Cartesian Therapeutics(RNAC) - 2025 Q2 - Quarterly Results

Company Overview and Q2 2025 Highlights 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 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] - Preliminary data from the Phase 2 trial of Descartes-08 in systemic lupus erythematosus (SLE) are expected in the second half of 2025[1] - 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] CEO Commentary 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] - 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] - 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] Recent Pipeline Progress and Anticipated Milestones 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) 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] - 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] - 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] Descartes-08 in Systemic Lupus Erythematosus (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] - 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] Descartes-08 Pediatric Basket Trial 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] - Descartes-08 previously received FDA Rare Pediatric Disease designation for JDM[10] Descartes-15 Development 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] - This dose-escalation trial aims to evaluate the safety and tolerability of outpatient administration of Descartes-15[10] - The company anticipates evaluating Descartes-15 in autoimmune indications following the Phase 1 trial[10] Product Candidate Descriptions 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 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] - It is designed for outpatient administration without preconditioning chemotherapy and carries no genomic integration risk associated with oncogenesis[6] - It has received FDA Orphan Drug designation, Regenerative Medicine Advanced Therapy designation for MG, and Rare Pediatric Disease designation for JDM[6] About Descartes-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] - Preclinical studies showed Descartes-15 improved CAR expression and selective target-specific killing by approximately ten-fold compared to Descartes-08[7] - Similar to Descartes-08, Descartes-15 is designed for administration without preconditioning chemotherapy and does not use integrating vectors[7] Second Quarter 2025 Financial Results 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 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] 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] Consolidated Balance Sheets 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) 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] - 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] About Cartesian Therapeutics 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 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] - 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] - 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] Forward Looking Statements 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 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] - 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] - The company expressly disclaims any intent to update any forward-looking statements in this press release unless required by law[11] Investor and Media Contacts This section provides contact information for investor relations and media inquiries, including specific individuals and their respective email addresses Contact Information 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] - Media Contact: David Rosen, Argot Partners, email: david.rosen@argotpartners.com[16]