Drug Development and Approval - TA-ERT is intended as an enzyme replacement therapy for Mucopolysaccharidosis Type IIIB (MPS IIIB), aiming to restore rhNAGLU enzyme activity in the central nervous system [20]. - The company plans to seek U.S. accelerated approval for TA-ERT based on existing clinical data and will initiate a confirmatory trial as a condition for the biologics license application (BLA) [21]. - TA-ERT has received multiple designations including Rare Pediatric Disease Designation, Fast Track Designation, Breakthrough Therapy Designation, and Orphan Drug Designation in the U.S. and EU [41]. - The FDA confirmed that CSF HS-NRE is a surrogate biomarker likely to predict clinical benefit, which could support accelerated approval for TA-ERT [35]. - The company anticipates submitting the BLA for TA-ERT in Q4 2026, following the FDA's requirements for drug product process performance qualification [39]. - The FDA requires satisfactory completion of an advisory committee review and approval of the NDA or BLA before any commercial marketing of the product in the U.S. [88]. - Phase 1 clinical trials focus on safety, dosage tolerance, and early evidence of effectiveness, often involving healthy subjects or patients with severe diseases [89]. - Phase 2 trials evaluate the drug in a limited patient population to identify adverse effects and preliminarily assess efficacy [89]. - Phase 3 trials are conducted to establish the overall benefit/risk ratio and typically require two well-controlled trials for FDA approval [89]. - The FDA aims to review and act on standard NDAs or BLAs within ten months from the filing date, although this process often takes longer due to additional information requests [94]. - Accelerated approval may be granted for drugs treating serious conditions based on surrogate endpoints, contingent on post-approval confirmatory studies [99]. - The FDA may require Phase 4 testing to monitor the effects of approved products and ensure ongoing safety and efficacy [106]. - The company must demonstrate safety and efficacy to regulatory authorities, which is a lengthy and complex process that may delay commercialization [192]. - Regulatory approval for product candidates is uncertain and can take many years, with the FDA having substantial discretion in the approval process [213]. - The company has not previously submitted an NDA or BLA to the FDA, which is required before marketing any product candidates in the U.S. [213]. Clinical Trials and Efficacy - In clinical studies, TA-ERT significantly reduced CSF HS-NRE levels by 91.5 ng/mL from baseline at 240 weeks, with most participants normalizing levels within eight weeks of therapy initiation [30]. - Cognitive function in children treated with TA-ERT remained stable over time, contrasting with untreated children who experienced cognitive decline starting around five years of age [31]. - The mean exposure to TA-ERT in clinical studies was 4.2 years, with no deaths reported and the most common treatment-emergent adverse event being vomiting in 100% of participants [34]. - The immediate goal of treatment for Congenital Adrenal Hyperplasia (CAH) is to prevent adrenal crises by replacing missing physiological levels of corticosteroids [50]. - The incidence of classic CAH is estimated at approximately one in 14,000 to 18,000 live births, highlighting the need for effective treatment options [51]. - The Phase 2 clinical trial TAMARIND aimed to explore the efficacy of 400mg twice-daily tildacerfont versus placebo in improving depressive symptoms in MDD patients who are Cortibon-positive, but was discontinued in Q1 2026 due to a serious adverse event [47]. - The TAMARIND Phase 2 study of tildacerfont in MDD was discontinued in Q1 2026 following a serious adverse event involving elevated liver enzymes [198]. - Patient enrollment challenges for clinical trials may lead to delays or abandonment of trials, particularly for rare disorders with limited patient populations [201]. Financial Performance and Funding - For the year ended December 31, 2025, the company incurred a net loss of $39.0 million and used $33.3 million of cash in operations [172]. - As of December 31, 2025, the company had an accumulated deficit of $289.2 million and cash and cash equivalents of $48.9 million [172]. - The company expects to continue generating operating losses and significant cash outflows for at least the next few years [172]. - The company raised net proceeds of $93.4 million from its IPO in October 2020 and $50.9 million from a private placement in February 2023 [175]. - In October 2025, the company entered into a Securities Purchase Agreement, resulting in total net proceeds of $46.6 million [175]. - The company has a Loan Agreement with Avenue Capital, providing term loans of up to $50.0 million, contingent on achieving certain regulatory milestones [176]. - The company will require substantial additional financing to develop its product candidates and implement its operating plan [174]. - The company may need to raise additional funds sooner if it chooses to expand more rapidly than currently anticipated [178]. - The company’s ability to continue as a going concern is in doubt due to insufficient working capital for planned operations over the next twelve months [172]. - The company reported net losses of $39.0 million and $53.0 million for the years ended December 31, 2025 and 2024, respectively, with an accumulated deficit of $289.2 million as of December 31, 2025 [184]. - The company anticipates continuing to incur significant net losses for the foreseeable future as it advances clinical development and seeks regulatory approvals for its product candidate, TA-ERT [185]. Market and Competitive Landscape - The company has not yet generated any product revenue and has no products approved for commercial sale to date [184]. - The company faces significant competition from other biotechnology and pharmaceutical companies, which may impact its operating results and market position [194]. - The company may need to seek additional capital through equity offerings, debt financings, or strategic partnerships, which could dilute existing stockholders' interests [181]. - The company has a limited operating history and has not yet demonstrated the ability to successfully complete clinical development or commercialize products [182]. - The company is subject to various risks and uncertainties in drug development, which may affect its ability to achieve profitability [185]. Regulatory and Compliance Challenges - The company is subject to extensive regulation by government authorities in the U.S. and other countries, impacting all aspects of drug development and marketing [83]. - The company’s commercial success will depend on its ability to maintain patent protection and proprietary rights, as well as to navigate regulatory approvals effectively [76][83]. - The company may be subject to significant penalties, including civil, criminal, and administrative penalties, if found in violation of healthcare laws [124]. - Third-party payors are increasingly challenging drug prices and may limit coverage to specific products on an approved list, impacting sales [127]. - Participation in governmental programs may require the company to engage in discount and rebate programs, potentially lowering product prices [128]. - The process for determining coverage by third-party payors may differ from the process for setting drug prices and reimbursement rates [127]. - The company may need to conduct expensive pharmaco-economic studies to demonstrate the medical necessity and cost-effectiveness of its products [127]. - The Inflation Reduction Act of 2022 requires the U.S. Department of Health and Human Services to negotiate prices for certain single-source biologics, potentially affecting up to 20 products annually [129]. - The downward pressure on healthcare costs, particularly for prescription drugs, has intensified, leading to higher barriers for new product entries [131]. - The U.S. government is pursuing policies to reduce drug prices, including Most-Favored Nation pricing, which may impact manufacturers' global pricing strategies and profitability [135]. - The Health Technology Assessment Regulation in the EU will apply to new active substances for cancer treatment starting January 12, 2025, with further expansions planned [138]. - The implementation of cost containment measures may hinder the ability to generate revenue and achieve profitability for approved products [139]. - Compliance with evolving data privacy laws, such as the GDPR, imposes significant operational challenges and potential penalties for noncompliance [141]. - The U.S. Foreign Corrupt Practices Act mandates accurate accounting and internal controls for international operations, impacting compliance obligations [144]. - The Clinical Trials Regulation in the EU aims to streamline clinical trial authorizations and improve transparency, effective from January 31, 2025 [146]. - The marketing authorization process in the EU requires submission of a Marketing Authorization Application, which can only be granted to applicants established in the EU [149]. Intellectual Property and Patent Strategy - As of December 31, 2025, the company has acquired rights to 19 patent families, including 26 issued U.S. patents and 216 granted patents in various markets outside the United States [68]. - The patent portfolio covering TA-ERT is expected to expire in 2033-2034, while the patent for tildacerfont is expected to expire in 2027, absent any extensions [69][72]. - The company has licensed 2 patent families from HBM Alpha Therapeutics, including 2 pending U.S. patent applications and 11 pending applications in various markets outside the United States [70]. - The company is required to pay tiered royalties on annual worldwide net sales of licensed products, with rates ranging from high-single digits to low double digits for MPS IIIB products [60]. - The BioMarin License Agreement includes obligations to pay up to $88.0 million upon achieving certain development and regulatory milestones, and up to $100.0 million per licensed product upon achieving certain sales milestones [60].

(Mark One) ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-K ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2025 OR Commission File Number: 001-38541 Dianthus Therapeutics, Inc. (Exact name of Registrant as specified in its Charter) Delaware 81-0724163 (State or other jurisdiction of incorpo ...

Revenue Performance - Fourth quarter revenue was $106.3 million, a 16% sequential increase, exceeding guidance of 8% to 10% growth[5] - For the full year 2025, total revenue decreased 12% to $386.9 million, with a 7% decline when adjusted for the divestiture of Geomagic[9] - Healthcare Solutions revenue increased 25% to $50.5 million in the fourth quarter, while Industrial Solutions revenue decreased 21% to $55.8 million[7] - Total revenue for the year ended December 31, 2025, was $386.9 million, a decrease of 12.1% from $440.1 million in 2024[25] - 3D Systems reported adjusted revenue of $106.3 million for Q4 2025, a 3.0% increase from $103.3 million in Q4 2024[35] Profitability and Loss - The company achieved a gross profit margin of 30.8% in Q4 2025, down from 31.0% in the prior year period[7] - Net loss attributable to 3D Systems Corporation decreased by $14.2 million to $19.5 million compared to the prior year period[8] - Adjusted EBITDA improved by $13.8 million to a loss of $5.3 million in Q4 2025, primarily driven by reductions in operating expenses[8] - Gross profit for the year ended December 31, 2025, was $131.0 million, down 20.2% from $164.2 million in 2024[22] - The company reported a loss from operations of $96.1 million for the year ended December 31, 2025, compared to a loss of $277.4 million in 2024[22] - Adjusted EBITDA for the year ended December 31, 2025, was $(45.4) million, compared to $(66.4) million for the year ended December 31, 2024[39] Cash and Assets - Cash and cash equivalents totaled $95.6 million as of December 31, 2025, with $3.9 million in principal debt maturing in Q4 2026[14] - Cash and cash equivalents decreased to $95.6 million as of December 31, 2025, from $171.3 million in 2024, representing a decline of 44.2%[23] - Total current assets decreased to $346.7 million in 2025, down 19.2% from $428.8 million in 2024[21] - The company generated net cash used in operating activities of $87.8 million for the year ended December 31, 2025, compared to $44.9 million in 2024[23] - The company reported a total stockholders' equity of $240.4 million as of December 31, 2025, an increase from $176.2 million in 2024[21] Cost Management - Cost reduction initiatives delivered approximately $55 million in annualized savings in 2025[5] - The company’s non-GAAP operating expense for Q4 2025 was $42.5 million, down from $58.4 million in Q4 2024[38] - Research and development expenses for the year ended December 31, 2025, were $65.0 million, a decrease of 24.8% from $86.5 million in 2024[22] Future Outlook - The company expects continued momentum in top-line growth and bottom-line performance in 2026, targeting 20% annual revenue growth in aerospace and defense[5][4] - First quarter 2026 revenue is projected to be between $91 million and $94 million, with Adjusted EBITDA expected to range from a loss of $5 million to $3 million[15] Stock Performance - The company’s diluted loss per share (GAAP) for Q4 2025 was $(0.15), compared to $(0.25) in Q4 2024[41] - Non-GAAP diluted loss per share for the year ended December 31, 2025, was $(0.37), an improvement from $(0.62) in the previous year[41] Divestiture Impact - 3D Systems excluded the impact of Geomagic from its financial measures, which was divested for $119.4 million in cash on April 1, 2025[32] - The company continues to evaluate its performance excluding stock-based compensation and other non-cash expenses to provide clearer insights into operational efficiency[30] - 3D Systems does not provide forward-looking guidance for certain GAAP measures due to the unpredictability of various costs, including litigation and acquisition expenses[34]

Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-K (Mark One) ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2025 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 FOR THE TRANSITION PERIOD FROM TO Commission file number 001-41989 BOUNDLESS BIO, INC. (Exact name of registrant as specified in its charter) Delaware 83-0751369 (State or othe ...

Exhibit 99.1 NEWS RELEASE NASDAQ:EU TSXV:EU March 9, 2026 www.encoreuranium.com enCore Energy Reports Year-End Financial Results, Strengthens Balance Sheet Through Warrant Exercises and Advances Key U.S. Uranium Projects March 9, 2026 – Dallas, Texas – enCore Energy Corp. (NASDAQ:EU | TSXV:EU) (the "Company" or "enCore"), America's Clean Energy CompanyTM, announced today its financial and operational results for the year ended December 31, 2025. "Our year end results underscore the strength of enCore's oper ...

KOMODO-1 first-in-human clinical trial of BBI-940 open for enrollment $108 million in cash provides runway into the second half of 2028, through expected clinical proof-of-concept readout for KOMODO-1 SAN DIEGO, March 09, 2026 – Boundless Bio (Nasdaq: BOLD), a clinical-stage oncology company interrogating extrachromosomal DNA (ecDNA) biology to deliver transformative therapies to patients with previously intractable oncogene amplified cancers, today announced financial results and business highlights for th ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 10-K þ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2025 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from ____ to ____ Commission file number: 001-37798 Cartesian Therapeutics, Inc. (Exact name of registrant as specified in its charter) | Delaware | | 26-1622110 | | --- | --- | - ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 10-K þ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2025 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from ____ to ____ Commission file number: 001-37798 Cartesian Therapeutics, Inc. (Exact name of registrant as specified in its charter) | Delaware | | 26-1622110 | | --- | --- | - ...

Exhibit 99.1 Cartesian Therapeutics Reports Full Year 2025 Financial Results and Provides Business Update Enrollment continues to progress in Phase 3 AURORA trial of Descartes-08 in myasthenia gravis Pipeline Progress and Anticipated Milestones • Enrollment Continues to Progress in the Phase 3 AURORA Trial of Descartes-08 in Participants with MG. The randomized, double-blind, placebo-controlled Phase 3 AURORA trial is designed to assess Descartes-08, Cartesian's autologous anti-B cell maturation antigen (BC ...

Exhibit 99.1 Preliminary Estimated Financial Information Year Ended December 31, 2025 HOUSTON, March 9, 2026 – W&T Offshore, Inc. (NYSE: WTI) ("W&T," the "Company," "we" or "us") today announced preliminary estimated unaudited financial results for the fourth quarter and full year ended December 31, 2025. The Company is filing this exhibit to the Current Report on Form 8-K to provide preliminary estimated financial information for the year ended December 31, 2025. The Company's financial statements for the ...