5 unchanged sentences
Please also see the section entitled “Special Note Regarding Forward-Looking Statements.” We do not assume any obligation to update any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by law.
−Removed: We are a clinical-stage 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.
−Removed: Our proprietary CABA ® , or Cabaletta Approach to B cell Ablation, platform encompasses two strategies.
−Removed: Our CARTA, or Chimeric Antigen Receptor T cells for Autoimmunity, approach is designed to potentially reset the immune system.
−Removed: Our legacy CAART, or Chimeric AutoAntibody Receptor T cells, approach is designed to engineer T cells to selectively engage and eliminate only disease-causing B cells.
−Removed: 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.
−Removed: 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 our lead product candidate within the CARTA strategy.
−Removed: Rese-cel is designed to achieve transient and deep depletion of all B cells following a single treatment by using T cells engineered to express an antibody fragment that recognizes a B cell receptor expressed on the surface of all B cells.
−Removed: 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 naïve B cells.
−Removed: This approach has the potential to reset the immune system, providing meaningful durable and complete clinical responses to patients off immunosuppressive therapies.
−Removed: In March 2023, 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 SLE in patients with active lupus nephritis, or LN, or active SLE without renal involvement.
−Removed: 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.
−Removed: SLE affects an estimated up to 320,000 patients in the U.S., and 150,000 patients in Europe, with LN as the most common end-organ manifestation, affecting approximately 40% of SLE patients.
−Removed: In May 2023, we announced the FDA granted Fast Track Designation for rese-cel, designed to deplete CD19-positive B cells and improve disease activity in patients with SLE and LN.
−Removed: The RESET-SLE TM Phase 1/2 clinical trial of rese-cel 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 10 6 cells/kg.
−Removed: In March 2024, Health Canada issued a No Objection Letter in response to a Clinical Trial Application, or CTA, for the RESET-SLE TM trial submitted by Cabaletta, enabling us to begin the process to activate clinical trial sites and pursue patient enrollment for the RESET-SLE TM trial in Canada.
−Removed: In October 2024, the European Medicines Agency allowed a CTA submitted by Cabaletta for the RESET-SLE TM trial to proceed, enabling us to begin the process of activating clinical trial sites and pursuing patient enrollment for the RESET-SLE TM trial.
−Removed: The trial is open for enrollment across multiple sites in the United States and one site in the European Union.
−Removed: In May 2023, the FDA granted clearance of our rese-cel IND application for treatment of idiopathic inflammatory myopathies, or IIM, or myositis.
−Removed: Myositis refers to a group of autoimmune diseases characterized by inflammation and muscle weakness.
−Removed: The three myositis subtypes being evaluated in the RESET-Myositis TM Phase 1/2 clinical trial of rese-cel affect approximately 70,000 patients in the U.S.
−Removed: and approximately 85,000 patients in Europe and typically affect middle-aged individuals, particularly women.
−Removed: The RESET-Myositis TM clinical trial, which is actively enrolling patients, is designed to treat six patients with dermatomyositis, six patients with anti-synthetase syndrome, and six patients with immune-mediated necrotizing myopathy, all in separate parallel cohorts.
−Removed: We announced the FDA granted Fast Track Designation for rese-cel for the treatment of patients with dermatomyositis to improve disease activity and Orphan Drug Designation for rese-cel for the treatment of myositis in January and February 2024,
−Removed: respectively.
+Added: We are a late clinical-stage 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.
+Added: Our proprietary CABA ® , or Cabaletta Approach to B cell Ablation platform, focuses on the CARTA approach.
+Added: CARTA refers to Chimeric Antigen Receptor T cells for Autoimmunity and is designed to potentially reset the immune system.
+Added: 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.
+Added: Resecabtagene autoleucel, or 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 our lead product candidate within the CARTA strategy.
+Added: 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.
+Added: 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.
+Added: This approach has demonstrated the potential to reset the immune system and result in meaningful clinical responses without chronic therapy requirements in patients.
+Added: The efficacy and safety of rese-cel was recently reviewed along with all other commercial and academic constructs in development in a February 2026 Nature Biotechnology publication.
+Added: In December 2025, we initiated a registrational trial with rese-cel for patients with dermatomyositis or anti-synthetase syndrome.
+Added: In addition, we have ongoing Phase 1/2 trials evaluating rese-cel with a standard preconditioning regimen, fludarabine and cyclophosphamide, in systemic lupus erythematosus, or SLE, in patients with active lupus nephritis, or LN, or active SLE without renal involvement, systemic sclerosis, or SSc, and generalized myasthenia gravis, or gMG.
+Added: In addition to our core development program across multiple indications using standard preconditioning regimens and standard manufacturing processes with partnered Contract and Development Manufacturing Organizations, or CDMOs, 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 LN patients.
+Added: In addition, in January 2026 we announced INDa clearance for rese-cel to be manufactured using an automated manufacturing platform – the Cell Shuttle TM from Cellares - offering the potential for scalability to produce rese-cel
+Added: for thousands of patients per year with minimal capital investment by the Company.
+Added: The first clinical experience from these patients is expected to be presented in the first half of 2026.
+Added: Durability data from the no-preconditioning SLE, LN and PV patients as well as the patients treated with rese-cel manufactured by the Cellares Cell Shuttle TM is expected to be presented in the second half of 2026.
+Added: RESET-Myositis ®
+Added: 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.
+Added: Myositis typically affects middle-aged individuals, particularly women, and disease is often refractory, despite existing therapies.
+Added: 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.
+Added: 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 x 10 6 cells/kg.
+Added: We announced the FDA granted Fast Track Designation for rese-cel for the treatment of patients with dermatomyositis 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 juvenile dermatomyositis.
−Removed: The trial is open for enrollment across multiple sites in the United States and one site in the United Kingdom.
−Removed: In October 2023, we announced that the FDA granted clearance of our rese-cel IND application for treatment of systemic sclerosis, or SSc.
+Added: In May 2025, we announced the FDA granted Regenerative Medicine Advanced Therapy, or RMAT, designation to rese-cel for the treatment of myositis.
+Added: Based on clinical data presented in October 2025 at the American College of Rheumatology, or the ACR, Convergence 2025, we have initiated a DM/ASyS registrational cohort within the RESET-Myositis ® trial.
+Added: There are approximately 60,000 patients with DM in the U.S.
+Added: who have IVIg as their only FDA-approved treatment option and approximately 15,000 patients with ASyS in the U.S.
+Added: who have no FDA-approved treatment options.
+Added: Our registrational trial design includes a 16-week primary endpoint of moderate or major TIS response while off immunomodulators and on no or low-dose steroids.
+Added: Based on the safety data from the phase 1/2 cohort, the protocol permits outpatient administration.
+Added: In addition, we are planning for a pediatric submission in juvenile idiopathic inflammatory myopathy, or JIIM, based on data available at the time of adult submission from the ongoing Ph 1/2 cohort to support a pediatric label claim.
+Added: 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.
+Added: 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.
+Added: 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%.
+Added: 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.
+Added: The registrational cohorts will evaluate the same single, weight-based infusion of rese-cel at 1 x 10 6 cells/kg as used in the Phase 1/2 myositis cohorts with similar enrollment criteria.
+Added: 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.
+Added: Based on discussions with the FDA, we plan to use pooled rese-cel safety data from across the entire RESET TM clinical trial program to supplement myositis specific safety data for the Biologics License Application, or 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.
+Added: We initiated enrollment in the registrational DM/ASyS cohort in December 2025 and anticipate BLA submission in 2027.
+Added: 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.
+Added: SLE affects an estimated up to 320,000 patients in the U.S., with LN as the most common end-organ manifestation, affecting approximately 30-40% of SLE patients.
+Added: The RESET-SLE TM 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
+Added: 10 6 cells/kg.
+Added: In May 2023, we announced the FDA granted Fast Track Designation for rese-cel in patients with SLE and LN.
+Added: In November 2025, we announced the FDA granted RMAT designation to rese-cel for treatment of SLE and LN.
+Added: In January 2026, Cabaletta announced registrational cohort designs in RESET-SLE TM 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.
+Added: Complete Phase 1/2 data from both cohorts is anticipated in the first half of 2026.
+Added: Cabaletta will provide an update on next steps for these cohorts in 2026, subject to dose-ranging data evaluating rese-cel without preconditioning in lupus patients.
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.
−Removed: SSc affects approximately 90,000 patients in the U.S.
−Removed: and approximately 60,000 patients in Europe, typically middle-aged individuals, particularly women.
−Removed: The RESET-SSc TM 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.
−Removed: 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 systemic sclerosis in January and March 2024, respectively.
−Removed: The trial is open for enrollment across multiple sites in the United States.
−Removed: In November 2023, the FDA granted clearance of our rese-cel IND application for treatment of generalized myasthenia gravis, or gMG, a subset of patients with myasthenia gravis, or MG.
−Removed: MG is a rare autoimmune disease characterized by autoantibodies that interfere with signaling at the neuromuscular junction, or NMJ, leading to potentially life-threatening muscle weakness.
+Added: SSc affects approximately 90,000 patients in the U.S., typically middle-aged individuals, particularly women.
+Added: The RESET-SSc TM 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 10 6 cells/kg.
+Added: 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.
+Added: In January 2026, Cabaletta announced the FDA granted RMAT designation to rese-cel for treatment of SSc.
+Added: Complete Phase 1/2 data from both cohorts is anticipated in the first half of 2026, and we anticipate announcing the registrational cohort design for SSc in the first half of 2026.
+Added: 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 AChR.
gMG affects approximately 100,000 patients in the U.S.
−Removed: and approximately 100,000 patients in Europe.
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.
−Removed: Standard of care therapies include cholinesterase inhibitors, steroids, immunomodulators, and biologics, which typically require chronic administration, increasing the risk of serious long-term side effects.
−Removed: The RESET-MG TM 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.
−Removed: The trial is open for enrollment across multiple sites in the United States.
−Removed: In May 2024, we announced that we are working with active clinical sites to incorporate the RESET-PV TM trial as a sub-study within the Phase 1 DesCAARTes TM trial following the submission of a protocol amendment.
−Removed: The RESET-PV TM trial will evaluate rese-cel as a monotherapy without preconditioning in patients with mucosal pemphigus vulgaris, or mPV, and mucocutaneous pemphigus vulgaris, or mcPV.
−Removed: Approximately 15,000 patients in the U.S.
−Removed: and approximately 20,000 patients in Europe are affected by PV.
−Removed: The trial is open for enrollment across multiple sites in the United States.
−Removed: In June 2024, we announced the initial clinical data from each of the first two patients dosed with rese-cel in the RESET-SLE TM and RESET-Myositis TM trials.
−Removed: In both of these patients, no cytokine release syndrome, or CRS, immune effector cell-associated neurotoxicity syndrome, or ICANS, infections or serious adverse events were observed through data cut-off of May 28, 2024.
−Removed: Rese-cel exhibited the anticipated profile of CAR T cell expansion and contraction with complete B cell depletion observed in both patients by day 15 post-infusion.
−Removed: Improvements in both patients’ specific disease measures were observed, consistent with academic experience of a similar 4-1BB CD19-CAR T.
−Removed: In late June 2024, a lupus nephritis patient with very active, refractory disease was dosed with rese-cel and experienced Grade 1 CRS and a protocol-defined dose-limiting toxicity of Grade 4 ICANS.
−Removed: The ICANS resolved rapidly following standard management.
−Removed: The study’s Independent Data Monitoring Committee reviewed data from the patient, and recommended that the study proceed as designed, without delay, at the current dose.
−Removed: We recommended protocol modifications designed to improve patient safety, including enhanced monitoring for fever and neurologic symptoms along with seizure prophylaxis for all patients, in line with the practice at many academic sites including at Erlangen University, the site of the CD19-CAR T studies led by Dr.
−Removed: Georg Schett.
−Removed: In July 2024, we provided standard notice to the FDA and communicated details of the event and proposed protocol changes to all active clinical sites within the RESET TM clinical trial program, including the requirement that the investigator promptly discuss the appropriateness and timing of infusion with the trial’s Medical Monitor.
−Removed: In November 2024, we announced updated clinical data at the American College of Rheumatology Convergence 2024 conference in the first 8 patients dosed across the lupus, myositis and systemic sclerosis clinical trials.
−Removed: Clinical data from these patients in the RESET-SLE TM , RESET-Myositis TM trial and RESET-SSC TM trial were presented in oral and poster presentations where compelling clinical responses were observed in lupus and myositis patients with up to six months of follow-up, and the first SSc patient demonstrated an emerging, drug-free clinical response.
−Removed: In January 2025, we announced the FDA granted clearance of our rese-cel IND application for treatment of multiple sclerosis, or MS.
−Removed: In addition, we announced the FDA granted Fast Track Designation for rese-cel for the treatment of relapsing and progressive forms of MS.
−Removed: The RESET-MS TM trial is a Phase 1/2 open-label, dose escalation study of rese-cel in subjects with relapsing and progressive forms of MS, evaluated in separate cohorts.
+Added: The RESET-MG TM 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 10 6 cells/kg.
+Added: In October 2025, we announced that rese-cel was generally well tolerated across two AChR-positive and two AChR-negative patients (both seronegative;
+Added: no anti-MuSK or anti-LRP4 antibodies).
+Added: No CRS (cytokine release syndrome) occurred in three of four patients, and grade 2 CRS occurred in AChR-pos-2 that resolved with no sequelae.
+Added: As of the September 11, 2025 data cut-off, two evaluable patients (AChR-neg-1 and AChR-neg-2) remained off immunomodulatory medication and achieved significant improvements in MG-ADL (with AChR-neg-1 achieving Minimal Symptom Expression).
+Added: AChR-pos-1 is not evaluable due to use of a prohibited cytotoxic medication that may have inhibited CAR T activity and AChR-pos-2 has insufficient follow-up.
+Added: Both cohorts have been fully enrolled.
+Added: Complete Phase 1/2 data from both cohorts is anticipated in the first half of 2026, and we anticipate announcing the registrational cohort design for studies in MG in mid-2026.
+Added: Pemphigus vulgaris, or PV, is an autoimmune disease that occurs when the immune system produces antibodies that attack a protein called desmoglein, or DSG.
+Added: DSG normally enables skin cells and the cells lining the inside of your mouth, nose, throat, eyelids, etc.
+Added: to bind tightly together.
+Added: Disruption by the antibodies directed to DSG causes the painful blisters and erosions characteristic of PV.
Approximately 15,000 patients in the U.S.
−Removed: and approximately 550,000 patients in Europe are affected by MS.
−Removed: In February 2025, we announced updated clinical and translational data from the first 10 patients in the RESET TM clinical trial program, with a data cut off of January 8, 2025.
−Removed: Overall, clinical responses continued to deepen over three SLE patients in DORIS remission, the first LN patient achieving complete renal response, and the first dermatomyositis patient maintaining a major total improvement score, or TIS improvement.
−Removed: Each of these patients discontinued all immunosuppressants and were off or tapering steroids as of January 8, 2025.
−Removed: The safety profile continued to suggest a favorable risk-benefit in the first 10 patients dosed with 90% of patients having experienced either no CRS or Grade 1 CRS and 90% of patients having experienced no ICANS.
−Removed: In March 2025, we learned of an important protocol deviation in the RESET-SSc TM trial.
−Removed: In this case, the patient reported a fever three days prior to infusion.
−Removed: The Cabaletta Medical Monitor was not notified by the investigator prior to the site infusing the patient.
−Removed: Nine days following rese-cel infusion, the patient experienced a dose-limiting toxicity of grade 3 immune effector cell-associated neurotoxicity syndrome (ICANS) based on a transient period of confusion.
−Removed: There was no cerebral edema, seizures or motor dysfunction associated with the ICANS event, and the patient was arousable throughout.
−Removed: The ICANS resolved rapidly following treatment with dexamethasone, and the patient was discharged without further symptoms.
−Removed: After data review, the Independent Data Monitoring Committee recommended that the trial proceed at the current dose without delay and endorsed our proposal to require investigators to affirmatively confirm in writing to the company the absence of fevers or evidence of infection.
−Removed: As of March 14, 2025, 56 clinical sites across the U.S.
−Removed: and Europe were actively recruiting with 33 patients enrolled across the RESET TM clinical trial program.
−Removed: Our manufacturing strategy is comprised of two stages.
−Removed: The initial stage is designed to leverage the extensive early-stage manufacturing expertise of our academic partners and contract development and manufacturing organizations, or CDMOs, for rapid early development and clinical supply, and in parallel partner with commercially compliant CDMOs capable of supporting late-stage clinical studies and commercial production.
−Removed: Our aim is to achieve full manufacturing readiness through expanded CDMO relationships, establishment of our own manufacturing facilities, and/or through strategic partnership(s).
−Removed: We are leveraging the expertise in cell and vector manufacturing of our partners at the Children’s Hospital of Philadelphia, or CHOP, and the University of Pennsylvania, or Penn.
−Removed: For supply of lentiviral vector for the late-stage clinical and commercial manufacturing of rese-cel, we are working with Oxford Biomedica (UK) Limited, or Oxford.
−Removed: We have also collaborated with WuXi Advanced Therapies, Inc., or WuXi, to serve as an additional and commercially compliant cell manufacturing partner for our MusCAARTes TM and RESET TM clinical trials to meet planned capacity and international supply requirements.
−Removed: In July 2024, we entered into a new technology transfer agreement with Lonza Houston Inc., or Lonza, another commercially compliant CDMO, to execute a technology transfer of our expected commercial manufacturing process for rese-cel.
−Removed: In December 2024, we entered into a Development and Manufacturing Services Agreement, or the Lonza Agreement, with Lonza to serve as one of our manufacturing partners for the global clinical development of rese-cel in multiple indications, including potential late-stage clinical trials and preparations for commercial readiness.
−Removed: This improved process is nearly fully closed, semi-automated, and more easily scaled than the current process.
−Removed: Transfer of this updated process will be performed from Cabaletta to Lonza in anticipation of being able to supply rese-cel drug product for any of Cabaletta’s ongoing and planned RESET TM clinical trials.
−Removed: We plan to secure commercial, scalable manufacturing capabilities through multiple potential strategies, including expanding existing or establishing new CDMO relationships, leasing, building, qualifying and operating our own manufacturing facility, and/or establishing a strategic partnership to rapidly and reliably scale manufacturing by leveraging the partner’s manufacturing expertise.
−Removed: We believe this later stage will enable control of product development and commercial supply for products arising from our CABA platform, enabling us to achieve continuous improvement of our product candidates.
−Removed: Multiple members of our team have previously built and led organizations that have constructed and commissioned cell therapy facilities, which we believe will enable us to build our own manufacturing organizations and facilities, if desirable.
−Removed: As part of our innovative manufacturing strategy where we intend to increase scale, reduce cost of goods and improve patient experience, in November 2023, we partnered with Cellares Corp., or Cellares, to evaluate their automated manufacturing platform, the Cell Shuttle TM , through the Cellares Technology Adoption Program, or TAP.
−Removed: As part of the collaboration, the companies have agreed on a proof-of-concept technology transfer process for the automated manufacture and release testing of rese-cel.
−Removed: In August 2024, we expanded our partnership with Cellares to facilitate the potential to incorporate the Cellares manufacturing platform to support the RESET TM clinical program.
−Removed: In March 2025, we and Cellares announced the successful conclusion of the Technology Adoption Program on Cellares’ automated cell therapy manufacturing Cell Shuttle, facilitating the potential integration of the Cell Shuttle TM into our clinical and commercial, if approved, manufacturing strategy for rese-cel.
−Removed: We are also evaluating pathways to improve patient experience and scalability of collection through the removal of the requirement for apheresis.
−Removed: Data were published at the American Society of Cell and Gene Therapy conference in May 2024 illustrating the feasibility of this approach.
+Added: are affected by PV.
+Added: The ongoing RESET-PV ® trial is designed to evaluate rese-cel as a monotherapy without preconditioning in patients with mucosal pemphigus vulgaris, or mPV, and mucocutaneous pemphigus vulgaris, or mcPV.
+Added: In October 2025, we announced that rese-cel exhibited similar CAR T cell expansion and contraction kinetics relative to translational data reported from other RESET TM trials with preconditioning.
+Added: All three patients experienced substantial depletion of B cells within the first month post-infusion, with patients 2 and 3 achieving complete
+Added: peripheral B cell depletion.
+Added: In these two patients, rapid reduction in autoantibodies to desmoglein was observed and the increase in peak B cell activating factor, or BAFF, was at the low end of the range of patients dosed with rese-cel plus preconditioning from pre-infusion through the latest follow-up, suggestive of potential deep B cell depletion in the tissue.
+Added: Additional follow up will be required to determine if the initial clinical effects are durable and to determine if the findings can be replicated in other autoimmune diseases.
+Added: Rese-cel was generally well tolerated with no immune effector cell-associated neurotoxicity syndrome, or ICANS, reported as of the data cutoff.
+Added: After infusion, patient 1 experienced transient fever (grade 1 cytokine release syndrome).
+Added: Patient 2 required a course of steroids for a disease flare in the first two weeks following infusion after discontinuing immunomodulators.
+Added: PDAI activity scores have formed the basis for recent regulatory approvals in PV, and total PDAI scores in these patients were also reported to be consistent with the PDAI activity scores in the late breaking clinical trial session.
+Added: PDAI improvements were most significant in the two patients who seemed to experience complete peripheral B cell depletion.
We were incorporated in April 2017 and started principal operations in August 2018.
−Removed: 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
−Removed: follow-on offerings of shares of our common stock and pre-funded warrants.
−Removed: As of December 31, 2024, we had $164.0 million in cash and cash equivalents.
+Added: 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.
+Added: As of December 31, 2025, we had $133.6 million in cash, cash equivalents and investments.
Material Agreements
49 unchanged sentences
We expect our general and administrative expenses to increase over the next several years to support our continued research and development activities, manufacturing activities, increased costs of operating as a public company and the potential commercialization of our product candidates.
−Removed: We anticipate our general and administrative costs will increase with respect to the hiring of additional personnel, developing commercial infrastructure, fees to outside consultants, lawyers and accountants, and increased costs associated with being a public company such as expenses related to services associated with maintaining compliance with Nasdaq listing rules and SEC requirements, insurance and investor relations costs.
+Added: We anticipate our general and administrative costs will increase with respect to the hiring of additional personnel, developing commercial infrastructure, fees to outside consultants, lawyers and accountants, and increased costs associated with being a public company such as expenses related to services associated with maintaining compliance with Nasdaq listing rules and the Securities and Exchange Commission, or the SEC, requirements, insurance and investor relations costs.
Other income consists of interest earned on our cash, cash equivalents and short-term investments and amortization of bond discount or premium.
1 unchanged sentence
Interest expense consists primarily of interest expense associated with finance lease arrangements.
+Added: Other Income, net
+Added: Other income, net primarily consists of foreign currency gains and losses and proceeds received from the sale of our Pennsylvania research and development tax credits.
Results of Operations for the years ended December 31, 2025 and 2024
8 unchanged sentences
Loss from operations
−Removed: Other income:
+Added: Other income (expense):
Interest income
Interest expense
+Added: Other income, net
Research and Development
3 unchanged sentences
(in thousands)
−Removed: License of intellectual property
−Removed: Manufacturing of preclinical and clinical supplies
Clinical trials
+Added: Manufacturing of preclinical and clinical supplies
Development services
+Added: License of intellectual property
Specific changes in our research and development expenses year over year include a:
+Added: • $22.7 million increase in manufacturing costs primarily due to expanded cell processing capabilities, increase in patient enrollment and related activities, including those for commercial readiness;
+Added: • $17.3 million increase in clinical trial costs primarily due to higher enrollment and clinical trial sites across multiple clinical studies for rese-cel;
• $7.7 million increase in personnel costs primarily driven by an increase in headcount to support overall growth related to our rese-cel program, including an increase of $1.3 million in stock-based compensation expense;
−Removed: • $14.0 million increase in clinical trial costs primarily due to rese-cel clinical trial costs;
−Removed: • $7.0 million increase in manufacturing costs primarily due to expanded cell processing capabilities and related activities;
−Removed: • $3.9 million increase in development services due to expanded lab space and related costs to support increased headcount performing research and translational activities;
−Removed: • $0.8 million increase in other primarily due to increased travel, conference and training costs and other costs to support headcount growth;
partially offset by a
−Removed: • $0.9 million decrease in license of intellectual property costs due to a $1.2 million upfront fee to Autolus pursuant to the Autolus Option and License Agreement and a $1.0 million milestone payment to IASO for IND clearance of rese-cel in the first quarter of 2023 compared to a $1.5 million milestone payment to IASO in the first quarter of 2024 for the first patient dosed in the rese-cel trial.
+Added: • $1.5 million decrease in license of intellectual property costs due to a $1.5 million milestone payment to IASO in the first quarter of 2024 for the first patient dosed in the rese-cel trial;
+Added: • $1.1 million decrease in development services due to lower spend on laboratory consumables and external research activities.
General and Administrative Expenses
1 unchanged sentence
The increase of $1.6 million in our general and administrative expenses year over year includes:
−Removed: • $6.5 million of additional personnel costs, primarily driven by an increase in headcount to support overall company growth, including an increase of $3.5 million in stock-based compensation expense;
−Removed: • $2.2 million higher administrative costs, including legal, information technology, and travel as well as other administrative costs.
−Removed: Interest income has increased $3.0 million for the year ended December 31, 2024 as compared to the year ended December 31, 2023, primarily as a result of increasing interest rates on a higher cash and cash equivalents balance due to a financing in May 2023 and proceeds from sales of common stock pursuant to the ATM Program in the fourth quarter of 2023, first quarter of 2024 and fourth quarter of 2024.
+Added: • $1.6 million increase in personnel costs, primarily driven by higher personnel-related expenses, including a $0.2 million increase in stock-based compensation expense.
+Added: Interest Income
+Added: Interest income decreased by $4.0 million for the year ended December 31, 2025 as compared to the year ended December 31, 2024, primarily due to lower cash, cash equivalents and investment balances earning interest during 2025 as prior financing proceeds were utilized to fund operating activities, as well as reductions in interest rates on government securities.
Interest Expense
−Removed: Interest expense has increased $0.8 million for the year ended December 31, 2024 as compared to the year ended December 31, 2023, primarily as a result of finance lease arrangements from embedded leases within our WuXi manufacturing agreement.
+Added: Interest expense increased $1.3 million for the year ended December 31, 2025 as compared to the year ended December 31, 2024, primarily as a result of finance lease arrangements from embedded leases within our manufacturing agreements with Minaris and Lonza.
Liquidity, Capital Resources and Going Concern
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.
−Removed: Since our IPO, 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 $280.0 million.
−Removed: As of December 31, 2024, we had $164.0 million in cash and cash equivalents which should enable us to fund our operations and capital expenditures into the first half of 2026.
+Added: Since our IPO and through December 31, 2025, 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 $384.0 million.
+Added: As of December 31, 2025, we had $133.6 million in cash and cash equivalents which should enable us to fund our operations and capital expenditures into the fourth quarter of 2026.
Cash in excess of immediate requirements is invested in accordance with our investment policy, primarily with a view to liquidity and capital preservation.
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Any product candidates we may develop may never achieve commercialization and we anticipate that we will continue to incur losses for the foreseeable future.
−Removed: We expect that our research and development expenses, general and administrative expenses, and capital expenditures will continue to increase.
+Added: We expect that our research and development expenses, general
+Added: and administrative expenses, and capital expenditures will continue to increase.
As a result, until such time, if ever, as we can generate substantial product revenue, we expect to finance our cash needs through a combination of equity offerings, debt financings or other capital sources, including potentially collaborations, licenses and other similar arrangements.
2 unchanged sentences
Based on our current operating plan, we believe there is substantial doubt about our ability to continue as a going concern for at least twelve months following the filing of this Annual Report on Form 10-K, and we will need to obtain additional funding.
−Removed: Our cash forecast
−Removed: contains estimates and assumptions based on success of ongoing clinical trials, and we cannot predict the amount or timing of all expenditures with certainty.
+Added: Our cash forecast contains estimates and assumptions based on success of ongoing clinical trials, and we cannot predict the amount or timing of all expenditures with certainty.
We will continue to seek funds through equity offerings, debt financings or other capital sources, including potentially collaborations, licenses and other similar arrangements.
5 unchanged sentences
At-The-Market Offering Sales Agreement
−Removed: On March 21, 2024, we filed an automatic shelf registration statement (File No.
−Removed: 333-278126), or 2024 S-3ASR, 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.
−Removed: We also simultaneously entered into a Sales Agreement, or the 2024 Sales Agreement, with Cowen and Company, LLC, or the Sales Agent, to provide for the offering, issuance and sale of up to an aggregate amount of $200.0 million of our common stock from time to time in “at-the-market” offerings, or the 2024 ATM Program, under the 2024 S-3ASR and subject to the limitations thereof.
−Removed: We intend to convert the S-3ASR to S-3 by post-effective amendments in connection with the filing of this Annual Report.
−Removed: In December 2024, we sold 1,225,000 shares pursuant to the 2024 ATM Program for net proceeds of $5.1 million, after deducting commissions of $0.1 million.
−Removed: We previously had a Sales Agreement with Cowen to provide for the offering, issuance and sale of up to an aggregate amount of $100.0 million of common stock from time to time in “at-the-market” offerings, or 2023 ATM Program, pursuant to our shelf registration statement on Form S-3 (File No.
−Removed: 333-270599), which was declared effective April 26, 2023.
−Removed: During the year ended December 31, 2023, we sold 4,760,899 shares pursuant to the 2023 ATM Program for net proceeds of $91.7 million, after deducting commissions of $2.4 million.
−Removed: In the first quarter of 2024, we sold 258,070 additional shares, completing the 2023 ATM Program for net proceeds of $5.7 million, after deducting commissions of $0.1 million.
−Removed: December 2022 Financing
−Removed: In December 2022, we issued 126,815 shares of our common stock at a price of $5.52 per share and to certain investors in lieu of common stock, pre-funded warrants to purchase 6,213,776 shares of our common stock at a price of $5.51999 per pre-funded warrant.
−Removed: The purchase price per share of each pre-funded warrant represents the per share offering price for the common stock, minus the $0.00001 per share exercise price of such pre-funded warrant.
−Removed: Aggregate net proceeds were $32.6 million after deducting underwriting discounts and commissions and offering expenses of $2.4 million.
−Removed: As of December 31, 2024, 6,213,775 pre-funded warrants had been exercised and no warrants remain outstanding.
−Removed: May 2023 Financing
−Removed: In May 2023, we issued 8,337,500 shares of our common stock in an underwritten public offering, including the exercise in full by the underwriters of their option to purchase an additional 1,087,500 shares, at a public offering price of $12.00 per share.
−Removed: Aggregate net proceeds were $93.8 million after deducting underwriting discounts and commissions and offering expenses of $6.3 million.
+Added: On March 31, 2025, we converted the Form S-3ASR to a Form S-3 (File No.
+Added: 333-278126) by post-effective amendments.
+Added: This Form S-3 was declared effective on March 31, 2025.
+Added: We had a Sales Agreement with TD Securities (USA) LLC, as successor to Cowen and Company, LLC, or TD Cowen, to provide for the offering, issuance and sale of up to an aggregate amount of $200.0 million of common stock from time to time in “at-the-market” offerings, or the 2024 ATM Program, pursuant to its S-3, and subject to the limitations thereof.
+Added: On June 11, 2025, the 2024 ATM Program with TD Cowen was terminated.
+Added: Prior to termination, we sold an aggregate of 2,609,865 shares pursuant to the 2024 ATM Program for total net proceeds of $7.7 million, consisting of $5.1 million in 2024 and $2.6 million in 2025.
+Added: On August 7, 2025, we filed a Registration Statement (File No.
+Added: 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.
+Added: 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.
+Added: 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.
+Added: Subsequent to December 31, 2025, we sold 8,055,260 shares of common stock pursuant to the 2025 ATM Program for net proceeds of $22.6 million.
+Added: June 2025 Financing
+Added: 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.
+Added: The combined offering price of each share of common stock and accompanying common stock warrant was $2.00.
+Added: The combined offering price of each pre-funded warrant and accompanying common stock warrant was $1.99999.
+Added: The pre-funded warrants were
+Added: exercisable immediately.
+Added: 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.
+Added: Each common stock warrant has an exercise price per share of $2.50.
+Added: The common stock warrants are immediately exercisable from the date of issuance and will expire on September 12, 2026, fifteen months from the date of issuance.
+Added: Aggregate net proceeds were $93.6 million after deducting underwriting discounts and commissions and offering expenses.
+Added: As of December 31, 2025, 4,800,000 pre-funded warrants had been exercised and 6,000,000 remain outstanding.
+Added: As of December 31, 2025, no common stock warrants had been exercised and 53,090,190 remain outstanding.
+Added: Subsequent to December 31, 2025, 2,775,100 common stock warrants were exercised for proceeds of $6.9 million.
Because of the numerous risks and uncertainties associated with research, development and commercialization of pharmaceutical products, we are unable to estimate the exact amount of our operating capital requirements.
21 unchanged sentences
Effect of exchange rate changes on cash and cash equivalents
−Removed: Net (decrease) increase in cash and cash equivalents
+Added: Net decrease in cash and cash equivalents
Operating Activities
+Added: During the year ended December 31, 2025, cash used in operating activities of $131.1 million was attributable to our net loss of $167.9 million, partially offset by non-cash charges of $37.2 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 $0.4 million in our net operating assets and liabilities.
During the year ended December 31, 2024, cash used in operating activities of $88.2 million was attributable to our net loss of $115.9 million, partially offset by non-cash charges of $26.0 million for stock-based compensation charges, amortization of finance lease, non-cash operating lease expense, depreciation, amortization of premium on investments, accretion of operating lease liabilities and foreign currency exchange rates and a net change of $1.7 million in our net operating assets and liabilities.
−Removed: During the year ended December 31, 2023, cash used in operating activities of $53.5 million was attributable to our net loss of $67.7 million, partially offset by non-cash charges of $14.1 million for stock-based compensation charges, amortization of premium on investments, non-cash lease expense, accretion of lease liabilities and depreciation and a net change of $0.1 million in our net operating assets and liabilities.
Investing Activities
+Added: During the year ended December 31, 2025, cash used in investing activities of $50.2 million was attributable to $99.0 million of purchases of investments and $1.2 million of purchases of property and equipment partially offset by $50.0 million from the maturity of short-term investments.
During the year ended December 31, 2024, cash provided by investing activities of $47.3 million was attributable to $49.5 million from the maturity of short-term investments, partially offset by purchases of $2.2 million of property and equipment.
−Removed: During the year ended December 31, 2023, cash used in investing activities of $22.5 million was attributable to $84.3 million of purchases of investments and $0.7 million of purchases of property and equipment, partially offset by $62.5 million of proceeds from maturities of investments.
Financing Activities
−Removed: During the year ended December 31, 2024, cash provided by financing activities of $11.7 million was from $10.9 million in sales of common stock, net of issuance costs paid, $1.7 million from the exercise of employee stock and purchases of shares under our 2019 Employee Stock Purchase Plan, or 2019 ESPP, offset by $0.9 million in principal payments on finance leases.
−Removed: During the year ended December 31, 2023, cash provided by financing activities of $187.6 million was from $185.2 million in sales of common stock, net of issuance costs paid and $2.4 million from the exercise of employee stock options and purchases of shares under our 2019 ESPP.
+Added: During the year ended December 31, 2025, cash provided by financing activities of $100.3 million was attributable to $93.6 million in sales of common stock, warrants and pre-funded warrants to purchase common stock, net of issuance costs paid, $12.7 million in sales of common stock under our 2024 ATM Program and 2025 ATM Program, net of sales agent commission and fees and $0.3 million from the purchases of shares under our 2019 Employee Stock Purchase Plan, or 2019 ESPP, offset by $6.3 million in principal payments on finance leases.
+Added: During the year ended December 31, 2024, cash provided by financing activities of $11.7 million was from $10.9 million in sales of common stock under our 2024 ATM Program, net of issuance costs paid, $1.7 million from the exercise of employee stock and purchases of shares under our 2019 ESPP, offset by $0.9 million in principal payments on finance leases.
Contractual Obligations and Commitments
−Removed: We lease our headquarters office space and lab space under non-cancelable operating lease agreements.
+Added: We lease our headquarters office space and laboratory space under non-cancelable operating lease agreements.
The lease term of our office space commenced in May 2019 and was amended in October 2024 for an additional 12 months through June 30, 2026.
−Removed: The lease term of our lab space was amended in September 2024 for 23 months through August 2026.
−Removed: See Note 9 of the consolidated financial statements for additional detail on our leases.
−Removed: We also have an embedded lease with WuXi, our cell processing manufacturing partner through August 2026.
+Added: The lease term for our laboratory space was amended in September 2024 through August 2026 and further extended in October 2025 through November 2026.
+Added: We also have embedded manufacturing leases with Minaris and Lonza, our cell processing manufacturing partners.
+Added: Minaris' lease term is through August 2026 and Lonza's is for an initial 12 months with the ability to extend the manufacturing period on a rolling basis.
Total undiscounted aggregate future finance and operating lease obligations under all of our leases as of December 31, 2025 are $28.8 million.
+Added: See Note 9 of the consolidated financial statements for additional detail on our leases.
We have no material contractual obligations not fully recorded on our balance sheets or fully disclosed in the notes to the consolidated financial statements.
2 unchanged sentences
As partial consideration for the exclusive license, IASO received an upfront payment of $2.5 million.
−Removed: IASO is also eligible to receive up to mid double digit millions in milestone payments based upon the achievement of specified pre-clinical, development and regulatory milestones, and up to an additional low triple digit millions in milestone payments based upon achievement of specified sales milestones, for a total consideration, inclusive of the upfront payment, of up to $162 million, along with tiered mid-single digit royalties on future net sales for licensed products that may result from the IASO Agreement.
+Added: IASO is also eligible to receive up to mid double digit millions in milestone payments based upon the achievement of specified pre-clinical, development and regulatory milestones, and up to an additional low triple digit millions in milestone payments based upon achievement of specified sales milestones, for a total consideration, inclusive of the upfront payment, of up to $162 million, along with tiered mid-single digit royalties on future net sales for licensed products
+Added: that may result from the IASO Agreement.
We also may sublicense through multiple tiers the rights granted to it by IASO under the IASO Agreement at any time, however, we must pay IASO a low double-digit percentage of any revenue obtained from sublicenses or options to third parties, subject to certain customary exclusions.
4 unchanged sentences
In May 2023, we amended the LSA with Oxford to expand the license to include our rese-cel program for an upfront fee of $0.5 million and in August 2023, we entered into a vector supply agreement with Oxford, and a related second amendment to the LSA, for rese-cel with a total cost of up to approximately $5.0 million under the vector supply agreement.
−Removed: In February 2024, the Company and Oxford entered into a third amendment to the LSA to update the patent schedule.
−Removed: We can terminate the agreement at will upon advance written notice and subject to certain manufacturing slot cancellation fees.
+Added: In February 2024, we and Oxford entered into a third amendment to the LSA to update the patent schedule.
+Added: In June 2024, we and Oxford entered into a fourth amendment to the LSA eliminating royalties on net sales of products that incorporate the Oxford technology if Oxford manufactures the vector.
+Added: Starting in December 2024, we and Oxford entered into work orders for certain process characterization and process performance qualification activities as part of commercial readiness activities.
+Added: We can terminate the LSA or any work order under the LSA at will upon advance written notice and subject to certain cancellation fees.
• Autolus Option and License Agreement.
10 unchanged sentences
As of December 31, 2025, we are unable to estimate the timing or likelihood of achieving the milestones or making future product sales.
−Removed: Under the License Agreement, we must use commercially reasonable efforts to develop and commercialize a product in each subfield.
+Added: o Under the License Agreement, we must use commercially reasonable efforts to develop and commercialize a product in each subfield.
During the term of the License Agreement until the first commercial sale of the first product, we are obligated to pay Penn a non-refundable, non-creditable annual license maintenance fee of $10,000.
6 unchanged sentences
Technology transfer activities would be at our cost and subject to agreement as to the technology to be transferred.
−Removed: • Master Translational Research Services Agreement with Penn.
−Removed: Under the Services Agreement, we have contracted for additional research and development services from various laboratories within Penn.
−Removed: The Services Agreement will expire upon completion of the services for which we have engaged Penn under the Services Agreement.
−Removed: In May 2020, the Company amended its Addendum with CAROT to expand access to vector manufacturing.
−Removed: We may incur additional expenses up to $0.6 million through the remaining term of the CAROT Amended Addendum.
−Removed: In February 2023, we entered into a second Master Translational Research Services Agreement with Penn, or the CARTA Services Agreement, pursuant to which Penn agreed to perform certain research, development and manufacturing activities.
−Removed: The services encompassed by the CARTA Services Agreement are performed by different organizations at Penn pursuant to certain addenda to the CARTA Services Agreement.
−Removed: The CARTA Services Agreement will expire on the later of (i) February 9, 2026 or (ii) completion of the services for which we have engaged Penn under the CARTA Services Agreement.
−Removed: Either party may terminate this agreement with or without cause upon a certain number of days’ prior written notice.
−Removed: We are committed to pay up to $3.0 million for cell processing manufacturing under the CARTA Services Agreement through December 31, 2025.
−Removed: • WuXi Manufacturing agreement .
−Removed: In January 2021, we entered into the WuXi Agreement to serve as an additional cell processing manufacturing partner for the MusCAARTes TM trial.
−Removed: In August 2023, we entered into new work orders under the WuXi Agreement for WuXi to serve as one of our cell processing manufacturing partners for the global clinical development of rese-cel in multiple indications, including potential late-stage clinical trials and commercial readiness activities for rese-cel.
−Removed: Under the August 2023 work orders, WuXi will convert our non-dedicated suite to a dedicated suite for GMP manufacturing for our rese-cel and MuSK-CAART programs for an initial term of 18 months with two 18 month extensions at our sole option on six months' notice prior to the end of the term.
+Added: • Minaris Manufacturing agreement .
+Added: In January 2021, we entered into the Development and Manufacturing Services Agreement, or the Minaris Agreement, to serve as an additional cell processing manufacturing partner for the MusCAARTes TM trial.
+Added: In August 2023, we entered into new work orders under the Minaris Agreement for Minaris to serve as one of our cell processing manufacturing partners for the global clinical development of rese-cel in multiple indications, including potential late-stage clinical trials and commercial readiness activities for rese-cel.
+Added: Under the August 2023 work orders, Minaris will convert our non-dedicated suite to a dedicated suite for GMP manufacturing for our rese-cel and MuSK-CAART programs for an initial term of 18 months with two 18 month extensions at our sole option on six months' notice prior to the end of the term.
In addition, we agreed to certain monthly minimum runs.
We would incur up to a $1.08 million termination fee if we terminate both the rese-cel and MuSK-CAART work orders for any reason.
−Removed: We may terminate for convenience the WuXi Agreement or any work order with six months' prior written notice, however, we may not terminate the Dedicated Suite without terminating both the MuSK-CAART and rese-cel GMP run work orders.
+Added: We may terminate for convenience the Minaris Agreement or any work order with six months' prior written notice, however, we may not terminate the Dedicated Suite without terminating both the MuSK-CAART and rese-cel GMP run work orders.
+Added: In February 2026, we notified Minaris that we intend to permit the term to expire in August 2026.
• Lonza Manufacturing agreement .
−Removed: In December 2024, we entered into the Lonza Agreement with Lonza to serve as one of our manufacturing partners for the global clinical development of rese-cel in multiple indications, including potential late-stage clinical trials and preparations for commercial readiness.
−Removed: Under the initial work order, Lonza will perform cell therapy manufacturing activities for our CAR-T cell therapy product rese-cel for a term of 12 months and total cost of approximately $16.0 million with the ability to extend the manufacturing period subject to the terms of the Lonza Agreement.
+Added: In December 2024, we entered into a Development and Manufacturing Services Agreement, or the Lonza Agreement, with Lonza to serve as one of our manufacturing partners for the global clinical development of rese-cel in multiple indications, including potential late-stage clinical trials and preparations for commercial readiness.
+Added: The Lonza Agreement has a term of five years and can be extended for an additional three year term upon notice to Lonza at least 18 months prior to the expiration of the Lonza Agreement.
+Added: We can terminate the Lonza Agreement at will upon nine months advance written notice to Lonza subject to the terms of the Lonza Agreement.
+Added: Lonza can terminate the Lonza Agreement at will upon 24 months advance written notice to us subject to the terms of the Lonza Agreement.
+Added: Under the initial work order, Lonza will perform cell therapy manufacturing activities for our CAR-T cell therapy product, rese-cel, for an initial term of 12 months with the ability to extend the manufacturing period on a rolling basis subject to the terms of the Lonza Agreement.
+Added: • Cellares Agreement .
+Added: 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.
+Added: The Cellares Agreement has a term of five years.
+Added: 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.
+Added: 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.
+Added: Under the initial work order, Cellares will perform clinical cell therapy manufacturing activities for our CAR-T cell therapy product, rese-cel.
• Other Purchase Commitments.
25 unchanged sentences
Compared sentence by sentence after normalising whitespace, quotation marks, case and digits, so re-formatting and restated figures do not read as changed language. Wording changes appear as one removal and one addition. The current filing and the prior one are authoritative.