Cabaletta Bio, Inc. (CABA)

Cabaletta Bio, Inc. (CABA) Presents at Citi Annual Global Healthcare Conference 2025 Transcript

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.

PHILADELPHIA, Nov. 04, 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 the following upcoming investor conferences in November and December:

Cabaletta Bio, Inc. (NASDAQ: CABA - Get Free Report) saw a significant growth in short interest in the month of October. As of October 15th, there was short interest totaling 11,220,000 shares, a growth of 85.8% from the September 30th total of 6,040,000 shares. Currently, 13.8% of the shares of the stock are short sold. Based

– All myositis patients in the Phase 1/2 DM/ASyS cohort with sufficient follow-up who met key registrational inclusion criteria exceeded the registrational primary endpoint, demonstrating major TIS responses with no immunomodulators – – Myositis registrational trial being initiated this quarter with a planned cohort of 14 DM/ASyS patients and a 16-week primary endpoint – moderate or major TIS while off immunomodulators and on no or low-dose steroids – consistent with FDA alignment on key trial parameters – – All systemic sclerosis patients with sufficient follow-up demonstrated ongoing, transformative clinical responses off all immunomodulators and steroids – – Seven of 8 lupus patients with sufficient follow-up achieved DORIS or renal response; RESET-SLE™ trial expanding to include a no preconditioning cohort with initial clinical data expected in 2026 – – 76 patients enrolled at 77 clinical trial sites globally as of October 24, 2025 – PHILADELPHIA, Oct. 27, 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 positive 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). These data are being presented in multiple oral and poster presentations at the ongoing American College of Rheumatology (ACR) Convergence 2025, which is being held at the McCormick Place Convention Center in Chicago, Illinois, from October 24-29, 2025.

– Gavel brings highly relevant CAR T experience from Legend Biotech where he led the launch and commercialization of CARVYKTI® from 2018 until 2025 – PHILADELPHIA, Oct. 14, 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 the appointment of Steve Gavel as Chief Commercial Officer, effective immediately. In his role, Mr.

– Complete B cell depletion, rapid reduction in autoantibodies and near-complete resolution of clinical symptoms in two of three refractory patients; all three patients remained off immunomodulators since infusion and are off or tapering steroids as of the data cut-off –

Cabaletta Bio (CABA) offers pioneering CAR T-cell therapy for autoimmune diseases, with recent data showing promising efficacy and manageable safety. CABA's lead candidate, rese-cel, has demonstrated meaningful responses in lupus and scleroderma, with additional pivotal data and FDA discussions expected in 2025-2027. Despite a recent stock rally and a strong pipeline, CABA faces significant cash runway concerns, making future dilution likely before regulatory milestones.

Cabaletta Bio (CABA) might move higher on growing optimism about its earnings prospects, which is reflected by its upgrade to a Zacks Rank #2 (Buy).

Cabaletta Bio (CABA) Q2 Loss Widens 30%

– Registrational cohort enrollment in RESET-Myositis™ trial on track to start in 2H25 with anticipated 2027 BLA submission for rese-cel in myositis –

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-funded warrants in lieu thereof) and (ii) in lieu of common stock, to certain investors, pre-funded warrants to purchase an aggregate of up to 10,800,000 shares of its common stock and accompanying warrants to purchase an aggregate of 10,800,000 shares of common stock (or pre-funded warrants in lieu thereof), at an exercise price of $0.00001 per pre-funded warrant. Cabaletta also granted the underwriters a 30-day option to purchase up to an additional 15,000,000 shares of common stock and/or warrants at the public offering price, less underwriting discounts and commissions. The common stock and pre-funded warrants are being sold in combination with an accompanying warrant to purchase one share of common stock (or a pre-funded warrant in lieu thereof) issued for each share of common stock or pre-funded warrant sold. The accompanying warrant has an exercise price of $2.50 per share, is immediately exercisable from the date of issuance and will expire fifteen months from the date of issuance. The combined offering price of each share of common stock and accompanying common stock warrant is $2.00. The combined offering price of each pre-funded warrant and accompanying common stock warrant is $1.99999.

Cabaletta Bio's CAR T-cell therapy shows durable efficacy in autoimmune diseases, with manageable side effects and promising early clinical data updates. The company plans a BLA submission for myositis in 2027, supported by FDA's RMAT designation and a focused clinical trial strategy. Financial risk is significant: current cash plus a new offering extends runway only modestly, likely insufficient to reach commercialization without further dilution.

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 that it has commenced an underwritten public offering of shares of its common stock and accompanying warrants to purchase shares of its common stock (or pre-funded warrants in lieu thereof) and, in lieu of common stock, to certain investors, pre-funded warrants to purchase shares of its common stock and accompanying warrants to purchase shares of its common stock (or pre-funded warrants in lieu thereof). Cabaletta also intends to grant the underwriters a 30-day option to purchase up to an additional fifteen percent (15%) of the shares of common stock and warrants offered in the public offering. All of the shares, pre-funded warrants and accompanying common stock warrants to be sold in the proposed offering are to be sold by Cabaletta.

– 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 –