Cabaletta Bio, Inc. (CABA) appears an attractive pick, as it has been recently upgraded to a Zacks Rank #2 (Buy). This upgrade is essentially a reflection of an upward trend in earnings estimates -- one of the most powerful forces impacting stock prices.A company's changing earnings picture is at the core of the Zacks rating. The system tracks the Zacks Consensus Estimate -- the consensus measure of EPS estimates from the sell-side analysts covering the stock -- for the current and following years.Individua ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 FORM 10-Q (Mark One) ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from_______________ to _______________ Commission File Number: 001-39103 CABALETTA BIO, INC. (Exact Name of Registrant as Specified in its Charter) | Delaware | 82-1685768 | | --- | --- | | (State or other jurisdiction of | (I.R.S. Employer | | incorporation or organization) | Identification No.) | | 29 ...

Exhibit 99.1 Cabaletta Bio Reports Second Quarter 2025 Financial Results and Provides Business Update – Registrational cohort enrollment in RESET-Myositis™ trial on track to start in 2H25 with anticipated 2027 BLA submission for rese-cel in myositis – – Five disease-specific cohorts fully enrolled in the RESET™ clinical development program from over 70 clinical sites as of July 31, 2025, with expansion phase enrollment continuing – Recent Operational Highlights and Upcoming Anticipated Milestones Rese-cel: ...

Rese-cel Development and Regulatory Strategy - Cabaletta Bio plans to submit a Biologics License Application (BLA) for Rese-cel in 2027 following recent alignment with the FDA [7] - The company is rapidly accelerating enrollment across a broad portfolio of indications at 67 active clinical sites [7, 14] - The initial BLA submission is planned in myositis, which affects approximately 80,000 US patients, followed by rapid expansion to SLE/LN and SSc [7] - The FDA has aligned with Cabaletta Bio on an open-label, single-arm evaluation of two registrational cohorts in the RESET-Myositis trial, with approximately 15 patients in each subtype-specific cohort [8] - Over 40% of the safety database is already enrolled across the RESET clinical development program [18] Clinical Data and Efficacy - Clinically meaningful responses have been observed with most patients off all immunomodulatory medications and steroids [8] - Deep transient systemic B cell depletion in blood and tissues has been confirmed by lymph node biopsy in an SSc patient [8] - In non-renal SLE, 3 out of 4 patients achieved DORIS (Definition of Remission in SLE) at the latest follow-up [84] - In the LN cohort, the first patient achieved CRR (Complete Renal Response) at week 44 [89] Manufacturing and Innovation - Cabaletta Bio is evaluating a whole blood process to eliminate apheresis [112] - The company has an expanded partnership for automated manufacturing with Cellares and completed the Technology Adoption Program [110]

PHILADELPHIA, June 11, 2025 (GLOBE NEWSWIRE) -- Cabaletta Bio, Inc. (“Cabaletta” or the “Company”) (Nasdaq: CABA), a clinical-stage biotechnology company focused on developing and launching the first curative targeted cell therapies designed specifically for patients with autoimmune diseases, announced today the pricing of an underwritten public offering consisting of (i) 39,200,000 shares of its common stock and accompanying warrants to purchase an aggregate of 39,200,000 shares of common stock (or pre-fun ...

Core Insights - Cabaletta Bio (NASDAQ: CABA) shows promising efficacy signals in its approach, which is gaining traction in the medical community [1] Company Analysis - The company is being analyzed with cautious optimism due to its potential in the biotech sector [1] - The focus is on educating investors about the scientific basis of the company's business model [1] Industry Context - The medical community is increasingly gaining experience with the methodologies employed by Cabaletta Bio, indicating a positive trend in the industry [1]

Core Viewpoint - Cabaletta Bio, Inc. has initiated an underwritten public offering of its common stock and accompanying warrants, aiming to raise capital for its clinical-stage biotechnology operations focused on autoimmune diseases [1][2]. Group 1: Offering Details - The public offering includes shares of common stock and pre-funded warrants, with an option for underwriters to purchase an additional 15% of the offering [1][2]. - The offering is expected to close around June 12, 2025, subject to market conditions and customary closing conditions [2]. Group 2: Company Overview - Cabaletta Bio is a clinical-stage biotechnology company dedicated to developing curative targeted cell therapies for autoimmune diseases [5]. - The company’s CABA™ platform employs two strategies to advance engineered T cell therapies, with a focus on the CARTA strategy and its lead investigational therapy, rese-cel [5]. - Rese-cel is currently being evaluated in the RESET™ clinical development program, which spans multiple therapeutic areas including rheumatology, neurology, and dermatology [5].

Core Insights - Cabaletta Bio, Inc. announced promising clinical data from its ongoing RESET clinical trials for autoimmune diseases, highlighting the potential of rese-cel to provide drug-free, symptom-free lives for patients [1][2][6] Clinical Trial Results - In the RESET-Myositis trial, 7 out of 8 patients achieved clinically meaningful total improvement scores (TIS) while off all immunomodulators and steroids, with 4 patients experiencing grade 1 cytokine release syndrome (CRS) [1][2][3] - All systemic lupus erythematosus (SLE) patients without nephropathy achieved remission as per DORIS criteria, with 7 out of 7 patients responding clinically while off immunomodulators and glucocorticoids [1][2] - Both patients in the RESET-SSc trial showed significant improvements in modified Rodnan Skin Score (mRSS) after discontinuing immunomodulatory drugs, with one patient meeting the revised Composite Response Index in Systemic Sclerosis (CRISS) criteria [1][8] Safety Profile - Among 18 patients with follow-up of 4 weeks or more, 94% experienced no CRS or only Grade 1 CRS, and 89% had no immune effector cell-associated neurotoxicity syndrome (ICANS) [1][2] - In the RESET-SLE trial, 2 out of 8 patients experienced grade 1 CRS, and one ICANS event was reported [3][8] Regulatory and Development Plans - Cabaletta plans to initiate enrollment in two registrational myositis cohorts in 2025 and has scheduled discussions with the FDA regarding registrational pathways for SLE/LN in 3Q25, scleroderma in 4Q25, and myasthenia gravis in 1H26 [1][9] - The RESET clinical trial program is accelerating, with 51 patients actively enrolled across over 65 clinical sites as of May 30, 2025 [1][2][6] Company Overview - Cabaletta Bio is focused on developing curative targeted cell therapies for autoimmune diseases, with rese-cel being a key investigational therapy designed to deplete CD19-positive B cells [5][6] - The company aims to change treatment paradigms for autoimmune diseases through its innovative CARTA platform, which includes multiple disease-specific clinical trials [5][6]

Summary of Caballetta Bio's Conference Call Company Overview - **Company**: Caballetta Bio - **Event**: Jefferies Global Healthcare Conference - **CEO**: Steven Key Industry Insights - **Regulatory Alignment**: Caballetta Bio has aligned with the FDA on the registrational trial design for Reza cel, focusing on myositis as a target indication [3][4] - **Clinical Endpoint**: The primary endpoint for the trial will be the TIS score, a validated clinical endpoint previously used for IVIG approval in dermatomyositis [3][4] - **Cohort Design**: The trial will include two cohorts, one for ACEs and dermatomyositis subtypes (85% of myositis patients) and another for the necrotizing form (IMNM subtype, 15% of patients) [6][8] Efficacy and Safety Data - **Patient Enrollment**: The trial will enroll approximately 15 patients per cohort, focusing on those refractory to other therapies [4][10] - **Safety Database**: A safety database of over 100 patients will be utilized for the filing, with 35 patients having myositis-specific data [10][11] - **Weight-Adjusted Dosing**: Caballetta Bio is the only company using weight-adjusted dosing, which is believed to enhance safety and efficacy [18][19] Market Dynamics - **Competitive Landscape**: There are currently 35 cell therapies IND cleared for lupus, indicating a crowded market where payers require specific data for reimbursement [15] - **Patient Expectations**: Patients desire to eliminate symptoms and stop immunosuppressants, while physicians prioritize organ protection [22][24] Future Milestones - **Upcoming Presentations**: Caballetta Bio will present data at EULAR, including safety and efficacy results from 18 patients dosed for at least one month [31][36] - **Regulatory Alignment**: Expected regulatory alignments with the FDA for lupus and scleroderma in the second half of the year [45][46] - **Enrollment Projections**: Enrollment is exceeding aggressive forecasts, with ongoing updates expected at medical meetings [44][46] Additional Considerations - **Unmet Need**: There is a profound unmet need in the myositis and scleroderma markets, with significant patient enrollment observed [29][28] - **Cost Reduction Potential**: Collaborations with Solaris may lead to reduced manufacturing costs and increased scalability [48] Conclusion Caballetta Bio is positioned to make significant strides in the treatment of autoimmune diseases with its innovative approach to CAR T therapies, focusing on safety, efficacy, and regulatory alignment. The upcoming data presentations and regulatory milestones will be critical in shaping the company's future trajectory in the market.

Core Insights - Cabaletta Bio, Inc. is a clinical-stage biotechnology company focused on developing curative targeted cell therapies for autoimmune diseases [3] - The company will participate in a fireside chat at the Jefferies Global Healthcare Conference on June 4, 2025 [1] - The lead strategy, CARTA, is centered on the investigational therapy rese-cel, which is currently in the RESET clinical development program [3] Company Overview - Cabaletta Bio is dedicated to advancing engineered T cell therapies that may provide deep and durable, potentially curative treatments for a variety of autoimmune diseases [3] - The company is headquartered in Philadelphia, PA, and has a comprehensive platform that includes two complementary strategies for therapy development [3] - Rese-cel is a fully human CD19-CAR T cell therapy that contains 4-1BB and is being evaluated across multiple therapeutic areas, including rheumatology, neurology, and dermatology [3]