Cabaletta Bio Files 8-K Report

Ticker: CABA · Form: 8-K · Filed: Oct 27, 2025 · CIK: 1759138

Sentiment: neutral

Topics: 8-k, sec-filing, financials

TL;DR

Cabaletta Bio filed an 8-K, likely with financial updates.

AI Summary

On October 27, 2025, Cabaletta Bio, Inc. filed an 8-K report. The filing primarily concerns financial statements and exhibits, along with other events and a Regulation FD disclosure. No specific financial figures or new material events were detailed in the provided excerpt.

Why It Matters

This 8-K filing indicates Cabaletta Bio is providing updates to the SEC, which could include financial information or other material events relevant to investors.

Risk Assessment

Risk Level: low — The filing is a standard 8-K report without immediate indication of significant negative or positive news.

Key Players & Entities

FAQ

What specific items are included in this 8-K filing?

The filing includes items related to Regulation FD Disclosure, Other Events, and Financial Statements and Exhibits.

What is the exact name of the reporting company?

The exact name of the registrant is Cabaletta Bio, Inc.

On what date was this report filed or effective?

The report was filed as of October 27, 2025, and the date of the earliest event reported is also October 27, 2025.

Where are Cabaletta Bio, Inc.'s principal executive offices located?

The principal executive offices are located at 2929 Arch Street Suite 600, Philadelphia, Pennsylvania, 19104.

What is the company's telephone number?

The company's telephone number, including area code, is (267) 759-3100.

Filing Stats: 2,207 words · 9 min read · ~7 pages · Grade level 18.2 · Accepted 2025-10-27 07:02:07

Key Financial Figures

Filing Documents

01 Regulation FD Disclosure

Item 7.01 Regulation FD Disclosure. On October 27, 2025, Cabaletta Bio, Inc. ("Cabaletta" or the "Company") issued a press release reporting new clinical data and development updates across the RESET-Myositis, RESET-SSc and RESET-SLE trials evaluating rese-cel (resecabtagene autoleucel, formerly known as CABA-201) (the "Press Release"). A copy of the Press Release is furnished herewith as Exhibit 99.1 to this Current Report on Form 8-K. The information contained in Item 7.01 of this Current Report on Form 8-K, including Exhibit 99.1 attached hereto, is being furnished and shall not be deemed to be "filed" for the purposes of Section 18 of the Exchange Act, or otherwise subject to the liabilities of that section and shall not be incorporated by reference in any filing under the Securities Act or the Exchange Act, except as shall be expressly set forth by specific reference in such filing.

01 Other Events

Item 8.01 Other Events. On October 27, 2025, the Company posted to the "Investors & Media" section of the Company's website at www.cabalettabio.com an updated corporate presentation (the "Corporate Presentation"). A copy of the Corporate Presentation is attached hereto as Exhibit 99.2 to this Current Report on Form 8-K and incorporated herein by reference. Cabaletta is presenting new clinical data and development updates across the RESET-Myositis, RESET-SSc and RESET-SLE trials evaluating rese-cel (resecabtagene autoleucel, formerly known as CABA-201) in multiple oral and poster presentations at the American College of Rheumatology ("ACR") Convergence 2025. Highlights of the rese-cel clinical and translational data being presented at ACR Convergence 2025 as of the data cut-off date of September 11, 2025, and development updates include: RESET-Myositis: Complete Adult Phase 1/2 Data and Registrational Cohort Update Cabaletta is presenting complete adult Phase 1/2 clinical data from 6 patients in the combined DM/ASyS (4 dermatomyositis and 2 antisynthetase syndrome) cohort and 6 patients in the immune-necrotizing myopathy ("IMNM") cohort, in addition to 1 patient in the juvenile idiopathic inflammatory myopathy cohort, within the RESET-Myositis trial. Regarding safety, 4 of 13 patients experienced fever, or grade 1 cytokine release syndrome ("CRS"), and no immune effector cell-associated neurotoxicity syndrome ("ICANS") was observed. All 4 DM/ASyS patients who met the key inclusion criteria for the registrational cohort with sufficient follow-up achieved immunomodulatory-free total improvement score ("TIS") responses of moderate or major improvement at week 16. Based on these clinical data, Cabaletta is initiating a DM/ASyS registrational cohort within the RESET-Myositis trial. There are approximately 60,000 patients with DM in the U.S. who have IVIg as their only U.S. Food and Drug Administration ("FDA")-approved treatment option and approximately 15,000 pa

Forward-Looking Statements

Forward-Looking Statements The information under this Item 8.01 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: Cabaletta's business plans and objectives as a whole; Cabaletta's ability to realize its vision of launching the first curative targeted cell therapy designed specifically for patients with autoimmune diseases; Cabaletta's ability to successfully complete research and further development and commercialization of its drug candidates in current or future indications, including the timing and results of Cabaletta's clinical trials and its ability to conduct and complete clinical trials; expectation that clinical results will support rese-cel's safety and activity profile; statements regarding the timing of interactions with regulatory authorities, including such authorities' review of safety information from Cabaletta's ongoing clinical trials and alignment with regulatory authorities on potential registrational pathway for rese-cel; Cabaletta's ability to leverage its emerging clinical data and its efficient development strategy; Cabaletta's ability to capitalize on and potential benefits resulting from its research and translational insights; the clinical significance of the clinical data read-out at upcoming scientific meetings and timing thereof; Cabaletta's expectations around the potential success and therapeutic benefits of rese-cel, including its belief that rese-cel has the potential to reset the immune system and result in profound clinical responses without chronic therapy requirements in patients; the Company's advancement of separate Phase 1/2 clinical trials of rese-cel in patients with SLE, myositis, SSc, gMG and PV and advancement of the RESET-MS trial, including updates related to status, safety data, efficiency of clinical trial design and timing of data read-outs or otherwise; Ca

01 Financial Statements and Exhibits

Item 9.01 Financial Statements and Exhibits. (d) Exhibits 99.1 Press Release issued by the registrant on October 27, 2025, furnished herewith. 99.2 Cabaletta Bio, Inc. Corporate Presentation, dated October 2025, filed herewith. 104 Cover Page Interactive Data File (embedded within the Inline XBRL Document). SIGNATURE Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned thereunto duly authorized. CABALETTA BIO, INC. Date: October 27, 2025 By: /s/ Steven Nichtberger Steven Nichtberger Chief Executive Officer and President (Principal Executive Officer)

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