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PHILADELPHIA - Cabaletta Bio, Inc. (NASDAQ:CABA), a clinical-stage biotech company with a market capitalization of $119 million and strong liquidity position according to InvestingPro data, announced on Wednesday new clinical data showing that its investigational cell therapy rese-cel demonstrated positive responses in patients with myositis, lupus, and systemic sclerosis who were able to discontinue immunomodulatory drugs and steroids.
According to the company’s press release statement, seven of eight myositis patients achieved clinically meaningful total improvement score responses while off immunomodulators and either off or tapering steroids. All systemic lupus erythematosus patients without nephropathy achieved definition of remission in SLE, and both scleroderma patients showed improvement in modified Rodnan Skin Score. While the clinical results are promising, InvestingPro data shows the company is currently unprofitable with an EBITDA of -$132.4 million in the last twelve months.
The safety profile showed that among 18 patients with at least four weeks of follow-up, 94% experienced either no cytokine release syndrome or only Grade 1 CRS (transient fever), and 89% had no immune effector cell-associated neurotoxicity syndrome.
Cabaletta is advancing its RESET clinical trial program, which has enrolled 51 patients with 24 dosed across its U.S. clinical site network as of May 30, 2025. The company plans to initiate two registrational myositis cohorts with approximately 15 patients each this year.
"These new clinical and translational findings reinforce our belief that a single, weight-based dose of rese-cel leads to deep B cell depletion and compelling clinical data," said David J. Chang, Chief Medical Officer of Cabaletta, in the press release.
Cabaletta has scheduled registrational discussions with the FDA for SLE/LN in the third quarter of 2025, and anticipates similar discussions for scleroderma in the fourth quarter of 2025 and myasthenia gravis in the first half of 2026. The company maintains a healthy current ratio of 3.96 and holds more cash than debt on its balance sheet, though InvestingPro analysis indicates rapid cash burn remains a concern. Analysts have set price targets ranging from $3 to $28, reflecting the market’s mixed outlook on the company’s development pipeline.
The data was presented in three oral presentations at the European Alliance of Associations for Rheumatology 2025 Congress in Barcelona, Spain.
In other recent news, Cabaletta Bio has announced a repricing of stock options for its employees, including executive officers and certain consultants. This move, approved by the Board of Directors, aims to motivate and retain key personnel by setting a new exercise price of $1.92 per share for options under the company’s 2018 and 2019 Stock Option and Grant Plans. Meanwhile, UBS has adjusted its price target for Cabaletta Bio to $7.00 from $10.00, while maintaining a Buy rating. This decision follows the company’s fourth-quarter 2024 earnings report, which met expectations, and the report of a new Grade 3 ICANS case in the RESET-SSc trial. The trial will continue at the current dosage, with additional precautions now in place to prevent further ICANS cases. Stifel has also revised its outlook on Cabaletta Bio, reducing the stock’s price target to $13 from $26, but still endorsing it with a Buy rating. This revision comes amid discussions about the safety of CAR-T therapies and the introduction of new mitigation strategies to address potential risks. Despite the lowered price targets, both UBS and Stifel maintain a positive outlook on Cabaletta Bio’s potential.
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