ARTV 10-K & 10-Q changes, risk factors and insider trading

We have a limited operating history, have not completed any clinical trialshistory and have no products approved for commercial sale, which may make it difficult for you to evaluate our current business and predict our future success and viability.

AlloNK, our lead product candidate, is in early clinical development and our other product candidates and programs are in preclinical development or discovery stages. We have not yet demonstrated an ability to successfully complete a clinical program, including large-scale, pivotal clinical trials, obtainingobtain marketing approval, manufacturingmanufacture product at a commercial scale, or arrangingarrange for a third party to do so on our behalf, or conductingconduct sales and marketing activities necessary for successful product commercialization. This may make it difficult to evaluate the success of our business to date and assess our future viability.

Our operations have consumed significant amounts of cash since inception. As of December 31, 2024,2025, our cash, cash equivalents and investments were $185.4$108.0 million. Based on our current cash, cash equivalents and investments, we estimate that our funds will be sufficient to enable us to fund our operating expenses and capital expenditure requirements at least throughinto the endsecond quarter of 2026.2027. This estimate is based on assumptions that may prove to be wrong, and we could use our available capital resources sooner than we currently expect. Changing circumstances could cause us to consume capital significantly faster than we currently anticipate, and we may need to spend more than currently expected because of circumstances beyond our control. Because the length of time and activities associated with successful development of our product candidates is highly uncertain, we are unable to estimate the actual funds we will require for development and any marketing and commercialization activities.

There is currently no cell therapy approved in the United States or elsewhere in the world for the treatment of any autoimmune disease, and our research and development activities related to AlloNK for treatment of autoimmune diseases, such as RA, Sjögren’s disease, idiopathic inflammatory myopathies, systemic sclerosis, SLE, LN, RA, PV, GPA / MPA, and other autoimmune diseases, may never lead to an approved product.

We are evaluating AlloNK in combination with B-cell targeted monoclonal antibodies (mAbs) to treat autoimmune diseases, such as RA, Sjögren’s disease, idiopathic inflammatory myopathies, systemic sclerosis, SLE, LN, RA,and PV,other GPAautoimmune / MPA.diseases. There is currently no cell therapy approved in the United States or elsewhere in the world for the treatment of any autoimmune disease. We cannot be certain that our approach will lead to the development of an approvable or marketable product. We may not succeed in demonstrating safety and efficacy of AlloNK in combination with B-cell targeted mAbs for the treatment of autoimmune diseases in our ongoing or anticipated clinical trials or in larger-scale clinical trials. Advancing AlloNK in development creates significant challenges for us, including:

Regulatory requirements in the United States and in other countries governing cell therapy products are evolving and the FDA or comparable foreign regulatory authorities may change the requirements, or identify different regulatory pathways, for approval for any of our product candidates. For example, within the FDA, the Center for Biologics Evaluation and Research (CBER) restructured and created a new Office of Tissues and Advanced Therapies to better align its oversight activities with FDA Centers for Drugs and Medical Devices. It is possible that over time new or different divisions may be established or be granted the responsibility for regulating cell therapy products, including NK cell-based products, such as ours. As a result, we may be required to change our regulatory strategy or to modify our applications for regulatory approval, which could delay and impair our ability to complete the preclinical and clinical development and manufacture of, and obtain regulatory approval for, our product candidates. Changes in FDA or comparable foreign regulatory authorities and advisory groups, or any new requirements or guidelines they promulgate, may lengthen the regulatory review process, require us to perform additional studies, increase our development and manufacturing costs, lead to changes in regulatory pathways, positions and interpretations, delay or prevent approval and commercialization of our product candidates or lead to significant post-approval limitations or restrictions.

We have concentrated our research and development efforts on utilizing NK cell-based therapies. To date, the FDA has approved only a few cell-based therapies for commercialization and no NK cell-based therapy has been approved for commercial use by any regulatory authority. The processes and requirements imposed by the FDA or comparable foreign regulatory authorities may cause delays and additional costs in obtaining approvals for marketing authorization for our product candidates. Because our platform is novel, and cell-based therapies are relatively new, especially as potential treatments for autoimmune diseases, regulatory authorities may lack experience in evaluating product candidates like our product candidates. This novelty may lengthen the regulatory review process, including the time it takes for the FDA or comparable foreign regulatory authorities to review our Investigational New Drug applications (INDs) or comparable foreign applications if and when submitted, increase our development costs and delay or prevent commercialization of our product candidates. Additionally, advancing novel immune-oncology therapies creates significant challenges for us, including:

We are early in our development efforts and are substantially dependent on the success of our lead product candidate, AlloNK, which is in early clinical development. Although we have other product candidates in our pipeline being developed by our partners, all of our other internally developed product candidates are in the preclinical or discovery stage. If we are unable to advance our product candidates in clinical development, obtain regulatory approval and ultimately commercialize our product candidates, or experience significant delays in doing so, our business will be materially harmed.

We are in the early stages of our development efforts and are substantially dependent on the success of our lead product candidate, AlloNK, which is in early clinical development. Although we have other product candidates in our pipeline being developed by our partners, all of our other internally developed product candidates are still in the preclinical or discovery stages. We have not yet completed any clinical trials for any product candidate. We will need to progress AlloNK through ourclinical recentlydevelopment initiatedbefore trialwe may seek regulatory approval, and we will need to progress our other early product candidates through preclinical studies and submit INDs to the FDA or comparable foreign regulatory applications to applicable foreign regulatory authorities prior to initiating clinical trials.

receipt of regulatory approvals from applicable regulatory authorities, including biologic license applications (BLAs) or new drug applications (NDAs) from the FDA and approvals from comparable foreign regulatory authorities and maintaining such approvals;

We have not yet succeeded and may not succeed in demonstrating efficacy and safety for any product candidates in clinical trials or in obtaining marketing approval thereafter. Given our early stage of development, it will take several years before we can demonstrate the safety and efficacy of a product candidate sufficient to warrant approval for commercialization, if we can do so at all. If we are unable to develop, or obtain marketing approval for, or, if approved, successfully commercialize our product candidates, we may not be able to generate sufficient revenue to continue our business.

Current clinical data regarding the efficacy of NK cell therapies against autoimmune diseases are limited, raising uncertainties about the therapeutic benefits of treatments like AlloNK for conditions such as RA, Sjögren’s disease, idiopathic inflammatory myopathies, systemic sclerosis, SLE, LN, RA, PV, GPA / MPA and other autoimmune diseases. Moreover, these therapies may not prove to be competitive compared to existing treatments for autoimmune diseases.

While we believe in the potential of our allogeneic NK cell-based product candidate, AlloNK, in combination with a B-cell targeted mAb may have a clinical benefit for autoimmune diseases, such as RA, Sjögren’s disease, idiopathic inflammatory myopathies, systemic sclerosis, SLE, LN, RA, PV and GPAother /autoimmune MPA,diseases, the use of NK cell-based therapies in combination with mAbs represents a novel approach for the treatment of autoimmune disease, and is supported by limited clinical data. To date, the FDA has not approved any cell therapies for autoimmune diseases, adding to the uncertainty surrounding our ongoing clinical trials.

Our belief that AlloNK may be effective as a treatment for autoimmune disease is based on our interpretation of positive clinical data from academic groups and commercial entities using autologous CD19 chimeric antigen receptor (CAR) T-cell therapy (auto-CAR-T) or CAR-NK in a limited autoimmune disease patient cohort, preliminary data from our former collaborator Affimed GmbH, a subsidiary of Affimed N.V. (Affimed) in their ongoing investigation of AlloNK in a Phase 2 trial in combination with acimtamig, a CD30-targeted NK cell engager, in CD30+ Hodgkin lymphoma (HL), as well as our own preliminary data from our ongoing Phase 1/2 clinical trial of AlloNK in combination with rituximab in patients with relapsed or refractory B-NHL, which demonstrated complete responses in B-NHL patients as measured by imaging of tumor lesions. We have made certain assumptions regarding the approach responsible for the preliminary activity shown in the reported studies and how that approach and our own preliminary data from our Phase 1/2 clinical trial in patients with aggressive B-NHL will translate to patients with autoimmune diseases, such as LN, which may not be correct. In July 2025, we completed this trial and decided to discontinue the remaining long term follow up period to focus our resources on pursuing autoimmune indications.

We cannot be certain whether AlloNK in combination with a B-cell targeted mAb will effectively treat RA, Sjögren’s disease, idiopathic inflammatory myopathies, systemic sclerosis, LN, other manifestations of SLE, RA, PV, GPA / MPA or any autoimmune disease for that matter, nor can we guarantee its competitiveness against auto-CAR-T. Additionally, we face competition from numerous cell therapy companies with strong oncology backgrounds, all pursuing development programs in autoimmune diseases, which could hinder our efforts to successfully develop and commercialize AlloNK in combination with a B-cell targeted mAb.

If our clinical trials reveal insufficient activity or unfavorable tolerability of AlloNK in combination with a B-cell targeted mAb against autoimmune diseases, such as RA, Sjögren’s disease, idiopathic inflammatory myopathies, systemic sclerosis, SLE, LN, RA, PV and GPAother /autoimmune MPA,diseases, encounter delays in advancing AlloNK through clinical development, or if we struggle to compete with other companies in developing and marketing AlloNK in combination with a B-cell targeted mAb, it would significantly impact the commercial prospects of AlloNK, as well as our business, financial condition and growth outlook.

We are developing AlloNK for combination with approved B-cell targeted mAbs. ForIn example,addition our ongoing Phase 1/2 clinical trial is administering AlloNK in combination with rituximab in patients with relapsed or refractory B-NHL. Beyondto rituximab and other anti-CD20 mAbs, we have already conducted numerous preclinical studies in which we have shown cytotoxic activity of AlloNK in combination with other approved B-cell targeted mAb therapies, such as anti-CD19 and anti-CD38 mAbs. Even if any product candidate we develop were to receive marketing approval or be commercialized for use in combination with other existing therapies, we would continue to be subject to the risks that the FDA or comparable foreign regulatory authorities could revoke approval of the therapy used in combination with our product candidate. There is also a risk that safety, efficacy, manufacturing or supply issues could arise with these other existing therapies. For example, the other therapies may lead to toxicities that are improperly attributed to our product candidates or the combination of our product candidates with other therapies may result in negative or inconclusive results that the product candidate or other therapy does not produce when used alone or in combination with a different therapy. This could result in our own products being removed from the market or being less successful commercially. Additionally, the results observed in combinations of any of our product candidates with another therapy may not be predictive of future results of combinations of our product candidates in other combinations or indications.

Clinical testing is expensive and takes many years to complete, and is subject to uncertainty. Our planned clinical trials may not be conducted as planned or completed on schedule, if at all. For example, in July 2025, we completed the Phase 1/2 B-NHL clinical trial and decided to discontinue the remaining long term follow up period to focus our resources on pursuing autoimmune indications. Delays and failures can occur at any time during the clinical trial process. Even if our future clinical trials are completed as planned, their results may not support the safety and effectiveness of our product candidates for their targeted indications or support continued clinical development of such product candidates. Our future clinical trial results may not be successful.

To date, we have not completed anythe clinical trials required for the approval of our product candidates. We may experience delays in conducting any clinical trials, and we do not know whether our clinical trials will begin on time, will need to be redesigned, will recruit and enroll patients on time or have data readouts or be completed on schedule, or at all. Events that may prevent successful or timely commencement, readouts, and completion of clinical development and preclinical studies include:

failure to perform in accordance with the FDA’s good clinical practice (GCP) requirements, or applicable regulatory guidelines in other countries;

Our lead product candidate, AlloNK, will require extensive clinical testing before we are prepared to submit a biologics license application (BLA) or marketing authorization application (MAA) for regulatory approval. We cannot predict with any certainty if or when we might complete the clinical development for our product candidates and submit a BLA or MAA for regulatory approval of any of our product candidates or whether any such BLA or MAA will be approved. We may also seek feedback from the FDA, or other comparable foreign regulatory authorities on our clinical development program, and the FDA or such other comparable foreign regulatory authorities may not provide such feedback on a timely basis, or such feedback may not be favorable, which could further delay our development programs.

We have not yet completed any human clinical trials of our product candidates. Undesirable side effects that may be caused by our product candidates could cause us or regulatory authorities to interrupt, delay or halt clinical trials and could result in a more restrictive label than anticipated or the delay or denial of regulatory approval by the FDA or comparable foreign regulatory authorities. Results of our clinical trials could reveal a high and unacceptable severity and prevalence of side effects or unexpected characteristics.

While we believe the interim data reported to date from our Phase 1/2 B-NHL clinical trial indicate that NK cell-based therapies may have the potential to be better tolerated as compared to T cellT-cell based therapies due to biologic differences between these cell typestypes, there remains a risk of serious adverse events. In addition, historically, clinical trials using NK cell therapies in human subjects have been well-tolerated; however, it is possible that adverse events, including CRS, neurotoxicity or graft-versus-host disease will occur in human subjects during clinical trials.

If unacceptable side effects or deaths arise in the development of our product candidates, we, the FDA, the IRBs or ethics committees at the institutions in which our studies are conducted, DSMB or comparable foreign regulatory authorities could suspend or terminate our clinical trials or the FDA or comparable foreign regulatory authorities could order us to cease clinical trials or deny approval of our product candidates for any or all targeted indications. For example, the FDA put our Phase 1/2 clinical trial of AlloNK in combination with rituximab in patients with relapsed or refractory B-NHL on clinical hold in April 2021 due to a patient death and lifted the clinical hold in June 2021 after our investigation and amendments to the clinical trial protocol. Although there was no definitive cause of death, the autopsy findings included widespread metastatic disease and cardiovascular disease, and concluded that the death was possibly due to cardiac arrhythmia. The principal investigator determined that this serious adverse event was not related to AlloNK. We may observe undesirable side effects and we may not be able to complete a clinical trialtrials for AlloNK or any of our other product candidates without further delays or at all. Further undesirable side effects, dose-limiting toxicity events, or deaths in clinical trials with our product candidates may cause the FDA or comparable foreign regulatory authorities to place a clinical hold on the associated clinical trials, to require additional studies, dose de-escalation, or additional protocol amendments, or otherwise to delay or deny approval of our product candidates for any or all targeted indications. Treatment-related side effects could also affect site initiation, patient recruitment or the ability of enrolled patients to complete the trial or result in potential product liability claims. In addition, these side effects may not be appropriately recognized or managed by the treating medical staff. We expect to have to train medical personnel using our product candidates to understand the side effect profiles for our clinical trials and upon any commercialization of any of our product candidates. Inadequate training in recognizing or managing the potential side effects of our product candidates could result in patient injury or death. Any of these occurrences may harm our business, financial condition and prospects significantly.

Patients treated with our product candidates in clinical trials may also receive treatment with cytotoxic lymphodepletion agents, cytokines, monoclonal antibodies and/or other treatments, and may therefore experience side effects or adverse events, including death, that are unrelated to our product candidates. While these side effects or adverse events may be unrelated to our product candidates, they may still affect the success of our clinical studies. The inclusion of seriously ill patients in our autoimmune clinical trials, and critically ill patients in our oncology clinical trialstrials, may result in deaths or other adverse medical events due to underlying disease or to other therapies or medications that such patients may receive. Any of these events could prevent us from advancing our product candidates through clinical development, and from obtaining regulatory approval, and would impair our ability to commercialize our product candidates. Any inability to advance our existing product candidates or any other product candidate through clinical development would have a material adverse effect on our business, and the value of our common stock would decline.

Our business depends upon our ability to identify, develop and commercialize product candidates. A key element of our strategy is to discover and develop additional product candidates based upon our NK cell therapy platform. We are seeking to do so through our collaborations with GC Cell and Affimed,Cell, and may also explore additional strategic collaborations for the discovery of new product candidates. Research programs to identify product candidates require substantial technical, financial and human resources, whether or not any product candidates are ultimately identified. In addition, targets for different autoimmune diseases or cancers may require changes to our manufacturing processes, which may slow down development of or make it impossible to manufacture our product candidates. Our research programs may initially show promise in identifying potential product candidates, yet fail to yield product candidates for clinical development for many reasons, including the following:

Results of any patient who receives our product candidate in an IIT shouldmay not be viewed as representative of how the product candidate will perform in our clinical trials and may not be able to be used to establish safety or efficacy for regulatory approval.

We select the targets for development of our product candidates based on a number of factors, including the estimated patient populations where we believe there is a meaningful addressable market opportunity. However, our projections of the number of people who have the diseases we are seeking to treat, as well as the subset of people with these diseases who have the potential to benefit from treatment with our product candidates, are estimates based on our knowledge and understanding of these diseases. The total addressable market opportunity for our product candidates will ultimately depend upon a number of factors, including the diagnosis and treatment criteria included in the final label, if approved for sale in specified indications, acceptance by the medical community, patient access, alternative therapies and product pricing and reimbursement. For example, we intend to prioritize evaluation and seeking approval for AlloNK in combination with a B-cell targeted mAb in autoimmune diseases.diseases, with refractory RA as our lead indication. Incidence and prevalence estimates are frequently based on information and assumptions that are not exact and may not be appropriate, and the methodology is forward-looking and speculative. The process we have used in developing an estimated incidence and prevalence range for the indications we are targeting has involved collating limited data from multiple sources. Accordingly, the incidence and prevalence estimates we use should be viewed with caution. Further, the data and statistical information we use, including estimates derived from them, may differ from information and estimates made by our competitors or from current or future studies conducted by independent sources.

Disruptions atto the FDAoperations andof the FDA, the SEC, other governmentU.S. governmental agencies or comparable foreign regulatory authorities caused by funding shortagesshortages, leadership changes, staffing cuts or globalother healthstaffing concernsshortages, along with uncertainty regarding the potential for new initiatives, laws, regulations, policies and guidance affecting our product candidates or other aspects of our business, could hinder their ability to hire, retain or deploy key leadershipmaterially and otheradversely personnel, or otherwise prevent new or modified products from being developed, cleared or approved or commercialized in a timely manner or at all, which could negatively impactaffect our business.

The ability of the FDA or other comparable foreign regulatory authorities to review and approve new products or take action with respect to other regulatory matters can be affected by a variety of factors, including government budget and funding levels, statutory, regulatory and policyleadership changes, the FDA’s ability to hire and retain key personnel and accept the payment of user fees, the availability of personnel and other eventsresources, changes in statutes, regulations and policies that may otherwise affect the FDA’s or comparable foreign regulatory authorities’ ability to perform routine functions.functions, and other business disruptions. Average review times at the agencyFDA and comparable foreign regulatory authorities have fluctuated in recent years as a result. In addition, government funding of the SEC and other government agencies on which our operations may rely, including those that fund research and development activitiesactivities, is subject to the political process, which is inherently fluid and unpredictable.

We do not independently conduct clinical trials. We rely on medical institutions, clinical investigators, contract laboratories and other third parties, such as CROs, to conduct or otherwise support clinical trials for our product candidates. In addition, our partner GC Cell will be engaging in initial clinical development for AB-201,AB-201 and hasis dosedconducting initiala patientclinical trial for AB-205 outside our licensed territories to generate initial proof of concept data. We rely heavily on these parties for execution of clinical trials for our product candidates and control only certain aspects of their activities. Nevertheless, we are responsible for ensuring that each of our clinical trials is conducted in accordance with the applicable protocol, legal and regulatory requirements and scientific standards, and our reliance on CROs and other third parties will not relieve us of our regulatory responsibilities. For any violations of laws and regulations during the conduct of our clinical trials, we could be subject to untitled letters, warning letters or enforcement action that may include civil penalties up to and including criminal prosecution.

We and the third parties on which we rely for clinical trials are required to comply with regulations and requirements, including GCP for conducting, monitoring, recording and reporting the results of clinical trials to ensure that the data and results are scientifically credible and accurate, and that the trial patients are adequately informed of the potential risks of participating in clinical trials and their rights are protected. These regulations are enforced by the FDA, the competent authorities of the EU Member States, and comparable foreign regulatory authorities for any drugs in clinical development. The FDA and competent authorities of EU Member States enforces GCP requirements through periodic inspections of clinical trial sponsors, principal investigators and trial sites. If we or these third parties fail to comply with applicable GCP, the clinical data generated in our clinical trials may be deemed unreliable and the FDA or comparable foreign regulatory authorities may require us to perform additional clinical trials before approving our marketing applications. We cannot assure you that, upon inspection, the FDA or comparable foreign regulatory authorities will determine that any of our future clinical trials will comply with GCP. In addition, our clinical trials must be conducted with product candidates produced under current Good Manufacturing Practices (cGMP) regulations. Our failure or the failure of these third parties to comply with these regulations may require us to repeat clinical trials, which would delay the marketing approval process and could also subject us to enforcement action. We also are required to register certain ongoing clinical trials and provide certain information, including information relating to the trial’s protocol, on a government-sponsored database, ClinicalTrials.gov, within specific timeframes. Failure to do so can result in fines, adverse publicity and civil and criminal sanctions.

Our collaboration agreementsagreement with Affimed, GC Cell and any future collaborations with third parties to develop or commercialize our product candidates, mean that our prospects with respect to the product candidates involved will depend in significant part on the success of those collaborations.

Our collaborations, including our collaborationscollaboration with Affimed and GC Cell, and any future collaborations we may enter with third parties, could result in the following risks:

As a result, if we enter into collaboration agreements and strategic partnerships or license our intellectual property, products or businesses, such as our agreementsagreement with GC Cell and Affimed,Cell, we may not be able to realize the benefit of such transactions if we are unable to successfully integrate them with our existing operations, which could delay our timelines or otherwise adversely affect our business. Following a strategic transaction or license, we may not achieve the revenue or specific net income that justifies such transaction.

The advancement of our product candidates and development programs and the potential commercialization of our current and future product candidates will require substantial additional cash to fund expenses. For some of our programs, we may seek to collaborate with pharmaceutical and biotechnology companies to develop and commercialize such product candidates, such as our collaborations with Affimed.candidates. Any of these relationships may require us to incur non-recurring and other charges, increase our near and long-term expenditures, issue securities that dilute our existing stockholders, or disrupt our management and business.

The manufacture of cell therapy products is novel, complex and subject to multiple risks. We couldhave experiencebuilt and are operating our own clinical manufacturing problems,facility and may decide to operate our manufacturing facility at commercial scale, but we could encounter manufacturing problems such as delays or quality issues, and/or we could be required to or choose to modify our manufacturing processes, which could result in delays in the development or commercialization of our product candidates or otherwise harm our business.

While we have built our own clinical manufacturing facility, we currently do not operate our manufacturing facilities at commercial-scalecommercial scale and outsource the manufacturing of our product candidates to third parties, including GC Cell, for certain of our product candidates. Moreover, while we are operating our own clinical manufacturing facility and may decide to operate our manufacturing facility at commercial-scale,commercial scale, we currently have limited personnel with experience in commercial drug manufacturing and currently lack the full resources and capabilities to manufacture any of our product candidates on a commercial scale. Our reliance on GC Cell and on a limited number of third-party manufacturers exposes us to the following risks:

Though we have built our own clinical manufacturing facility, we expect that we willmay continue to rely on third parties for various manufacturing needs.

We are dependent on third parties to acquire, ship and store our cord blood units, NK cell masterintermediate cell banks and drug product lots, viral vectors, and master and working feeder cell banks, and any disruption, quality concerns, damage or loss would cause delays in replacement and our business could suffer.

Our product candidates and certain other materials generated or used during their production, including cord blood units, viral vectorsunits and working feeder cell banks, are acquired from and shipped by third parties and stored in freezers maintained by us and by third parties. In addition, our masterintermediate cell banks are stored in freezers maintained by third parties. If there is a disruption to the supply of these materials, if available materials fail to meet quality standards, or if any of these materials are damaged while in transit or while stored at these facilities, including by the loss or malfunction of these freezers or back-up power systems, as well as by damage from fire, power loss or other natural disasters, we would need to establish replacement products, which could adversely impact our clinical supply and delay our clinical trials and preclinical studies. If we are unable to establish replacement materials in a timely fashion, we could incur significant additional expenses and potential liability to our clinical trial patients whose treatment is delayed, and our business could suffer.

Our cell therapy products depend on the availability of reagents and specialized materials and equipment, including cord blood and viral vectors,blood, which in each case are required to be acceptable to the FDA and comparable foreign regulatory authorities, and such reagents, materials, and equipment may not be available to us on acceptable terms or at all. We and our third-party manufacturers rely on third-party suppliers for various components, materials and equipment required for the manufacture of our product candidates, some of which are single-source products, and do not have supply arrangements for certain of these components.

Manufacturing of our product candidates, including by GC Cell and certain other of our third-party manufacturers, requires many reagents and other specialty materials and equipment, including cord blood and viral vectors,blood, some of which are sourced from sole suppliers. Reagents and other key materials from these suppliers may have inconsistent attributes and introduce variability into our manufactured product candidates, which may contribute to possible adverse events. We and our third-party manufacturers rely on the general commercial availability of materials required for the manufacture of our product candidates, and do not have supply contracts with many of these suppliers and may not be able to obtain supply contracts with them on acceptable terms or at all. Even if we or our third-party manufacturers are able to enter into such contracts, we may be limited to a sole third-party for the supply of certain required components. An inability by us or our third-party manufacturers to continue to source product from any of these suppliers, which could be due to regulatory actions or requirements affecting the supplier, adverse financial or other strategic developments experienced by a supplier, labor disputes or shortages, availability of raw materials, unexpected demands, or quality issues, could adversely affect our ability to satisfy demand for our product candidates, which could adversely and materially affect our product sales and operating results or our ability to conduct clinical trials, either of which could significantly harm our business.

The biopharmaceutical industry in general, and the cell therapy field in particular, is characterized by rapidly advancing and changing technologies, intense competition and a strong emphasis on intellectual property. We face substantial and increasing competition from large and specialty biopharmaceutical companies, as well as public and private medical research institutions and governmental agencies. A large number of cell therapy companies with capabilities and expertise in oncology are advancing development programs in autoimmune diseases. Our known biopharmaceutical competitors that are developing allogeneic CAR-NKNK, CAR-NK, or CAR-T cell therapies or T-cell engaging bispecific antibodies include, but may not be limited to, the following: Adicet Bio, Inc., Allogene Therapeutics, Inc., Amgen Inc., Artec Biotech, Inc., Autolus Therapeutics plc, Bristol-Myers Squibb Co, Cabaletta Bio, Inc., Capstan Therapeutics, Inc. (acquired by AbbVie), Candid Therapeutics, Inc., Caribou Biosciences, Inc., Cartesian Therapeutics, Inc., Celularity Inc., Century Therapeutics, Inc., Chimeric Therapeutics Ltd., Climb Bio, Inc., Coeptis Therapeutics Holdings, Inc., Cullinan Therapeutics Inc., Deverra Therapeutics Inc., Fate Therapeutics, Inc., GalapagosGamida NV,Cell Ltd., Gilead Sciences, Inc., Glycostem Therapeutics B.V., Gracell Biopharmaceuticals, Inc. (acquired by AstraZeneca), GSK plc, iCell Gene Therapeutics Inc., ImmPACT Bio USA, Inc. (acquired by Lyell Immunopharma, Inc.), ImmunityBio, Inc., Indapta Therapeutics, Inc., Interius BioTherapuetics, Inc., ITabMed Co., Ltd., Johnson & Johnson, Kyverna Therapeutics, Inc., Luminary Therapeutics, Inc., Merck & Co., Inc., MiNK Therapeutics, Inc., Nkarta, Inc., NKGen Biotech, Inc., NÖK Therapeutics, Inc., Novartis AG, Orbital Therapeutics, Inc., Regeneron Pharmaceuticals, Inc., Roche, Rui Therapeutics Biotechnology Co., Ltd., Sana Biotechnology, Inc., Sanofi, Shoreline Biosciences Inc., Synthekine Inc., Takeda Pharmaceuticals Company Limited, UCI Therapeutics, Wugen, Inc. and Xencor, Inc.

Obtaining coverage and reimbursement of a product from a government or other third-party payor is a time-consuming and costly process that could require us to provide to the payor supporting scientific, clinical and cost-effectiveness data for the use of our products. Even if we obtain coverage for a given product, if the resulting reimbursement rates are insufficient, hospitals may not approve our product for use in their facility or third-party payors may require co-payments that patients find unacceptably high. Patients are unlikely to use our product candidates unless coverage is provided and reimbursement is adequate to cover a significant portion of the cost of our product candidates. Separate reimbursement for the product itself may or may not be available. Instead, the hospital or administering physician may be reimbursed only for providing the treatment or procedure in which our product is used. Further, from time to time, the Centers for Medicare & Medicaid Services (CMS) revises the reimbursement systems used to reimburse healthcare providers, including the Medicare Physician Fee Schedule and Outpatient Prospective Payment System, which may result in reduced Medicare payments. In some cases, private third-party payors rely on all or portions of Medicare payment systems to determine payment rates. Changes to government healthcare programs that reduce payments under these programs may negatively impact payments from private third-party payors, and reduce the willingness of physicians to use our product candidates.

In addition, we may experience delays or rejections based upon additional government regulation from future legislation or administrative action, or changes in regulatory authority policy during the period of product development, clinical trials and the review process. Accordingly, the regulatory approval pathway for our product candidates may be uncertain, complex, expensive and lengthy, and approval may not be obtained. For instance, the regulatory landscape related to clinical trials in the EU recentlyhas evolved.evolved in recent years. The EU Clinical Trials Regulation, (CTR), which was adopted in April 2014 and repeals the EU Clinical Trials Directive, became applicable on January 31, 2022. The CTR allows sponsors to make a single submission to both the competent authority and an ethics committee in each EU Member State, leading to a single decision for each EU Member State. The assessment procedure for the authorization of clinical trials has been harmonized as well, including a joint assessment by all EU Member States concerned, and a separate assessment by each EU Member State with respect to specific requirements related to its own territory, including ethics rules. Each EU Member State’s decision is communicated to the sponsor via the centralized EU portal. Once the clinical trial is approved, clinical study development may proceed. The CTR foresaw a three-year transition period that ended on January 31, 2025. Since thisthat date, all new or ongoing trials arehave been subject to the provisions of the CTR.

In addition, the EU pharmaceutical legislation is currently the subject of proposals for a complete review, in the context of the Pharmaceutical Strategy for Europe initiative,initiative launched by the European Commission in November 2020. On April 26, 2023, the European Commission adopted a proposal for a new Directive and Regulation to revise the existing pharmaceutical legislation. The proposed revisions remain to be agreed and adopted by the European Council. Moreover, on December 1, 2024, a new European Commission took office. The proposal could, therefore, still be subject to revisions. If adopted in the form proposed, the recent European Commission proposals to revise the existing EU laws governing authorization of medicinal products may result in a number of changes to the regulatory framework governing medicinal products, including a decrease in data and market exclusivity opportunities for our product candidates in the EU and make them open to generic or biosimilar competition earlier than is currently the case with a related reduction in reimbursement status. The proposed revisions remain to be agreed and adopted by the European Parliament and European Council and the proposals may therefore be substantially revised before adoption, the date of which cannot currently be anticipated. The revisions may however have a significant impact on the pharmaceutical industry and our business in the long term.

We are a clinical-stage biotechnology company focused on developing natural killer (NK) cell-based therapies for patients suffering from devastating autoimmune diseases and cancers. Our product candidates are derived from donor cells (allogeneic) rather than a patient’s own cells (autologous) and are pre-manufactured, stored frozen and ready to ship to a patient’s treatment location, making them what we believe to be “off-the-shelf.” Our lead product candidate, AlloNK, is a non-genetically modified, cryopreserved NK cell therapy being evaluated in combination with B-cell targeted monoclonal antibodies (mAbs) in anthree ongoing clinical trials for the treatment of B-cell driven autoimmune diseases, including a Phase 1/1b2a basket trial in systemicmultiple lupusautoimmune erythematosusindications including rheumatoid arthritis (SLERA) withand orSjögren’s without lupus nephritis (LN)disease and a basket investigator-initiated trial (IIT) in multipleB-cell driven autoimmune indications. Seminal peer-reviewed clinical studies using autologous CD19 chimeric antigen receptor (CAR) T-cell therapy (auto-CAR-T) for the treatment of autoimmune diseases have demonstrated that deep B-cell depletion in the periphery and in the lymphoid tissue can lead to drug free disease remission. We have already demonstrated that AlloNK in combination with rituximab was able to drive deep B-cell depletion in the periphery and observed complete responses (CRs) in heavily pre-treated patients naïve to auto-CAR-T in our ongoing Phase 1/2 clinical trial in patients with relapsed or refractory B-cell non-Hodgkin lymphoma (B-NHL). We believe the preliminary results from our Phase 1/2 clinical trial evaluating AlloNK in combination with rituximab in patients with B-NHL provide a readthrough to autoimmune disease because efficacy in both diseases appears to be accomplished with a shared mechanism of action involving B-cell depletion in the periphery and in the lymphoid tissues, followed by an immunological reset and B-cell reconstitution. We expect to report initial data on autoimmune indications from at least one of our Phase 1/1b trial or the basket IIT in the first half of 2025.

We have incurred a net loss of $65.4$83.9 million and $28.7$65.4 million during the years ended December 31, 20242025 and 2023,2024, respectively. As of December 31, 2024,2025, we had an accumulated deficit of $246.7$330.5 million, cash, cash equivalents and investments of $185.4$108.0 million. We expect to continue to incur significant losses for the foreseeable future as we advance our current and future product candidates through preclinical and clinical development, continue to build our operations and transition to operating as a public company. Accordingly, until such time as we can generate significant revenue from sales of our product candidates, if ever, we expect to finance our cash needs through public or private equity or debt financings or other capital sources, which may include sales of shares of common stock under the Sales Agreement (as defined below) entered into with Leerink Partners LLC in August 2025, or other sources, such as our existing and any future strategic collaborations and other strategic arrangements with third parties. However, we may not be able to raise additional funds or enter into such other arrangements when needed or on favorable terms, or at all. To the extent that we raise additional capital through the sale of equity or convertible debt securities, the ownership interest of our stockholders will be or could be diluted, and the terms of these securities may include liquidation or other preferences that adversely affect the rights of our common stockholders. Debt financing and equity financing, if available, may involve agreements that include covenants limiting or restricting our ability to take specific actions, such as incurring additional debt, making capital expenditures or declaring dividends. If we raise additional funds through collaboration or licensing arrangements with third parties or other strategic transactions, we may have to relinquish rights to our intellectual property, future revenue streams, research programs, or product candidates or grant licenses on terms that may not be favorable to us and/or may reduce the value of our common stock. If we are unable to raise additional capital or enter into such arrangements when needed, we could be forced to delay, limit, reduce or terminate our research and development programs or future commercialization efforts, or grant rights to develop and market our product candidates even if we would otherwise prefer to develop and market such product candidates ourselves.

The manufacturing of our cell therapy products is novel and complex, and we have invested substantial resources to optimize the manufacturing process of our product candidates, including selection and optimization of cord blood units, establishing cold chain supply logistics and leveraging the current Good Manufacturing Practices (cGMP) manufacturing facility of GC Cell Corporation (GC Cell) to expand NK cells and create our product candidates. We also currently operate manufacturing facilities at our leased facility in San Diego, California to support NK and CAR-NK cell production for our pipeline development and clinical trial (and potentially commercial) supply. We also currently rely on other third-parties to ship and store our cord blood units and drug product lots, viral vectors and master and working feeder cell banks, as well as other components used in the manufacturing process for our product candidates, and we expect to continue to do so to meet our preclinical, clinical, and potential commercial activities. We expect that we and GC Cell will be capable of providing and processing sufficient quantities of our product candidates to meet anticipated clinical trial demands cost-effectively. However, any disruption in the supply or manufacture of our product candidates could result in delays in our preclinical studies and clinical trials and increase the costs of our research and development activities. We plan to continue to invest in our manufacturing capability and cryopreservation techniques to continuously improve our production and supply chain capabilities over time.

License and development support-related revenue recognized in the statements of operations and comprehensive loss, related to GC Cell’s development support activities under the Amended AB-201 Agreement, was $0.3 millionzero and $0.6$0.3 million during the years ended December 31, 20242025 and 2023,2024, respectively.

Total reimbursements for development costs invoiced to GC Cell in connection with the AB-205 License Agreement were $0.1 millionzero and $1.6$0.1 million for the years ended December 31, 20242025 and 2023,2024, respectively. Through December 31, 2024,2025, we received $1.7 million in payments from GC Cell.

License and development support-related revenues related to GC Cell’s development support activities under the AB-201 Agreement were $0.3 millionzero and $0.6$0.3 million during the years ended December 31, 20242025 and 2023,2024, respectively.

Research and development activities are central to our business model. There are numerous factors associated with the successful commercialization of any of our product candidates, including future trial design and various regulatory requirements, many of which cannot be determined with accuracy at this time based on our stage of development. In addition, future regulatory factors beyond our control may impact our development programs. Product candidates in later stages of clinical development generally have higher development costs than those in earlier stages of clinical development, primarily due to the increased size and duration of later-stage clinical trials.

Interest income consists of interest on our money market funds and short-term investments.

In connection with the closing of the IPO,IPO in July 2024, the outstanding SAFEs converted into 2,391,418 shares of our common stock.

The following table summarizes our results of operations for the years ended December 31, 20242025 and 20232024 (in thousands):

License and Development Support Revenue. License and development support revenues were zero for the year ended December 31, 2025, compared to $0.3 million for the year ended December 31, 2024, compared to $0.6 million for the year ended December 31, 2023.2024. Revenues were related to the achievement of a research-related milestone in 2023 and development support activities under the AB-201 Agreement with GC Cell.Agreement.

Research and development expenses were $50.3$69.5 million for the year ended December 31, 2024,2025, compared to $50.3 million for the year ended December 31, 2023.2024. The increase of $0.1$19.2 million was primarily due to a $2.4$12.1 million increase in external research and development expense, offset byand a $2.3$7.1 million decreaseincrease in internal research and development expense. The $2.4$12.1 million increase in external research and development expense is primarily due to a $5.9 millionan increase in AB-101AlloNK costs related to product candidate development and ongoing clinical trials as we progressed towards the end of our clinical trial for the B-NHL program and commencement of our clinical trial on theexploring AlloNK forin SLE/LNautoimmune program.diseases. The increase was offset by a $3.5$7.1 million decrease in other programs as we narrowed our research focus to our AB-101 programs. The $2.3 million decreaseincrease in internal research and development expense is primarily due to a $2.7 million decrease in operating costs associated with discovery activities that were discontinued in 2023, offset by a $0.4$6.2 million increase in personnel-related expenses due to increased headcount and a $0.9 million increase in 2024.other operating costs.

General and Administrative Expenses. General and administrative expenses were $20.3 million for the year ended December 31, 2025, compared to $17.2 million for the year ended December 31, 2024, compared to $13.9 million for the year ended December 31, 2023.2024. The increase of $3.3$3.1 million was primarily comprised of a $1.5$2.6 million increase in personnel-related costs due to increased headcount, including a $1.3$2.5 million increase in administrative personnel expenses and a $0.2$0.1 million increase in non-cash stock-based compensation, in addition to a $1.8$0.5 million increase in other operational and legal costs.

Other Income, Net. Other incomeincome, net was $5.9 million for the year ended December 31, 2025, compared to other income, net of $1.9 million for the year ended December 31, 2024,2024. comparedThe to other incomeincrease of $2.0 million for the year ended December 31, 2023. The decrease of $0.1$4.0 million was primarily due to thea $2.9$3.6 million change in fair value of SAFEs, which we entered intoSAFEs in late2024 2023,that offsetdid bynot occur in 2025. Additionally, there was a $2.8$0.6 million increase in interest income due to morehigher favorableinvestment ratesbalances ofin return2025. duringThese 2024.increases were partially offset by a $0.2 million decrease in other income (expense), net.

Unrealized Gain (Loss) on Investments. Unrealized lossgain on investments was $0.2 million for the year ended December 31, 2025, compared to an unrealized loss of $0.4 million for the year ended December 31, 2024, compared to an unrealized gain of $0.3 million for the year ended December 31, 2023.2024. The decreaseincrease between periods of $0.7 million was primarily due to the change in fair value of investments.

We have incurred net losses and negative cash flows from operations since our inception and expect to continue to incur significant and increasing operating losses for the foreseeable future. We have never generated any revenue from product sales and do not expect to generate any revenues from product sales unless and until we successfully complete development of and obtain regulatory approval for our product candidates, which will not be for several years, if ever. In addition, if we obtain regulatory approval for any of our product candidates, we expect to incur significant commercialization expenses related to product sales, marketing, manufacturing and distribution. From our inception through December 31, 2024,2025, we have raised aggregate gross proceeds of $401.4$441.7 million to fund our operations, comprised primarily fromof proceeds received from the IPO, including proceeds from the underwriters’ partial exercise of their overallotment option, our issuance of convertible promissory notes, SAFEs andSAFEs, private placements of our convertible preferred stock.stock, Inand February 2021, wefunds received a $30.0 million up-front payment from Merckcollaboration for our two target programs. In addition, as of December 31, 2024, we have received $9.9 million related to reimbursable research services from Merck.arrangements. As of December 31, 2024,2025, we had cash, cash equivalents and investments of $185.4$108.0 million, and an accumulated deficit of $246.7$330.5 million. Based on our current operating plans, we expect our existing cash, cash equivalents and investments will be sufficient to fund our planned operating expenses and capital expenditure requirements at least throughinto the endsecond quarter of 2026.2027. Our total future capital requirements will depend on many factors and is subject to the risks and uncertainties set forth in the section titled “Risk Factors.”

the potential expansion of our current development programs to seek new indications or other monoclonal antibodies;

the costs associated with hiring additional personnel and consultants as our business grows, including additional executive officers and clinical developmentdevelopment, regulatory and commercial personnel;

patients’ willingness to pay out-of-pocket for any approved products in the absence of coverage and/or adequate reimbursement from third-party payors; and costs associated with any products or technologies that we may in-license or acquire.

Net cash used in operating activities for the year ended December 31, 2024,2025, was $55.0$76.8 million, consisting primarily of our net loss incurred during the period of $65.4$83.9 million and net changes in operating assets and liabilities of $0.4 million, partially offset by $10.7$7.5 million of net non-cash charges. Non-cashNet non-cash charges consisted of $7.0$6.8 million in stock-based compensation expense, $3.6 million in change in fair value of SAFEs, $2.4$2.6 million in depreciation and amortization expense, andpartially $2.3offset by $1.9 million ofin accretion of discounts on short-term investments. Changes in operating assets and liabilities included a $2.0 million increase in accrued expenses, a $1.5 million increase in prepaid expense and other current assets, a $1.6$0.8 million decrease in receivables, a $0.7 million decrease in accrued expenses, a $0.5 million increase in accounts payable, and a $0.3$0.1 million change in other net balance sheet assets and liabilities.

Net cash used in operating activities for the year ended December 31, 2023,2024, was $47.4$55.0 million, consisting primarily of our net loss incurred during the period of $28.7$65.4 million, partially offset by $9.6$10.7 million of non-cash charges and $28.3 million of a net decrease in operating assets and liabilities.charges. Non-cash charges consisted primarily of $7.1$7.0 million in stock-based compensation expense, $2.3 million in depreciation and amortization expense, $0.7$3.6 million in change in fair value of SAFEsSAFEs, $2.4 million in depreciation and $0.5amortization expense, and $2.3 million of accretion of discounts on short-term investments. The net changeChanges in operating assets and liabilities related primarily toincluded a $26.5$2.0 million decreaseincrease in deferredprepaid revenue,expense and other current assets, a $1.2$1.6 million decrease in receivables, a $0.9$0.7 million decrease in accrued expenses, and a $0.4$0.5 million decreaseincrease in accounts payable, partiallyand offseta by decreases of $0.5$0.3 million change in prepaid expenses and other currentnet balance sheet assets and $0.2 million of other balance sheet items.liabilities.

Net cash usedprovided inby investing activities for the year ended December 31, 2024,2025, was $120.5$63.4 million related to $176.2$110.9 million in maturities of investments, partially offset by $44.9 million in purchases of investments and $0.6$2.6 million ofin purchases of property and equipment, partially offset by $56.3 million in maturities of short-term investments.equipment.

Net cash used in investing activities for the year ended December 31, 2023,2024, was $26.0$120.5 million related to $49.5$176.2 million of purchases of short-term investments and $3.3$0.6 million related toof purchases of property and equipment, partially offset by $26.8$56.3 million in maturities of short-term investments.

We leaseleased certain office space in San Diego, California, under a non-cancelable operating lease, with a term through December 2025 (the Executive Drive Lease). The Executive Drive Lease commenced on December 23, 2019, with a six-year initial term and includesincluded aggregate monthly payments to the lessor of approximately $2.8 million. The Executive Drive Lease also providesprovided for rent abatements and scheduled increases in base rent. In connection with the lease, we made a one-time cash security deposit in the amount of $0.4 million, of which $0.2 million was refunded in October 2021 and the remaining $0.2 million is refundable at the end of the lease term and is included in long-termprepaid expenses and other current assets in the balance sheets. The Executive Drive Lease includesincluded a renewal option, which includesincluded an option to renew for five additional years. We willdid not exercise the option and, as such, is not reflected as part of the rightExecutive ofDrive useLease assetterminated andin associatedDecember lease liabilities.2025.

In June 2021, we entered into a lease agreement for corporate office and laboratory space in San Diego, California (the Morehouse Lease), which represented a portion of a new facility that was under construction. The Morehouse Lease includes multiple, successive commencement dates. The office and laboratory space commenced in the second quarter of 2022 and the third quarter of 2022 for the cGMP manufacturing center. The Morehouse Lease has an initial term of 88 months and includes aggregate monthly payments to the lessor of approximately $23.2 million with a rent escalation clause, and a tenant improvement allowance of $12.3 million. We are also required to maintain a cash security deposit in the form of an unconditional and irrevocable letter of credit of $0.2 million which must remain in place until the termination of the lease and is considered a non-current asset as of December 31, 2024.2025. These obligations are further described in Note 1110 to our financial statements appearing elsewhere in this this Annual Report.

In August 2022, we entered into a lease agreement to use designated laboratory and vivarium space in San Diego, California (the Explora Lease). The Explora Lease is accounted for as an operating lease and commenced in August 2022. The Explora Lease hashad an initial term of 36 months with automatic one-year renewals for up to three additional years and includes aggregate monthly payments to the lessor of approximately $0.8 million with a rent escalation clause. We extended the lease through August 2026.

Investment in biopharmaceutical product development is highly speculative because it entails substantial upfront capital expenditures and the significant risk that product candidates will fail to demonstrate adequate efficacy or an acceptable safety profile, gain regulatory approval or become commercially viable. For the threesix months ended MarchJune 31,30, 2026 and for the year ended December 31, 2025, our net losses were $23.5$48.5 million and $83.9 million, respectively. As of MarchJune 31,30, 2026, we had an accumulated deficit of $354.1$379.1 million. Substantially all of our losses have resulted from expenses incurred in connection with our research and development programs and from general and administrative costs associated with our operations.

Our operations have consumed significant amounts of cash since inception. As of MarchJune 31,30, 2026, our cash, cash equivalents and investments were $86.8$349.4 million. Based on our current cash, cash equivalents and investments, we estimate that our funds will be sufficient to enable us to fund our operating expenses and capital expenditure requirements into the second quarter of 2027.2029. This estimate is based on assumptions that may prove to be wrong, and we could use our available capital resources sooner than we currently expect. Changing circumstances could cause us to consume capital significantly faster than we currently anticipate, and we may need to spend more than currently expected because of circumstances beyond our control. Because the length of time and activities associated with successful development of our product candidates is highly uncertain, we are unable to estimate the actual funds we will require for development and any marketing and commercialization activities.

The current administration is pursuing policies to reduce regulations and expenditures across government agencies including at HHS, the FDA, CMS and related agencies. These actions, presently directed by executive orders or memoranda from the Office of Management and Budget, may propose policy changes that create additional uncertainty for our business. For example, the current administration has announced agreements with severalcertain pharmaceutical companies that require the drug manufacturers to offer, through a direct to consumer platform (TrumpRx) U.S. patients and Medicaid programs prescription drug Most-Favored Nation pricing equal to or lower than those paid in other developed nations, with additional mandates for direct-to-patient discounts and repatriation of foreign revenues. Other recent actions, for example, include (1) directing agencies to reduce agency workforce and cut programs; (2) directing HHS and other agencies to lower prescription drug costs through a variety of initiatives; (3) imposing tariffs on certain imported pharmaceutical products; and (4) as part of the Make America Healthy Again (MAHA) Commission’s Strategy Report released in September 2025, working across government agencies to increase enforcement on direct-to-consumer pharmaceutical advertising. Additionally, the current administration recently called on Congress to enact “The Great Healthcare Plan,” to codify and expand Most-Favored Nation pricing, lower government subsidies to private insurance companies, increase healthcare price transparency, expand pharmaceutical drugs available for over-the-counter purchase, and enact restrictions on pharmacy benefit manager (PBM) payment methodologies, among other things. These actions and policies may significantly reduce U.S. drug prices, potentially impacting manufacturers’ global pricing strategies and profitability, while increasing their operational costs and compliance risks. In June 2024, the U.S. Supreme Court’s Loper Bright decision greatly reduced judicial deference to regulatory agencies, which could increase successful legal challenges to federal regulations affecting our operations. Congress may introduce and ultimately pass health care related legislation that could impact the drug approval process and make changes to the Medicare Drug Price Negotiation Program. Individual states in the United States have also become increasingly active in passing legislation and implementing regulations designed to control pharmaceutical product pricing, including price or patient reimbursement constraints, discounts, restrictions on certain product access and marketing cost disclosure and transparency measures and, in some cases, designed to encourage importation from other countries and bulk purchasing. For example, on June 15, 2026, the FDA approved Colorado’s Section 804 Importation Program (SIP) proposal to import certain drugs from Canada for specific state healthcare programs. It is unclear how this and Florida’s similar program, approved by the FDA in 2024, will be implemented and whether they will overcome potential legal, regulatory, or industry challenges in the United States and/or Canada. Any such approved importation plans, when implemented, may result in lower drug prices for products covered by those programs.

We will need to expand our organization, and we may experience challenges in managing this growth as we build our capabilities, which could disrupt our operations.*

As of MarchJune 31,30, 2026, we had 106115 full-time employees. We will need to expand our organization, and we may have difficulty identifying, hiring and integrating new personnel. Future growth would impose significant additional responsibilities on our management, including the need to identify, recruit, maintain, motivate and integrate additional employees, consultants and contractors. Also, our management may need to divert a disproportionate amount of its attention away from our day-to-day activities and devote a substantial amount of time to managing these growth activities. We may not be able to effectively manage the expansion of our operations, which may result in weaknesses in our infrastructure, give rise to operational mistakes, loss of business opportunities, loss of employees and reduced productivity among remaining employees. Our expected growth could require significant capital expenditures and may divert financial resources from other projects, such as the development of product candidates. If our management is unable to effectively manage our growth, our expenses may increase more than expected, our ability to generate and/or grow revenues could be reduced, and we may not be able to implement our business strategy. Our future financial performance and our ability to commercialize our product candidates and compete effectively will depend, in part, on our ability to effectively manage any future growth.

New income, sales, use or other tax laws, statutes, rules, regulations or ordinances could be enacted at any time, which could adversely affect our business operations and financial performance. Further, existing tax laws, statutes, rules, regulations or ordinances could be interpreted, changed, modified or applied adversely to us. For example, the OBBBA and the Inflation Reduction Act (the IRA) enacted many significant changes to the U.S. tax laws. Future guidance from the Internal Revenue Service and other tax authorities with respect to new and existing legislation may affect us, and certain aspects of such legislation could be repealed or modified in future legislation. In addition, it is uncertain if and to what extent various states will conform to such legislation or any newly enacted federal tax legislation. Changes in corporate tax rates, the realization of net deferred tax assets relating to our operations, the taxation of foreign earnings and the deductibility of expenses or future reform legislation could have a material impact on the value of our deferred tax assets, could result in significant one-time charges and could increase our future U.S. tax expense.

For example, in August 2025 we entered into a Sales Agreement with Leerink Partners LLC under which we may, from time to time, sell shares of our common stock having an aggregate offering price of up to $11,950,000 in “at the market” offerings.offerings (the 2025 ATM Offering). In addition, in May 2026, we completed the May 2026 Offering pursuant to which we issued and sold 23,871,526 shares of our common stock and pre-funded warrants to purchase 2,170,138 shares of our common stock for aggregate gross proceeds of $300.0 million, which resulted in dilution to our then-existing stockholders. In connection with the May 2026 Offering, we suspended the 2025 ATM Offering. To the extent that we raise additional capital through theother salesales of equity or convertible debt securities, your ownership interest will be further diluted, and the terms may include liquidation or other preferences that adversely affect your rights as a stockholder.

We are a clinical-stage biotechnology company focused on developing off-the-shelf, allogeneic, natural killer (NK) cell-based therapies for patients suffering from debilitating autoimmune diseases. Our product candidates are derived from donor cells (allogeneic) rather than a patient’s own cells (autologous) and are pre-manufactured, stored frozen and ready to ship to a patient’s treatment location, making them what we believe to be “off-the-shelf.” Our lead product candidate, AlloNK, is a non-genetically modified, cryopreserved NK cell therapy being evaluated in combination with B-cell targeted monoclonal antibodies (mAbs) in three ongoing clinical trials for the treatment of B-cell driven autoimmune diseases, including a Phase 2a basket trial in multiple autoimmune indications including rheumatoid arthritis (RA) and Sjögren’s disease (SjD) and a basket investigator-initiated trial (IIT) in B-cell driven autoimmune indications.

Uniform and consistent B-cell depletion in peripheral blood was observed by Day 13 in all 51 patients treated with cyclophosphamide/fludarabine, AlloNK and rituximab who had available samples as of the April 3, 2026 data cutoff. Complete B-cell depletion was observed using a high-sensitivity assay in all 28 RA patients evaluated as of the data cutoff. B-cellA reconstitutionpredominance of naïve/transitional B cells was observed in all 13 patients treated with AlloNK plus rituximab demonstratedwho ahad predominanceB-cell reconstitution as of naïve/transitionalthe Bdata cells,cutoff date, consistent with the hypothesized B-cell “reset” mechanism.

Following athe recent FDA interaction, we planare toin initiatethe process of initiating a Phase 3 randomized controlled trial evaluating AlloNK in approximately 150 RA patients who have had an inadequate response to two or more b/tsDMARDs of distinct classes. We have alignment with the FDA on our plans to conduct a single registrational trial design. Patients are expected to be randomized 2:1 to receive AlloNK plus rituximab or rituximab alone, with ACR50 response at six months as the primary efficacy endpoint. Rituximab was selected as the active comparator because it is a component of the proposed AlloNK treatment regimen, is approved for the treatment of RA and has demonstrated ACR50 responses at six months in line with other approved RA therapies. Patients randomized to the rituximab-alone control arm who do not respond are expected to have the opportunity to cross over to the AlloNK plus rituximab arm at six months.

Subject to final protocol and regulatory considerations, the trial is expected to be conducted globally across more than 80 sites, including approximately 40 sites already active in our ongoing autoimmune clinical program. We expectare to initiateinitiating the registrational trial in the second half of 2026 and expect to report primary efficacy data in the second half of 2028, with a potential BLA submission in 2029.

We commenced our operations in 2019 and have devoted substantially all of our resources to date to organizing and staffing our company, business planning, raising capital, establishing and engaging in collaborations, conducting research and development, advancing and scaling up product candidate manufacturing, establishing cold chain delivery logistics, establishing and protecting our intellectual property portfolio and providing general and administrative support for these activities. From our inception through MarchJune 31,30, 2026, we have raised aggregate gross proceeds of $8.0 million from the issuance and sale of convertible promissory notes, $70.0 million from our Series A convertible preferred stock financings, $120.0 million from our Series B convertible preferred stock financing and $24.4 million from our SAFEs. Additionally, in July 2024, we closed on our IPO, in which we issued and sold 13,920,000 shares of common stock at a public offering price of $12.00 per share. We also sold an additional 1,000,000 shares of common stock upon the partial exercise of the underwriters’ purchase option. The aggregate net proceeds of the IPO, inclusive of the partial exercise of the underwriters’ purchase option and after deducting underwriting discounts, commissions, and offering expenses, was $162.3 million. In May 2026, we closed on our May 2026 Offering, in which we issued and sold 23,871,526 shares of common stock at a price of $11.52 per share and pre-funded warrants, in lieu of common stock to certain investors, to purchase 2,170,138 shares of common stock at a price of $11.5199 per pre-funded warrant. The net proceeds of the May 2026 Offering, after deducting underwriting discounts, commissions, and offering expenses, was $282.7 million.

We have incurred a net loss of $23.5$48.5 million and $20.3$41.6 million during the threesix months ended MarchJune 31,30, 2026 and 2025, respectively. As of MarchJune 31,30, 2026, we had an accumulated deficit of $354.1$379.1 million, cash, cash equivalents and investments of $86.8$349.4 million. We expect to continue to incur significant losses for the foreseeable future as we advance our current and future product candidates through preclinical and clinical development, continue to build our operations and transition to operating as a public company. Accordingly, until such time as we can generate significant revenue from sales of our product candidates, if ever, we expect to finance our cash needs through public or private equity or debt financings or other capital sources, which may include sales of shares of common stock under the Sales Agreement (as defined below) entered into with Leerink Partners LLC in August 2025, or other sources, such as our existing and any future strategic collaborations and other strategic arrangements with third parties. However, we may not be able to raise additional funds or enter into such other arrangements when needed or on favorable terms, or at all. To the extent that we raise additional capital through the sale of equity or convertible debt securities, the ownership interest of our stockholders will be or could be diluted, and the terms of these securities may include liquidation or other preferences that adversely affect the rights of our common stockholders. Debt financing and equity financing, if available, may involve agreements that include covenants limiting or restricting our ability to take specific actions, such as incurring additional debt, making capital expenditures or declaring dividends. If we raise additional funds through collaboration or licensing arrangements with third parties or other strategic transactions, we may have to relinquish rights to our intellectual property, future revenue streams, research programs, or product candidates or grant licenses on terms that may not be favorable to us and/or may reduce the value of our common stock. If we are unable to raise additional capital or enter into such arrangements when needed, we could be forced to delay, limit, reduce or terminate our research and development programs or future commercialization efforts, or grant rights to develop and market our product candidates even if we would otherwise prefer to develop and market such product candidates ourselves.

Other (Expense) Income, Net

Other (expense) income, net consists primarily of interest expense and realized gains and /losses on investments.foreign exchange transactions.

Provision for income taxes consists of U.S. federal and state income taxes in which we conduct business. Since our inception, we have not recorded any income tax benefits for the net losses we have incurred in each year or for our research and development tax credits, as we believe, based upon the weight of available evidence, that it is more likely than not that all of our net operating loss (NOL) carryforwards and tax credits will not be realized. Accordingly, we have recorded a full valuation allowance against our net deferred tax assets at MarchJune 31,30, 2026 and December 31, 2025.

Comparison of the Three Months Ended MarchJune 31,30, 2026 and 2025

The following table summarizes our results of operations for the three months ended MarchJune 31,30, 2026 and 2025 (in thousands):

Research and Development Expenses. We track outsourced development, outsourced personnel costs and other external research and development costs of specific programs. We do not track our internal research and development costs on a program-by-program basis. The following table summarizes our research and development expenses for the three months ended MarchJune 31,30, 2026 and 2025 (in thousands):

Research and development expenses were $19.3$21.9 million for the three months ended MarchJune 31,30, 2026, compared to $17.1$17.9 million for the three months ended MarchJune 31,30, 2025. The increase of $2.3$4.1 million was primarily due to a $2.4$3.2 million increase in external research and development expense, partially offset byand a $0.1$0.9 million decreaseincrease in internal research and development expense. The $2.4$3.2 million increase in external research and development expense is primarily due to an increase in AlloNK costs related to product candidate development and ongoing clinical trials exploring AlloNK in autoimmune diseases. The $0.1$0.9 million decreaseincrease in internal research and development expense is primarily due to a $0.8$1.0 million increase in personnel-related expenses due to increased headcount, partially offset by a $0.1 million decrease in other operating costs, partially offset by an increase of $0.7 million in personnel-related expenses.costs.

General and Administrative Expenses. General and administrative expenses were $5.1$5.0 million for each of the three months ended MarchJune 31,30, 20262026, andcompared to $4.9 million for the three months ended June 30, 2025. Changes included a $0.1$0.2 million increase in personnel-related costs, offset by a $0.1$0.2 million decrease in other operational and legal costs.

Other Income, Net. Other income, net was $0.9$1.9 million for the three months ended MarchJune 31,30, 2026, compared to other income, net of $1.9$1.6 million for the three months ended MarchJune 31,30, 2025. The decreaseincrease of $0.9$0.3 million was primarily due to aan decreaseincrease in interest income due to a higher money market and investment balancesbalance in 2025.the second quarter of 2026 from the May 2026 Offering.

Unrealized (Loss) Gain on Investments, Net. Unrealized loss on investments was $0.1$3 millionthousand for the three months ended MarchJune 31,30, 2026, compared to an unrealized gain of $0.1$2 millionthousand for the three months ended MarchJune 31,30, 2025. The decrease between periods of $0.3$5 millionthousand was due to the change in fair value of investments.

We have incurred net losses and negative cash flows from operations since our inception and expect to continue to incur significant and increasing operating losses for the foreseeable future. We have never generated any revenue from product sales and do not expect to generate any revenues from product sales unless and until we successfully complete development of and obtain regulatory approval for our product candidates, which will not be for several years, if ever. In addition, if we obtain regulatory approval for any of our product candidates, we expect to incur significant commercialization expenses related to product sales, marketing, manufacturing and distribution. From our inception through MarchJune 31,30, 2026, we have raised aggregate gross proceeds of $441.8$741.9 million to fund our operations, comprised primarily of proceeds received from the IPO, including proceeds from the underwriters’ partial exercise of their overallotment option, proceeds received from the May 2026 Offering, our issuance of convertible promissory notes, SAFEs, private placements of our convertible preferred stock, and funds received from collaboration arrangements. As of MarchJune 31,30, 2026, we had cash, cash equivalents and investments of $86.8$349.4 million, and an accumulated deficit of $354.1$379.1 million. Based on our current operating plans, we expect our existing cash, cash equivalents and investments will be sufficient to fund our planned operating expenses and capital expenditure requirements into the second quarter of 2027.2029. Our total future capital requirements will depend on many factors and is subject to the risks and uncertainties set forth in the section titled “Risk Factors.”

In August 2025, we entered into a sales agreement (the Sales Agreement) with Leerink Partners LLC (the Agent or Leerink Partners), under which we may, from time to time, sell shares of our common stock having an aggregate offering price of up to $11,950,000 in “at the market” offerings (the ATM Offering Program) through the Agent. Sales of the shares of common stock will be made at prevailing market prices at the time of sale, or as otherwise agreed with the Agent. We will pay a commission to the Agent of up to 3.0% of the gross proceeds of any shares of common stock sold under the Sales Agreement. In May 2026, we suspended the ATM Offering Program, though the Sales Agreement remains in full force and effect. No shares of common stock were sold under the ATM Offering Program during the three and six months ended MarchJune 31,30, 2026.

Comparison of the ThreeSix Months Ended MarchJune 31,30, 2026, and 2025

The following table sets forth a summary of the net cash flow activity for the threesix months ended MarchJune 31,30, 2026, and 2025 (in thousands):

Net cash used in operating activities for the threesix months ended MarchJune 31,30, 2026, was $21.0$41.3 million, consisting primarily of our net loss incurred during the period of $23.5$48.5 million, partially offset by $2.1$4.5 million of net non-cash charges and $0.5$2.7 million of net changes in operating assets and liabilities. Net non-cash charges consisted of $1.6$3.5 million in stock-based compensation expense, $0.7$1.3 million in depreciation and amortization expense, partially offset by $0.2$0.3 million in accretion of discounts on investments. Changes in operating assets and liabilities included a $4.0 million decrease in accrued expenses, a $2.6$1.9 million decrease in prepaid expense and other current assets, a $1.8$1.0 million increase in accounts payable, and a $0.1$0.2 million decreasechange in receivables.other net balance sheet assets and liabilities.

Net cash used in operating activities for the threesix months ended MarchJune 31,30, 2025, was $19.8$42.8 million, consisting primarily of our net loss incurred during the period of $20.3$41.6 million and net changes in operating assets and liabilities of $4.9 million, partially offset by $2.0$3.6 million of net non-cash charges. Non-cashNet non-cash charges consisted of $2.1$3.6 million in stock-based compensation expense, $0.7 million of accretion of discounts on investments, and $0.6$1.2 million in depreciation and amortization expense.expense, partially offset by $1.2 million in accretion of discounts on investments. Changes in operating assets and liabilities included a $0.9 million decrease in accrued expenses, a $0.8$3.6 million increase in prepaid expense and other current assets, a $1.5 million decrease in accrued expenses, and a $0.2 million change in other net balance sheet assets and liabilities.

Net cash provided by investing activities for the threesix months ended MarchJune 31,30, 2026, was $15.3$32.9 million related to $22.0$40.0 million in maturities of investments, partially offset by $6.4 million in purchases of investments and $0.2$0.7 million in purchases of property and equipment.

Net cash provided by investing activities for the threesix months ended MarchJune 31,30, 2025, was $10.0$31.1 million related to $29.0$57.3 million in maturities of investments, partially offset by $18.5$24.6 million in purchases of investments and $0.5$1.6 million in purchases of property and equipment.

Net cash provided by financing activities for the threesix months ended MarchJune 31,30, 2025,2026, was $0.2$283.2 million primarily related to $300.0 million in gross proceeds received from the May 2026 Offering and $0.2 million in cash received fromfor stock option exercises and stock issued in association with our 2024 Employee Stock Purchase Plan (ESPP)., partially offset by $16.8 million in issuance costs paid for the May 2026 Offering and $0.2 million in payments to taxing authorities related to net-settlement of vested RSUs.

In June 2021, we entered into a lease agreement for corporate office and laboratory space in San Diego, California (the Morehouse Lease), which represented a portion of a new facility that was under construction. The Morehouse Lease includes multiple, successive commencement dates. The office and laboratory space commenced in the second quarter of 2022 and the third quarter of 2022 for the cGMP manufacturing center. The Morehouse Lease has an initial term of 88 months and includes aggregate payments to the lessor of approximately $23.2 million with a rent escalation clause, and a tenant improvement allowance of $12.3 million. We are also required to maintain a cash security deposit in the form of an unconditional and irrevocable letter of credit of $0.2 million which must remain in place until the termination of the lease and is considered a non-current asset as of MarchJune 31,30, 2026. These obligations are further described in Note 11 to our audited financial statements appearing in the Annual Report and Note 10 to our unaudited condensed financial statements appearing elsewhere in this Quarterly Report.

As of MarchJune 31,30, 2026, we have future remainingminimum obligations under the Company's operating lease paymentsleases of $11.7$11.1 million relating to leases we have recognized in the condensed balance sheets, of which $2.3$1.7 million is payable before December 31, 2026.

Under our collaboration agreements, we have milestone payment obligations that are contingent upon the achievement of specified development, regulatory and commercial sales milestones and are required to make certain royalty payments in connection with the sale of products developed under the agreement (see Note 7 to our unaudited condensed financial statements included elsewhere in this Quarterly Report). As of MarchJune 31,30, 2026, we are unable to estimate the timing or likelihood of achieving the milestones or making future product sales.