine algorithms that could negatively impact website traffic and operating results[120]. Employee and Corporate Structure - The company employs 40 full-time employees as of December 31, 2025, and considers its employee relations to be good[73]. - The company is classified as a "smaller reporting company" with a public float of less than $250 million, allowing for simplified disclosures in SEC filings[74]. - The company has 825 holders of record of its common stock as of December 31, 2025[176]. - Approximately 20% of the outstanding shares of common stock are beneficially owned by insiders, which may adversely affect the price of the common stock and limit stockholder influence[153]. Marketing and Customer Engagement - CardCash intends to increase its marketing efforts to accelerate gift card sales and enhance customer engagement[30]. - The company plans to significantly increase its marketing and branding expenditures, which may adversely affect its financial results[117]. - Attracting and retaining customers on cost-effective terms is critical for future revenue growth[109]. - The reliance on email marketing is critical, and any restrictions on email delivery could materially harm the business[118]. Cybersecurity and Technology - The company has implemented a cybersecurity risk management program to identify, assess, and mitigate risks from cybersecurity threats, integrating it into overall risk management processes[160]. - The company has not experienced material adverse effects from cybersecurity threats to date, but has faced threats and breaches of data and systems[163]. - CardCash's technology, FraudFix, ensures transaction security and integrity, contributing to its competitive advantage in the market[24]. - The company's advanced fraud-prevention technology, FraudFix, has contributed to saving consumers over $100 million since inception[193]. Real Estate and Facilities - The principal executive offices are located in Schaumburg, IL, covering approximately 7,850 square feet, with a lease executed in April 2023 for a 36-month term at an average base rent of approximately $7,500 per month[167]. - CardCash signed a lease in April 2024 for its office in Woodbridge, NJ, with a term of 61 months through April 2029, and an average base rent of approximately $28,000 per month[168]. Stock and Market Activity - The company's common stock is now trading on the Nasdaq Marketplace, but there is limited trading activity and no assurance that an active market will develop in the future[146]. - The trading price of the common stock may fluctuate significantly due to various factors, including operating results and market conditions[155]. - The company is classified as a "smaller reporting company," which may make it more challenging for investors to analyze its results of operations and financial prospects[155].

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 ...