RNAC
Cartesian TherapeuticsBDocument history
Earnings documents stored for RNAC.
Investor releaseQuarter not tagged2026-08-06Cartesian Therapeutics Reports Second Quarter 2026 Financial Results and Provides Business Update
GlobeNewswire
Cartesian Therapeutics Reports Second Quarter 2026 Financial Results and Provides Business Update
Phase 3 AURORA trial of Descartes-08 in myasthenia gravis (MG) continues to advance; data expected in 1Q27, biologics license application (BLA) filing planned for mid-2027 Phase 2 TRITON trial of Descartes-08 in myositis on track with data from subset of patients expected in 1H27 Phase 1/2 HELIOS pediatric trial of Descartes-08 in juvenile dermatomyositis (JDM) continues to progress with data expected in 1H27 Phase 1 in vivo trial in MG patients, in partnership with WestGene BioPharma (WestGene), expected to initiate in 2H26; clinical data expected in 1H27 Approximately $149.3 million cash, cash equivalents and restricted cash as of June 30, 2026, expected to support planned operations into 2028 FREDERICK, Md., Aug. 06, 2026 (GLOBE NEWSWIRE) -- Cartesian Therapeutics, Inc. (NASDAQ: RNAC) (“we”, the “Company” or “Cartesian”), a late clinical-stage biotechnology company pioneering cell therapy for autoimmune diseases, today reported financial results for the second quarter ended June 30, 2026, and outlined recent business updates. “This quarter was marked by significant progress as we secured a strategic partnership to explore an in vivo platform and executed a non-dilutive financing, enhancing our pipeline and extending cash runway. As we prepare for four expected clinical readouts over the next twelve months, including from our Phase 3 AURORA trial in patients with MG in the first quarter of 2027, these agreements further strengthen our emerging pipeline and financial position,” said Carsten Brunn, Ph.D., President and Chief Executive Officer of Cartesian. “Our partnership with WestGene gives us an efficient, accelerated path to extend our payloads into in vivo delivery, with in-human clinical data expected in the first half of next year. While our top priority remains executing on our Phase 3 AURORA trial, our WestGene partnership is intended to create future optionality for Cartesian across MG and other autoimmune indications, with the potential to further enhance cell therapy delivery and shift the treatment paradigm. As we advance toward this next phase of growth, an extended cash runway into 2028, supported by up to $150 million of non-dilutive financing through a credit facility with K2 HealthVentures (“K2HV”), allows us to continue investing in precommercial readiness activities in parallel with clinical execution. We look forward to a robust set of n…Read full documentShow less
Phase 3 AURORA trial of Descartes-08 in myasthenia gravis (MG) continues to advance; data expected in 1Q27, biologics license application (BLA) filing planned for mid-2027 Phase 2 TRITON trial of Descartes-08 in myositis on track with data from subset of patients expected in 1H27 Phase 1/2 HELIOS pediatric trial of Descartes-08 in juvenile dermatomyositis (JDM) continues to progress with data expected in 1H27 Phase 1 in vivo trial in MG patients, in partnership with WestGene BioPharma (WestGene), expected to initiate in 2H26; clinical data expected in 1H27 Approximately $149.3 million cash, cash equivalents and restricted cash as of June 30, 2026, expected to support planned operations into 2028 FREDERICK, Md., Aug. 06, 2026 (GLOBE NEWSWIRE) -- Cartesian Therapeutics, Inc. (NASDAQ: RNAC) (“we”, the “Company” or “Cartesian”), a late clinical-stage biotechnology company pioneering cell therapy for autoimmune diseases, today reported financial results for the second quarter ended June 30, 2026, and outlined recent business updates. “This quarter was marked by significant progress as we secured a strategic partnership to explore an in vivo platform and executed a non-dilutive financing, enhancing our pipeline and extending cash runway. As we prepare for four expected clinical readouts over the next twelve months, including from our Phase 3 AURORA trial in patients with MG in the first quarter of 2027, these agreements further strengthen our emerging pipeline and financial position,” said Carsten Brunn, Ph.D., President and Chief Executive Officer of Cartesian. “Our partnership with WestGene gives us an efficient, accelerated path to extend our payloads into in vivo delivery, with in-human clinical data expected in the first half of next year. While our top priority remains executing on our Phase 3 AURORA trial, our WestGene partnership is intended to create future optionality for Cartesian across MG and other autoimmune indications, with the potential to further enhance cell therapy delivery and shift the treatment paradigm. As we advance toward this next phase of growth, an extended cash runway into 2028, supported by up to $150 million of non-dilutive financing through a credit facility with K2 HealthVentures (“K2HV”), allows us to continue investing in precommercial readiness activities in parallel with clinical execution. We look forward to a robust set of near-term milestones ahead, each bringing us closer to addressing the significant unmet need for deep and durable treatments in autoimmune diseases.” Pipeline Progress and Anticipated Milestones Phase 3 AURORA Trial of Descartes-08 in Participants with MG; Data Expected in 1Q27, with BLA Planned for Mid-2027. 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 antigen receptor T-cell therapy (CAR-T) versus placebo (1:1 randomization) administered as six once-weekly outpatient infusions without preconditioning chemotherapy in approximately 100 patients with acetylcholine receptor autoantibody positive (AChR Ab+) MG. The primary endpoint will assess the proportion of Descartes-08 participants with an improvement in MG Activities of Daily Living (MG-ADL) score of three points or more at Month 4 compared to placebo. Announced New Strategic Licensing Agreement with WestGene Intended to Accelerate the Development of In Vivo CAR-T Platform in Autoimmune Diseases; Phase 1 Data Expected in 1H27. Cartesian has partnered with WestGene to conduct a Phase 1 dose-escalation trial of the mRNA used in Descartes-08 delivered via WestGene’s proprietary targeted lipid nanoparticles (tLNPs) in patients with MG. Intravenous infusions will be administered across multiple dose levels using a Bayesian Optimal Interval (BOIN) adaptive design with a comprehensive translational assessment package including clinical response measures. The program represents a novel in vivo approach to BCMA-directed T-cell engineering that, if successful, could eliminate the need for ex vivo manufacturing. Cartesian is also planning to advance multiple internally developed next-generation anti-BCMA CAR constructs and a BCMA-directed T-cell engager (TCE) as part of its expanding mRNA payload portfolio. The WestGene partnership is designed to provide an efficient framework to move additional Cartesian payloads into human trials, extending the platform’s potential to generate clinical proof-of-concept data across multiple programs in several disease states. Under the terms of the agreement, WestGene received an upfront payment and is eligible to receive potential development and commercial based milestone payments. This clinical trial is expected to initiate in the second half of 2026 with in-human data expected in the first half of 2027. Phase 2 TRITON Trial in Myositis Remains on Track with Data from Subset of Patients Expected in 1H27 to Inform Path Forward to Pivotal Trial. The randomized, double-blind, placebo-controlled Phase 2 TRITON trial in myositis is designed to assess Descartes-08 versus placebo (1:1 randomization) administered as six weekly outpatient infusions without preconditioning chemotherapy in patients with moderate to severe multi-refractory dermatomyositis and antisynthetase syndrome. The primary endpoint is to assess the safety and efficacy of Descartes-08 compared to placebo added to standard of care in participants with myositis. The Company plans to evaluate a subset of patients from the trial to determine the potential path to a pivotal trial in myositis. Phase 1/2 HELIOS Pediatric Trial of Descartes-08 in Autoimmune Diseases, Including JDM, Continues to Progress with Data Expected in 1H27. Enrollment remains ongoing in the Phase 1/2 HELIOS pediatric trial of Descartes-08 in children and young adults with autoimmune diseases, including JDM. JDM is a rare pediatric autoimmune disorder marked by pathognomonic skin rash and muscle inflammation affecting multiple organ systems. The U.S. Food and Drug Administration (FDA) previously granted Rare Pediatric Disease Designation to Descartes-08 for the treatment of JDM. Corporate Update Cash Runway Extended into 2028 with Up to $150 Million of Non-Dilutive Financing from K2HV Secured. Under the Company’s credit facility with K2HV, the first $50 million term loan was funded upon signing of the agreement in May 2026. The second $25 million term loan is expected to be available to be drawn between January 1, 2027 and December 1, 2027, subject to the Company’s achievement of specified clinical and financing milestones and the third $25 million term loan is expected to be available to be drawn between January 1, 2028 and June 1, 2028, subject to the Company’s achievement of specified approval and sales milestones. An additional $50 million tranche is available for draw at the Company’s option subject to K2HV’s discretion. The Company now anticipates current cash resources to support planned operations into 2028, including through four expected clinical data readouts and accelerated investment in precommercial activities. Second Quarter 2026 Financial Results Cash, cash equivalents and restricted cash as of June 30, 2026 was $149.3 million, inclusive of the initial $50 million tranche of non-dilutive financing from K2HV and $19.3 million raised year to date after commissions and expenses through the Company’s at the market (ATM) offering program. The Company’s current cash resources on hand are expected to support planned operations, including completion of the ongoing Phase 3 AURORA trial, into 2028. Research and development expenses were $20.4 million for the three months ended June 30, 2026, compared to $14.9 million for the three months ended June 30, 2025. The increase was primarily a result of increased expenses associated with the ongoing Phase 3 AURORA trial, partially offset by a decrease in stock-based compensation expenses and a decrease in expenses for early stage programs. General and administrative expenses were $8.7 million for the three months ended June 30, 2026, compared to $7.2 million for the three months ended June 30, 2025. The increase was primarily the result of higher professional and consulting fees. Net income was $15.8 million, or $0.47 net income per share allocable to common stockholders (basic), for the three months ended June 30, 2026, compared to net income of $15.9 million, or $0.51 net income per share allocable to common stockholders (basic), for the three months ended June 30, 2025. About Descartes-08 Descartes-08, Cartesian’s lead cell therapy candidate, is an autologous CAR-T product targeting BCMA in clinical development for generalized MG and myositis, specifically dermatomyositis and antisynthetase syndrome. In contrast to conventional DNA-based CAR T-cell therapies, Cartesian’s CAR-T administration is designed to not require preconditioning chemotherapy, can be administered in the outpatient setting, and does not carry the risk of genomic integration associated with cancerous transformation. Descartes-08 has been granted Orphan Drug Designation and Regenerative Medicine Advanced Therapy Designation by the U.S. Food and Drug Administration for the treatment of MG, and Rare Pediatric Disease Designation for the treatment of JDM. About Cartesian Therapeutics Cartesian Therapeutics is a late clinical-stage company pioneering cell therapy for the treatment of autoimmune diseases. The Company’s lead asset, Descartes-08, is a CAR-T in Phase 3 clinical development for patients with generalized myasthenia gravis, Phase 2 clinical development in myositis, specifically dermatomyositis and antisynthetase syndrome, and in Phase 1/2 clinical development for pediatric autoimmune diseases, including juvenile dermatomyositis. For more information, please visit www.cartesiantherapeutics.com or follow the Company on LinkedIn or X. Forward Looking Statements Any statements in this press release about the future expectations, plans and prospects of the Company, including without limitation, statements regarding the Company’s expected cash resources and cash runway, the availability and use of funds under the Company’s credit facility with K2HV, statements regarding the partnership and strategic licensing agreement between the Company and WestGene and the ability of the Company and WestGene to develop therapies, treat disease, extend mRNA payloads into in vivo delivery, the integration and complementary nature of the Company’s product candidates and WestGene’s lipid nanoparticles platform, the speed and efficiency of the development pathway for collaboration products between the Company and WestGene, the ability of the Company and its partnership with WestGene to generate clinical proof-of-concept data across multiple programs in several disease states, the ability of the Company and its partnership with WestGene to advance multiple internally developed next-generation anti-BCMA CAR constructs and a BCMA-directed TCE and the speed at which these constructs and TCE are developed, the ability of the Company’s product candidates to be administered in an outpatient setting or without the need for preconditioning lymphodepleting chemotherapy, the potential of Descartes-08, or any of the Company’s other product candidates to treat MG, juvenile MG, myositis, JDM, or any other disease, the anticipated timing or the outcome of ongoing and planned clinical trials, studies and data readouts, including the ongoing Phase 3 AURORA trial of Descartes-08 in MG, the ongoing Phase 2 TRITON trial of Descartes-08 in myositis, and the ongoing Phase 1/2 HELIOS pediatric trial of Descartes-08 in autoimmune diseases, including JDM, the anticipated timing or the outcome of the FDA’s review of the Company’s regulatory filings, including the number of trials that may be necessary in order to obtain marketing approval, the Company’s ability to conduct its clinical trials and preclinical studies, the timing or making of any regulatory filings, the anticipated timing or outcome of selection of developmental product candidates, the ability of the Company to enter into and maintain potential collaborations or partnerships, the novelty of treatment paradigms that the Company is able to develop, the potential of any therapies developed by the Company to fulfill unmet medical needs, and enrollment in the Company’s clinical trials and other statements containing the words “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “hypothesize,” “intend,” “may,” “plan,” “potential,” “predict,” “project,” “should,” “target,” “would,” and similar expressions, constitute forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including, but not limited to, the following: the uncertainties inherent in the initiation, completion and cost of clinical trials including proof of concept trials, including uncertain outcomes, the availability and timing of data from ongoing and future clinical trials and the results of such trials, whether preliminary results from a particular clinical trial will be predictive of the final results of that trial and whether results of early clinical trials will be indicative of the results of later clinical trials, the ability to predict results of studies performed on human beings based on results of studies performed on non-human subjects, the unproven approach of the Company’s technology, potential delays in enrollment of patients, undesirable side effects of the Company’s product candidates, political uncertainty, the Company’s reliance on third parties to conduct its clinical trials, the Company’s inability to maintain its existing or future collaborations, licenses or contractual relationships, its inability to protect its proprietary technology and intellectual property, potential delays in regulatory approvals, the availability of funding sufficient for its foreseeable and unforeseeable operating expenses and capital expenditure requirements, the Company’s recurring losses from operations and negative cash flows, substantial fluctuation in the price of the Company’s common stock, risks related to geopolitical conflicts, pandemics, and macroeconomic impacts, and other important factors discussed in the “Risk Factors” section of the Company’s most recent Annual Report on Form 10-K and subsequently filed Quarterly Reports on Form 10-Q, and in other filings that the Company makes with the Securities and Exchange Commission. In addition, any forward-looking statements included in this press release represent the Company’s views only as of the date of its publication and should not be relied upon as representing its views as of any subsequent date. The Company specifically disclaims any intention to update any forward-looking statements included in this press release, except as required by law. Investor Contact Megan LeDucAssociate Director of Investor [email protected] Media ContactDavid RosenArgot [email protected]
Investor releaseQuarter not tagged2026-05-26Cartesian Therapeutics Secures up to $150 Million of Non-Dilutive Financing from K2 HealthVentures and Expects Topline Data from the Phase 3 AURORA Trial in First Quarter 2027
GlobeNewswire
Cartesian Therapeutics Secures up to $150 Million of Non-Dilutive Financing from K2 HealthVentures and Expects Topline Data from the Phase 3 AURORA Trial in First Quarter 2027
Secured up to $150 million of non-dilutive financing from K2 HealthVentures; funding of $50 million from initial tranche extends cash runway into 2028 Financing strengthens Cartesian’s financial flexibility, further supporting advancement of multiple clinical programs to data read out including myasthenia gravis and myositis, while also accelerating pre-launch activities Topline data from Phase 3 AURORA trial of Descartes-08 in myasthenia gravis expected in 1Q27; BLA filing planned for mid-2027 Data from subset of patients in Phase 2 TRITON trial of Descartes-08 in myositis expected in 1H27 Data from Phase 1/2 HELIOS pediatric trial of Descartes-08 in juvenile dermatomyositis expected in 1H27 FREDERICK, Md., May 26, 2026 (GLOBE NEWSWIRE) -- Cartesian Therapeutics, Inc. (NASDAQ: RNAC) (the “Company”), a clinical-stage biotechnology company pioneering cell therapy for autoimmune diseases, today announced that it has entered into an agreement with K2 HealthVentures LLC (“K2HV”), an alternative investment firm that provides flexible, long-term financing solutions in life sciences, to provide a credit facility of up to $150 million including an initial $50 million tranche. The proceeds from the initial tranche under the credit facility are expected to allow the Company to accelerate the ongoing investment in the commercial launch preparation activities for Descartes-08 in myasthenia gravis (MG) and myositis and to extend cash runway into 2028. The Company also announced progress across its pipeline, including updated timelines for all ongoing trials of Descartes-08, an autologous anti-B cell maturation antigen (BCMA) mRNA chimeric antigen receptor T-cell therapy (CAR-T). “We are very excited to partner with K2 HealthVentures for this financing, which we expect to provide us with access to the additional capital necessary to help support our continued growth. With this additional financing, we believe we are now fully funded beyond anticipated timelines for achievement of three near-term clinical catalysts, including topline data from our Phase 3 AURORA trial in MG in the first quarter of 2027, data from our Phase 2 TRITON trial in myositis and data from our Phase 1/2 HELIOS trial in JDM,” said Carsten Brunn, Ph.D., President and Chief Executive Officer of Cartesian. “Descartes-08 remains the only CAR-T in autoimmune disease that we are aware of that is designed f…Read full documentShow less
Secured up to $150 million of non-dilutive financing from K2 HealthVentures; funding of $50 million from initial tranche extends cash runway into 2028 Financing strengthens Cartesian’s financial flexibility, further supporting advancement of multiple clinical programs to data read out including myasthenia gravis and myositis, while also accelerating pre-launch activities Topline data from Phase 3 AURORA trial of Descartes-08 in myasthenia gravis expected in 1Q27; BLA filing planned for mid-2027 Data from subset of patients in Phase 2 TRITON trial of Descartes-08 in myositis expected in 1H27 Data from Phase 1/2 HELIOS pediatric trial of Descartes-08 in juvenile dermatomyositis expected in 1H27 FREDERICK, Md., May 26, 2026 (GLOBE NEWSWIRE) -- Cartesian Therapeutics, Inc. (NASDAQ: RNAC) (the “Company”), a clinical-stage biotechnology company pioneering cell therapy for autoimmune diseases, today announced that it has entered into an agreement with K2 HealthVentures LLC (“K2HV”), an alternative investment firm that provides flexible, long-term financing solutions in life sciences, to provide a credit facility of up to $150 million including an initial $50 million tranche. The proceeds from the initial tranche under the credit facility are expected to allow the Company to accelerate the ongoing investment in the commercial launch preparation activities for Descartes-08 in myasthenia gravis (MG) and myositis and to extend cash runway into 2028. The Company also announced progress across its pipeline, including updated timelines for all ongoing trials of Descartes-08, an autologous anti-B cell maturation antigen (BCMA) mRNA chimeric antigen receptor T-cell therapy (CAR-T). “We are very excited to partner with K2 HealthVentures for this financing, which we expect to provide us with access to the additional capital necessary to help support our continued growth. With this additional financing, we believe we are now fully funded beyond anticipated timelines for achievement of three near-term clinical catalysts, including topline data from our Phase 3 AURORA trial in MG in the first quarter of 2027, data from our Phase 2 TRITON trial in myositis and data from our Phase 1/2 HELIOS trial in JDM,” said Carsten Brunn, Ph.D., President and Chief Executive Officer of Cartesian. “Descartes-08 remains the only CAR-T in autoimmune disease that we are aware of that is designed for outpatient administration without preconditioning chemotherapy, and our prior data demonstrate deep and durable responses after a single course of therapy. We look forward to advancing Descartes-08 toward registration and commercial launch in MG.” Cash Runway and Credit Facility Under the Company’s credit facility with K2HV, the first $50 million term loan was funded upon signing of the agreement. The second $25 million term loan is expected to be available to be drawn between January 1, 2027 and December 1, 2027, subject to the Company’s achievement of specified clinical and financing milestones and the third $25 million term loan is expected to be available to be drawn between January 1, 2028 and June 1, 2028, subject to the Company’s achievement of specified approval and sales milestones. An additional $50 million tranche is available for draw at Cartesian's option subject K2 HealthVentures’ discretion. Morgan Stanley served as sole structuring agent for the transaction. The Company now anticipates current cash resources to support planned operations into 2028, including three clinical data readouts and accelerated investment in precommercial activities. Multiple Clinical Catalysts Expected over the Next 12 Months Phase 3 AURORA data in MG expected in 1Q27; biologics license application (BLA) filing planned for mid-2027 Phase 2 TRITON data in myositis expected in 1H27 Phase 1/2 HELIOS data in juvenile dermatomyositis (JDM) expected in 1H27 Phase 3 AURORA Trial in MG The Company anticipates reporting topline data from the Phase 3 AURORA trial in the first quarter of 2027 with BLA filing planned for mid-2027. The randomized, double-blind, placebo-controlled trial is designed to assess Descartes-08 versus placebo (1:1 randomization) administered as six once-weekly outpatient infusions without preconditioning chemotherapy in approximately 100 patients with acetylcholine receptor autoantibody positive (AChR Ab+) MG. The primary endpoint will assess the proportion of Descartes-08 participants with an improvement in MG Activities of Daily Living (MG-ADL) score of three points or more at Month 4 compared to placebo (a two-point reduction in MG-ADL is considered clinically meaningful). In January 2026, the Company published a peer-reviewed journal article in Nature Medicine outlining the efficacy and safety data from the Phase 2b trial of Descartes-08 in participants with MG. After a single course of therapy, Descartes-08-treated participants were observed to sustain deep responses through long-term follow-up, with an average 4.8-point reduction in MG-ADL at Month 12. The deepest and most compelling sustained responses were observed in Descartes-08-treated participants who did not have prior exposure to biologic therapies, with an average 7.1-point reduction in MG-ADL and 57% of patients in this subgroup maintaining minimum symptom expression at Month 12. The safety profile of Descartes-08 was consistent with previously reported data and continues to support outpatient administration. Phase 2 TRITON Trial in Myositis Cartesian expects to evaluate clinical data from a subset of patients from the trial in the first half of 2027 to determine the path to a pivotal trial in these indications with significant unmet need. The Phase 2 TRITON trial of Descartes-08 was initiated in April 2026, and enrollment continues to progress well. The randomized, double-blind, placebo-controlled trial in myositis is designed to assess Descartes-08 versus placebo (1:1 randomization) administered as six once-weekly outpatient infusions without preconditioning chemotherapy in patients with moderate to severe multi-refractory dermatomyositis and antisynthetase syndrome. The primary endpoint is expected to assess safety and efficacy of Descartes-08 compared to placebo added to standard of care in participants with myositis at Week 24. Phase 1/2 HELIOS Trial in JDM Clinical data from the Phase 1/2 HELIOS pediatric trial is expected in the first half of 2027. The Phase 1/2 HELIOS trial of Descartes-08 in JDM was initiated in January 2026 and is designed to assess the safety, tolerability and efficacy of Descartes-08 in children, adolescents and young adults with childhood-onset autoimmune diseases, including JDM. The U.S. Food and Drug Administration (FDA) previously granted Rare Pediatric Disease Designation to Descartes-08 for the treatment of JDM. Corporate Updates Chief Medical Officer (CMO), Miloš Miljković, has informed the Company that he intends to step down from his role for personal reasons to return to practicing medicine. Dr. Miljković has helped support the development of both Descartes-08 and Cartesian through the Company’s transition from an early-stage research and development company to a late-stage clinical company. Peter Traber, MD, Cartesian’s Head of R&D, who assisted in directing the Company’s clinical trials over the past year, is expected to continue supporting Cartesian through the full completion of the Company’s ongoing clinical trials and the preparation for BLA filing of Descartes-08 in MG in mid-2027. Dr. Traber brings more than three decades of leadership spanning academic medicine and biotechnology. He previously served as CMO of Selecta Biosciences, CEO of Galectin Therapeutics and CMO at GlaxoSmithKline. In previous academic roles, he served as the President of the Baylor College of Medicine and Chairman of Medicine and CEO of the University of Pennsylvania Health System. About Descartes-08 Descartes-08, Cartesian’s lead cell therapy candidate, is an autologous CAR-T product targeting BCMA in clinical development for generalized MG and myositis, specifically dermatomyositis and antisynthetase syndrome. In contrast to conventional DNA-based CAR T-cell therapies, Cartesian’s CAR-T administration is designed to not require preconditioning chemotherapy, can be administered in the outpatient setting, and does not carry the risk of genomic integration associated with cancerous transformation. Descartes-08 has been granted Orphan Drug Designation and Regenerative Medicine Advanced Therapy Designation by the U.S. Food and Drug Administration for the treatment of MG, and Rare Pediatric Disease Designation for the treatment of juvenile dermatomyositis. About Cartesian TherapeuticsCartesian Therapeutics is a late clinical-stage company pioneering cell therapy for the treatment of autoimmune diseases. The Company’s lead asset, Descartes-08, is a CAR-T in Phase 3 clinical development for patients with generalized myasthenia gravis, in Phase 2 clinical development in myositis, specifically dermatomyositis and antisynthetase syndrome, and in Phase 1/2 clinical development of juvenile dermatomyositis. For more information, please visit www.cartesiantherapeutics.com or follow the Company on LinkedIn or X. Forward Looking StatementsAny statements in this press release about the future expectations, plans and prospects of the Company, including without limitation, statements regarding the Company’s expected cash resources and cash runway, the availability and use of funds under the Company’s credit facility with K2HV, the ability of the Company’s product candidates to be administered in an outpatient setting or without the need for preconditioning lymphodepleting chemotherapy, the potential of Descartes-08 or any of the Company’s other product candidates to treat myasthenia gravis, juvenile myasthenia gravis, juvenile dermatomyositis, myositis, multi-refractory dermatomyositis, antisynthetase syndrome, or any other disease, the anticipated timing or the outcome of ongoing and planned clinical trials, studies and data readouts, including the ongoing Phase 3 AURORA trial of Descartes-08 in myasthenia gravis, the ongoing Phase 2 HELIOS pediatric basket trial of Descartes-08 in juvenile dermatomyositis, juvenile systemic lupus erythematosus, juvenile myasthenia gravis, and anti-neutrophil cytoplasmic antibody-associated vasculitis, the ongoing Phase 2 trial of Descartes-08 in systemic lupus erythematosus, and the ongoing Phase 2 TRITON trial of Descartes-08 in myositis, the anticipated timing or the outcome of the FDA’s review of the Company’s regulatory filings, including the number of trials that may be necessary in order to obtain marketing approval, the Company’s ability to conduct its clinical trials and preclinical studies, the timing or making of any regulatory filings, the anticipated timing or outcome of selection of developmental product candidates, the novelty of treatment paradigms that the Company is able to develop, the potential of any therapies developed by the Company to fulfill unmet medical needs, enrollment in the Company’s clinical trials, and changes in the Company’s scientific and medical personnel and other statements containing the words “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “hypothesize,” “intend,” “may,” “plan,” “potential,” “predict,” “project,” “should,” “target,” “would,” and similar expressions, constitute forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including, but not limited to, the following: the uncertainties inherent in the initiation, completion and cost of clinical trials including proof of concept trials, including uncertain outcomes, the availability and timing of data from ongoing and future clinical trials and the results of such trials, whether preliminary results from a particular clinical trial will be predictive of the final results of that trial and whether results of early clinical trials will be indicative of the results of later clinical trials, the ability to predict results of studies performed on human beings based on results of studies performed on non-human subjects, the unproven approach of the Company’s technology, potential delays in enrollment of patients, undesirable side effects of the Company’s product candidates, political uncertainty, the Company’s reliance on third parties to conduct its clinical trials, the Company’s inability to maintain its existing or future collaborations, licenses or contractual relationships, its inability to protect its proprietary technology and intellectual property, potential delays in regulatory approvals, the availability of funding sufficient for its foreseeable and unforeseeable operating expenses and capital expenditure requirements, the Company’s recurring losses from operations and negative cash flows, substantial fluctuation in the price of the Company’s common stock, risks related to geopolitical conflicts, pandemics, and macroeconomic impacts, and other important factors discussed in the “Risk Factors” section of the Company’s most recent Annual Report on Form 10-K and subsequently filed Quarterly Reports on Form 10-Q, and in other filings that the Company makes with the Securities and Exchange Commission. In addition, any forward-looking statements included in this press release represent the Company’s views only as of the date of its publication and should not be relied upon as representing its views as of any subsequent date. The Company specifically disclaims any intention to update any forward-looking statements included in this press release, except as required by law. Investor Contact Megan LeDucAssociate Director of Investor [email protected] Media ContactDavid RosenArgot [email protected]
Investor releaseQuarter not tagged2026-04-30Cartesian Therapeutics Reports First Quarter 2026 Financial Results and Provides Business Update
GlobeNewswire
Cartesian Therapeutics Reports First Quarter 2026 Financial Results and Provides Business Update
Enrollment continues to progress in Phase 3 AURORA trial of Descartes-08 in myasthenia gravis Phase 2 TRITON trial of Descartes-08 in dermatomyositis and antisynthetase syndrome initiated Multiple patients enrolled in Phase 1/2 HELIOS pediatric trial of Descartes-08 in juvenile dermatomyositis Approximately $120.4 million cash, cash equivalents and restricted cash as of March 31, 2026, expected to support planned operations into mid-2027, including completion of ongoing Phase 3 AURORA trial FREDERICK, Md., April 30, 2026 (GLOBE NEWSWIRE) -- Cartesian Therapeutics, Inc. (NASDAQ: RNAC) (“we”, the “Company” or “Cartesian”), a late clinical-stage biotechnology company pioneering cell therapy for autoimmune diseases, today reported financial results for the first quarter ended March 31, 2026, and outlined recent business updates. “Descartes-08 represents a significant opportunity to address the many unmet needs of patients living with autoimmune diseases, with the potential to simultaneously improve quality of life through depth and durability of response. With three clinical programs in progress, we remain focused on advancing this mission with near-term milestones across our pipeline,” said Carsten Brunn, Ph.D., President and Chief Executive Officer of Cartesian. “We continue to prioritize our myasthenia gravis (MG) program as we enroll patients into the Phase 3 AURORA trial. In parallel, we initiated our Phase 2 TRITON trial of adult patients with dermatomyositis and antisynthetase syndrome. We have also enrolled multiple patients in the Phase 1/2 HELIOS pediatric trial in juvenile dermatomyositis (JDM) and are encouraged by the early enrollment observed to-date. The momentum across all three programs strengthens our conviction in Descartes-08’s promise as we advance it toward its full potential.” 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 (BCMA) chimeric antigen receptor T-cell therapy (CAR-T) versus placebo (1:1 randomization) administered as six once-weekly outpatient infusions without preconditioning chemotherapy in approximately 100 patients with acetylcholine receptor autoantibody positive (AChR…Read full documentShow less
Enrollment continues to progress in Phase 3 AURORA trial of Descartes-08 in myasthenia gravis Phase 2 TRITON trial of Descartes-08 in dermatomyositis and antisynthetase syndrome initiated Multiple patients enrolled in Phase 1/2 HELIOS pediatric trial of Descartes-08 in juvenile dermatomyositis Approximately $120.4 million cash, cash equivalents and restricted cash as of March 31, 2026, expected to support planned operations into mid-2027, including completion of ongoing Phase 3 AURORA trial FREDERICK, Md., April 30, 2026 (GLOBE NEWSWIRE) -- Cartesian Therapeutics, Inc. (NASDAQ: RNAC) (“we”, the “Company” or “Cartesian”), a late clinical-stage biotechnology company pioneering cell therapy for autoimmune diseases, today reported financial results for the first quarter ended March 31, 2026, and outlined recent business updates. “Descartes-08 represents a significant opportunity to address the many unmet needs of patients living with autoimmune diseases, with the potential to simultaneously improve quality of life through depth and durability of response. With three clinical programs in progress, we remain focused on advancing this mission with near-term milestones across our pipeline,” said Carsten Brunn, Ph.D., President and Chief Executive Officer of Cartesian. “We continue to prioritize our myasthenia gravis (MG) program as we enroll patients into the Phase 3 AURORA trial. In parallel, we initiated our Phase 2 TRITON trial of adult patients with dermatomyositis and antisynthetase syndrome. We have also enrolled multiple patients in the Phase 1/2 HELIOS pediatric trial in juvenile dermatomyositis (JDM) and are encouraged by the early enrollment observed to-date. The momentum across all three programs strengthens our conviction in Descartes-08’s promise as we advance it toward its full potential.” 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 (BCMA) chimeric antigen receptor T-cell therapy (CAR-T) versus placebo (1:1 randomization) administered as six once-weekly outpatient infusions without preconditioning chemotherapy in approximately 100 patients with acetylcholine receptor autoantibody positive (AChR Ab+) MG. The primary endpoint will assess the proportion of Descartes-08 participants with an improvement in MG Activities of Daily Living (MG-ADL) score of three points or more at Month 4 compared to placebo. Phase 2 TRITON Trial Initiated in Myositis. The randomized, double-blind, placebo-controlled Phase 2 TRITON trial in myositis is designed to assess Descartes-08 versus placebo (1:1 randomization) administered as six weekly outpatient infusions without preconditioning chemotherapy in patients with moderate to severe multi-refractory dermatomyositis and antisynthetase syndrome. The primary endpoint is expected to assess safety and efficacy of Descartes-08 compared to placebo added to standard of care in participants with myositis at Week 24. The Company plans to evaluate the first 10 patients from the study to determine the path to a pivotal trial in this indication with significant unmet need. Multiple Patients Enrolled in Phase 1/2 HELIOS Pediatric Trial of Descartes-08 in Autoimmune Diseases, Including JDM. In January 2026, Cartesian announced the initiation of its Phase 1/2 HELIOS pediatric trial of Descartes-08 in children and young adults with autoimmune diseases, including JDM. JDM is a rare pediatric autoimmune disorder marked by pathognomonic skin rash and muscle inflammation affecting multiple organ systems. The FDA previously granted Rare Pediatric Disease Designation to Descartes-08 for the treatment of JDM. Full Year 2026 Financial Results Cash, cash equivalents and restricted cash as of March 31, 2026 was $120.4 million. During the first quarter of 2026, the Company raised $14.6 million after commissions and expenses through its active at the market (ATM) offering program. The Company’s current cash resources on hand are expected to support planned operations, including completion of the ongoing Phase 3 AURORA trial, into mid-2027. Research and development expenses were $19.5 million for the three months ended March 31, 2026, compared to $14.7 million for the three months ended March 31, 2025. The increase was primarily a result of increased expenses associated with the ongoing Phase 3 AURORA trial, partially offset by a decrease in expenses for early stage programs, primarily related to the decision to no longer pursue development of Descartes-08 in systematic lupus erythematosus. General and administrative expenses were $7.1 million for the three months ended March 31, 2026, compared to $8.3 million for the three months ended March 31, 2025. The decrease was primarily the result of lower professional and consulting fees. Net loss was $39.2 million, or $1.46 net loss per share allocable to common stockholders (basic), for the three months ended March 31, 2026, compared to net loss of $17.7 million, or $0.68 net loss per share allocable to common stockholders (basic), for the three months ended March 31, 2025. About Descartes-08 Descartes-08, Cartesian’s lead cell therapy candidate, is an autologous CAR-T product targeting BCMA in clinical development for generalized MG and myositis, specifically dermatomyositis and antisynthetase syndrome. In contrast to conventional DNA-based CAR T-cell therapies, Cartesian’s CAR-T administration is designed to not require preconditioning chemotherapy, can be administered in the outpatient setting, and does not carry the risk of genomic integration associated with cancerous transformation. Descartes-08 has been granted Orphan Drug Designation and Regenerative Medicine Advanced Therapy Designation by the U.S. Food and Drug Administration for the treatment of MG, and Rare Pediatric Disease Designation for the treatment of JDM. About Cartesian Therapeutics Cartesian Therapeutics is a late clinical-stage company pioneering cell therapy for the treatment of autoimmune diseases. The Company’s lead asset, Descartes-08, is a CAR-T in Phase 3 clinical development for patients with generalized myasthenia gravis, Phase 2 clinical development in myositis, specifically dermatomyositis and antisynthetase syndrome, and in Phase 1/2 clinical development for pediatric autoimmune diseases, including juvenile dermatomyositis. For more information, please visit www.cartesiantherapeutics.com or follow the Company on LinkedIn or X. Forward Looking Statements Any statements in this press release about the future expectations, plans and prospects of the Company, including without limitation, statements regarding the Company’s expected cash resources and cash runway, the ability of the Company’s product candidates to be administered in an outpatient setting or without the need for preconditioning lymphodepleting chemotherapy, the potential of Descartes-08, or any of the Company’s other product candidates to treat MG, juvenile MG, myositis, JDM, or any other disease, the anticipated timing or the outcome of ongoing and planned clinical trials, studies and data readouts, including the ongoing Phase 3 AURORA trial of Descartes-08 in MG, the ongoing Phase 2 TRITON trial of Descartes-08 in myositis, and the ongoing Phase 1/2 HELIOS pediatric trial of Descartes-08 in autoimmune diseases, including JDM, the anticipated timing or the outcome of the FDA’s review of the Company’s regulatory filings, including the number of trials that may be necessary in order to obtain marketing approval, the potential for in-vivo delivery of the Company’s product candidates, the Company’s ability to conduct its clinical trials and preclinical studies, the timing or making of any regulatory filings, the anticipated timing or outcome of selection of developmental product candidates, the ability of the Company to enter into and maintain potential collaborations or partnerships, the novelty of treatment paradigms that the Company is able to develop, the potential of any therapies developed by the Company to fulfill unmet medical needs, and enrollment in the Company’s clinical trials and other statements containing the words “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “hypothesize,” “intend,” “may,” “plan,” “potential,” “predict,” “project,” “should,” “target,” “would,” and similar expressions, constitute forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including, but not limited to, the following: the uncertainties inherent in the initiation, completion and cost of clinical trials including proof of concept trials, including uncertain outcomes, the availability and timing of data from ongoing and future clinical trials and the results of such trials, whether preliminary results from a particular clinical trial will be predictive of the final results of that trial and whether results of early clinical trials will be indicative of the results of later clinical trials, the ability to predict results of studies performed on human beings based on results of studies performed on non-human subjects, the unproven approach of the Company’s technology, potential delays in enrollment of patients, undesirable side effects of the Company’s product candidates, political uncertainty, the Company’s reliance on third parties to conduct its clinical trials, the Company’s inability to maintain its existing or future collaborations, licenses or contractual relationships, its inability to protect its proprietary technology and intellectual property, potential delays in regulatory approvals, the availability of funding sufficient for its foreseeable and unforeseeable operating expenses and capital expenditure requirements, the Company’s recurring losses from operations and negative cash flows, substantial fluctuation in the price of the Company’s common stock, risks related to geopolitical conflicts, pandemics, and macroeconomic impacts, and other important factors discussed in the “Risk Factors” section of the Company’s most recent Annual Report on Form 10-K and subsequently filed Quarterly Reports on Form 10-Q, and in other filings that the Company makes with the Securities and Exchange Commission. In addition, any forward-looking statements included in this press release represent the Company’s views only as of the date of its publication and should not be relied upon as representing its views as of any subsequent date. The Company specifically disclaims any intention to update any forward-looking statements included in this press release, except as required by law. Investor Contact Megan LeDuc Associate Director of Investor Relations [email protected] Media Contact David Rosen Argot Partners [email protected]
Investor releaseQuarter not tagged2026-03-09Cartesian Therapeutics Reports Full Year 2025 Financial Results and Provides Business Update
GlobeNewswire
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 Phase 2 TRITON trial of Descartes-08 in dermatomyositis and antisynthetase syndrome, expected to initiate in 1H26 Phase 1/2 HELIOS pediatric trial of Descartes-08 in juvenile dermatomyositis actively enrolling Approximately $126.9 million cash, cash equivalents and restricted cash as of December 31, 2025, expected to support planned operations into mid-2027, including completion of ongoing Phase 3 AURORA trial FREDERICK, Md., March 09, 2026 (GLOBE NEWSWIRE) -- Cartesian Therapeutics, Inc. (NASDAQ: RNAC) (“we”, the “Company” or “Cartesian”), a late clinical-stage biotechnology company pioneering cell therapy for autoimmune diseases, today reported financial results for the year ended December 31, 2025, and outlined recent business updates. “Building on a productive year, we look forward to a potentially transformative 2026 as we advance Descartes-08 across several autoimmune indications,” said Carsten Brunn, Ph.D., President and Chief Executive Officer of Cartesian. “Our top priority remains delivering on our Phase 3 AURORA trial in myasthenia gravis (MG), for which we are on track to enroll approximately 100 patients. This trial represents a crucial opportunity to demonstrate the potential of Descartes-08 to improve patient outcomes and redefine the standard-of-care for MG. Descartes-08’s ease of use, including, flexible, convenient outpatient administration with no preconditioning chemotherapy, combined with deep and durable responses observed through 12 months following a single course of treatment, and a favorable safety profile, underscore our belief that Descartes-08 holds significant promise to deliver meaningful benefit to patients.” Dr. Brunn continued, “Beyond MG, we are working to activate sites for our Phase 2 TRITON trial of Descartes-08 in myositis, which we plan to initiate in the first half of 2026. In parallel, we are also excited to explore potentially enhanced cell therapy delivery options of existing product candidates and next generation agents in development through in-vivo platforms with multiple feasibility studies underway. With an upcoming year of focused clinical execution, we believe we are well-positioned to fill the significant unmet need that remains within the autoimmune treatment landscape.” Pipeline Progress and Anticipated Milestone…Read full documentShow less
Enrollment continues to progress in Phase 3 AURORA trial of Descartes-08 in myasthenia gravis Phase 2 TRITON trial of Descartes-08 in dermatomyositis and antisynthetase syndrome, expected to initiate in 1H26 Phase 1/2 HELIOS pediatric trial of Descartes-08 in juvenile dermatomyositis actively enrolling Approximately $126.9 million cash, cash equivalents and restricted cash as of December 31, 2025, expected to support planned operations into mid-2027, including completion of ongoing Phase 3 AURORA trial FREDERICK, Md., March 09, 2026 (GLOBE NEWSWIRE) -- Cartesian Therapeutics, Inc. (NASDAQ: RNAC) (“we”, the “Company” or “Cartesian”), a late clinical-stage biotechnology company pioneering cell therapy for autoimmune diseases, today reported financial results for the year ended December 31, 2025, and outlined recent business updates. “Building on a productive year, we look forward to a potentially transformative 2026 as we advance Descartes-08 across several autoimmune indications,” said Carsten Brunn, Ph.D., President and Chief Executive Officer of Cartesian. “Our top priority remains delivering on our Phase 3 AURORA trial in myasthenia gravis (MG), for which we are on track to enroll approximately 100 patients. This trial represents a crucial opportunity to demonstrate the potential of Descartes-08 to improve patient outcomes and redefine the standard-of-care for MG. Descartes-08’s ease of use, including, flexible, convenient outpatient administration with no preconditioning chemotherapy, combined with deep and durable responses observed through 12 months following a single course of treatment, and a favorable safety profile, underscore our belief that Descartes-08 holds significant promise to deliver meaningful benefit to patients.” Dr. Brunn continued, “Beyond MG, we are working to activate sites for our Phase 2 TRITON trial of Descartes-08 in myositis, which we plan to initiate in the first half of 2026. In parallel, we are also excited to explore potentially enhanced cell therapy delivery options of existing product candidates and next generation agents in development through in-vivo platforms with multiple feasibility studies underway. With an upcoming year of focused clinical execution, we believe we are well-positioned to fill the significant unmet need that remains within the autoimmune treatment landscape.” 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 (BCMA) chimeric antigen receptor T-cell therapy (CAR-T) versus placebo (1:1 randomization) administered as six once-weekly outpatient infusions without preconditioning chemotherapy in approximately 100 patients with acetylcholine receptor autoantibody positive (AChR Ab+) MG. The primary endpoint will assess the proportion of Descartes-08 participants with an improvement in MG Activities of Daily Living (MG-ADL) score of three points or more at Month 4 compared to placebo. In December 2025, the AURORA trial was named to Nature Medicine’s “Eleven clinical trials that will shape medicine in 2026” list. Phase 2 TRITON Trial Initiation in Myositis Anticipated in 1H26. In January 2026, Cartesian announced that the U.S. Food and Drug Administration (FDA) accepted the investigational new drug (IND) application for its planned Phase 2 TRITON trial in myositis. The randomized, double-blind, placebo-controlled Phase 2 trial in myositis is designed to assess Descartes-08 versus placebo (1:1 randomization) administered as six weekly outpatient infusions without preconditioning chemotherapy in up to 50 patients with moderate to severe multi-refractory dermatomyositis and antisynthetase syndrome. The primary endpoint is expected to assess safety and efficacy of Descartes-08 compared to placebo added to standard of care in participants with myositis at Week 24. The Company currently intends to conduct a blinded interim analysis through the Data Safety Monitoring Board (DSMB) after ten patients reach the primary endpoint, at which point Cartesian may revise sample size assumptions to what could be necessary to support the trial becoming pivotal, pending FDA review. Phase 1/2 HELIOS Pediatric Trial of Descartes-08 in Juvenile Dermatomyositis (JDM) Remains Ongoing. In January 2026, Cartesian announced the initiation of its Phase 1/2 (HELIOS) pediatric trial of Descartes-08 in children and young adults with autoimmune diseases, including JDM. JDM is a rare pediatric autoimmune disorder marked by pathognomonic skin rash and muscle inflammation affecting multiple organ systems. The FDA previously granted Rare Pediatric Disease Designation to Descartes-08 for the treatment of JDM. Descartes-08’s Mechanism of Action and Phase 2b 12-Month Data in MG Highlighted in Nature Medicine. In January 2026, Cartesian announced the publication of two peer reviewed journal articles in Nature Medicine detailing the mechanism of action of Descartes-08 and outlining deep and durable response data observed throughout 12 months after a single course of therapy in the Phase 2b trial of Descartes-08, consistent with previously announced 12-month data. Continuing Evaluation of the Potential for Enhanced Delivery Platforms for Cell Therapies. The Company continues to evaluate the potential for enhanced delivery platforms for its cell therapies with multiple agreements in place to explore optimizing in-vivo delivery of Descartes-08 and next generation agents currently in development. Corporate Updates Adrian Bot Appointed to Cartesian’s Board of Directors. Adrian Bot, M.D., Ph.D., was appointed to the Company’s Board of Directors in December 2025. Dr. Bot is a biopharma executive with three decades of experience in research and development with a focus on immune, cell, gene therapy and nanomedicines. His appointment to the Board of Directors supports the Company’s strategic expansion to explore potential enhanced delivery platforms for cell therapies. Carsten Brunn Named Cartesian’s Chairman of the Board of Directors. Dr. Brunn was appointed Cartesian’s Chairman of the Board of Directors in October 2025 following the departure of Carrie S. Cox who stepped down to focus on other responsibilities, including her recent appointment as Executive Chair of another publicly-traded company. In connection with Dr. Brunn’s assumption of the role of Chairman of the Board, Patrick Zenner, M.B.A., was named as Lead Independent Director of the Board of Directors. Full Year 2025 Financial Results Cash, cash equivalents and restricted cash as of December 31, 2025 was $126.9 million and is expected to support planned operations, including completion of the ongoing Phase 3 AURORA trial and initiation of its Phase 2 TRITON trial in myositis, into mid-2027. Research and development expenses were $58.0 million for the year ended December 31, 2025, compared to $45.1 million for the year ended December 31, 2024. The increase in expenses was primarily a result of increased expenses associated with the ongoing Phase 3 AURORA trial coupled with an increase in employee expenses as a result of headcount growth. General and administrative expenses were $31.5 million for the year ended December 31, 2025, compared to $30.1 million for the year ended December 31, 2024. The increase in expenses was primarily the result of increased facilities and stock-based compensation expenses. Net loss was $130.3 million, or $5.02 net loss per share allocable to common stockholders (basic), for the year ended December 31, 2025, compared to net loss of $77.4 million, or $4.48 net loss per share allocable to common stockholders (basic), for the year ended December 31, 2024. About Descartes-08 Descartes-08, Cartesian’s lead cell therapy candidate, is an autologous CAR-T product targeting BCMA in clinical development for generalized MG and myositis, specifically dermatomyositis and antisynthetase syndrome. In contrast to conventional DNA-based CAR T-cell therapies, Cartesian’s CAR-T administration is designed to not require preconditioning chemotherapy, can be administered in the outpatient setting, and does not carry the risk of genomic integration associated with cancerous transformation. Descartes-08 has been granted Orphan Drug Designation and Regenerative Medicine Advanced Therapy Designation by the U.S. Food and Drug Administration for the treatment of MG, and Rare Pediatric Disease Designation for the treatment of juvenile dermatomyositis. About Cartesian Therapeutics Cartesian Therapeutics is a late clinical-stage company pioneering cell therapy for the treatment of autoimmune diseases. The Company’s lead asset, Descartes-08, is a CAR-T in Phase 3 clinical development for patients with generalized myasthenia gravis and in Phase 1/2 clinical development of juvenile dermatomyositis with plans to initiate a Phase 2 trial in myositis, specifically dermatomyositis and antisynthetase syndrome in the first half of 2026. For more information, please visit www.cartesiantherapeutics.com or follow the Company on LinkedIn or X. Forward-Looking Statements Any statements in this press release about the future expectations, plans and prospects of the Company, including without limitation, statements regarding the Company’s expected cash resources and cash runway, the ability of the Company’s product candidates to be administered in an outpatient setting or without the need for preconditioning lymphodepleting chemotherapy, the potential of Descartes-08, or any of the Company’s other product candidates to treat MG, juvenile MG, myositis, JDM, or any other disease, the anticipated timing or the outcome of ongoing and planned clinical trials, studies and data readouts, including the ongoing Phase 3 AURORA trial of Descartes-08 in MG, the planned Phase 2 TRITON trial of Descartes-08 in myositis, and the planned Phase 2 pediatric HELIOS trial of Descartes-08 in autoimmune diseases, including JDM, the anticipated timing or the outcome of the FDA’s review of the Company’s regulatory filings, including the number of trials that may be necessary in order to obtain marketing approval, the potential for in-vivo delivery of the Company’s product candidates, the Company’s ability to conduct its clinical trials and preclinical studies, the timing or making of any regulatory filings, the anticipated timing or outcome of selection of developmental product candidates, the ability of the Company to enter into and maintain potential collaborations or partnerships, the novelty of treatment paradigms that the Company is able to develop, the potential of any therapies developed by the Company to fulfill unmet medical needs, and enrollment in the Company’s clinical trials and other statements containing the words “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “hypothesize,” “intend,” “may,” “plan,” “potential,” “predict,” “project,” “should,” “target,” “would,” and similar expressions, constitute forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including, but not limited to, the following: the uncertainties inherent in the initiation, completion and cost of clinical trials including proof of concept trials, including uncertain outcomes, the availability and timing of data from ongoing and future clinical trials and the results of such trials, whether preliminary results from a particular clinical trial will be predictive of the final results of that trial and whether results of early clinical trials will be indicative of the results of later clinical trials, the ability to predict results of studies performed on human beings based on results of studies performed on non-human subjects, the unproven approach of the Company’s technology, potential delays in enrollment of patients, undesirable side effects of the Company’s product candidates, political uncertainty, the Company’s reliance on third parties to conduct its clinical trials, the Company’s inability to maintain its existing or future collaborations, licenses or contractual relationships, its inability to protect its proprietary technology and intellectual property, potential delays in regulatory approvals, the availability of funding sufficient for its foreseeable and unforeseeable operating expenses and capital expenditure requirements, the Company’s recurring losses from operations and negative cash flows, substantial fluctuation in the price of the Company’s common stock, risks related to geopolitical conflicts, pandemics, and macroeconomic impacts, and other important factors discussed in the “Risk Factors” section of the Company’s most recent Annual Report on Form 10-K and subsequently filed Quarterly Reports on Form 10-Q, and in other filings that the Company makes with the Securities and Exchange Commission. In addition, any forward-looking statements included in this press release represent the Company’s views only as of the date of its publication and should not be relied upon as representing its views as of any subsequent date. The Company specifically disclaims any intention to update any forward-looking statements included in this press release, except as required by law. Investor Contact Megan LeDuc Associate Director of Investor Relations [email protected] Media Contact David Rosen Argot Partners [email protected]
Investor releaseQuarter not tagged2025-11-06Cartesian Therapeutics Reports Third Quarter 2025 Financial Results and Provides Business Update
GlobeNewswire
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 Preliminary data from Phase 2 trial of Descartes-08 in systemic lupus erythematosus expected by end of year Initiation of Phase 2 pediatric basket trial of Descartes-08 in select autoimmune indications expected by end of year Approximately $145.1 million cash, cash equivalents and restricted cash as of September 30, 2025, expected to support planned operations into mid-2027, including completion of ongoing Phase 3 AURORA trial FREDERICK, Md., Nov. 06, 2025 (GLOBE NEWSWIRE) -- Cartesian Therapeutics, Inc. (NASDAQ: RNAC) (“we”, the “Company” or “Cartesian”), a clinical-stage biotechnology company pioneering cell therapy for autoimmune diseases, today reported financial results for the third quarter ended September 30, 2025, and outlined recent corporate updates. “As we approach the end of what has been a productive year of meaningful progress in our mission to deliver transformative therapies for patients with autoimmune diseases, we remain focused on driving continued execution and enrollment in our Phase 3 AURORA trial of Descartes-08 in myasthenia gravis (MG),” said Carsten Brunn, Ph.D., President and Chief Executive Officer of Cartesian. “Supported by compelling results from our Phase 2b trial in which we observed deep and sustained benefits at Month 12 following a single course of therapy, we firmly believe Descartes-08, if approved, has the potential to serve as an impactful new therapy for patients with MG that can be administered safely in the outpatient setting and without the need for preconditioning chemotherapy. Beyond MG, we remain on track to share preliminary data from our ongoing Phase 2 trial of Descartes-08 in patients with systemic lupus erythematosus (SLE) and to initiate a pediatric basket trial in select autoimmune indications by the end of this year.” 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 antigen receptor T-cell therapy (CAR-T) versus placebo (1:1 randomization) administered as six once-weekly outpatient infusions without preconditioning chemotherapy in approximately 100 participants…Read full documentShow less
Enrollment on track in Phase 3 AURORA trial of Descartes-08 in myasthenia gravis Preliminary data from Phase 2 trial of Descartes-08 in systemic lupus erythematosus expected by end of year Initiation of Phase 2 pediatric basket trial of Descartes-08 in select autoimmune indications expected by end of year Approximately $145.1 million cash, cash equivalents and restricted cash as of September 30, 2025, expected to support planned operations into mid-2027, including completion of ongoing Phase 3 AURORA trial FREDERICK, Md., Nov. 06, 2025 (GLOBE NEWSWIRE) -- Cartesian Therapeutics, Inc. (NASDAQ: RNAC) (“we”, the “Company” or “Cartesian”), a clinical-stage biotechnology company pioneering cell therapy for autoimmune diseases, today reported financial results for the third quarter ended September 30, 2025, and outlined recent corporate updates. “As we approach the end of what has been a productive year of meaningful progress in our mission to deliver transformative therapies for patients with autoimmune diseases, we remain focused on driving continued execution and enrollment in our Phase 3 AURORA trial of Descartes-08 in myasthenia gravis (MG),” said Carsten Brunn, Ph.D., President and Chief Executive Officer of Cartesian. “Supported by compelling results from our Phase 2b trial in which we observed deep and sustained benefits at Month 12 following a single course of therapy, we firmly believe Descartes-08, if approved, has the potential to serve as an impactful new therapy for patients with MG that can be administered safely in the outpatient setting and without the need for preconditioning chemotherapy. Beyond MG, we remain on track to share preliminary data from our ongoing Phase 2 trial of Descartes-08 in patients with systemic lupus erythematosus (SLE) and to initiate a pediatric basket trial in select autoimmune indications by the end of this year.” 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 antigen receptor T-cell therapy (CAR-T) versus placebo (1:1 randomization) administered as six once-weekly outpatient infusions without preconditioning chemotherapy in approximately 100 participants with acetylcholine receptor autoantibody positive (AChR Ab+) MG. The primary endpoint will assess the proportion of Descartes-08 participants with an improvement in MG Activities of Daily Living (MG-ADL) score of three points or more at Month 4 compared to placebo. Preliminary Data from Ongoing Phase 2 Open-Label Trial of Descartes-08 in Patients with SLE Expected by End of Year. The trial is designed to assess the safety, tolerability and clinical activity of outpatient Descartes-08 administration without preconditioning chemotherapy in patients with SLE. SLE is an incurable autoimmune disease marked by systemic inflammation that affects multiple organ systems and impacts approximately 1.5 million people in the United States. Phase 2 Pediatric Basket Trial of Descartes-08 in Select Autoimmune Diseases Expected to Initiate by End of Year. This pediatric basket trial will target juvenile SLE, juvenile MG, juvenile dermatomyositis (JDM) and anti-neutrophil cytoplasmic antibody associated vasculitis. The U.S. Food and Drug Administration (FDA) previously granted Rare Pediatric Disease Designation to Descartes-08 for the treatment of JDM, which is a rare pediatric autoimmune disorder. First-in-Human Phase 1 Clinical Trial of Descartes-15 Remains Ongoing. The Phase 1 dose escalation trial of Cartesian’s next-generation, autologous anti-BCMA CAR-T cell therapy is designed to assess the safety and tolerability of outpatient Descartes-15 administration in patients with multiple myeloma. Third Quarter 2025 Financial Results Cash, cash equivalents and restricted cash as of September 30, 2025 was $145.1 million and is expected to support planned operations, including completion of the ongoing Phase 3 AURORA trial for Descartes-08 in MG, into mid-2027. Research and development expenses were $13.8 million for the three months ended September 30, 2025, compared to $11.4 million for the three months ended September 30, 2024. The increase in expenses was primarily a result of increased expenses associated with the ongoing Phase 3 AURORA trial for Descartes-08 for MG coupled with an increase in employee expenses as the result of headcount growth. General and administrative expenses were $7.7 million for the three months ended September 30, 2025, compared to $6.6 million for the three months ended September 30, 2024. The increase in expenses was primarily the result of increased facilities and stock-based compensation expenses. Net loss was $35.9 million, or $1.38 net loss per share allocable to common stockholders (basic and diluted), for the three months ended September 30, 2025, compared to net loss of $24.2 million, or $1.13 net loss per share allocable to common stockholders (basic and diluted), for the three months ended September 30, 2024. About Descartes-08 Descartes-08, Cartesian’s lead cell therapy candidate, is an autologous chimeric antigen receptor T-cell therapy (CAR-T) product targeting B-cell maturation antigen (BCMA) in clinical development for generalized myasthenia gravis (MG) and systemic lupus erythematosus. In contrast to conventional DNA-based CAR T-cell therapies, Cartesian’s CAR-T administration is designed to not require preconditioning chemotherapy, can be administered in the outpatient setting, and does not carry the risk of genomic integration associated with cancerous transformation. Descartes-08 has been granted Orphan Drug Designation and Regenerative Medicine Advanced Therapy Designation by the U.S. Food and Drug Administration for the treatment of MG, and Rare Pediatric Disease Designation for the treatment of juvenile dermatomyositis. About Descartes-15 Descartes-15 is a next-generation, autologous anti-BCMA CAR-T cell therapy. In preclinical studies, Descartes-15 has been observed to achieve an approximately ten-fold increase in CAR expression and selective target-specific killing, relative to Descartes-08. Similar to Descartes-08, Descartes-15 is designed to be administered without preconditioning chemotherapy and does not use integrating vectors. About Cartesian Therapeutics Cartesian Therapeutics is a clinical-stage company pioneering cell therapy for the treatment of autoimmune diseases. The Company’s lead asset, Descartes-08, is a CAR-T in Phase 3 clinical development for patients with generalized myasthenia gravis and Phase 2 development for systemic lupus erythematosus, with a Phase 2 basket trial planned in additional autoimmune indications. The Company’s clinical-stage pipeline also includes Descartes-15, a next-generation, autologous anti-BCMA CAR-T currently being evaluated in a Phase 1 trial in patients with multiple myeloma. For more information, please visit www.cartesiantherapeutics.com or follow the Company on LinkedIn or X, formerly known as Twitter. Forward Looking Statements Any statements in this press release about the future expectations, plans and prospects of the Company, including without limitation, statements regarding the Company’s expected cash resources and cash runway, the ability of the Company’s product candidates to be administered in an outpatient setting or without the need for preconditioning lymphodepleting chemotherapy, the potential of Descartes-08, Descartes-15, or any of the Company’s other product candidates to treat myasthenia gravis, juvenile myasthenia gravis, systemic lupus erythematosus, juvenile systemic lupus erythematosus, juvenile dermatomyositis, anti-neutrophil cytoplasmic antibody-associated vasculitis, multiple myeloma, or any other disease, the anticipated timing or the outcome of ongoing and planned clinical trials, studies and data readouts, including the Phase 3 AURORA trial of Descartes-08 in myasthenia gravis, the planned Phase 2 pediatric basket trial of Descartes-08 in juvenile dermatomyositis, juvenile systemic lupus erythematosus, juvenile myasthenia gravis, and anti-neutrophil cytoplasmic antibody-associated vasculitis, the ongoing Phase 2 trial of Descartes-08 in systemic lupus erythematosus, and the Phase 1 clinical trial of Descartes-15 in multiple myeloma, the anticipated timing or the outcome of the FDA’s review of the Company’s regulatory filings, the Company’s ability to conduct its clinical trials and preclinical studies, the timing or making of any regulatory filings, the anticipated timing or outcome of selection of developmental product candidates, the novelty of treatment paradigms that the Company is able to develop, the potential of any therapies developed by the Company to fulfill unmet medical needs, and enrollment in the Company’s clinical trials and other statements containing the words “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “hypothesize,” “intend,” “may,” “plan,” “potential,” “predict,” “project,” “should,” “target,” “would,” and similar expressions, constitute forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including, but not limited to, the following: the uncertainties inherent in the initiation, completion and cost of clinical trials including proof of concept trials, including uncertain outcomes, the availability and timing of data from ongoing and future clinical trials and the results of such trials, whether preliminary results from a particular clinical trial will be predictive of the final results of that trial and whether results of early clinical trials will be indicative of the results of later clinical trials, the ability to predict results of studies performed on human beings based on results of studies performed on non-human subjects, the unproven approach of the Company’s technology, potential delays in enrollment of patients, undesirable side effects of the Company’s product candidates, political uncertainty, the Company’s reliance on third parties to conduct its clinical trials, the Company’s inability to maintain its existing or future collaborations, licenses or contractual relationships, its inability to protect its proprietary technology and intellectual property, potential delays in regulatory approvals, the availability of funding sufficient for its foreseeable and unforeseeable operating expenses and capital expenditure requirements, the Company’s recurring losses from operations and negative cash flows, substantial fluctuation in the price of the Company’s common stock, risks related to geopolitical conflicts, pandemics, and macroeconomic impacts, and other important factors discussed in the “Risk Factors” section of the Company’s most recent Annual Report on Form 10-K and subsequently filed Quarterly Reports on Form 10-Q, and in other filings that the Company makes with the Securities and Exchange Commission. In addition, any forward-looking statements included in this press release represent the Company’s views only as of the date of its publication and should not be relied upon as representing its views as of any subsequent date. The Company specifically disclaims any intention to update any forward-looking statements included in this press release, except as required by law. Investor Contact Megan LeDuc Associate Director of Investor Relations [email protected] Media Contact David Rosen Argot Partners [email protected]
Investor releaseQuarter not tagged2025-08-08Cartesian Therapeutics Second Quarter 2025 Earnings: EPS Beats Expectations, Revenues Lag
Simply Wall St.
Cartesian Therapeutics Second Quarter 2025 Earnings: EPS Beats Expectations, Revenues Lag
Net income: US$15.9m (up 65% from 2Q 2024). EPS: US$0.61 (up from US$0.58 in 2Q 2024). Trump has pledged to "unleash" American oil and gas and these 15 US stocks have developments that are poised to benefit. All figures shown in the chart above are for the trailing 12 month (TTM) period Revenue missed analyst estimates by 63%. Earnings per share (EPS) exceeded analyst estimates. Looking ahead, revenue is forecast to grow 78% p.a. on average during the next 3 years, compared to a 19% growth forecast for the Biotechs industry in the US. Performance of the American Biotechs industry. The company's shares are down 15% from a week ago. You still need to take note of risks, for example - Cartesian Therapeutics has 6 warning signs (and 2 which can't be ignored) we think you should know about. Have feedback on this article? Concerned about the content? Get in touch with us directly. Alternatively, email editorial-team (at) simplywallst.com. This article by Simply Wall St is general in nature. We provide commentary based on historical data and analyst forecasts only using an unbiased methodology and our articles are not intended to be financial advice. It does not constitute a recommendation to buy or sell any stock, and does not take account of your objectives, or your financial situation. We aim to bring you long-term focused analysis driven by fundamental data. Note that our analysis may not factor in the latest price-sensitive company announcements or qualitative material. Simply Wall St has no position in any stocks mentioned.
Investor releaseQuarter not tagged2025-08-07Cartesian Therapeutics Reports Second Quarter 2025 Financial Results and Provides Business Update
GlobeNewswire
Cartesian Therapeutics Reports Second Quarter 2025 Financial Results and Provides Business Update
Initiated Phase 3 AURORA trial of Descartes-08 in myasthenia gravis Preliminary data from Phase 2 trial of Descartes-08 in systemic lupus erythematosus expected in 2H25 Initiation of Phase 2 pediatric basket trial of Descartes-08 in select autoimmune indications expected in 2H25 Approximately $162.1 million cash, cash equivalents and restricted cash as of June 30, 2025, expected to support planned operations into mid-2027, including completion of ongoing Phase 3 AURORA trial FREDERICK, Md., Aug. 07, 2025 (GLOBE NEWSWIRE) -- Cartesian Therapeutics, Inc. (NASDAQ: RNAC) (the “Company” or “Cartesian”), a clinical-stage biotechnology company pioneering cell therapy for autoimmune diseases, today reported financial results for the second quarter ended June 30, 2025, and outlined recent corporate updates. “Following the recent initiation of our pivotal Phase 3 AURORA trial of Descartes-08 in myasthenia gravis (MG), we have entered the second half of the year with significant momentum as we continue to advance our mission to deliver transformative cell therapies to patients with autoimmune diseases,” said Carsten Brunn, Ph.D., President and Chief Executive Officer of Cartesian. “Supported by deep and sustained responses observed through month 12 in the Phase 2b trial along with a clearly defined regulatory pathway, we believe that, if approved, Descartes-08 has the potential to serve as an impactful new MG therapy with the ability to be safely dosed in the outpatient setting and without the need for preconditioning chemotherapy. Additionally, we continue to make progress advancing the balance of our programs and remain on track to share preliminary data from our ongoing Phase 2 trial of Descartes-08 in patients with systemic lupus erythematosus (SLE) and to initiate a pediatric basket trial in select autoimmune indications by the end of this year.” Recent Pipeline Progress and Anticipated Milestones Initiated Phase 3 AURORA Trial of Descartes-08 in Participants with MG. In May 2025, the Company announced that the first participant had been enrolled in the Phase 3 AURORA trial. 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 antigen receptor T-cell therapy (CAR-T) versus placebo (1:1 randomization) administered as six once-weekly outpatient…Read full documentShow less
Initiated Phase 3 AURORA trial of Descartes-08 in myasthenia gravis Preliminary data from Phase 2 trial of Descartes-08 in systemic lupus erythematosus expected in 2H25 Initiation of Phase 2 pediatric basket trial of Descartes-08 in select autoimmune indications expected in 2H25 Approximately $162.1 million cash, cash equivalents and restricted cash as of June 30, 2025, expected to support planned operations into mid-2027, including completion of ongoing Phase 3 AURORA trial FREDERICK, Md., Aug. 07, 2025 (GLOBE NEWSWIRE) -- Cartesian Therapeutics, Inc. (NASDAQ: RNAC) (the “Company” or “Cartesian”), a clinical-stage biotechnology company pioneering cell therapy for autoimmune diseases, today reported financial results for the second quarter ended June 30, 2025, and outlined recent corporate updates. “Following the recent initiation of our pivotal Phase 3 AURORA trial of Descartes-08 in myasthenia gravis (MG), we have entered the second half of the year with significant momentum as we continue to advance our mission to deliver transformative cell therapies to patients with autoimmune diseases,” said Carsten Brunn, Ph.D., President and Chief Executive Officer of Cartesian. “Supported by deep and sustained responses observed through month 12 in the Phase 2b trial along with a clearly defined regulatory pathway, we believe that, if approved, Descartes-08 has the potential to serve as an impactful new MG therapy with the ability to be safely dosed in the outpatient setting and without the need for preconditioning chemotherapy. Additionally, we continue to make progress advancing the balance of our programs and remain on track to share preliminary data from our ongoing Phase 2 trial of Descartes-08 in patients with systemic lupus erythematosus (SLE) and to initiate a pediatric basket trial in select autoimmune indications by the end of this year.” Recent Pipeline Progress and Anticipated Milestones Initiated Phase 3 AURORA Trial of Descartes-08 in Participants with MG. In May 2025, the Company announced that the first participant had been enrolled in the Phase 3 AURORA trial. 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 antigen receptor T-cell therapy (CAR-T) versus placebo (1:1 randomization) administered as six once-weekly outpatient infusions without preconditioning chemotherapy in approximately 100 participants with acetylcholine receptor autoantibody positive (AChR Ab+) MG. The primary endpoint will assess the proportion of Descartes-08 participants with an improvement in MG Activities of Daily Living (MG-ADL) score of three points or more at Month 4 compared to placebo. In April 2025, the Company announced updated efficacy and safety data from the Phase 2b trial of Descartes-08 in participants with MG. After a single course of therapy, Descartes-08-treated participants were observed to sustain deep responses through long-term follow-up, with an average 4.8-point reduction in the MG-ADL score at Month 12. The deepest and most compelling sustained responses were observed in Descartes-08-treated participants who did not have prior exposure to biologic therapies, with an average 7.1-point reduction in MG-ADL score and 57% of patients in this subgroup maintaining minimum symptom expression at Month 12. The safety profile of Descartes-08 was consistent with previously reported data and continues to support outpatient administration. An encore presentation of the data, which were originally shared at the 2025 American Academy of Neurology Annual Meeting, was featured during the 15th International Conference on Myasthenia Gravis and Related Disorders on May 15, 2025 in The Hague, Netherlands. Preliminary Data from Ongoing Phase 2 Open-Label Trial of Descartes-08 in Patients with SLE Expected in the Second Half of 2025. The trial is designed to assess the safety, tolerability and clinical activity of outpatient Descartes-08 administration without preconditioning chemotherapy in patients with SLE. SLE is an incurable autoimmune disease marked by systemic inflammation that affects multiple organ systems and impacts approximately 1.5 million people in the United States. Phase 2 Pediatric Basket Trial of Descartes-08 in Select Autoimmune Diseases Expected to Initiate in the Second Half of 2025. This pediatric basket trial will target juvenile SLE, juvenile MG, juvenile dermatomyositis (JDM) and anti-neutrophil cytoplasmic antibody associated vasculitis. The FDA previously granted Rare Pediatric Disease Designation to Descartes-08 for the treatment of JDM, which is a rare pediatric autoimmune disorder. Dosing is On Track in First-in-Human Phase 1 Clinical Trial of Descartes-15. The Phase 1 dose escalation trial of Cartesian’s next-generation, autologous anti-BCMA CAR-T cell therapy is designed to assess the safety and tolerability of outpatient Descartes-15 administration in patients with multiple myeloma. Following the Phase 1 dose escalation trial, the Company expects to subsequently assess Descartes-15 in autoimmune indications. Second Quarter 2025 Financial Results Cash, cash equivalents and restricted cash as of June 30, 2025 was $162.1 million and is expected to support planned operations, including completion of the ongoing Phase 3 AURORA trial for Descartes-08 in MG, into mid-2027. Research and development expenses were $14.9 million for the three months ended June 30, 2025, compared to $12.7 million for the three months ended June 30, 2024. The increase in expenses was primarily a result of increased expenses associated with the ongoing Phase 3 AURORA trial for Descartes-08 for MG. General and administrative expenses were $7.2 million for the three months ended June 30, 2025, compared to $7.0 million for the three months ended June 30, 2024. The increase in expenses was primarily the result of increased facilities expenses. Net income was $15.9 million, or $0.51 net income per share allocable to common stockholders (basic), for the three months ended June 30, 2025, compared to net income of $13.8 million, or $0.58 net income per share allocable to common stockholders (basic), for the three months ended June 30, 2024. About Descartes-08 Descartes-08, Cartesian’s lead cell therapy candidate, is an autologous chimeric antigen receptor T-cell therapy (CAR-T) product targeting B-cell maturation antigen (BCMA) in clinical development for generalized myasthenia gravis (MG) and systemic lupus erythematosus. In contrast to conventional DNA-based CAR T-cell therapies, Cartesian’s CAR-T administration is designed to not require preconditioning chemotherapy, can be administered in the outpatient setting, and does not carry the risk of genomic integration associated with cancerous transformation. Descartes-08 has been granted Orphan Drug Designation and Regenerative Medicine Advanced Therapy Designation by the U.S. Food and Drug Administration for the treatment of MG, and Rare Pediatric Disease Designation for the treatment of juvenile dermatomyositis. About Descartes-15 Descartes-15 is a next-generation, autologous anti-BCMA CAR-T cell therapy. In preclinical studies, Descartes-15 has been observed to achieve an approximately ten-fold increase in CAR expression and selective target-specific killing, relative to Descartes-08. Similar to Descartes-08, Descartes-15 is designed to be administered without preconditioning chemotherapy and does not use integrating vectors. About Cartesian Therapeutics Cartesian Therapeutics is a clinical-stage company pioneering cell therapy for the treatment of autoimmune diseases. The Company’s lead asset, Descartes-08, is a CAR-T in Phase 3 clinical development for patients with generalized myasthenia gravis and Phase 2 development for systemic lupus erythematosus, with a Phase 2 basket trial planned in additional autoimmune indications. The Company’s clinical-stage pipeline also includes Descartes-15, a next-generation, autologous anti-BCMA CAR-T currently being evaluated in a Phase 1 trial in patients with multiple myeloma. For more information, please visit www.cartesiantherapeutics.com or follow the Company on LinkedIn or X, formerly known as Twitter. Forward Looking Statements Any statements in this press release about the future expectations, plans and prospects of the Company, including without limitation, statements regarding the Company’s expected cash resources and cash runway, the ability of the Company’s product candidates to be administered in an outpatient setting or without the need for preconditioning lymphodepleting chemotherapy, the potential of Descartes-08, Descartes-15, or any of the Company’s other product candidates to treat myasthenia gravis, juvenile myasthenia gravis, systemic lupus erythematosus, juvenile systemic lupus erythematosus, juvenile dermatomyositis, anti-neutrophil cytoplasmic antibody-associated vasculitis, multiple myeloma, or any other disease, the anticipated timing or the outcome of ongoing and planned clinical trials, studies and data readouts, including the Phase 3 AURORA trial of Descartes-08 in myasthenia gravis, the planned Phase 2 pediatric basket trial of Descartes-08 in juvenile dermatomyositis, juvenile systemic lupus erythematosus, juvenile myasthenia gravis, and anti-neutrophil cytoplasmic antibody-associated vasculitis, and the ongoing Phase 2 trial of Descartes-08 in systemic lupus erythematosus, the anticipated timing or the outcome of the FDA’s review of the Company’s regulatory filings, the Company’s ability to conduct its clinical trials and preclinical studies, the timing or making of any regulatory filings, the anticipated timing or outcome of selection of developmental product candidates, the novelty of treatment paradigms that the Company is able to develop, the potential of any therapies developed by the Company to fulfill unmet medical needs, and enrollment in the Company’s clinical trials and other statements containing the words “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “hypothesize,” “intend,” “may,” “plan,” “potential,” “predict,” “project,” “should,” “target,” “would,” and similar expressions, constitute forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including, but not limited to, the following: the uncertainties inherent in the initiation, completion and cost of clinical trials including proof of concept trials, including uncertain outcomes, the availability and timing of data from ongoing and future clinical trials and the results of such trials, whether preliminary results from a particular clinical trial will be predictive of the final results of that trial and whether results of early clinical trials will be indicative of the results of later clinical trials, the ability to predict results of studies performed on human beings based on results of studies performed on non-human subjects, the unproven approach of the Company’s technology, potential delays in enrollment of patients, undesirable side effects of the Company’s product candidates, political uncertainty, the Company’s reliance on third parties to conduct its clinical trials, the Company’s inability to maintain its existing or future collaborations, licenses or contractual relationships, its inability to protect its proprietary technology and intellectual property, potential delays in regulatory approvals, the availability of funding sufficient for its foreseeable and unforeseeable operating expenses and capital expenditure requirements, the Company’s recurring losses from operations and negative cash flows, substantial fluctuation in the price of the Company’s common stock, risks related to geopolitical conflicts, pandemics, and macroeconomic impacts, and other important factors discussed in the “Risk Factors” section of the Company’s most recent Annual Report on Form 10-K and subsequently filed Quarterly Reports on Form 10-Q, and in other filings that the Company makes with the Securities and Exchange Commission. In addition, any forward-looking statements included in this press release represent the Company’s views only as of the date of its publication and should not be relied upon as representing its views as of any subsequent date. The Company specifically disclaims any intention to update any forward-looking statements included in this press release, except as required by law. Investor Contact Megan LeDuc Associate Director of Investor Relations [email protected] Media Contact David Rosen Argot Partners [email protected]
Investor releaseQuarter not tagged2025-05-11Cartesian Therapeutics, Inc. (NASDAQ:RNAC) Just Released Its First-Quarter Results And Analysts Are Updating Their Estimates
Simply Wall St.
Cartesian Therapeutics, Inc. (NASDAQ:RNAC) Just Released Its First-Quarter Results And Analysts Are Updating Their Estimates
Cartesian Therapeutics, Inc. (NASDAQ:RNAC) investors will be delighted, with the company turning in some strong numbers with its latest results. Overall results were decent, with revenues of US$1.1m beating estimates by60%. Statutory losses were subsequently less thanthe analysts had expected, at US$0.65 per share. This is an important time for investors, as they can track a company's performance in its report, look at what experts are forecasting for next year, and see if there has been any change to expectations for the business. We've gathered the most recent statutory forecasts to see whether the analysts have changed their earnings models, following these results. We've found 21 US stocks that are forecast to pay a dividend yield of over 6% next year. See the full list for free. After the latest results, the consensus from Cartesian Therapeutics' eight analysts is for revenues of US$2.79m in 2025, which would reflect a sizeable 92% decline in revenue compared to the last year of performance. Per-share losses are expected to explode, reaching US$3.29 per share. Before this earnings announcement, the analysts had been modelling revenues of US$2.75m and losses of US$3.05 per share in 2025. So it's pretty clear consensus is mixed on Cartesian Therapeutics after the new consensus numbers; while the analysts held their revenue numbers steady, they also administered a modest increase to per-share loss expectations. See our latest analysis for Cartesian Therapeutics As a result, there was no major change to the consensus price target of US$37.33, with the analysts implicitly confirming that the business looks to be performing in line with expectations, despite higher forecast losses. Fixating on a single price target can be unwise though, since the consensus target is effectively the average of analyst price targets. As a result, some investors like to look at the range of estimates to see if there are any diverging opinions on the company's valuation. There are some variant perceptions on Cartesian Therapeutics, with the most bullish analyst valuing it at US$42.00 and the most bearish at US$22.00 per share. There are definitely some different views on the stock, but the range of estimates is not wide enough as to imply that the situation is unforecastable, in our view. These estimates are interesting, but it can be useful to paint some more broad strokes when…Read full documentShow less
Cartesian Therapeutics, Inc. (NASDAQ:RNAC) investors will be delighted, with the company turning in some strong numbers with its latest results. Overall results were decent, with revenues of US$1.1m beating estimates by60%. Statutory losses were subsequently less thanthe analysts had expected, at US$0.65 per share. This is an important time for investors, as they can track a company's performance in its report, look at what experts are forecasting for next year, and see if there has been any change to expectations for the business. We've gathered the most recent statutory forecasts to see whether the analysts have changed their earnings models, following these results. We've found 21 US stocks that are forecast to pay a dividend yield of over 6% next year. See the full list for free. After the latest results, the consensus from Cartesian Therapeutics' eight analysts is for revenues of US$2.79m in 2025, which would reflect a sizeable 92% decline in revenue compared to the last year of performance. Per-share losses are expected to explode, reaching US$3.29 per share. Before this earnings announcement, the analysts had been modelling revenues of US$2.75m and losses of US$3.05 per share in 2025. So it's pretty clear consensus is mixed on Cartesian Therapeutics after the new consensus numbers; while the analysts held their revenue numbers steady, they also administered a modest increase to per-share loss expectations. See our latest analysis for Cartesian Therapeutics As a result, there was no major change to the consensus price target of US$37.33, with the analysts implicitly confirming that the business looks to be performing in line with expectations, despite higher forecast losses. Fixating on a single price target can be unwise though, since the consensus target is effectively the average of analyst price targets. As a result, some investors like to look at the range of estimates to see if there are any diverging opinions on the company's valuation. There are some variant perceptions on Cartesian Therapeutics, with the most bullish analyst valuing it at US$42.00 and the most bearish at US$22.00 per share. There are definitely some different views on the stock, but the range of estimates is not wide enough as to imply that the situation is unforecastable, in our view. These estimates are interesting, but it can be useful to paint some more broad strokes when seeing how forecasts compare, both to the Cartesian Therapeutics' past performance and to peers in the same industry. These estimates imply that revenue is expected to slow, with a forecast annualised decline of 96% by the end of 2025. This indicates a significant reduction from annual growth of 32% over the last year. By contrast, our data suggests that other companies (with analyst coverage) in the same industry are forecast to see their revenue grow 18% annually for the foreseeable future. It's pretty clear that Cartesian Therapeutics' revenues are expected to perform substantially worse than the wider industry. The most important thing to note is the forecast of increased losses next year, suggesting all may not be well at Cartesian Therapeutics. Fortunately, the analysts also reconfirmed their revenue estimates, suggesting that it's tracking in line with expectations. Although our data does suggest that Cartesian Therapeutics' revenue is expected to perform worse than the wider industry. The consensus price target held steady at US$37.33, with the latest estimates not enough to have an impact on their price targets. Following on from that line of thought, we think that the long-term prospects of the business are much more relevant than next year's earnings. At Simply Wall St, we have a full range of analyst estimates for Cartesian Therapeutics going out to 2027, and you can see them free on our platform here.. Plus, you should also learn about the 5 warning signs we've spotted with Cartesian Therapeutics (including 3 which are potentially serious) . Have feedback on this article? Concerned about the content? Get in touch with us directly. Alternatively, email editorial-team (at) simplywallst.com. This article by Simply Wall St is general in nature. We provide commentary based on historical data and analyst forecasts only using an unbiased methodology and our articles are not intended to be financial advice. It does not constitute a recommendation to buy or sell any stock, and does not take account of your objectives, or your financial situation. We aim to bring you long-term focused analysis driven by fundamental data. Note that our analysis may not factor in the latest price-sensitive company announcements or qualitative material. Simply Wall St has no position in any stocks mentioned.
Investor releaseQuarter not tagged2025-05-10Cartesian Therapeutics First Quarter 2025 Earnings: Beats Expectations
Simply Wall St.
Cartesian Therapeutics First Quarter 2025 Earnings: Beats Expectations
Revenue: US$1.10m (down 81% from 1Q 2024). Net loss: US$17.7m (loss narrowed by 69% from 1Q 2024). US$0.68 loss per share (improved from US$10.50 loss in 1Q 2024). AI is about to change healthcare. These 20 stocks are working on everything from early diagnostics to drug discovery. The best part - they are all under $10bn in marketcap - there is still time to get in early. All figures shown in the chart above are for the trailing 12 month (TTM) period Revenue exceeded analyst estimates by 60%. Earnings per share (EPS) also surpassed analyst estimates by 7.9%. Looking ahead, revenue is forecast to grow 58% p.a. on average during the next 3 years, compared to a 18% growth forecast for the Biotechs industry in the US. Performance of the American Biotechs industry. The company's shares are down 22% from a week ago. We don't want to rain on the parade too much, but we did also find 5 warning signs for Cartesian Therapeutics (3 can't be ignored!) that you need to be mindful of. Have feedback on this article? Concerned about the content? Get in touch with us directly. Alternatively, email editorial-team (at) simplywallst.com. This article by Simply Wall St is general in nature. We provide commentary based on historical data and analyst forecasts only using an unbiased methodology and our articles are not intended to be financial advice. It does not constitute a recommendation to buy or sell any stock, and does not take account of your objectives, or your financial situation. We aim to bring you long-term focused analysis driven by fundamental data. Note that our analysis may not factor in the latest price-sensitive company announcements or qualitative material. Simply Wall St has no position in any stocks mentioned.
Investor releaseQuarter not tagged2025-05-08Cartesian Therapeutics Reports First Quarter 2025 Financial Results and Provides Business Update
GlobeNewswire
Cartesian Therapeutics Reports First Quarter 2025 Financial Results and Provides Business Update
Initiation of Phase 3 AURORA trial of Descartes-08 in myasthenia gravis expected in 2Q25; deep and sustained benefits observed through Month 12 after a single course of therapy in Phase 2b trial Preliminary data from Phase 2 trial of Descartes-08 in systemic lupus erythematosus expected in 2H25 Initiation of Phase 2 pediatric basket trial of Descartes-08 in select autoimmune indications expected in 2H25 Approximately $182.1 million cash, cash equivalents and restricted cash as of March 31, 2025 expected to support planned operations into mid-2027, including completion of planned Phase 3 AURORA trial FREDERICK, Md., May 08, 2025 (GLOBE NEWSWIRE) -- Cartesian Therapeutics, Inc. (NASDAQ: RNAC) (the “Company”), a clinical-stage biotechnology company pioneering cell therapy for autoimmune diseases, today reported financial results for the first quarter ended March 31, 2025, and outlined recent corporate updates. “We are off to a strong start in what we expect to be a productive year marked by several potential value-creating milestones across our pipeline,” said Carsten Brunn, Ph.D., President and Chief Executive Officer of Cartesian. “This includes the recent presentation of updated data from our Phase 2b trial of Descartes-08 in participants with myasthenia gravis (MG), in which we observed deep and sustained benefits at Month 12 following a single course of therapy, particularly in participants without exposure to prior biologic therapies. These data underscore the potential of Descartes-08, which is designed to be dosed conveniently in an outpatient setting without the need for preconditioning chemotherapy, to truly transform the current treatment paradigm, and we look forward to commencing our Phase 3 AURORA trial by the end of this quarter.” Dr. Brunn continued, “In addition, progress continues across the balance of our pipeline, with preliminary data from our ongoing Phase 2 trial of Descartes-08 in patients with systemic lupus erythematosus (SLE), as well as the initiation of a pediatric basket trial in select autoimmune diseases, expected in the second half of this year.” Recent Pipeline Progress and Anticipated Milestones Announced Positive Updated Long-Term Results from Phase 2b Trial of Descartes-08 in Participants with MG, with Sustained Benefits Observed Through 12 Months After a Single Course of Therapy. In April 2025, the Company announced updated…Read full documentShow less
Initiation of Phase 3 AURORA trial of Descartes-08 in myasthenia gravis expected in 2Q25; deep and sustained benefits observed through Month 12 after a single course of therapy in Phase 2b trial Preliminary data from Phase 2 trial of Descartes-08 in systemic lupus erythematosus expected in 2H25 Initiation of Phase 2 pediatric basket trial of Descartes-08 in select autoimmune indications expected in 2H25 Approximately $182.1 million cash, cash equivalents and restricted cash as of March 31, 2025 expected to support planned operations into mid-2027, including completion of planned Phase 3 AURORA trial FREDERICK, Md., May 08, 2025 (GLOBE NEWSWIRE) -- Cartesian Therapeutics, Inc. (NASDAQ: RNAC) (the “Company”), a clinical-stage biotechnology company pioneering cell therapy for autoimmune diseases, today reported financial results for the first quarter ended March 31, 2025, and outlined recent corporate updates. “We are off to a strong start in what we expect to be a productive year marked by several potential value-creating milestones across our pipeline,” said Carsten Brunn, Ph.D., President and Chief Executive Officer of Cartesian. “This includes the recent presentation of updated data from our Phase 2b trial of Descartes-08 in participants with myasthenia gravis (MG), in which we observed deep and sustained benefits at Month 12 following a single course of therapy, particularly in participants without exposure to prior biologic therapies. These data underscore the potential of Descartes-08, which is designed to be dosed conveniently in an outpatient setting without the need for preconditioning chemotherapy, to truly transform the current treatment paradigm, and we look forward to commencing our Phase 3 AURORA trial by the end of this quarter.” Dr. Brunn continued, “In addition, progress continues across the balance of our pipeline, with preliminary data from our ongoing Phase 2 trial of Descartes-08 in patients with systemic lupus erythematosus (SLE), as well as the initiation of a pediatric basket trial in select autoimmune diseases, expected in the second half of this year.” Recent Pipeline Progress and Anticipated Milestones Announced Positive Updated Long-Term Results from Phase 2b Trial of Descartes-08 in Participants with MG, with Sustained Benefits Observed Through 12 Months After a Single Course of Therapy. In April 2025, the Company announced updated efficacy and safety data from the Phase 2b trial of Descartes-08 in participants with MG. After a single course of therapy, Descartes-08-treated participants were observed to sustain deep responses through long-term follow-up, with an average 4.8-point reduction in the MG Activities of Daily Living Scale (MG-ADL) at Month 12. The deepest and most compelling sustained responses observed in Descartes-08-treated participants who did not have prior exposure to biologic therapies, with an average 7.1-point reduction in MG-ADL and 57% of patients in this subgroup maintaining minimum symptom expression at Month 12. The safety profile of Descartes-08 was consistent with previously reported data and continues to support outpatient administration. An encore presentation of the data, which were originally shared at the 2025 American Academy of Neurology Annual Meeting, will be featured during the 15th International Conference on Myasthenia Gravis and Related Disorders being held May 13-15, 2025, in The Hague, Netherlands. The presentation, titled “Efficacy and safety of autologous BCMA-directed mRNA CAR T-cell therapy in generalized myasthenia gravis: Results from a phase 2b randomized placebo-controlled trial”, will be delivered by James (Chip) F. Howard, Jr., M.D., Cartesian Clinical Advisor and Professor of Neurology, Medicine, and Allied Health at the University of North Carolina School of Medicine, on May 15, 2025 during the 8:25 am CEST session. Initiation of Phase 3 AURORA Trial of Descartes-08 in MG on Track for 2Q25. The randomized, double-blind, placebo-controlled Phase 3 AURORA trial is designed to assess Descartes-08 versus placebo (1:1 randomization) administered as six once-weekly outpatient infusions without preconditioning chemotherapy in approximately 100 participants with acetylcholine receptor autoantibody positive (AChR Ab+) MG. The primary endpoint will assess the proportion of Descartes-08 participants with an improvement in MG-ADL score of three points or more at Month 4 compared to placebo. Descartes-08, Cartesian’s lead product candidate, is an autologous anti-B cell maturation antigen (BCMA) chimeric antigen receptor T-cell therapy (CAR-T). Preliminary Data from Ongoing Phase 2 Open-Label Trial of Descartes-08 in Patients with SLE Expected in the Second Half of 2025. The trial is designed to assess the safety, tolerability and clinical activity of outpatient Descartes-08 administration without preconditioning chemotherapy in patients with SLE. SLE is an incurable autoimmune disease marked by systemic inflammation that affects multiple organ systems and impacts approximately 1.5 million people in the United States. Phase 2 Pediatric Basket Trial of Descartes-08 in Select Autoimmune Diseases Expected to Initiate in the Second Half of 2025. This pediatric basket trial will target juvenile SLE, juvenile MG, juvenile dermatomyositis (JDM) and anti-neutrophil cytoplasmic antibody associated vasculitis. The FDA previously granted Rare Pediatric Disease Designation to Descartes-08 for the treatment of JDM, which is a rare pediatric autoimmune disorder. Dosing Continues in First-in-Human Phase 1 Clinical Trial of Descartes-15. The Phase 1 dose escalation trial of Cartesian’s next-generation, autologous anti-BCMA CAR-T cell therapy, is designed to assess the safety and tolerability of outpatient Descartes-15 administration in patients with multiple myeloma. Following the Phase 1 dose escalation trial, the Company expects to subsequently assess Descartes-15 in autoimmune indications. First Quarter 2025 Financial Results Cash, cash equivalents and restricted cash as of March 31, 2025 was $182.1 million and is expected to support planned operations, including completion of planned Phase 3 AURORA trial for Descartes-08 in MG, into mid-2027. Research and development expenses were $14.7 million for the three months ended March 31, 2025, compared to $9.7 million for the three months ended March 31, 2024. The increase in expenses was primarily a result of increased expenses for the Phase 2b trial and the activities associated with the Phase 3 AURORA trial for Descartes-08 for MG. General and administrative expenses were $8.3 million for the three months ended March 31, 2025, compared to $9.5 million for the three months ended March 31, 2024. The decrease in expenses was primarily the result of reductions in professional fees incurred in connection with the 2023 merger. Net loss was $(17.7) million, or $(0.68) net loss per share (basic), for the three months ended March 31, 2025, compared to net loss of $(56.8) million, or $(10.50) net loss per share (basic), for the three months ended March 31, 2024. About Descartes-08 Descartes-08, Cartesian’s lead cell therapy candidate, is an autologous chimeric antigen receptor T-cell therapy (CAR-T) product targeting B-cell maturation antigen (BCMA) in clinical development for generalized myasthenia gravis (MG) and systemic lupus erythematosus. In contrast to conventional DNA-based CAR T-cell therapies, Cartesian’s CAR-T administration is designed to not require preconditioning chemotherapy, can be administered in the outpatient setting, and does not carry the risk of genomic integration associated with cancerous transformation. Descartes-08 has been granted Orphan Drug Designation and Regenerative Medicine Advanced Therapy Designation by the U.S. Food and Drug Administration for the treatment of MG, and Rare Pediatric Disease Designation for the treatment of juvenile dermatomyositis. About Descartes-15 Descartes-15 is a next-generation, autologous anti-BCMA CAR-T cell therapy. In preclinical studies, Descartes-15 has been observed to achieve an approximately ten-fold increase in CAR expression and selective target-specific killing, relative to Descartes-08. Similar to Descartes-08, Descartes-15 is designed to be administered without preconditioning chemotherapy and does not use integrating vectors. About Cartesian Therapeutics Cartesian Therapeutics is a clinical-stage company pioneering cell therapy for the treatment of autoimmune diseases. The Company’s lead asset, Descartes-08, is a CAR-T entering Phase 3 clinical development for patients with generalized myasthenia gravis and Phase 2 development for systemic lupus erythematosus, with a Phase 2 basket trial planned in additional autoimmune indications. A Phase 3 trial of Descartes-08 in patients with generalized myasthenia gravis has received written agreement from the FDA under the Special Protocol Assessment process. The Company’s clinical-stage pipeline also includes Descartes-15, a next-generation, autologous anti-BCMA CAR-T currently being evaluated in a Phase 1 trial in patients with multiple myeloma. For more information, please visit www.cartesiantherapeutics.com or follow the Company on LinkedIn or X, formerly known as Twitter. Forward Looking Statements Any statements in this press release about the future expectations, plans and prospects of the Company, including without limitation, statements regarding the Company’s expected cash resources and cash runway, the ability of the Company’s product candidates to be administered in an outpatient setting or without the need for preconditioning lymphodepleting chemotherapy, the potential of Descartes-08, Descartes-15, or any of the Company’s other product candidates to treat myasthenia gravis, juvenile myasthenia gravis, systemic lupus erythematosus, juvenile systemic lupus erythematosus, juvenile dermatomyositis, anti-neutrophil cytoplasmic antibody-associated vasculitis, multiple myeloma, or any other disease, the anticipated timing or the outcome of ongoing and planned clinical trials, studies and data readouts, including the planned Phase 3 AURORA trial of Descartes-08 in myasthenia gravis, the planned Phase 2 pediatric basket trial of Descartes-08 in juvenile dermatomyositis, juvenile systemic lupus erythematosus, juvenile myasthenia gravis, and anti-neutrophil cytoplasmic antibody-associated vasculitis, and the ongoing Phase 2 trial of Descartes-08 in systemic lupus erythematosus, the anticipated timing or the outcome of the FDA’s review of the Company’s regulatory filings, the Company’s ability to conduct its clinical trials and preclinical studies, the timing or making of any regulatory filings, the anticipated timing or outcome of selection of developmental product candidates, the novelty of treatment paradigms that the Company is able to develop, the potential of any therapies developed by the Company to fulfill unmet medical needs, and enrollment in the Company’s clinical trials and other statements containing the words “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “hypothesize,” “intend,” “may,” “plan,” “potential,” “predict,” “project,” “should,” “target,” “would,” and similar expressions, constitute forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including, but not limited to, the following: the uncertainties inherent in the initiation, completion and cost of clinical trials including proof of concept trials, including uncertain outcomes, the availability and timing of data from ongoing and future clinical trials and the results of such trials, whether preliminary results from a particular clinical trial will be predictive of the final results of that trial and whether results of early clinical trials will be indicative of the results of later clinical trials, the ability to predict results of studies performed on human beings based on results of studies performed on non-human subjects, the unproven approach of the Company’s technology, potential delays in enrollment of patients, undesirable side effects of the Company’s product candidates, political uncertainty, the Company’s reliance on third parties to conduct its clinical trials, the Company’s inability to maintain its existing or future collaborations, licenses or contractual relationships, its inability to protect its proprietary technology and intellectual property, potential delays in regulatory approvals, the availability of funding sufficient for its foreseeable and unforeseeable operating expenses and capital expenditure requirements, the Company’s recurring losses from operations and negative cash flows, substantial fluctuation in the price of the Company’s common stock, risks related to geopolitical conflicts, pandemics, and macroeconomic impacts, and other important factors discussed in the “Risk Factors” section of the Company’s most recent Annual Report on Form 10-K and subsequently filed Quarterly Reports on Form 10-Q, and in other filings that the Company makes with the Securities and Exchange Commission. In addition, any forward-looking statements included in this press release represent the Company’s views only as of the date of its publication and should not be relied upon as representing its views as of any subsequent date. The Company specifically disclaims any intention to update any forward-looking statements included in this press release, except as required by law. Investor Contact Megan LeDuc Associate Director of Investor Relations [email protected] Media Contact David Rosen Argot Partners [email protected]
Investor releaseQuarter not tagged2025-03-14Cartesian Therapeutics Full Year 2024 Earnings: EPS Beats Expectations, Revenues Lag
Simply Wall St.
Cartesian Therapeutics Full Year 2024 Earnings: EPS Beats Expectations, Revenues Lag
Revenue: US$38.9m (up 50% from FY 2023). Net loss: US$77.4m (loss narrowed by 70% from FY 2023). US$4.48 loss per share (improved from US$49.76 loss in FY 2023). All figures shown in the chart above are for the trailing 12 month (TTM) period Revenue missed analyst estimates by 2.1%. Earnings per share (EPS) exceeded analyst estimates by 24%. Looking ahead, revenue is forecast to grow 37% p.a. on average during the next 3 years, compared to a 20% growth forecast for the Biotechs industry in the US. Performance of the American Biotechs industry. The company's shares are down 6.9% from a week ago. We should say that we've discovered 4 warning signs for Cartesian Therapeutics (3 are a bit concerning!) that you should be aware of before investing here. Have feedback on this article? Concerned about the content? Get in touch with us directly. Alternatively, email editorial-team (at) simplywallst.com. This article by Simply Wall St is general in nature. We provide commentary based on historical data and analyst forecasts only using an unbiased methodology and our articles are not intended to be financial advice. It does not constitute a recommendation to buy or sell any stock, and does not take account of your objectives, or your financial situation. We aim to bring you long-term focused analysis driven by fundamental data. Note that our analysis may not factor in the latest price-sensitive company announcements or qualitative material. Simply Wall St has no position in any stocks mentioned.
Investor releaseQuarter not tagged2025-03-13Cartesian Therapeutics Reports Full Year 2024 Financial Results and Provides Business Update
GlobeNewswire
Cartesian Therapeutics Reports Full Year 2024 Financial Results and Provides Business Update
Phase 3 AURORA trial of Descartes-08 in myasthenia gravis on track to commence in 1H25; Deep and durable responses maintained over 12 months in Descartes-08-treated participants in Phase 2b trial Phase 2 trial of Descartes-08 in systemic lupus erythematosus ongoing with expected data readout in 2H25 Company expects to initiate Phase 2 pediatric basket trial of Decartes-08 in select autoimmune indications in 2H25 Dosing underway in first-in-human Phase 1 trial of Descartes-15 Approximately $214.3 million cash, cash equivalents and restricted cash as of December 31, 2024 expected to support planned operations into mid-2027, including completion of planned Phase 3 AURORA trial FREDERICK, Md., March 13, 2025 (GLOBE NEWSWIRE) -- Cartesian Therapeutics, Inc. (NASDAQ: RNAC) (the “Company”), a clinical-stage biotechnology company pioneering mRNA cell therapy for autoimmune diseases, today reported financial results for the full year ended December 31, 2024, and outlined recent corporate updates. “Following a year marked by tremendous progress, we remain committed to advancing our pipeline of mRNA cell therapies designed to be dosed in the convenient outpatient setting, without the need for preconditioning chemotherapy,” said Carsten Brunn, Ph.D., President and Chief Executive Officer of Cartesian. “Notably, we remain on track to commence our planned Phase 3 AURORA trial of Descartes-08 in patients with myasthenia gravis (MG) in the first half of this year. Supported by positive results from our Phase 2b trial demonstrating deep and durable improvements for Descartes-08-treated participants, along with our Special Protocol Assessment (SPA) agreement with U.S. Food and Drug Administration (FDA), we are confident that we have a clear path toward potential approval of this promising new therapy.” Dr. Brunn continued, “Beyond MG, we remain on track to report preliminary data from our ongoing Phase 2 open-label trial of Descartes-08 in patients with systemic lupus erythematosus (SLE) and expect to initiate our Phase 2 pediatric basket trial of Descartes-08 in select autoimmune diseases in the second half of this year. With these anticipated milestones, along with our strong balance sheet, we believe we are well-positioned to deliver on our mission to expand the reach of cell therapy to autoimmunity.” Recent Pipeline Progress and Anticipated Milestones Phase 3 AURORA Trial…Read full documentShow less
Phase 3 AURORA trial of Descartes-08 in myasthenia gravis on track to commence in 1H25; Deep and durable responses maintained over 12 months in Descartes-08-treated participants in Phase 2b trial Phase 2 trial of Descartes-08 in systemic lupus erythematosus ongoing with expected data readout in 2H25 Company expects to initiate Phase 2 pediatric basket trial of Decartes-08 in select autoimmune indications in 2H25 Dosing underway in first-in-human Phase 1 trial of Descartes-15 Approximately $214.3 million cash, cash equivalents and restricted cash as of December 31, 2024 expected to support planned operations into mid-2027, including completion of planned Phase 3 AURORA trial FREDERICK, Md., March 13, 2025 (GLOBE NEWSWIRE) -- Cartesian Therapeutics, Inc. (NASDAQ: RNAC) (the “Company”), a clinical-stage biotechnology company pioneering mRNA cell therapy for autoimmune diseases, today reported financial results for the full year ended December 31, 2024, and outlined recent corporate updates. “Following a year marked by tremendous progress, we remain committed to advancing our pipeline of mRNA cell therapies designed to be dosed in the convenient outpatient setting, without the need for preconditioning chemotherapy,” said Carsten Brunn, Ph.D., President and Chief Executive Officer of Cartesian. “Notably, we remain on track to commence our planned Phase 3 AURORA trial of Descartes-08 in patients with myasthenia gravis (MG) in the first half of this year. Supported by positive results from our Phase 2b trial demonstrating deep and durable improvements for Descartes-08-treated participants, along with our Special Protocol Assessment (SPA) agreement with U.S. Food and Drug Administration (FDA), we are confident that we have a clear path toward potential approval of this promising new therapy.” Dr. Brunn continued, “Beyond MG, we remain on track to report preliminary data from our ongoing Phase 2 open-label trial of Descartes-08 in patients with systemic lupus erythematosus (SLE) and expect to initiate our Phase 2 pediatric basket trial of Descartes-08 in select autoimmune diseases in the second half of this year. With these anticipated milestones, along with our strong balance sheet, we believe we are well-positioned to deliver on our mission to expand the reach of cell therapy to autoimmunity.” Recent Pipeline Progress and Anticipated Milestones Phase 3 AURORA Trial of Descartes-08 in MG on Track to Commence in the First Half of 2025. The randomized, double-blind, placebo-controlled Phase 3 AURORA trial is designed to assess Descartes-08 versus placebo (1:1 randomization) administered as six once weekly outpatient infusions without preconditioning chemotherapy in approximately 100 participants with acetylcholine receptor autoantibody positive (AChR Ab+) MG. The primary endpoint will assess the proportion of Descartes-08 participants with an improvement in MG Activities of Daily Living (MG-ADL) score of three points or more at Month 4 compared to placebo. Descartes-08, Cartesian’s lead product candidate, is an autologous anti-B cell maturation antigen (BCMA) mRNA-engineered chimeric antigen receptor T-cell therapy (mRNA CAR-T). In January 2025, Cartesian announced that it has received written agreement from the FDA under the SPA process on the overall design of the planned Phase 3 AURORA trial. The SPA agreement indicates that the FDA has determined that the proposed trial design is acceptable to support a future Biologics License Application for Descartes-08 in MG, subject to the ultimate outcome of the trial. Announced Positive Updated Results from Phase 2b Trial of Descartes-08 in Participants with MG, with Deepening Response Observed Over Time, Durable Through Month 12. In December 2024, the Company announced updated efficacy and safety data from the Phase 2b trial of Descartes-08 in participants with MG. Participants included in the primary efficacy dataset (n=12)1 experienced an average MG-ADL reduction of 5.5 (±1.1) at Month 4. Responses were observed to be durable through Month 12, with 80% (4/5) of evaluable participants from the primary efficacy dataset maintaining a clinically meaningful response, defined as a reduction in MG-ADL score of at least 2 points. Descartes-08 continues to be observed as well-tolerated, supporting outpatient administration without the need for lymphodepleting chemotherapy. Dr. Tuan Vu, one of Cartesian’s Clinical Advisors, will Present at the American Academy of Neurology Annual Meeting on April 9, 2025 at 1:12 pm PT. The presentation and abstract are titled, “The Efficacy and Safety of Autologous BCMA-directed mRNA CAR T-Cell Therapy in Generalized Myasthenia Gravis: Results from a Phase 2b Randomized Placebo-controlled Trial.” Preliminary Data from Ongoing Phase 2 Open-Label Trial of Descartes-08 in Patients with SLE Expected in the Second Half of 2025. The trial is designed to assess the safety, tolerability and clinical activity of outpatient Descartes-08 administration without preconditioning chemotherapy in patients with SLE. SLE is an incurable autoimmune disease marked by systemic inflammation that affects multiple organ systems and impacts approximately 1.5 million people in the United States. Phase 2 Pediatric Basket Trial of Descartes-08 in Select Autoimmune Diseases Expected to Initiate in the Second Half of 2025. This pediatric basket trial will target juvenile SLE, juvenile MG, juvenile dermatomyositis (JDM) and anti-neutrophil cytoplasmic antibody (ANCA) associated vasculitis. The FDA previously granted Rare Pediatric Disease Designation to Descartes-08 for the treatment of JDM, which is a rare pediatric autoimmune disorder. Dosing Ongoing in First-in-Human Phase 1 Clinical Trial of Descartes-15. The Phase 1 dose escalation trial of Cartesian’s next-generation, autologous anti-BCMA mRNA CAR-T cell therapy, is designed to assess the safety and tolerability of outpatient Descartes-15 administration in patients with multiple myeloma. Following the Phase 1 dose escalation trial, the Company expects to subsequently assess Descartes-15 in autoimmune indications. Corporate Updates Emily English Promoted to Chief Operations Officer. Emily English, formerly Cartesian’s Senior Vice President and Head of Manufacturing Operations, was promoted to Chief Operations Officer in January 2025. Emily’s significant contributions, including her leadership in the expansion of the new, state-of-the-art current good manufacturing practice (cGMP) facility in Frederick, Maryland, have been instrumental in Cartesian’s progress as the Company continues to advance its pipeline. Full Year 2024 Financial Results Cash, cash equivalents and restricted cash as of December 31, 2024 was $214.3 million and is expected to support planned operations, including completion of planned Phase 3 AURORA trial for Descartes-08 in MG, into mid-2027. Research and development expenses were $45.1 million for the year ended December 31, 2024, compared to $71.3 million for the year ended December 31, 2023. The decrease was primarily a result of the Company’s restructuring in 2023 prior to the merger between Cartesian and Selecta Biosciences, including reductions in expenses for preclinical and clinical programs due to the strategic reprioritization, stock compensation in connection with the Selecta Biosciences/ Cartesian Therapeutics merger, and higher expenses in 2023 compared to 2024 due to one-time cash charges related to salaries and benefits. General and administrative expenses were $30.1 million for the year ended December 31, 2024, compared to $40.5 million for the year ended December 31, 2023. The decrease in expense for the year ended December 31, 2024 was primarily the result of reductions in expenses incurred for stock compensation and professional fees in connection with the merger between Cartesian and Selecta Biosciences. Net loss was $(77.4) million, or $(4.48) net loss per share (basic), for the year ended December 31, 2024, compared to net loss of $(219.7) million, or $(49.76) net loss per share (basic), for the year ended December 31, 2023. About Descartes-08 Descartes-08, Cartesian’s lead mRNA cell therapy candidate, is an autologous mRNA-engineered chimeric antigen receptor T-cell therapy (mRNA CAR-T) product targeting B-cell maturation antigen (BCMA) in clinical development for generalized myasthenia gravis (MG) and systemic lupus erythematosus. In contrast to conventional DNA-based CAR T-cell therapies, mRNA CAR-T administration is designed to not require preconditioning chemotherapy, can be administered in the outpatient setting, and does not carry the risk of genomic integration associated with cancerous transformation. Descartes-08 has been granted Orphan Drug Designation and Regenerative Medicine Advanced Therapy Designation by the U.S. Food and Drug Administration for the treatment of MG, and Rare Pediatric Disease Designation for the treatment of juvenile dermatomyositis. About Descartes-15 Descartes-15 is a next-generation, autologous anti-BCMA mRNA CAR-T cell therapy. In preclinical studies, Descartes-15 has been observed to achieve an approximately ten-fold increase in CAR expression and selective target-specific killing, relative to Descartes-08. Similar to Descartes-08, Descartes-15 is designed to be administered without preconditioning chemotherapy and does not use integrating vectors. About Cartesian Therapeutics Cartesian Therapeutics is a clinical-stage company pioneering mRNA cell therapy for the treatment of autoimmune diseases. The Company’s lead asset, Descartes-08, is an mRNA CAR-T entering Phase 3 clinical development for patients with generalized myasthenia gravis and Phase 2 development for systemic lupus erythematosus, with a Phase 2 basket trial planned in additional autoimmune indications. A Phase 3 trial of Descartes-08 in patients with generalized myasthenia gravis has received written agreement from the FDA under the Special Protocol Assessment process. The Company’s clinical-stage pipeline also includes Descartes-15, a next-generation, autologous anti-BCMA mRNA CAR-T currently being evaluated in a Phase 1 trial in patients with multiple myeloma. For more information, please visit www.cartesiantherapeutics.com or follow the Company on LinkedIn or X, formerly known as Twitter. Forward Looking Statements Any statements in this press release about the future expectations, plans and prospects of the Company, including without limitation, statements regarding the Company’s expected cash resources and cash runway, the ability of the Company’s product candidates to be administered in an outpatient setting or without the need for preconditioning lymphodepleting chemotherapy, the potential of Descartes-08, Descartes-15, or any of the Company’s other product candidates to treat myasthenia gravis, juvenile myasthenia gravis, systemic lupus erythematosus, juvenile systemic lupus erythematosus, juvenile dermatomyositis, multiple myeloma, or any other disease, the amount and occurrence of any payments to holders of the Company’s contingent value rights, the anticipated timing or the outcome of ongoing and planned clinical trials, studies and data readouts, including the planned Phase 3 AURORA trial of Descartes-08 in myasthenia gravis, the planned Phase 2 pediatric basket trial of Descartes-08 in juvenile dermatomyositis, juvenile systemic lupus erythematosus, juvenile myasthenia gravis and other conditions, and the ongoing Phase 2 trial of Descartes-08 in systemic lupus erythematosus, the anticipated timing or the outcome of the FDA’s review of the Company’s regulatory filings, the Company’s ability to conduct its clinical trials and preclinical studies, the timing or making of any regulatory filings, the anticipated timing or outcome of selection of developmental product candidates, the novelty of treatment paradigms that the Company is able to develop, the potential of any therapies developed by the Company to fulfill unmet medical needs, and enrollment in the Company’s clinical trials and other statements containing the words “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “hypothesize,” “intend,” “may,” “plan,” “potential,” “predict,” “project,” “should,” “target,” “would,” and similar expressions, constitute forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including, but not limited to, the following: the uncertainties inherent in the initiation, completion and cost of clinical trials including proof of concept trials, including uncertain outcomes, the availability and timing of data from ongoing and future clinical trials and the results of such trials, whether preliminary results from a particular clinical trial will be predictive of the final results of that trial and whether results of early clinical trials will be indicative of the results of later clinical trials, the ability to predict results of studies performed on human beings based on results of studies performed on non-human subjects, the unproven approach of the Company’s technology, potential delays in enrollment of patients, undesirable side effects of the Company’s product candidates, political uncertainty, the Company’s reliance on third parties to conduct its clinical trials, the Company’s inability to maintain its existing or future collaborations, licenses or contractual relationships, its inability to protect its proprietary technology and intellectual property, potential delays in regulatory approvals, the availability of funding sufficient for its foreseeable and unforeseeable operating expenses and capital expenditure requirements, the Company’s recurring losses from operations and negative cash flows, substantial fluctuation in the price of the Company’s common stock, risks related to geopolitical conflicts and pandemics and other important factors discussed in the “Risk Factors” section of the Company’s most recent Annual Report on Form 10-K and subsequently filed Quarterly Reports on Form 10-Q, and in other filings that the Company makes with the Securities and Exchange Commission. In addition, any forward-looking statements included in this press release represent the Company’s views only as of the date of its publication and should not be relied upon as representing its views as of any subsequent date. The Company specifically disclaims any intention to update any forward-looking statements included in this press release, except as required by law. Investor Contact Megan LeDuc Associate Director of Investor Relations [email protected] Media Contact David Rosen Argot Partners [email protected] 1 Primary efficacy dataset consisted of a modified intent-to-treat population of all subjects enrolled at academic medical centers who received at least one dose of Descartes-08 and completed at least one post-Month 3 MG-ADL score follow-up assessment.

