CABA — what changed in the latest 10-Q

Text added 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 three adult myositis subtypes, dermatomyositis, or DM, anti-synthetase syndrome, or ASyS, and immune-mediated necrotizing myopathy, or IMNM, being evaluated in the RESET-Myositis® Phase 1/2 clinical trial of rese-cel affect approximately 80,000 patients in the U.S. Myositis typically affects mid…

• 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…

Text removed vs the prior filing · source: 10-Q · 2025-11-10

• The United States Food and Drug Administration, or the FDA, granted clearance of our rese-cel Investigational New Drug, or IND, application for treatment of systemic lupus erythematosus, or SLE, in patients with active lupus nephritis, or LN, or active SLE without renal involvement in March 2023. We…

• The three adult myositis subtypes, dermatomyositis, or DM, anti-synthetase syndrome, or ASyS, and immune-mediated necrotizing myopathy, or IMNM, being evaluated in the RESET-MyositisTM Phase 1/2 clinical trial of rese-cel affect approximately 80,000 patients in the U.S. and approximately 85,000 pati…

• The RESET-MyositisTM Phase 1/2 clinical trial, which is actively enrolling patients, is designed to treat six patients with DM, six patients with ASyS, six patients with IMNM, as well as six patients with juvenile idiopathic inflammatory myopathy, or JIIM, all in separate parallel cohorts, with a si…

• Based on clinical data presented in October 2025 at the American College of Rheumatology (ACR) Convergence 2025, we are initiating a DM/ASyS registrational cohort within the RESET-MyositisTM trial. There are approximately 60,000 patients with DM in the U.S. who have IVIg as their only FDA-approved t…

• trial protocol in August 2025, we are aligned on a registrational cohort with a 16-week primary endpoint of moderate or major TIS response while off immunomodulators and on no or low-dose steroids.

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

• and expense of the clinical development of our product candidates or limit market acceptance of such product candidates, if approved, any of which could have a material adverse effect on our business and financial condition.

• Our registrational trials may rely on a single-arm design and an external control; if regulatory authorities determine that the external control is unsuitable, we may be unable to obtain approval on our anticipated timelines, or at all.

• We plan to conduct registrational trials using an open-label, single-arm design with an external comparator(s) rather than a blinded, randomized controlled trial. As a result, data generated from these studies may be subject to heightened FDA scrutiny regarding potential bias, confounding variables,…

• Use of a registry dataset introduces risks, including whether the dataset is sufficiently comparable to our trial population and whether key clinical and demographic variables are assessed consistently. If the FDA disagrees with, or subsequently revises or withdraws its prior feedback regarding the …

• If our external control dataset, its pre-specification, or our planned analyses are viewed as inadequate, the FDA may determine that our single-arm registrational trial does not constitute an “adequate and well‑controlled” investigation under applicable regulations, and may make such determination e…

Text removed vs the prior filing · source: 10-Q · 2025-11-10

• Social media is increasingly being used to communicate about our clinical development programs and the diseases our product candidates are being developed to treat. We intend to utilize appropriate social media in connection with communicating about our

• development programs. Social media practices in the biopharmaceutical industry continue to evolve and regulations relating to such use are not always clear. This evolution creates uncertainty and risk of noncompliance with regulations applicable to our business. For example, patients may use social …

• limitations on our recourse in our CRO relationship with Penn as compared to a CRO that is not an academic institution;

• safer, more easily commercialized or less costly than our product candidates or may develop proprietary technologies or secure patent protection that we may need for the development of our technologies and products.

• Specifically, while rituximab is the first drug to have received regulatory approval in the United States in over 60 years for the treatment of PV, the target indication for DSG3-CAART, and the indication we are evaluating in the RESET-PVTM study, we are aware that multiple biopharmaceutical compani…

Text added 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.