8-K

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

FORM 8-K

CURRENT REPORT

Pursuant to Section 13 or 15(d) of

the Securities Exchange Act of 1934

Date of Report (Date of earliest event reported): January 8, 2024

CARTESIAN THERAPEUTICS, INC.

(Exact name of registrant as specified in its charter)

Delaware	001-37798	26-1622110
(State or other jurisdiction of incorporation)	(Commission File Number)	(IRS Employer Identification No.)

704 Quince Orchard Road, Gaithersburg, MD 20878

(Address of principal executive offices)(Zip Code)

(617) 923-1400

Registrant’s telephone number, including area code

N/A

(Former name or former address, if changed since last report)

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:

☐	Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
☐	Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
☐	Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
☐	Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

Securities registered pursuant to Section 12(b) of the Act:
Title of each class	Trading Symbol(s)	Name of each exchange on which registered
Common Stock (Par Value $0.0001)	RNAC	The Nasdaq Stock Market LLC

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).

Emerging growth company  ☐

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act.  ☐

Item 7.01. Regulation FD Disclosure.

Cartesian Therapeutics, Inc. (the “Company”) from time to time presents and/or distributes to the investment community at various industry and other conferences slide presentations to provide updates and summaries of its business. A copy of its current corporate slide presentation is attached to this Current Report on Form 8-K as Exhibit 99.1.

Additionally, on January 8, 2024, the Company issued press releases announcing long-term follow-up data from its Phase 2a study of Descartes-08 in patients with myasthenia gravis and announcing its 2024 strategic priorities, respectively. These press releases are attached to this Current Report on Form 8-K as Exhibits 99.2 and 99.3, respectively.

The information in Item 7.01 of this Form 8-K, including Exhibits 99.1, 99.2, and 99.3 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. The Company undertakes no obligation to update, supplement or amend the materials attached hereto as Exhibits 99.1, 99.2, or 99.3, except as required by law.

Item 9.01  Financial Statements and Exhibits.

(d) Exhibits

Exhibit No.	Exhibit Description
99.1	Corporate slide presentation of Cartesian Therapeutics, Inc. dated January 2024
99.2	Press release announcing long-term follow-up data from Phase 2a study of Descartes-08 in myasthenia gravis issued on January 8, 2024
99.3	Press release announcing the Company’s 2024 strategic priorities issued on January 8, 2024
104	Cover Page Interactive Data File (embedded within the Inline XBRL document)

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: January 8, 2024	By:	/s/ Carsten Brunn, Ph.D.
		Carsten Brunn, Ph.D.
		President and Chief Executive Officer

EX-99.1

Exhibit 99.1

 ®  THERAPEUTICS  Pioneering mRNA Cell Therapy for Autoimmunity  January 2024  C A R T ES I AN T H E R APEUT I CS  

 Forward-Looking Statements  Disclosures  For the purposes of this notice, the “presentation” that follows shall mean and include the slides that follow, the oral presentation of the slides by members of management of Cartesian Therapeutics, Inc. (the “Company”) or any person on their behalf, any question-and-answer session that follows such oral presentation, hard copies of this document and any materials distributed at, or in connection with, such oral presentation.  Forward-looking Statements  Any statements in this presentation 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 Company’s estimated cash on hand, the expected receipt of proceeds from the Company’s November 2023 private placement, conversion of the Company’s Series A Non-Voting Convertible Preferred Stock, the potential of RNA Armory® to enable precision control and optimization of engineered cells for diverse cell therapies leveraging multiple modalities, the potential of Descartes-08, Descartes-15, Descartes-33 and the Company’s other product candidates to treat myasthenia gravis, systemic lupus erythematosus, 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 anticipated timing or outcome of selection of developmental product candidates, the ability of the Company to consummate any expected agreements and licenses and to realize the anticipated benefits thereof, 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, the Company’s ability to enter into and maintain its strategic partnerships, 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 RNA Armory® technology, potential delays in enrollment of patients, undesirable side effects of the Company’s product candidates, its 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 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 presentation 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 presentation, except as required by law.  2 

 3  Clinical-stage company pioneering mRNA cell  therapies designed to  expand the reach of cell therapy to autoimmunity  Pipeline of mRNA cell therapies designed to be dosed more reliably and safely in an outpatient setting without lymphodepletion  Descartes-08: Potential first-in-class mRNA CAR T-cell (CAR-T) demonstrated deep and durable clinical responses in Phase 2a study in patients with myasthenia gravis (MG)  Wholly-owned GMP manufacturing designed to enable rapid optimization of processes in iterative manner  MULTIPLE ANTICPATED NEAR-TERM CATALYSTS  $118M as of end of 2023; expected to fund currently planned operations into 2H26  Expected to provide for continued clinical development of Descartes-08 in MG through Phase 3 and multiple additional clinical programs  PRO FORMA CASH RESOURCES*  DESCARTES-08  Phase 2b topline data in MG expected mid-2024  Initiation of Phase 2 study in SLE expected in 1H 2024  Initiation of studies in additional autoimmune indications expected in 2H 2024  DESCARTES-15  Next-generation mRNA CAR-T candidate  IND cleared, with first-in-human Phase 1 planning activities underway  *Reflects the anticipated receipt of $40M through two delayed settlement payments previously announced as part of the November 2023 financing, which are expected in January 2024 and February 2024  CAR, Chimeric antigen receptor SLE, Systemic Lupus Erythematosus 

 Experienced management team to lead the mRNA cell therapy company of the future  Matthew Bartholomae  General Counsel  Metin Kurtoglu, MD, PhD  COO  Milos Miljkovic, MD  CMO  Blaine Davis  CFO  Chris Jewell, PhD  Chief Scientific Officer  Carsten Brunn, PhD  President and CEO  MANAGEMENT  Emily English, PhD  VP, Quality  4  Murat Kalayoglu, MD, PhD  Director | Cartesian Co- Founder & pre-merger CEO  Timothy Springer, PhD Director  Carrie  S. Cox  Chairman  BOARD MEMBERS  Michael Singer, MD, PhD  Director | Cartesian Co- Founder & pre-merger Chief Strategy Officer  Timothy Barabe Director  Nishan De Silva, MD  Director  Aymeric Sallin, MS Director  Patrick Zenner Director 

 DNA CAR-T cell therapy creates increased patient burden  Patients receiving DNA CAR-T require inpatient administration and pre-treatment chemotherapy (lymphodepletion)  Indirect costs high due to monitoring/treatment of toxicities  DNA transduced CAR-T associated with:  Cytokine release syndrome (CRS)  Neurotoxicity and parkinsonism  Cytopenia (from pre-treatment chemo)  Infections  Secondary malignancies  Death  5  Conventional engineered cell therapy uses DNA, which can   lead to toxicity and increased patient burden   Effector function of cell therapy engineered with DNA amplifies exponentially with cell replication and frequently leads to uncontrollable PK/PD  Cells administered at subtherapeutic levels quickly proliferate beyond therapeutic window 

 6  Time  Therapeutic window  Subtherapeutic  Toxicity  CAR+ Cells  6 Doses  Expectation for cells to be administered at the  therapeutic but sub-toxic doses  Descartes-08 has been administered to 66 patients with autoimmune diseases and cancer1 with no CRS, neurotoxicity, or infections observed  Ability to treat in outpatient setting offers potential to be administered in community clinics  Potential for safe re-dosing  mRNA CAR-Ts have potential to overcome challenges of DNA CAR-Ts  No expected need for hospitalization, lymphodepletion, toxicity management, and monitoring  Produces multiple cycles from one apheresis  Lower manufacturing costs  1All open-label patients treated with Descartes-08 as of Oct 30, 2023  Cartesian’s mRNA approach is designed to expand the reach of potent cell therapy products to address  potential autoimmune indications  mRNA does not replicate  predictable half-life with more controllable PK/PD defined by the dose  No requirement for cell proliferation  no expected need for pre-treatment chemotherapy  no Grade 3-4 cytopenias 

 Wholly-owned pipeline targets autoimmune disease  AAAD, autoantibody-associated autoimmune diseases SLE, Systemic Lupus Erythematosus mRNA MSC, Mesenchymal Stem Cells transfected with mRNA LN, Lymph node  BCMA, B-cell maturation antigen  Asset  Indications  Discovery/Preclinical  Phase 1  Phase 2  Pivotal  Descartes-08 Autologous mRNA CAR-T  Myasthenia Gravis  SLE, other AAAD  Descartes-15 Autologous mRNA CAR-T  AAAD  Descartes-33 Allogeneic mRNA MSC  AAAD  In situ LN transfection  Undisclosed  7  Data from Phase 2b study expected in mid-2024  Expect to initiate Phase 2 studies in SLE and additional autoimmune indications in 2024  Next-gen anti-BCMA mRNA CAR-T with >10x preclinical potency 

 ®  THERAPEUTICS  8  Descartes-08 is believed to be the first mRNA CAR-T in clinical  development for autoimmune  disease  Engineered by transfection of autologous CD8+ T cells with mRNA encoding anti-BCMA CAR  Typical lot processed for infusion within ~3 weeks Positive Phase 2a data in myasthenia gravis  underscores potential for deep and durable responses  Granted U.S. FDA orphan designation for generalized myasthenia gravis 

 ®  THERAPEUTICS  Initial indication for Descartes-08:  Myasthenia gravis  Affects over 120,000 patients in US and EU  Characterized by debilitating weakness: limbs, respiratory, ocular, facial muscles  Standard of care includes chronic use of immunosuppressants, which are often toxic:  Progressive disease that is fatal in 1/3 of patients without immunosuppressants  Newer agents include complement inhibitors and anti-FcRn mAbs, which must be administered chronically to maintain responses  Pathogenesis is similar across many autoimmune diseases;  involves attack on self by both T cells and B/plasma cells  9 

 Phase 2 study of Descartes-08 in MG (NCT04146051)  All doses observed to be safe and well-tolerated  10  Patient eligibility  MG-ADL > 6  MGFA Class II-IV  Stable medication dosing > 8 wks prior to infusion  4-week washout for biologics  IVIg and plasma exchange not allowed after starting Descartes-08  Patients on immunosuppression or complement inhibitors expected to be able to continue their treatment while receiving Descartes-08  Cell manufacturing platform tolerates most standard immunosuppressive therapies  Part 1 Identify safe dose  (n = 3)  Complete  Part 2 Determine optimal dosing schedule  (n = 11)  Complete1  Part 3 Phase 2b comparing Descartes-08 to placebo  (n = 30)  Enrolling  1 Continues to enroll patients with MuSK MG and subjects who are otherwise not eligible for Part 3 MG-ADL, Myasthenia Gravis Activities of Daily Living scale  MGFA, Myasthenia Gravis Foundation of America  Six weekly infusions led to observed deep, durable responses  Placebo-controlled trial for engineered adoptive cell therapy 

 ®  THERAPEUTICS  Phase 1/2a  study population comprises patients  with significant disease  Baseline MG-ADL mean score of 10  79% were MGFA Class III-IV at screening  All patients presented with disease that was not controlled with standard of care therapies  Volume 22, Issue 7, July 2023, Pages 578-590  11  Mean age, years (SD)  52 (18)  Female  10 (71%)  Male  4 (29%)  Mean weight, kg (SD)  84 (21)  Mean BMI, kg/m2 (SD)  31.6 (8.1)  Race and ethnicity  White, non-Hispanic  11 (79%)  White, Hispanic  1 (7%)  Asian  2 (14%)  MGFA class at screening  II  3 (21%)  III  10 (71%)  IV  1 (7%)  Median age of disease onset, years (range)  40 (14-79)  Median duration of disease, years (range)  14 (3-27)  Myasthenia gravis antibody status  Anti-AChR antibody  11 (79%)  Anti-MuSK antibody  2 (14%)  Seronegative (for AChR, MuSK, and LRP4 antibodies)  1 (7%)  Mean baseline scores (SD)  QMG  15.3 (4.1)  MG-ADL  10.0 (3.2)  MGC  21.9 (5.7)  MG-QoL-15r  19.9 (5.8)  Previous myasthenia gravis therapies (standard of care)  Pyridostigmine  14 (100%)  Prednisone  14 (100%)  Other immunosuppressants  14 (100%)  Eculizumab  2 (14%)  Rituximab  2 (14%)  Previous intravenous immunoglobin  12 (86%)  Previous plasma exchange  8 (57%)  Diagnosis of thymoma  0  Previous thymectomy  6 (43%)  Previous myasthenia gravis crisis requiring intubation  4 (29%)  Myasthenia gravis ongoing therapy  Pyridostigmine  11 (79%)  Prednisone  10 (71%)  Azathioprine  1 (7%)  Mycophenolate mofetil  1 (7%) 

 ®  THERAPEUTICS  Descartes-08  was observed to  be safe and  well-tolerated in MG  KEY OBSERVATIONS:  No dose-limiting toxicities  No cytokine release syndrome  No neurotoxicity  No pre-treatment chemotherapy and related cytopenias  Outpatient treatment  Volume 22, Issue 7, July 2023, Pages 578-590  12  Grade*  Part 1 (n=3)  Part 2: all groups (n=11)  Part 2:  group 1 (n=3)  Part 2:  group 2 (n=7)  Part 2:  group 3 (n=1)  Hand numbness  2  1 (33%)  0  0  0  0  Headache  1  1 (33%)  5 (45%)  1 (33%)  3 (43%)  1 (100%)  Muscle soreness  1  1 (33%)  1 (9%)  0  1 (14%)  0  Nausea  1  1 (33%)  4 (36%)  2 (67%)  2 (29%)  0  Rash  3  0  1 (9%)  1 (33%)  0  0  Itchy throat  1  0  2 (18%)  0  1 (14%)  1 (100%)  Vomiting  1  0  3 (27%)  2 (67%)  1 (14%)  0  Weakness  1  0  2 (18%)  2 (67%)  0  0  Line infiltration  1  0  1 (9%)  1 (33%)  0  0  Fever  1  0  4 (36%)  1 (33%)  3 (43%)  0  Shortness of breath1  1  0  2 (18%)  1 (33%)  1 (14%)  0  Chills  1  0  2 (18%)  1 (33%)  1 (14%)  0  Diarrhoea  1  0  1 (9%)  1 (33%)  1 (14%)  0  Gum inflammation  1  0  1 (9%)  0  1 (14%)  0  Teeth sensitivity  1  0  1 (9%)  0  1 (14%)  0  Night sweats  1  0  1 (9%)  0  1 (14%)  0  Restless leg  1  0  1 (9%)  0  1 (14%)  0  Light-headedness  1  0  1 (9%)  0  1 (14%)  0  *There were no adverse events of grade 3 or higher reported in part 1, and no grade 2 or grade 4 events reported in part 2, where grade 1 is mild, grade 2 is moderate, grade 3 is severe, and grade 4 is life-  threatening.  1Not associated with hypoxia 

 ®  THERAPEUTICS  Descartes-08 observed to  induce deep and  durable clinical  improvement in MG  Notable magnitude and duration of response across all 4 standard MG severity scales  Responses appear to deepen after completing treatment at Week 6  Positive twelve-month follow-up data from Phase 2a study reinforce prior findings published in Lancet Neurology  13  Manuscript submitted for peer review; pre-print available at medRxiv.org  Efficacy dataset includes all MG patients completing the 6-dose once-weekly regimen (n=7). Data are mean score improvement (point) and standard error (light blue shading). Note that QOL scale does not have an agreed-upon threshold for clinically meaningful disease improvement; MG-ADL, MGC and QMG scales are validated, quantitated, standardized instruments of disease severity and have been acceptable endpoints for registration studies. 

 Retreated patient experienced rapid improvement in clinical scores which was ongoing at Month 6 of retreatment follow-up with minimal symptom expression  14  Descartes-08 demonstrated durable depletion of autoantibodies and retreatment potential in MG  Lasting reductions in autoantibody titers are consistent with the observed clinical responses and mechanism of action 

 Informed Consent/Screening (Days -61 to -12)  Screening (Days -60 to -11)  Leukapheresis & Cell Processing (Days -59 to -10)  Descartes-08  (Day 1, 8, 15, 22, 29, 36)  Placebo  (Day 1, 8, 15, 22, 29, 36)  Follow up visits  Day 57 (± 7 days) Day 85* (± 7 days) Day 113 (± 7 days)  Month 6 (± 2 weeks)  Month 9 (± 2 weeks)  Month 12 (± 2 weeks)  Descartes-08  (Crossover Day 1, 8, 15, 22, 29, 36)  Follow up visits  Crossover Day 57 (± 7 days) Crossover Day 85* (± 7 days) Crossover Day 113 (± 7 days)  Crossover Month 6 (± 2 weeks)  Crossover Month 9 (± 2 weeks)  Crossover Month 12 (± 2 weeks)  Phase 2b randomized, placebo-controlled, double-masked study of Descartes-08 in MG  Enrollment underway, with top-line results expected in mid-2024  Plan to treat ~30 patients  PRIMARY ENDPOINT  Proportion of MG Composite responders (≥5-point reduction) at Day 85  SECONDARY OBJECTIVES  Safety and tolerability  Quantify clinical effect of Descartes-08 over 1 year  QMG, MG QoL 15R, MG ADL, and MG PIS  (change from baseline to Day 85)  Compare effect of Descartes-08 versus placebo on MG scales (change from baseline to Day 85) in patients who cross over from placebo to Descartes-08  15  Randomization  MG QMG, Quantitative MG Scores  MG QOL15R, MG Quality of Life 15-revised  MG ADL, MG Activities of Daily Living MG PIS, MG Post-intervention Status 

 Exploring potential of Descartes-08 in Systemic Lupus Erythematosus (SLE)  16  IND CLEARED  PHASE 2 STUDY ON TRACK FOR 1H 2024  Open-label study in up to 30 adults with moderate to severe multi-refractory SLE and no CNS involvement  Designed to assess safety, tolerability, and manufacturing feasibility of Descartes-08 in patients with SLE  Secondary objectives include standard measures of clinical activity in SLE:  Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K)  Physician Global Assessment (PGA)  Systemic Lupus Erythematosus Responder Index (SRI)  British Isles Lupus Assessment Group (BILAG)–based Composite Lupus Assessment (BICLA)  Screening (Days -60 to -15)  Leukapheresis & Cell Processing (Days -59 to -14)  2 - 3 Weeks  Descartes-08  (Day 1, 8, 15, 22, 29, 36)  Safety/Response Assessment  (Day 50)  Follow up visits  (Months 3, 6, 9, 12) 

 Exploring additional applications for Descartes-08 in autoantibody- associated autoimmune diseases (AAAD)  17  Potential significant Descartes-08-associated improvement observed in a patient with autoimmune retinitis (AIR)  61-year-old man with DPPX antibody-positive AIR, colitis, encephalitis refractory to prednisone, rituximab, bortezomib, IVIg; positive for 5/5 disease-associated autoantibodies pre-treatment  Post-treatment: experienced a clinically-significant, 2-line improvement in visual acuity; 3 of 5 autoantibodies became undetectable  Test  Pre-treatment  Month 2  Month 4  Month 6  Visual acuity  20/60  20/40  20/40  20/40  Carbonic anhydrase II Ab  +  -  -  NP*  Tubulin Ab  +  -  -  NP*  PKM2 Ab  +  -  -  NP*  Aldolase Ab  +  +  +  NP*  Enolase Ab  +  +  +  NP*  *NP – not performed  Clinical data suggest that Descartes-08 could lead to clinical benefit along with disappearance of disease-associated autoantibodies, suggesting potential in additional autoimmune indications  DPPX, , Dipeptidyl-peptidase–like protein 6 IVIg, Intravenous immunoglobulin 

 RNA Armory® example: Descartes-15, a next generation anti-BCMA mRNA CAR-T with >10x potency observed in preclinical studies  Potent killing (single target exposure)  Persistent killing (multiple exposures)  (1:2)  (1:8)  (1:32)  0  50  100  % Specific Killing  DC-15  DC-08  Vehicle EP  Descartes-15 Descartes-08 Control  (1:2)  (1:8)  (1:32)  0  100  50  % Specific Killing  DC-15  DC-08  Vehicle EP  Descartes-15 Descartes-08 Control  Descartes-15 is an anti-BCMA mRNA CAR-T with potential disruptive features:  Engineered for maximum potency and CAR stability, even in the presence of target-driven suppression of CAR  Clinical strategy expected to leverage safety and clinical activity data from Descartes-08  0  Day 0 Day 1 Day 2 Day 5 Day 7 Day 9  1000  2000  MFI  DC-15  DC-08  Vehicle EP  Control  Superior CAR expression  3000  Descartes-15  Descartes-08  Control  Descartes-15  0  2×108  4×108  6×108  8×108  Day 21  Total Flux (p/s)  Control  Descartes-15  Control  Descartes-15  0  1×107  2×107  3×107  Day 11  Total Flux (p/s)  Day 21  Day 11  Efficient killing of BCMA+ target cells1  Day 11  1 MM1-S disseminated myeloma model in NSG mice infused with either control T-cells or Descartes-15  18 

 ®  THERAPEUTICS  19  In-house manufacturing  enhances control  of product quality, production schedules and costs  cGMP Cell Manufacturing  ISO14644 certified aseptic facility with dedicated QMS  cGMP mRNA  Synthesis  Clinical grade mRNA production  Quality Control  Internal assay validation and lot release  MSC Cell Banking  Part 1271, FDA-  reviewed huMSC collection & banking  Process Development  Processes optimized  through >200 cGMP runs 

 Platform offers potential development opportunities via three modalities: autologous, allogeneic and in situ  20  Autologous mRNA CAR-T  Descartes-08  Descartes-15: next generation anti- BCMA mRNA CAR-T with >10x potency observed in clinical studies  Allogeneic mRNA MSC  Descartes-33  rLN: In situ lymph node transfection  Undisclosed program 

 Maturing pipeline offers potential for multiple catalysts  21  Descartes- 08 in MG  Descartes- 08 in SLE   Descartes- 08 Additional Indications   Descartes- 15   Expect to report Phase 2b data mid-2024  Plan to initiate Phase 2 in 1H 2024  Plan to initiate basket studies in additional autoimmune indications in 2H 2024  IND cleared, with first-in-human Phase 1 planning activities underway  Mid 2024  1H 2024  2H 2024  2024  Funding expected to support development of Descartes-08 through Phase 3 and advance additional programs 

 ®  THERAPEUTICS  Strong  Financial Position  Expected to Support  Pipeline  Through Key Milestones  <50 employees  Based in Gaithersburg, MD  Anticipated cash runway into  2H 2026  162M common 696M basic** Shares outstanding as of 12/31/23  ~$118M  Pro forma cash as of 12/31/23*  *Reflects the anticipated receipt of $40M through two delayed settlement payments previously announced as part of the November 2023 financing, which are expected in January 2024 and February 2024  **Reflects 534,261 shares of Series A Non-Voting Convertible Preferred stock outstanding, which are convertible into approximately 534.3 million shares of common stock. 

 ®  THERAPEUTICS  P I O NE E RI NG m RNA CE L L T HE RA P I E S   Pipeline designed to expand the reach of cell therapy to autoimmunity  M AT U RI N G PI PEL I NE W I T H EX PE C T E D N EAR - T E R M CAT AL YS T S  Validated lead program, Descartes-08, with Phase 2b data expected mid-year  CA S H RE S O UR C E S E X P E C T E D T O F U ND O P E R A T I O NS I NT O 2 H 2 0 2 6  Expected to support Descartes-08 through Phase 3 and advance additional programs  ®  THERAPEUTICS  EX PE R I E N C E D L EAD ER S H I P T EAM   Focused on disciplined investment and creating value for stockholders and patients 

EX-99.2

Exhibit 99.2

Cartesian Therapeutics Announces Positive Long-Term Follow-Up Data from Phase 2a Study of Lead mRNA Cell Therapy Candidate Descartes-08 in Patients with Myasthenia Gravis

Durable depletion of autoantibodies and clinically meaningful improvements in myasthenia gravis (MG) severity scores observed after one-year follow-up period without need for lymphodepleting chemotherapy

Descartes-08 observed to be well tolerated following administration in outpatient setting

Publication is in peer review and available on the preprint server, medRxiv

Topline data from Phase 2b placebo-controlled study continues to be expected in mid-2024

GAITHERSBURG, MD, January 8, 2024 (GLOBE NEWSWIRE) – Cartesian Therapeutics, Inc. (NASDAQ: RNAC), (“the Company”) a clinical-stage biotechnology company pioneering mRNA cell therapies for autoimmune diseases, today announced positive twelve-month follow-up data from its Phase 2a trial of Descartes-08 in patients with generalized myasthenia gravis (MG), a chronic autoimmune disorder that causes disabling muscle weakness and fatigue. The manuscript titled, “Twelve-Month Follow-Up of Patients With Generalized Myasthenia Gravis Receiving BCMA-Directed mRNA Cell Therapy”, has been submitted for peer-review and can be accessed on the online preprint server, medRxiv.

Descartes-08, Cartesian’s lead mRNA cell therapy candidate and a potential first-in-class mRNA-engineered chimeric antigen receptor T-cell therapy (mRNA CAR-T), is an autologous anti-B-cell maturation antigen (BCMA) mRNA CAR-T. In contrast to conventional DNA-based CAR T-cell therapies, mRNA CAR-T administration is designed to not require preconditioning chemotherapy and has been observed to have predictable and controllable pharmacokinetics that allow outpatient administration and is designed to avoid the risk of genomic integration and cancer transformation.

“The 12-month data build on the positive data reported earlier this year in The Lancet Neurology, underscoring the potential of Descartes-08 to drive deep and durable responses in patients with MG,” said Milos Miljkovic, M.D., Chief Medical Officer of Cartesian Therapeutics. “Notably, most patients maintained robust, clinically meaningful improvements across all four standard MG severity scores approximately 10 months after the last infusion. In addition, the lasting reductions in autoantibody titers are consistent with the observed clinical responses and the proposed mechanism of action for Descartes-08, supporting the deep and long-lasting effects observed in the study. As the first clinical trial using mRNA CAR-T to treat autoimmunity, the study also highlights the potential of our approach to expand the capabilities of cell therapy to address a variety of autoimmune diseases.”

The Company previously announced positive data from a Phase 1b/2a study of 14 patients with MG who received Descartes-08 in the outpatient setting and without lymphodepletion. In that dataset, Descartes-08 was observed to be safe and well-tolerated and was observed to induce deep and durable responses.

Data reported today are headlined by long-term results from all participants who received a once-weekly infusion for six weeks (N=7) during the Phase 2a portion of the study:

• Descartes-08 was infused in an outpatient setting without lymphodepleting chemotherapy. Throughout the study and long-term follow-up interval, Descartes-08 was well-tolerated, with no dose-limiting toxicities, cytokine release syndrome, or neurotoxicity.

• At Month 9 follow-up, all participants continued to experience marked and long-lasting clinical improvements across four validated MG disease scoring systems: MG Composite, MG Activities of Daily Living, Quantitative MG scores, and Quality of Life 15-revised. These assessments occurred approximately 7 months after the last Descartes-08 infusion, and no participants received new or increased MG-directed drugs during the study period.

• At Month 12, five of the seven participants maintained clinically meaningful improvement in the same four scoring systems. These assessments occurred approximately 10 months after the final Descartes-08 infusion.

• Two participants experienced loss of clinical effect at Month 12 and were eligible for retreatment. One participant was retreated, and experienced rapid improvement in clinical scores, which was ongoing at Month 6 of follow-up with minimal symptom expression.

• All three participants with detectable anti-acetylcholine receptor (AChR) antibody levels at baseline experienced marked anti-AChR antibody reductions by Month 6, which deepened further by Month 9, and were maintained at Month 12.

Enrollment is ongoing in a Phase 2b randomized, double-blind, placebo-controlled trial (NCT04146051) in patients with MG. Topline results are expected in mid-2024.

Descartes-08 has been granted Orphan Drug Designation by the U.S. Food and Drug Administration for the treatment of MG, and Investigational New Drug (IND) allowance to begin trials in patients with an additional autoimmune disease, lupus.

About Cartesian Therapeutics

Cartesian Therapeutics is a clinical-stage company pioneering mRNA cell therapies for the treatment of autoimmune diseases. The Company’s lead asset, Descartes-08, is a potential first-in-class mRNA CAR-T in Phase 2b clinical development for patients with generalized myasthenia gravis. Additional Phase 2 studies are planned in systemic lupus erythematosus under an allowed IND, as well as basket trials in additional autoimmune indications. The Company’s clinical-stage pipeline also includes Descartes-15, a next-generation, autologous anti-BCMA mRNA CAR-T. Cartesian operates a wholly owned, state-of-the-art cGMP manufacturing facility in Gaithersburg, MD.

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 potential of Descartes-08, Descartes-15, and the Company’s product pipeline to treat MG, ocular autoimmune diseases, vasculitic autoimmune diseases, 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 anticipated timing or outcome of selection of developmental product candidates, 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 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 RNA Armory® technology, potential delays in enrollment of patients, undesirable side effects of the Company’s product candidates, its 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 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.

# # #

Contact Information:

Investor Relations:

Melissa Forst

Argot Partners

cartesian@argotpartners.com

Media:

David Rosen

Argot Partners

cartesian@argotpartners.com

EX-99.3

Exhibit 99.3

Cartesian Therapeutics Highlights Progress and 2024 Strategic Priorities Across Innovative Pipeline of mRNA Cell Therapies for Autoimmunity

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

Positive 12-month follow-up data from Phase 2a study in MG reported today; durable depletion of autoantibodies and clinically meaningful improvements in MG severity scores observed approximately 10 months after last infusion

Phase 2 study of Descartes-08 in systemic lupus erythematosus expected to initiate in 1H24

Clinical pipeline expanded following recent IND clearance for Descartes-15, a next-generation mRNA CAR-T product candidate

Approximately $118M pro forma cash and cash equivalents as of December 31, 2023, expected to support planned operations into second half of 2026

GAITHERSBURG, MD, January 8, 2024 (GLOBE NEWSWIRE) – Cartesian Therapeutics, Inc. (NASDAQ: RNAC) (the “Company”), a clinical-stage biotechnology company pioneering mRNA cell therapy for autoimmune diseases, today highlighted its recent progress and outlined 2024 strategic priorities across its pipeline of mRNA cell therapy product candidates.

“Following a transformative 2023 for Cartesian, we believe we are well-positioned to execute on several potential value-driving milestones anticipated in the year ahead across our growing pipeline of internally manufactured, innovative mRNA cell therapy product candidates,” said Carsten Brunn, Ph.D., President and Chief Executive Officer of Cartesian. “Notably, we continue to expect topline data from the ongoing Phase 2b study of our lead asset, Descartes-08, in patients with myasthenia gravis (MG) in the middle of 2024, which, supported by positive data from the Phase 2a portion of the study, we firmly believe could serve as a meaningful treatment option for patients with MG. We continue to expect the initiation of our Phase 2 study of Descartes-08 in patients with systemic lupus erythematosus (SLE) in the first half of 2024.”

Dr. Brunn added, “Beyond Descartes-08, we are also excited to announce that the U.S. Food and Drug Administration (FDA) recently cleared our investigational new drug (IND) application for Descartes-15, a next-generation mRNA-engineered chimeric antigen receptor T-cell therapy (mRNA CAR-T). We are steadfast in our commitment to delivering meaningful new therapies to patients with autoimmune diseases in areas of high unmet need and look forward to continuing to advance this mission in the coming year.”

Program Updates and Anticipated 2024 Milestones

Cartesian’s internally manufactured portfolio of mRNA cell therapies are purposefully designed to be administered conveniently in an outpatient setting. The Company’s RNA-engineering approach is designed to expand the reach of cell therapy to autoimmunity with potent therapies that can be dosed more reliably and safely in an outpatient setting without lymphodepletion. Cartesian’s proprietary technology platform, RNA Armory®, is designed to enable precision control and optimization of engineered cells for diverse cell therapies leveraging multiple modalities, including autologous, allogeneic, and in situ transfection.

Descartes-08

Descartes-08 is an autologous anti-B cell maturation antigen (BCMA) mRNA CAR-T. Compared to conventional DNA-based CAR T-cell therapies, mRNA CAR-T is designed not to require preconditioning chemotherapy, has been observed to have predictable and controllable pharmacokinetics, and is designed to avoid the risk of genomic integration. Descartes-08 has been granted Orphan Drug Designation by the U.S. FDA for the treatment of MG, a chronic autoimmune disorder that causes disabling muscle weakness and fatigue.

• Enrollment remains ongoing in the Company’s Phase 2b randomized, double-blind, placebo-controlled trial of Descartes-08 in patients with MG (NCT04146051), with topline results expected in mid-2024. In the open label Phase 2a portion of the study, Descartes-08 was administered in an outpatient setting without preconditioning chemotherapy. The drug was observed to be safe, well tolerated, and appeared to lead to deep, durable clinical responses. These results were published earlier this year in The Lancet Neurology.

• In a separate press release issued today, the Company announced positive twelve-month follow-up data from the Phase 2a portion of the Descartes-08 trial in patients with MG.In the study, five out of seven patients maintained clinically meaningful improvements across all four standard MG severity scores approximately 10 months after the last infusion.  In addition, all three participants with detectable anti-acetylcholine receptor antibody levels at baseline experienced durable depletion of autoantibodies through the one-year follow-up period.  Descartes-08 was observed to be well-tolerated, with no dose-limiting toxicities, cytokine release syndrome, or neurotoxicity.

• The Company remains on track to initiate a Phase 2 study of Descartes-08 in patients with SLE (NCT06038474) in the first half of 2024. SLE is an incurable autoimmune disease marked by systemic inflammation that affects multiple organ systems. It impacts approximately 1.5 million people in the United States. The Phase 2 study, for which the Company has received IND clearance, is designed to assess the safety and tolerability of outpatient Descartes-08 administration without preconditioning chemotherapy.

• Cartesian continues to anticipate the initiation of Phase 2 basket studies in additional autoimmune indications in the second half of 2024. The studies are designed to assess the safety and tolerability of outpatient Descartes-08 administration without preconditioning chemotherapy.

Descartes-15

Descartes-15 is a next-generation, autologous anti-BCMA mRNA CAR-T. In preclinical studies, Descartes-15 was observed to be significantly more potent than Descartes-08. As with Descartes-08, Descartes-15 is designed not to require preconditioning chemotherapy, has been observed to have predictable and controllable pharmacokinetics and is designed to avoid the risk of genomic integration.

• The Company today announced that the U.S. FDA has cleared its IND application for Descartes-15.  Planning for a first-in-human Phase 1 dose escalation study is underway. The study will be designed to assess the safety and tolerability of outpatient Descartes-15 administration in patients with multiple myeloma. The Company expects to subsequently assess Descartes-15 in autoimmune indications.

Financial Update

Cartesian ended 2023 with a pro forma cash position of approximately $118 million, which reflects the anticipated receipt of $40 million through two delayed settlement payments previously announced as part of the November 2023 financing, which are expected later this month and in February 2024. The Company’s current pro forma cash balance is expected to support planned operations and the development of Cartesian’s pipeline into the second half of 2026, through the Phase 3 study of lead candidate Descartes-08. As of December 31, 2023, the Company had 161.9 million shares of common stock outstanding and 534,261 shares of Series A Non-Voting Convertible Preferred Stock outstanding, which are convertible into approximately 534.3 million shares of common stock.

About Cartesian Therapeutics

Cartesian Therapeutics is a clinical-stage company pioneering mRNA cell therapies for the treatment of autoimmune diseases. The Company’s lead asset, Descartes-08, is a potential first-in-class mRNA CAR-T in Phase 2b clinical development for patients with generalized myasthenia gravis. Additional Phase 2 studies are planned in systemic lupus erythematosus under an allowed IND, as well as basket trials in additional autoimmune indications. The Company’s clinical-stage pipeline also includes Descartes-15, a next-generation, autologous anti-BCMA mRNA CAR-T. Cartesian operates a wholly owned, state-of-the-art cGMP manufacturing facility in Gaithersburg, MD.

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 Company’s estimated cash on hand, the expected receipt of proceeds from the Company’s November 2023 private placement, conversion of the Company’s Series A Non-Voting Convertible Preferred Stock, the potential of RNA Armory® to enable precision control and optimization of engineered cells for diverse cell therapies leveraging multiple modalities, the potential of Descartes-08, Descartes-15, Descartes-33 and the Company’s other product candidates to treat myasthenia gravis, systemic lupus erythematosus, 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 anticipated timing or outcome of selection of developmental product candidates, the ability of the Company to consummate any expected agreements and licenses and to realize the anticipated benefits thereof, 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, the Company’s ability to enter into and maintain its strategic partnerships, 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 RNA Armory® technology, potential delays in enrollment of patients, undesirable side effects of the Company’s product candidates, its 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 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.

# # #

Contact Information:

Investor Relations:

Melissa Forst

Argot Partners

cartesian@argotpartners.com

Media:

David Rosen

Argot Partners

cartesian@argotpartners.com

XML

Document and Entity Information	Jan. 08, 2024
Cover [Abstract]
Document Type	8-K
Amendment Flag	false
Document Period End Date	Jan. 08, 2024
Entity File Number	001-37798
Entity Registrant Name	Cartesian Therapeutics, Inc.
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Entity Incorporation, State or Country Code	DE
Entity Tax Identification Number	26-1622110
Entity Address, Address Line One	704 Quince Orchard Road
Entity Address, City or Town	Gaithersburg
Entity Address, State or Province	MA
Entity Address, Postal Zip Code	20878
City Area Code	617
Local Phone Number	923-1400
Title of 12(b) Security	Common Stock (Par Value $0.0001)
Trading Symbol	RNAC
Security Exchange Name	NASDAQ
Entity Emerging Growth Company	false
Written Communications	false
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