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 –

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.

– Two subtype specific cohorts with ~15 patients each added to the ongoing RESET-Myositis™ trial – – RMAT designation granted for rese-cel in myositis, which is a disabling, multi-system autoimmune disease affecting approximately 80,000 U.S. patients with no approved treatments other than monthly IVIg – – Multiple Phase 1/2 disease cohorts fully enrolled across the RESET™ clinical development program; 44 patients enrolled and 23 patients dosed as of May 9, 2025 – – 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 – PHILADELPHIA, May 15, 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 plans for an anticipated 2027 rese-cel BLA submission following a recent U.S. Food and Drug Administration (FDA) meeting on a proposed registrational cohort design for the RESET-Myositis trial of rese-cel (resecabtagene autoleucel, formerly known as CABA-201). “Myositis is a severe, disabling, and potentially life-threatening multi-system disease that affects approximately 80,000 patients in the U.S. with a three-fold increased mortality risk primarily due to interstitial lung disease, cardiovascular disease and an increased risk of cancer.

– 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.

SOUTH SAN FRANCISCO, Calif.--(BUSINESS WIRE)--Cellares, the first Integrated Development and Manufacturing Organization (IDMO), has concluded the Technology Adoption Program (TAP) on its automated cell therapy manufacturing Cell Shuttle™ for resecabtagene autoleucel, (rese-cel, previously known as CABA-201). Rese-cel is the lead clinical candidate in development by Cabaletta Bio, a biotechnology company focused on developing and launching the first curative targeted cell therapies designed spec.

PHILADELPHIA, Feb. 26, 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 TD Cowen 45th Annual Health Care Conference on Monday, March 3, 2025, at 11:50 a.m. ET in Boston, MA.

– Clinical efficacy continued to deepen over time with three SLE patients in DORIS remission, the first LN patient achieving complete renal response, and the first dermatomyositis patient maintaining a major TIS improvement; each of these patients discontinued all immunosuppressants and are off or tapering  steroids as of the latest follow-up –