Financial Performance - Net revenues for 2025 increased by 3% to $142.4 million, compared to $138.3 million in 2024[6] - Net income rose to $1.7 million, or $0.05 per diluted share, up from $0.7 million, or $0.02 per diluted share in 2024[8] - Cash provided by operating activities was $2.6 million, significantly higher than $0.3 million in the previous year[2] - Gross margin improved to 52.4%, up from 52.1% in 2024, due to better product costs and an optimized pricing system[7] - Operating income more than doubled from the prior year, driven by higher gross margin and improved operating efficiency[5] Operational Efficiency - Operating expenses as a percentage of net revenues decreased by 0.9% to 50.7% in 2025, compared to 51.6% in 2024, reflecting improved operational efficiency[7] Future Outlook - The company expects 2026 net revenue guidance to be between $143 million and $163 million, indicating flat to 15% year-over-year growth[10] - The company plans to expand its business by increasing the number of business managers, vendors, and SKUs in the upcoming years[11] Inventory and Procurement - Hour Loop's procurement strategy led to an increase in inventory levels, contributing to revenue growth[6] Cash Position - As of December 31, 2025, cash and cash equivalents increased to $3.8 million from $2.1 million in 2024, primarily due to operating profit[8]

Currency and Interest Rate Exposure - The Group's largest currency exposure is related to future instalments for newbuild vessels, amounting to USD 496 million[886]. - A 10% deterioration in the USD:EUR exchange rate would decrease the result before tax by EUR 1.6 million for 2025, compared to EUR 1.8 million for 2024 and EUR 4.6 million for 2023[887]. - The EURIBOR interest rate was 2.1%, 2.9%, and 3.9% at the end of 2025, 2024, and 2023, respectively[890]. - An increase of 100bps in the EURIBOR interest rate would raise interest costs by EUR 15.6 million for 2025, EUR 5.9 million for 2024, and EUR 2.1 million for 2023[891]. - The average fixed rate of interest rate swaps is 2.83% for 2025, slightly up from 2.78% in 2024 and 2.81% in 2023[924]. - The Group's interest rate risk has been partially hedged, with the average fixed rate of cap/floor swaps ranging between 2.1% and 1.1%[924]. Financial Obligations and Debt Financing - As of 31 December 2025, total obligations related to newbuild vessels amounted to EUR 462 million, with USD obligations translating to EUR 422 million[904]. - The Group anticipates seeking additional debt financing for milestone payments related to the delivery of the third A-class newbuild vessel[903]. - The total committed financial liabilities amount to EUR 1,696 million, with EUR 411 million unutilised as of 31 December 2025[940]. - The Group's outstanding guarantees totalled EUR 253 million as of December 31, 2025, related to offshore wind installation projects[975]. - The total utilized debt as of December 31, 2025, was EUR 468 million, due within 5 years[1043]. Derivative Assets and Liabilities - The Group's total derivative assets amounted to EUR 2,682 thousand as of 31 December 2025, a decrease from EUR 18,468 thousand in 2024[917]. - The total derivative liabilities were EUR 13,716 thousand as of 31 December 2025, down from EUR 16,414 thousand in 2024[917]. - As of 31 December 2025, derivatives measured at fair value through profit or loss resulted in a gain of EUR 2,116 thousand, compared to a loss of EUR 26 thousand in 2024 and a gain of EUR 403 thousand in 2023[918]. - The cumulative fair value change of cash flow hedges at 31 December 2025 is EUR (8,958) thousand, a significant improvement from EUR 1,799 thousand in 2024 and a loss of EUR (21,559) thousand in 2023[922]. - The cumulative fair value change for foreign currency risk hedging at year-end 2025 is EUR 881 thousand, compared to EUR 16,744 thousand in 2024[932]. - The fair value of derivative assets as of December 31, 2025, was EUR 2.64 million, while derivative liabilities amounted to EUR 13.7 million[1042]. Revenue and Profitability - The company reported a revenue of EUR 422,004,000 for 2025, a significant increase from EUR 126,680,000 in 2024, representing a growth of 233%[986]. - Gross profit for 2025 was EUR 200,686,000, compared to EUR 49,397,000 in 2024, indicating a gross margin improvement[986]. - Operating profit surged to EUR 145,469,000 in 2025 from EUR 11,050,000 in 2024, reflecting a substantial operational efficiency gain[986]. - Total revenue for 2025 reached EUR 422.0 million, a significant increase of 233% compared to EUR 126.7 million in 2024[1015]. - Revenue from Denmark was EUR 102.5 million in 2025, up from EUR 51.1 million in 2024, while UK revenue increased to EUR 131.6 million from EUR 68.1 million[1015]. Expenses and Employee Compensation - The cost of sales for 2025 was EUR 221.3 million, compared to EUR 77.3 million in 2024, reflecting a 186% increase[1016]. - Employee compensation for 2025 totaled EUR 60.6 million, a 67% increase from EUR 36.3 million in 2024[1023]. - The average number of full-time employees rose to 570 in 2025, up from 344 in 2024[1023]. - The total administrative expenses for 2025 were EUR 55.2 million, compared to EUR 38.3 million in 2024[1016]. Assets and Liabilities - The company’s total assets increased to EUR 1,881,851,000 in 2025, up from EUR 1,733,293,000 in 2024, marking a growth of 8.6%[989]. - Total equity rose to EUR 1,254,240,000 in 2025, compared to EUR 1,134,497,000 in 2024, an increase of 10.5%[990]. - The company’s non-current liabilities increased to EUR 472,665,000 in 2025 from EUR 372,243,000 in 2024, indicating a rise in long-term debt obligations[989]. - The carrying amount of investments in subsidiaries increased to EUR 1,105.5 million in 2025, up from EUR 745.5 million in 2024, due to additions of EUR 360.1 million[1037]. Newbuild Vessels and Commitments - The company has commitments for newbuild vessels totaling EUR 2,154,000,000, with remaining commitments of EUR 1,395,000,000 due by December 2024[978]. - The company delivered two new P-class WTIVs, Wind Peak and Wind Pace, in 2024 and 2025, respectively, with final payments made upon delivery[979]. - The company entered into contracts for three A-class FIVs, with the third expected to be delivered in Q2 2027[980]. Compliance and Audit Matters - There have been no breaches of financial covenants for any interest-bearing loans and borrowings in the current period[908]. - The Group is in compliance with all covenants across its debt facilities, including a minimum equity ratio of 35% and a debt service coverage ratio of at least 2:1 for the Holdco Facility[952][954]. - The audit focused on the complexity of determining performance obligations in contracts, making revenue recognition a key audit matter[1079]. - The company’s internal controls over the revenue recognition process were evaluated, including management's review controls over contracts[1080]. - The audit included inspection of customer contracts to assess the identification of distinct performance obligations and measurement methods against IFRS standards[1081]. - The adequacy of the company's disclosures in Note 3 to the consolidated financial statements was evaluated[1082].

Market Overview - Core & Main estimates its addressable market in the U.S. and Canada for water, wastewater, storm drainage, and fire protection products to be approximately $44 billion in fiscal 2025[28]. - The company's net sales represented approximately 17% of its $44 billion addressable market in fiscal 2025[64]. - Approximately 44% of net sales were derived from the municipal end market, 38% from non-residential, and 18% from residential[22]. - Approximately 18% and 38% of the company's net sales in fiscal 2025 were directly related to the U.S. residential and non-residential end markets[102]. - 44% of the company's net sales in fiscal 2025 were related to the municipal market, which is influenced by municipal infrastructure spending[104]. Product Sales Breakdown - Pipes, valves, and fittings accounted for approximately 67% of net sales in fiscal 2025[51]. - Storm drainage products represented about 16% of net sales in fiscal 2025[53]. - Fire protection products contributed approximately 8% to net sales in fiscal 2025[55]. - Meter products accounted for around 9% of net sales in fiscal 2025[57]. - Sales through the strategic accounts program represented approximately 5% of fiscal 2025 net sales[36]. Customer Base and Supplier Relationships - Core & Main has over 370 branch locations across the U.S. and Canada, serving over 60,000 customers[20]. - The company has a fragmented customer base of over 60,000 customers, with the top 50 customers accounting for approximately 12% of net sales in fiscal 2025[59]. - The largest single supplier represented about 7% of product expenditures, while the top ten suppliers accounted for approximately 45% of total product expenditures in fiscal 2025[62]. - The top supplier accounted for approximately 7% of the company's product expenditures, while the top ten largest suppliers accounted for approximately 45% of total purchases in fiscal 2025[126]. Financial Performance and Strategy - The company aims to enhance gross margins through private label product expansion and data-driven pricing strategies[42][45]. - The company plans to pursue strategic acquisitions to expand its geographic footprint and product offerings[39]. - The company invests in new technology and data systems to enhance long-term business operations[68]. - The company has a performance-based compensation structure that aligns associates' interests with branch profitability and working capital efficiency goals[80]. - The company maintains a pay-for-performance philosophy to attract and retain industry-leading talent[78]. Risks and Challenges - The company is subject to various federal, state, and local regulations, which may impact operating costs and financial performance[90]. - The company experienced price increases in fiscal 2022 due to supply chain constraints, inflationary pressures, and availability of raw materials[111]. - The company is exposed to price fluctuations due to tariffs and trade policies, with over three-quarters of products purchased being manufactured domestically[112]. - The company faces risks related to inventory management, where insufficient inventory may lead to lost sales opportunities, while excess inventory may negatively impact gross margin[114]. - The company cannot predict the duration of market conditions in the residential or non-residential construction industry, which may lead to fluctuations in operating results[103]. Operational and Compliance Issues - The company is subject to various federal, state, and local regulations that could increase operational costs, including changes in tax laws[138]. - The company anticipates significant costs related to compliance with environmental, health, and safety laws, which may exceed current estimates and reserves[136]. - Future capital and operating expenditures for environmental compliance could materially affect the company's financial condition[137]. - The company relies on IT systems for critical operations, and any disruptions could materially affect order processing and inventory management[155]. - The legal and regulatory environment surrounding information security and privacy is constantly evolving, impacting operational costs and potential liabilities[157]. Debt and Financial Obligations - As of February 1, 2026, total consolidated indebtedness was $2,166 million, with $325 million in outstanding lease commitments[169]. - The company is required to comply with a consolidated fixed charge coverage ratio under certain circumstances, affecting its ability to borrow additional amounts[173]. - The Senior ABL Credit Facility matures on February 9, 2029, with other loans maturing in 2028 and 2031, posing refinancing risks[183]. - Default on debt obligations could lead to foreclosure or bankruptcy, adversely impacting the company's financial condition[184]. - The company is dependent on distributions from Holdings and its subsidiaries to cover taxes and operating expenses, which may be restricted[187]. Stock and Shareholder Considerations - The company completed $155 million and $176 million of repurchases of Class A common stock under the Repurchase Program during fiscal 2025 and fiscal 2024, respectively[217]. - The board of directors authorized an increase of $500 million to the share repurchase program, allowing for a total of up to $1 billion in Class A common stock repurchases[217]. - The company currently does not have an approved plan to pay dividends on its Class A common stock, focusing instead on using future earnings for debt repayment and growth[216]. - The company may issue additional shares of Class A common stock or other equity securities, which could result in substantial dilution to existing shareholders[211]. - Anti-takeover provisions in the company's Certificate of Incorporation and By-laws may discourage changes in management or control, potentially affecting the market price of Class A common stock[212].

Financial Performance - Revenue for Q1 2026 was $2,500.4 million, a 5.4% increase year-on-year from $2,372.2 million in Q1 2025[3] - Operating income decreased to $118.6 million, representing 4.7% of revenue, down from $168.9 million or 7.1% in the prior year[3] - Non-GAAP operating income was $295.0 million, or 11.8% of revenue, compared to $321.5 million, or 13.6% in Q1 2025[3] - Adjusted EBITDA for the quarter was $348.2 million, with a margin of 13.9%, down from $374.2 million and 15.8% in the previous year[3] - Net income fell to $21.6 million, a 69.3% decrease from $70.3 million in Q1 2025[3] - Non-GAAP diluted earnings per share (EPS) was $2.61, down from $2.79 in the prior year, reflecting a 6.5% decline[3] - Total revenue for the three months ended February 28, 2026, was $2,500,391, representing a 5% increase compared to $2,372,222 for the same period in 2025[30] - Net income for the three months ended February 28, 2026, was $21,589, a decrease of 69% from $70,257 in the same period last year[30] - Operating income fell by 30% to $118,559 compared to $168,867 in the prior year[30] - Non-GAAP operating income for the three months ended February 28, 2026, was $295,023, down from $321,486 in the same period in 2025[32] - Adjusted EBITDA for the three months ended February 28, 2026, was $348,181, compared to $374,207 in the same period last year[32] - For the three months ended February 28, 2026, diluted earnings per share (EPS) was $0.33, a decrease from $1.04 in the same period of 2025[34] - Non-GAAP diluted EPS for the same period was $2.61, down from $2.79 year-over-year[34] Revenue Guidance - The company expects Q2 2026 revenue between $2.460 billion and $2.485 billion, implying constant currency growth of 1.0% to 2.0%[13] - Full year 2026 revenue guidance is set at $10.035 billion to $10.180 billion, indicating constant currency growth of 1.5% to 3.0%[13] - Revenue forecast for the three months ending May 31, 2026, is between $2,460,000 thousand and $2,485,000 thousand, reflecting a growth rate of 1.75% to 2.75%[35] - The fiscal year revenue forecast ranges from $10,035,000 thousand to $10,180,000 thousand, indicating a growth of 2.1% to 3.6%[35] Cash Flow and Dividends - The company anticipates generating approximately $630.0 million to $650.0 million of adjusted free cash flow in fiscal year 2026[10] - A quarterly dividend of $0.36 per share was declared, with a share repurchase of approximately 1 million shares at a cost of $42.0 million in Q1 2026[12] - Net cash used in operating activities was $(83,220) thousand, compared to $1,408 thousand in the prior year[34] - Free cash flow for the three months ended February 28, 2026, was $(137,122) thousand, significantly lower than $(49,210) thousand in 2025[34] Sector Performance - Revenue from the Banking, Financial Services, and Insurance sector increased by 15% to $421,605, while Technology and Consumer Electronics revenue decreased by 3% to $635,089[30] Balance Sheet - Total current liabilities increased to $2,575,333 as of February 28, 2026, from $2,196,350 as of November 30, 2025[28] - Cash and cash equivalents decreased to $222,699 as of February 28, 2026, from $327,347 as of November 30, 2025[28] - The company’s total assets decreased to $10,674,622 as of February 28, 2026, from $10,761,086 as of November 30, 2025[28] Other Financial Activities - Acquisition-related, integration, and restructuring expenses for the three months ended February 28, 2026, included costs associated with recent cost reduction initiatives[35] - The company incurred debt extinguishment costs of $600 million related to the early redemption of senior notes due in August 2026[35] - Foreign currency losses for the three months ended February 28, 2026, amounted to $0.20, compared to a gain of $(0.07) in the previous year[34]

Clinical Development and Trial Progress - NGN-401 is advancing towards commercialization as a potential one-time treatment for Rett Syndrome, with a clear path to registration through a single registrational trial for ages ≥ 3 years[9]. - 100% of participants in the Embolden trial have been enrolled, with over 50% dosed, and complete dosing is on track for Q2 2026[10]. - The trial includes pediatric participants aged 4-10 and those aged 11 and older, focusing on safety, tolerability, and efficacy of NGN-401[28]. - The Embolden trial is designed as a single registrational trial, enrolling 20 participants, with a primary endpoint based on a responder-based composite endpoint defined as CGI-I of ≤ 3 and gain from baseline of any one developmental milestone[48]. - The company plans to present 12+ months of Phase 1/2 data for all participants in mid-2026, further supporting the clinical evidence for NGN-401[11]. - The expected completion of the Process Performance Qualification (PPQ) campaign is planned to begin in mid-2026, enhancing the company's manufacturing capabilities[11]. - The anticipated timeline for starting the PPQ campaign and additional commercial-readiness activities is also set for mid-2026[67]. Efficacy and Patient Outcomes - Interim Phase 1/2 data shows that 100% of participants demonstrated functional improvements across core disease domains, with a total of 35 developmental milestones gained[35]. - NGN-401 treatment resulted in significant improvements across multiple developmental milestones, with 31 milestones achieved in fine motor/hand function, 26 in expressive and receptive communication, and 14 in gross motor/ambulation over a 12-month period[39]. - Patient 3 gained 6 developmental milestones across all core domains with durability out to 18 months post-treatment with NGN-401[75]. - Patient 4 achieved 4 developmental milestones across 2 core domains with durability out to 15 months post-treatment with NGN-401[77]. - Patient 8 gained 3 developmental milestones across 2 core domains at an early timepoint post-treatment with NGN-401[82]. - Patient 7 demonstrated a significant improvement by using a spoon/fork to eat without assistance post-treatment with NGN-401[80]. - Patient 3 showed improvements in fine motor skills, including the ability to transfer objects from one hand to the other post-treatment[75]. - Patient 4 was able to follow commands without gestures post-treatment, indicating progress in communication skills[77]. - Patient 8 followed commands with gestures and began using words with meaning post-treatment, reflecting advancements in communication[82]. - The improvements in developmental milestones suggest potential long-term benefits of NGN-401 treatment for patients[75][77][82]. Market Potential and Regulatory Status - The market opportunity for disease-modifying gene therapy for Rett Syndrome is estimated to be multi-billion dollars, with approximately 15,000 - 20,000 patients in the US, EU, and UK[16]. - NGN-401 has received FDA Breakthrough Therapy designation, along with other regulatory designations, positioning the company for significant value inflection in 2026[10]. - Payor research indicates strong reimbursement potential for NGN-401, with separate payment structures allowing hospitals to secure reimbursement without inpatient bundling constraints[59]. - The company is positioned for leadership in the Rett syndrome market, with anticipated milestones including the completion of dosing in the Embolden trial expected by 2Q'26 and a BLA submission following data readout[66]. Caregiver Insights and Treatment Priorities - Caregivers have highlighted the importance of improvements in fine motor/hand function, communication, and gross motor/ambulation as priorities for treatment[36]. - Caregiver testimonials highlighted substantial improvements in daily living activities, including enhanced communication and reduced physical burden on caregivers[43]. Manufacturing and Delivery Method - The ICV delivery method of NGN-401 has shown greater targeting of brain regions compared to IT-L, with an estimated 30,000 procedures performed annually in the U.S.[22]. - The company has established a 42,000 sq ft manufacturing facility in Houston, ensuring in-house AAV manufacturing capabilities to support commercial readiness[61].

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FOR IMMEDIATE RELEASE Core & Main Announces Fiscal 2025 Fourth Quarter and Full-Year Results ST. LOUIS, March 24, 2026—Core & Main, Inc. (NYSE: CNM) ("Core & Main"), a leading specialty distributor dedicated to advancing reliable infrastructure with local service, nationwide, today announced financial results for the fourth quarter and fiscal year ended February 1, 2026 ("fiscal 2025"). The fourth quarter and fiscal year ended February 1, 2026 represents 13- and 52-week periods, respectively, compared with ...

Financial Performance and Losses - The company incurred total net losses of $287.9 million and $155.1 million for the years ended December 31, 2025, and 2024, respectively, with an accumulated deficit of $822.6 million as of December 31, 2025[284]. - The company expects to continue incurring significant operating losses for at least the next several years due to ongoing research and development, clinical trials, and commercialization activities[284]. - The company has not generated any revenue to date and may never achieve profitability, which could adversely affect its ability to raise capital and continue operations[284]. - The company has accumulated trading losses for carry forward in the UK of $577.9 million and $280.8 million as of December 31, 2025 and December 31, 2024, respectively[443]. Funding and Financial Resources - As of December 31, 2025, the company had cash and cash equivalents of $149.6 million, which, along with net proceeds from the February 2026 Offering, is expected to fund operations into 2028[290]. - Future funding requirements will depend on various factors, including the progress of clinical trials and regulatory approvals, which may lead to increased costs and delays[291]. - The company may need to seek additional financing sooner than planned due to changing circumstances, including fluctuating inflation and interest rates[290]. - The company may borrow up to $100 million in three tranches under its Loan Agreement with Hercules, contingent on achieving specific regulatory and commercial milestones[305]. - The Loan Agreement includes a financial covenant requiring the company to maintain certain minimum cash balances starting October 1, 2027, which may necessitate additional financing or reduced operating expenses[307]. Regulatory and Approval Challenges - Regulatory scrutiny and potential delays in obtaining approvals could negatively impact the company's ability to raise capital and commercialize its products[296]. - Regulatory approval for COMP360 is subject to comprehensive regulations by authorities such as the FDA and EMA, and failure to obtain such approval will hinder commercialization efforts[314]. - The regulatory approval process for COMP360 is lengthy and unpredictable, with no prior submissions for NDA or MAA, which could significantly harm the business if approvals are not obtained[348]. - The company faces challenges in recruiting qualified healthcare professionals for clinical trials and must maintain compliance with various regulatory requirements[319]. - Delays in regulatory approvals for COMP360 may arise from increased governmental scrutiny and stricter labeling requirements in the pharmaceutical industry[332]. Clinical Trials and Development - The company is conducting a Phase 3 program for COMP360 in Treatment-Resistant Depression (TRD) and has received Breakthrough Therapy Designation from the FDA, with ongoing dialogue regarding trial design[350]. - The success of the investigational COMP360 psilocybin treatment depends on successful completion of clinical trials, including the Phase 3 program in TRD and related studies[316]. - The company must demonstrate a favorable risk versus benefit profile for COMP360 through extensive clinical trials before obtaining regulatory approvals[341]. - There is a significant risk of failure in clinical trials, as most product candidates do not receive regulatory approval after beginning trials[342]. - The company has faced difficulties in patient recruitment for its Phase 3 trials, which may further delay the approval process for COMP360[336]. Market and Commercialization Risks - The company currently has no approved treatments for commercial sale and is heavily reliant on the successful development and regulatory approval of its COMP360 psilocybin treatment[313]. - The market acceptance of COMP360 psilocybin treatment is contingent on factors such as safety, effectiveness, cost-effectiveness, and healthcare payor coverage[390]. - If COMP360 fails to gain market access, it will adversely impact revenue generation and return on investments[391]. - The commercialization strategy relies on establishing a network of third-party treatment sites to administer COMP360, which is critical for business growth[392]. - The company may face difficulties in patient enrollment and retention for clinical trials, which are critical for the success of its investigational treatments[377]. Legal and Compliance Issues - The company must comply with complex federal, state, and local laws, which may require significant financial and managerial resources[427]. - The company faces increased scrutiny and regulatory requirements regarding personal data transfers and transactions involving foreign countries, particularly concerning sensitive personal data[470]. - Compliance with U.S. federal and state healthcare laws and regulations is critical, as violations could lead to substantial penalties and operational disruptions[460]. - The company is subject to evolving and strict rules on the transfer of personal data out of the UK and EEA to third countries, which may adversely affect operations and financial position[479]. Taxation and Financial Incentives - The effective net credit for non-research intensive companies under the merged R&D tax relief scheme will be 16.2% for in-house expenditure and 10.5% for contracted work starting from January 1, 2025[444]. - The company is subject to UK corporation tax on tax-adjusted trading profits and has not paid any UK corporation tax due to ongoing losses[443]. - The company may benefit from the UK's "patent box" regime, allowing certain profits from patented products to be taxed at an effective rate of 10%[451]. - Changes to the UK R&D tax relief regime may impact the amount of R&D relief the company can claim in the future, effective from January 1, 2025[450].

Financial Performance - The net loss for Q4 2025 was $93.9 million, or $1.00 per share, compared to a net loss of $43.3 million, or $0.63 per share in Q4 2024[13] - For the full year 2025, net loss was $287.9 million, or $3.08 per share, compared to $155.1 million, or $2.30 per share in 2024[13] - The net loss for Q4 2025 was $93,878,000, compared to a net loss of $43,332,000 in Q4 2024, representing a significant increase of 116.7%[23] - The net loss per share attributable to ordinary shareholders for Q4 2025 was $1.00, compared to $0.63 in Q4 2024[23] - The company reported a comprehensive loss of $93,480,000 for Q4 2025, compared to a comprehensive loss of $42,984,000 in Q4 2024[23] Cash and Financing - Cash and cash equivalents as of December 31, 2025, were $149.6 million, down from $165.1 million as of December 31, 2024[13] - The company successfully raised $150 million in financing in February 2025, extending its cash runway into 2028[5] Research and Development - Research and development expenses for Q4 2025 were $29.9 million, a decrease from $32.1 million in Q4 2024[10] - Research and development expenses for the twelve months ended December 31, 2025, were $118,436,000, slightly down from $119,039,000 in 2024[23] Operating Expenses - General and administrative expenses for Q4 2025 were $16.0 million, slightly down from $16.3 million in Q4 2024[13] - Total operating expenses for Q4 2025 were $45,952,000, a decrease of 5.4% from $48,414,000 in Q4 2024[23] Other Financial Metrics - Total other (expense) income, net for Q4 2025 was $(50,660,000), a decline from $6,105,000 in Q4 2024[23] - The fair value change of warrant liabilities resulted in an expense of $38,163,000 for Q4 2025, with no such expense reported in Q4 2024[23] - Interest income for the twelve months ended December 31, 2025, was $7,182,000, down from $8,268,000 in 2024[23] - The income tax benefit for Q4 2025 was $2,734,000, compared to an expense of $1,023,000 in Q4 2024[23] Product Development and Regulatory Updates - COMP360 has shown a rapid onset of action with symptom reduction as early as the day after administration, and durability lasting at least 6 months after just one or two doses[11] - COMP360 is expected to fit seamlessly across over 7,300 treatment centers, which are rapidly growing in anticipation of its launch[11] - The FDA has accepted the IND application for COMP360 for PTSD, allowing the initiation of a Phase 2b/3 trial[11] - The company plans to meet with the FDA to confirm its NDA submission strategy, expecting to complete the submission in Q4 2026[6]

Drug Development and Approval - The FDA granted Breakthrough Therapy designation for cytisinicline for nicotine e-cigarette cessation in July 2024, expediting its development and review process [21]. - Cytisinicline is expected to be commercially launched in the first half of 2027, with a PDUFA targeted action date for its NDA set for June 20, 2026 [23]. - The FDA accepted the NDA for cytisinicline as a treatment for smoking cessation in September 2025, with potential delays in approval due to manufacturing observations [40]. - The FDA awarded cytisinicline the Commissioner's National Priority Voucher in October 2025, highlighting its potential to address a major public health crisis [22]. - The company filed its NDA for cytisinicline in June 2025, with a PDUFA targeted action date of June 20, 2026, but there is potential for a delay in FDA approval [106]. - The FDA required six months and one year of cumulative exposure data from a minimum of 300 and 100 subjects, respectively, for the NDA submission [81]. - The company anticipates challenges in raising additional capital due to the current financing environment for biotechnology companies [150]. - The company expects to encounter similar regulatory challenges in other countries as it seeks to develop and commercialize cytisinicline [119]. - Regulatory authorities may require additional studies or impose restrictions that could affect the commercialization of cytisinicline [204]. - Changes in regulatory policies and potential legal challenges could disrupt the FDA's operations, impacting the review and approval process for new products [206]. Clinical Trials and Efficacy - The company has completed two Phase 3 clinical trials, with plans for a single open-label study to assess long-term safety effects of cytisinicline [39]. - In the Phase 2b ORCA-1 trial, cytisinicline treatment arms showed a median reduction in daily smoking of 74-80%, compared to a 62% reduction in placebo arms [59]. - The 3 mg TID cytisinicline arm achieved a 50% continuous abstinence rate at week 4, significantly higher than the 10% rate for placebo (p<0.0001) [60]. - In the Phase 3 ORCA-2 trial, the 12-week cytisinicline treatment demonstrated a continuous abstinence rate of 21.1% from week 9 to 24, compared to 4.8% for placebo (OR of 5.3, p<0.0001) [72]. - The ORCA-2 trial included 810 adult smokers and evaluated the efficacy of 3 mg cytisinicline dosed three times daily compared to placebo [71]. - The Phase 2 ORCA-V1 trial showed a vaping cessation rate of 31.8% for cytisinicline compared to 15.1% for placebo (p=0.04) [68]. - Subjects receiving 12 weeks of cytisinicline had 6.3 times higher odds of quitting smoking compared to placebo, with an abstinence rate of 32.6% versus 7.0% [74]. - In the ORCA-3 trial, 792 adult smokers were enrolled, confirming the efficacy of cytisinicline for smoking cessation [76]. - The continuous smoking cessation rate from week 9 to week 24 was 20.5% for the 12-week cytisinicline arm compared to 4.2% for placebo, with an odds ratio of 5.79 [79]. - Cytisinicline was well tolerated across trials, with no serious adverse events reported and compliance greater than 94% [62][69]. Financial and Operational Aspects - The company has incurred losses since inception and anticipates continuing to incur losses for the foreseeable future [160]. - The company has never generated any revenue from product sales and does not expect to do so in the near future [165]. - The company funded its operations primarily through the sale of equity securities and convertible promissory notes [161]. - The principal amounts due under the company's debt instruments totaled $15.0 million as of December 31, 2025 [154]. - The company's outstanding debt matures on December 1, 2027, and is subject to floating interest rates, increasing debt service costs due to rising interest rates [155]. - The company is required to keep substantially all cash and investments with Silicon Valley Bank, which faced closure in March 2023 but has since regained access to funds [171]. - The company has obligations to pay up to $4.8 million to the University of Bristol tied to specific financing, development, and commercialization milestones [103]. - The company has obligations for royalty payments in the low-single digits and up to mid-teens percentages of sublicense income based on net sales of licensed products [100]. - The company anticipates incurring significant expenses and increasing operating losses for at least the next several years as it continues clinical development and seeks regulatory approval for cytisinicline [148]. - The company plans to evaluate commercial partnerships in ex-U.S. territories and may consider direct marketing to consumers through various channels [130]. Supply Chain and Manufacturing - The company has partnered with Adare Pharma Solutions for U.S.-based manufacturing of cytisinicline, aiming to reduce supply chain risks and costs [23]. - The company is dependent on securing sufficient quantities of cytisinicline from limited plant sources, which poses a risk to its supply chain [173]. - The company is pursuing alternative sources for cytisinicline, including synthetic routes, but has not yet established commercial viability [173]. - The company currently partners with Sopharma for the supply and contract manufacturing of cytisinicline, utilizing third-party contract manufacturing organizations for clinical and commercial drug supply [125]. - Adverse weather conditions and climate change may disrupt the supply chain for cytisinicline, affecting production and availability [199]. Regulatory and Compliance Risks - The company is subject to various federal and state healthcare laws that regulate marketing practices and may impose penalties for non-compliance [110]. - Ongoing regulatory requirements for approved products like cytisinicline will incur costs and compliance risks, including potential penalties for non-compliance [215]. - Continuous compliance with cGMP regulations is mandatory for manufacturers, and failure to meet these standards could severely harm the company's operations [216]. - Post-approval monitoring and clinical trial obligations may lead to increased costs and potential withdrawal of marketing approvals if not met [217]. - Regulatory agencies may impose restrictions or require product withdrawals if unknown problems are discovered, significantly affecting the company's market position [218]. - Government investigations into alleged violations could divert significant resources and generate adverse publicity, impacting the company's ability to commercialize products [219]. Market Potential and Competitive Landscape - Cytisinicline is positioned to be the first new prescription medicine in two decades aimed at aiding individuals in overcoming nicotine dependence [92]. - The global revenues for prescription smoking cessation therapies are projected to reach $5.6 billion by 2030 [88]. - Cytisinicline could potentially be the first prescription drug indicated for vape and e-cigarette users ready to quit nicotine dependence [87].