Cabaletta Bio, Inc. Stock Price, News & Analysis

Cabaletta Bio (NASDAQ: CABA), a clinical-stage biotech company developing curative targeted cell therapies for autoimmune diseases, has announced a public offering of common stock and warrants. The offering includes common stock shares, pre-funded warrants, and accompanying warrants to purchase common stock. The company will grant underwriters a 30-day option to purchase up to 15% additional shares and warrants. Jefferies, TD Cowen, and Cantor are serving as joint book-running managers. The offering is expected to close around June 12, 2025, subject to market conditions and customary closing requirements. The securities will be offered through a shelf registration statement on Form S-3 that was declared effective on March 31, 2025.

Cabaletta Bio (CABA) presented promising new clinical data for rese-cel (resecabtagene autoleucel) at EULAR 2025 Congress. The data showed strong efficacy across multiple autoimmune conditions: 7/8 myositis patients achieved meaningful responses, all SLE patients without nephropathy reached remission, and both scleroderma patients demonstrated significant skin improvements. Notably, these responses were achieved while patients discontinued immunomodulators and steroids. Safety data from 18 patients showed 94% had either no or Grade 1 CRS, and 89% had no ICANS. The company is advancing its RESET clinical program with 51 patients enrolled and 24 dosed across their network. Cabaletta plans registrational discussions with FDA for SLE/LN in Q3 2025, scleroderma in Q4 2025, and myasthenia gravis in 1H 2026.

Cabaletta Bio (NASDAQ: CABA), a clinical-stage biotech company developing curative targeted cell therapies for autoimmune diseases, announced its participation in the upcoming Jefferies Global Healthcare Conference. The company will engage in a fireside chat on June 4, 2025, at 11:05 a.m. ET in New York. Investors and interested parties can access a live webcast of the presentation through Cabaletta's website, with replays available for 30 days following the event.

Cabaletta Bio (NASDAQ: CABA) has announced plans for a 2027 BLA submission for rese-cel in myositis following FDA alignment. The company received RMAT designation for rese-cel in treating myositis, a severe autoimmune disease affecting 80,000 U.S. patients. The RESET-Myositis trial will include two registrational cohorts of ~15 patients each: one for dermatomyositis/antisynthetase syndrome and another for immune-mediated necrotizing myopathy. The primary endpoint will use the total improvement score (TIS) within 26 weeks of rese-cel infusion. Currently, 44 patients are enrolled and 23 dosed across the RESET program. The company has $131.8M cash as of March 2025, funding operations into H1 2026. New clinical data will be presented at EULAR 2025 Congress in June.

Cabaletta Bio (NASDAQ: CABA) has reported its Q4 and full year 2024 financial results. The company is enrolling approximately one patient per week across its RESET™ clinical program, with 33 patients enrolled across 56 active clinical sites in the U.S. and Europe as of March 14, 2025.

Key highlights include:

• FDA meeting planned for 1H25 to align on myositis registrational trial designs
• Cash position of $164.0 million as of December 31, 2024, providing runway into 1H26
• Three oral presentations on rese-cel planned for EULAR 2025 Congress in June

In clinical developments, the company reported positive responses across multiple indications: three out of four SLE patients achieved DORIS remission, the first lupus nephritis patient achieved complete renal response, and dermatomyositis patients showed improvement. However, one systemic sclerosis patient experienced a grade 3 ICANS toxicity event, which resolved following treatment.

Cellares and Cabaletta Bio have successfully completed their Technology Adoption Program (TAP) for manufacturing rese-cel using the Cell Shuttle™ platform. The collaboration demonstrates the capability of Cellares' IDMO Smart Factory to automate and scale manufacturing for Cabaletta's clinical-stage CAR T program targeting autoimmune diseases.

The TAP successfully achieved automated, concurrent production of multiple rese-cel batches on a single Cell Shuttle. The platform performed all unit operations automatically, including cell isolation, enrichment, gene editing, activation, and expansion, meeting predefined quality requirements.

This partnership could enable Cabaletta Bio to meet global patient demand across multiple autoimmune conditions, including:

• Myositis (~70,000 US patients)
• Scleroderma (~90,000 US patients)
• Lupus nephritis (~100,000 US patients)

Through Cellares' network of planned global IDMO Smart Factories in the US, Europe, and Japan, the collaboration aims to reduce costs and enable rapid technology transfer for global expansion of rese-cel manufacturing.

Cabaletta Bio (Nasdaq: CABA), a clinical-stage biotechnology company specializing in curative targeted cell therapies for autoimmune diseases, has announced its participation in the TD Cowen 45th Annual Health Care Conference. The company will engage in a fireside chat on March 3, 2025, at 11:50 a.m. ET in Boston, MA.

Interested parties can access a live webcast of the presentation through the News and Events section on www.cabalettabio.com. The presentation recording will remain available for replay on the company's website for 30 days following the event.

Cabaletta Bio (NASDAQ: CABA) reported updated clinical data for resecabtagene autoleucel (rese-cel) across multiple autoimmune diseases. Key highlights from the first 10 patients include:

- Three SLE patients achieved DORIS remission
- First lupus nephritis patient reached complete renal response
- First dermatomyositis patient maintained major TIS improvement
- 90% of patients experienced either no CRS or Grade 1 CRS
- Deep B cell depletion observed in all patients

The RESET clinical development program has expanded to 50 clinical sites across the U.S. and Europe, with 26 patients enrolled as of February 13, 2025. The company plans to meet with FDA in the first half of 2025 to discuss registrational trial designs. Patient enrollment has accelerated to approximately one patient per week since November.

Cabaletta Bio (NASDAQ: CABA) has reported updated clinical data for resecabtagene autoleucel (rese-cel) across multiple autoimmune indications. The data covers 10 patients treated through the RESET clinical development program, showing significant clinical responses:

Key highlights include three SLE patients achieving DORIS remission, the first lupus nephritis patient reaching complete renal response, and the first dermatomyositis patient maintaining major TIS improvement. Notably, all these patients discontinued immunosuppressants and steroids. The safety profile remains favorable, with 90% of patients experiencing either no or Grade 1 CRS, and 90% showing no ICANS.

The company's clinical trial network has expanded to 50 sites across the U.S. and Europe, with 26 patients enrolled in the RESET program as of February 13, 2025. Deep B cell depletion was observed in all patients post-treatment, with B cell repopulation typically starting around 2 months post-infusion.