Arcellx, Inc. (ACLX)

Arcellx, Inc. is a clinical-stage biotechnology company focused on delivering a new class of innovative immunotherapies for patients with cancer and other incurable diseases. The company believes immunotherapies are one of the forward pillars of medicine, and its mission is to advance humanity by engineering immunotherapies that are safer, more effective and more broadly accessible. The company's novel synthetic binding scaffold, the D-Domain, is designed to overcome the limitations of traditional CAR-Ts. Existing CAR-T therapy solutions, most of which use a biologic-based, single chain variable fragment (scFv) binding domain, tend to be difficult to manufacture, beneficial to a limited segment of patients, often result in high toxicity, and have narrow applicability in treatable indications. The company believes it can address these limitations by engineering a new class of D-Domain powered immunotherapies, including classical single infusion CAR-Ts called ddCARs and dosable and controllable universal CAR-Ts called ARC-SparX, to address hematologic cancers, solid tumors, and indications outside of oncology, such as autoimmune diseases. The company estimates that the size of the global MM market was approximately $26 billion in 2025 and that the current total addressable global CAR-T market for rrMM to be $12 billion or more based on the number of patients who are receiving second line treatments and beyond. MM is the third most common hematological malignancy in the United States and Europe, with approximately 36,000 new cases diagnosed per year in the United States. Sales of CAR-T therapies in hematologic cancers exceeded $5.9 billion in 2025, representing year over year growth of 30%.

The foundation of the company's competitive advantage is its proprietary technology, clinical evidence, track record of execution, manufacturing success, and assembly of a proven management team. The company believes these advantages, and its recent partnership around its lead program anito-cel with global CAR-T leader, Kite, position it to achieve significant market share in a large and attractive market and to ultimately transform the CAR-T market. The company anticipates substantial direct competition from other organizations developing advanced CAR-Ts, other types of genetically modified cell therapies, or other anti-BCMA biologics due to their promising clinical therapeutic effect in clinical trials including: AbbVie, Allogene, Amgen, AstraZeneca, Autolus, Bristol Myers Squibb, Cabaletta, Caribou Biosciences, CARsgen, Cartesian, Cellectis, Cellular Biomedicine Group, Celyad, Crispr, Gilead, GSK, Immix, Innovent, Johnson & Johnson, Kelonia, Kyverna, Legend, Nanjing IASO Biotherapeutics Ltd, Novartis, Pfizer, Precision BioSciences, Pregene, Regeneron and Roche. The company also expects to compete with companies developing T-cells with CARs that are reactive to tumor associated antigens; T-cells with T-cell receptors (TCRs) that are reactive to tumor associated antigens; T-cells with adapter platforms; bispecifics, trispecifics, and other multispecifics that bring T-cells and diseased cells into close proximity with each other; other immune cells that can be targeted using antibodies; natural killer (NK)-based cell therapies; in vivo CAR-T therapeutics; and allogeneic cell therapies.

The company has not generated any revenue from product sales and does not expect to generate any revenue from product sales unless and until it obtains both regulatory approval and commercializes any of its product candidates. Revenue consists of amounts recognized from its collaboration with Kite for research and development performed under the Kite Collaboration Agreement and its amendment, recognized on a cost-to-cost percentage of completion basis applied to the total estimated transaction price. The company's lead program is a BCMA-targeting ddCAR product candidate called anitocabtagene autoleucel or anito-cel (formerly, CART-ddBCMA), which is currently being evaluated in its pivotal Phase 2 iMMagine-1, Phase 3 iMMagine-3, and Phase 2 GEM-AnitoFIRST trials in patients with multiple myeloma (MM). The company has partnered anito-cel with Kite Pharma Inc., a Gilead company (Kite), through its co-development/co-commercialization collaboration agreement. Outside of its collaboration with Kite, the company intends to evaluate anito-cel for the treatment of certain non-oncology indications, including some autoimmune disorders. The company also is advancing several ARC-SparX programs: ACLX-001, which targets BCMA in rrMM and for which Kite exercised its option under the Kite Collaboration Agreement to negotiate a license in November 2023; its wholly-owned ACLX-002, which targets CD123 in relapsed or refractory acute myeloid leukemia (AML) and high-risk myelodysplastic syndrome (MDS); and its wholly-owned ACLX-004, which targets CD33 and CD123 in relapsed or refractory AML.

The company's lead program is a BCMA-targeting ddCAR product candidate called anitocabtagene autoleucel or anito-cel (formerly, CART-ddBCMA), which is currently being evaluated in its pivotal Phase 2 iMMagine-1, Phase 3 iMMagine-3, and Phase 2 GEM-AnitoFIRST trials in patients with multiple myeloma (MM). In 2024, the company completed dosing in its pivotal Phase 2 clinical trial (iMMagine-1) of anito-cel in patients with fourth line or later relapsed or refractory MM (rrMM). In December 2025, the company announced interim data from its pivotal iMMagine-1 study in patients with rrMM after three or more prior lines of therapy. As of the October 7, 2025 data cutoff date for the iMMagine-1 ASH presentation, the 117 patients dosed in the study had a median follow-up of 15.9 months. All patients received a single infusion of anito-cel (target dose of 115x10^6 CAR+ T cells). Within the study population, 102 of 117 patients (87%) were triple refractory, 48 of 117 patients (41%) were penta refractory, 21 of 117 patients (18%) had extramedullary disease, and 47 of 117 patients (40%) had high risk cytogenetics. Patients received a median of three prior lines of therapy, with 65 of 117 patients (56%) having received three prior lines. Key highlights from the interim data presented for iMMagine-1 as of the October 7, 2025 data cutoff date are as follows: For the 117 patients with median follow-up of 15.9 months, 96% (112 of 117) overall response rate (ORR) achieved; 86 of 117 (74%) patients achieved complete response (CR) or a stringent complete response (sCR); and 103 of 117 (88%) patients achieved very good partial response (VGPR) or higher. Of the overall MRD evaluable group, 91 of 96 patients (94.8%) were MRD-negative at a minimum of 10^-5 sensitivity and 68 of 87 patients (78.2%) were MRD-negative at a minimum of 10^-6 sensitivity. Of the MRD evaluable group with sufficient follow up, 54 of 65 patients (83.1%) were MRD-negative for at least 6 months at a minimum of 10^-5 sensitivity. Median progression free survival (PFS), and overall survival (OS) were not reached, as less than half of all dosed subjects had experienced an event of progression or death. Using the Kaplan-Meier analysis, PFS rates at 6, 12, 18, and 24 months were 93%, 82% and 67%, and 62%, respectively; OS rates at 6, 12, 18 and 24 months were 96%, 94%, 88%, and 83%, respectively. To date, no delayed neurotoxicities, including no Parkinsonism, no cranial nerve palsies, no Guillain-Barré syndrome, and no immune effector cell-associated enterocolitis have been observed with anito-cel with all patients dosed more than 12 months ago. The company also is advancing several ARC-SparX programs: ACLX-001, which targets BCMA in rrMM and for which Kite exercised its option under the Kite Collaboration Agreement to negotiate a license in November 2023; its wholly-owned ACLX-002, which targets CD123 in relapsed or refractory acute myeloid leukemia (AML) and high-risk myelodysplastic syndrome (MDS); and its wholly-owned ACLX-004, which targets CD33 and CD123 in relapsed or refractory AML. The company initiated its Phase 1 clinical trial of ACLX-001, the first product candidate developed under its ARC-SparX platform, for the treatment of rrMM in 2022. The company initiated the Phase 1 clinical trial for ACLX-002, an ARC-SparX product candidate targeting CD123, for the treatment of AML/MDS in 2022 and received FDA clearance of an IND application for ACLX-004, which targets CD33 and CD123, for the treatment of AML in 2025. In the second half of 2025, the company began dosing patients in its Phase 1 clinical trial of anito-cel in generalized Myasthenia Gravis (gMG), a rare autoimmune disease characterized by severe muscle weakness. The company estimates that gMG affects over 100,000 people in the United States and there is no known cure.

In December 2022, the company entered into a Collaboration and License Agreement (the Kite Collaboration Agreement) with Kite Pharma, Inc., a Gilead company (Kite), to co-develop and co-commercialize anito-cel and next-generation autologous and non-autologous CAR-T cell therapy products that use the same D-domain BCMA binder used in anito-cel, in each case for the treatment of MM. The company also granted Kite an option to include autologous CAR-T-cell therapy products that utilize its ARC-SparX platform that are directed to BCMA, such as ACLX-001, as well as ARC-SparX products directed to CS1. In December 2023, the company amended the Kite Collaboration Agreement, expanding the scope of the collaboration to include lymphomas. Kite also exercised its option to negotiate a license for ACLX-001. In connection with the initial Kite Collaboration Agreement, the company received a $225 million upfront cash payment in February 2023 and will be eligible to receive up to approximately $3.9 billion in clinical, regulatory, and commercial milestone payments. In connection with the amendment to the Kite Collaboration Agreement, the company received a $85 million upfront cash payment in December 2023 and are eligible for additional potential milestone payments, including for the advancement of lymphoma and the license for ACLX-001, as well as additional milestone payments, to offset prespecified development costs over a limited period of time. In 2024, the company achieved a clinical milestone for anito-cel and received $68.3 million from Kite relating to enrollment in the iMMagine-1 trial. In connection with the Kite Collaboration Agreement, the company also entered into a common stock purchase agreement (the Purchase Agreement) and a standstill and stock restriction agreement (the Standstill Agreement) with Gilead in December 2022, pursuant to which, upon closing in January 2023, the company issued and sold to Gilead 3,478,261 shares of its common stock for an aggregate purchase price of approximately $100.0 million and Gilead agreed to certain transfer and standstill restrictions and received certain registration rights. In connection with the amendment to the Kite Collaboration Agreement, in December 2023, the company entered into a second common stock purchase agreement with Gilead and amended and restated the standstill and stock restriction agreement (the Amended Standstill Agreement), pursuant to which the company issued and sold to Gilead 3,242,542 shares of its common stock for an aggregate purchase price of $200.0 million which shares are also subject to certain transfer and standstill restrictions and registration rights. On February 22, 2026, the company entered into an Agreement and Plan of Merger (the Merger Agreement) with Gilead and Purchaser. Pursuant to the Merger Agreement, and upon the terms and subject to the conditions thereof, Purchaser will commence a tender offer, to acquire all of the company's issued and outstanding shares of common stock, par value $0.001 per share, other than any shares owned immediately prior to the effective time of the Merger by the company (including shares held in its treasury) and any shares owned both as of the date of the commencement of the Offer and immediately prior to the effective time of the Merger by Gilead, Purchaser or any other direct or indirect wholly owned subsidiary of Gilead, for (x) $115.00 per Share (the Closing Amount), net to the seller in cash, without interest and subject to any required withholding of taxes, and (y) one contractual contingent value right (a CVR), which will represent the right to receive one contingent payment of $5.00 per CVR, in cash, without interest and subject to any required withholding of taxes, payable upon the achievement of a specified milestone in accordance with the terms and subject to the conditions of a contingent value rights agreement (the CVR Agreement). Each CVR will represent a non-tradable contractual contingent right to receive one contingent payment in an amount equal to $5.00 per CVR, in cash, without interest (except deemed interest for tax purposes, as applicable), payable if, after the closing of the Merger, the cumulative worldwide Sales (as defined in the CVR Agreement) of the anito-cel product exceed $6.0 billion on or prior to December 31, 2029. Upon termination of the Merger Agreement under specified circumstances, the company will be required to pay Gilead a termination fee in the amount of $260.0 million. In 2025, the company sold a total of 1,905,715 shares of common stock under its at-the-market offering program for total net proceeds of $131.6 million. In connection with the net settlement of vested restricted stock units, the company withheld issuance of 546,938 shares to satisfy the Chief Executive Officer's $38.4 million tax withholding obligations.

The company has incurred losses in each period since its inception in December 2014. Net losses were $228.9 million and $107.3 million for the years ended December 31, 2025 and 2024, respectively. As of December 31, 2025, the company had an accumulated deficit of $725.8 million. Collaboration revenue was $22.3 million for the year ended December 31, 2025 compared to $107.9 million for the year ended December 31, 2024, a decrease of $85.7 million. Research and development expenses were $157.6 million for the year ended December 31, 2025 compared to $157.1 million for the year ended December 31, 2024, an increase of $0.5 million. General and administrative expenses were $117.8 million for the year ended December 31, 2025 compared to $88.4 million for the year ended December 31, 2024, an increase of $29.3 million. Other income, net was $24.2 million for the year ended December 31, 2025 compared to $32.3 million for the year ended December 31, 2024, a decrease of $8.1 million. As of December 31, 2025, the company had cash and cash equivalents and marketable securities of $520.1 million. Based on its expected operating cash requirements and capital expenditures, the company believes its current cash and cash equivalents and investments in marketable securities are adequate to fund operations into 2028.

On February 20, 2026, the FDA notified the company that it has accepted its BLA for anito-cel with an anticipated PDUFA action date of December 23, 2026. Kite expects the iMMagine-3 trial to be fully enrolled by mid-2026. The company and its partners at Kite are planning manufacturing capacity to capture the majority of 4L+ rrMM within 12 months of approval and targeting turnaround time of 17 days.

The company is collaborating with Kite to co-develop and co-commercialize anito-cel as well as other autologous and non-autologous CAR-T cell therapies that use the same D-domain BCMA binder for the treatment of MM, pursuant to the Kite Collaboration Agreement. In 2024, Kite initiated a global Phase 3 randomized controlled clinical trial (iMMagine-3) of anito-cel in patients with second through fourth line rrMM. Kite is manufacturing anito-cel for iMMagine-3 and expects the trial to be fully enrolled by mid-2026. This follows the completion of the technical transfer to Kite, which was announced in May 2024, as well as the transfer of the Investigational New Drug (IND) application for anito-cel in MM, which has been cleared by the FDA. The company is also rapidly pursuing clinical development of anito-cel in earlier lines of therapy through its Phase 3 iMMagine-3 clinical trial in second through fourth line rrMM in collaboration with Kite, which is expected to complete enrollment in mid-2026. Outside of its collaboration with Kite, the company intends to evaluate anito-cel for the treatment of certain non-oncology indications, including some autoimmune disorders. The company began dosing patients in a Phase 1 trial in generalized Myasthenia Gravis (gMG) in the second half of 2025. The company estimates that gMG affects over 100,000 people in the United States and there is no known cure. The company also is advancing several ARC-SparX programs: ACLX-001, which targets BCMA in rrMM and for which Kite exercised its option under the Kite Collaboration Agreement to negotiate a license in November 2023; its wholly-owned ACLX-002, which targets CD123 in relapsed or refractory acute myeloid leukemia (AML) and high-risk myelodysplastic syndrome (MDS); and its wholly-owned ACLX-004, which targets CD33 and CD123 in relapsed or refractory AML. The company initiated its Phase 1 clinical trial of ACLX-001, the first product candidate developed under its ARC-SparX platform, for the treatment of rrMM in 2022. The company initiated the Phase 1 clinical trial for ACLX-002, an ARC-SparX product candidate targeting CD123, for the treatment of AML/MDS in 2022 and received FDA clearance of an IND application for ACLX-004, which targets CD33 and CD123, for the treatment of AML in 2025. The company is also integrating AI-powered discovery and computational tools to expand the applicability of its platforms. The company plans to expand its pipeline beyond hematologic and solid cancers to autoimmune disease, as well as to allogeneic and other cell types, including through its collaboration with Kite.

In the United States, the company and Kite will equally share profits and losses from the commercialization of the anito-cel and any next-generation autologous CAR-T cell therapy product for which the company may exercise its option to co-promote with Kite (collectively, the Co-Promote Products). For Co-Promote Products outside of the United States and for any other products the company may license to Kite that are not a Co-Promote Product (Non-Co-Promote Products), the company will be eligible for tiered royalties in the low to mid teen percentages. The company and Kite will jointly develop the Co-Promote Products in accordance with mutually agreed development plans and development budgets. The company will conduct the iMMagine-1 trial for anito-cel and Kite will conduct all other development of the other Co-Promote Products. Other than certain items expressly set forth in the Kite Collaboration Agreement and amendment, the out-of-pocket development costs for activities conducted in the United States for Co-Promote Products will be shared equally by the company and Kite, and the out-of-pocket development costs for activities conducted outside the United States as part of a global clinical trial for Co-Promote Products will be borne 60% by Kite and 40% by the company, however Kite will be solely responsible for the costs for country-specific clinical trials and CMC commercial readiness. Kite will be solely responsible for the conduct of development of the Non-Co-Promote Products at its sole cost. In the United States, the company and Kite will be jointly responsible for commercialization of the Co-Promote Products. Kite will be responsible, at its sole cost, for commercialization of the Co-Promote Products outside the United States and the Non-Co-Promote Products worldwide. Kite will manufacture the licensed products and bear the CMC commercial readiness costs and capital expenses, except that the company is responsible for manufacturing anito-cel prior to transferring the manufacturing process to Kite and the parties share associated out-of-pocket costs.

The company expects to continue to incur significant expenses and increasing operating losses for the foreseeable future, and its net losses may fluctuate significantly from period to period, depending on the timing of and expenditures on its planned research and development activities and commercial readiness activities. The company expects its operating expenses and capital requirements will increase substantially in connection with its ongoing activities, as it establishes a sales, marketing and distribution infrastructure to commercialize any product candidate for which it may obtain regulatory approval; advances the clinical program for anito-cel and subsequent clinical trials focused on earlier lines of therapy in collaboration with its partner Kite; pursues regulatory approval of product candidates that successfully complete clinical trials; attracts, hires, and retains additional clinical, scientific, manufacturing, management, administrative and commercial personnel; adds operational, financial, and management information systems and personnel, including personnel to support its product development; determines and executes its long-term manufacturing strategy for anito-cel in collaboration with its partner Kite; grows its supply and contract manufacturing infrastructure to support the continued development of anito-cel and its other product candidates; initiates clinical trials to evaluate anito-cel in other indications outside of oncology; initiates or continues to advance clinical trials to evaluate its clinical-stage candidates, such as anito-cel in non-oncology indications, including selected autoimmune disorders; and ARC-SparX product candidates, such as ACLX-001, ACLX-002, and other preclinical pipeline programs such as ACLX-004; expands its pipeline of product candidates, including through its own product discovery and development efforts or through acquisition or in-licensing; continues to develop its proprietary platforms to expand their use; and obtains, maintains, expands and protects its intellectual property portfolio.

Based on its expected operating cash requirements and capital expenditures, the company believes its current cash and cash equivalents and investments in marketable securities are adequate to fund operations into 2028. In 2025, the company sold a total of 1,905,715 shares of common stock under its at-the-market offering program for total net proceeds of $131.6 million. In connection with the net settlement of vested restricted stock units, the company withheld issuance of 546,938 shares to satisfy the Chief Executive Officer's $38.4 million tax withholding obligations. The company's future capital requirements will depend on many factors, including the scope, progress, timing, results and costs of developing and manufacturing its product candidates, and their components, and conducting preclinical studies and clinical trials and other testing of its product candidates; its ability to continue its business operations and product candidate research and development, and to adapt to any changes in the regulatory approval process, manufacturing supply, or clinical trial requirements and timing; the costs, timing and outcome of regulatory review of any of its product candidates; the costs and timing of preparing, filing and prosecuting patent applications, maintaining and enforcing its intellectual property rights and defending any intellectual property-related claims, including any claims by third parties that it is infringing upon their intellectual property rights; its ability to establish and maintain strategic collaborations, licensing or other arrangements and the financial terms of any such agreements, including the timing and amount of any future milestone, royalty or other payments due under any such agreement; the costs and timing of future commercialization activities, including manufacturing, marketing, sales and distribution, for any of its product candidates for which it receives marketing approval; the extent to which its product candidates, if approved, can be offered by prescribers in various clinical settings, including academic hospitals and community practices, the acceptance of its products, if and when approved, by patients, the medical community and third-party payors, and the revenue received from commercial sale of any products for which it receives marketing approval; the effect of competing technologies and market developments; and the extent to which it acquires or invests in other businesses, products and technologies and any other licensing or collaboration arrangements for any of its product candidates.

The company faces significant competition from other biotechnology and pharmaceutical companies, and its operating results will suffer if it fails to compete effectively. The company anticipates substantial direct competition from other organizations developing advanced CAR-T or other types of genetically modified cell therapies due to their promising clinical therapeutic effect in clinical trials, including, among others, AbbVie, Allogene, Amgen, AstraZeneca, Autolus, Bristol Myers Squibb, Cabaletta, Caribou Biosciences, CARsgen, Cartesian, Cellectis, Cellular Biomedicine Group, Celyad, Crispr, Gilead, GSK, Immix, Innovent, Johnson & Johnson, Kelonia, Kyverna, Legend, Nanjing IASO Biotherapeutics Ltd., Novartis, Pfizer, Precision BioSciences, Pregene, Regeneron, and Roche. Many of the company's competitors have substantially greater financial, technical and other resources, such as larger research and development staff, greater access to clinical sites and patients, experienced regulatory, marketing and manufacturing teams and well-established sales forces. The company may not be able to implement its business plan if the acceptance of its product candidates is inhibited by price competition or the reluctance of physicians to switch from existing methods of treatment to its product candidates, or if physicians switch to other new drug or biologic products or choose to reserve its product candidates for use in limited circumstances.

The company may be unable to obtain regulatory approval for its product candidates. The denial or delay of any such approval would delay commercialization and have a material adverse effect on its potential to generate revenue, its business and its results of operations. The FDA can delay, limit or deny approval of the company's product candidates for many reasons, including its inability to satisfactorily demonstrate that the product candidates have acceptable safety and efficacy profiles for the requested indication; the FDA's disagreement with its trial designs or the interpretation of data from preclinical studies or clinical trials; the population studied in the clinical trial may not be sufficiently broad or representative to assess safety in the full population for which it seeks approval; its inability to demonstrate that clinical or other benefits of its product candidates outweigh any safety or other perceived risks; the FDA's determination that additional preclinical or clinical trials are required; the FDA's non-approval of the formulation, labeling or the specifications of its product candidates; the FDA's failure to accept the manufacturing processes, drug product characteristics or facilities of third-party manufacturers with which it contracts; or the potential for approval policies or regulations of the FDA to significantly change in a manner rendering its clinical data insufficient for approval. Even if the company eventually completes clinical testing and receives approval of any regulatory filing for its product candidates, the FDA may grant approval contingent on the performance of costly additional post-approval clinical trials. The FDA may also approve its product candidates for a more limited indication or a narrower patient population than it originally requested, and the FDA may not approve the labeling that it believes is necessary or desirable for the successful commercialization of its product candidates.

The company's ddCAR and ARC-SparX platforms represent novel and unproven approaches to treatment, which makes it difficult to predict the timing, results and costs of product candidate development and the likelihood of obtaining regulatory approval. In addition, the company may experience difficulty in identifying appropriate target binding domains. The company has concentrated its research and development efforts on its ddCAR and ARC-SparX platforms, and its future success depends on the successful development of these platforms. Although there are other cell therapies and adapter platforms in clinical development, its platform technologies, including its D-Domain technology, have not been extensively tested over any significant period of time. In addition, while the company believes that its platforms may be capable of overcoming certain challenges faced by conventional CAR-T therapies, it cannot be certain that its approach will result in the intended benefits or will not result in unforeseen negative consequences over time. As an example, the company may not be able to identify D-Domain binders that can recognize certain antigen targets that it would like to pursue, or the development of the applicable D-Domain, ddCAR or SparX protein targeting such antigens may be too challenging or expensive to be commercially viable. The company does not currently have any approved or commercialized products. As with other targeted therapies, off-tumor or off-target activity could delay development or require the company to re-engineer or abandon a particular product candidate. There can be no assurance that any problems the company experiences in the future related to preclinical and clinical development of its novel platforms and its product candidates will not cause significant delays or unanticipated costs or that such problems can be solved.

Management's message emphasizes the company's mission to advance humanity by engineering immunotherapies that are safer, more effective and more broadly accessible. The key themes include the potential of the D-Domain platform to overcome the limitations of traditional CAR-Ts, the promising clinical data from the iMMagine-1 trial for anito-cel, and the strategic partnership with Kite for co-development and co-commercialization. Management highlights the belief that the preliminary clinical data for anito-cel have demonstrated that D-Domains can potentially provide meaningful clinical benefits. The strategic priorities emphasized for the period ahead include advancing anito-cel to treat MM patients in the United States and abroad in collaboration with Kite, evaluating anito-cel for the treatment of certain non-oncology indications including selected autoimmune disorders, enabling greater access to CAR-T therapy through clinical trials in broader patient populations, investing in building out infrastructure and technologies that lower customer friction, increasing capacity and improving responsiveness, developing a comprehensive ARC-SparX AML/MDS program, expanding the pipeline including to select solid tumor indications and indications outside of oncology, applying D-Domain technology outside of autologous CAR-T solutions including through the collaboration with Kite, leveraging AI, machine learning, and other novel technologies to drive discovery efforts, and opportunistically pursuing strategic partnerships and collaborations such as the collaboration with Kite to maximize the full potential of the platform. On February 22, 2026, the company entered into the Merger Agreement with Gilead and Purchaser, providing for the acquisition of the company by Gilead in a two-step transaction, consisting of a tender offer followed by a subsequent merger, with the company continuing as the surviving corporation. Pursuant to the Merger Agreement, Purchaser will commence a tender offer to acquire all of the company's issued and outstanding shares of common stock for $115.00 per Share (the Closing Amount) and one contractual contingent value right (a CVR) representing the right to receive one contingent payment of $5.00 per CVR, payable if the cumulative worldwide Sales of the anito-cel product exceed $6.0 billion on or prior to December 31, 2029.

For the year ended December 31, 2025, the company reported a net loss of $228.9 million ⁵ compared to a net loss of $107.3 million ⁶ for the year ended December 31, 2024. Collaboration revenue was $22.3 million ⁷ for 2025, compared to $107.9 million ⁸ for 2024. Research and development expenses were $157.6 million ⁹ in 2025 versus $157.1 million ¹⁰ in 2024. General and administrative expenses were $117.8 million ¹¹ in 2025 versus $88.4 million ¹² in 2024. Loss from operations was $253.1 million ¹³ in 2025 compared to $137.6 million ¹⁴ in 2024. Total other income, net was $24.2 million ¹⁵ in 2025 versus $32.3 million ¹⁶ in 2024. Income tax expense was $69.0 thousand ¹⁷ in 2025 compared to $2.1 million ¹⁸ in 2024. As of December 31, 2025, the company had cash and cash equivalents and marketable securities of $520.1 million ¹⁹ compared to $625.7 million ²⁰ as of December 31, 2024. The accumulated deficit as of December 31, 2025 was $725.8 million ²¹. Net cash used in operating activities was $210.3 million ²² for 2025 versus $83.5 million ²³ for 2024. Net cash provided by investing activities was $86.3 million ²⁴ for 2025 versus net cash used in investing activities of $183.0 million ²⁵ for 2024. Net cash provided by financing activities was $98.5 million ²⁶ for 2025 versus net cash used in financing activities of $24.1 million ²⁷ for 2024. Share-based compensation was $77.9 million ²⁸ for 2025 compared to $61.1 million ²⁹ for 2024. Depreciation and amortization was $6.7 million ³⁰ for 2025 compared to $5.2 million ³¹ for 2024.

The company faces significant risks related to its proposed acquisition by Gilead, including uncertainties as to the timing of the tender offer and subsequent merger, the risk that the merger may not be completed in a timely manner or at all, and the requirement to pay a termination fee of $260.0 million ¹ to Gilead if the Merger Agreement is terminated under specified circumstances. The company has a limited operating history and has incurred significant losses since its inception, with net losses of $228.9 million ² and $107.3 million ³ for the years ended December 31, 2025 and 2024, respectively, and an accumulated deficit of $725.8 million ⁴ as of December 31, 2025. The company expects to continue to incur losses for the foreseeable future. The company's ddCAR and ARC-SparX platforms represent novel and unproven approaches to treatment, making it difficult to predict the timing, results and costs of product candidate development and the likelihood of obtaining regulatory approval. The company's product candidates may cause undesirable side effects or have other properties that could halt their clinical development, prevent their regulatory approval, require expansion of the trial size, limit their commercial potential, or result in significant negative consequences. The company depends on Kite for certain development, manufacturing and commercialization activities with respect to certain of its product candidates pursuant to its collaboration with Kite, and if such collaboration is not successful, the company may not be able to realize the market potential of those product candidates. The company may be unable to obtain and maintain sufficient intellectual property protection for its platforms and its product candidates, and third-party claims of intellectual property infringement may prevent or delay its product discovery and development efforts.