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Disclaimer The following presentation, including any printed or electronic copy of these slides, the talks given by the presenters, the information communicated during any delivery of the presentation and any question an

Key Takeaway: Cabaletta Bio, Inc. provided a corporate presentation outlining its business strategies and forward-looking statements related to their CAAR T and CARTA technologies. The presentation details their ongoing clinical trials and potential benefits for patients suffering from autoimmune diseases. However, it also cautions about numerous risks and uncertainties associated with drug development and regulatory approvals. The company emphasizes that actual results may differ from expectations due to various factors, including the impact of the COVID-19 pandemic.

Market Sentiment Analysis

POSITIVE FACTORS

  • Cabaletta Bio is actively preparing for future drug applications and clinical trials.
  • The company has established partnerships that may enhance their research and development capabilities.
  • Potential improvements in patient outcomes for autoimmune diseases are being explored.

CONCERNS & RISKS

  • The presentation includes numerous forward-looking statements that carry substantial risks and uncertainties.
  • There is a risk that clinical trial results may not predict future success.
  • COVID-19 and other external factors could impact trial timelines and operations.

Full Press Release Details

Corporate Presentation march 2023
Disclaimer The following presentation,
including any printed or electronic copy of these slides, the talks given by the presenters, the information communicated during any delivery of the presentation and any question and answer session and any document or material distributed at or in
connection with the presentation (collectively, the "Presentation") has been prepared by Cabaletta Bio, Inc. ("we," "us," "our," "Cabaletta" or the "Company") and is made for
informational purposes only. This Presentation does not purport to be a prospectus, to be complete or to contain all of the information you may desire. Statements contained herein are made as of the date of this Presentation unless stated otherwise,
and this Presentation shall not under any circumstances create an implication that the information contained herein is correct as of any time after such date or that information will be updated or revised to reflect information that subsequently
becomes available or changes occurring after the date hereof. This Presentation may contain "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995 relating to our business, operations, and
financial conditions, and include, but are not limited to, express or implied statements regarding our current beliefs, expectations and assumptions regarding: our business, future plans and strategies for our CAAR T and CARTA technologies and
CABA platform; our ability to grow its autoimmune-focused pipeline; the ability to capitalize on and potential benefits resulting from the translational research partnership with Professor Georg Schett and the exclusive license agreement with
IASO Bio; the timing of our expected clearance of an Investigational New Drug application (IND) for CABA-201 to the U.S. Food and Drug Administration as well as other planned regulatory filings for our development programs; the progress and results
of our DesCAARTes Phase 1 trial, including the significance and impact around reported safety and clinical and translational data of cohorts from our DesCAARTes trial; the therapeutic potential and clinical benefits of our product
candidates; the expectation that Cabaletta may improve outcomes for patients suffering from mucosal pemphigus vulgaris, myasthenia gravis, or other autoimmune diseases; our ability to escalate dosing as high as 10 to 15 billion cells in cohort A6m,
initiate dosing in a combination cohort or otherwise; our ability to implement a pre-treatment regimen and the potential ability to enhance in vivo DSG3-CAART exposure; our ability to advance dose escalation in the DesCAARTes Phase 1 trial at
the current dose ranges for the current cohorts and any projected potential dose ranges for future cohorts, and to optimize our targeted cell therapy; our ability to evaluate, and the potential significance of, the relationship between DSG3-CAART
persistence and potential clinical responses in patients with mPV; our ability to safely retreat additional patients and whether we will continue to observe a lack of immune-mediated clearance of DSG3-CAART cells after retreatment and repeat dosing
of patients; our ability to successfully complete our preclinical and clinical studies for our product candidates, including CABA-201, our ongoing Phase 1 DesCAARTes trial, and our ongoing Phase 1 MusCAARTes trial of MuSK-CAART,
including our ability to enroll the requisite number of patients, dose each dosing cohort in the intended manner, and progress the trial; the ability of MuSK-CAART to target B cells that differentiate into antibody secreting cells, which produce
autoantibodies against muscle-specific kinase; our ability to obtain and maintain regulatory approval of our product candidates, including our expectations regarding the intended incentives conferred by and ability to retain Orphan Drug Designation
and Fast Track Designation for DSG3-CAART for the treatment of pemphigus vulgaris and Orphan Drug Designation and Fast Track Designation for MuSK-CAART to improve activities of daily living and muscle strength in patients with MuSK antibody-positive
myasthenia gravis; the further expansion and development of our modular CABA platform across a range of autoimmune diseases; our ability to contract with third-party suppliers and manufacturers, implement an enhanced manufacturing process and
further develop our internal manufacturing strategy, capabilities and facilities; our potential commercial opportunities, including value and addressable market, for our product candidates; our expectations regarding our use of capital and other
financial results; and our ability to fund operations into the first quarter of 2025. Words such as, but not limited to, "look forward to," "believe," "expect," "anticipate," "estimate,"
"intend," "plan," "would," "should" and "could," and similar expressions or words, identify forward-looking statements. Various risks, uncertainties and assumptions could cause actual
results to differ materially from those anticipated or implied in our forward-looking statements. Such risks and uncertainties include, but are not limited to, risks related to the success, cost, and timing of our product candidate development
activities and preclinical studies and clinical trials, risks related to our ability to demonstrate sufficient evidence of safety, efficacy and tolerability in our preclinical studies and clinical trials of CABA-201, DSG3-CAART and MuSK-CAART, the
risk that the results observed with the similarly-designed construct employed in the recent Nature Medicine publication are not indicative of the results we seek to achieve with CABA-201, our plans to evaluate additional cohorts in the
DesCAARTes trial, including a cohort implementing a pre-treatment regimen, the risk that signs of biologic activity or persistence may not inform long-term results, the risk that persistence observed with effective CART-19 oncology studies in
combination with lymphodepletion is not indicative of, or applicable to, clinical responses in patients with mPV, risks related to clinical trial site activation or enrollment rates that are lower than expected, our ability to protect and maintain
our intellectual property position, risks related to our relationship with third parties, uncertainties related to regulatory agencies' evaluation of regulatory filings and other information related to our product candidates, our ability to
retain and recognize the intended incentives conferred by any Orphan Drug Designation and Fast Track Designations, the risk that any one or more of our product candidates will not be successfully developed and commercialized, the risk that the
results of preclinical studies or clinical studies will not be predictive of future results in connection with future studies, the impact of COVID-19 on the timing, progress, interpretability of data, and results of ongoing or planned clinical
trials and risks relating to as a result of extraordinary events or circumstances such as the COVID-19 pandemic, and any business interruptions to our operations or to those of our clinical sites, manufacturers, suppliers, or other vendors resulting
from the COVID-19 pandemic or similar public health crisis. New risks and uncertainties may emerge from time to time, and it is not possible to predict all risks and uncertainties. Except as required by applicable law, we do not plan to publicly
update or revise any forward-looking statements contained herein, whether as a result of any new information, future events, changed circumstances or otherwise. Although we believe the expectations reflected in such forward-looking statements are
reasonable, we can give no assurance that such expectations will prove to be correct. Accordingly, you are cautioned not to place undue reliance on these forward-looking statements. No representations or warranties (expressed or implied) are made
about the accuracy of any such forward-looking statements. For a discussion of these and other risks and uncertainties, and other important factors, any of which could cause our actual results to differ materially from those contained in the
forward-looking statements, see the section entitled "Risk Factors" in our most recent annual report on Form 10-K, as well as discussions of potential risks, uncertainties, and other important factors in our other filings with the Securities and
Exchange Commission. Certain information contained in this Presentation relates to or is based on studies, publications, surveys and other data obtained from third-party sources and the Company's own internal estimates and research. While the
Company believes these third-party sources to be reliable as of the date of this Presentation, it has not independently verified, and makes no representation as to the adequacy, fairness, accuracy or completeness of, any information obtained from
third-party sources. The Company is the owner of various trademarks, trade names and service marks. Certain other trademarks, trade names and service marks appearing in this Presentation are the property of third parties. Solely for convenience, the
trademarks and trade names in this Presentation are referred to without the and TM symbols, but such references should not be construed as any indicator that their respective owners will not assert, to the fullest extent under applicable law,
their rights thereto.
Develop and launch the first curative
targeted cellular therapies for patients with autoimmune diseases
Experienced team uniquely positioned to
efficiently advance CABA-201 in a range of autoimmune diseases Cabaletta : Pursuing cures for a broad range of autoimmune diseases CAART - Chimeric AutoAntibody Receptor T cells; CARTA - Chimeric Antigen Receptor T cells for
Autoimmunity; IND - Investigational New Drug; SLE - Systemic lupus erythematosus; RA - Rheumatoid arthritis Subject to and pending clearance of CABA-201 IND by the FDA. Mackensen, Andreas, et al. "Anti-CD19 CAR T cell therapy for
refractory systemic lupus erythematosus." Nature Medicine (2022): 1-9. M ller, Fabian, et al. "CD19-targeted CAR T cells in refractory antisynthetase syndrome." The Lancet (2023). Dai, Zhenyu, et al. "Development and functional characterization
of novel fully human anti CD19 CARs for T cell therapy." Journal of Cellular Physiology 236.8 (2021): 5832-5847. Assumes no dose-limiting toxicities are observed in the cohort and uninterrupted enrollment occur in the trials. Builds on
academic clinical data2,3 revealing potential for CD19-CAR T to reset immune system in refractory autoimmune patients Exclusive translational research partnership with lead investigator2,3 providing early & actionable insights for CABA-201
CABA-201 has been specifically engineered for patients with autoimmune diseases Including the same 4-1BB costimulatory domain and similar CD19 binder affinity4 as used in the academic SLE2 & myositis studies3 Fully human CD19 binder in CABA-201
with a favorable clinical tolerability profile in ~20 oncology patients Potential to cure a broad range of autoimmune diseases where B cells have a role initiating or maintaining disease DesCAARTes trial in mucosal pemphigus vulgaris -
1 month safety & persistence data anticipated 1H235 Enrolling in combination sub-study using pre-treatment with IVIg & cyclophosphamide MusCAARTes trial in MuSK myasthenia gravis - leveraging insights from autoimmune experience
with DSG3-CAART Initiated in 4Q22; received FDA Fast Track Designation & Orphan Drug Designation CARTA Strategy | CABA-201 (4-1BB CD19-CAR T) expecting 1H23 IND clearance1 CAART Strategy | DSG3-CAART & MuSK-CAART clinical studies evaluating
combination regimens Initial CABA-201 clinical data1 and 6-month combination data from CAART trials expected by 1H245
One CABA platform, two
strategies to address autoimmune diseases Complementary strategies to optimize clinical outcomes using cellular therapies in autoimmune diseases Mackensen, Andreas, et al. "Anti-CD19 CAR T cell therapy for refractory systemic lupus erythematosus."
Nature Medicine (2022): 1-9. Ellebrecht, Christoph T., et al. "Reengineering chimeric antigen receptor T cells for targeted therapy of autoimmune disease." Science 353.6295 (2016): 179-184. Fully Human Anti-CD19 Targeting Domain CARTA
Chimeric Antigen Receptor T cells for Autoimmunity CAART Chimeric AutoAntibody Receptor T cells CABA-201 4-1BB Costimulatory Domain & CD3-Zeta Signaling Domain DSG3-CAART Potential to reset the immune system' in patients with
autoimmune diseases driven by B cells, through generalized transient B cell depletion and repopulation of healthy B cells1 In autoimmune diseases with a limited number of well-defined pathogenic autoantibodies, permanent antigen-specific B cell
depletion may provide an elegant biologic solution to disease2 Autoantigen Targeting Domain 4-1BB Costimulatory Domain & CD3-Zeta Signaling Domain
Biologic opportunity for cure or
treatment may be possible in dozens of autoimmune diseases* CABA platform may apply across a range of autoimmune diseases Pemphigus Vulgaris1,2,3 Pemphigus Foliaceus1,2,3 Epidermolysis Bullosa Acquisita3 Bullous Pemphigoid1,2,3 Lupus
Nephritis3,4 Membranous Nephropathy1,2,3 Goodpasture's Syndrome1,2,3,4 Myasthenia Gravis1,2,3,5 Multiple Sclerosis6 Neuromyelitis Optica3 Chronic Inflammatory Demyelinating Polyneuropathy1.2 Anti-NMDAR Encephalitis3,6 Lambert-Eaton Syndrome5
Systemic Lupus Erythematosus3,4,5,6 Rheumatoid Arthritis2,3,4 Myositis5 Systemic sclerosis6 ANCA-Associated Vasculitis3,4,5 Immune Thrombocytopenic Purpura3 Thrombotic Thrombocytopenic Purpura1,2,3 Antiphospholipid Syndrome4,5 Autoimmune Hemolytic
Anemia3 Type 1 Diabetes3,6 Graves' Disease3,5 Hashimoto's Disease5 Illustrative list of autoimmune diseases where B cells may play a role in initiating or maintaining disease, and where biologic opportunity for cure or treatment with
CAART or CARTA approach may be possible. Diseases in bold represent where clinical studies are underway or plan to be initiated by Cabaletta or by Professor Schett Koneczny, Inga. "Update on IgG4-mediated autoimmune diseases: new insights and new
family members." Autoimmunity Reviews (2020): 102646. Huijbers, Maartje G., et al. "IgG4-mediated autoimmune diseases: a niche of antibody-mediated disorders." Annals of the New York Academy of Sciences 1413.1 (2018): 92. Ludwig, Ralf J., et al.
"Mechanisms of autoantibody-induced pathology." Frontiers in immunology 8 (2017): 603. Suurmond, Jolien, and Betty Diamond. "Autoantibodies in systemic autoimmune diseases: specificity and pathogenicity." The Journal of clinical investigation 125.6
(2015): 2194-2202. Xiao, Ze Xiu, Joseph S. Miller, and Song Guo Zheng. "An updated advance of autoantibodies in autoimmune diseases." Autoimmunity Reviews (2020): 102743. Hampe, Christiane S. "B cells in autoimmune diseases." Scientifica 2012
(2012). Dermatology Nephrology Neurology Rheumatology Hematology Endocrinology
Pipeline targeting autoimmune diseases
where cure is possible Additional disease targets in discovery stage in our CAART pipeline portfolio include hemophilia and two undisclosed indications. CABA Platform Indication Program Discovery Preclinical Phase 1 Phase 2/3 CARTA Chimeric
Antigen Receptor T cells for Autoimmunity Multiple Undisclosed Indications CABA-201 4-1BB CD19-CAR T CAART1 Chimeric AutoAntibody Receptor T cells Mucosal Pemphigus Vulgaris DSG3-CAART MuSK Myasthenia Gravis MuSK-CAART PLA2R Membranous Nephropathy
PLA2R-CAART Mucocutaneous Pemphigus Vulgaris DSG3/1-CAART
Chimeric Antigen Receptor T Cells for
Autoimmunity CABA-201
SLE - Systemic lupus
erythematosus; ASyS - Anti-synthetase syndrome; scFv - Single chain variable fragment; SLEDAI-2K - Systemic Lupus Erythematosus Disease Activity Index 2000; CRS - Cytokine release syndrome; ICANS - Immune effector
cell-associated neurotoxicity syndrome; Anti-dsDNA Abs - Anti-double-stranded deoxyribonucleic acid antibodies Mackensen, Andreas, et al. "Anti-CD19 CAR T cell therapy for refractory systemic lupus erythematosus." Nature Medicine (2022): 1-9.
M ller, Fabian, et al. "CD19-targeted CAR T cells in refractory antisynthetase syndrome." The Lancet (2023). The construct utilized in this study has a similar design to CABA-201, sharing the 4-1BB costimulatory domain, but is a different
construct. Exclusive translational research partnership with lead investigator informing our CD19 clinical strategy Academic data: Immune system reset in SLE & myositis patients1,2 5/5 SLE patients Anti-dsDNA Abs undetectable Complement levels
normalized Myositis patient (antisynthetase syndrome): Creatinine kinase dropped to normal Durable clinical responses1,2 5-17 months of follow up Off other immunosuppressive medications CAR T cells CD19+ B cells White blood count Patient 1
Patient 2 Patient 3 Patient 4 Patient 5 Days Days Days Cells/microliter N/microliter Promising safety data1,2 Grade 1 CRS (fever) in 4/6 patients No ICANS of any grade 4-1BB CD19-CAR T3 resulted in rapid, deep & transient CD19+ B cell depletion
1x106 cells/kg preceded by standard Flu/Cy regimen CD19 binder (FMC63 scFv) & 4-1BB costim domain3 Clinical & serologic responses within 3 mo. of CD19-CAR T therapy in refractory patients with SLE1 & patient with myositis2 Repopulation
of healthy B cells1,2 New B cells in 6/6 patients in 2-5 months Limited decline in vaccination titers Rapid & robust improvement in clinical disease activity Normalization of serum markers of disease SLE (N=5) SLEDAI-2K Myositis (N=1) Total
Cabaletta's CD19 binder with
similar in vitro & in vivo activity to FMC631 (binder used in academic studies2,3) CABA-201: CD19-targeting CAR T therapy for autoimmune diseases SLE - Systemic lupus erythematosus; IIT - Investigator-initiated trial; Flu/Cy -
Fludarabine/Cyclophosphamide; CRS - Cytokine release syndrome; ICANS - Immune effector cell-associated neurotoxicity syndrome Dai, Zhenyu, et al. "Development and functional characterization of novel fully human anti CD19 chimeric
antigen receptors for T cell therapy." Journal of Cellular Physiology 236.8 (2021): 5832-5847. Mackensen, Andreas, et al. "Anti-CD19 CAR T cell therapy for refractory systemic lupus erythematosus." Nature Medicine (2022): 1-9. M ller,
Fabian, et al. "CD19-targeted CAR T cells in refractory antisynthetase syndrome." The Lancet (2023). Evaluated as part of CT120, a dual-CD19xCD22 CAR T product candidate under development by Nanjing IASO Biotherapeutics, Co., Ltd. (IASO Bio). CD19
binder for CABA-201 CD19 binder used in academic studies2,3 In vitro (Nalm 6) In vivo Fully human anti-CD19 binder 4-1BB costimulatory domain CD3-Zeta signaling domain CABA-201 Similar in vitro & in vivo biologic activity to FMC631 Same
co-stimulatory domain as used in academic SLE & myositis studies2,3 CD19-CAR Construct Clinical data reported by Iaso using licensed CD19 binder4 Fully human binder Evaluated within dual-CAR combined with CD22 binder with standard Flu/Cy
preconditioning Evaluated in ~20 patients to date4 Under evaluation in patients with B cell leukemia and lymphoma in IIT in China Safety data supports autoimmune development4 Used in oncology patients with high target cell burden CABA-201
Differentiated asset, exclusive
translational insights & track record of timely CAART clinical implementation Accelerating development of CABA-201 for autoimmune diseases SLE - Systemic lupus erythematosus Mackensen, Andreas, et al. "Anti-CD19 CAR T cell therapy for
refractory systemic lupus erythematosus." Nature Medicine (2022): 1-9. M ller, Fabian, et al. "CD19-targeted CAR T cells in refractory antisynthetase syndrome." The Lancet (2023). IND clearance for CABA-201 expected in first half of 2023 1
Cabaletta is uniquely positioned to efficiently advance CABA-201 in autoimmune diseases Expertise in conducting complex, interdisciplinary autoimmune-focused cell therapy clinical trials Track record of positive regulatory interactions to support
cell therapy trials in autoimmune diseases since 2018 2 INDs cleared within routine 30-day period; multiple clinical protocol modifications, Fast Track designations granted Successful track record of manufacturing novel cell therapy products with
academic and industry partners Deep understanding of autoimmunity allows potential application across broad range of diseases 2 Clinically-evaluated binder & translational research partnership support CABA-201 development CABA-201 leverages

Frequently Asked Questions

What is the purpose of Cabaletta's Corporate Presentation?

The presentation is for informational purposes only and not a complete prospectus.

What types of statements does the presentation include?

It includes forward-looking statements about Cabaletta's business, operations, and strategies.

What are the risks mentioned in the presentation?

Risks include uncertainties in product development, regulatory evaluations, and clinical study results.

When is Cabaletta expected to submit an IND application for CABA-201?

The expected timing of the IND submission is mentioned but not specified in detail.

Why should readers be cautious with forward-looking statements?

Because actual results may differ materially due to various risks and uncertainties.

Last updated: Mar 6, 2023