Item 2. Management’s Discussion and Analysis
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations.
You should read the following discussion and analysis of our financial condition and results of operations together with our unaudited condensed consolidated financial statements and the related notes included in Part I, Item 1, of this Quarterly Report on Form 10-Q for the fiscal quarter ended March 31, 2026 (“Form 10-Q”) and with the audited consolidated financial statements and the related notes for the fiscal year ended December 31, 2025, included in our Annual Report on Form 10-K (“Form 10-K”) filed with the U.S. Securities and Exchange Commission (“SEC”) on March 5, 2026.
Special Note Regarding Forward-Looking Statements
This Form 10-Q contains “forward-looking” statements within the meaning of Section 27A of the Securities Act of 1933, as amended (“Securities Act”), and Section 21E of the Securities Exchange Act of 1934, as amended (“Exchange Act”). All statements, other than statements of historical facts, contained in this Form 10-Q are forward-looking statements, including statements regarding our business strategy, plans, and objectives; expectations regarding our clinical-stage CAR-T cell therapy product candidates, including our expectations about the development timelines for such product candidates; the expected timing of disclosure of clinical data; expectations regarding the safety, efficacy, and potential advantages of our CAR-T cell therapy product candidates; expectations about our future regulatory filings and interactions with regulatory authorities, including expectations about our phase 3 pivotal trial design for vispa-cel; our results of operations and financial position; plans and objectives of management for future operations; and the like. In some cases, you can identify forward-looking statements by terms such as “may,” “will,” “should,” “expect,” “plan,” “anticipate,” “could,” “intend,” “target,” “project,” “contemplate,” “believe,” “estimate,” “predict,” “potential,” or “continue” or the negative of these terms or other similar expressions, although not all forward-looking statements contain these words.
As a result of many factors, including but not limited to the risks described in the section of our Form 10-K titled “Risk Factors,” in the section entitled “Risk Factors” in this Form 10-Q, and in other filings we make with the SEC, the events and circumstances reflected in our forward-looking statements may not be achieved or may not occur, and actual results could differ materially from those described in or implied by the forward-looking statements. As a result of these risks, you should not place undue reliance on these forward-looking statements. We assume no obligation to revise or update any forward-looking statements for any reason, except as required by law.
Overview
We are a clinical-stage C lustered R egularly I nterspaced S hort P alindromic R epeats (“CRISPR”) genome-editing biopharmaceutical company dedicated to developing transformative therapies for patients with devastating diseases. Our genome-editing platform is based on our novel chRDNA ( C RISPR h ybrid R NA- DNA , pronounced “chardonnay”) technology, which enables more precise genome editing of allogeneic cell therapies. Our allogeneic, or off-the-shelf, chimeric antigen receptor (“CAR”)-T (“CAR-T”) cell therapy product candidates are manufactured in advance with cells from healthy donors, with the goal of enabling broad patient access, rapid patient treatment, and increased manufacturing scale. Our allogeneic CAR-T cell therapy product candidates in clinical development are directed at established cell surface targets against which autologous CAR-T cell therapeutics have already demonstrated clinical proof of concept, CD19 and B cell maturation antigen (“BCMA”). We use our chRDNA technologies to armor our allogeneic CAR-T cell therapies through multiple genome-editing strategies, such as checkpoint disruption and immune cloaking, to enhance activity against hematologic malignancies.
We are advancing two clinical-stage allogeneic CAR-T cell therapies for the treatment of patients with hematologic malignancies:
• Vispacabtagene regedleucel (“vispa-cel,” formerly CB-010): an allogeneic anti-CD19 CAR-T cell therapy that has been evaluated in patients with relapsed or refractory B cell non-Hodgkin lymphoma (“r/r B-NHL”) in our ANTLER phase 1 clinical trial
• CB-011: an allogeneic anti-BCMA CAR-T cell therapy that is being evaluated in patients with relapsed or refractory multiple myeloma (“r/r MM”) in our CaMMouflage phase 1 clinical trial
Vispa-cel has received regenerative medicine advanced therapy (“RMAT”) designation for relapsed or refractory large B cell lymphoma (“r/r LBCL”), fast track designation for r/r B-NHL, and orphan drug designation for follicular lymphoma (“FL”) from the U.S. Food and Drug Administration (“FDA”). CB-011 has received RMAT, fast track, and orphan drug designations for r/r MM from the FDA.
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To our knowledge, vispa-cel is the first clinical-stage allogeneic CAR-T cell therapy with a genome-edited knockout of the PDCD1 gene to prevent PD-1 expression on the CAR-T cell surface. On November 3, 2025, we announced that, as of the September 2, 2025, safety data cutoff date, 84 patients with r/r B-NHL had been enrolled in the ANTLER phase 1 clinical trial. We selected a single dose of 80x10⁶ viable CAR-T cells following lymphodepletion (“LD”) with 60 mg/kg/day for two days of cyclophosphamide and 25 mg/m 2 /day for five days of fludarabine as the recommend phase 2 dose (“RP2D”).
By leveraging our allogeneic CAR-T cell therapy clinical data set of more than 140 patients dosed across multiple clinical trials, we identified key factors that we believe are linked to successful patient outcomes, and we have incorporated these learnings to develop an optimized vispa-cel profile. Two of the key attributes of the optimized vispa-cel profile are donor age (young donors drive enhanced outcomes relative to older donors) and partial human leukocyte antigen (“HLA”) matching (matching two or more alleles correlates with enhanced patient outcomes). As of the September 2, 2025, 84 patients had been treated in our ANTLER phase 1 clinical trial, of which 35 CD19-naïve LBCL patients received vispa-cel with the optimized profile. As of the September 29, 2025 efficacy data cutoff, the results for the 35-patient optimized profile cohort included an 86% overall response rate (“ORR”), a 63% complete response (“CR”) rate, and 53% progression-free survival (“PFS”) at 12 months. Median follow up for the optimized profile cohort was 11.8 months.
Vispa-cel is generally well tolerated. As of the September 2, 2025, safety data cutoff date, treatment emergent adverse events (“TEAEs”) at any grade in 25% or greater of all 84 patients who had received vispa-cel were thrombocytopenia (62%), cytokine release syndrome (“CRS”) (55%), anemia (52%), neutropenia (39%), hypokalemia (26%), and leukopenia (26%). In the optimized profile cohort (N=35), there were no cases of graft versus host disease (“GvHD”) or grade 3 or greater immune effector cell-associated neurotoxicity syndrome (“ICANS”), 1% of patients experienced grade 3 or greater CRS, and 28% (out of 80 patients) experienced prolonged cytopenias.
We reached alignment with the FDA regarding our vispa-cel pivotal phase 3 clinical trial design following interactions to date with the agency enabled by the RMAT designation for vispa-cel.We plan to evaluate vispa-cel in the ANTLER-3 trial, a randomized, controlled pivotal phase 3 clinical trial in approximately 250 2L LBCL CD19-naïve patients who are not eligible for transplant and who are not candidates for, or who are not eligible for, autologous CAR-T cell therapy based on access challenges or medical criteria, including the need for urgent therapy. Patients randomized to the study arm would receive a single dose of vispa-cel at the RP2D following LD and patients randomized to the comparator arm would be treated with the investigator’s choice of standard-of-care regimen, such as polatuzumab vedotin (“Pola”), bendamustine, rituximab (”R”)(“Pola-BR”); R, gemcitabine, and oxaliplatin (“R-GemOx”); Pola-R-GemOx (“Pola-RGO”); or tafasitamab and lenalidomide, with crossover to the vispa-cel arm permitted after progressive disease. The primary endpoint would be PFS. Secondary endpoints would be ORR, overall survival (“OS”), event-free survival (“EFS”), duration of response (“DoR”), duration of CR, quality of life (“QoL”), and safety. Clinical trial sites would include both academic and sophisticated community centers in the United States and globally.
To our knowledge, CB-011 is the first allogeneic CAR-T cell therapy incorporating an immune cloaking approach that includes both the removal of the endogenous beta-2 microglobulin (“B2M”) protein and insertion of a beta-2-microglobulin–human-leukocyte-antigen-E–peptide transgene (“B2M–HLA-E”). On November 3, 2025, we announced results from the dose escalation portion of our ongoing CaMMouflage phase 1 trial evaluating CB-011 in r/r MM patients. Forty-eight fourth-line or later (“4L+”) patients were enrolled in the dose escalation portion of the trial; enrollment in dose escalation is completed. Patients had been treated with three or more prior lines of therapy including a proteasome inhibitor, an immunomodulatory drug, and an anti-CD38 antibody. Prior treatment with an autologous CAR-T cell therapy was not permitted and no BCMA-targeted therapy was permitted within the prior three months. We evaluated two different LD regimens and multiple CAR-T cell dose levels. Thirty-five patients were treated with an LD regimen of 500 mg/m 2 cyclophosphamide and 30 mg/m 2 fludarabine daily for three days (“the selected LD regimen”). A single dose of CB-011 preceded by the selected LD regimen resulted in responses at all dose levels evaluated (150x10 6 viable CAR-T cells, N=6; 300x10 6 viable CAR-T cells, N=13; 450x10 6 viable CAR-T cells, N=13; and 800x10 6 viable CAR-T cells, N=3).
CB-011 had a manageable safety profile across all dose levels and LD regimens (N=48), with no cases of GvHD, immune effector cell-associated enterocolitis (“IEC-EC”), parkinsonism, or cranial nerve palsies as of the September 24, 2025 data cutoff date. TEAEs in 25% or greater of all patients treated with CB-011 following the selected LD regimen (N=35) were as follows: neutropenia (80%), anemia (60%), thrombocytopenia (49%), infections (49%), dizziness (31%), CRS (31%), fatigue (31%), leukopenia (29%), decreased appetite (29%), constipation (26%), and pyrexia (26%). Notable adverse events in the recommend dose for expansion (“RDE”) cohort as of the data cutoff date included one CB-011-related grade 5 immune effector cell-associated hematotoxicity (“ICAHT”) on day 90, one grade 5 pneumonia not related to CB-011 on day 50, and one grade 4 CB-011-related Guillain-Barré Syndrome on day 129, which is resolving. In the cohort evaluating the 300x10 6 viable CAR-T cell dose level following the selected LD regimen, there was one grade 5
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respiratory syncytial virus not related to CB-011 on day 73. Prophylactic measures for cytopenias and infections and early intervention for certain immune effector cell disorders have been successfully implemented in our clinical protocol.
We also announced on November 3, 2025, that we have selected the 450x10 6 viable CAR-T cell dose with the selected LD regimen as our RDE. As of the September 24, 2025, data cutoff date, the 12-patient, BCMA-naïve cohort treated with the selected LD regimen and a single dose of 450x10 6 viable CAR-T cells had the following outcomes: an ORR of 92%, a CR/stringent CR (“sCR”) rate of 75%, and 91% of evaluable patients achieved minimal residual disease (“MRD”) negativity (≤10 -5 ). Seven of the 12 patients remained on study as of the data cutoff date in very good partial response (“VGPR”) or better six months or longer following receipt of a single dose of CB-011. The median follow up for these 12 patients was 8.3 months. We initiated the dose expansion portion of the CaMMouflage phase 1 clinical trial in late 2025, which includes enrollment of BCMA-naive and BCMA-exposed patient cohorts.
Since our founding in 2011, we have devoted substantially all of our resources to organizing and staffing, business planning, raising capital, expanding our genome-editing platform technologies, developing our CAR-T cell therapy product candidates and building our pipeline, creating and maintaining our intellectual property portfolio, and establishing arrangements with third parties for the manufacture, testing, and clinical trial evaluations of our CAR-T cell therapy product candidates. We do not have any products approved for commercial sale and have not generated any revenue from product sales. We have incurred operating losses since commencement of our operations.
To date, we have primarily funded our operations through proceeds from the sales of our capital stock, revenue from our license and collaboration agreements, and proceeds from the sale of shares of Intellia Therapeutics, Inc. (“Intellia”) common stock.
Our net losses for the three months ended March 31, 2026, and March 31, 2025, were $25.1 million and $40.0 million, respectively. We had an accumulated deficit of $621.6 million as of March 31, 2026. Our net losses and operating losses may fluctuate from quarter to quarter and year to year depending primarily on the timing of expenses associated with our clinical trials and development of our product candidates. We anticipate that our expenses will increase substantially as we:
• progress our clinical trials for our vispa-cel and CB-011 CAR-T cell therapy product candidates, particularly as we advance vispa-cel in our planned pivotal phase 3 clinical trial;
• hire additional personnel, as needed;
• acquire or in-license intellectual property, new technologies, and/or additional product candidates;
• expand, maintain, enforce, and defend our intellectual property portfolio;
• seek regulatory and marketing approvals for our vispa-cel and CB-011 CAR-T cell therapy product candidates if our clinical trials are successful;
• expand manufacturing capabilities and supply chain capacity for our vispa-cel and CB-011 CAR-T cell therapy product candidates;
• experience any delays, challenges, or other issues associated with any of the above, including the failure of clinical trials meeting endpoints, generation of clinical trial data subject to differing interpretations, or the occurrence of potential safety issues or other development or regulatory challenges;
• make royalty, milestone, or other payments under current, and any future, in-license or assignment agreements with third parties;
• establish a sales, marketing, and distribution infrastructure to commercialize any product candidates for which we obtain marketing approval; and
• continue to operate as a public company, including defending against any future class action securities litigation and shareholder derivative lawsuits.
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We do not own or operate any manufacturing facilities. We use multiple contract manufacturing organizations (“CMOs”) to individually manufacture, under current good manufacturing processes, our chRDNA guides, Cas9 and Cas12a proteins, plasmids, and adeno-associated virus serotype 6 (“AAV6”) vectors used in the manufacture of our CAR-T cell therapy product candidates as well as the CAR-T cell therapy product candidates themselves. We expect to continue to rely on our CMOs for manufacturing our clinical trial materials, and most of these CMOs have capabilities for commercial manufacturing. Additionally, we may decide to build our own manufacturing facility in the future to provide greater flexibility and control over our clinical or commercial manufacturing needs.
Components of Results of Operations
Licensing and Other Third-party Revenue
We have not generated any revenue from product sales to date and do not expect to generate any revenue from the sale of products in the foreseeable future. We cannot predict if, when, or to what extent we will generate revenue from the commercialization and sale of our CAR-T cell therapy product candidates if we succeed in obtaining regulatory approval for such product candidates.
To date, all of our revenue has been earned from licensing, collaboration, and other third-party agreements, including agreements with related parties. Under these agreements, we may license rights to certain intellectual property controlled by us. The terms of these arrangements typically include payments to us of one or more of the following: nonrefundable, upfront license fees or exclusivity fees; annual maintenance fees; regulatory and/or commercial milestone payments; research and development payments; and royalties on the net sales of products and/or services. Each of these payments results in licensing and other revenue. Revenue under such agreements was $2.4 million for each of the three-month periods ended March 31, 2026, and March 31, 2025. See Notes 5 and 7 to our unaudited condensed consolidated financial statements included elsewhere in this Form 10-Q for additional information.
For the foreseeable future, we expect substantially all our revenue will be generated from licensing and other third-party agreements. See Note 2 to the consolidated financial statements included in our Form 10-K for additional information about our revenue recognition policy related to our licensing and other third-party agreements.
Operating Expenses
Research and Development Expenses
Our research and development expenses consist of internal and external expenses incurred in connection with the development of our CAR-T cell therapy product candidates and our genome-editing platform technologies, and our in-licensing, assignment, and other third-party agreements.
External costs include:
• costs associated with acquiring technology and intellectual property licenses that have no alternative future uses, sublicensing revenues, and milestones;
• costs incurred in connection with the clinical development and manufacturing of our CAR-T cell therapy product candidates, including under agreements with CMOs, suppliers, contract research organizations (“CROs”), and clinical sites; and
• other research and development costs, including lab supplies, and consulting services.
Internal costs include:
• personnel-related costs, including salaries, benefits, and stock-based compensation expense, for our research and development personnel; and
• allocated facilities and other overhead expenses, including expenses for rent, facilities maintenance, and depreciation.
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We expense research and development costs as incurred. Costs of certain activities are recognized based on an evaluation of the progress to completion of specific tasks. However, payments made prior to the receipt of goods or services that will be used or rendered for future research and development activities are deferred and capitalized as prepaid expenses and other current assets in our unaudited condensed consolidated balance sheets. The capitalized amounts are recognized as expenses as the goods are delivered or as related services are performed. We separately track certain external costs on a program-by-program basis; however, we do not track costs that are deployed across our programs. We do not allocate internal costs as several of our departments support our programs and our payroll and other personnel expenses are not tracked on a program-by-program basis.
Clinical development activities are central to our business model. 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. We expect that our research and development expenses will increase substantially for the foreseeable future as we continue to implement our business strategy; advance our CAR-T cell therapy product candidates through clinical trials; conduct translational research to support our product candidates; seek regulatory approvals for our product candidates that successfully complete clinical trials; and hire additional personnel to support our clinical development efforts.
The successful development of our CAR-T cell therapy product candidates is highly uncertain. Accordingly, at this time, we cannot reasonably estimate or know the nature, timing, and costs of the efforts that will be necessary to complete the development of our product candidates. We are also unable to predict when, if ever, we will generate revenue and material net cash inflows from the commercialization and sale of any of our product candidates for which we may obtain marketing approval. We may never succeed in achieving regulatory approval for any of our product candidates. The duration, costs, and timing of clinical trials and development of our product candidates will depend on a variety of factors, including:
• sufficiency of our financial and other resources;
• acceptance of our CRISPR chRDNA genome-editing technology;
• ability to develop differentiating features so that our products have a competitive edge;
• establishment, maintenance, enforcement, and defense of our patents and other intellectual property rights;
• our ability to not infringe, misappropriate, or otherwise violate third-party intellectual property rights;
• successful enrollment in, and completion of, our clinical trials of our CAR-T cell therapy product candidates;
• data from our clinical trials that support an acceptable risk-benefit profile of our vispa-cel and CB-011 CAR-T cell therapy product candidates for the intended patient populations and that demonstrate safety and efficacy;
• entry into new collaborations to further the development of our CAR-T cell therapy product candidates;
• successful development of our internal process development and transfer to CMOs;
• establishment and maintenance of agreements with CMOs and suppliers for clinical and commercial supplies and scaling up manufacturing processes and capabilities to support our clinical trials;
• receipt of timely responses and marketing approvals from applicable regulatory authorities;
• grant of nonpatent regulatory exclusivity for our CAR-T cell therapy product candidates;
• establishment of sales, marketing, and distribution capabilities necessary for commercialization of our CAR-T cell therapy product candidates, if approved by the applicable regulatory authorities, whether by us or in collaboration with third parties;
• maintenance of a continued acceptable safety profile of our products post-approval;
• acceptance of our CAR-T cell therapy product candidates, if approved by the applicable regulatory authorities, by patients, the medical community, and third-party payors;
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• ability of our products to compete with other therapies and treatment options;
• establishment and maintenance of healthcare coverage and adequate reimbursement; and
• expanded indications and patient populations for our products.
The following table summarizes our research and development expenses for the periods indicated:
Three Months Ended March 31,
2026 2025
(in thousands)
External costs:
Expenses related to licenses, sublicensing revenue, and milestones
$ 622 $ 1,092
Services provided by CROs, CMOs, and third parties that conduct nonclinical studies and clinical trials on our behalf
7,922 15,643
Other research and development expenses 2,146 5,124
Total external costs 10,690 21,859
Internal costs:
Personnel-related expenses 7,507 10,313
Facilities and other allocated expenses 2,414 3,359
Total internal costs 9,921 13,672
Total research and development expenses $ 20,611 $ 35,531
General and Administrative Expenses
Our general and administrative expenses consist primarily of personnel-related costs, intellectual property costs, consulting costs, and allocated overhead, including rent, equipment depreciation, and utilities. Personnel-related costs consist of salaries, benefits, and stock-based compensation expense for our general and administrative personnel. Intellectual property costs include expenses for filing, prosecuting, and maintaining patents and patent applications, including certain patents and patent applications that we license from third parties. We are entitled to receive reimbursement from third parties of a portion of the costs for filing, prosecuting, and maintaining certain patents and patent applications. We accrue for these reimbursements as the respective expenses are incurred and classify such reimbursements as a reduction of general and administrative expenses.
We expect that our general and administrative expenses will increase in the future if our clinical trials are successful and if we prepare for potential commercialization of our CAR-T cell therapy product candidates.
Other Income
Other income consists primarily of interest income earned on cash and marketable securities.
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Results of Operations
Comparison of the Three Months Ended March 31, 2026, and March 31, 2025
The following table summarizes our results of operations for the periods indicated:
Three Months Ended March 31,
2026 2025 Change
(in thousands)
Licensing and other third-party revenue $ 2,397 $ 2,353 $ 44
Operating expenses:
Research and development 20,611 35,531 (14,920)
General and administrative 8,066 9,735 (1,669)
Total operating expenses 28,677 45,266 (16,589)
Loss from operations (26,280) (42,913) 16,633
Other income
Other income, net 1,195 2,922 (1,727)
Total other income 1,195 2,922 (1,727)
Net loss $ (25,085) $ (39,991) $ 14,906
Licensing and Other Third-party Revenue
Licensing and other third-party revenue increased by less than $0.1 million to $2.4 million for the three months ended March 31, 2026, from $2.4 million for the three months ended March 31, 2025.
Research and Development Expenses
Research and development expenses decreased by $14.9 million to $20.6 million for the three months ended March 31, 2026, from $35.5 million for the three months ended March 31, 2025. This decrease was primarily related to decreases of (i) $7.7 million in external CMO and CRO activities for our clinical CAR-T cell therapy product candidates, driven by decreases of (a) $4.5 million in CRO activities for our clinical trials and (b) $3.2 million due to timing of CMO activities, (ii) $3.0 million in other research and development expenses primarily related to the reduction in workforce and strategic pipeline prioritization, (iii) $2.8 million in personnel-related expenses related to the reduction in workforce and strategic pipeline prioritization, (iv) $0.9 million in other facilities and allocated expenses, and (v) $0.5 million in expenses related to licenses, sublicensing revenue, and milestones.
General and Administrative Expenses
General and administrative expenses decreased by $1.7 million to $8.1 million for the three months ended March 31, 2026, from $9.7 million for the three months ended March 31, 2025. This decrease was primarily related to a decrease of $1.2 million in personnel-related expenses related to the reduction in workforce and strategic pipeline prioritization and a decrease of $0.5 million in legal and other service-related expenses.
Total Other Income
Total other income decreased by $1.7 million for the three months ended March 31, 2026, as compared to the three months ended March 31, 2025. This decrease was primarily related to a $1.4 million decrease in interest income earned from marketable securities.
Liquidity, Capital Resources, and Capital Requirements
Sources of Liquidity
Since our inception through March 31, 2026, we have raised an aggregate net proceeds of $852.8 million to fund our operations through our initial public offering (“IPO”); sales of convertible preferred stock; a follow-on public offering; proceeds from our licensing, licensing and collaboration, service, and patent assignment agreements, including sales of Intellia stock; private placements; at-the-market equity offerings; and government grants.
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As of March 31, 2026, we had cash, cash equivalents, and marketable securities of $118.6 million.
Shelf Registration Statement
See Note 9 to our unaudited condensed consolidated financial statements included elsewhere in this Form 10-Q for additional information.
At-the-Market Equity Offering Program
See Note 9 to our unaudited condensed consolidated financial statements included elsewhere in this Form 10-Q for additional information.
Funding Requirements
We expect that our existing cash, cash equivalents, and marketable securities will be sufficient to fund our operations for at least the next 12 months from the date this Form 10-Q is filed. We have based these estimates on our current assumptions, which may require future adjustments based on our ongoing business decisions.
We will continue to be dependent on equity financing, debt financing, licensing arrangements, and/or other forms of capital raises, including structured or other non-dilutive financings, to fund operating expenses, including to fully fund our planned vispa-cel pivotal phase 3 trial, at least until we are able to generate significant positive cash flows from our operations. We have no current ongoing material financing commitments, such as lines of credit or guarantees, that are expected to affect our liquidity over the next five years, except for our lease commitments and payments under certain of our license agreements as described in Notes 4 and 8 to our unaudited condensed consolidated financial statements included elsewhere in this Form 10-Q.
Our primary use of cash is to fund operating expenses and research and development expenses, which primarily consists of expenditures related to clinical trials. Cash used to fund operating expenses is impacted by the timing of when we pay these expenses, as reflected in the change in our outstanding accounts payable, accrued expenses, and prepaid expenses.
Our future funding requirements will depend on many factors, including the following:
• the initiation, progress, timing, costs, and results of clinical trials for our vispa-cel and CB-011 CAR-T cell therapy product candidates;
• the clinical development plans we establish for these product candidates;
• the outcome, timing, and cost of meeting regulatory requirements established by the FDA and other comparable foreign regulatory authorities;
• the potential impact of reductions in government spending and personnel;
• whether we enter into any collaboration agreements and the terms of any such agreements;
• the cost of filing and prosecuting our patent applications, and maintaining and enforcing our patents and other intellectual property rights;
• the cost of defending intellectual property disputes, including patent infringement actions brought by third parties against our products after we receive regulatory approval;
• the effect of competing technological and market developments;
• the cost and timing of completion of commercial-scale outsourced manufacturing activities or the cost and timing of completion of clinical-scale and commercial-scale internal manufacturing activities;
• the cost of establishing sales, marketing, and distribution capabilities for any CAR-T cell therapy product candidates for which we may receive regulatory approval in regions where we choose to commercialize our products;
• the amount of revenue, if any, received from commercial sales of our CAR-T cell therapy product candidates, should any of our product candidates receive marketing approval;
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• the achievement of milestones or occurrence of other developments that trigger payments by or to third parties;
• our implementation of various computerized informational systems and efforts to enhance operational systems;
• the impact of public health crises or geopolitical events on our clinical development or operations;
• the impact of inflationary pressures and tariffs on the cost of our operations; and
• the costs of operating as a public company, including defending against any future class action securities litigation and shareholder derivative lawsuits.
Furthermore, our operating plans may change, and we expect to need additional funds to meet operational needs and capital requirements for our clinical trials and development of our CAR-T cell therapy product candidates.
Because of the numerous risks and uncertainties associated with therapeutic product development, we may never achieve profitability and, unless and until we are able to develop and commercialize our CAR-T cell therapy product candidates, we will need to continue to raise additional capital. Until we can generate significant revenue from product sales, if ever, we expect to finance our operations through equity offerings (including our at-the-market equity offering program), debt financings, new collaborations, structured or other non-dilutive financings, licensing arrangements, and/or other sources. We cannot provide any assurance that we will be successful in obtaining an adequate level of financing to support our business plans as needed on acceptable terms, or at all. If we raise additional funds through new collaborations or licensing arrangements with third parties, we may have to relinquish valuable rights to our intellectual property, future revenue streams, or product candidates or grant licenses on terms that may not be favorable to us. Disruptions and volatility in the global and domestic capital markets resulting from heightened inflation, tariffs, capital market volatility, interest rate and currency rate fluctuations, artificial intelligence (“AI”), political and geopolitical tensions, government agency changes, any potential economic slowdown or recession, including trade wars or civil or political unrest (such as the ongoing war between Ukraine and Russia, conflicts in the Middle East, including the recent hostilities involving Iran, tension between China and Taiwan, geopolitical tensions in Europe, South America, and elsewhere) may increase the cost of capital and limit our ability to access capital. If we are unable to raise capital as and when needed or on attractive terms, we may have to significantly delay, reduce, or discontinue the development and commercialization of our CAR-T cell therapy product candidates or scale back or terminate our pursuit of new in-licenses and acquisitions.
Cash Flows
Comparison of the Three Months Ended March 31, 2026, and March 31, 2025
The following table summarizes our cash flows for the periods indicated:
Three Months Ended March 31,
2026 2025 Change
(in thousands)
Cash used in operating activities $ (26,984) $ (36,725) $ 9,741
Cash provided by investing activities 23,985 49,381 (25,396)
Cash provided by financing activities 2,696 468 2,228
Net (decrease) increase in cash, and cash equivalents, and restricted cash $ (303) $ 13,124 $ (13,427)
Cash Used in Operating Activities
Net cash used in operating activities was $27.0 million for the three months ended March 31, 2026, compared to $36.7 million for the three months ended March 31, 2025. The decrease was primarily driven by a decrease in net loss for the three months ended March 31, 2026; partially offset by a decrease in net changes in our operating assets and liabilities primarily related to a decrease in net changes in accounts payable.
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Cash Provided by Investing Activities
Net cash provided by investing activities was $24.0 million for the three months ended March 31, 2026, compared to $49.4 million for the three months ended March 31, 2025. The decrease was primarily driven by a decrease in proceeds from maturities of marketable securities and higher cash utilized for purchases of marketable securities.
Cash Provided by Financing Activities
Net cash provided by financing activities was $2.7 million for the three months ended March 31, 2026, compared to $0.5 million for the three months ended March 31, 2025. The increase was primarily driven by proceeds from the issuance of common stock under the ATM Sales Agreement, net of offering expenses, during the three months ended March 31, 2026. We did not sell any common stock pursuant to the ATM Sales Agreement during the three months ended March 31, 2025.
Critical Accounting Policies and Significant Judgments and Estimates
Our critical accounting policies are disclosed in our audited consolidated financial statements for the year ended December 31, 2025, and the related notes included in our Form 10-K. Since the date of such financial statements, there have been no material changes to our significant accounting policies. There have been no material changes to our critical accounting estimates as compared to those disclosed in our Form 10-K.
Recently Issued Accounting Pronouncements
See Note 2 to our unaudited condensed consolidated financial statements included elsewhere in this Form 10-Q for additional information.
Item 3. Quantitative and Qualitative Disclosures about Market Risk.
There have been no material changes to our market risk during the three months ended March 31, 2026. For a discussion of our exposure to market risk, refer to the section titled “Quantitative and Qualitative Disclosures About Market Risk” in our Form 10-K.
Text extracted from the filing as submitted to EDGAR. Formatting, tables and exhibits are simplified for reading; the original document is authoritative for anything you rely on.