Every 8-K that Cabaletta Bio, Inc. (CABA) has filed with the SEC in the last 24 months is listed below, newest first, and each one links through to the document itself with the summary and the scores our analysis gives it.
A 8-K covers material events a company has to report between its quarterly reports, so if you follow CABA and want that one kind of document rather than the whole filing history, this is the page to keep. The company's other filings, of every form, are on the full CABA filings page.
Cabaletta Bio reported second quarter 2026 results and updated progress for its lead CAR T cell therapy, rese-cel, across multiple autoimmune indications. Net loss was $51.0 million for the quarter, compared with $45.1 million a year earlier, driven mainly by higher research and development spending of $44.4 million versus $37.6 million. General and administrative expenses were $7.6 million, slightly below $8.3 million in the prior-year quarter.
As of June 30, 2026, Cabaletta held $225.1 million in cash, cash equivalents and short-term investments, up from $133.6 million at year-end 2025, and expects this to fund its operating plan into mid-2027. The company is advancing rese-cel through its RESET program, with registrational RESET-Myositis data expected in mid-2027 to support a planned BLA submission in 2H27, and a registrational SSc-associated ILD cohort targeted to start in 4Q26.
Cabaletta highlighted favorable safety data to support outpatient dosing, PC-free dosing strategies in multiple RESET trials, and expanded manufacturing partnerships with ElevateBio, Lonza and Cellares, including a 10-year commercial supply agreement to support large-scale, potentially lower-cost autologous cell therapy production.
Cabaletta Bio, Inc. reported results from its Annual Meeting of Stockholders held on June 9, 2026. Stockholders approved an amendment to the company’s charter to increase authorized common shares from 300,000,000 to 600,000,000, expanding the company’s capacity to issue new equity in the future.
As of April 20, 2026, there were 111,324,796 shares of voting common stock outstanding. Stockholders elected two Class I directors, Scott Brun, M.D. and Shawn Tomasello, MBA, each to serve terms expiring at the 2029 annual meeting. They also ratified Ernst & Young LLP as independent registered public accounting firm for the year ending December 31, 2026.
Stockholders approved, on a non-binding advisory basis, the compensation of the company’s named executive officers and passed a proposal permitting adjournment of the meeting if needed for additional proxy solicitation in connection with the charter amendment. Proposal 3, a plan amendment proposal, was withdrawn by the board and not voted upon.
Cabaletta Bio reported new clinical data for its CD19 CAR-T therapy rese-cel across myositis, systemic sclerosis and lupus, alongside development plans toward pivotal trials. In Phase 1/2 RESET-Myositis, 80% of dermatomyositis and antisynthetase patients would have met the planned registrational primary endpoint, with most maintaining immunomodulator‑free responses for up to 1.5 years.
RESET-SSc patients with interstitial lung disease showed a median 7.5% improvement in lung function at 36 weeks and high rCRISS response rates while off immunomodulators. In RESET-SLE, 75% of preconditioned patients with 12‑month follow-up achieved remission by DORIS criteria off immunomodulators, with favorable safety: over 90% of patients across trials had no or only mild cytokine release syndrome and almost all had no ICANS. Cabaletta plans a ~25‑patient SSc registrational study starting 4Q26, topline myositis data in mid‑2027, and a 2H27 BLA including adult and juvenile dermatomyositis.
Cabaletta Bio reported a larger first-quarter 2026 net loss of $43.5 million, or $0.39 per share, as it increased spending to advance its cell therapy pipeline. Research and development expenses rose to $37.4 million, while general and administrative costs were $6.9 million.
Cash, cash equivalents and short-term investments were $116.6 million as of March 31, 2026, down from $133.6 million at year-end 2025. The company also closed a $150 million registered direct offering in May 2026 and now expects to fund its operating plan into mid-2027.
Operationally, Cabaletta highlighted progress for its lead CAR T candidate rese-cel, including a pivotal RESET-Myositis cohort intended to support a planned Biologics License Application in 2027, expanding commercial manufacturing through a 10-year Cellares supply agreement, and multiple upcoming data readouts across its RESET trials in autoimmune diseases.
Cabaletta Bio is highlighting new clinical and manufacturing data for its investigational CD19 CAR T therapy rese-cel in autoimmune diseases. In pemphigus vulgaris, four patients received the lowest preconditioning-free dose; all completed at least 24 weeks of follow-up.
All four showed early clinical improvement, and two maintained compelling, drug-free responses through six months. Three of four had complete peripheral B cell depletion, with antibody levels against DSG3 and DSG1 decreasing alongside disease activity scores.
The company also reports that the first two clinical rese-cel doses manufactured on Cellares’ fully automated Cell Shuttle met all release specifications, with key quality metrics and early pharmacology profiles consistent with prior manual manufacturing runs. Cabaletta plans to test higher PC-free doses and expand across lupus and other autoimmune indications during 2026.
Cabaletta Bio, Inc. is selling 51,725,000 shares of common stock at $2.90 per share in an underwritten public offering. Gross proceeds are expected to be about $150 million, with estimated net proceeds of approximately $141 million after underwriting discounts and expenses.
As of March 31, 2026, Cabaletta held about $117 million in cash and cash equivalents. The company plans to use the new capital with existing cash mainly to expand clinical development and manufacturing for its CD19 CAR-T candidate rese-cel, and now believes it can fund operations into mid‑2027.
Cabaletta Bio filed a current report describing plans to present new clinical and translational data from four refractory pemphigus vulgaris patients treated with rese-cel in its RESET-PV trial. These patients received the lowest rese-cel dose without preconditioning chemotherapy and had 24–36 weeks of follow-up as of an April 2, 2026 data cut.
The company will share these data at the ASGCT 2026 Annual Meeting on May 14, 2026. Cabaletta also highlights broader development plans for rese-cel across several autoimmune diseases and notes it plans to add a new dose-escalation cohort to the RESET-SLE trial, with initial no-preconditioning dose data anticipated in the first half of 2026.
Cabaletta Bio, Inc. updated its corporate presentation highlighting progress of rese-cel (CABA-201), a CD19 CAR T cell therapy being developed for multiple autoimmune diseases. The company outlines Phase 1/2 data in myositis, systemic lupus erythematosus (SLE), systemic sclerosis (SSc), myasthenia gravis (MG) and pemphigus vulgaris (PV).
Early results show immunomodulator-free clinical responses in dermatomyositis and antisynthetase syndrome using a single weight-based dose, with patients achieving meaningful Total Improvement Score responses while tapering or stopping steroids. In SLE, SSc and MG, patients with active, refractory disease showed improvements in validated disease scores and reductions in autoantibodies after discontinuing multiple prior therapies.
The presentation emphasizes a safety profile that supports outpatient administration, with low rates and delayed onset of cytokine release syndrome and rare neurotoxicity across the first 40 rese-cel–treated autoimmune patients. Cabaletta also details an automation strategy with Cellares and exploration of no-preconditioning regimens aimed at scaling manufacturing, reducing cost of goods and expanding access across high-need autoimmune indications.
Cabaletta Bio reported fourth quarter and full year 2025 results and highlighted rapid progress of its CD19 CAR-T candidate rese-cel across multiple autoimmune diseases. R&D expenses rose to $36.2M for the quarter and $142.7M for the year, reflecting expansion of the RESET clinical program. The company ended December 31, 2025 with $133.6M in cash, cash equivalents and short-term investments and subsequently raised an additional $30.0M via ATM sales and warrant exercises. Management believes this cash position can fund the operating plan into the fourth quarter of 2026.
Cabaletta outlined a 17-patient single-arm registrational myositis cohort targeting a potential 2027 BLA submission, reported favorable early safety data in the first 40 rese-cel patients with preconditioning, and detailed an expanding Phase 1/2 dataset in systemic lupus erythematosus, systemic sclerosis and myasthenia gravis with complete Phase 1/2 data expected in the first half of 2026. The company is also advancing a no-preconditioning strategy, automated manufacturing with Cellares’ Cell Shuttle and plans multiple readouts in 2026 that are intended to support FDA discussions on registrational designs across indications.
Cabaletta Bio filed an 8-K outlining its 2026 strategic priorities for rese-cel, its investigational CD19 CAR T therapy for autoimmune diseases. The company has initiated a dermatomyositis and antisynthetase myositis registrational cohort expected to evaluate 17 patients, targeting a Biologics License Application submission for rese-cel in myositis next year. Cabaletta has aligned with the FDA on new registrational cohort designs in systemic lupus erythematosus and lupus nephritis and received a Regenerative Medicine Advanced Therapy designation for systemic sclerosis, with further regulatory alignment updates planned in 1H26 and mid-2026. The company also obtained IND clearance to use Cellares’ automated Cell Shuttle platform for rese-cel manufacturing and expects multiple Phase 1/2 data readouts across RESET trials in 1H26.
Cabaletta Bio, Inc. filed an 8-K announcing it released financial results for the third quarter ended September 30, 2025. The press release detailing these results was furnished as Exhibit 99.1.
The company stated that the information in Item 2.02, including Exhibit 99.1, is being furnished and is not deemed “filed” under Section 18 of the Exchange Act, nor incorporated by reference into Securities Act or Exchange Act filings except as specifically referenced. Cabaletta Bio’s common stock trades on the Nasdaq Global Select Market under the symbol CABA.
Cabaletta Bio reported an administrative update. The company filed an 8-K stating it posted an updated corporate presentation on October 29, 2025, available on the Investors & Media section of its website. The presentation is attached as Exhibit 99.1 and incorporated by reference. The filing is presented under Item 8.01 (Other Events) with related exhibits listed under Item 9.01(d).
Cabaletta Bio (CABA) furnished new rese‑cel clinical data and development updates across RESET‑Myositis, RESET‑SSc and RESET‑SLE, aligned to an ACR Convergence 2025 data cut as of September 11, 2025.
In RESET‑Myositis, all 4 DM/ASyS patients who met registrational criteria with sufficient follow‑up achieved immunomodulatory‑free TIS moderate or major improvement at week 16; safety included 4 of 13 with grade 1 CRS and no ICANS. The company will initiate a DM/ASyS registrational cohort enrolling 14 patients with a 16‑week primary endpoint, with enrollment starting this quarter. In IMNM, 2 of 4 with sufficient follow‑up achieved TIS at week 24 and additional Phase 1/2 enrollment is planned.
In RESET‑SSc, 4 of 4 patients with at least 3 months’ follow‑up achieved an rCRISS‑25 response off immunomodulators and steroids; low‑grade CRS occurred in three patients and one previously reported grade 3 ICANS event. In RESET‑SLE (n=9), three of four SLE patients achieved DORIS and renal responses were seen in lupus nephritis; all nine were off immunomodulators at cut‑off, with a median 8‑point SLEDAI‑2K reduction. A no‑preconditioning, weight‑based dose cohort will be added to RESET‑SLE, with initial data anticipated in 2026.
Cabaletta Bio reported early clinical and translational data for its autologous CAR T candidate rese-cel from three patients. All three showed substantial peripheral B cell depletion within the first month and rapid reductions in disease‑linked autoantibodies in two patients, consistent with deep tissue B cell depletion. Rese-cel had a generally tolerable safety profile: no ICANS was reported, one transient fever consistent with grade 1 cytokine release syndrome occurred, and one patient required a short steroid course for a post‑infusion flare but tapered below baseline by 3 months. Meaningful early clinical responses were seen by Pemphigus Disease Area Index (PDAI) scores: Patient 1 improved from 24 to 10 at 4 months, Patient 2 from 83 to 3 at 3 months, and Patient 3 from 22 to 2 at 1 month.
Cabaletta Bio, Inc. furnished an updated corporate presentation for investors under a Regulation FD disclosure. On September 3, 2025, the company posted this new “Corporate Presentation” to the “Investors & Media” section of its website and furnished it as Exhibit 99.1. The presentation is dated September 2025 and is provided as supplemental information only, as it is being furnished rather than filed and is not automatically incorporated into other Securities Act or Exchange Act filings unless specifically referenced.