UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 For the fiscal year ended December 31, 2025 OR ☐ 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 incorporation or organization) 2929 Arch Street, Suite 600 Philadelphia, PA 19104 (I.R.S. Employer Identific ...

Cabaletta Bio Reports Fourth Quarter and Full Year 2025 Financial Results and Provides Business Update Rese-cel myositis BLA submission on track for 2027 based on a 17-patient, single arm registrational cohort design, including an outpatient dosing option No-preconditioning program enrolling in lupus and PV; anticipating initial RESET-SLE™ data in 1H26 and durability data from the RESET-SLE and RESET-PV ® trials throughout 2026 Exhibit 99.1 Automated manufacturing of rese-cel with Cellares' Cell Shuttle™ un ...

Core Insights - Cabaletta Bio is advancing its investigational CAR T cell therapy, rese-cel, targeting autoimmune diseases, with a Biologics License Application (BLA) submission planned for 2027 based on a 17-patient cohort study in myositis [1][3] - The company is implementing an automated manufacturing process using Cellares' Cell Shuttle, which could enable production for thousands of patients annually with reduced costs [1][3] - Initial clinical data from trials involving rese-cel with no preconditioning are expected in the first half of 2026, with durability data to follow later in the year [2][7] Clinical Development - Rese-cel is designed to reset the immune system by depleting CD19-positive cells through a single weight-based infusion, aiming for durable clinical responses without chronic therapy [3][5] - The RESET clinical program includes multiple trials across various autoimmune diseases, with pivotal trial designs for systemic lupus erythematosus (SLE) and lupus nephritis (LN) announced, each involving approximately 25 patients [1][3] - The registrational cohort for dermatomyositis and antisynthetase syndrome is currently enrolling, with a primary endpoint focused on improvement while off immunomodulators [3][7] Financial Performance - For the fourth quarter of 2025, research and development expenses were $36.2 million, up from $25.5 million in the same quarter of 2024, while general and administrative expenses were $6.4 million, down from $8.3 million [4][10] - The total net loss for the year ended December 31, 2025, was $167.9 million, compared to a net loss of $115.9 million in 2024 [10] - As of December 31, 2025, the company had cash and equivalents of $133.6 million, a decrease from $164.0 million in 2024, but has since raised an additional $30 million [11][10] Upcoming Milestones - Initial clinical experience with rese-cel manufactured by Cellares is expected in the first half of 2026, which will confirm Good Manufacturing Practice readiness [3][7] - Complete Phase 1/2 data from the RESET-SLE, RESET-SSc, and RESET-MG trials are anticipated to be presented in the first half of 2026, supporting discussions with the FDA on potential registrational pathways [7][3] - The company plans to announce additional clinical data from the RESET trials throughout 2026, including updates on registrational designs for various indications [7][8]

Corporate Presentation MARCH 2026 © 2026 Cabaletta Bio. All rights reserved. Disclaimer This 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 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 may co ...

Investors might want to bet on Cabaletta Bio, Inc. (CABA) , as it has been recently upgraded to a Zacks Rank #2 (Buy). This upgrade primarily reflects an upward trend in earnings estimates, which is one of the most powerful forces impacting stock prices.The Zacks rating relies solely on a company's changing earnings picture. It tracks EPS estimates for the current and following years from the sell-side analysts covering the stock through a consensus measure -- the Zacks Consensus Estimate.The power of a cha ...

Summary of Cabaletta Bio FY Conference Call Company Overview - **Company**: Cabaletta Bio (NasdaqGS:CABA) - **Focus**: Development of autologous CAR T therapies for autoimmune diseases Key Points Industry and Product Development - Cabaletta has initiated enrollment in a pivotal 17-patient myositis trial, a significant step in their clinical development strategy [2] - The company is utilizing a fully automated manufacturing process in partnership with Cellares, which is expected to lower costs and improve margins [3] Clinical Trials and Efficacy - The company has reported promising results in treating pemphigus patients with their product rese-cel, showing elimination or reduction of severe symptoms without preconditioning [4] - There is an ongoing evaluation of higher doses of rese-cel to enhance efficacy, with expectations for durability data in lupus patients later this year [5][6] - A complete data set from Phase I/II clinical studies in scleroderma, lupus nephritis, and myasthenia gravis is anticipated in the first half of the year [7] Safety Profile - The safety profile of rese-cel is reported to be significantly better than traditional CAR T therapies, with 95% of patients experiencing grade 1 or no cytokine release syndrome (CRS) [16] - The company believes that the autoimmune patient population will have a safer profile compared to oncology patients [16][24] Market Potential - The potential market for lupus and lupus nephritis is substantial, with a strong belief that a no preconditioning regimen could significantly expand market opportunities [30][31] - Market research indicates that if rese-cel can achieve 18 months of disease-free remission, it would be highly favored by physicians [29] Manufacturing and Cost Efficiency - The Cellares automation platform allows for the simultaneous manufacturing of multiple patient samples, significantly reducing the need for skilled technicians and capital investment [43][45] - The cost structure is expected to be competitive, with the total cost of goods per patient treated being among the best in the industry [47] Future Outlook - Cabaletta plans to file for a Biologics License Application (BLA) next year, with expectations for a profitable launch [49] - The company is optimistic about partnerships with pharmaceutical companies due to its unique manufacturing capabilities and favorable safety profile [48][49] Challenges - The historical challenges faced by autologous CAR T companies include unpredictable cash requirements and scaling issues, which Cabaletta aims to address through its innovative manufacturing process [8] Additional Insights - The company is focused on differentiating itself from competitors by leveraging its unique manufacturing process and targeting a healthier patient population [36][37] - The management team is experienced, which is expected to facilitate the company's growth and operational success [40] This summary encapsulates the critical aspects of Cabaletta Bio's current status, clinical developments, market potential, and strategic direction as discussed in the conference call.

Group 1 - Biodesix, Inc. (BDSX) has gained approximately 131.6% year-to-date, significantly outperforming the average return of 1.9% for the Medical sector [4] - The Zacks Rank for Biodesix, Inc. is currently 2 (Buy), indicating a positive outlook based on earnings estimates and revisions [3] - The consensus estimate for BDSX's full-year earnings has increased by 3.5% over the past quarter, reflecting improved analyst sentiment [3] Group 2 - Biodesix, Inc. is part of the Medical Services industry, which consists of 66 companies and is currently ranked 90 in the Zacks Industry Rank [5] - The average performance of stocks in the Medical Services industry has been a loss of 2.5% this year, highlighting Biodesix's strong performance relative to its peers [5] - Another outperforming stock in the Medical sector is Cabaletta Bio, Inc. (CABA), which has returned 50.7% year-to-date [4]

PHILADELPHIA, Feb. 24, 2026 (GLOBE NEWSWIRE) -- Cabaletta Bio, Inc. (Nasdaq: CABA), a late-stage clinical biotechnology company focused on developing and launching the first curative targeted cell therapies designed specifically for patients with autoimmune diseases, today announced that the Company will participate in a fireside chat at the TD Cowen 46th Annual Health Care Conference on Tuesday, March 3, 2026, at 11:10 a.m. ET in Boston, MA. A live webcast of the presentation will be available on the News ...

Jacob Funds, a mutual fund company, released its fourth-quarter 2025 investor letter. A copy of the same can be downloaded here. After an optimistic quarter, equity markets corrected slightly in November. Although overall economic growth has been robust throughout the year, recent divergent data on consumer spending and the labor market have put doubt on future projections. This pattern has become somewhat familiar over the past few years, as conflicting economic data has become the norm. As for the Fund’s ...

Cabaletta Bio (NasdaqGS:CABA) 2026 Conference February 12, 2026 09:30 AM ET Company ParticipantsDavid Chang - CMOSteve Gavel - Chief Commercial OfficerSteven Nichtberger - President, CEO and Co-FounderYatin Suneja - Senior Managing DirectorConference Call ParticipantsDalma Caiati - Biotech AnalystYatin SunejaAll right, we will go ahead and get started. Good morning, everyone. Welcome to Guggenheim Emerging Outlook Biotech Summit 2026. My name is Yatin Suneja, one of the biotech analysts here at the firm, jo ...