CABA — what changed in the latest 10-Q

Text added vs the prior filing · source: 10-Q · 2026-08-13

• We are evaluating rese-cel across the RESETTM (REstoring SElf-Tolerance) clinical development program, which includes multiple ongoing company-sponsored clinical trials in rheumatology, neurology, and dermatology with disease-specific cohorts designed to evolve directly into registrational studies. …

• At the EULAR 2026 Congress (EULAR) held in June 2026, our presentations included data from 52 evaluable autoimmune disease patients living with myositis (17), lupus (20) and systemic sclerosis (15) who were treated with rese-cel, including the first juvenile dermatomyositis (JDM) patient and the fir…

• In addition, at EULAR, we reported updated safety data from the first 63 patients treated with rese-cel with PC across four RESETTM trials. This follows a review of the efficacy and safety of rese-cel in a February 2026 Nature Biotechnology publication, along with all other commercial and academic c…

• The RESET-Myositis® Phase 1/2 clinical trial is designed to treat at least six patients with DM or ASyS, at least six patients with IMNM, as well as at least six patients with juvenile idiopathic inflammatory myopathy (JIIM), all in separate parallel cohorts, with a

• single weight-based dose of 1.0 x 106cells/kg. We announced the U.S. Food and Drug Administration (FDA) granted Fast Track Designation for rese-cel for the treatment of patients with DM and Orphan Drug Designation for rese-cel for the treatment of myositis in January and February 2024, respectively.…

Text removed vs the prior filing · source: 10-Q · 2026-05-14

• In December 2025, we initiated a registrational trial with rese-cel for patients with dermatomyositis or anti-synthetase syndrome. In addition, we have ongoing Phase 1/2 trials evaluating rese-cel with a standard preconditioning regimen, fludarabine and cyclophosphamide, in systemic lupus erythemato…

• In addition to our development program across multiple indications using standard preconditioning regimens, based on early data from a Phase 1/2 trial evaluating rese-cel without preconditioning in pemphigus vulgaris patients, we are evaluating rese-cel without preconditioning in non-renal SLE and L…

• In January 2026, we announced investigational new drug, or IND, clearance for rese-cel to be manufactured using an automated manufacturing platform - the Cell ShuttleTM from Cellares Corporation, or Cellares - offering the potential for scalability to produce rese-cel for thousands of patients per y…

• The RESET-Myositis® Phase 1/2 clinical trial is designed to treat at least six patients with DM or ASyS, at least six patients with IMNM, as well as at least six patients with juvenile idiopathic inflammatory myopathy, or JIIM, all in separate parallel cohorts, with a single weight-based dose of 1.0…

• SLE is a chronic, potentially severe, autoimmune disease, most commonly impacting young women between the ages of 15 and 40 with higher frequency and more severity in people of color, where the immune system attacks healthy tissue throughout the body. SLE affects an estimated up to 320,000 patients …

Text added vs the prior filing · source: 10-Q · 2026-08-13

• of common stock will be issued for nominal or no additional consideration, which will result in dilution to the then existing holders of our common stock and will increase the number of shares eligible for resale in the public market.

• could disrupt our business and have a material adverse effect on our financial condition and results of operations. Even if we are able to successfully transition these services, they may be more expensive or less efficient than the services we are receiving from Penn during the transition period.

• Transferring processes, methods, and know-how to a new manufacturers or manufacturing site is complex and time-consuming, may necessitate method bridging/transfer, and can introduce site-specific changes in equipment, raw materials, or procedures. As is customary, we have been, and may continue, opt…

• additional manufacturing sites. Regulators expect sponsors to demonstrate comparability—analytically, and when needed via nonclinical or clinical bridging—between products made before and after process changes and across manufacturing sites. If our manufacturers fail to demonstrate adequate comparab…

• Our manufacturing process may be susceptible to technical and logistics delays or failures due to the fact that each patient is an independent manufacturing lot, and also due to unique supply chain requirements. These include the collection of white blood cells from patients’ blood, variability in t…

Text removed vs the prior filing · source: 10-Q · 2026-05-14

• provide Penn with the right to terminate such addenda with limited notice periods. If we do not have adequate personnel and capabilities at the time that we assume responsibilities for such services, we may not be successful in effectively or efficiently transitioning these services from Penn, which…

• The Minaris Agreement is scheduled to expire upon completion of Minaris' services related to MuSK-CAART and rese-cel. In August 2023, and as extended in August 2024, we entered into an agreement with Minaris to serve as one of our manufacturing partners for the RESETTM clinical trials through August…

• Transferring processes, methods, and know-how to a new manufacturers or manufacturing site is complex and time-consuming, may necessitate method bridging/transfer, and can introduce site-specific changes in equipment, raw materials, or procedures. As is customary, we have been, and may continue, opt…

• Our manufacturing process may be susceptible to technical and logistics delays or failures due to the fact that each patient is an independent manufacturing lot, and also due to unique supply chain requirements. These include the collection of white blood cells from patients’ blood, variability in t…

• an extended period of time to investigate and remedy the contamination. Further, as product candidates are developed through preclinical studies to late-stage clinical trials toward approval and commercialization, it is common that various aspects of the development program, such as manufacturing me…

Text removed vs the prior filing · source: 10-Q · 2026-05-14

• Aggregate Number of Securities Subject to Trading Arrangement

• * Denotes whether the trading plan is intended, when adopted, to satisfy the affirmative defense of Rule 10b5-1(c).

• (1) Except as indicated by footnote, each trading arrangement permitted or permits transactions through and including the earlier to occur of (a) the completion of all purchases or sales or (b) the date listed in the table.

• (2) Represents the modification, as described in Rule 10b5-1(c)(1)(iv) under the Exchange Act, of a written trading arrangement adopted on August 30, 2023 that was intended to satisfy the affirmative defense conditions of Rule 10b5-1(c) under the Exchange Act.