Cartesian Therapeutics Files 8-K

TL;DR

Cartesian Therapeutics filed a standard 8-K, no major news.

AI Summary

Cartesian Therapeutics, Inc. filed an 8-K on December 3, 2024, to report on other events and financial statements. The filing does not contain specific details about new agreements, material events, or financial figures beyond the standard reporting requirements.

Why It Matters

This 8-K filing indicates routine corporate reporting by Cartesian Therapeutics, Inc. without disclosing any immediately material events.

Risk Assessment

Risk Level: low — The filing is a routine 8-K with no disclosed material events, indicating low immediate risk from this specific report.

Key Players & Entities

• Cartesian Therapeutics, Inc. (company) — Registrant
• December 3, 2024 (date) — Date of earliest event reported
• Delaware (jurisdiction) — State of incorporation
• 7495 New Horizon Way, Frederick, MD 21703 (address) — Principal executive offices

FAQ

Key Financial Figures

• $0.0001 — ich registered Common Stock (Par Value $0.0001) RNAC The Nasdaq Stock Market LLC Ind

Filing Documents

• rnac-20241203.htm (8-K) — 66KB
• rnac_phase2bdataupdate.htm (EX-99.1) — 33KB
• rnac_dec2024mgupdatex.htm (EX-99.2) — 21KB
• cartesian_logoxcolorxcmyka.jpg (GRAPHIC) — 1239KB
• rnac_dec2024mgupdatex001.jpg (GRAPHIC) — 82KB
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• rnac_dec2024mgupdatex018.jpg (GRAPHIC) — 28KB
• 0001453687-24-000143.txt ( ) — 4500KB
• rnac-20241203.xsd (EX-101.SCH) — 2KB
• rnac-20241203_lab.xml (EX-101.LAB) — 22KB
• rnac-20241203_pre.xml (EX-101.PRE) — 13KB
• rnac-20241203_htm.xml (XML) — 3KB

01 Regulation FD Disclosure

Item 7.01 Regulation FD Disclosure. On December 3, 2024, Cartesian Therapeutics, Inc. (the "Company") issued a press release announcing positive updated results from its Phase 2b trial of Descartes-08 in patients with generalized myasthenia gravis ("MG") and outlining the design of its planned Phase 3 AURORA trial in patients with MG. A copy of the press release is attached hereto as Exhibit 99.1 and incorporated herein by reference. The Company will host a conference call to discuss the updated Phase 2b data and the planned Phase 3 AURORA trial on December 3, 2024 at 7:30 a.m., Eastern Time, and a live audio webcast of the call will be available through the Events & Presentations section of the Company's website. A copy of the slide presentation to be used during the presentation is attached hereto as Exhibit 99.2 and incorporated herein by reference. The information in Item 7.01 of this Form 8-K, including Exhibits 99.1 and 99.2 attached hereto, shall not be deemed "filed" for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the "Exchange Act"), or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended, or the Exchange Act, except as expressly set forth by specific reference in such a filing.

01 Other Information

Item 8.01 Other Information. On December 3, 2024, the Company announced positive updated efficacy and safety data from its Phase 2b trial of Descartes-08 in participants with MG. In the Phase 2b double-blind, placebo-controlled, crossover trial, a total of 36 heavily pre-treated, highly symptomatic participants with MG were randomized 1:1 to receive either Descartes-08 or placebo administered as six weekly outpatient infusions without preconditioning chemotherapy. The primary efficacy dataset for the follow-up portion of the trial consisted of a modified intent-to-treat ("mITT") 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 Activities of Daily Living ("MG-ADL") score follow-up assessment. As of an October 31, 2024 cutoff date, 12 participants in the primary efficacy dataset completed their Month 4 and Month 6 follow-up assessments, with eight participants evaluable for their Month 9 assessment, and five participants evaluable for their Month 12 assessment. Two participants who were MG Composite responders at Month 3 were lost to follow-up after their Month 3 assessments and were not assessed in the follow-up portion of the treatment. Deepening responses were observed over time, with participants included in the primary efficacy dataset (n=12) experiencing an average MG-ADL reduction of 5.5 (1.1) at Month 4. At Month 4, particularly deep responses were observed in participants without prior exposure to biologic therapies (n=7), including complement or neonatal fragment crystallizable receptor inhibitors, with an average MG-ADL reduction of 6.6 (1.5). Responses were observed to further deepen at Month 6, with 33% (4/12) of participants in the primary efficacy dataset and 57% (4/7) of participants with no prior exposure to biologic therapy observed to have minimum symptom expression, defined as an MG-ADL score of 0 or 1. Responses were observed to be durable t

Forward Looking Statements

Forward Looking Statements Any statements in this Current Report on Form 8-K about the future expectations, plans and prospects of the Company, including without limitation, statements regarding observations and data from the myasthenia gravis Phase 2a/2b trial, 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, systemic lupus erythematosus, juvenile dermatomyositis, or any other disease, the anticipated timing or the outcome of ongoing and planned clinical trials, studies and data readouts, 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 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 cl

01 Financial Statements and Exhibits

Item 9.01 Financial Statements and Exhibits. (d) Exhibits Exhibit No. Exhibit Description 99.1 Press Release of Cartesian Therapeutics, Inc., dated December 3, 2024. 99.2 Cartesian Therapeutics, Inc. Phase 2b Updated Data Presentation. 104 Cover Page Interactive Data File (embedded within the Inline XBRL document)

SIGNATURES

SIGNATURES Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized. CARTESIAN THERAPEUTICS, INC. Date: December 3, 2024 By: /s/ Carsten Brunn, Ph.D. Carsten Brunn, Ph.D. President and Chief Executive Officer

View Full Filing

View this 8-K filing on SEC EDGAR