Cabaletta Bio, Inc.
For the period ended Sep 30, 2026. Filed Nov 5, 2026.
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A company's report for each of its first three quarters. The financial statements are not audited. It shows how the business has moved since the last annual report, and what management says changed.
Sep 30, 2026 · Filed Nov 5, 2026
CABA$1.30+1.6%Stored close · as of Nov 6, 2026
What changed in Management’s Discussion and Analysis?
Read the current filingPrevious report: 10-Q
Period ended 2026-06-30; filed 2026-08-13.
0001759138-26-000039
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of OperationsCurrent report: 10-Q
Period ended 2026-09-30; filed 2026-11-05.
0001759138-26-000047
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of OperationsThe baseline is this issuer’s latest earlier reporting period of the same form that was filed before the current report. A previous 10-Q is a different quarter, not a year-over-year comparison. Amendments are excluded.
Compared 169 previous paragraphs and 174 current paragraphs.
100 unchanged; 43 reworded; 30 added; 25 removed; 1 previous and 1 current paragraphs rearranged.
Tables are not compared: 5 previous and 5 current tables excluded. Dates, whitespace, punctuation and numbering changes are ignored; changes to financial figures remain significant.
A changed paragraph is not evidence that risk increased or decreased. An unchanged paragraph does not establish that risk stayed the same.
Added paragraphs (30)
Current report
Resecabtagene autoleucel
Current report
Rese-cel has been granted multiple regulatory designations in support of accelerating its clinical development, including: (i) FDA Regenerative Medicine Advanced Therapy designation for myositis, systemic sclerosis (SSc), systemic lupus erythematosus (SLE), lupus nephritis (LN), and generalized myasthenia gravis (gMG); (ii) FDA Orphan Drug designation for myositis, SSc, and gMG; (iii) FDA Fast Track designation for dermatomyositis (DM), SSc, SLE, LN, and gMG; (iv) FDA Rare Pediatric Disease designation for juvenile dermatomyositis (JDM); and (v) European Medicines Agency PRIME scheme access for myositis.
Current report
RESET™ Clinical Development Program
Current report
RESET™ clinical trials have consistent design principles. These include T cell collection via apheresis, a routine and well-characterized nine-day manufacturing process, a standard CAR T preconditioning (PC) regimen of fludarabine and cyclophosphamide intended to reduce the initial B cell target burden, administration of a single, weight-based infusion of rese-cel, and long-term patient follow-up and monitoring. In addition, we are leveraging the design characteristics of rese-cel and in combination with several innovations which, if successful, may broaden and deepen rese-cel’s patient reach and impact. These include PC-free treatment with rese-cel dose exploration, automated manufacturing intended to enable scalable and flexible commercial supply, outpatient dosing, pediatric treatment, and use of a whole blood draw for patient T cell collection.
Current report
Across its reported RESET™ clinical development program experience, rese-cel has exhibited a predictable translational profile when administered with and without PC, consistent across each indication evaluated, and a generally well-tolerated clinical safety profile. Our reported clinical efficacy and translational data have demonstrated the potential of rese-cel to reset the immune system and result in responses that last throughout follow-up without IMs and/or other chronic therapies and with low-dose or absence of chronic steroids.
Current report
Research and Development Updates from RESET™ Trials
Current report
We regularly communicate clinical, translational, and scientific data from the RESET™ clinical development program at peer-reviewed scientific and medical conferences and in peer-reviewed publications.
Current report
At the American Association of Neuromuscular & Electrodiagnostic Medicine 2026 Annual Meeting, we presented clinical and translational data from the first 14 RESET-MG patients treated with rese-cel and preconditioning. Rese-cel was generally well tolerated, with no cytokine release syndrome in 12 patients and no immune effector cell-associated neurotoxicity syndrome or immune effector cell-associated hemophagocytic lymphohistiocytosis-like syndrome. At 24 weeks, patients who remained off immunomodulators (n=10) had a mean change from baseline of -7.9 on the Myasthenia Gravis Activities of Daily Living scale (MG-ADL) and -7.8 on the Quantitative Myasthenia Gravis score, and 10 of the 14 patients achieved a clinically meaningful MG-ADL improvement as of latest follow-up (median follow-up of 38 weeks) while off immunomodulators.
Current report
At the European Society of Gene and Cell Therapy 2026 Annual Meeting, we presented a poster presentation titled, “Differential macrophage responses to CAR T cell produced cytokines across autoimmune diseases may confer differential risk among indications.” Data in the presentation indicate the potential relationship between the pro-inflammatory activation of monocyte-derived macrophages in different autoimmune diseases, with a focus on Phase 1/2 dermatomyositis and systemic sclerosis patients treated with rese-cel, and the observation of adverse safety events in autoimmune disease patients. In addition, longer-term Phase 1/2 clinical efficacy data in systemic sclerosis patients treated with rese-cel were shared. At one year and off immunomodulators, the five patients with interstitial lung disease achieved a mean percent-predicted FVC improvement of approximately 9%, and among all systemic sclerosis patients with at least one year follow up, and six of seven (86%) patients achieved rCRISS-25.
Current report
At the upcoming American College of Rheumatology Convergence 2026 annual meeting, we will present one oral and three poster presentations. Data to be shared include one-year clinical data from the complete Phase 1/2 DM cohort within RESET-Myositis®, histological remission and response in severe and refractory LN patients after treatment with rese-cel, and aggregate safety data across the RESET™ clinical development program. In addition, we will host an industry-supported innovation theater discussing rese-cel and insights from the RESET™ clinical development program.
Current report
Myositis is an autoimmune disease whereby the immune system attacks muscle and causes muscular inflammation and weakness. It typically affects middle-aged individuals, particularly women. Despite existing therapies, most patients remain refractory and must continue concurrent treatment with IMs. In addition, there are approximately 60,000 adult DM and approximately 15,000 adult antisynthetase syndrome (ASyS) patients in the U.S. who have no or limited FDA-approved treatment options.
Current report
We anticipate reporting registrational myositis topline results in the second half of 2027 to support a potential BLA submission in the first quarter of 2028. At the time of the adult BLA submission, we expect to submit available Phase 1/2 JDM clinical data to support a potential pediatric indication. This strategy may allow for priority review voucher eligibility from the FDA, as rese-cel has been granted Rare Pediatric Disease designation for the treatment of JDM.
Current report
Our registrational, single-arm SSc cohort focused on interstitial lung disease has initiated and is open for patient enrollment. The cohort is expected to enroll approximately 25 patients, and the primary endpoint is designed to measure the mean change from baseline in percent-predicted forced vital capacity without any IMs or anti-fibrotic medications and off or on a low-dose of steroids.
Current report
Our current focus for RESET-SLE® is the evaluation of the PC-free approach with rese-cel dose exploration. PC-free dose exploration is ongoing with higher-dose rese-cel in patients with SLE and LN. We expect to provide an update regarding go-forward clinical development plans for the PC-free approach in the first half of 2027.
Current report
In addition, we have the potential to initiate registrational SLE and LN cohorts, each evaluating approximately 25 patients with unique endpoints for each cohort with PC, based on prior regulatory alignment with the FDA. This was based on previously reported clinical data from Phase 1/2 SLE and LN cohorts with preconditioning. We also incorporated adolescent patient enrollment in the Phase 1/2 cohorts with preconditioning.
Current report
Our current focus for RESET-MG® is the evaluation of the PC-free approach with rese-cel. PC-free dose exploration is ongoing in patients with AChR-positive gMG and AChR-negative gMG. We expect to provide an update regarding go-forward clinical development plans for the PC-free approach in the first half of 2027.
Current report
The Phase 1/2 RESET-PV® trial is designed to evaluate PC-free rese-cel in patients with mucosal pemphigus vulgaris (mPV) and mucocutaneous pemphigus vulgaris (mcPV). We expect to provide an update regarding go-forward clinical development plans for the PC-free approach in the first half of 2027.
Current report
Manufacturing Partnerships
Current report
Oxford Biomedica (UK) Limited (Oxford) provides supply of lentiviral vector used in the manufacturing process for rese-cel.
Current report
Our current manufacturing process, Process B, partners include Lonza Houston Inc. (Lonza) and ElevateBio Basecamp, Inc. (ElevateBio). Process B is partially automated with a commercially scalable process intended for initial commercial launch, and it was implemented prior to the start of our first registrational study following multiple meetings with FDA CMC reviewers to align on comparability strategy with our initial process, Process A, which supplied a subset of Phase 1/2 patients.
Current report
We anticipate additional supply from Cellares Corporation (Cellares) as part of Process C, a fully automated version of Process B that has been reviewed by the FDA and verified in a clinical setting. We believe the potential for fully automated manufacturing via Process C complements Process B supply and offers the potential for scalability to produce rese-cel for thousands of patients per year with minimal capital investment by us.
Current report
Interest Income
Current report
Interest Income
Current report
Other Income, net
Current report
Other income, net decreased by $0.5 million for the three months ended September 30, 2026 compared to the three months ended September 30, 2025, primarily due to proceeds received from the sale of our Pennsylvania research and development tax credits in 2025.
Current report
Results of Operations for the nine months ended September 30, 2026 and 2025
Current report
$0.9 million increase in other research and development costs primarily due to company growth and related expenses; partially offset by a
Current report
Other Income, net
Current report
Liquidity and Capital Resources
Current report
As disclosed in our Quarterly Report on Form 10-Q for the quarter ended June 30, 2026, we had previously identified conditions that raised substantial doubt about our ability to continue as a going concern. During the quarter ended September 30, 2026, we raised additional funds through the exercise of common stock warrants for proceeds of $115.0 million and sold 1.9 million shares pursuant to the 2025 ATM Program for net proceeds of $6.0 million. As a result of these cash raises, the conditions that previously raised substantial doubt are no longer present. We expect that our cash and cash equivalents as of September 30, 2026, will be sufficient to fund our projected operations for at least 12 months following the date we file this Quarterly Report on Form 10-Q with the Securities and Exchange Commission (“SEC”).
Removed paragraphs (25)
Previous report
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 first two lupus patients treated with PC-free rese-cel. Rese-cel exhibited a predictable translational profile when administered with and without PC, consistent across each indication evaluated. Patients were generally able to discontinue all immunomodulators (IMs) and require no or only low-doses of steroids while achieving significant improvement in disease activity following rese-cel treatment.
Previous report
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 constructs in development. Pan-translational findings were also presented highlighting that pharmacokinetic/pharmacodynamic (PK/PD) dynamics show a short-term rese-cel activity phase that results in evidence of deep B cell depletion and immune system reset, while minimizing the potential for prolonged B cell aplasia and other delayed adverse events as B cells repopulate with a median time of approximately 2 months.
Previous report
The three adult myositis subtypes, dermatomyositis (DM), antisynthetase syndrome (ASyS), and immune-mediated necrotizing myopathy (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 middle-aged individuals, particularly women, and the disease is often refractory, despite existing therapies. In the United States, we believe approximately 20% to 25% of the prevalent population, or 16,000 to 20,000 people, would be potentially eligible patients for rese-cel.
Previous report
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 106 cells/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. In March 2024, we announced the FDA granted Rare Pediatric Disease designation for rese-cel for JDM. In May 2025, we announced the FDA granted Regenerative Medicine Advanced Therapy (RMAT) designation to rese-cel for the treatment of myositis.
Previous report
Based on clinical data presented in October 2025 at the American College of Rheumatology (ACR) Convergence 2025, we initiated a DM/ASyS registrational cohort within the RESET-Myositis® trial. There are approximately 60,000 patients with DM in the U.S. who have IVIg as their only FDA-approved treatment option and approximately 15,000 patients with ASyS in the U.S. who have no FDA-approved treatment options. Our registrational trial design includes a 16-week primary endpoint of moderate or major Total Improvement Score (TIS) response while off immunomodulators and on no or low-dose steroids. Based on the safety data from the Phase 1/2 cohort, the protocol permits outpatient administration. In addition, we are planning for a pediatric submission in JDM based on data available at the time of adult submission from the ongoing Phase 1/2 cohort to support a pediatric label claim. This strategy may allow the Company to receive a priority review voucher as rese-cel has been granted Rare Pediatric Disease Designation for the treatment of JDM.
Previous report
As presented at EULAR in June 2026, as of the cut-off date of April 16, 2026, Phase 1/2 cohort data demonstrated 80% (8/10) of DM and ASyS patients would have met the primary endpoint of the registrational cohort. After discontinuation of all immunomodulators, 83% (5/6) of DM patients achieved an immunomodulator-free (IM-free), moderate-to-major TIS response at 16 weeks; all patients maintained their IM-free response through latest follow-up as long as 1.5 years. 75% (3/4) of ASyS patients achieved an IM-free, moderate-to-major TIS response at 16 weeks. Durability in these patients was variable, consistent with reported academic CD19-CAR T data. The first JDM patient achieved an IM-free, moderate TIS response at 16 weeks, with response maintained through latest follow-up at 32 weeks. 100% (17/17) of patients experienced either no cytokine release syndrome (CRS) or transient fever (Grade 1 CRS) and no immune effector cell-associated neurotoxicity syndrome (ICANS) of any grade was observed in any patient.
Previous report
The RESET-SSc® Phase 1/2 clinical trial of rese-cel is designed to treat six patients with severe skin manifestations and six patients with severe organ involvement associated with SSc, each in separate parallel cohorts, with a single weight-based dose of 1.0 x 106 cells/kg. We announced the FDA granted Fast Track Designation for rese-cel for the treatment of patients with SSc to improve associated organ dysfunction and Orphan Drug Designation for rese-cel for the treatment of SSc in January and March 2024, respectively. In January 2026, we announced the FDA granted RMAT designation to rese-cel for treatment of SSc. Complete Phase 1/2 data from both cohorts were presented at EULAR in June 2026. As of the cut-off date of April 16, 2026, Phase 1/2 cohort patients showed overall improvement in skin and lung disease activity and achieved clinical responses while off IMs and off or tapering steroids that appear to improve with longer follow-up. Patients with interstitial lung disease (ILD) at screening demonstrated an IM-free improvement in percent predicted FVC, with a median improvement of 7.5% in patients with 36 weeks of follow-up. 83% (5/6) of patients achieved revised Composite Response Index in Systemic Sclerosis (rCRISS)-25 and 67% (4/6) of patients achieved rCRISS-50 at 36 weeks while off all immunomodulators and off or tapering steroids. 87% (13/15) of patients experienced either no CRS or transient fever (Grade 1 CRS); 93% (14/15) of patients experienced no ICANS (one Grade 3 ICANS previously reported March 2025).
Previous report
Based on the complete Phase 1/2 cohort data and FDA feedback, we are conducting a single-arm registrational study of approximately 25 patients with SSc-associated ILD using a forced vital capacity (FVC)-based primary endpoint at 52 weeks. We anticipate initiating this study in the fourth quarter of 2026.
Previous report
The RESET-SLE® Phase 1/2 clinical trial is designed to treat six SLE patients with active LN, and in a separate parallel cohort, six patients with active SLE without renal involvement, with a single weight-based dose of 1.0 x 106 cells/kg. In May 2023, we announced the FDA granted Fast Track Designation for rese-cel in patients with SLE and LN. In November 2025, we announced the FDA granted RMAT designation to rese-cel for treatment of SLE and LN. In January 2026, we announced registrational cohort designs in RESET-SLE® to evaluate the current rese-cel weight-based dose of 1 million cells/kg in a single infusion with preconditioning, including two independent, single-arm cohorts, one consisting of patients with non-renal SLE and one consisting of patients with LN, each evaluating approximately 25 patients with unique endpoints in each cohort. Complete Phase 1/2 data from both cohorts were presented at EULAR in June 2026. We will provide an update on next steps for these cohorts based on dose-ranging data evaluating PC-free rese-cel in lupus patients.
Previous report
In the RESET-SLE® trial evaluating PC-free rese-cel in patients with lupus, the initial dose cohort is fully enrolled with initial data at the lowest dose presented at EULAR in June 2026. As of the cut-off date of May 15, 2026, based on data from the first two patients, the lowest dose of PC-free rese-cel appears to be a threshold dose; patients who received rese-cel with preconditioning achieved meaningful clinical responses off IMs with no or low-dose steroids at 12 months.
Previous report
In the first two PC-free lupus patients, initial PK/PD findings suggest the lowest PC-free rese-cel dose may represent a threshold dose, as seen in RESET-PV®evaluating PC-free rese-cel in pemphigus vulgaris, where some patients achieved deep B cell depletion with substantial clinical benefit. One of the two lupus patients experienced deep B cell depletion, similar to what has been observed in lupus patients treated with rese-cel plus preconditioning who achieved an immune reset. The second patient experienced a reduction in peripheral B cells of ~90%. One patient experienced Grade 1 CRS and no ICANS was observed.
Previous report
In the preconditioning cohorts in patients with 12 months of follow-up, 75% (6/8) of patients achieved Definition of Remission in SLE (DORIS) while remaining off IMs for the duration of follow-up. 83% (15/18) of patients remain IM-free and on no or low-dose steroids at latest follow-up. 94% (17/18) of patients experienced either no CRS or transient fever (Grade 1 CRS); 94% (17/18) of patients experienced no ICANS (one Grade 4 ICANS reported in August 2024).
Previous report
The RESET-MG® Phase 1/2 clinical trial of rese-cel is designed to treat six patients with AChR-positive gMG and six patients with AChR-negative gMG, each in separate parallel cohorts, with a single weight-based dose of 1.0 x 106 cells/kg. In August 2026, we announced that rese-cel was granted RMAT designation by the FDA for the treatment of gMG.
Previous report
Complete Phase 1/2 data from both cohorts were presented at the American Academy of Neurology (AAN) Annual Meeting in April 2026. In the RESET-MG trial, 13 patients with active, refractory disease were treated with rese-cel with preconditioning with a data cut-off of March 6, 2026, and follow-up between 8 and 40 weeks. 7 patients were in the AChR-positive cohort, and 6 patients were in the AChR-negative cohort. 11 of 13 patients experienced no CRS and 13 of 13 patients experienced no ICANS. 10 of 13 patients experienced clinically meaningful improvements in Myasthenia Gravis Activities of Daily Living (MG-ADL) scores off immunomodulators for MG while 3 patients received rescue medications for insufficient response. Of the 10 MG-ADL responders, 9 were off or tapering steroids, and one patient remained on chronic steroids for adrenal insufficiency.
Previous report
Based on the complete Phase 1/2 cohort data from RESET-MG® shared at the AAN Annual Meeting in April 2026 and emerging insights from the broader PC-free program for rese-cel, we are incorporating dose exploration with PC-free rese-cel in RESET-MG®.
Previous report
The ongoing RESET-PV® trial is designed to evaluate PC-free rese-cel in patients with mucosal pemphigus vulgaris (mPV) and mucocutaneous pemphigus vulgaris (mcPV). In October 2025, we announced that rese-cel exhibited similar CAR T cell expansion and contraction kinetics relative to translational data reported from other RESETTM trials with preconditioning. All three patients experienced substantial depletion of B cells within the first month post-infusion, with patients 2 and 3 achieving complete peripheral B cell depletion. Rese-cel was generally well tolerated with no ICANS reported as of the data cutoff.
Previous report
As of the data cutoff of April 2, 2026, in the RESET-PV® trial, 4 patients received rese-cel at the lowest dose without preconditioning and had follow-up between 24 and 36 weeks. 3 of 4 patients experienced no CRS (1 patient with Grade 1 CRS) and 4 of 4 patients experienced no ICANS. Complete peripheral B cell elimination was observed in 3 of 4 patients. 2 of 4 patients demonstrated compelling clinical activity through 6 months follow-up and 3 of 4 patients remained off all immunomodulators and steroids as of the data cut-off. We presented this data at the American Society of Gene & Cell Therapy (ASGCT) 2026 Annual Meeting in May 2026. Based on the safety profile observed at the lowest dose, multiple additional patients have been enrolled at a higher dose cohort in the RESET-PV® trial.
Previous report
Manufacturing
Previous report
We have established and implemented a phase-appropriate manufacturing supply strategy that includes Process A (early clinical phase), Process B (partially automated, commercially scalable process intended for initial commercial launch), and Process C (fully automated version of Process B). For cell manufacturing, we have partnered with Lonza Houston Inc. (Lonza) and ElevateBio Basecamp, Inc. (ElevateBio) to serve as our manufacturing partners for the global clinical development of rese-cel. For supply of lentiviral vector, we are working with Oxford Biomedica (UK) Limited (Oxford).
Previous report
As part of our manufacturing strategy, in January 2026, we entered into a clinical supply agreement with Cellares Corporation (Cellares) to serve as a clinical supplier of rese-cel using Cellares’ automated manufacturing platform, the Cell Shuttle TM, and we announced Investigational New Drug (IND) application amendment clearance for rese-cel to be manufactured using the Cellares Cell Shuttle TM, offering the potential for scalability to produce rese-cel for thousands of patients per year with minimal capital investment by the Company.
Previous report
In April 2026, we entered into a commercial supply agreement with Cellares under which Cellares would supply rese-cel using Cellares’ automated Cell Shuttle TM and through future implementation of Cellares’ Cell QTM platform. We presented initial translational data from the first two autoimmune patients treated with rese-cel manufactured using the automated Cellares Cell Shuttle TM platform in the RESETTM clinical development program at ASGCT in May 2026.
Previous report
Results of Operations for the six months ended June 30, 2026 and 2025
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Interest income decreased by $0.2 million for the six months ended June 30, 2026 as compared to the six months ended June 30, 2025, primarily due to reductions in interest rates on government securities.
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Other Income (Expense), net
Previous report
Liquidity, Capital Resources and Going Concern
Reworded paragraphs (43)
Previous wording
We are a late-stage clinical biotechnology company focused on the discovery and development of innovative engineered T cell therapies that have the potential to provide deep and durable, perhaps curative, responses with one-time administration for patients with autoimmune diseases. Our proprietary CABA®, or Cabaletta Approach to B cell Ablation, platform focuses on the Chimeric Antigen Receptor T cells for Autoimmunity (CARTA) approach, which is designed to potentially reset the immune system. Based on clinical data reported to date, we believe our CABA® platform has the potential to safely enable complete and durable responses for a broad range of autoimmune diseases and that it has potential applicability across dozens of autoimmune diseases that we have identified, evaluated and prioritized.
Current wording
We are a late-stage clinical biotechnology company focused on developing and launching potentially curative targeted cell therapies designed specifically for patients with autoimmune diseases.
Previous wording
Resecabtagene autoleucel (rese-cel), formerly referred to as CABA-201, is a 4-1BB co-stimulatory domain-containing fully human CD19-CAR T construct designed to treat patients with a broad range of autoimmune diseases and is our lead product candidate within the CARTA strategy. Rese-cel is designed to achieve transient and deep depletion of all B cells following a single, weight-based infusion of T cells that are engineered to express an antibody fragment that recognizes a B cell receptor expressed on the surface of all B cells. The construct is designed to allow for the deep elimination of all B cells, including all B cells that contribute to disease, with subsequent repopulation by healthy transitional, naïve B cells. This approach has demonstrated the potential to reset the immune system and result in meaningful clinical responses without chronic therapy requirements in patients.
Current wording
Resecabtagene autoleucel (rese-cel, formerly referred to as CABA-201), our lead product candidate, is an investigational autologous chimeric antigen receptor (CAR) T cell therapy designed specifically for the treatment of patients living with autoimmune diseases. Its CAR construct features a fully-human CD19-binding domain, a CD8 transmembrane domain, a 4-1BB co-stimulatory domain, and a CD3ζ signaling domain. Rese-cel is produced by collecting and engineering a patient’s own T cells to express an antibody fragment that recognizes the CD19 receptor expressed on the surface of B cells. The production of rese-cel leverages a standard and well-characterized nine-day manufacturing process which is common across U.S. Food and Drug Administration (FDA)-approved CAR T therapies in oncology. Rese-cel is designed to be administered as a single infusion at a weight-based dose after discontinuing all immunomodulators (IMs). Following treatment, rese-cel induces transient and deep depletion of all CD19-positive B cells, including those that contribute to disease, with subsequent repopulation of non-autoreactive B cells.
Previous wording
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. As part of its clinical development, we are evaluating rese-cel with a standard preconditioning (PC) regimen, which consists of fludarabine and cyclophosphamide, and PC-free rese-cel, initially based on early data from a Phase 1/2 trial evaluating PC-free rese-cel in pemphigus vulgaris (PV) patients and supporting the broader opportunity with the approach in autoimmune diseases.
Current wording
We are evaluating rese-cel across the REstoring SElf-Tolerance (RESET™) 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. Active clinical trials evaluating rese-cel as a potential treatment for autoimmune diseases within the RESET™ clinical development program include RESET-Myositis®for myositis, RESET-SSc® for SSc, RESET-SLE® for lupus, RESET-MG® for gMG, and RESET-PV® for pemphigus vulgaris (PV).
Previous wording
Patient enrollment is progressing in the registrational, single-arm DM/ASyS cohort in RESET-Myositis®, which includes an outpatient dosing option. The primary endpoint will assess whether a moderate or major TIS response after discontinuation of all IMs can be achieved at 16 weeks while remaining off IMs and on no or low-dose steroids.
Current wording
Our registrational, single-arm DM/ASyS cohort is open for patient enrollment and includes an outpatient dosing option. The primary endpoint will assess whether a moderate or major Total Improvement Score (TIS) response after discontinuation of all IMs can be achieved at 16 weeks while remaining off IMs and on no or low-dose steroids.
Previous wording
The planned size of 17 patients for the registrational cohort is based on the assumed treatment effect of rese-cel in DM/ASyS patients and an estimated background rate. The estimated background rate will be determined from a retrospective analysis of an external myositis patient registry and will include patients with similar inclusion criteria as those in the registrational DM/ASyS cohort. Based on comprehensive literature review to estimate the background rate, we estimate the likelihood of an active, refractory myositis patient achieving moderate or major TIS response within 16 weeks and concurrently discontinuing all immunomodulators to be less than 10%. Changes in the assumed background rate would result in a change in the number of rese-cel treated patients who would need to achieve the primary endpoint in the 17-patient registrational cohort.
Current wording
The planned size of 17 patients, comprised of 14 DM patients and 3 ASyS patients, for the registrational cohort is based on the assumed treatment effect of rese-cel in DM/ASyS patients and an estimated background rate. The estimated background rate will be determined from a retrospective analysis of an external myositis patient registry and will include patients with similar inclusion criteria as those in the registrational DM/ASyS cohort. Based on comprehensive literature review, we estimate the likelihood of an active, refractory myositis patient achieving moderate or major TIS response within 16 weeks and concurrently discontinuing all immunomodulators to be less than 10%. Changes in the assumed background rate would result in a change in the number of rese-cel treated patients who would need to achieve the primary endpoint in the registrational cohort.
Previous wording
The registrational cohort will evaluate the same single, weight-based infusion of rese-cel at 1.0 x 106 cells/kg as used in the Phase 1/2 myositis cohorts with similar enrollment criteria. As presented at ACR Convergence 2025, all myositis patients in the Phase 1/2 DM/ASyS cohort with sufficient follow-up who met key registrational inclusion criteria exceeded the registrational primary endpoint, demonstrating major TIS responses with no immunomodulators. Based on discussions with the FDA, we plan to use pooled rese-cel safety data from across the entire RESETTM clinical trial program to supplement myositis-specific safety data for the Biologics License Application (BLA) submission in myositis, and the required safety database is expected to be approximately 100 autoimmune disease patients treated with the same single weight-based dose. We initiated enrollment in the registrational DM/ASyS cohort in December 2025 and anticipate reporting BLA-enabling topline data in mid-2027 to support a potential BLA submission in the second half of 2027.
Current wording
Based on FDA interactions, we plan to use pooled rese-cel safety data from the entire RESET™ clinical development program to supplement myositis-specific safety data for the Biologics License Application (BLA) submission in myositis. The required safety database is expected to be approximately 100 autoimmune disease patients treated with the same single, weight-based dose of rese-cel. In addition, based on a Type B regulatory interaction with the FDA, we plan to include multi-year Phase 1/2 myositis durability data to support the planned BLA submission. We expect to have three-year durability data from some Phase 1/2 patients at the time of projected launch.
Previous wording
Systemic sclerosis (SSc) is a rare and potentially fatal chronic autoimmune disease characterized by progressive skin and internal organ fibrosis that can be life-threatening, including interstitial lung disease, pulmonary hypertension, and scleroderma renal crisis. SSc affects approximately 90,000 patients in the U.S., typically middle-aged individuals, particularly women.
Current wording
SSc is a rare and potentially fatal chronic autoimmune disease characterized by progressive skin and internal organ fibrosis that can be life-threatening, including interstitial lung disease, pulmonary hypertension, cardiac involvement, and scleroderma renal crisis. It affects approximately 90,000 patients in the United States, typically middle-aged women.
Previous wording
Systemic lupus erythematosus (SLE), or lupus, 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 in the U.S., with lupus nephritis (LN) as the most common end-organ manifestation, affecting approximately 30-40% of SLE patients.
Current wording
As the most common subtype of lupus, 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 in the United States, with LN as the most common end-organ manifestation, affecting approximately 30-40% of SLE patients.
Previous wording
Myasthenia gravis (MG) is a rare autoimmune disease characterized by autoantibodies that interfere with signaling at the neuromuscular junction, leading to potentially life-threatening muscle weakness. The majority of patients with MG have autoantibodies known to be pathogenic based on their interference with proteins in the NMJ, of which the majority target the acetylcholine receptor (AChR). Generalized myasthenia gravis (gMG) affects approximately 100,000 patients in the U.S. Symptoms of gMG include profound muscle weakness throughout the body, disabling fatigue, and potential shortness of breath due to respiratory muscle weakness, with risk for episodes of respiratory failure.
Current wording
Myasthenia gravis (MG) is a rare autoimmune disease characterized by autoantibodies that interfere with signaling at the neuromuscular junction, leading to potentially life-threatening muscle weakness. Most patients with MG have autoantibodies known to be pathogenic based on their interference with proteins in the neuromuscular junction, of which most target the acetylcholine receptor (AChR). gMG affects approximately 100,000 patients in the United States. Symptoms of gMG include profound muscle weakness throughout the body, disabling fatigue, and potential shortness of breath due to respiratory muscle weakness, with risk for episodes of respiratory failure.
Previous wording
PV is an autoimmune disease that occurs when the immune system produces antibodies that attack a protein called desmoglein (DSG). DSG normally enables skin cells and the cells lining the inside of your mouth, nose, throat, eyelids, etc. to bind tightly together. Disruption by the antibodies directed to DSG causes the painful blisters and erosions characteristic of PV. Approximately 15,000 patients in the U.S. are affected by PV.
Current wording
PV is an autoimmune disease that occurs when the immune system produces antibodies that attack a protein called desmoglein (DSG). DSG normally enables skin cells and the cells lining the inside of your mouth, nose, throat, eyelids, etc. to bind tightly together. Disruption by the antibodies directed to DSG causes painful blisters and erosions characteristic of PV. Approximately 15,000 patients in the United States are affected by PV.
Previous wording
Our manufacturing strategy utilizes proven external suppliers, with a philosophy of maintaining redundant supply capability for cellular products.
Current wording
Our phase-appropriate manufacturing supply strategy for rese-cel utilizes proven external suppliers, with a philosophy of maintaining redundant supply capability.
Previous wording
We were incorporated in April 2017 and started principal operations in August 2018. Our operations to date have been financed primarily by proceeds from the sale of convertible notes and convertible preferred stock prior to our initial public offering, or IPO, and proceeds from the sale of our common stock in public equity offerings, including our IPO, “at-the-market” offerings and follow-on offerings of shares of our common stock and pre-funded warrants. As of June 30, 2026, we had $225.1 million in cash and cash equivalents.
Current wording
We were incorporated in April 2017 and started principal operations in August 2018. Our operations to date have been financed primarily by proceeds from the sale of convertible notes and convertible preferred stock prior to our initial public offering, or IPO, and proceeds from the sale of our common stock in public equity offerings, including our IPO, “at-the-market” offerings and follow-on offerings of shares of our common stock and pre-funded warrants. As of September 30, 2026, we had $299.4 million in cash and cash equivalents.
Previous wording
In January 2026, we entered into a Development and Clinical Manufacturing Services Agreement, or the Cellares Agreement, with Cellares to serve as one of our manufacturing partners for the clinical development of rese-cel in multiple indications, including potential late-stage clinical trials and preparations for commercial readiness. The Cellares Agreement has a term of five years. We can terminate the Cellares Agreement at will by providing a certain advance written notice to Cellares subject to the terms of the Cellares Agreement. Cellares can terminate the Cellares Agreement at will by providing a certain advance written notice to us subject to the terms of the Cellares Agreement. Under the initial work order, Cellares will perform clinical cell therapy manufacturing activities for our CAR-T cell therapy product, rese-cel.
Current wording
In January 2026, we entered into a Development and Clinical Manufacturing Services Agreement, or the Cellares Agreement, with Cellares to serve as one of our manufacturing partners for the clinical development of rese-cel in multiple indications, including potential late-stage clinical trials and preparations for commercial readiness. The Cellares Agreement has a term of five years. We can terminate the Cellares Agreement at will by providing a certain advance written notice to Cellares subject to the terms of the Cellares
Previous wording
Research and development expenses were $44.4 million for the three months ended June 30, 2026 compared to $37.6 million for the three months ended June 30, 2025. The table below summarizes our research and development expenses:
Current wording
Research and development expenses were $47.1 million for the three months ended September 30, 2026 compared to $39.8 million for the three months ended September 30, 2025. The table below summarizes our research and development expenses:
Previous wording
$2.2 million increase in manufacturing costs primarily due to expanded cell processing capabilities, including those for commercial readiness;
Current wording
$4.5 million increase in manufacturing costs primarily due to expanded cell processing capabilities, including those for commercial readiness;
Previous wording
$2.4 million increase in clinical trial costs primarily due to higher enrollment and clinical trial sites across multiple clinical studies for rese-cel;
Current wording
$2.5 million increase in clinical trial costs primarily due to higher enrollment and clinical trial sites across multiple clinical studies for rese-cel;
Previous wording
$0.8 million increase in personnel costs primarily driven by an increase in headcount to support overall growth related to our rese-cel program; partially offset by a
Current wording
$1.4 million increase in personnel costs primarily driven by an increase in headcount to support overall growth related to our rese-cel program; partially offset by a
Previous wording
$2.0 million decrease in development services due to lower spend on research lab consumables and external research activities.
Current wording
$1.3 million decrease in development services due to lower spend on research lab consumables and external research activities.
Previous wording
General and administrative expenses were $7.6 million for the three months ended June 30, 2026 compared to $8.3 million for the three months ended June 30, 2025. The decrease of $0.7 million in our general and administrative expenses includes:
Current wording
General and administrative expenses were $7.6 million for the three months ended September 30, 2026 compared to $6.8 million for the three months ended September 30, 2025. The increase of $0.8 million in our general and administrative expenses includes:
Previous wording
$2.2 million lower personnel related costs due to decreased headcount; partially offset by a
Current wording
$0.5 million higher personnel related costs due to increased headcount; and a
Previous wording
Interest income increased by $0.2 million for the three months ended June 30, 2026 compared to the three months ended June 30, 2025, primarily due to higher cash, cash equivalents and investment balances earning interest during 2026 due to the proceeds from sales of common stock pursuant to the 2025 ATM Program, proceeds from the exercise of common stock warrants and proceeds from the May 2026 financing.
Current wording
Interest income increased by $0.3 million for the three months ended September 30, 2026 compared to the three months ended September 30, 2025, primarily due to higher cash, cash equivalents and investment balances earning interest during 2026 due to the proceeds from sales of common stock pursuant to the 2025 ATM Program, proceeds from the exercise of common stock warrants and proceeds from the May 2026 financing.
Previous wording
The following sets forth our results of operations for the six months ended June 30, 2026 and 2025:
Current wording
The following sets forth our results of operations for the nine months ended September 30, 2026 and 2025:
Previous wording
Research and development expenses were $81.8 million for the six months ended June 30, 2026 compared to $66.7 million for the six months ended June 30, 2025. The table below summarizes our research and development expenses:
Current wording
Research and development expenses were $128.9 million for the nine months ended September 30, 2026 compared to $106.5 million for the nine months ended September 30, 2025. The table below summarizes our research and development expenses:
Previous wording
$8.0 million increase in manufacturing costs primarily due to expanded cell processing capabilities, including those for commercial readiness;
Current wording
$12.5 million increase in manufacturing costs primarily due to expanded cell processing capabilities, including those for commercial readiness;
Previous wording
$4.9 million increase in clinical trial costs primarily due to higher enrollment and clinical trial sites across multiple clinical studies for rese-cel;
Current wording
$7.3 million increase in clinical trial costs primarily due to higher enrollment and clinical trial sites across multiple clinical studies for rese-cel;
Previous wording
$1.8 million increase in personnel costs primarily driven by an increase in headcount to support overall growth related to our rese-cel program; partially offset by a
Current wording
$3.3 million increase in personnel costs primarily driven by an increase in headcount to support overall growth related to our rese-cel program;
Previous wording
$3.2 million decrease in development services due to lower spend on research lab consumables and external research activities.
Current wording
$4.5 million decrease in development services due to lower spend on research lab consumables and external research activities.
Previous wording
General and administrative expenses were $14.5 million for the six months ended June 30, 2026 compared to $16.4 million for the six months ended June 30, 2025. The decrease of $1.9 million in our general and administrative expenses includes:
Current wording
General and administrative expenses were $22.1 million for the nine months ended September 30, 2026 compared to $23.1 million for the nine months ended September 30, 2025. The decrease of $1.0 million in our general and administrative expenses includes:
Previous wording
$1.1 million lower personnel related costs due to decreased headcount; partially offset by a
Current wording
$1.7 million decrease in personnel related costs due to lower average headcount; partially offset by a
Previous wording
$0.4 million increase in administrative costs primarily due to increased spend for commercial readiness activities.
Current wording
$0.7 million increase in administrative costs primarily due to increased spend for commercial readiness activities.
Previous wording
Interest expense increased by $0.3 million for the six months ended June 30, 2026 as compared to the six months ended June 30, 2025, as a result of finance lease arrangements from embedded leases within our manufacturing agreements with Minaris and Lonza.
Current wording
Interest expense increased by $0.2 million for the nine months ended September 30, 2026 as compared to the nine months ended September 30, 2025, as a result of finance lease arrangements from embedded leases within our manufacturing agreements with Minaris and Lonza.
Previous wording
Other income (expense), net increased by $0.3 million for the six months ended June 30, 2026 as compared to the six months ended June 30, 2025, primarily due to proceeds received from the sale of our Pennsylvania research and development tax credits.
Current wording
Other income, net decreased by $0.2 million for the nine months ended September 30, 2026 as compared to the nine months ended September 30, 2025, primarily due to proceeds received from the sale of our Pennsylvania research and development tax credits in 2025.
Previous wording
From our inception in April 2017 to the time of our initial public offering, or IPO, our operations were financed by proceeds of $86.4 million from the sale of convertible notes and our convertible preferred stock and proceeds of $71.0 million from the sale of common stock in our IPO. Since our IPO and through June 30, 2026, we have generated cash from public offerings of our common stock and pre-funded warrants to purchase our common stock resulting in aggregate net proceeds of approximately $567.0 million. Our cash and cash equivalents balance of $225.1 million as of June 30, 2026, should enable us to fund our operations and capital expenditures into mid-2027. Cash in excess of immediate requirements is invested in accordance with our investment policy, primarily with a view to liquidity and capital preservation.
Current wording
From our inception in April 2017 to the time of our initial public offering, or IPO, our operations were financed by proceeds of $86.4 million from the sale of convertible notes and our convertible preferred stock and proceeds of $71.0 million from the sale of common stock in our IPO. Since our IPO and through September 30, 2026, we have generated cash from public offerings of our common stock and pre-funded warrants to purchase our common stock, and from the exercise of common stock warrants, resulting in aggregate net proceeds of approximately $688.0 million. Our cash and cash equivalents balance of $299.4 million as of September 30, 2026, should enable us to fund our operations and capital expenditures into the first quarter of 2028. Cash in excess of immediate requirements is invested in accordance with our investment policy, primarily with a view to liquidity and capital preservation.
Previous wording
We have incurred losses since our inception and, as of June 30, 2026, we had an accumulated deficit of $611.5 million. Our primary use of cash is to fund operating expenses, which consist primarily of research and development expenditures, and to a lesser extent, general and administrative expenditures. Cash used to fund operating expenses is impacted by the timing of when we pay these expenses, as reflected in the change in our outstanding prepaid expenses and other current assets, accounts payable and accrued expenses.
Current wording
We have incurred losses since our inception and, as of September 30, 2026, we had an accumulated deficit of $664.5 million. Our primary use of cash is to fund operating expenses, which consist primarily of research and development expenditures, and to a lesser extent, general and administrative expenditures. Cash used to fund operating expenses is impacted by the timing of when we pay these expenses, as reflected in the change in our outstanding prepaid expenses and other current assets, accounts payable and accrued expenses.
Previous wording
We evaluated whether there are conditions and events, considered in the aggregate, that raise substantial doubt about our ability to continue as a going concern within one year after the date that the unaudited condensed consolidated financial statements are issued. We expect that our current cash and cash equivalents may be sufficient to fund our operations for at least the next twelve months from the date of issuance of these unaudited condensed consolidated financial statements; however, our cash forecast contains estimates and assumptions with significant variability and we cannot predict the amount or timing of all expenditures with certainty. Our ultimate success depends on the outcome of our research and development activities. We expect to incur additional losses in the future as we continue our research and development and we will need to raise additional capital to fully implement our business plan and to fund our operations. Accordingly, we have concluded that substantial doubt exists about the Company’s ability to continue as a going concern. We will continue to seek funds through equity offerings, debt financings or other capital sources, including potentially collaborations, licenses and other similar arrangements. However, we may be unable to raise additional funds or enter into such other arrangements when needed on favorable terms or at all. If we do raise additional capital through public or private equity offerings, the ownership interest of our existing stockholders will be diluted, and the terms of these securities may include liquidation or other preferences that adversely affect our stockholders’ rights. If we raise additional capital through debt financing, we may be subject to covenants limiting or restricting our ability to take specific actions, such as incurring additional debt, making capital expenditures or declaring dividends. Any failure to raise capital as and when needed could have a negative impact on our financial condition and on our ability to pursue our business plans and strategies. If we are unable to raise capital, we will need to delay, reduce or terminate certain planned activities to reduce costs.
Current wording
We have based this estimate on assumptions that may prove to be wrong, and we could utilize our available capital resources sooner than we currently expect. We will continue to require additional financing to advance our current product candidates through clinical development, to develop, acquire or in-license other potential product candidates and to fund operations for the foreseeable future. We will continue to seek funds through equity offerings, debt financings or other capital sources, including potentially collaborations, licenses and other similar arrangements. However, we may be unable to raise additional funds or enter into such other arrangements when needed on favorable terms or at all. If we do raise additional capital through public or private equity offerings, the ownership interest of our existing stockholders will be diluted, and the terms of these securities may include liquidation or other preferences that adversely affect our stockholders’ rights. If we raise additional capital through debt financing, we may be subject to covenants limiting or restricting our ability to take specific actions, such as incurring additional debt, making capital expenditures or declaring dividends. Any failure to raise capital as and when needed could have a negative impact on our financial condition and on our ability to pursue our business plans and strategies. If we are unable to raise capital, we will need to delay, reduce or terminate planned activities to reduce costs.
Previous wording
On August 7, 2025, we filed a Registration Statement (File No. 333-289339) with the SEC, which was declared effective on August 15, 2025, or the 2025 Shelf Registration Statement, in relation to the registration of common stock, preferred stock, debt securities, warrants and/or units of any combination thereof for the purposes of selling, from time to time, our common stock, debt securities or other equity securities in one or more offerings. We also simultaneously entered into a Sales Agreement with TD Cowen to provide for the offering, issuance and sale of up to an aggregate amount of $150.0 million of our common stock from time to time in “at-the-market” offerings, or the 2025 ATM Program, under the 2025 Shelf Registration Statement and subject to the limitations thereof, or the 2025 Sales Agreement. During the year ended December 31, 2025, we sold 4,160,176 shares pursuant to the 2025 ATM Program for net proceeds of $10.2 million. During the six months ended June 30, 2026, we sold 10,132,367 shares, for net proceeds of $28.7 million. Subsequent to June 30, 2026, we sold 1,802,770 additional shares, for net proceeds of $5.5 million.
Current wording
On August 7, 2025, we filed a Registration Statement (File No. 333-289339) with the SEC, which was declared effective on August 15, 2025, or the 2025 Shelf Registration Statement, in relation to the registration of common stock, preferred stock, debt securities, warrants and/or units of any combination thereof for the purposes of selling, from time to time, our common stock, debt securities or other equity securities in one or more offerings. We also simultaneously entered into a Sales Agreement with TD Cowen to provide for the offering, issuance and sale of up to an aggregate amount of $150.0 million of our common stock from time to time in “at-the-market” offerings, or the 2025 ATM Program, under the 2025 Shelf Registration Statement and subject to the limitations thereof, or the 2025 Sales Agreement. During the year ended December 31, 2025, we sold 4,160,176 shares pursuant to the 2025 ATM Program for net proceeds of $10.2 million. During the nine months ended September 30, 2026, we sold 12,057,202 shares, for net proceeds of $34.7 million.
Previous wording
In June 2025, we issued (i) 39,200,000 shares of our 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 our 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. The combined offering price of each share of common stock and accompanying common stock warrant was $2.00. The combined offering price of each pre-funded warrant and accompanying common stock warrant was $1.99999. The pre-funded warrants were exercisable immediately. The common stock and pre-funded warrants were sold in combination with an accompanying common stock warrant to purchase one share of common stock (or a pre-funded warrant in lieu thereof) for each share of common stock or pre-funded warrant sold. Each common stock warrant has an exercise price per share of $2.50. The common stock warrants are immediately exercisable from the date of issuance and will expire fifteen months from the date of issuance. Aggregate net proceeds were $93.6 million after deducting underwriting discounts and commissions and offering expenses. As of June 30, 2026, 4,800,000 pre-funded warrants had been exercised and 6,000,000 remain outstanding. In addition, as of June 30, 2026, 5,275,100 common stock warrants were exercised for proceeds of $13.2 million and 47,815,090 common stock warrants remain outstanding.
Current wording
In June 2025, we issued (i) 39,200,000 shares of our 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 our 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. The combined offering price of each share of common stock and accompanying common stock warrant was $2.00. The combined offering price of each pre-funded warrant and accompanying common stock warrant was $1.99999. The pre-funded warrants were exercisable immediately. The common stock and pre-funded warrants were sold in combination with an accompanying common stock warrant to purchase one share of common stock (or a pre-funded warrant in lieu thereof) for each share of common stock or pre-funded warrant sold. Each common stock warrant has an exercise price per share of $2.50. The common stock warrants are immediately exercisable from the date of issuance and expired fifteen months from the date of issuance. Aggregate net proceeds were $93.6 million after deducting underwriting discounts and commissions and offering expenses. As of September 30, 2026, 4,800,000 pre-funded warrants had been exercised and 6,000,000 remain outstanding. In addition, as of September 30, 2026, 51,287,000 common stock warrants were exercised for proceeds of $128.2 million. The remaining common stock warrants expired and no common stock warrants remain outstanding.
Previous wording
During the six months ended June 30, 2025, cash used in operating activities of $61.2 million was attributable to our net loss of $81.1 million, partially offset by non-cash charges of $18.8 million for stock-based compensation charges, amortization of finance lease, non-cash operating lease expense, depreciation, accretion of operating lease liabilities and foreign currency exchange rates and a net change of $1.0 million in our net operating assets and liabilities.
Current wording
During the nine months ended September 30, 2026, cash used in operating activities of $126.8 million was attributable to our net loss of $147.6 million, partially offset by non-cash charges of $30.3 million for stock-based compensation charges, amortization of finance lease, non-cash operating lease expense, depreciation, accretion of operating lease liabilities and foreign currency exchange rates and further increased by a net change of $9.5 million in our net operating assets and liabilities.
Previous wording
During the six months ended June 30, 2026, cash used in operating activities of $84.1 million was attributable to our net loss of $94.5 million and a net change of $9.9 million in our net operating assets and liabilities, partially offset by non-cash charges of $20.3 million for stock-based compensation charges, amortization of finance lease, non-cash operating lease expense, depreciation, accretion of operating lease liabilities and foreign currency exchange rates.
Current wording
During the nine months ended September 30, 2025, cash used in operating activities of $95.7 million was attributable to our net loss of $125.9 million, partially offset by non-cash charges of $29.0 million for stock-based compensation charges, amortization of finance lease, non-cash operating lease expense, depreciation, accretion of operating lease liabilities and foreign currency exchange rates and a net change of $1.2 million in our net operating assets and liabilities.
Previous wording
During the six months ended June 30, 2026, cash provided by investing activities of $51.0 million was attributable to the maturity of short-term investments.
Current wording
During the nine months ended September 30, 2026, cash provided by investing activities of $50.8 million was attributable to $51.0 million from the maturity of short-term investments, partially offset by $0.2 million of purchases of property and equipment.
Showing the first 40 of 43 pairs. Open the source sections for the rest.
Rearranged current paragraphs (1)
Current report — wording carried from elsewhere
Agreement. Cellares can terminate the Cellares Agreement at will by providing a certain advance written notice to us subject to the terms of the Cellares Agreement. Under the initial work order, Cellares will perform clinical cell therapy manufacturing activities for our CAR-T cell therapy product, rese-cel.
Rearranged previous paragraphs (1)
Previous report — wording carried elsewhere
$3.0 million increase in license of intellectual property costs due to a $2.5 million milestone payment to IASO and $0.5 million milestone payment to Oxford after the first patient in a rese-cel pivotal trial was dosed;