Financial Performance - The company reported a net loss of $34.4 million, or $0.37 per share, for Q3 2025, compared to a net loss of $72.7 million, or $1.07 per share, for the same period in 2024[11]. - Net loss for the three months ended September 30, 2025, was $34.386 million, an improvement from a net loss of $72.704 million in the same period of 2024[26]. - Loss before income taxes for the nine months ended September 30, 2025, was $111.736 million, compared to a loss of $263.955 million in the same period of 2024, indicating a reduction of 57.6%[26]. - The net loss per share for the three months ended September 30, 2025, was $0.37, an improvement from $1.07 in the same period of 2024[26]. Expenses - Research and development expenses for Q3 2025 were $19.9 million, a decrease from $21.2 million in Q3 2024, primarily due to reduced spending on AMX0035[9]. - Selling, general, and administrative expenses for Q3 2025 were $16.2 million, down from $17.8 million in Q3 2024, mainly due to lower consulting and professional service costs[10]. - Total operating expenses for the nine months ended September 30, 2025, were $116.686 million, a decrease of 67.7% compared to $362.113 million in the same period of 2024[26]. - Research and development expenses for the nine months ended September 30, 2025, totaled $69.191 million, down from $81.192 million in the same period of 2024, representing a decrease of 14.7%[26]. Cash and Assets - Cash, cash equivalents, and marketable securities totaled $344.0 million as of September 30, 2025, up from $180.8 million at June 30, 2025, reflecting net proceeds of approximately $191 million from a public offering[12]. - Cash, cash equivalents, and marketable securities increased significantly to $343.990 million as of September 30, 2025, compared to $176.501 million at the end of 2024, marking a growth of 94.8%[24]. - Total assets increased to $362.741 million as of September 30, 2025, compared to $193.634 million on December 31, 2024, reflecting a growth of 87.5%[24]. - Total liabilities increased slightly to $30.745 million as of September 30, 2025, from $28.869 million on December 31, 2024, reflecting a growth of 6.1%[24]. - Stockholders' equity rose to $331.996 million as of September 30, 2025, compared to $164.765 million at the end of 2024, representing an increase of 101.5%[24]. Clinical Trials and Development - Recruitment for the pivotal Phase 3 LUCIDITY trial of avexitide is expected to be completed in Q1 2026, with topline data anticipated in Q3 2026[6]. - The company plans to initiate a pivotal Phase 3 trial for AMX0035 in Wolfram syndrome in the second half of 2026, pending FDA alignment[13]. - Avexitide demonstrated a 64% least-squares mean reduction in the composite rate of Level 2 and Level 3 hypoglycemic events in the Phase 2b trial, with a p-value of 0.0031[7]. - Early cohort data from the Phase 1 LUMINA trial of AMX0114 in ALS will be presented at the 36th International Symposium on ALS/MND in December 2025[4]. - Amylyx is advancing a collaboration with Gubra A/S for a novel long-acting GLP-1 receptor antagonist, with a decision on a potential development candidate expected soon[13].

Financial Performance - Net Sales for Q3 2025 were $892 million, a decrease of 1% compared to the prior year[4] - Operating Profit increased by 14% to $108 million, with Operating Margin rising by 160 basis points to 12.1%[4] - Earnings per Share (EPS) rose by 986% to $0.76, including a $0.64 per share discrete tax benefit[4] - Adjusted EPS increased by 25% to $0.15, compared to $0.12 per diluted share in the prior year[11] - Net sales for the quarter ended September 27, 2025, were $891.7 million, a decrease of 1.0% compared to $900.4 million in the same quarter of 2024[30] - Gross profit for the quarter was $363.5 million, down 2.7% from $373.5 million year-over-year, with a gross margin of 40.8%[30] - Operating profit increased by 14.3% to $107.5 million, compared to $94.0 million in the prior year, representing 12.1% of net sales[30] - Net income for the quarter was $270.7 million, significantly up from $30.0 million in the same quarter of 2024, with earnings per share (EPS) of $0.76 compared to $0.09[30] - For the nine months ended September 27, 2025, net sales were $2.64 billion, a slight increase of 0.9% from $2.62 billion in the same period of 2024[30] - The company reported a gross profit of $1.09 billion for the nine months, up 12.7% from $969.3 million year-over-year[30] - Operating profit for the nine months surged to $342.1 million, a 416.4% increase from $66.2 million in the previous year[30] - The diluted EPS from continuing operations for the nine months was $1.04, compared to a loss of $0.41 in the same period of 2024[30] Sales and Market Trends - U.S. net sales decreased by 4.5% due to unanticipated shifts in ordering patterns, but unit point-of-sale trends improved each month[12] - International net sales decreased by 8% on a reported basis, with a $4 million headwind from unfavorable foreign exchange rates[14] - The impact of foreign currency on net sales for the quarter was a decrease of $4.3 million, while the constant currency sales showed a decline of only 0.5%[32] - U.S. segment net sales for the quarter decreased by 4.5% to $647.5 million, while international segment net sales decreased by 8.1% to $204.4 million[43] Cash Flow and Liquidity - Cash Flow from Operations was $28 million, down from $92 million in the prior year, with Free Cash Flow at $22 million compared to $88 million last year[16] - Cash and cash equivalents as of September 27, 2025, were $217.6 million, compared to $316.8 million a year earlier[45] - Net cash from operating activities for the quarter was $27.597 million, a decrease from $92.215 million in the prior year[47] - Free cash flow for the quarter ended September 27, 2025, was $22,266 thousand, compared to $88,127 thousand in the same quarter of 2024[54] Debt and Leverage - The leverage ratio improved to 3.3 times net debt-to-adjusted EBITDA, down from 4.3 times in the prior year[16] - Long-term debt remained stable at approximately $2.21 billion, compared to $2.19 billion at the end of 2024[45] - Net debt as of September 27, 2025, was $2,042,260 thousand, down from $2,977,998 thousand a year earlier[53] - The leverage ratio, defined as Debt/Income from continuing operations, was 5.7 as of September 27, 2025, compared to (73.5) for the same period in 2024[53] Inventory and Assets - Inventory at the end of Q3 2025 was $991 million, an increase of 10% year-over-year, primarily due to tariffs[16] - Total assets increased to $4.28 billion from $3.84 billion at the end of 2024[45] - The company experienced a significant inventory write-down charge of $113.528 million during the nine months ended September 27, 2025[47] Strategic Initiatives - The company is focused on strategic plans including supply chain restructuring and cost-saving initiatives to enhance operational efficiency[30] - HanesBrands and Gildan entered into a definitive merger agreement, and no guidance will be provided due to the pending transaction[4] Other Financial Metrics - Total segment operating profit for the quarter was $164.8 million, down 7.1% from $177.3 million in the prior year[43] - The total operating profit margin for the quarter improved to 12.1%, up from 10.4% in the same quarter of 2024[43] - The company reported a significant increase in other net sales, which rose to $39.8 million from a loss of $0.4 million in the prior year quarter[43] - The company’s retained earnings increased to $577.5 million from $234.5 million at the end of 2024[45] - GAAP gross profit for the quarter was $363.450 million, representing 40.8% of net sales, compared to $373.477 million or 41.5% in the prior year[49] - Non-GAAP operating profit for the quarter was $115.808 million, which is 13.0% of net sales, up from 12.5% in the same quarter of 2024[49] - The company incurred restructuring and other action-related charges, including $3.119 million for professional services in the quarter[50] - The company incurred total restructuring and other action-related charges of $33,864 thousand for the last twelve months ended September 27, 2025[53] - The company reported a discrete tax benefit of $(227,732) thousand for the quarter ended September 27, 2025[51] - Non-GAAP income from continuing operations, as adjusted, was $52,455 thousand for the quarter ended September 27, 2025, up from $43,667 thousand in the prior year[51] - GAAP income from continuing operations for the quarter ended September 27, 2025, was $271,907 thousand, compared to a loss of $143,663 thousand for the same period in 2024[51] - Total EBITDA for the last twelve months ended September 27, 2025, was $455,868 thousand, significantly higher than $208,956 thousand for the same period in 2024[53]

Revenue Performance - Revenue for Q3 2025 was $37.2 million, representing a 14% year-over-year increase[3] - Revenue for Q3 2025 was $37,162,000, representing a 14.8% increase from $32,589,000 in Q3 2024[27] - B2 Cloud Storage revenue reached $20.7 million, reflecting a 28% year-over-year growth[3] - Annual recurring revenue (ARR) was $147.2 million, a 13% year-over-year increase[7] - B2 Cloud Storage ARR was $81.8 million, showing a 26% year-over-year growth[7] - The company expects Q4 2025 revenue to be between $37.3 million and $37.9 million[6] Profitability Metrics - Gross profit was $23.1 million, or 62% of revenue, up from 55% in Q3 2024[3] - Gross profit for Q3 2025 was $23,071,000, up 29.5% from $17,800,000 in Q3 2024, resulting in a gross margin of 62%[27][31] - Adjusted EBITDA was $8.4 million, or 23% of revenue, compared to 12% in Q3 2024[3] - Adjusted EBITDA for Q3 2025 was $8,387,000, compared to $3,749,000 in Q3 2024, reflecting an adjusted EBITDA margin of 23%[32] - Adjusted gross margin for Q3 2025 was 79%, up from 78% in Q3 2024[33] - Non-GAAP net income for Q3 2025 was $1,886,000, compared to a loss of $4,137,000 in Q3 2024[34] Cash Flow and Expenses - Cash flow from operations for the nine months ended September 30, 2025, was $14.2 million, compared to $10.3 million in the same period of 2024[3] - Adjusted Free Cash Flow for the nine months ended September 30, 2025 was $(9,485,000), an improvement from $(15,603,000) in the same period of 2024[35] - Adjusted Free Cash Flow Margin for the nine months ended September 30, 2025 was -9%, an improvement from -17% in the same period of 2024[35] - Operating expenses for Q3 2025 totaled $26,392,000, down from $29,998,000 in Q3 2024[27] - Adjusted operating expenses for Q3 2025 totaled $20,972,000, slightly lower than $21,720,000 in Q3 2024[33] - Total stock-based compensation expense for Q3 2025 was $5,445,000, down from $8,438,000 in Q3 2024[36] Balance Sheet and Equity - Total assets increased to $191,530,000 as of September 30, 2025, up from $168,558,000 as of December 31, 2024[26] - Cash and cash equivalents decreased to $29,077,000 from $45,776,000 at the end of 2024[29] - The company reported a total stockholders' equity of $82,829,000 as of September 30, 2025, up from $77,622,000 at the end of 2024[26] - The weighted average common shares outstanding for Q3 2025 was 56,977,764, compared to 43,515,110 in Q3 2024[27] Losses and Improvements - Net loss for the nine months ended September 30, 2025, was $20,199,000, an improvement from a net loss of $34,154,000 for the same period in 2024[29][32] - The company reported a net loss of $3,778,000 for Q3 2025, an improvement from a loss of $12,753,000 in Q3 2024[34] - Net revenue retention rate (NRR) was 106%, down from 118% in Q3 2024[7] Research and Development - Research and development expenses increased to $11,235,000 in Q3 2025, compared to $10,734,000 in Q3 2024[27] - Research and development expenses for Q3 2025 were $11,235,000, compared to $10,734,000 in Q3 2024[33] Future Projections - Adjusted EBITDA margin for full-year 2025 is projected to be between 18% and 20%, raised from 17% to 19%[6]

Exhibit 99.1 Cartesian Therapeutics Reports Third Quarter 2025 Financial Results and Provides Business Update Enrollment on track in Phase 3 AURORA trial of Descartes-08 in myasthenia gravis Recent Pipeline Progress and Anticipated Milestones • Enrollment On Track 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 (BCMA) chimeric a ...

Financial Position - As of September 30, 2025, Cartesian Therapeutics reported cash, cash equivalents, and restricted cash of $145.1 million, expected to support operations into mid-2027[1] - The total assets as of September 30, 2025, were $372.7 million, down from $435.0 million as of December 31, 2024[12] - The total stockholders' deficit increased to $35.8 million as of September 30, 2025, compared to $6.8 million as of December 31, 2024[12] Revenue and Expenses - Total revenue for the three months ended September 30, 2025, was $452,000, compared to $387,000 for the same period in 2024, representing a 16.8% increase[14] - Collaboration and license revenue for the nine months ended September 30, 2025, was $400 million, a significant increase from $39.111 million in the same period of 2024[14] - Research and development expenses for Q3 2025 were $13.8 million, up from $11.4 million in Q3 2024, primarily due to increased costs associated with the Phase 3 AURORA trial[9] - General and administrative expenses increased to $7.7 million in Q3 2025 from $6.6 million in Q3 2024, driven by higher facilities and stock-based compensation expenses[9] - Total operating expenses for the nine months ended September 30, 2025, were $66.616 million, compared to $56.838 million in 2024, marking a 17.1% increase[14] Net Loss - The net loss for Q3 2025 was $35.9 million, or $1.38 per share, compared to a net loss of $24.2 million, or $1.13 per share, in Q3 2024[9] - The net loss for the three months ended September 30, 2025, was $35.902 million, compared to a net loss of $24.183 million in the same period of 2024, indicating a 48.3% increase in losses[14] - Basic and diluted net loss per share for the three months ended September 30, 2025, was $(1.38), compared to $(1.13) for the same period in 2024[14] - The total comprehensive loss for the three months ended September 30, 2025, was $35.912 million, compared to $24.198 million in 2024, reflecting a 48.3% increase[14] Trials and Designations - The Phase 3 AURORA trial of Descartes-08 in myasthenia gravis is on track, with approximately 100 participants enrolled[3] - Preliminary data from the ongoing Phase 2 trial of Descartes-08 in systemic lupus erythematosus is expected by the end of 2025[2] - A Phase 2 pediatric basket trial of Descartes-08 in select autoimmune diseases is anticipated to initiate by the end of 2025[3] - Descartes-08 has received Orphan Drug Designation and Regenerative Medicine Advanced Therapy Designation from the FDA for the treatment of myasthenia gravis[5] Other Financial Metrics - Interest income for the three months ended September 30, 2025, was $1.548 million, down from $2.573 million in the same period of 2024, a decrease of 39.8%[14] - Grant revenue for the nine months ended September 30, 2025, was $1.450 million, compared to $561,000 in the same period of 2024, representing a 158.3% increase[14] - The weighted-average common shares outstanding for the three months ended September 30, 2025, were 26,002,892, compared to 21,471,408 in 2024, an increase of 21.0%[14]

Financial Performance - Collaboration revenue for Q3 2025 was $12.8 million, up from $9.2 million in Q3 2024, reflecting growth in partnerships with Roche and Novartis [10]. - Net loss for Q3 2025 was $27.1 million, compared to a net loss of $23.9 million in Q3 2024 [13]. - Total operating expenses for Q3 2025 increased to $45.743 million, compared to $35.743 million in Q3 2024, representing a 28% rise [27]. - The net loss for Q3 2025 was $27.081 million, compared to a net loss of $23.859 million in Q3 2024, indicating a worsening of 13.3% [27]. - Total assets increased to $459.841 million as of September 30, 2025, compared to $438.732 million at the end of 2024, a growth of 4.8% [25]. - The total stockholders' equity increased to $245.837 million as of September 30, 2025, from $222.936 million at the end of 2024, a rise of 10.3% [25]. Research and Development - R&D expenses for Q3 2025 increased to $36.7 million from $27.6 million in Q3 2024, driven by advancements in clinical studies and the QuEEN™ discovery engine [11]. - Research and development expenses for the nine months ended September 30, 2025, were $99.521 million, up from $82.697 million in the same period of 2024, a 20.2% increase [27]. - MRT-8102, a NEK7-directed MGD, is currently in a Phase 1 study, with initial data expected in H1 2026 [4]. - MRT-6160 is advancing towards multiple Phase 2 studies in immune-mediated diseases, with Novartis responsible for funding these studies [7]. - MRT-2359 is being evaluated in a Phase 1/2 study for mCRPC, with updated results expected by year-end 2025 [8]. - The company expects to submit an IND for a second-generation NEK7-directed MGD optimized for CNS penetration in 2026 [22]. - Monte Rosa plans to submit an IND application for a CDK2 and/or cyclin E1-directed MGD in 2026 [9]. - MRT-8102 is anticipated to provide initial Phase 1 data in the first half of 2026, targeting inflammatory and cardio-immunology indications [22]. Cash Position - Cash position as of September 30, 2025, was $396.2 million, an increase of $100.7 million from $295.5 million as of June 30, 2025, primarily due to a $120 million upfront payment from Novartis [14]. - Cash and cash equivalents as of September 30, 2025, were $208.343 million, down from $224.254 million at the end of 2024 [25]. - The company expects its cash and cash equivalents to be sufficient to fund operations through 2028 [15]. - The company has a cash runway to fund operations through 2028, supporting multiple anticipated Phase 2 readouts for MRT-8102, MRT-6160, and MRT-2359 [22]. Collaboration and Partnerships - Monte Rosa is eligible to receive up to $5.7 billion from the collaboration with Novartis, including upfront payments, milestones, and tiered royalties [6]. - Collaboration revenue for Q3 2025 was $12.768 million, up 38.5% from $9.216 million in Q3 2024 [27].

Financial Performance - Total revenue for Q3 2025 was $19.6 million, reflecting a decrease from $22.5 million in Q3 2024[6] - Net loss for Q3 2025 was $15.3 million, compared to a net loss of $12.6 million in Q3 2024[9] - Adjusted EBITDA for Q3 2025 was a loss of $4.5 million, down from an adjusted EBITDA of $0.7 million in Q3 2024[10] - Net loss for the nine months ended September 30, 2025, was $69,392 thousand, compared to a net loss of $37,798 thousand for the same period in 2024, indicating an increase of 83.6%[28] - Adjusted EBITDA for the nine months ended September 30, 2025, was $(7,918) thousand, a decline from $4,262 thousand in the same period of 2024[30] Operating Expenses - Operating expenses for Q3 2025 were $29.6 million, slightly up from $29.1 million in Q3 2024[8] - Operating expenses for the nine months ended September 30, 2025, were $88,444 thousand, slightly down from $89,362 thousand in the same period of 2024[31] Cash Flow and Assets - Cash balance increased to $147.6 million as of September 30, 2025, including $65.9 million from a convertible note offering[11] - Cash and cash equivalents rose to $28,815 thousand as of September 30, 2025, compared to $13,056 thousand on December 31, 2024, reflecting a growth of 120.5%[27] - Total current assets reached $201,042 thousand as of September 30, 2025, significantly higher than $106,736 thousand at the end of 2024, marking an increase of 88.5%[27] - Cash flows from operating activities resulted in a net cash used of $18,992 thousand for the nine months ended September 30, 2025, compared to $4,567 thousand for the same period in 2024[28] - Cash flows from financing activities generated a net cash inflow of $144,942 thousand for the nine months ended September 30, 2025, compared to $55,901 thousand in 2024[28] Liabilities and Contractual Obligations - Total liabilities increased to $289,801 thousand as of September 30, 2025, from $160,157 thousand on December 31, 2024, representing an increase of 80.8%[27] - The company reported a significant increase in contract liabilities, with current contract liabilities rising to $21,662 thousand as of September 30, 2025, compared to $2,183 thousand at the end of 2024[27] Contracts and Future Outlook - The company has a backlog of $322.7 million, with approximately 91% from international contracts[5] - The company won over $60 million in new contract awards, driven by strong international demand for space-based intelligence solutions[3] - The next Gen-3 satellite is at the launch site, with an anticipated launch in the coming weeks[5] - The company is maintaining its full-year 2025 guidance for revenue, adjusted EBITDA, and capital expenditures[13] - Approximately $43.4 million in unbilled contract assets is expected to be billed and received over the next 12 months[11] Asset Growth - Total assets increased to $380,857 thousand as of September 30, 2025, up from $254,146 thousand on December 31, 2024, representing a growth of 49.7%[27]

Clinical Development - CLN-049 demonstrated a ~30% complete response rate in heavily pretreated patients with relapsed/refractory AML, with updated results to be presented at the 2025 ASH Annual Meeting[1] - The company plans to share initial clinical data for CLN-978 in autoimmune diseases in the first half of 2026[2] - The Phase 1 OUTRACE Program for CLN-978 is currently enrolling patients across multiple studies[6] - Taiho plans to initiate a rolling submission of an NDA for zipalertinib by year-end 2025, following a positive pre-NDA meeting with the FDA[3] - The core pipeline is now focused on T cell engagers, with discontinued programs CLN-619 and CLN-617[3] Financial Performance - Cash and investments totaled $475.5 million as of September 30, 2025, providing a runway into 2029[1] - Research and development expenses increased to $42.0 million for Q3 2025, compared to $35.5 million in Q3 2024[7] - General and administrative expenses were $13.6 million for Q3 2025, slightly up from $13.3 million in Q3 2024[7] - Net loss attributable to Cullinan was $50.6 million for Q3 2025, compared to $40.6 million for the same period in 2024[7] - Total stockholders' equity decreased to $451.4 million as of September 30, 2025, down from $590.3 million at the end of 2024[14]

Exhibit 99.1 Moderna Reports Third Quarter 2025 Financial Results and Provides Business Updates Reports third quarter revenue of $1.0 billion, GAAP net loss of $(0.2) billion and GAAP EPS of $(0.51) Narrows 2025 projected revenue range to $1.6 - $2.0 billion Improves 2025 expected GAAP operating expenses by $0.7 billion to a range of $5.2 - $5.4 billion Increases 2025 expected year-end cash balance by $0.5 billion - $1 billion to a range of $6.5 - $7.0 billion CAMBRIDGE, MA / ACCESSWIRE / November 6, 2025 / ...

Entrada Therapeutics Reports Third Quarter 2025 Financial Results -- Company on track to report ELEVATE-44-201 data from first patient cohort in Q2 2026 -- -- First patient dosed in ELEVATE-45-201 and the Company is on track to report data from the first patient cohort in mid-2026 -- -- Filed for regulatory authorization in U.K. to initiate ELEVATE-50-201, a global Phase 1/2 MAD clinical study of ENTR-601-50 -- -- Expected cash runway extended into Q3 2027 with $327 million in cash, cash equivalents and mar ...