Cartesian Therapeutics, Inc. · NASDAQ:RNAC
Cartesian Therapeutics — Selecta Biosciences — Merger or Acquisition (November 2023)
34 slides from Cartesian Therapeutics's merger presentation, Nov 13, 2023
Slide 1: Cartesian Therapeutics and Selecta Biosciences
Cartesian °< } Selecta. aie O° Biosciences
Slide 2: Disclosures
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 Selecta Biosciences, Inc. (“Selecta”) and Cartesian Therapeutics, Inc. (“Cartesian”) or any person on their beha
Slide 3: No Offer or Solicitation; Important Information About the Proposed Merger
No Offer or Solicitation; Important Information About the Proposed Merger and Where to Find It This presentation is not a proxy statement or solicitation of a proxy, consent or authorization with respect to any securities or in respect of the Proposed Merger and shall not constitute an offer to sell
Slide 4: Selecta and Cartesian merger to create publicly traded RNA cell therapy company
Selecta and Cartesian merger to create publicly traded company pioneering RNA cell therapy to treat autoimmune disease Pro forma cash resources expected to fund continued clinical development of Descartes-08 through Phase 3 and multiple additional clinical programs Cartesian Opportunity Leader in RN
Slide 5: Deal Overview
Planning to announce sign and close of Selecta/Cartesian stock for stock Merger on or about Nov 13, 2023 Selecta to issue < 20% of voting common stock plus non-voting convertible securities as consideration Conversion of convertible securities to be subject to stockholder vote post-close Relative ow
Slide 6: Cartesian – Clinical-stage company pioneering RNA cell therapy for autoimmunity
Cartesian – Clinical-stage company pioneering RNA cell therapy for autoimmunity Expanding the Reach and Potential of Cell Therapy RNA cell therapies do not require lymphodepletion Designed to be dosed more reliably and repeatedly at safe therapeutic doses versus DNA analogs Promising Lead Asset Desc
Slide 7: Combined organization overview
Combined organization overview 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 Murat Kalayoglu, MD, PhD Director Cartesian Co-Founder and pre-merger CEO Carrie S.
Slide 8: DNA-engineered cell therapy effector function amplifies with cell replication
Effector function of cell therapy engineered with DNA amplifies exponentially with cell replication, frequently leading to uncontrollable PK/PD Cells administered at subtherapeutic levels quickly proliferate beyond therapeutic window Conventional engineered cell therapy uses DNA, which can lead to t
Slide 9: Limited experience with DNA CAR-T in autoimmunity shows significant toxicity
Limited experience with DNA CAR-T in autoimmunity shows significant toxicity that can be incompatible with outpatient treatment DNA CAR-T in neuromyelitis optica1 12 of 12 patients with Grade 3-4 cytopenias 12 of 12 patients with CRS 7 of 12 patients with Grade ≥3 infections DNA CAR-T in systemic lu
Slide 10: mRNA does not replicate, giving predictable half-life and controllable PK/PD
mRNA does not replicate à predictable half-life with more controllable PK/PD defined by the dose No requirement for cell proliferation à no expected need for pre-treatment chemo à no Grade 3-4 cytopenias Cartesian’s RNA approach designed to expand reach of cell therapy to autoimmunity with safer, po
Slide 11: Wholly-owned pipeline targets autoimmune disease
Wholly-owned pipeline targets autoimmune disease AAAD, autoantibody-associated autoimmune diseasesSLE, Systemic Lupus Erythematosus rMSC, Mesenchymal Stem Cells transfected with mRNALN, Lymph node Asset Indications Discovery/ Preclinical Phase 1 Phase 2 Pivotal Descartes-08 Autologous rCAR-T Myasthe
Slide 12: In-house manufacturing enhances control of quality, schedules and costs
In-house manufacturing enhances control of product quality, production schedules and costs cGMP Cell Manufacturing State-of-the-art facility with dedicated QMS cGMP RNA Synthesis Large-scale RNA production MSC Cell Banking Part 1271, FDA-reviewed huMSC collection & banking Process Development Proces
Slide 13: Initial indication for Descartes-08: Myasthenia gravis
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
Slide 14: Descartes-08 is believed to be the first rCAR-T in autoimmune disease
Descartes-08 is believed to be the first rCAR-T in clinical development for autoimmune disease Descartes-08 Engineered by transfection of autologous CD8+ T cells with mRNA encoding anti-BCMA CAR Typical lot processed for infusion within ~3 weeks Observed to enhance killing and suppression of inflamm
Slide 15: CAR-T in autoimmunity offers differentiated, multi-modal mechanism of action
CAR-T in autoimmunity offers differentiated, multi-modal mechanism of action FcRn Inhibitors Complement Inhibitors Reduces complement Reduces autoantibody CAR-T Cells Designed to: Reduce target cell populations (BCMA+ or B cells) Reduce plasma cell ligands (Descartes-08 only) Reduce autoantibody Red
Slide 16: Phase 2 study of Descartes-08 in MG
Phase 2 study of Descartes-08 in MG (NCT04146051) Part 1: Identify safe dose (n = 3) Complete Part 2: Determine optimal dosing schedule (n = 12) Complete1 Part 3: Phase 2b comparing Descartes-08 to placebo (n = 30) Enrolling All doses safe and well-tolerated Six weekly infusions led to deep, durable
Slide 17: Phase 2a study population comprises patients with significant disease
Phase 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 well-managed under standard of care therapies
Slide 18: Descartes-08 observed to induce deep and durable clinical improvement in MG
Descartes-08 observed to induce deep and durable clinical improvement in MG Efficacy dataset includes all MG patients completing the 6-dose regimen (n=10). Data are mean score improvement (point) and standard error (light blue shading). Note that QOL scale does not have an agreed-upon threshold for
Slide 19: Descartes-08 was observed to be safe and well-tolerated in MG
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 chemo, so no induced hematological toxicities Outpatient treatment
Slide 20: Phase 2a case study: sustained clinical response for >1 year
Phase 2a case study: sustained dramatic clinical response for >1 year Treatment Clinical benefit sustained for >1 year Descartes-08 course
Slide 21: Phase 2a case study: re-treatment restores response
Phase 2a case study: re-treatment at 1 year restores dramatic response First treatment Clinical benefit sustained for ~1 year Re-treatment First Descartes-08 course (6 weeks) Second Descartes-08 course (6 weeks)
Slide 22: Reduction in pro-inflammatory cytokines
Reduction in pro-inflammatory cytokines Phase 2a data show potential of Descartes-08 treatment to transform the immunologic autoimmune environment Cytokine levels correlate with symptom severity Post-infusion changes in T cell repertoire Proportion of all clonotypes ⃝ = Product rearrangement
Slide 23: Phase 2b randomized, placebo-controlled study of Descartes-08 in MG
Plan to treat ~30 patients Primary endpoint Proportion of MG ADL responders (≥6-point reduction) at Day 85 Secondary objectives Safety and tolerability Quantify clinical effect of Descartes-08 over 1 year QMG, MG QoL 15R, MG Composite, and MG PIS (change from baseline to Day 85) Compare effect of De
Slide 24: Exploring additional applications for Descartes-08 in autoimmune diseases
Exploring additional applications for Descartes-08 in autoantibody-associated autoimmune diseases 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-treatm
Slide 25: RNA Armory: proprietary technology and manufacturing platform
Proprietary technology and manufacturing platform, RNA Armory®: Designed for precision control and optimization of engineered cells for diverse cell therapies Select and combine constructs In-house RNA inventory Optimize RNA for max expression and stability Indication-specific designs Optimized RNA
Slide 26: Platform offers three modalities: autologous, allogeneic and in situ
Platform offers potential development opportunities via three modalities: autologous, allogeneic and in situ rCAR-T: Autologous RNA cell therapy rMSC: Allogeneic RNA cell therapy rLN: In vivo lymph node transfection Descartes-08 Descartes-15: next generation anti-BCMA rCAR-T with >10x potency Undisc
Slide 27: Descartes-15 is an anti-BCMA CAR with disruptive features
Descartes-15 is an anti-BCMA CAR with disruptive features: Engineered for maximum potency and CAR stability, even in the presence of target-driven suppression of CAR Clinical strategy expected to leverage strong safety and efficacy data from Descartes-08 RNA Armory® example: Descartes-15, a next gen
Slide 28: Platform for off-the-shelf RNA cell therapy
Platform for off-the-shelf RNA cell therapy RNA Armory® example: allogeneic RNA stem cell therapies (rMSC) rMSCs engineered for potent degradation of disease-enabling NETs rMSCs engraft and function without alloreactive clearance in patients DNA degradation NET degradation
Slide 29: Advanced R&D infrastructure to support pipeline
Advanced R&D infrastructure to support pipeline Discovery and Preclinical Clinical 4. Support trial design & MoA Week 8 Screening 1. Engineer RNA constructs 3. Enhance CAR cell features 2. Tune construct delivery TCR/BCR sequencing Single cell gene expression Multiplexing cytokine profiling Example:
Slide 30: Considerable regulatory, manufacturing, and clinical operations experience
Considerable regulatory, manufacturing, and clinical operations experience Regulatory 6 RNA cell therapy INDs allowed in the past 5 years Indications Autoimmune diseases Cancer Respiratory disease Products Autologous T-cells Off-the-shelf MSCs Cells engineered with up to 3 RNAs Clinical Operations I
Slide 31: Products and platform supported by a strong IP portfolio
Products and platform are supported by a strong IP portfolio Composition-of-Matter IP Wholly Owned by Cartesian US and ROW patents issued and pending on target-binding proteins Other pending applications covering assets in development Coverage through 2039 or later plus PTE/PTA where applicable Mult
Slide 32: Funding to support development of Descartes-08 through Phase 3
Funding to support development of Descartes-08 through Phase 3 and advance additional programs Anticipate >$100 million at close, including proceeds from potential PIPE financing Maturing pipeline offers potential for multiple value creating events Descartes-08 in MG Expect to report Phase 2b data m
Slide 33: Selecta and Cartesian merger to create publicly traded RNA cell therapy company
Selecta and Cartesian merger to create publicly traded company pioneering RNA cell therapy to treat autoimmune disease Pro forma cash resources expected to fund continued clinical development of Descartes-08 through Phase 3 and multiple additional clinical programs Cartesian Opportunity Leader in RN
Slide 34: Cartesian Therapeutics and Selecta Biosciences
Cartesian °< } Selecta. aie O° Biosciences
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