Financial Performance - EquipmentShare reported significant growth in revenue, achieving $500 million in total revenue for the fiscal year, representing a 25% increase year-over-year[9]. - The management has set a performance guidance of $575 million in revenue for the next fiscal year, reflecting continued optimism about market conditions[9]. User Growth and Demand - The company expanded its user base to 150,000 active users, a 30% increase compared to the previous year, indicating strong demand for its services[10]. - EquipmentShare anticipates a 10% growth in rental rates due to increased demand and reduced competition in the market[10]. Technology and Platform Development - EquipmentShare's cloud-based platform, T3, has seen a 40% increase in usage, reflecting the growing reliance on technology in the construction equipment rental industry[10]. - EquipmentShare's investment in cybersecurity measures has increased by 20% to safeguard user data and enhance platform security[10]. Expansion and Market Strategy - The company plans to open 20 new branch locations in the next fiscal year, aiming to enhance its market presence and accessibility[10]. - EquipmentShare is actively pursuing strategic acquisitions to bolster its market position, with a target of acquiring at least two companies in the next 12 months[10]. Fleet Growth and Sales Projections - EquipmentShare's innovative capital-light fleet growth model, known as the "OWN Program," is expected to contribute to a projected 15% increase in equipment sales in the upcoming year[10]. Competitive Landscape - The company faces competitive pressures that could impact market share, with a focus on maintaining strong supplier relationships to mitigate risks[10].

Dividend Distribution and Restrictions - As of December 31, 2025, the maximum amount available for dividend distribution from the Bank to the Company was approximately $46 million[72]. - The Company is subject to restrictions on dividends and stock repurchases due to California law and Federal Reserve policies[69][73]. - The Bank is required to maintain certain capital levels under Basel III capital rules, impacting its ability to pay dividends[72]. Regulatory Compliance and Risks - The Company must comply with various consumer protection laws, which may lead to increased compliance costs[82][83]. - The Company is subject to potential enforcement actions for unsafe practices or regulatory violations, which could affect its operations[88]. - The Bank's lending practices are guided by federal regulations to ensure compliance and mitigate risks associated with commercial real estate lending[78]. Financial Performance and Expenses - The Bank's FDIC insurance expense totaled $871 thousand for 2025[79]. - The FRB's monetary policy significantly influences the Company's profitability, primarily through interest rate spreads[90]. Lending Limits and Ratings - The Bank's limit on aggregate secured loans-to-one-borrower was $67 million and unsecured loans-to-one-borrower was $40 million as of December 31, 2025[74]. - The Bank's most recent Community Reinvestment Act rating was "Satisfactory," which is crucial for future growth through acquisitions or new branches[75].

Financial Performance - Q4 2025 revenue was $5.8M, unchanged from Q4 2024 and a 1% increase from Q3 2025[5] - Full year 2025 total revenue was $22.6M, a 2% decrease from $23.1M in 2024[9] - Revenues for Q4 2025 were $5,799 million, a slight decrease of 0.5% compared to $5,826 million in Q4 2024[31] - Gross profit for the year ended December 31, 2025, was $17,314 million, down from $17,440 million in 2024, reflecting a decrease of 0.7%[31] - Cash provided by operating activities for the year 2025 was $558 million, compared to $3,160 million in 2024, indicating a decline in cash flow[33] Profitability Metrics - Gross margin for Q4 2025 increased to 77%, up from 75% in Q4 2024[5] - Full year 2025 gross margin was 77% of revenue, compared to 76% in 2024[9] - Adjusted EBITDA for Q4 2025 was $0.9M, or 15% of revenue, consistent with Q4 2024[6] - Operating loss for 2025 was $1.9M, significantly reduced from $16.3M in 2024[9] - Operating loss for Q4 2025 was $(761) million, significantly improved from $(14,322) million in Q4 2024[31] - Net loss from continuing operations for Q4 2025 was $0.5M, or $0.13 per diluted share, compared to $10.9M, or $2.85 per diluted share, in Q4 2024[6] - The company reported a net loss from continuing operations of $1,558,000, or $0.40 per diluted share for the year ended December 31, 2025, compared to a loss of $13,281,000, or $3.47 per diluted share in 2024[17] - Net income for the year ended December 31, 2025, was $4,291 million, a recovery from a net loss of $(10,793) million in 2024[33] Cash Flow and Assets - Free cash flow from continuing operations for the three months ended December 31, 2025, was $109,000, down from $293,000 in the same period of 2024[18] - Adjusted free cash flow from continuing operations for the year ended December 31, 2025, was $1,266,000, compared to $2,786,000 in 2024[18] - Total assets decreased to $41,992,000 as of December 31, 2025, from $50,638,000 in 2024[29] - Cash and cash equivalents at the end of 2025 were $3,025 million, down from $4,103 million at the end of 2024[33] Liabilities and Shareholder Information - The company’s total liabilities decreased to $11,647,000 as of December 31, 2025, from $25,412,000 in 2024[29] - The weighted average number of common shares outstanding for the year ended December 31, 2025, was 3,859,000, compared to 3,829,000 in 2024[17] - The weighted average number of common shares outstanding for Q4 2025 was 3,864 million, slightly up from 3,837 million in Q4 2024[31] Impairment and Gains - The company reported an impairment loss of $250,000 for the year ended December 31, 2025, compared to $14,150,000 in 2024[17] - The company incurred an impairment loss of $250 million in 2025, compared to $14,150 million in 2024[31] - The company reported a gain on the disposal of business amounting to $(8,974) million in 2025, with no such gain reported in 2024[33] Future Plans and Developments - The company trained over 1,800 students across 60-plus universities on its ACCESS PR platform in the past 90 days[3] - The company plans to launch new products, including Access Verified and a social monitoring platform, expected to generate incremental revenue starting Q2 2026[2] - The company expects to launch a social monitoring platform with an AI Interactive Distribution Report before the end of March 2026[25] - The company anticipates generating incremental revenue through premium subscription tiers and per release pricing for new offerings starting in Q2 2026[25]

Clinical Development - The company has developed late-stage clinical product candidates, including setrusumab for osteogenesis imperfecta (OI) and alvelestat for severe alpha-1 antitrypsin deficiency-associated lung disease (AATD-LD), both of which have received orphan designations from regulatory authorities [533]. - The company has successfully completed large, randomized Phase 2 clinical trials for four product candidates and announced results from two Phase 3 studies for setrusumab in OI [534]. - Research and development expenses are expected to include costs associated with the preparation of alvelestat for the Phase 3 study, including regulatory and manufacturing activities [541]. - The company anticipates costs related to the collaboration with Ultragenyx for setrusumab and potential future clinical trials for alvelestat [593]. Financial Performance - Revenue for the year ended December 31, 2025 was $0.5 million, a one-time milestone payment from ReproNovo, compared to no revenue in 2024 [565]. - Total operating expenses decreased by $3.2 million from $47.4 million in 2024 to $40.1 million in 2025 [568]. - Research and development (R&D) expenses decreased by $3.2 million from $20.9 million in 2024 to $17.8 million in 2025, primarily due to reductions in expenses for alvelestat and etigilimab [568][569]. - General and administrative expenses decreased by $3.4 million from $26.4 million in 2024 to $23.0 million in 2025, attributed to lower cash bonus accruals and professional fees [571]. - Interest income decreased by $0.9 million from $3.0 million in 2024 to $2.2 million in 2025 due to lower interest rates and cash balances [574]. - The accumulated deficit as of December 31, 2025 was $501.0 million, with expectations of continued significant operating losses [589]. Taxation and Losses - As of December 31, 2025, the company reported cumulative carry-forward U.K. tax losses of $64.1 million and U.S. federal tax losses of approximately $67.0 million, with $20.5 million of these losses able to be carried forward indefinitely [553][561]. - The U.K. corporation tax rate applied for 2025 was 25%, and the company has not paid U.K. corporation tax since inception, except in 2021 [560]. - The company has recorded the entire benefit from U.K. R&D tax credits as a benefit included in net loss before income tax, which is not reflected as part of the income tax provision [556]. - The company expects to claim under the Merged Scheme for R&D tax credits from 2025 onward, as it does not qualify as an R&D intensive company for 2025 [557]. Cash Flow and Funding - Net cash used in operating activities was $31.0 million in 2025, a decrease of $1.9 million from $32.8 million in 2024 [587]. - Net cash provided by financing activities was $0.3 million in 2025, a decrease of $45.8 million from $46.1 million in 2024, reflecting no significant financing activities in 2025 [588]. - The company anticipates needing additional external funding to complete development plans and potentially commercialize selected rare disease products [580]. - The company may need to obtain substantial additional funds to achieve business objectives, which may not be available on acceptable terms [595]. - As of December 31, 2025, the company held cash and cash equivalents of $41.0 million [607]. - The company expects existing cash and cash equivalents to fund clinical trials and operating expenses into mid-2027 [591]. Currency and Inflation - The foreign currency translation adjustment for 2025 was a gain of $8.0 million, compared to a loss of $1.4 million in 2024, reflecting changes in currency value impacts [579]. - For the year ended December 31, 2025, there was an unrealized gain of $8.0 million on foreign currency translation compared to an unrealized loss of $1.4 million for the year ended December 31, 2024 [608]. - The company has not entered into foreign exchange contracts to hedge against fluctuations but maintains cash in U.S. dollars for anticipated commitments [609]. - Inflation has increased operating expenses, but it has not had a material effect on the company's financial condition during the year ended December 31, 2025 [610].

Financial Performance - The company incurred a net loss of $27.2 million in 2023, $10.6 million in 2024, and $6.1 million in 2025, with an accumulated deficit of $237 million as of December 31, 2025[38]. - The company anticipates ongoing losses as it invests in research and development and seeks regulatory approvals for its product candidates[38]. - The company expects continued significant expenses and operating losses over the next several years as it conducts advanced-stage clinical studies for SGT-610 and develops SGT-210[43]. - The company may need to raise substantial additional funding to pursue its business objectives, which could lead to dilution of shareholder value[43]. Product Development and Regulatory Approval - The company has not yet obtained regulatory approval for its product candidates in the United States or any other country, which poses a risk to its business[31]. - The company may face increased costs and delays in the marketing approval process if the FDA requires additional studies or data for its product candidates[49]. - The company expects to utilize the FDA's Section 505(b)(2) pathway for some product candidates, but if unavailable, development could take significantly longer and cost more[79]. - The company has filed two NDAs under Section 505(b)(2) of the FDCA, with Twyneo receiving FDA marketing approval in July 2021 and Epsolay in April 2022[189]. - The company may be required to perform additional clinical trials to support changes from branded reference drugs, potentially delaying regulatory approvals[192]. Market Competition and Commercialization - The company faces intense competition in the dermatology market, which may hinder its ability to achieve commercial success[31]. - The company’s future success is highly dependent on the market perception of its products and their safety and quality[31]. - The company faces significant competition for its product candidates, including SGT-610, Twyneo, and Epsolay, from established companies with greater resources and market experience[126][129]. - Sales of SGT-610, Twyneo, and Epsolay will depend heavily on third-party payor coverage and reimbursement levels, which are critical for profitability[135]. Clinical Trials and Patient Enrollment - The company may face challenges in enrolling patients for clinical trials, which could delay the development of its product candidates[31]. - The company faces intense competition for patient enrollment in clinical trials, which could delay or prevent the trials from proceeding[68]. - The company is dependent on ongoing clinical trials, and any delays could significantly harm its ability to generate product revenues[66]. - The company may experience delays in clinical trials due to various factors, including patient recruitment challenges and regulatory compliance issues[63]. Intellectual Property and Legal Risks - The company’s success is contingent on its ability to protect its intellectual property, which involves complex legal challenges[173]. - The company may face patent infringement lawsuits that could delay or prevent the review or approval of its product candidates[189]. - The company has granted licenses to third parties for its intellectual property, which may lead to increased competition and reduced market share[179]. - The company may incur substantial costs and management resource diversion due to legal proceedings related to intellectual property rights[183]. Regulatory Environment and Compliance - The company must comply with extensive regulatory requirements, including manufacturing and labeling, which could affect the commercial viability of its products[93]. - The enforcement of healthcare laws is uncertain and may change rapidly, complicating compliance efforts and diverting resources[141]. - The company faces risks related to compliance with healthcare regulatory laws, which could lead to significant penalties and operational impacts[139]. - Regulatory approval processes are lengthy and unpredictable, with the potential for changes in approval policies that could affect the company's product candidates[69]. Operational Challenges - The company relies on third-party partners for the commercialization of its products, which may affect its ability to achieve significant market penetration[31]. - The company is dependent on contract manufacturers for compliance with cGMP requirements, and any failure could jeopardize regulatory approvals[162]. - Manufacturing difficulties could significantly impact the ability to provide product candidates to patients and delay commercialization efforts[171]. - The company relies on third-party manufacturers for the production of product candidates and approved products, increasing risks related to supply and compliance[161]. External Factors and Risks - The company faces significant risks due to political, economic, and military conditions in Israel, which could adversely affect its operations and financial condition[196]. - Recent hostilities, including attacks from Hamas and Hezbollah, have escalated tensions in the region, potentially impacting the company's ability to conduct business[197]. - Exchange rate fluctuations between the U.S. dollar and the New Israeli Shekel may negatively impact future revenues, as a substantial portion of revenues is expected to be generated in foreign currencies[201]. - The company may face claims for remuneration or royalties for assigned service invention rights by employees, which could lead to litigation and adversely affect its business[211].

Financial Performance - Fourth quarter net sales were $695.1 million, an increase of 8.7% year-over-year, with Brand Portfolio sales up 20.3% and organic sales up 1.5%[5] - GAAP loss per diluted share was $0.70, while adjusted loss per diluted share was $0.36; excluding Stuart Weitzman, adjusted loss per diluted share was $0.06[5] - Gross profit for the fourth quarter was $290.3 million, with a gross margin of 41.8%, down 230 basis points compared to the previous year[8] - For fiscal 2026, total sales are expected to increase low to mid-single digits, with GAAP earnings per diluted share projected between $1.31 and $1.61[12] - First quarter 2026 guidance anticipates net sales to increase mid to high-single digits, with GAAP earnings per diluted share expected to be between $0.21 and $0.26[11] - Consolidated net sales for the same period reached $695.1 million, a 8.8% increase from $639.2 million in the prior year[27] - For the fiscal year ended January 31, 2026, consolidated net sales reached $2,757.9 million, a slight increase from $2,722.7 million in the previous year[31] Profitability and Margins - Gross profit for the thirteen weeks ended January 31, 2026, was $290,340, representing a gross margin of 41.7%, compared to $275,108 and a gross margin of 43.0% in the prior year[23] - The gross profit margin for the consolidated segment was 41.8%, down from 44.1% in the previous year[27] - Gross profit for the same period was $1,184.8 million, down from $1,222.0 million, resulting in a gross margin of 43.0%, compared to 44.9% in the prior year[31] - Adjusted gross profit, excluding Stuart Weitzman, was $1,152.3 million, reflecting a decrease from $1,222.0 million[32] - Operating earnings for the fiscal year were $6.4 million, significantly lower than $149.9 million in the previous year, with an operating margin of 0.2% compared to 5.5%[31] - The adjusted operating margin for the consolidated segment was -1.7%, compared to 0.2% in the prior year, reflecting operational challenges[27] Losses and Expenses - Operating loss for the thirteen weeks ended January 31, 2026, was $(26,473), a decline from operating earnings of $7,870 in the same period last year[23] - Net loss attributable to Caleres, Inc. for the thirteen weeks ended January 31, 2026, was $(22,734), compared to net earnings of $4,930 in the prior year[23] - Total charges and other items amounted to $14.9 million, impacting adjusted earnings negatively by $0.34 per share[26] - For the thirteen weeks ended January 31, 2026, Caleres reported a net loss of $24.3 million, compared to net earnings of $3.9 million for the same period in 2025[34] - The adjusted net loss for the same period was $13.3 million, while adjusted net earnings were $10.1 million in the prior year, indicating a significant decline[35] - For the fiscal year ended January 31, 2026, Caleres, Inc. reported a net loss of $9.9 million, down from net earnings of $106.1 million in the previous year[34] Sales by Segment - Famous Footwear sales declined 1.2%, while comparable sales were up 0.1%[5] - The Famous Footwear segment reported net sales of $354.0 million, slightly down from $358.4 million in the previous year, with a comparable sales increase of 0.1%[27] - The Brand Portfolio segment achieved net sales of $361.2 million, up from $300.3 million in the prior year, indicating a significant growth[27] - Stuart Weitzman net sales were $56.3 million for the thirteen weeks ended January 31, 2026, contributing to the overall financial results[27] Operational Metrics - Direct-to-consumer sales represented approximately 74% of total net sales in the fourth quarter[8] - The integration of Stuart Weitzman was completed on time and on budget, with minimal business disruption[5] - Selling and administrative expenses were $310.0 million, or 44.6% of net sales, reflecting a deleverage of 370 basis points compared to the previous year[8] - Inventory at year-end was $610.5 million, up $45.2 million year-over-year, with approximately $57 million attributed to Stuart Weitzman[14] - Total assets increased to $1,965,790 as of January 31, 2026, up from $1,894,754 as of February 1, 2025[24] - Total current liabilities increased to $845,540 as of January 31, 2026, from $757,933 as of February 1, 2025[24] - Cash and cash equivalents at the end of the period were $29,769, slightly up from $29,636 at the beginning of the period[25] - Net cash provided by operating activities for the thirteen weeks ended January 31, 2026, was $103,177, compared to $104,562 in the prior year[25] - The company incurred $108,858 in cash outflows for the acquisition of Stuart Weitzman during the period[25] - The company ended the period with 1,009 company-operated stores, an increase from 960 stores in the previous year[27] - The company operated 1,009 stores at the end of the fiscal year, an increase from 960 stores in the previous year[31] Shareholder Information - Basic loss per share attributable to Caleres, Inc. shareholders for the thirteen weeks ended January 31, 2026, was $(0.70), compared to earnings of $0.15 in the same period last year[23] - The diluted adjusted loss per common share, excluding Stuart Weitzman, was $(0.06) for the thirteen weeks ended January 31, 2026, compared to $0.33 in the prior year[36] - The company reported a total of 32.5 million basic common shares for the thirteen weeks ended January 31, 2026, slightly up from 32.5 million shares in the previous year[35] - Caleres, Inc. anticipates adjusted diluted earnings per share for fiscal 2026 to be between $1.35 and $1.65[38] - The company provided guidance for the first quarter of 2026, projecting GAAP diluted earnings per share between $0.21 and $0.26, and adjusted diluted earnings per share between $0.25 and $0.30[38]

Financial Performance - The net loss for the full year ended December 31, 2025, was $41.9 million, compared to $43.3 million in 2024, reflecting an operating loss of $40.1 million[9]. - Revenue for the year ended December 31, 2025, is reported at $500 million, compared to no revenue in 2024[21]. - Operating loss decreased to $40.1 million in 2025 from $47.4 million in 2024, indicating improved operational efficiency[21]. - Net loss for 2025 is $41.9 million, a slight improvement from a net loss of $43.3 million in 2024[21]. - Loss per share improved to $0.05 in 2025 from $0.06 in 2024, indicating a reduction in losses on a per-share basis[21]. - Total comprehensive loss for 2025 is $33.9 million, compared to $44.6 million in 2024, showing a reduction in overall losses[21]. - Other comprehensive income from foreign currency translation adjustments was $8.0 million in 2025, contrasting with a loss of $1.4 million in 2024[21]. - Interest income decreased to $2.2 million in 2025 from $3.0 million in 2024, indicating a decline in interest-earning assets[21]. - The company reported a benefit from research and development tax credit of $1.9 million in 2025, slightly up from $1.6 million in 2024[21]. Research and Development - Total research and development expenses decreased by $3.2 million from $20.9 million in 2024 to $17.8 million in 2025, primarily due to reductions in expenses for alvelestat and etigilimab[7]. - Research and development expenses decreased to $17.8 million in 2025 from $20.9 million in 2024, reflecting cost management efforts[21]. - Mereo anticipates a single Phase 3 trial enrolling approximately 220 patients for alvelestat, with a primary efficacy endpoint based on the St. George's Respiratory Questionnaire Total Score[5]. - Setrusumab demonstrated statistically significant improvements in bone mineral density and reductions in vertebral fractures in pediatric patients, although it did not achieve statistical significance against primary endpoints[5]. - Mereo has designed a potential Phase 2b study of alvelestat in bronchiectasis to support ongoing partnering discussions[5]. Corporate Developments - Mereo is in active discussions for the Phase 3 development and commercialization of alvelestat, with potential partners indicating progress[5]. - The company has retained EU and UK commercial rights for setrusumab while partnering with Ultragenyx, which includes potential milestone payments of up to $245 million[12]. - The total ordinary shares issued as of December 31, 2025, were 795,658,504, an increase from 775,728,034 in 2024[11]. - Weighted average shares outstanding increased to 797.1 million in 2025 from 739.6 million in 2024, suggesting potential dilution effects[21]. Expenses - General and administrative expenses decreased by $3.4 million from $26.4 million in 2024 to $23.0 million in 2025, attributed to lower accruals for bonuses and reduced professional fees[8].

Clinical Trial Results - Moleculin reported a preliminary blinded complete remission composite (CRc) rate of 40% in the first 30 subjects treated in the MIRACLE trial, consisting of a 30% complete remission (CR) rate and a 10% complete remission with partial hematological recovery (CRh) rate[5]. - The MIRACLE trial is expected to unblind data for 45 subjects in mid-2026, with a total of 222 additional subjects to be randomized in Part B of the trial[9][7]. - Approximately 35% of subjects treated to date in the MIRACLE trial are relapsed or refractory from a venetoclax regimen, indicating a challenging patient population[5]. Financial Performance - The company reported a net loss of $33.6 million for the year ended December 31, 2025, compared to a net loss of $26.0 million in 2024, with a net loss per common share of $28.42[23]. - Research and development (R&D) expenses for the year ended December 31, 2025, were $15.9 million, a decrease of $1.8 million from $17.7 million in 2024, primarily due to reduced sponsored research activities[13]. - General and administrative (G&A) expenses increased to $9.2 million in 2025 from $8.9 million in 2024, attributed to higher regulatory, legal, consulting, and investor relations expenses[14]. Assets and Liabilities - As of December 31, 2025, the company had cash and cash equivalents of $8.9 million, with total current assets amounting to $9.7 million, an increase from $5.2 million in 2024[15][23]. - Moleculin's total assets as of December 31, 2025, were $22.1 million, up from $16.9 million in 2024, while total liabilities increased to $7.1 million from $5.7 million[23]. Future Plans - The company anticipates starting a Phase 1B/2 study of Annamycin in third-line pancreatic cancer in the second half of 2026[9][10]. - The company has entered a new research collaboration focused on glioblastoma multiforme (GBM) to evaluate intra-arterial delivery of Annamycin in preclinical models[6].

Financial Performance - Net income attributable to common stockholders decreased by $2.9 million to $1.6 million ($0.06/share) in Q4 2025, compared to $4.5 million ($0.17/share) in Q4 2024[6] - Revenues and other income increased 8% to $23.3 million in Q4 2025, up from $21.6 million in Q4 2024[6] - Total revenues for the three months ended December 31, 2025, increased to $21,106,000, up from $17,935,000 in the same period of 2024, representing a growth of 12.1%[30] - Net income attributable to common stockholders for the three months ended December 31, 2025, was $1,581,000, compared to $4,483,000 in the same period of 2024, reflecting a decrease of 64.8%[30] - The company reported an operating loss of $2,292,000 for the three months ended December 31, 2025, compared to a loss of $2,126,000 in the same period of 2024[30] - Total expenses for the three months ended December 31, 2025, were $18,814,000, up from $15,809,000 in the same period of 2024, marking an increase of 18.9%[30] - The company incurred a stock compensation expense of $554,000 for the three months ended December 31, 2025, compared to $96,000 in the same period of 2024[35] - Investment income for the three months ended December 31, 2025, was $165,000, down from $430,000 in the same period of 2024, a decline of 61.7%[30] - The company’s total other income, net for the three months ended December 31, 2025, was $90,000, compared to $348,000 in the same period of 2024, a decrease of 74.1%[30] Farming Segment Performance - Farming segment revenues increased 26% to $12.2 million in Q4 2025, compared to $9.7 million in Q4 2024[6] - Farming segment revenues increased 34.6% to $18.7 million in 2025, driven by a return of pistachio production contributing $5.3 million[16] - For the three months ended December 31, 2025, farming revenues increased to $12,240,000, up from $9,676,000 in the same period of 2024, representing a growth of 26%[44] - Adjusted EBITDA for the farming segment reached $3,804,000 for the three months ended December 31, 2025, compared to $2,676,000 in the same period of 2024, reflecting a 42% increase[44] - The adjusted farming EBITDA before fixed water obligations was $4,428,000 for the three months ended December 31, 2025, compared to $3,429,000 in the same period of 2024, indicating a 29% increase[44] - The company's fixed water obligations for the farming segment were $624,000 for the three months ended December 31, 2025, down from $753,000 in the same period of 2024[44] Capital and Liquidity - Total capital, including debt, was $584.5 million as of December 31, 2025, with total liquidity of approximately $91.0 million[13] Operational Developments - The TRCC industrial portfolio is 100% leased, comprising 2.8 million square feet of gross leasable area[10] - The construction of the Nestlé USA distribution facility, over 700,000 square feet, has been completed and is preparing to become operational[11] Future Outlook - The Company expects net income to fluctuate based on development activity, commodity prices, and timing of land sales[15] - The Company planted 150 acres of olives in 2025 and plans to plant an additional 150 acres in 2026 as part of its crop diversification strategy[18] Shareholder Information - Basic and diluted earnings per share for the three months ended December 31, 2025, were both $0.06, consistent with the previous quarter[46] - The period-end share price was $15.77, a slight decrease from $15.98 in the previous quarter[46] - The weighted average number of diluted shares outstanding for the three months ended December 31, 2025, was 26,965,558, compared to 26,829,344 in the same period of 2024[30] - The weighted average shares outstanding increased to 26,907,329 for the three months ended December 31, 2025, compared to 26,890,979 in the previous quarter[46] Debt and Interest - The company reported a total interest expense of $3,892,000, with a significant portion attributed to unconsolidated joint ventures[39] - The company's share of equity in earnings of unconsolidated joint ventures for the year ended December 31, 2025, was $8,362,000, down from $10,881,000 in 2024, a decrease of 23.1%[30] Depreciation and Amortization - The total depreciation and amortization for the company was $11,638,000, with $4,885,000 attributed to consolidated operations[39]

Clinical Development and Trials - TSHA-102 is in clinical development for Rett syndrome, with a focus on addressing severe unmet medical needs in patients aged 2 years and older[1]. - A total of 12 patients have been dosed in Part A of the REVEAL trials, with positive clinical data reported showing that the first 10 patients gained or regained developmental milestones[20]. - The REVEAL pivotal trial will enroll 15 females aged 6 to <22 years, with a low likelihood (0% to <6.7%) of gaining new developmental milestones[22]. - The ASPIRE trial will enroll three females aged 2 to <4 years to evaluate the safety and preliminary efficacy of TSHA-102, with dosing expected to be completed in the second quarter of 2026[24]. - The REVEAL pivotal trial protocol has been aligned with the FDA, including a 6-month interim analysis that may support a biologics license application (BLA) submission[23]. - The REVEAL pivotal trial will enroll 15 females aged 6 to <22 years, with a minimum success threshold of a 33% response rate (5 out of 15 patients) for developmental milestones[43]. - A total of 100% of patients in the high dose cohort (N=6) gained or regained developmental milestones post-TSHA-102 treatment, compared to a 0% likelihood without treatment[49]. - The high dose cohort achieved a 100% responder rate by 12 months, with a 75% responder rate at 6 months[60]. - A total of 165 additional skills and improvements were achieved across 10 patients, supporting the broad therapeutic impact of TSHA-102[55]. - The average R-MBA score improvement post-TSHA-102 was -12.2 for the high dose cohort at 6 months, compared to -9.8 for the low dose cohort[60]. - No treatment-related serious adverse events were reported among 12 patients aged 6-21 years, indicating good tolerability of TSHA-102[61]. - The REVEAL pivotal trial is expected to complete patient dosing by Q2 2026, with interim analysis potentially expediting the BLA submission by at least two quarters[47]. - The ASPIRE trial is underway to evaluate the safety and preliminary efficacy of TSHA-102 in younger patients aged 2 to <4 years, with dosing expected to complete in Q2 2026[48]. Regulatory Designations and Approvals - The FDA has granted Breakthrough Therapy designation to TSHA-102 based on positive clinical evidence from 12 patients treated in Part A of the REVEAL trials[27]. - The company has received orphan drug designation and rare pediatric disease designation from the FDA for TSHA-102, as well as Fast Track Designation[26]. - The FDA provided written alignment on key elements of the REVEAL pivotal trial design, enabling a potential BLA submission for TSHA-102[42]. - The company plans to initiate a Process Performance Qualification campaign in the second quarter of 2026 to support the BLA submission for TSHA-102[25]. - The FDA requires extensive preclinical and clinical testing before biological product candidates can be marketed, including submission of an IND application[98]. - The BLA submission process includes a 60-day review period by the FDA to determine if the application is complete for substantive review[105]. - The FDA aims to review standard BLA applications within 10 months and priority applications within 6 months after acceptance[106]. - The RMAT program aims to expedite the development and review of regenerative medicine therapies intended to treat serious diseases, potentially allowing for priority review or accelerated approval[112]. - A product eligible for priority review must show significant improvement in treating serious conditions, with the FDA aiming to act on applications within six months of filing[114]. - Accelerated approval may be granted based on effects on surrogate endpoints likely to predict clinical benefits, with post-marketing studies required to verify these effects[115]. - Orphan Drug Designation can be granted for drugs treating rare diseases affecting fewer than 200,000 individuals in the U.S., providing seven years of exclusivity upon first approval[118]. - The FDA may withdraw approval if regulatory compliance is not maintained, which could lead to product recalls or additional studies[122]. Financial Overview - The company incurred net losses of $109.0 million and $89.3 million for the years ended December 31, 2025 and 2024, respectively, with an accumulated deficit of $711.3 million as of December 31, 2025[189]. - The company has financed operations with $961.0 million in gross proceeds from equity financings, including pre-IPO private placements and public offerings[189]. - All product candidates are in preclinical or clinical development, with no products approved for commercialization and no revenue generated from product sales to date[190]. - The company expects to incur significant expenses and operating losses over the next several years, with expenses anticipated to increase substantially as it advances its product candidates[190]. - As of December 31, 2025, the company had cash and cash equivalents of $319.8 million, which is expected to fund operations into 2028[197]. - The company may require additional capital to achieve its business objectives, and unfavorable global economic conditions could adversely affect its ability to raise such capital[198]. - The company’s existing indebtedness contains restrictions that may limit operational flexibility and could lead to an event of default if certain conditions are not met[199]. - The company does not expect to generate revenue from its product candidates for several years, if at all, and the success of TSHA-102 will depend on various factors including regulatory approval and market acceptance[212]. Intellectual Property and Collaborations - The company entered into a license agreement with Abeona for Rett syndrome, involving a one-time upfront fee of $3.0 million and potential milestone payments totaling up to $56.5 million per licensed product[81]. - The Abeona Rett Agreement triggered a regulatory milestone payment of $1.0 million upon CTA filing approval in March 2022, and a $3.5 million payment after dosing the first patient in May 2023[82]. - The company has in-licensed six U.S. patents and 13 foreign patents as of January 22, 2026, to protect its proprietary technology in gene therapy[89]. - The company has sub-licensed 9 pending patent applications worldwide for feedback-enabled synthetic genes aimed at treating Rett Syndrome, with patents expected to expire in 2039[92]. - The company owns two pending U.S. provisional patent applications for assessing the severity of Rett Syndrome, with expected patent expiration in 2046[93]. - The company in-licenses 5 pending patent applications for RNA interference constructs targeting MAPT for Tauopathies, with patents expected to expire in 2042[94]. - The company in-licenses 3 pending patent applications for FMR1-encoding transgene packaged in an AAV vector for treating Fragile X Syndrome, with patents expected to expire in 2043[95]. - The company has a research collaboration with UT Southwestern, which includes a royalty-free license for certain patent rights and know-how, with no future milestone obligations[76][77]. - The Option Agreement with Astellas expired in October 2025 without exercise, allowing the company to regain full rights to TSHA-102[85]. Market and Competitive Landscape - The company may face significant competition from other biotechnology and pharmaceutical companies, which could adversely affect its operating results[190]. - The company has a pipeline of early-stage gene therapy programs targeting CNS diseases for future development or partnerships[62]. - TSHA-113 is being developed for tauopathies, affecting an estimated 11,000 patients in the U.S. and Europe, including Alzheimer's disease, which impacts approximately 6.2 million Americans and 7.8 million Europeans[63][65]. - TSHA-113 demonstrated significant reduction in tau mRNA and protein levels in PS19 mice, with treatment improving survival rates and alleviating symptoms of neurodegeneration[68]. - TSHA-114 is under development for Fragile X syndrome, which affects about 75,000 patients in the U.S. and Europe, characterized by cognitive impairment and behavioral issues[73][69]. - TSHA-114 showed robust FMRP expression and normalization of hyperactivity and sleep in treated Fmr1 KO mice, supporting its continued development[71][72]. Regulatory Challenges and Compliance - The regulatory approval processes for product candidates are lengthy and unpredictable, which could significantly impact the company's business[187]. - The company must comply with varying international regulatory requirements for marketing products outside the U.S., which may differ significantly from FDA processes[129]. - The maximum evaluation timeframe for a Marketing Authorization Application (MAA) under the centralized procedure is 210 days, which can be reduced to 150 days for accelerated assessments[135]. - The decentralized MAA procedure requires a separate application to each EU Member State, with a draft assessment prepared within 120 days[136]. - Innovative products targeting unmet medical needs may be eligible for expedited development programs like the Priority Medicines (PRIME) scheme, enhancing regulatory support[139]. - A conditional Marketing Authorization (MA) can be granted for products lacking complete safety and efficacy data, valid for one year and renewable annually until conditions are fulfilled[141]. - The EU provides eight years of data exclusivity and ten years of market exclusivity for innovative medicinal products post-MAA, with potential extensions for new therapeutic indications[147]. - Orphan medicinal products receive a ten-year market exclusivity period, which can be extended by two years if a Pediatric Investigation Plan (PIP) is complied with[151]. - The market exclusivity period may be reduced to six years if the product no longer meets orphan criteria or if it is sufficiently profitable[153]. - MA holders must establish a pharmacovigilance system and comply with regulatory obligations, including expedited reporting of serious adverse reactions[154]. - New MAAs must include a risk management plan (RMP) detailing the risk management system and measures to minimize associated risks[155]. - The company is subject to various healthcare regulations, including the U.S. federal Anti-Kickback Statute and the civil False Claims Act, which impose strict compliance requirements on promotional activities and claims for payment[158]. - The company faces significant uncertainty regarding the coverage and reimbursement status of its pharmaceutical products, which can vary widely among third-party payors[164]. - The U.S. Department of Health and Human Services imposes rebates on Medicare products to penalize price increases that exceed inflation, impacting the company's pricing strategies[168]. - The company must navigate complex pricing negotiations in the European Union, where pricing and reimbursement schemes differ significantly across member states[169]. - The Affordable Care Act (ACA) has substantially changed the financing of healthcare in the U.S., affecting the pharmaceutical industry through new rebate methodologies and annual fees[171]. - Recent legislative changes, such as the One Big Beautiful Bill Act, are expected to reduce Medicaid spending and enrollment, potentially impacting the company's market[171]. - The current administration's policies aim to reduce drug prices through initiatives like Most-Favored Nation pricing, which could affect the company's profitability and operational costs[172]. - The company may face increased compliance risks due to proposed changes in regulations affecting drug pricing and marketing practices[172]. - The company is required to report payments and transfers of value to healthcare professionals under the U.S. federal Physician Payments Sunshine Act, impacting its marketing strategies[162]. - The company must conduct clinical studies to demonstrate cost-effectiveness for pricing negotiations in various countries, which could delay commercialization efforts[169]. Future Outlook and Challenges - The company aims to advance the preclinical and clinical development of its product candidates and establish a commercialization infrastructure[191]. - The company has a limited operating history since its inception in 2019, making it difficult for investors to evaluate its future viability[194]. - The company may face significant delays or challenges in achieving sustainable production of its product candidates, impacting commercialization efforts[215]. - The regulatory landscape for gene therapy products is complex, uncertain, and subject to change, making it difficult for the company to predict the time and cost of obtaining regulatory approval for product candidates[216]. - Very few therapeutic products in the genetic medicine field have received marketing authorization from the FDA or the European Commission[216]. - Regulatory requirements for gene therapy and cell therapy products have changed frequently and are expected to continue evolving in the future[216]. - There is substantial overlap in the regulatory bodies responsible for existing gene therapy and cell therapy products[216].