CABA Cabaletta Bio Inc.

7
-0.14  -2%
Previous Close 7.14
Open 7.04
52 Week Low 7.05
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Market Cap $174,498,331
Shares 24,928,333
Float 20,776,443
Enterprise Value $83,937,364
Volume 44,744
Av. Daily Volume 132,809
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DSG3-CAART
Pemphigus vulgaris
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Latest News

  1. Dr. Brun's early and late-stage clinical development expertise in autoimmune, neurologic, and renal disease areas aligns well with Cabaletta's rapidly emerging pipeline

    PHILADELPHIA, June 28, 2021 (GLOBE NEWSWIRE) -- Cabaletta Bio, Inc. (NASDAQ:CABA), a clinical-stage biotechnology company focused on the discovery and development of engineered T cell therapies for patients with B cell-mediated autoimmune diseases, today announced the appointment of veteran biopharmaceutical leader, Scott Brun, M.D., to its Board of Directors. Dr. Brun has over 20 years of wide-ranging drug development and business development experience, including his time as Vice President and Head of Pharmaceutical Development at AbbVie Inc., or AbbVie, and the predecessor…

    Dr. Brun's early and late-stage clinical development expertise in autoimmune, neurologic, and renal disease areas aligns well with Cabaletta's rapidly emerging pipeline

    PHILADELPHIA, June 28, 2021 (GLOBE NEWSWIRE) -- Cabaletta Bio, Inc. (NASDAQ:CABA), a clinical-stage biotechnology company focused on the discovery and development of engineered T cell therapies for patients with B cell-mediated autoimmune diseases, today announced the appointment of veteran biopharmaceutical leader, Scott Brun, M.D., to its Board of Directors. Dr. Brun has over 20 years of wide-ranging drug development and business development experience, including his time as Vice President and Head of Pharmaceutical Development at AbbVie Inc., or AbbVie, and the predecessor company, Abbott Laboratories, and Head of AbbVie Ventures, a corporate venture fund responsible for investment opportunities.

    "Scott is an accomplished physician and executive whose pharmaceutical perspective on early and late-stage clinical development, strategic partnership and investment experience, including particular expertise in clinical development of products in the autoimmune, neurologic, and renal disease therapeutic areas, aligns well with our rapidly advancing pipeline. His expertise will be particularly valuable to Cabaletta as we advance our lead program, DSG3-CAART, in mucosal pemphigus vulgaris," said Steven Nichtberger, M.D., Chief Executive Officer and Co-founder of Cabaletta. "We welcome him to the Board of Directors and look forward to his contributions to our strategic and operational objectives as we seek to increase shareholder value."

    Dr. Brun spent two decades at AbbVie and Abbott Laboratories, the predecessor company, where he was most recently Vice President of Scientific Affairs and Head of AbbVie Ventures, a corporate venture fund responsible for investment opportunities within AbbVie's R&D therapeutic areas as well as technology platforms of interest. Previously, Dr. Brun served as Vice President and Head of Pharmaceutical Development. During his tenure, Dr. Brun oversaw a global organization with responsibilities for AbbVie's entire portfolio of early and late-stage clinical pre-registration pipeline compounds as well as marketed compounds within oncology, neurology, immunology, renal, infectious disease, and women's and men's health therapeutic areas. Earlier in his career, he held positions of increasing leadership responsibility in drug development within the R&D organization at Abbott Laboratories. Dr. Brun is currently President at Gold Mast Consulting, LLC, an advisory firm he founded to provide technical advice and strategic guidance related to biopharmaceutical research and development, pipeline portfolio management, commercialization of new therapeutics and strategic communications related to R&D activities. Dr. Brun received his B.S. in Biochemistry from the University of Illinois at Urbana-Champaign and earned his M.D. from the Johns Hopkins University School of Medicine. He completed his residency in ophthalmology at the Massachusetts Eye and Ear Infirmary, Harvard Medical School.

    "Based on a robust and elegant scientific platform, Cabaletta has the potential to revolutionize the treatment landscape for autoimmune disease and I look forward to contributing to the Board of Directors and partnering with leadership team as they seek to achieve their mission of providing a deep and durable treatment for patients with B cell-mediated autoimmune diseases," said Scott Brun, M.D.

    Dr. Brun will become a member of the Audit Committee and the Nominating and Corporate Governance Committee. Dr. Brun will succeed Brian Daniels, M.D., who resigned from the Board of Directors effective June 24, 2021, and subsequently joined the Scientific Advisory Board. Dr. Daniels has served on Cabaletta's Board of Directors since October 2018.

    "Speaking for the entire leadership team and his colleagues on the Board of Directors at Cabaletta, I want to thank Dr. Daniels for his keen insights and thoughtful, probing questions over the last three years and his service to the Board of Directors. His advice and counsel proved invaluable. We are fortunate to be able to continue our engagement with Dr. Daniels moving forward as a member of our Scientific Advisory Board," continued Dr. Nichtberger.

    About Cabaletta Bio

    Cabaletta Bio is a clinical-stage biotechnology company focused on the discovery and development of engineered T cell therapies, and exploring their potential to provide a deep and durable, perhaps curative, treatment for patients with B cell-mediated autoimmune diseases. The Cabaletta Approach to selective B cell Ablation (CABA™) platform, in combination with Cabaletta's proprietary technology, utilizes Chimeric AutoAntibody Receptor (CAAR) T cells that are designed to selectively bind and eliminate only specific autoantibody-producing B cells while sparing normal antibody-producing B cells, which are essential for human health. The Company's lead product candidate, DSG3-CAART, is being evaluated in the DesCAARTes™ Phase 1 clinical trial as a potential treatment for patients with mucosal pemphigus vulgaris, a prototypical B cell-mediated autoimmune disease. The FDA granted Fast Track Designation for DSG3-CAART in May 2020. For more information about the DesCAARTes™ Phase 1 clinical trial, please see www.clinicaltrials.gov. The Company's lead preclinical product candidate, MuSK-CAART, is in IND-enabling studies and is designed as a potential treatment for patients with MuSK-associated myasthenia gravis. For more information, visit www.cabalettabio.com.

    Forward-Looking Statements

    This press release contains "forward-looking statements" of Cabaletta within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, including without limitation, express or implied statements regarding the company's business plans and objectives; expectations regarding the progress and results of its DesCAARTes™ Phase 1 trial; the effectiveness and timing of product candidates that Cabaletta may develop, including in collaboration with academic partners; statements regarding regulatory filings regarding its development programs; and the anticipated contribution of the members of our board of directors and our executives to our operations and progress.

    Any forward-looking statements in this press release are based on management's current expectations and beliefs of future events, and are subject to a number of risks and uncertainties that could cause actual results to differ materially and adversely from those set forth in or implied by such forward-looking statements. These risks and uncertainties include, but are not limited to: Cabaletta's ability to demonstrate sufficient evidence of safety, efficacy and tolerability in its clinical trials of DSG3-CAART; risks related to unexpected safety or efficacy data observed during clinical studies; risks related to the impact of public health epidemics affecting countries or regions in which we have operations or do business, such as COVID-19; and the risk that the initial or interim results of clinical studies will not be predictive of future results in connection with future studies. For a discussion of these and other risks and uncertainties, and other important factors, any of which could cause Cabaletta's actual results to differ from those contained in the forward-looking statements, see the section entitled "Risk Factors" in Cabaletta's most recent annual report on Form 10-K as well as discussions of potential risks, uncertainties, and other important factors in Cabaletta's other filings with the Securities and Exchange Commission. All information in this press release is as of the date of the release, and Cabaletta undertakes no duty to update this information unless required by law.

    Contacts:

    Anup Marda

    Chief Financial Officer

    Sarah McCabe

    Stern Investor Relations, Inc.

    212-362-1200

     



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  2. PHILADELPHIA, May 27, 2021 (GLOBE NEWSWIRE) -- Cabaletta Bio, Inc. (NASDAQ:CABA), a clinical-stage biotechnology company focused on the discovery and development of engineered T cell therapies for patients with B cell-mediated autoimmune diseases, today announced that Steven Nichtberger, M.D., President and Chief Executive Officer, will participate in a fireside chat at the Jefferies Healthcare Conference on Thursday, June 3, 2021 at 4:30 p.m. ET.

    A live webcast of the fireside chat will be available on the News and Events section of the company's website at www.cabalettabio.com. Following the presentation, a replay of the webcast will be available on the website for 90 days.

    About Cabaletta Bio
    Cabaletta Bio is a clinical-stage biotechnology…

    PHILADELPHIA, May 27, 2021 (GLOBE NEWSWIRE) -- Cabaletta Bio, Inc. (NASDAQ:CABA), a clinical-stage biotechnology company focused on the discovery and development of engineered T cell therapies for patients with B cell-mediated autoimmune diseases, today announced that Steven Nichtberger, M.D., President and Chief Executive Officer, will participate in a fireside chat at the Jefferies Healthcare Conference on Thursday, June 3, 2021 at 4:30 p.m. ET.

    A live webcast of the fireside chat will be available on the News and Events section of the company's website at www.cabalettabio.com. Following the presentation, a replay of the webcast will be available on the website for 90 days.

    About Cabaletta Bio

    Cabaletta Bio is a clinical-stage biotechnology company focused on the discovery and development of engineered T cell therapies, and exploring their potential to provide a deep and durable, perhaps curative, treatment, for patients with B cell-mediated autoimmune diseases. The Cabaletta Approach to selective B cell Ablation (CABA™) platform, in combination with Cabaletta's proprietary technology, utilizes Chimeric AutoAntibody Receptor (CAAR) T cells that are designed to selectively bind and eliminate only specific autoantibody-producing B cells while sparing normal antibody-producing B cells, which are essential for human health. The Company's lead product candidate, DSG3-CAART, is being evaluated in the DesCAARTes™ Phase 1 clinical trial as a potential treatment for patients with mucosal pemphigus vulgaris, a prototypical B cell-mediated autoimmune disease. The FDA granted Fast Track Designation for DSG3-CAART in May 2020. For more information about the DesCAARTes™ Phase 1 clinical trial, please see www.clinicaltrials.gov. The Company's lead preclinical product candidate, MuSK-CAART, is in IND-enabling studies and is designed as a potential treatment for patients with MuSK-associated myasthenia gravis. For more information, visit www.cabalettabio.com.

    Contacts:

    Anup Marda

    Chief Financial Officer

    Sarah McCabe

    Stern Investor Relations, Inc.

    212-362-1200



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  3. – Acute safety data from the first cohort in the DesCAARTes™ trial announced today; no dose limiting toxicities (DLTs) or clinically relevant adverse events observed in the first dose cohort as of April 30, 2021 –

    – PLA2R-CAART announced as a new development program for patients with PLA2R-associated membranous nephropathy; pre-IND meeting with FDA planned in the second half of 2021 –

    – MuSK-CAART Investigational New Drug (IND) application submission planned for the second half of 2021 –

    PHILADELPHIA, May 03, 2021 (GLOBE NEWSWIRE) -- Cabaletta Bio, Inc. (NASDAQ:CABA), a clinical-stage biotechnology company focused on the discovery and development of engineered T cell therapies for patients with B cell-mediated autoimmune diseases, today…

    – Acute safety data from the first cohort in the DesCAARTes™ trial announced today; no dose limiting toxicities (DLTs) or clinically relevant adverse events observed in the first dose cohort as of April 30, 2021 –

    – PLA2R-CAART announced as a new development program for patients with PLA2R-associated membranous nephropathy; pre-IND meeting with FDA planned in the second half of 2021 –

    – MuSK-CAART Investigational New Drug (IND) application submission planned for the second half of 2021 –

    PHILADELPHIA, May 03, 2021 (GLOBE NEWSWIRE) -- Cabaletta Bio, Inc. (NASDAQ:CABA), a clinical-stage biotechnology company focused on the discovery and development of engineered T cell therapies for patients with B cell-mediated autoimmune diseases, today reported financial results for the first quarter ended March 31, 2021, and provided new pipeline updates.

    "The initial safety data from the first low dose cohort of three patients in the DesCAARTes™ clinical trial for DSG3-CAART, our lead clinical candidate, support the acute safety profile of DSG3-CAART at the administered dose in mucosal-dominant pemphigus vulgaris patients, and are an encouraging indicator for the safety of the CAAR T platform overall. We look forward to reporting additional topline data on safety and potential target engagement on completed dose cohorts throughout the second half of 2021," said Steven Nichtberger, M.D., Chief Executive Officer and Co-founder of Cabaletta. "On the heels of this important milestone, which we believe begins to de-risk our CABA™ platform, we are pleased to announce a new development program, PLA2R-CAART, for the treatment of patients with PLA2R-associated membranous nephropathy with a pre-IND meeting planned for the second half of 2021. In addition, we look forward to submitting our second IND application for MuSK-CAART, our lead preclinical candidate, in the second half of 2021."

    Acute Safety Data from First Dose Cohort of DesCAARTes™ Trial

    Today, the Company reported results from the first cohort of three patients dosed with DSG3-CAART. There were no clinically relevant adverse events, including cytokine release syndrome or neurotoxicity, during the 8-day acute safety window, which the Company expects is the period with highest probability of observing treatment-related toxicities. In addition, no dose-limiting toxicities (DLTs) were observed in the first two subjects who have completed the 28-day DLT monitoring period post-infusion. The third patient has completed the 8-day acute safety window, and is in the DLT follow-up period. These safety data were observed with an administered dose of 20 million DSG3-CAART cells, without preconditioning and in the presence of circulating anti-DSG3 antibodies; DSG3-CAART was detected at low levels via quantitative polymerase chain reaction in both patients who have completed the 28-day DLT period and been evaluated. The third patient is scheduled to be evaluated for presence of DSG3-CAART after completion of the 28-day DLT monitoring period.

    The DesCAARTes™ trial is currently enrolling patients in the second cohort at a treatment dose of 100 million DSG3-CAART cells. Infusions are planned to initiate following the third patient in the first cohort completing the 28-day monitoring period without any DLTs. Cabaletta expects to announce acute safety data for the second and third cohorts in the third and fourth quarters of 2021, respectively. Topline data on target engagement from the first cohort are anticipated during the second half of 2021. Cabaletta will continue to provide additional topline safety and target engagement data from the DesCAARTes™ trial once available on a cohort-by-cohort basis.

    Other Pipeline Highlights

    MuSK-CAART: Muscle Specific Kinase (MuSK) chimeric autoantibody receptor T (MuSK-CAART) cells as potential treatment for patients with MuSK-associated myasthenia gravis.

    • IND-enabling studies consistent with U.S. Food and Drug Administration (FDA) guidance received during the Pre-IND meeting are ongoing and the Company plans to submit an IND to the FDA in the second half of 2021, which will incorporate clinical trial design insights from the DesCAARTes™ trial with DSG3-CAART.

    PLA2R-CAART: Phospholipase A2 receptor (PLA2R) chimeric autoantibody receptor T (PLA2R-CAART) cells as a potential treatment for patients with PLA2R-associated membranous nephropathy.

    • Cabaletta plans to advance PLA2R-CAART discovery candidates for the treatment of patients with PLA2R-associated membranous nephropathy.



    • Given the role of autoantibodies and proteinuria in risk stratification for patients with membranous nephropathy and as biomarkers disease progression and resolution, Cabaletta believes it can advance a product candidate to address the existing unmet need.



    • The Company plans to request a Pre-IND submission meeting with the FDA during the second half of 2021 to gain clarity on the future development path and potential IND submission timing for the program.

    Upcoming Events

    • Cabaletta will participate in a fireside chat at the virtual Jefferies Healthcare Conference from June 1-4, 2021.

    First Quarter 2021 Financial Results

    The Company expects that its cash, cash equivalents and investments as of March 31, 2021, along with proceeds from sales under the Company's at-the-market offering program in April 2021, will enable it to fund its operating plan through at least the fourth quarter of 2022.  

    • Research and development expenses for the three months ended March 31, 2021 were $6.6 million, compared to $4.6 million for the same period in 2020.



    • General and administrative expenses for the three months ended March 31, 2021 were $3.2 million, compared to $3.3 million for the same period in 2020.



    • As of March 31, 2021, cash, cash equivalents and investments totaled $102.0 million, compared to $108.7 million as of December 31, 2020.

    About Cabaletta Bio

    Cabaletta Bio is a clinical-stage biotechnology company focused on the discovery and development of engineered T cell therapies, and exploring their potential to provide a deep and durable, perhaps curative, treatment, for patients with B cell-mediated autoimmune diseases. The Cabaletta Approach to selective B cell Ablation (CABA™) platform, in combination with Cabaletta's proprietary technology, utilizes Chimeric AutoAntibody Receptor (CAAR) T cells that are designed to selectively bind and eliminate only specific autoantibody-producing B cells while sparing normal antibody-producing B cells, which are essential for human health. The Company's lead product candidate, DSG3-CAART, is being evaluated in the DesCAARTes™ phase 1 clinical trial as a potential treatment for patients with mucosal pemphigus vulgaris, a prototypical B cell-mediated autoimmune disease. The FDA granted Fast Track Designation for DSG3-CAART in May 2020. For more information about the DesCAARTes™ Phase 1 clinical trial, please see www.clinicaltrials.gov. The Company's lead preclinical product candidate, MuSK-CAART, is in IND-enabling studies and is designed as a potential treatment for patients with MuSK-associated myasthenia gravis. For more information, visit www.cabalettabio.com.

    Forward-Looking Statements

    This press release contains "forward-looking statements" of Cabaletta within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, including without limitation, express or implied statements regarding expectations regarding the progress and results of its DesCAARTes™ Phase 1 trial, including Cabaletta's ability to enroll the requisite number of patients, progress of the trial, results and expected timing to report additional acute safety data for the second and third cohorts in the third and fourth quarters of 2021, respectively, and topline data on any completed dosing cohorts in the second half of 2021; the expectation that Cabaletta may improve outcomes for patients suffering from mPV; the effectiveness and timing of product candidates that Cabaletta may develop, including in collaboration with academic partners; the safety, efficacy and tolerability of DSG3-CAART for the treatment of mPV;  MuSK-CAART program, including the completion and expected results of its ongoing IND-enabling studies and plans to submit an IND application or equivalent regulatory filing for MuSK-CAART in the second half of 2021; presentation of additional data at upcoming scientific conferences, and other preclinical data; expectations regarding the design, implementation, timing and success of its current and planned clinical trials and the successful completion of nonclinical studies; planned potential timing and advancement of its preclinical studies and clinical trials and related regulatory submissions; ability and the potential to successfully maintain or secure the necessary cell processing capacity and supply for its product candidates for clinical trials, including Cabaletta's planned development and timing of next generation T cell engineering tools and process advancement; ability to replicate results achieved in preclinical studies or clinical trials in any future studies or trials; ability to continue its growth and realize the anticipated contribution of the members of its board of directors and executives to its operations and progress; expectations of the potential impact of COVID-19 on strategy, future operations, and the timing of its clinical trials, including the potential impacts on enrollment and initiation of its DesCAARTes™ Phase 1 trial; statements regarding regulatory filings regarding its development programs; use of capital, expenses, future accumulated deficit and other financial results in the future; and ability to fund operations through the fourth quarter of 2022.

    Any forward-looking statements in this press release are based on management's current expectations and beliefs of future events, and are subject to a number of risks and uncertainties that could cause actual results to differ materially and adversely from those set forth in or implied by such forward-looking statements. These risks and uncertainties include, but are not limited to: risks related to the impact of COVID-19 affecting countries or regions in which we have operations or do business, including potential negative impacts on our employees, customers, supply chain and production as well as global economies and financial markets; risks related to Cabaletta's ability to protect and maintain its intellectual property position; Cabaletta's ability to demonstrate sufficient evidence of safety, efficacy and tolerability in its clinical trials of DSG3-CAART; risks related to clinical trial site activation or enrollment rates that are lower than expected; risks related to unexpected safety or efficacy data observed during clinical studies; risks related to Cabaletta's ability to protect and maintain its intellectual property position; uncertainties related to the initiation and conduct of studies and other development requirements for its product candidates; and the risk that the results of preclinical studies or clinical studies will not be predictive of future results in connection with future studies. For a discussion of these and other risks and uncertainties, and other important factors, any of which could cause Cabaletta's actual results to differ from those contained in the forward-looking statements, see the section entitled "Risk Factors" in Cabaletta's most recent annual report on Form 10-K as well as discussions of potential risks, uncertainties, and other important factors in Cabaletta's other filings with the Securities and Exchange Commission. All information in this press release is as of the date of the release, and Cabaletta undertakes no duty to update this information unless required by law.

    CABALETTA BIO, INC.

    SELECTED FINANCIAL DATA

    (unaudited; in thousands, except share and per share data)



    Statements of Operations

     Three Months Ended

    March 31,

      2021  2020

        
     Unaudited

    Operating expenses:   
    Research and development$6,556  $4,620 
    General and administrative 3,156   3,275 
    Total operating expenses 9,712   7,895 
    Loss from operations (9,712)  (7,895)
    Other income:   
    Interest income 10   410 
    Net loss (9,702)  (7,485)
    Net loss per share of voting and non-voting common stock, basic and diluted$(0.41) $(0.33)

    Selected Balance Sheet Data

     March 31,

    2021
     December 31,

    2020
        
     (unaudited)
        
    Cash, cash equivalents and investments$        102,028 $        108,662
    Total assets 107,283  114,724
    Total liabilities 3,969  5,180
    Total stockholders' equity 103,314  109,544

    Contacts:

    Anup Marda

    Chief Financial Officer

    Sarah McCabe

    Stern Investor Relations, Inc.

    212-362-1200



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  4. No dose limiting toxicities (DLTs) or clinically relevant adverse events observed in the first dose cohort as of April 30, 2021

    Second dose cohort to be initiated after the third patient completes 28 day follow up, absent any DLT

    Acute safety data from the second and third cohorts are anticipated in the third and fourth quarters of 2021, respectively. Topline data on target engagement in the first cohort are expected in the second half of 2021

    Company to host conference call today at 8:30 a.m. ET

    PHILADELPHIA, May 03, 2021 (GLOBE NEWSWIRE) -- Cabaletta Bio, Inc. (NASDAQ:CABA), a clinical-stage biotechnology company focused on the discovery and development of engineered T cell therapies for patients with B cell-mediated…

    No dose limiting toxicities (DLTs) or clinically relevant adverse events observed in the first dose cohort as of April 30, 2021

    Second dose cohort to be initiated after the third patient completes 28 day follow up, absent any DLT

    Acute safety data from the second and third cohorts are anticipated in the third and fourth quarters of 2021, respectively. Topline data on target engagement in the first cohort are expected in the second half of 2021

    Company to host conference call today at 8:30 a.m. ET

    PHILADELPHIA, May 03, 2021 (GLOBE NEWSWIRE) -- Cabaletta Bio, Inc. (NASDAQ:CABA), a clinical-stage biotechnology company focused on the discovery and development of engineered T cell therapies for patients with B cell-mediated autoimmune diseases, today announced acute safety data from the first dose cohort of the ongoing DesCAARTes™ Phase 1 clinical trial of DSG3-CAART for the treatment of patients with mucosal-dominant pemphigus vulgaris (mPV).

    "We are encouraged by the acute safety profile of DSG3-CAART in this initial low dose cohort. In the first cohort of three patients dosed with DSG3-CAART, there were no clinically relevant adverse events, including cytokine release syndrome or neurotoxicity, during the 8-day acute safety window, which we expect is the period with highest probability of observing treatment-related toxicities. In addition, no dose-limiting toxicities or clinically relevant adverse events were observed in the two patients who have completed more than the full 28-day DLT monitoring period post-infusion," said David J. Chang, M.D., Chief Medical Officer of Cabaletta. These safety data were observed with an administered dose of 20 million DSG3-CAART cells, without preconditioning and in the presence of circulating anti-DSG3 antibodies; DSG3-CAART was detected at low levels via quantitative polymerase chain reaction in both patients who have been evaluated and completed the 28-day DLT period. The third patient is scheduled to be evaluated for presence of DSG3-CAART after the 28-day follow-up period.

    "The pace of the clinical trial is accelerating with the ongoing enrollment of patients and engagement of additional clinical sites. We believe these initial safety data represent an important step towards achieving our goal to offer a therapy that may provide deep and durable responses, and potentially cures, for patients in the pemphigus community," said Dr. Chang.

    The DesCAARTes™ trial is currently enrolling patients in the second cohort at a treatment dose of 100 million DSG3-CAART cells. Infusions are planned to initiate following the third patient in the first dose cohort completing the 28-day monitoring period without any DLTs. Cabaletta expects to announce acute safety data for the second and third cohorts in the third and fourth quarters of 2021, respectively. Topline data on target engagement from the first cohort are anticipated during the second half of 2021. Cabaletta will continue to provide additional topline safety and target engagement data from the DesCAARTes™ trial once available on a cohort-by-cohort basis.

    Conference Call Details

    Cabaletta management will host a conference call today at 8:30 a.m. ET to discuss this data and other recent pipeline updates. To participate in the conference call, please dial 866-939-3921 (domestic) or 678-302-3550 (international) and refer to the conference ID 50150570. A live webcast of the presentation can be accessed under "Events & Presentations" in the Investors & Media section of Cabaletta's website at www.cabalettabio.com.

    About the DesCAARTes™ Clinical Trial

    Cabaletta's DesCAARTes™ Phase 1 trial is an open-label, multi-center study of DSG3-CAART in adults with mucosal-dominant pemphigus vulgaris. The trial is designed to evaluate the safety and tolerability of DSG3-CAART as well as to identify evidence of target engagement and early signs of efficacy. The study consists of three parts: 1) dose escalation, 2) dose consolidation, and 3) cohort expansion at the final selected dose and schedule. The trial is expected to enroll approximately 30 patients across multiple clinical sites throughout the United States. Visit clinicaltrials.gov (NCT04422912) for more information.

    About Pemphigus Vulgaris

    mPV is a rare autoimmune blistering disease that is characterized by the loss of adhesion between cells of the skin or mucous membranes. mPV is caused by the production of autoantibodies that disrupt structural proteins within the skin and/or mucosa that connect with other proteins to enable the skin and/or mucosal cells to connect with each other. The autoantibodies can target DSG3 and/or desmoglein 1 (DSG1), which are primarily expressed in the mucosal membranes and skin, respectively. mPV is characterized by autoantibodies against DSG3 only whereas mucocutaneous PV (mcPV) is characterized by autoantibodies against DSG3 and DSG1.

    About CAAR T Cell Therapy

    Chimeric AutoAntibody Receptor (CAAR) T cells are designed to selectively bind and eliminate only disease-causing B cells, while sparing the normal B cells that are essential for human health. CAAR T cells are based on the chimeric antigen receptor (CAR) T cell technology. While CAR T cells typically contain a CD19-targeting molecule, CAAR T cells express an autoantibody-targeted antigen on their surface. The co-stimulatory domain and the signaling domain of both a CAR T cell and a CAAR T cell carry out the same activation and cytotoxic functions. Thus, Cabaletta's CAARs are designed to direct the patient's T cells to kill only the pathogenic cells that express disease-causing autoantibodies on their surface, potentially leading to complete and durable remission of disease while sparing all other B cell populations that provide beneficial immunity from infection.



    About Cabaletta Bio

    Cabaletta Bio is a clinical-stage biotechnology company focused on the discovery and development of engineered T cell therapies, and exploring their potential to provide a deep and durable, perhaps curative, treatment, for patients with B cell-mediated autoimmune diseases. The Cabaletta Approach to selective B cell Ablation (CABA™) platform, in combination with Cabaletta's proprietary technology, utilizes CAAR T cells that are designed to selectively bind and eliminate only specific autoantibody-producing B cells while sparing normal antibody-producing B cells, which are essential for human health. The Company's lead product candidate, DSG3-CAART, is being evaluated in the DesCAARTes™ phase 1 clinical trial as a potential treatment for patients with mucosal pemphigus vulgaris, a prototypical B cell-mediated autoimmune disease. The FDA granted Fast Track Designation for DSG3-CAART in May 2020. For more information about the DesCAARTes™ Phase 1 clinical trial, please see www.clinicaltrials.gov. The Company's lead preclinical product candidate, MuSK-CAART, is in IND-enabling studies and is designed as a potential treatment for patients with MuSK-associated myasthenia gravis. For more information, visit www.cabalettabio.com.

    Forward-Looking Statements

    This press release contains "forward-looking statements" of Cabaletta within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, including without limitation, express or implied statements regarding expectations regarding the progress and results of its DesCAARTes™ Phase 1 trial, including Cabaletta's ability to enroll the requisite number of patients in the trial; the expectation that Cabaletta may improve outcomes for patients suffering from mPV; the effectiveness and timing of product candidates that Cabaletta may develop, including in collaboration with academic partners; the safety, efficacy and tolerability of DSG3-CAART for the treatment of mPV; expectations of the potential impact of COVID-19 on strategy, future operations, and the timing of its clinical trials, including the potential impacts on enrollment and initiation of its DesCAARTes™ Phase 1 trial; and statements regarding regulatory filings regarding its development programs.

    Any forward-looking statements in this press release are based on management's current expectations and beliefs of future events, and are subject to a number of risks and uncertainties that could cause actual results to differ materially and adversely from those set forth in or implied by such forward-looking statements. These risks and uncertainties include, but are not limited to: Cabaletta's ability to demonstrate sufficient evidence of safety, efficacy and tolerability in its clinical trials of DSG3-CAART; risks related to clinical trial site activation or enrollment rates that are lower than expected; risks related to unexpected safety or efficacy data observed during clinical studies; risks related to the impact of public health epidemics affecting countries or regions in which we have operations or do business, such as COVID-19; risks related to Cabaletta's ability to protect and maintain its intellectual property position; uncertainties related to the initiation and conduct of studies and other development requirements for its product candidates; and the risk that the initial or interim results of clinical studies will not be predictive of future results in connection with future studies. For a discussion of these and other risks and uncertainties, and other important factors, any of which could cause Cabaletta's actual results to differ from those contained in the forward-looking statements, see the section entitled "Risk Factors" in Cabaletta's most recent annual report on Form 10-K as well as discussions of potential risks, uncertainties, and other important factors in Cabaletta's other filings with the Securities and Exchange Commission. All information in this press release is as of the date of the release, and Cabaletta undertakes no duty to update this information unless required by law.

    Contacts:

    Anup Marda

    Chief Financial Officer

    Sarah McCabe

    Stern Investor Relations, Inc.



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  5. PHILADELPHIA, April 07, 2021 (GLOBE NEWSWIRE) -- Cabaletta Bio, Inc. (NASDAQ:CABA), a clinical-stage biotechnology company focused on the discovery and development of engineered T cell therapies for patients with B cell-mediated autoimmune diseases, today announced that Steven Nichtberger, M.D., President and Chief Executive Officer, will participate in a fireside chat at the 20th Annual Needham Healthcare Conference on Wednesday, April 14, 2021 at 3:00 p.m. ET.

    A live webcast of the fireside chat will be available on the News and Events section of the company's website at www.cabalettabio.com. Following the presentation, a replay of the webcast will be available on the website for 90 days.

    About Cabaletta Bio
    Cabaletta Bio is a clinical-stage…

    PHILADELPHIA, April 07, 2021 (GLOBE NEWSWIRE) -- Cabaletta Bio, Inc. (NASDAQ:CABA), a clinical-stage biotechnology company focused on the discovery and development of engineered T cell therapies for patients with B cell-mediated autoimmune diseases, today announced that Steven Nichtberger, M.D., President and Chief Executive Officer, will participate in a fireside chat at the 20th Annual Needham Healthcare Conference on Wednesday, April 14, 2021 at 3:00 p.m. ET.

    A live webcast of the fireside chat will be available on the News and Events section of the company's website at www.cabalettabio.com. Following the presentation, a replay of the webcast will be available on the website for 90 days.

    About Cabaletta Bio

    Cabaletta Bio is a clinical-stage biotechnology company focused on the discovery and development of engineered T cell therapies, and exploring their potential to provide a deep and durable, perhaps curative, treatment, for patients with B cell-mediated autoimmune diseases. The Cabaletta Approach to selective B cell Ablation (CABA) platform, in combination with Cabaletta's proprietary technology, utilizes Chimeric AutoAntibody Receptor (CAAR) T cells that are designed to selectively bind and eliminate only specific autoantibody-producing B cells while sparing normal antibody-producing B cells, which are essential for human health. The Company's lead product candidate, DSG3-CAART, is being evaluated in the DesCAARTes™ phase 1 clinical trial as a potential treatment for patients with mucosal pemphigus vulgaris, a prototypical B cell-mediated autoimmune disease. The FDA granted Fast Track Designation for DSG3-CAART in May 2020. For more information about the clinical trial, please see www.clinicaltrials.gov. The Company's lead preclinical product candidate, MuSK-CAART, is in IND-enabling studies and is designed as a potential treatment for patients with MuSK-associated myasthenia gravis. For more information, visit www.cabalettabio.com.

    Contacts:

    Anup Marda

    Chief Financial Officer

    Sarah McCabe

    Stern Investor Relations, Inc.

    212-362-1200



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