Core Viewpoint - Cartesian Therapeutics has received RMAT designation from the FDA for its lead product candidate Descartes-08, aimed at treating myasthenia gravis, highlighting its potential as a first-in-class mRNA CAR-T therapy in the autoimmune disease treatment landscape [1][3]. Company Overview - Cartesian Therapeutics is a clinical-stage biotechnology company focused on mRNA cell therapies for autoimmune diseases, with Descartes-08 being its lead asset currently in Phase 2b clinical development for generalized myasthenia gravis [7]. Product Details - Descartes-08 is an autologous mRNA CAR-T therapy targeting the B cell maturation antigen (BCMA), specifically developed for myasthenia gravis, a chronic autoimmune disorder characterized by muscle weakness and fatigue [2][4]. - The therapy has previously received Orphan Drug Designation from the FDA for the treatment of myasthenia gravis [4]. Clinical Development - Positive twelve-month follow-up data from a Phase 2a study indicated that Descartes-08 was well-tolerated, showing durable depletion of autoantibodies and clinically meaningful improvements in MG severity scores without dose-limiting toxicities [5]. - The company is on track to report topline data from its ongoing Phase 2b randomized, double-blind, placebo-controlled trial in mid-2024 [6]. Regulatory Designation - The RMAT designation allows for expedited development processes, including early and frequent interactions with the FDA, aimed at addressing unmet medical needs for serious conditions [3].

UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 10-Q þ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended March 31, 2024 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from _______ to _______ Securities registered pursuant to Section 12(b) of the Act: | Title of each class | Trading Symbol(s) | Name of each exchange on which registered | | ...

Exhibit 99.1 Cartesian Therapeutics Reports First Quarter 2024 Financial Results and Provides Business Update Topline data from Phase 2b trial of Descartes-08, the Company's potential first-in-class mRNA CAR-T cell therapy, in myasthenia gravis on track for mid-2024 On track to dose first patient in Phase 2 trial of Descartes-08 in SLE in 2Q24, as well as Phase 2 basket studies in additional autoimmune indications in 2H24 Dr. Brunn continued, "Additionally, we were excited to announce plans to transition to ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 10-K þ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2023 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from ____ to ____ Commission file number: 001-37798 Cartesian Therapeutics, Inc. (Exact name of registrant as specified in its charter) Delaware 26-1622110 (State or other jurisdi ...

Exhibit 99.1 Cartesian Therapeutics Reports Full Year 2023 Financial Results and Provides Business Update Topline data from Phase 2b study of Descartes-08, the Company's potential first-in-class mRNA CAR- T cell therapy, in myasthenia gravis (MG) remains on track for mid-2024 On track to initiate Phase 2 study of Descartes-08 in systemic lupus erythematosus (SLE) in 1H24 as well as Phase 2 basket studies in additional autoimmune indications in 2H24 Following recent IND clearance, planning underway for first ...

Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 10-Q ☑ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended September 30, 2023 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission File Number: 001-37798 Cartesian Therapeutics, Inc. (Exact name of registrant as specified in its charter) Delaware 26-1622110 (State ...

Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 10-Q ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended June 30, 2023 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission File Number: 001-37798 Selecta Biosciences, Inc. (Exact name of registrant as specified in its charter) Delaware 26-1622110 (State or othe ...

Selecta Biosciences, Inc. (SELB) Q1 2023 Earnings Conference Call May 4, 2023 8:30 AM ET Company Participants Blaine Davis - CFO Carsten Brunn - CEO, President & Director Peter Traber - Chief Medical Officer Conference Call Participants Joseph Schwartz - SVB Securities Kristen Kluska - Cantor Fitzgerald John Newman - Canaccord Genuity Dipesh Patel - H.C. Wainwright & Co. Uy Ear - Mizuho Securities Gil Blum - Needham & Company Operator Good morning, and thank you for joining the Selecta Biosciences First Qua ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 10-Q þ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended March 31, 2023 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from _______ to _______ Commission File Number: 001-37798 Selecta Biosciences, Inc. (Exact name of registrant as specified in its charter) Delaware 26-1622110 (I.R.S. Employe ...

Selecta Biosciences, Inc. (SELB) Q4 2022 Earnings Conference Call March 2, 2023 8:30 AM ET Company Participants Blaine Davis - Chief Financial Officer Carsten Brunn - President, Chief Executive Officer & Director Peter Traber - Chief Medical Officer Conference Call Participants Joseph Schwartz - SVB Securities Kristen Kluska - Cantor Fitzgerald John Newman - Canaccord Genuity Yun Zhong - BTIG Gil Blum - Needham & Company Tiffany Marchell - William Blair Boobalan Pachaiyappan - H.C. Wainwright Uy Ear - Mizuh ...