CABA

Preconditioning-free (PC-free) 6-to-9-month clinical data with a single infusion of the lowest dose of rese-cel in the RESET-PV® study presented today at ASGCT 2026 Annual Meeting along with initial rese-cel translational data using Cellares’ industrialized, automated manufacturing PC-free rese-cel initial data from the lowest dose RESET-SLE™ cohort expected in 1H26 Pivotal RESET-Myositis® cohort with outpatient dosing option progressing to support first planned BLA submission for rese-cel next year Second pivotal indication for advancement to be announced after presentation of complete Phase 1/2 lupus and scleroderma data during June 2026 EULAR Congress PHILADELPHIA, May 14, 2026 (GLOBE NEWSWIRE) -- Cabaletta Bio, Inc. (Nasdaq: CABA), a late-stage clinical biotechnology company focused on developing and launching curative targeted cell therapies designed specifically for patients with autoimmune diseases, today reported financial results for the first quarter ended March 31, 2026, and provided a business update. “Since January, while advancing our myositis pivotal trial and planning to initiate a second pivotal indication, we announced that we have signed a long-term commercial supply agreement with Cellares which provides the potential to produce rese-cel for thousands of patients per year at among the lowest cost of goods in the industry with minimal capital investment. In addition, today we are presenting data at ASGCT demonstrating that without preconditioning, even the lowest dose of rese-cel demonstrated compelling drug-free clinical responses in half of the pemphigus vulgaris patients through 6-months of follow-up,” said Steven Nichtberger, M.D., Chief Executive Officer of Cabaletta. “Later this quarter, we expect to announce initial data from the lowest dose cohort of lupus patients dosed without preconditioning. In the second half of 2026, we expect to report longer-term, PC-free rese-cel data from the lowest dose RESET-PV and RESET-SLE cohorts as well as data from patients treated with a higher PC-free dose of rese-cel. Bolstered by our recent oversubscribed financing, we believe we are well-positioned to advance rese-cel to BLA submission and potential commercial launch while continuing to differentiate and deliver rese-cel to autoimmune disease patients at scale.” Recent Operational Highlights and Upcoming Anticipated Milestones Rese-cel: Rese-c...

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 Automated manufacturing of rese-cel with Cellares’ Cell Shuttle™ underway in the RESET™ clinical program, offering the potential to produce rese-cel for thousands of patients per year with minimal capital investment Pivotal trial designs announced for SLE and LN single arm cohorts, each with ~25 patients; on track to announce SSc design in 1H26; FDA registrational design discussions and no preconditioning data will inform pivotal plans across the rese-cel program Complete Phase 1/2 data to be presented in 1H26 from the RESET-SSc™, RESET-SLE and RESET-MG™ trials evaluating rese-cel with preconditioning PHILADELPHIA, March 23, 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 reported financial results for the fourth quarter and full year ended December 31, 2025, and provided a business update. “As we advance our core clinical programs for rese-cel with preconditioning and standard manufacturing, we have meaningfully advanced two potentially transformative innovations: rese-cel with no preconditioning and automated manufacturing using the Cellares Cell Shuttle. Clinical data on both innovations are on track to be shared in the first half of this year with durability data to follow later this year. Clinical data currently suggest that rese-cel offers a competitive profile that may reliably deliver an immune reset following a single, weight-based infusion with a safety profile that facilitates outpatient delivery with – or potentially without – preconditioning,” said Steven Nichtberger, M.D., Chief Executive Officer of Cabaletta. Recent Operational Highlights and Upcoming Anticipated Milestones Rese-cel: Rese-cel (resecabtagene autoleucel) is an investigational, autologous CAR T cell therapy engineered with a fully human CD19 binder and a 4-1BB co-stimulatory domain, designed specifically for the treatment of autoimmune diseases. Administered...

Rese-cel data presented at multiple medical meetings demonstrated potentially transformative, drug-free clinical responses with a favorable safety profile for autoimmune patients supporting outpatient use All myositis patients in the Phase 1/2 DM/ASyS cohort with sufficient follow-up who would have met key criteria for the registrational cohort met the registrational, 16-week primary endpoint Planned BLA submission for rese-cel in 2027 based on 14-patient, single-arm DM/ASyS registrational cohort initiating enrollment this quarter within the RESET-Myositis™ trial FDA alignment on additional registrational cohort designs for RESET-SSc™ and RESET-SLE™ anticipated by year-end 2025 PHILADELPHIA, Nov. 10, 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 reported financial results for the third quarter ended September 30, 2025, and provided a business update. “Our team continued to execute with discipline and precision to extend our leadership through the RESET™ clinical development program. Rapid enrollment has resulted in multiple clinical data presentations highlighting rese-cel’s ability to deliver drug-free, transformative clinical responses for patients across multiple autoimmune diseases,” said Steven Nichtberger, M.D., Chief Executive Officer of Cabaletta. “In addition, the early no preconditioning data from our initial dose cohort support our plan to evaluate the efficacy and durability of rese-cel in lupus and other autoimmune patients using a single, weight-based dose without preconditioning.” Recent Operational Highlights and Upcoming Anticipated Milestones Rese-cel: Rese-cel (resecabtagene autoleucel, formerly CABA-201) is an investigational, autologous CAR T cell therapy engineered with a fully human CD19 binder and a 4-1BB co-stimulatory domain, designed specifically for the treatment of autoimmune diseases. Administered as a single, weight-based infusion, rese-cel is intended to transiently and deeply deplete CD19-positive cells, with the goal of resetting the immune system and achieving durable clinical responses without the need for chronic therapy. Cabaletta is evaluating rese-cel in the RESET (REstoring SElf-Tolerance) clinical development program, wh...

Cabaletta Bio (CABA) drew fresh attention from investors after announcing encouraging clinical trial results for rese-cel in several autoimmune diseases. Presentations at the American College of Rheumatology Convergence showcased their progress and prepared the company for key regulatory updates. See our latest analysis for Cabaletta Bio. All this news comes on the heels of a remarkable run for Cabaletta Bio’s share price, which climbed 86% over the last 90 days, clearly reflecting growing excitement as clinical and business milestones stack up. Even with a 36% decrease in total shareholder return over the past year, recent momentum hints at renewed optimism and shifting risk perceptions following the company’s strong data presentations and expansion of investor outreach. If Cabaletta’s recent surge caught your attention, now is a smart time to see what other healthcare innovators are making waves — See the full list for free. After such an impressive rally, investors are now left to wonder whether Cabaletta Bio’s current valuation still offers upside or if the market has already factored in all the company’s potential growth. Cabaletta Bio’s shares are trading at a price-to-book ratio of 1.4x, notably below the US Biotechs industry average of 2.5x. This suggests that investors are currently valuing the stock at a significant discount compared to its peers when measured by net asset value. The price-to-book ratio compares the market value of a company’s shares with its book value. For biotech firms like Cabaletta Bio, where traditional earnings measures may not be relevant due to a lack of profitability or revenue, price-to-book can highlight how the market views the company’s assets and future prospects relative to others in the space. This below-average price-to-book multiple could indicate market caution around Cabaletta’s profitability outlook, or possibly skepticism about the realization of asset value given clinical stage risks. Still, the disparity with industry and peer averages is stark. There could be a sizable gap for the market to close if sentiment improves for the company. See what the numbers say about this price — find out in our valuation breakdown. Result: Price-to-Book of 1.4x (UNDERVALUED) However, clinical-stage uncertainties and consistent net losses remain key risks. These factors could quickly shift sentiment and impact Cabaletta Bio’...

Cabaletta Bio (CABA) has attracted fresh attention after presenting early data from its RESET-PV clinical trial at the ESGCT Congress. The company reported that its CAR T cell therapy, rese-cel, achieved promising results in pemphigus vulgaris patients without preconditioning. See our latest analysis for Cabaletta Bio. Following the RESET-PV update, Cabaletta Bio’s share price has seen dramatic swings: a 42% surge in the past three months captures the excitement, while the 1-year total shareholder return remains deeply negative at -45%. This jump reflects renewed optimism around clinical progress, but the volatile track record highlights how investor sentiment often pivots quickly on biotech headlines. Long-term returns remain mixed. If breakthrough therapies are on your radar, it’s worth exploring other innovators in the space. See the full list of healthcare stocks at See the full list for free. With Cabaletta Bio’s bold data fueling debate and shares still well below analyst price targets, investors have to ask: Is the market overlooking the potential here, or is all the good news already built in? Based on its price-to-book ratio of 1.2x, Cabaletta Bio's stock appears notably cheap when compared to both its industry and its peer averages, especially given the last close at $2.32 per share. The price-to-book ratio compares a company’s market value to its book value, giving investors insight into how much they are paying for the assets net of liabilities. For biotechs, where profitability may be far off, this metric offers a baseline to gauge market expectations versus reality. Cabaletta Bio trades at less than half the US Biotechs industry average (2.5x) and at a fraction of the peer group average (30.9x). This deep discount suggests investors remain highly skeptical, despite the company’s bold clinical advancements. If market sentiment improves or the science delivers, there could be significant rerating potential to levels that better reflect industry standards. See what the numbers say about this price — find out in our valuation breakdown. Result: Price-to-Book Ratio of 1.2x (UNDERVALUED) However, persistent losses and a sharp one-year decline show that clinical setbacks or continued lack of profitability could quickly reverse investor optimism. Find out about the key risks to this Cabaletta Bio narrative. Switching gears, the Simply Wall St DCF model...

– 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 – – FDA meetings to align on the next wave of registrational cohorts for rese-cel anticipated in 3Q25 for lupus, 4Q25 for systemic sclerosis and 1H26 for myasthenia gravis – – Rese-cel clinical data presented at the EULAR 2025 Congress reinforce compelling clinical responses with nearly all patients off immunomodulatory medications and steroids; favorable risk-benefit profile observed across myositis, lupus and systemic sclerosis patients – – Closed $100 million public offering to support late clinical-stage development and commercial readiness activities for rese-cel; cash runway extended into 2H26 – PHILADELPHIA, Aug. 07, 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 reported financial results for the second quarter ended June 30, 2025, and provided a business update. “We achieved significant progress advancing rese-cel in the first half of 2025, including aligning with the FDA on a registrational pathway for rese-cel in myositis to support an anticipated 2027 first BLA submission. We also presented new data that reinforce the therapeutic potential of rese-cel across several autoimmune diseases,” said Steven Nichtberger, M.D., Chief Executive Officer of Cabaletta. “As our early clinical data are emerging, enrollment in dermatomyositis, scleroderma and myasthenia gravis has been particularly robust. We look forward to building on this momentum by initiating the myositis registrational program, obtaining regulatory alignment on registrational pathways for two additional indications this year and presenting new clinical data at multiple scientific meetings in the second half of 2025, including complete Phase 1/2 data from RESET-Myositis as well as initial clinical data from RESET-PV™ evaluating rese-cel without pre-conditioning.” Recent Operational Highlights and Upcoming Anticipated Milestones Rese-cel: Rese-cel (resecabtagene autoleuce...

– FDA meeting to align on myositis registrational trial designs for rese-cel in 1H25 on track – – Enrolling approximately one patient per week across the RESET™ clinical development program since ACR Convergence presentation in November 2024 with 33 patients enrolled across 56 active clinical trial sites in the U.S. & Europe as of March 14, 2025 – – Clinical and translational data on rese-cel to be presented in three oral presentations at the EULAR 2025 Congress in June – – Operational runway into 1H26 with cash and cash equivalents of $164.0 million as of December 31, 2024 – PHILADELPHIA, March 31, 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 reported financial results for the fourth quarter and full year ended December 31, 2024, and provided a business update. “We are looking forward to meeting with the FDA to align on registrational trial designs in myositis, which affects approximately 70,000 patients in the U.S., by leveraging our emerging clinical data and our efficient development strategy. Since presenting clinical and translational data from the RESET program demonstrating that a single weight-based dose of rese-cel was able to provide potentially transformative clinical responses after discontinuation of all immunosuppressants and while off or tapering off steroids, we have seen robust physician and patient interest in the RESET clinical program,” said Steven Nichtberger, M.D., Chief Executive Officer of Cabaletta. “In addition, we are advancing innovations that have the potential to enhance the patient and physician experience, including an apheresis-free approach and evaluation of a RESET-PV™ cohort with no preconditioning.” Recent Operational Highlights and Upcoming Anticipated Milestones Rese-cel (resecabtagene autoleucel, formerly referred to as CABA-201): Autologous, engineered T cells designed with a chimeric antigen receptor containing a fully human CD19 binder and a 4-1BB co-stimulatory domain infused as a single weight-based dose as a potential treatment for a broad range of autoimmune diseases where B cells contribute to the initiation and/or maintenance of disease. Rheumatology Portfolio Systemic sclerosis (SSc) In March 2025, Cabaletta le...