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 ...

Cabaletta Bio (NASDAQ: CABA ) is a company I've covered with tentative optimism, given their signals of efficacy for an approach that the medical community is gaining increasing experience with. Today, I want to take another lookI have my PhD in biochemistry and have worked for years analyzing clinical trials and biotech companies. It is my passion to educate everyone possible on the science behind the businesses that we invest in, and it's my mission to help you do your due diligence and not get burned by ...

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].

– 7 of 8 myositis patients achieved clinically meaningful TIS responses after discontinuation of all immunomodulators, while off or actively tapering steroids; responses were sustained throughout the follow-up period in all responding patients – – All SLE patients without nephropathy achieved definition of remission in SLE (DORIS) as of the latest follow-up, and all 7 SLE and LN patients experienced SLEDAI-2K reductions, while off all immunomodulators and steroids – – Both scleroderma patients demonstrated ...

Cabaletta Bio (CABA) 2025 Conference June 04, 2025 11:05 AM ET Speaker0 morning, everyone. Thank you for attending Jefferies Global Healthcare Conference. My name is Kelly Xu, one of the equity analysts on the biotech team. We are very pleased to have Steven, CEO Caballetta Bio join us today for this fireside chat session. Welcome, Steven. Speaker1 Thanks. Thanks for having me. Speaker0 Maybe we can start a question with the great news from Caballetta. You've aligned with FDA on the registrational trial des ...

PHILADELPHIA, May 29, 2025 (GLOBE NEWSWIRE) -- Cabaletta Bio, Inc. (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, today announced that the Company will participate in a fireside chat at the Jefferies Global Healthcare Conference on Wednesday, June 4, 2025, at 11:05 a.m. ET in New York, NY. A live webcast of the presentation will be available on the News and Even ...

Financial Performance - As of March 31, 2025, Cabaletta Bio, Inc. reported total assets of $165,141,000, a decrease of 10.8% from $185,046,000 on December 31, 2024[15]. - The company incurred a net loss of $35,943,000 for the three months ended March 31, 2025, compared to a net loss of $25,047,000 for the same period in 2024, representing a 43.5% increase in losses year-over-year[18]. - The net loss per share for the three months ended March 31, 2025, was $0.71, compared to $0.51 for the same period in 2024[18]. - The accumulated deficit as of March 31, 2025, reached $385,044,000, an increase from $349,101,000 at the end of 2024[15]. - The total stock-based compensation for the three months ended March 31, 2025, was $5.16 million, compared to $3.79 million for the same period in 2024, reflecting a 36% increase[91]. - The net loss for Q1 2025 was reported at $35,943,000, compared to a net loss of $25,047,000 in Q1 2024, indicating increased operational expenditures[71]. - For the three months ended March 31, 2025, total operating expenses increased to $37.1 million from $28.0 million in the same period of 2024, representing a change of $9.1 million[144]. - Cash used in operating activities was $30.8 million for Q1 2025, compared to $24.0 million in Q1 2024, indicating an increase of $6.8 million[161]. - As of March 31, 2025, the company had $131.8 million in cash and cash equivalents, which is expected to fund operations into the first half of 2026[149]. Research and Development - Research and development expenses increased to $29,018,000 for the three months ended March 31, 2025, up 32.3% from $21,954,000 in the prior year[18]. - Research and development expenses for Q1 2025 totaled $28,973,000, a significant increase from $18,000,000 in Q1 2024, reflecting a rise in personnel and clinical trial costs[71]. - Research and development expenses rose to $29.0 million in Q1 2025, up from $22.0 million in Q1 2024, marking an increase of $7.1 million[145]. - The company anticipates continued increases in research and development and general administrative expenses, with a need for additional funding to support operations[153]. - The company plans to raise additional capital through equity offerings, debt financings, and strategic alliances to fund its operations[32]. - The company expects to incur additional losses in the future as it continues its research and development efforts and will need to raise additional capital[32]. Clinical Trials and Product Development - The FDA granted clearance for the rese-cel IND application for systemic lupus erythematosus (SLE) treatment, affecting an estimated 320,000 patients in the U.S. and 150,000 in Europe, with approximately 40% of SLE patients experiencing lupus nephritis (LN)[103]. - The RESET-SLE Phase 1/2 clinical trial is designed to treat 12 patients, with a single weight-based dose of 1.0 x 10^6 cells/kg, and is open for enrollment across multiple sites in the U.S. and one in the EU[103]. - The FDA granted Fast Track Designation for rese-cel for SLE and LN, and the RESET-Myositis trial is actively enrolling patients with three myositis subtypes, affecting approximately 70,000 patients in the U.S. and 85,000 in Europe[104]. - The RESET-SSc trial for systemic sclerosis (SSc) is designed to treat 12 patients, with SSc affecting approximately 90,000 patients in the U.S. and 60,000 in Europe[105]. - The RESET-MG trial for generalized myasthenia gravis (gMG) is open for enrollment, targeting approximately 55,000 patients in the U.S. and 100,000 in Europe[107]. - As of May 9, 2025, 44 patients are enrolled and 23 patients have been dosed across multiple Phase 1/2 disease cohorts in the RESET clinical development program[118]. - The company is collaborating with Cellares Corp. to evaluate an automated manufacturing platform, with successful integration of the Cell Shuttle™ into the manufacturing strategy for rese-cel[120]. - The company plans to implement two registrational cohorts in the RESET-Myositis trial, each evaluating approximately 15 patients, with a focus on achieving a broad label for myositis treatment[116]. Financial Position and Liabilities - Total current liabilities rose to $33,989,000 as of March 31, 2025, compared to $27,086,000 on December 31, 2024, indicating a 25.4% increase[15]. - The company has an accumulated deficit of $385.0 million as of March 31, 2025, indicating ongoing financial challenges[152]. - Future lease payments under non-cancelable leases as of March 31, 2025, total $25,444,000 for finance leases and $5,939,000 for operating leases[79]. - The company has no off-balance sheet risks, such as foreign exchange contracts or other hedging arrangements, ensuring a straightforward financial position[37]. - The company has not recorded any income tax benefits for the three months ended March 31, 2025, due to the likelihood of not recognizing deferred tax benefits[95]. Risks and Challenges - The company has not yet established sales and marketing capabilities, which will be crucial upon obtaining regulatory approval to gain market acceptance[192]. - The regulatory approval process for the company's novel product candidates is complex and may take longer than expected, with potential delays in commercialization[190]. - Patients receiving T cell-based immunotherapies may experience serious adverse events, which could negatively affect the clinical development and commercial potential of the company's product candidates[193]. - The company faces inherent product liability risks during clinical testing, which could lead to substantial liabilities and limit commercialization efforts[209]. - The company currently does not hold product liability insurance for commercialization, which could inhibit the ability to market products if claims arise[210]. - Adverse events from CAR T cell therapies have resulted in patient deaths, indicating significant risks associated with current and future product candidates[213]. - The company is early in its development efforts and may face significant delays in clinical trials if suitable doses are not identified[188]. - The company must navigate variability in T cell quality and quantity, which could affect the reliability of manufacturing its product candidates[186]. Agreements and Collaborations - The Company is committed to pay up to $2,250,000 under the CARTA Services Agreement for cell processing manufacturing through December 31, 2025[54]. - The IASO Agreement includes an upfront payment of $2.5 million and potential total consideration of up to $162 million based on milestone achievements[123]. - The Company entered into a License and Supply Agreement with Oxford Biomedica, which includes an upfront fee and potential regulatory and sales milestone payments in the low tens of millions[124]. - The Company has entered into a Development and Manufacturing Services Agreement with Lonza for a term of 12 months, with the ability to extend, focusing on the CAR-T cell therapy product rese-cel[62]. - An Option and License Agreement with Autolus was established, requiring an upfront license fee of $1,200, with potential regulatory milestones of up to $12,000 for each licensed target and sales milestones totaling up to $15,000[59].

UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of Report (Date of earliest event reported): May 15, 2025 CABALETTA BIO, INC. (Exact name of Registrant as Specified in Its Charter) (State or Other Jurisdiction of Incorporation) Delaware 001-39103 82-1685768 (Commission File Number) (IRS Employer 2929 Arch Street Suite 600 Philadelphia, Pennsylvania 19104 (Address of Principal Executive ...

– SLE and LN registrational discussions with FDA anticipated in 3Q25; systemic sclerosis registrational discussions with FDA anticipated in 4Q25 – – New clinical data on rese-cel in myositis, SLE / LN and systemic sclerosis to be presented in three oral sessions at the EULAR 2025 Congress in June – – Two subtype specific cohorts with ~15 patients each added to the ongoing RESET-Myositis™ trial – As of March 31, 2025, the Company had cash and cash equivalents of $131.8 million, per our Form 10-Q being filed ...