Revenue Performance - Total revenue for the three months ended September 30, 2025, was $452,000, a 16.8% increase from $387,000 in the same period of 2024[19] - Total revenue for the nine months ended September 30, 2025, was $1.85 million, a significant decrease from $39.67 million in the same period of 2024[161] - Collaboration and license revenue for the nine months ended September 30, 2025, was $400,000, a significant decrease from $39,111,000 in the same period of 2024[19] - Collaboration and license revenue for the nine months ended September 30, 2025, was $400,000, a significant decrease of 99% from $39.1 million in 2024[196] Expenses and Losses - Operating expenses for the three months ended September 30, 2025, totaled $21,518,000, up 19.1% from $17,962,000 in the same period of 2024[19] - Net loss for the three months ended September 30, 2025, was $35,902,000, compared to a net loss of $24,183,000 for the same period in 2024, representing a 48.4% increase in losses[19] - The company reported a net loss of $37.726 million for the nine months ended September 30, 2025, compared to a net loss of $67.171 million for the same period in 2024, indicating a 44% improvement in losses year-over-year[29] - Research and development expenses for the three months ended September 30, 2025, were $13.8 million, a 21% increase from $11.4 million in 2024[188] - General and administrative expenses for the three months ended September 30, 2025, rose to $7.7 million, an 18% increase from $6.6 million in 2024[189] - Research and development expenses for the nine months ended September 30, 2025, were $43.3 million, an increase of 28% from $33.8 million in 2024[199] Cash and Assets - Cash and cash equivalents decreased to $143,384,000 as of September 30, 2025, down from $212,610,000 as of December 31, 2024, a decline of 32.5%[16] - Total assets decreased to $372,675,000 as of September 30, 2025, from $435,023,000 as of December 31, 2024, a reduction of 14.3%[16] - The company had cash, cash equivalents, and restricted cash of $145.119 million at the end of the period, down from $220.867 million at the same time last year, representing a decrease of 34%[29] - As of September 30, 2025, the Company reported cash, cash equivalents, and restricted cash totaling $145.1 million, with $1.7 million classified as restricted cash[45] Stock and Financing - The company completed a private placement resulting in net proceeds of approximately $124.438 million from the issuance of common stock and Series B Preferred Stock[29] - The company executed a 1-for-30 reverse stock split on April 4, 2024, affecting all share-related figures in the financial statements[26] - The 2024 Private Placement raised approximately $130.0 million through the issuance of 3,563,247 shares of common stock and 2,937,903 shares of Series B Non-Voting Convertible Preferred Stock at $20.00 per share[38] - The Company entered into a Sales Agreement for an "at-the-market" equity offering program with potential gross sales proceeds of up to $100.0 million[104] Liabilities and Deficits - Total liabilities decreased to $408,519,000 as of September 30, 2025, from $441,825,000 as of December 31, 2024, a decline of 7.5%[16] - The accumulated deficit increased to $(729,797,000) as of September 30, 2025, compared to $(692,071,000) as of December 31, 2024[16] - The Company has an accumulated deficit of $729.8 million as of September 30, 2025, and anticipates continued operating losses due to ongoing research and development costs[47] Future Outlook and Risks - The Company currently has no source of product revenue and does not expect to generate product revenue for the foreseeable future, relying primarily on collaboration agreements for revenue[44] - The Company is subject to risks typical of biotechnology firms, including the need for significant additional capital for research and development efforts[40] - The Company expects to continue incurring significant expenses and operating losses for the foreseeable future as it advances its product candidates[167] - The company may need to seek additional funding sooner than expected if actual results differ from management's estimates regarding its ability to fund operations[45] Agreements and Milestones - Astellas paid a $10.0 million upfront payment under the Astellas Agreement, with potential future payments of up to $340.0 million contingent on development and regulatory milestones[124] - The Sobi License includes a one-time upfront payment of $75.0 million and potential milestone payments totaling up to $630.0 million, along with tiered royalty payments ranging from low double digits to high teens[127] - The Company must submit a BLA for a licensed product by the fourth quarter of 2026 and achieve a first commercial sale by the fourth quarter of 2028 under the NCI Agreement[147] Changes in Fair Value - The company recognized $16.9 million in expenses related to the change in fair value of the contingent value right liability for the three months ended September 30, 2025, compared to $15.1 million in 2024, an increase of 12%[192] - The estimated fair value of the CVR liability as of September 30, 2025, was $369,000,000, with a change in fair value of $(18,746,000) during the nine months ended September 30, 2025[74] - For the nine months ended September 30, 2025, the company recognized $18.7 million of income from the decrease in the fair value of the CVR liability, a change of $70.6 million compared to a $51.9 million expense in the prior period[203]

Financial Position - As of September 30, 2025, Cartesian Therapeutics reported approximately $145.1 million in cash, cash equivalents, and restricted cash, expected to support operations into mid-2027[1] - The total assets of Cartesian Therapeutics as of September 30, 2025, were $372.7 million, down from $435.0 million as of December 31, 2024[12] - The company's accumulated deficit increased to $729.8 million as of September 30, 2025, compared to $692.1 million at the end of 2024[12] Revenue - 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] - Grant revenue for the nine months ended September 30, 2025, was $1.450 million, compared to $561,000 in 2024, representing a 158.3% increase[14] Expenses - 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] Trials and Designations - The Phase 3 AURORA trial of Descartes-08 in myasthenia gravis is designed to enroll approximately 100 participants, with a primary endpoint assessing improvement in MG Activities of Daily Living score[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 targeting juvenile 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] Interest Income - 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] Comprehensive Loss - The total comprehensive loss for the nine months ended September 30, 2025, was $37.692 million, compared to $67.177 million in 2024, showing a decrease of 43.9%[14] Shares Outstanding - 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]

PART I. FINANCIAL INFORMATION [Item 1. Financial Statements (unaudited)](index=6&type=section&id=Item%201.%20Financial%20Statements%20%28unaudited%29) Unaudited consolidated financial statements detail balance sheets, operations, equity, and cash flows, showing reduced net loss for H1 2025 due to CVR liability changes [Consolidated Balance Sheets](index=6&type=section&id=Consolidated%20Balance%20Sheets%20as%20of%20June%2030%2C%202025%20and%20December%2031%2C%202024) Consolidated balance sheets as of June 30, 2025, and December 31, 2024, detail assets, liabilities, and stockholders' deficit | Metric | June 30, 2025 (in thousands) | December 31, 2024 (in thousands) | | :-------------------------------- | :--------------------------- | :----------------------------- | | Cash and cash equivalents | $160,324 | $212,610 | | Total assets | $388,893 | $435,023 | | Total liabilities | $391,420 | $441,825 | | Contingent value right liability | $352,100 | $395,500 | | Total stockholders' deficit | $(2,527) | $(6,802) | [Consolidated Statements of Operations and Comprehensive Income (Loss)](index=7&type=section&id=Consolidated%20Statements%20of%20Operations%20and%20Comprehensive%20Income%20%28Loss%29%20for%20the%20Three%20and%20Six%20Months%20ended%20June%2030%2C%202025%20and%202024) Consolidated statements of operations and comprehensive income (loss) for Q2 and H1 2025 and 2024, detailing revenue, expenses, and net income (loss) Three Months Ended June 30 (in thousands, except per share data) | Metric | 2025 | 2024 | Change (in thousands) | Change (%) | | :------------------------------------- | :----- | :----- | :-------------------- | :--------- | | Total revenue | $298 | $33,445 | $(33,147) | (99)% | | Operating (loss) income | $(21,811) | $13,757 | $(35,568) | (259)% | | Change in fair value of CVR liability | $35,300 | $2,500 | $32,800 | 1,312% | | Net income (loss) | $15,886 | $13,836 | $2,050 | 15% | | Basic EPS | $0.51 | $0.58 | $(0.07) | (12)% | | Diluted EPS | $0.50 | $0.54 | $(0.04) | (7)% | Six Months Ended June 30 (in thousands, except per share data) | Metric | 2025 | 2024 | Change (in thousands) | Change (%) | | :------------------------------------- | :----- | :----- | :-------------------- | :--------- | | Total revenue | $1,398 | $39,285 | $(37,887) | (96)% | | Operating (loss) income | $(43,700) | $409 | $(44,109) | (10,785)% | | Change in fair value of CVR liability | $35,646 | $(36,800) | $72,446 | (197)% | | Net income (loss) | $(1,824) | $(42,988) | $41,164 | (96)% | | Basic EPS | $(0.07) | $(3.88) | $3.81 | (98)% | | Diluted EPS | $(0.07) | $(3.88) | $3.81 | (98)% | [Consolidated Statements of Changes in Convertible Preferred Stock and Stockholders' Deficit](index=8&type=section&id=Consolidated%20Statements%20of%20Changes%20in%20Convertible%20Preferred%20Stock%20and%20Stockholders%27%20Deficit%20for%20the%20Three%20Months%20ended%20March%2031%2C%20and%20June%2030%2C%202025%20and%202024) Consolidated statements of changes in convertible preferred stock and stockholders' deficit for Q1 and Q2 2025 and 2024, reflecting equity movements and reverse stock split impact - Total stockholders' deficit improved from **$(6.8) million** at December 31, 2024, to **$(2.5) million** at June 30, 2025[16](index=16&type=chunk)[21](index=21&type=chunk) - The company effected a **1-for-30 reverse stock split** on April 4, 2024, impacting all share and per-share figures presented[21](index=21&type=chunk)[35](index=35&type=chunk) [Consolidated Statements of Cash Flows](index=10&type=section&id=Consolidated%20Statements%20of%20Cash%20Flows%20for%20the%20Six%20Months%20ended%20June%2030%2C%202025%20and%202024) Consolidated statements of cash flows for H1 2025 and 2024, detailing cash movements from operating, investing, and financing activities Six Months Ended June 30 (in thousands) | Cash Flow Activity | 2025 | 2024 | | :------------------------------------- | :------- | :------- | | Net cash used in operating activities | $(40,629) | $(30,363) | | Net cash used in investing activities | $(3,670) | $(2,189) | | Net cash (used in) provided by financing activities | $(7,965) | $43,151 | | Net change in cash, cash equivalents, and restricted cash | $(52,220) | $10,608 | - Net cash used in financing activities in 2025 was primarily due to payments of **contingent value rights distributions ($7.8 million)**, a significant shift from **proceeds from the 2023 Private Placement in 2024 ($40.0 million)**[27](index=27&type=chunk)[228](index=228&type=chunk) [Notes to Consolidated Financial Statements](index=11&type=section&id=Notes%20to%20Consolidated%20Financial%20Statements) Detailed notes to the consolidated financial statements provide additional context and explanations for reported figures and accounting policies [1. Description of the Business](index=11&type=section&id=1.%20Description%20of%20the%20Business) This note describes Cartesian Therapeutics, Inc.'s business as a clinical-stage biotechnology company focused on cell therapy for autoimmune diseases - Cartesian Therapeutics, Inc. is a clinical-stage biotechnology company pioneering **cell therapy for autoimmune diseases**, utilizing proprietary technology for repeated dosing without pre-treatment chemotherapy[30](index=30&type=chunk)[159](index=159&type=chunk) - The company completed a merger on November 13, 2023, and effected a **1-for-30 reverse stock split** on April 4, 2024[31](index=31&type=chunk)[35](index=35&type=chunk) - As of June 30, 2025, **cash, cash equivalents, and restricted cash totaled $162.1 million**, expected to fund operations into **mid-2027**[43](index=43&type=chunk)[166](index=166&type=chunk)[218](index=218&type=chunk) [2. Basis of Presentation](index=13&type=section&id=2.%20Basis%20of%20Presentation) This note outlines the basis of presentation for the consolidated financial statements, including U.S. GAAP conformity and management's significant estimates - The consolidated financial statements include the Company and its wholly owned subsidiaries, prepared in conformity with **U.S. GAAP**[40](index=40&type=chunk)[46](index=46&type=chunk) - Management makes significant estimates in areas including fair value of intangible assets, CVRs, deferred income taxes, revenue recognition, accrued R&D expenses, stock-based compensation, and warrant liabilities[47](index=47&type=chunk) - The Company operates and manages its business as a **single operating segment**[48](index=48&type=chunk) [3. Summary of Significant Accounting Policies](index=13&type=section&id=3.%20Summary%20of%20Significant%20Accounting%20Policies) This note summarizes the company's significant accounting policies and discusses the evaluation of new accounting pronouncements - There have been **no material changes** to the Company's significant accounting policies during the six months ended June 30, 2025[49](index=49&type=chunk) - The Company is evaluating the impact of **ASU 2023-09 (Income Taxes)** effective December 31, 2025, and **ASU 2024-03 (Expense Disaggregation Disclosures)** effective December 31, 2027[50](index=50&type=chunk)[51](index=51&type=chunk) [4. Goodwill and Intangible Assets](index=14&type=section&id=4.%20Goodwill%20and%20Intangible%20Assets) This note details the company's goodwill and indefinite-lived intangible assets, including in-process research and development assets - The Merger resulted in **goodwill of approximately $48.2 million**, with no changes to its carrying value during the six months ended June 30, 2025

[Company Overview and Q2 2025 Highlights](index=1&type=section&id=Company%20Overview%20and%20Q2%202025%20Highlights) Cartesian Therapeutics announced Q2 2025 financial results and business updates, including the launch of the Phase 3 AURORA trial for Descartes-08 in MG and anticipated SLE Phase 2 data [Introduction and Key Updates](index=1&type=section&id=Introduction%20and%20Key%20Updates) Cartesian Therapeutics reported Q2 2025 financial results and business updates, including the launch of the Phase 3 AURORA trial for Descartes-08 in MG, anticipated SLE Phase 2 data, and plans for a pediatric basket trial - Initiated the Phase 3 AURORA trial for Descartes-08 in myasthenia gravis (MG)[1](index=1&type=chunk) - Preliminary data from the Phase 2 trial of Descartes-08 in systemic lupus erythematosus (SLE) are expected in the second half of 2025[1](index=1&type=chunk) - As of June 30, 2025, the company held approximately **$162.1 million** in cash, cash equivalents, and restricted cash, projected to fund operations into mid-2027[1](index=1&type=chunk) [CEO Commentary](index=1&type=section&id=CEO%20Commentary) CEO Dr. Carsten Brunn highlighted strong momentum entering the second half of the year with the Phase 3 AURORA trial launch and commitment to transformative cell therapies for autoimmune diseases - The CEO stated the company enters the second half with strong momentum following the launch of the pivotal Phase 3 AURORA trial for Descartes-08 in myasthenia gravis[2](index=2&type=chunk) - Descartes-08 is poised to be an impactful new MG therapy, safely administered in an outpatient setting without preconditioning chemotherapy, based on deep and durable responses observed in Phase 2b trials[2](index=2&type=chunk) - The company continues to advance other programs, expecting to share preliminary data from the ongoing Phase 2 trial of Descartes-08 in SLE patients and initiate a pediatric basket trial by year-end[2](index=2&type=chunk) [Recent Pipeline Progress and Anticipated Milestones](index=1&type=section&id=Recent%20Pipeline%20Progress%20and%20Anticipated%20Milestones) This section details the latest clinical trial advancements and upcoming key milestones for Descartes-08 in MG, SLE, and pediatric indications, as well as Descartes-15 development [Descartes-08 in Myasthenia Gravis (MG)](index=1&type=section&id=Descartes-08%20in%20Myasthenia%20Gravis%20(MG)) The Phase 3 AURORA trial for Descartes-08 in MG has commenced, with updated Phase 2b data showing sustained deep responses and good safety, supporting outpatient administration without preconditioning chemotherapy - The Phase 3 AURORA trial for Descartes-08 in MG launched in May 2025, with the first subject enrolled[3](index=3&type=chunk) - The Phase 3 AURORA trial is a randomized, double-blind, placebo-controlled study involving approximately **100 AChR Ab+ MG patients**, receiving six weekly outpatient infusions without preconditioning chemotherapy; the primary endpoint is a **≥3-point improvement in MG-ADL score at Month 4**[3](index=3&type=chunk) - Updated Phase 2b trial data show subjects maintained deep responses for **12 months** post-Descartes-08 treatment, with an average **4.8-point reduction in MG-ADL score**; the bio-naïve subgroup showed an average **7.1-point reduction**, and **57%** maintained minimal symptom expression[3](index=3&type=chunk) [Descartes-08 in Systemic Lupus Erythematosus (SLE)](index=1&type=section&id=Descartes-08%20in%20Systemic%20Lupus%20Erythematosus%20(SLE)) Preliminary data from the ongoing Phase 2 open-label trial of Descartes-08 in SLE, evaluating safety and clinical activity without preconditioning chemotherapy, are anticipated in the second half of 2025 - Preliminary data from the ongoing Phase 2 open-label trial of Descartes-08 in SLE are expected in the second half of 2025[4](index=4&type=chunk) - This trial aims to assess the safety, tolerability, and clinical activity of Descartes-08 administered in an outpatient setting (without preconditioning chemotherapy) in SLE patients[4](index=4&type=chunk) [Descartes-08 Pediatric Basket Trial](index=2&type=section&id=Descartes-08%20Pediatric%20Basket%20Trial) A Phase 2 pediatric basket trial for Descartes-08 in specific autoimmune diseases, including juvenile SLE and MG, is expected to launch in the second half of 2025, following its FDA Rare Pediatric Disease designation for JDM - The Phase 2 pediatric basket trial for Descartes-08 in specific autoimmune diseases, including juvenile SLE, juvenile MG, juvenile dermatomyositis (JDM), and ANCA-associated vasculitis, is expected to launch in the second half of 2025[10](index=10&type=chunk) - Descartes-08 previously received FDA Rare Pediatric Disease designation for JDM[10](index=10&type=chunk) [Descartes-15 Development](index=2&type=section&id=Descartes-15%20Development) The first-in-human Phase 1 clinical trial for Descartes-15 in multiple myeloma patients is progressing as planned, evaluating safety and tolerability for outpatient administration, with future plans to assess it in autoimmune indications - The first-in-human Phase 1 clinical trial for Descartes-15 in multiple myeloma patients is proceeding with dosing as planned[10](index=10&type=chunk) - This dose-escalation trial aims to evaluate the safety and tolerability of outpatient administration of Descartes-15[10](index=10&type=chunk) - The company anticipates evaluating Descartes-15 in autoimmune indications following the Phase 1 trial[10](index=10&type=chunk) [Product Candidate Descriptions](index=2&type=section&id=Product%20Candidate%20Descriptions) This section provides an overview of Cartesian's lead cell therapy candidates, Descartes-08 and Descartes-15, highlighting their design, target indications, and regulatory designations [About Descartes-08](index=2&type=section&id=About%20Descartes-08) Descartes-08, Cartesian's lead BCMA-targeted autologous CAR-T cell therapy, is designed for outpatient administration without preconditioning chemotherapy for MG and SLE, holding multiple FDA designations - Descartes-08 is Cartesian's lead cell therapy candidate, an autologous B-cell maturation antigen (BCMA)-targeted CAR-T cell therapy, under development for generalized MG and SLE[6](index=6&type=chunk) - It is designed for outpatient administration without preconditioning chemotherapy and carries no genomic integration risk associated with oncogenesis[6](index=6&type=chunk) - It has received FDA Orphan Drug designation, Regenerative Medicine Advanced Therapy designation for MG, and Rare Pediatric Disease designation for JDM[6](index=6&type=chunk) [About Descartes-15](index=2&type=section&id=About%20Descartes-15) Descartes-15 is a next-generation autologous anti-BCMA CAR-T cell therapy, demonstrating significantly enhanced CAR expression and selective target-specific killing in preclinical studies, designed for outpatient administration without integrating vectors - Descartes-15 is a next-generation autologous anti-BCMA CAR-T cell therapy[7](index=7&type=chunk) - Preclinical studies showed Descartes-15 improved CAR expression and selective target-specific killing by approximately **ten-fold** compared to Descartes-08[7](index=7&type=chunk) - Similar to Descartes-08, Descartes-15 is designed for administration without preconditioning chemotherapy and does not use integrating vectors[7](index=7&type=chunk) [Second Quarter 2025 Financial Results](index=2&type=section&id=Second%20Quarter%202025%20Financial%20Results) This section presents Cartesian Therapeutics' financial performance for Q2 2025, including cash position, R&D and G&A expenses, net income, and balance sheet highlights [Financial Highlights](index=2&type=section&id=Financial%20Highlights) As of June 30, 2025, Cartesian Therapeutics reported $162.1 million in cash, cash equivalents, and restricted cash, with R&D expenses increasing by 17.3% to $14.9 million, and a net income of $15.9 million - As of June 30, 2025, cash, cash equivalents, and restricted cash totaled **$162.1 million**, projected to support planned operations into mid-2027[10](index=10&type=chunk) Key Financial Data for Q2 2025 vs. Q2 2024 (in millions USD) | Metric | Q2 2025 (in millions) | Q2 2024 (in millions) | YoY Change | | :----- | :-------------------- | :-------------------- | :--------- | | R&D Expenses | $14.9 | $12.7 | +17.3% | | G&A Expenses | $7.2 | $7.0 | +2.9% | | Net Income | $15.9 | $13.8 | +15.2% | | Basic EPS | $0.51 | $0.58 | -12.1% | - The increase in research and development expenses was primarily attributable to the Phase 3 AURORA trial for Descartes-08 in MG[10](index=10&type=chunk) [Consolidated Balance Sheets](index=5&type=section&id=Consolidated%20Balance%20Sheets) Total assets decreased to $388.9 million as of June 30, 2025, from $435.0 million at December 31, 2024, primarily due to a reduction in cash, while total liabilities also decreased, improving stockholders' deficit Consolidated Balance Sheet Highlights (in thousands USD) | Metric | June 30, 2025 | December 31, 2024 | Change | | :-------------------------------- | :------------ | :---------------- | :----- | | Cash and cash equivalents | $160,324 | $212,610 | $(52,286) | | Total current assets | $163,395 | $216,626 | $(53,231) | | Total assets | $388,893 | $435,023 | $(46,130) | | Total current liabilities | $12,256 | $22,976 | $(10,720) | | Contingent value right liability (non-current) | $352,100 | $387,739 | $(35,639) | | Total liabilities | $391,420 | $441,825 | $(50,405) | | Total stockholders' deficit | $(2,527) | $(6,802) | $4,275 | [Consolidated Statements of Operations and Comprehensive Income (Loss)](index=6&type=section&id=Consolidated%20Statements%20of%20Operations%20and%20Comprehensive%20Income%20(Loss)) Total revenue significantly decreased in Q2 2025 due to a lack of collaboration and licensing income, resulting in an operating loss, though net income was positively impacted by a fair value change in contingent value right liability Consolidated Statements of Operations and Comprehensive Income (Loss) Highlights (in thousands USD) | Metric | Three Months Ended June 30, 2025 | Three Months Ended June 30, 2024 | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | | :--------------------------------------- | :------------------------------- | :------------------------------- | :----------------------------- | :----------------------------- | | Total revenue | $298 | $33,445 | $1,398 | $39,285 | | Research and development | $14,869 | $12,661 | $29,543 | $22,399 | | General and administrative | $7,240 | $7,027 | $15,555 | $16,477 | | Operating (loss) income | $(21,811) | $13,757 | $(43,700) | $409 | | Change in fair value of contingent value right liability | $35,300 | $2,500 | $35,646 | $(36,800) | | Net income (loss) | $15,886 | $13,836 | $(1,824) | $(42,988) | | Basic Net income (loss) per share | $0.51 | $0.58 | $(0.07) | $(3.88) | | Diluted Net income (loss) per share | $0.50 | $0.54 | $(0.07) | $(3.88) | | Basic Weighted-average common shares outstanding | 25,980,262 | 16,723,479 | 25,941,670 | 11,068,749 | - Total revenue in Q2 2025 significantly decreased, primarily due to the absence of collaboration and licensing income compared to Q2 2024[15](index=15&type=chunk) - Net income in Q2 2025 was positively impacted by a **$35.3 million** favorable change in the fair value of contingent value right liability[15](index=15&type=chunk) [About Cartesian Therapeutics](index=2&type=section&id=About%20Cartesian%20Therapeutics) Cartesian Therapeutics is a clinical-stage biotechnology company focused on pioneering cell therapies for autoimmune diseases, with lead assets Descartes-08 and Descartes-15 in various clinical development phases [Company Overview](index=2&type=section&id=Company%20Overview) Cartesian Therapeutics is a clinical-stage biotechnology company pioneering cell therapies for autoimmune diseases, with Descartes-08 in Phase 3 for MG and Phase 2 for SLE, and Descartes-15 in Phase 1 for multiple myeloma - Cartesian Therapeutics is a clinical-stage biotechnology company dedicated to pioneering cell therapies for autoimmune diseases[8](index=8&type=chunk) - Its lead asset, Descartes-08, is in Phase 3 clinical development for generalized myasthenia gravis and Phase 2 development for systemic lupus erythematosus, with plans for Phase 2 basket trials in other autoimmune indications[8](index=8&type=chunk) - The company's clinical-stage pipeline also includes Descartes-15, a next-generation autologous anti-BCMA CAR-T therapy, currently in a Phase 1 trial for multiple myeloma patients[8](index=8&type=chunk) [Forward Looking Statements](index=2&type=section&id=Forward%20Looking%20Statements) This section provides a standard disclaimer regarding forward-looking statements, cautioning that actual results may differ materially due to various risks, and the company does not intend to update them unless legally required [Disclaimer](index=2&type=section&id=Disclaimer) This disclaimer warns that statements about future expectations, plans, and prospects are forward-looking, and actual results may vary significantly due to clinical trial uncertainties, regulatory approvals, funding, and third-party reliance - Any statements in this press release regarding the company's future expectations, plans, and prospects constitute forward-looking statements[11](index=11&type=chunk) - Actual results may differ materially from those indicated by forward-looking statements due to various important factors, including uncertainties in clinical trials, regulatory approvals, funding availability, and reliance on third parties[11](index=11&type=chunk) - The company expressly disclaims any intent to update any forward-looking statements in this press release unless required by law[11](index=11&type=chunk) [Investor and Media Contacts](index=7&type=section&id=Investor%20and%20Media%20Contacts) This section provides contact information for investor relations and media inquiries, including specific individuals and their respective email addresses [Contact Information](index=7&type=section&id=Contact%20Information) Contact details for investor relations and media inquiries are provided, including Megan LeDuc for investors and David Rosen from Argot Partners for media - Investor Contact: Megan LeDuc, Associate Director, Investor Relations, email: megan.leduc@cartesiantx.com[16](index=16&type=chunk) - Media Contact: David Rosen, Argot Partners, email: david.rosen@argotpartners.com[16](index=16&type=chunk)

Pipeline and Clinical Trials - Cartesian Therapeutics is pioneering mRNA cell therapies for autoimmunity, with multiple anticipated near-term catalysts[5] - Phase 3 AURORA study of Descartes-08 for Myasthenia Gravis (MG) is expected to commence in 1H25[8] - An open-label Phase 2 trial of Descartes-08 in Systemic Lupus Erythematosus (SLE) is ongoing, with data readout expected in 2H25[8] - A Phase 2 pediatric basket trial, including juvenile SLE, juvenile MG, and other conditions, is expected to initiate in 2H25[8, 12] - Dosing is underway in a first-in-human Phase 1 dose escalation trial for Descartes-15, a next-generation mRNA CAR-T candidate[8] Descartes-08 Efficacy and Safety - In a Phase 2b trial, participants treated with Descartes-08 maintained deep and durable responses over 12 months[16] - At Month 4, participants in the primary efficacy dataset experienced an average MG-ADL reduction of 5.5 points[23] - 33% of participants achieved minimum symptom expression at Month 6[23] - 80% of participants reaching Month 12 maintained a clinically meaningful response[23] - In participants with no prior exposure to biologics, the average MG-ADL reduction was 6.6 points at Month 4[26] - 57% of participants with no prior exposure to biologics achieved minimum symptom expression at Month 6[26] - 100% of participants with no prior exposure to biologics reaching Month 12 maintained a clinically meaningful response[26] - The safety profile of Descartes-08 supports outpatient administration, with no new types of adverse events reported[16, 28] Financial Position - Cartesian Therapeutics has a strong balance sheet with approximately $220.9 million as of September 30, 2024[9] - This is expected to support planned operations, including completion of the planned Phase 3 trial of Descartes-08 for MG, into mid-2027[9]

Financial Performance - Total revenue for Q1 2025 was $1.1 million, a decrease of 81.1% compared to $5.84 million in Q1 2024[19] - Net loss for Q1 2025 was $17.71 million, significantly improved from a net loss of $56.82 million in Q1 2024[19] - The company reported a basic and diluted net loss per share of $0.68 for Q1 2025, compared to $10.50 for Q1 2024[19] - The net loss for the three months ended March 31, 2025, was $17.71 million, compared to a net loss of $56.82 million for the same period in 2024[27] - For the three months ended March 31, 2025, total revenue was $1.1 million, a decrease of 81.1% compared to $5.84 million for the same period in 2024[150] - The net loss for the three months ended March 31, 2025, was $17.7 million, compared to a net loss of $56.8 million for the same period in 2024, representing a 68.9% improvement[150] Research and Development - Research and development expenses increased to $14.67 million in Q1 2025, up 50.1% from $9.74 million in Q1 2024[19] - Research and development expenses totaled $14.7 million for the three months ended March 31, 2025, an increase of 51.1% from $9.7 million in the same period in 2024[157] - The lead product candidate, Descartes-08, showed that 83% of participants maintained clinically meaningful improvements in myasthenia gravis severity scales at six months[153] Cash and Liquidity - Cash and cash equivalents decreased to $180.43 million as of March 31, 2025, down 15.1% from $212.61 million at the end of 2024[16] - The company reported cash, cash equivalents, and restricted cash of $182.10 million at the end of the period, down from $214.28 million at the beginning of the period[27] - As of March 31, 2025, the Company reported cash, cash equivalents, and restricted cash totaling $182.1 million, with $1.7 million being restricted cash related to lease commitments[43] - The company expects to fund its operating expenses and capital expenditures into mid-2027 based on current cash resources[160] - The company expects to continue incurring losses and will require additional capital to fund operations, potentially through equity offerings and collaborations[9] Assets and Liabilities - Total assets decreased to $409.13 million as of March 31, 2025, down 5.9% from $435.02 million at the end of 2024[16] - Total liabilities were $430.92 million as of March 31, 2025, a slight decrease from $441.83 million at the end of 2024[16] - The accumulated deficit increased to $709.78 million as of March 31, 2025, compared to $692.07 million at the end of 2024[16] - The Company had an accumulated deficit of $709.8 million as of March 31, 2025[156] Financing Activities - Cash used in operating activities for the three months ended March 31, 2025, was $23.11 million, an increase from $15.92 million in the prior year[27] - The company experienced a net cash used in financing activities of $8.03 million for the three months ended March 31, 2025, compared to a net cash provided of $43.03 million in the same period of 2024[27] - The company completed a private placement for the issuance of 149,330.115 shares of Series A Preferred Stock for approximately $60.25 million[32] - The Company completed a private placement resulting in gross proceeds of approximately $130.0 million from the sale of 3,563,247 shares of common stock and 2,937,903 shares of Series B Preferred Stock at $20.00 per share[98] Stock and Equity - The weighted-average common shares outstanding increased to 25,902,650 in Q1 2025 from 5,414,020 in Q1 2024[19] - The Company has authorized shares of common stock for future issuance totaling 12,374,230 as of March 31, 2025[104] - The company had 2,475,023 outstanding common stock options as of March 31, 2025, with a weighted-average exercise price of $13.96[114] - The company granted 256,790 restricted stock unit awards during the three months ended March 31, 2025, with a weighted-average fair value of $16.93 per share[115] Lease Obligations - The Company entered into a lease agreement for 19,199 square feet of manufacturing and office space at 7495 New Horizon Way, with an annual base rent of $0.9 million, subject to a 3% annual increase[78] - The total future minimum lease payments as of March 31, 2025, amount to $18.1 million, with total operating lease liabilities recorded at $14.1 million[95] - The company has lease obligations totaling approximately $9.0 million for laboratory and office space in Watertown, Massachusetts, through May 2028[203] Collaboration and Revenue - The company has not generated product revenue and relies primarily on collaboration agreements for revenue[42] - Collaboration and license revenue dropped to $0.4 million, down 93% from $5.8 million due to the termination of the Astellas Agreement[2] - The company recorded revenue of $5.8 million related to the Astellas Agreement during the three months ended March 31, 2024, but no revenue was recognized for the same agreement in 2025[119] Future Outlook - The Company is dependent on raising additional capital to fund its operations and product development, which may not be available on favorable terms[41] - The company expects that existing cash and equivalents will fund operations into mid-2027, but may need to seek additional funding sooner if actual results differ from estimates[201] - The Company must initiate a Phase 3 clinical trial by Q4 2024 and submit a BLA by Q4 2026 under the NCI Agreement[137]

[Business and Pipeline Update](index=1&type=section&id=Business%20and%20Pipeline%20Update) Cartesian Therapeutics updated its clinical pipeline, detailing progress for Descartes-08 in autoimmune diseases and Descartes-15 for multiple myeloma [Overview and Key Milestones](index=1&type=section&id=Overview%20and%20Key%20Milestones) Cartesian Therapeutics reported a strong start to 2025, highlighting positive long-term data for Descartes-08 in MG and outlining key upcoming clinical milestones - Initiation of the Phase 3 AURORA trial for Descartes-08 in myasthenia gravis (MG) is expected in **Q2 2025**[1](index=1&type=chunk)[3](index=3&type=chunk) - Preliminary data from the Phase 2 trial of Descartes-08 in systemic lupus erythematosus (SLE) are anticipated in the **second half of 2025**[1](index=1&type=chunk)[2](index=2&type=chunk)[9](index=9&type=chunk) - A Phase 2 pediatric basket trial for Descartes-08 in select autoimmune diseases is planned to start in the **second half of 2025**[1](index=1&type=chunk)[2](index=2&type=chunk)[9](index=9&type=chunk) - CEO Carsten Brunn highlighted that a single course of Descartes-08 therapy resulted in deep and sustained benefits at Month 12 for MG patients, particularly those without prior exposure to biologic therapies[2](index=2&type=chunk) [Descartes-08 Program](index=1&type=section&id=Descartes-08%20Program) Descartes-08 demonstrated sustained efficacy in MG Phase 2b, with a Phase 3 trial planned and expansion into other autoimmune indications - In the Phase 2b trial for MG, Descartes-08 treatment led to an average **4.8-point reduction in the MG-ADL score at Month 12**. Patients without prior biologic therapy exposure experienced a more significant **7.1-point reduction**[3](index=3&type=chunk) - The Phase 3 AURORA trial for MG is a randomized, placebo-controlled study set to begin in **Q2 2025**, enrolling about **100 patients**. The primary endpoint is a **≥3-point improvement in MG-ADL score at Month 4**[3](index=3&type=chunk)[4](index=4&type=chunk) - A Phase 2 pediatric basket trial is expected to initiate in **2H 2025**, targeting juvenile SLE, juvenile MG, juvenile dermatomyositis (JDM), and other vasculitis[9](index=9&type=chunk) - Descartes-08 is an autologous anti-BCMA CAR-T therapy that does not require preconditioning chemotherapy and avoids the risk of genomic integration. It has received Orphan Drug and Regenerative Medicine Advanced Therapy (RMAT) designations from the FDA for MG treatment[6](index=6&type=chunk) [Descartes-15 Program](index=2&type=section&id=Descartes-15%20Program) Descartes-15, a next-gen anti-BCMA CAR-T, is in Phase 1 for multiple myeloma, showing tenfold increased CAR expression, with future autoimmune plans - Dosing is ongoing in the first-in-human Phase 1 trial for multiple myeloma to assess safety and tolerability[9](index=9&type=chunk) - Descartes-15 is a next-generation therapy observed in preclinical studies to have an approximately **ten-fold increase in CAR expression** and selective killing compared to Descartes-08[7](index=7&type=chunk) - Similar to Descartes-08, it is designed for outpatient administration without preconditioning chemotherapy[7](index=7&type=chunk) - The company plans to assess Descartes-15 in autoimmune indications after the completion of the Phase 1 trial[9](index=9&type=chunk) [Financial Performance](index=1&type=section&id=First%20Quarter%202025%20Financial%20Results) Cartesian Therapeutics reported Q1 2025 financial results, showing a reduced net loss, strong cash, and shifts in operating expenses [Financial Highlights (Q1 2025)](index=1&type=section&id=Financial%20Highlights%20(Q1%202025)) Cartesian Therapeutics reported a Q1 2025 net loss of **$17.7 million**, a significant improvement, with **$182.1 million** cash expected to fund operations into mid-2027 - The company held **$182.1 million** in cash, cash equivalents, and restricted cash as of March 31, 2025, which is expected to support planned operations into **mid-2027**[1](index=1&type=chunk)[9](index=9&type=chunk) Q1 2025 Financial Summary | Metric | Q1 2025 | Q1 2024 | Change | | :--- | :--- | :--- | :--- | | Total Revenue | $1.1M | $5.8M | -81.2% | | R&D Expenses | $14.7M | $9.7M | +51.5% | | G&A Expenses | $8.3M | $9.5M | -12.6% | | Net Loss | $(17.7)M | $(56.8)M | Improved | | Net Loss Per Share | $(0.68) | $(10.50) | Improved | [Consolidated Balance Sheet](index=5&type=section&id=Consolidated%20Balance%20Sheets) As of March 31, 2025, total assets decreased to **$409.1 million**, primarily due to lower cash, with an increased stockholders' deficit Consolidated Balance Sheet Summary | Category | March 31, 2025 ($ thousands) | December 31, 2024 ($ thousands) | | :--- | :--- | :--- | | **Assets** | | | | Cash and cash equivalents | 180,434 | 212,610 | | Total Current Assets | 185,120 | 216,626 | | Total Assets | 409,130 | 435,023 | | **Liabilities & Stockholders' Deficit** | | | | Total Current Liabilities | 14,998 | 22,976 | | Total Liabilities | 430,919 | 441,825 | | Total Stockholders' Deficit | (21,789) | (6,802) | | **Total Liabilities & Stockholders' Deficit** | 409,130 | 435,023 | [Consolidated Statement of Operations](index=6&type=section&id=Consolidated%20Statements%20of%20Operations%20and%20Comprehensive%20Loss) Q1 2025 revenue decreased to **$1.1 million**, operating loss widened, but net loss significantly narrowed to **$17.7 million** due to fair value adjustments Consolidated Statement of Operations Summary | Metric ($ thousands) | Q1 2025 | Q1 2024 | | :--- | :--- | :--- | | Total Revenue | 1,100 | 5,840 | | Research and development | 14,674 | 9,738 | | General and administrative | 8,315 | 9,450 | | Operating loss | (21,889) | (13,348) | | Change in fair value of contingent value right liability | 346 | (39,300) | | Net loss | (17,710) | (56,824) | | Net loss per share (basic and diluted) | $(0.68) | $(10.50) |