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Sana Biotechnology, Inc.

For the period ended Mar 31, 2026. Filed May 11, 2026.

View on SEC.gov

About this filing

A company's report for each of its first three quarters. The financial statements are not audited. It shows how the business has moved since the last annual report, and what management says changed.

Mar 31, 2026 · Filed May 11, 2026

SANA$2.37+1.3%Stored close · as of Nov 6, 2026

What changed in Management’s Discussion and Analysis?

Read the current filing

The baseline is this issuer’s latest earlier reporting period of the same form that was filed before the current report. A previous 10-Q is a different quarter, not a year-over-year comparison. Amendments are excluded.

Compared 106 previous paragraphs and 99 current paragraphs.

58 unchanged; 28 reworded; 13 added; 16 removed; 4 previous and 0 current paragraphs rearranged.

Tables are not compared: 7 previous and 5 current tables excluded. Dates, whitespace, punctuation and numbering changes are ignored; changes to financial figures remain significant.

A changed paragraph is not evidence that risk increased or decreased. An unchanged paragraph does not establish that risk stayed the same.

Added paragraphs (13)

Current report

We are currently focused on advancing three distinct therapeutics, each of which leverages one of these platform technologies. SC451 is our HIP-edited product candidate for the treatment of type 1 diabetes. SG293 is our in vivo CAR T product candidate for the treatment of B cell malignancies and B cell mediated autoimmune diseases, and SG227 is ourin vivo CAR T product candidate for the treatment of multiple myeloma. We retain worldwide rights to each of these product candidates.

Current report

In vivo CAR T cells: Using our fusogen platform, which enables cell-specific, in vivo delivery of various payloads, we are developing twoin vivo CAR T cell product candidates, SG293 and SG227. In vivo CAR T cells have the potential to provide the clinical benefit of autologous, ex vivo manufactured CAR T cells while avoiding the need for lymphodepleting chemotherapy as well as significant complexity and bottlenecks related to manufacturing.

Current report

SG293 is a CD8-targeted fusosome that delivers genetic material to CD8+ T cells, which enables these cells to become CD19-targeting CAR T cells while avoiding potentially problematic delivery to tissues such as the liver and gonads. We plan to develop SG293 in a range of B cell cancers and B cell mediated autoimmune diseases and expect to generate initial clinical data as early as this year.

Current report

SG227 is a CD8-targeted fusosome that delivers the genetic material to make BCMA-directed CAR T cells. SG227 delivers a BCMA CAR that has been validated in the autologous CAR T setting for patients with multiple myeloma in a product that is currently approved in China. We plan to develop SG227 as a potential treatment for patients with multiple myeloma and are preparing to begin clinical testing as early as mid-2027, contingent upon the early clinical profile of SG293.

Current report

With respect to ourex vivo cell engineering efforts, in March 2026, we announced positive 14-month results from the UP421 IST. The study showed no drug product-related adverse events, and there was evidence of graft survival and function with detectable C-peptide production through 14 months following transplantation. C-peptide levels increased, as expected, during a mixed meal tolerance test, showing appropriate function of the transplanted islet cells. Immunological analysis revealed comprehensive immune evasion of HIP-modified pancreatic islet cells. In August 2025, The New England Journal of Medicine published a journal article titled "Survival of Transplanted Allogeneic Beta Cells with No Immunosuppression," which discusses the 12-week results of the trial. We continue preclinical development of SC451, which is currently completing nonclinical testing, manufacturing transfer, and clinical trial preparation.

Current report

With respect to ourin vivo cell engineering research efforts, in January 2026, we shared data from a preclinical study using a surrogate for SG293 that delivers a CD20 CAR capable of targeting non-human primate (NHP) B cells incynomolgus macaques in the absence of lymphodepletion. A single intravenous injection of the SG293 surrogate to these NHPs resulted in robustin vivo generation of CAR T cells and deep B cell depletion in the peripheral blood and lymph nodes. The B cell depletion was further confirmed by lymph node biopsies showing clearance of B cells as well as by “reset” of the NHPs’ B cell repertoire toward naïve B cells. We believe that deep B cell depletion in this preclinical model is the most significant biomarker for potential efficacy in patients with B cell cancers and B cell mediated autoimmune diseases. Separately, in vitro studies using SG293 have shown selective gene delivery to CD8+ T cells with no detectable off-target transduction in tissues such as the liver and gonadal tissue, supporting the specificity of SG293. We are currently conducting nonclinical testing, manufacturing transfer to a contract manufacturer, and clinical trial preparation for SG293.

Current report

Management has determined that our present capital resources may not be sufficient to fund our planned operations for at least one year from the date of this Quarterly Report, and there is substantial doubt as to our ability to continue as a going concern. Our ability to continue as a going concern will depend on, among other things, our ability to obtain additional funding and appropriately manage the amount of cash used to fund our operations. We plan to address this condition through equity or debt offerings or capital obtained in connection with strategic collaborations or licensing or other arrangements. If we are unable to obtain such financing, we may be required to pursue alternative sources of capital which may not be available to us on favorable terms, if at all, or significantly modify our operational plans by delaying, reducing the scope of, or ceasing some or all of our research and development programs, or pursue strategic alternatives.

Current report

a decrease of $2.2 million in third-party manufacturing costs at CDMOs primarily related to the suspension of our allogeneic CAR T programs; and

Current report

General and administrative expenses were $11.5 million for the three months ended March 31, 2026, unchanged compared to the three months ended March 31, 2025. Legal fees increased $0.2 million offset by decreased personnel-related costs, including stock-based compensation, of $0.2 million compared to the three months ended March 31, 2025.

Current report

In April 2026, we entered into a stock purchase agreement with Mayo Clinic (Stock Purchase Agreement), pursuant to which we agreed to sell to Mayo Clinic, and Mayo Clinic agreed to purchase, (i) 7,507,507 shares (the Initial Shares) of our common stock at a price of $3.33 per share, for gross proceeds of approximately $25.0 million, and (ii) if elected by Mayo Clinic on or prior to August 31, 2026, an additional 7,507,507 shares (the Additional Shares) of common stock at a price of $3.33 per share, for additional gross proceeds of approximately $25.0 million. The closing of the purchase and sale of the Initial Shares occurred on April 15, 2026. As of the date of this Quarterly Report, Mayo Clinic has not elected to purchase the Additional Shares. Pursuant to the Stock Purchase Agreement, we agreed to use the net proceeds from the sale of the Initial Shares and, if applicable, the Additional Shares, for the development of products upon which an affiliate of Mayo Clinic has the right to receive royalties pursuant to a collaboration and license agreement, dated April 10, 2026, between the Company and such affiliate (the License Agreement), including SC451 and certain genetically modified stem-cell derived islet cell products, as set forth in the License Agreement.

Current report

Management has determined that our present capital resources may not be sufficient to fund our planned operations for at least one year from the date of this Quarterly Report, and there is substantial doubt as to our ability to continue as a going concern. Our ability to continue as a going concern will depend on, among other things, our ability to obtain additional funding and appropriately manage the amount of cash used to fund our operations. We plan to address this condition through equity or debt offerings or capital obtained in connection with strategic collaborations or licensing or other arrangements. If we are unable to obtain such financing, we may be required to pursue alternative sources of capital which may not be available to us on favorable terms, if at all, or significantly modify our operational plans by delaying, reducing the scope of, or ceasing some or all of our research and development programs, or pursue strategic alternatives.
Removed paragraphs (16)

Previous report

We are currently focused on advancing our pipeline across two platforms for the treatment of various disease types, including type 1 diabetes (T1D), B-cell cancers, and B-cell mediated autoimmune diseases. We retain worldwide rights to each of the product candidates described below.

Previous report

Fusogen Platform –In vivo CAR T cells: Using our fusogen platform, which allows for cell-specific, in vivo delivery of various payloads, we are developing SG293, the next-generation version of our prior SG299 product candidate, which was renamed to reflect an updated construct and manufacturing process. SG293 is a CD8-targeted fusosome that delivers to CD8+ T cells the genetic material to make CD19-directed CAR T cells while avoiding potentially troublesome delivery to tissues such as the liver. SG293 builds on data from SG299, showing cell-specific delivery and deep B-cell depletion–as measured by depletion in circulating and lymph node B cells as well as a phenotypic reset when B cells return–in non-human primates without the use of any lymphodepleting chemotherapy. We intend to explore SG293 in both B-cell cancers and B-cell mediated autoimmune diseases and expect to file an IND for SG293 as early as 2027.

Previous report

We announced positive six-month results from the UP421 IST demonstrating that all primary and secondary endpoints were met. Results of the study through six months after cell transplantation demonstrate the survival and function of pancreatic beta cells as measured by the presence of circulating C-peptide, a biomarker indicating that transplanted beta cells are producing insulin. C-peptide levels also increase with a mixed meal tolerance test during testing at these timepoints, consistent with insulin secretion in response to a meal. 12-week PET-MRI scanning also demonstrated islet cells at the transplant site, a forearm muscle. The study identified no safety issues, and the HIP-modified islet cells evaded immune detection. The trial continues to evaluate safety, persistence, and function of the transplanted cells. In August 2025, The New England Journal of Medicine published a journal article titled "Survival of Transplanted Allogeneic Beta Cells with No Immunosuppression," which discusses the 12-week results of the trial. In June 2025, the six-month results of the trial were presented at the 85th Annual American Diabetes Association (ADA) Scientific Sessions. We and our collaborators at Uppsala University Hospital expect to report additional data from the study, including longer-term follow-up. We continue preclinical development of SC451, and recent regulatory interactions, including an FDA INTERACT meeting, increase our confidence in moving forward with our HIP-edited master cell bank for good manufacturing practices (GMP) manufacturing and our nonclinical testing plan.

Previous report

Impairment of long-lived assets consists of non-cash losses recognized for the impairment of the right-of-use (ROU) asset, construction in progress, and laboratory equipment for our manufacturing facility in Bothell, Washington (the Bothell facility), and the ROU asset, leasehold improvements, and laboratory equipment for certain office and laboratory space in Seattle, Washington (the Seattle facility). We also recognized additional non-cash impairment losses for other long-lived assets. The losses were recorded in operating expenses in the statement of operations in the second quarter of 2025. Refer to Note 11, Impairment of long-lived assets to our condensed consolidated financial statements included elsewhere in this Quarterly Report for details on the impairment.

Previous report

a decrease of $7.1 million in laboratory, research, and clinical development expenses primarily related to lower research and development headcount related to the portfolio prioritization announced in November 2024, the suspension of the ARDENT trial and the SC379 glial progenitor cell program in November 2024, and clinical development milestones recorded in the third quarter of 2024 that did not recur in 2025; and

Previous report

Research and development expense was $97.1 million and $170.5 million for the nine months ended September 30, 2025 and 2024, respectively. The decrease of $73.5 million was primarily due to:

Previous report

a decrease of $28.0 million in laboratory, research, and clinical development expenses primarily expenses primarily related to lower research and development headcount related to the portfolio prioritization announced in November 2024, the suspension of the ARDENT trial and the SC379 glial progenitor cell program in November 2024, and clinical development milestones recorded in the nine months ended September 30, 2024 that did not recur in 2025; and

Previous report

a decrease of $11.8 million in facility and other allocated costs primarily due to the portfolio prioritization announced in November 2024.

Previous report

General and administrative expenses were $10.3 million and $32.1 million for the three and nine months ended September 30, 2025, respectively, compared to $14.1 million and 46.8 million for the same periods in 2024.

Previous report

The decrease of $3.8 million for the three months ended September 30, 2025 was primarily due to lower personnel-related costs, including non-cash stock-based compensation of $3.2 million due to a decrease in headcount as a result of our portfolio prioritization announced in November 2024 and a decrease in legal fees of $0.5 million.

Previous report

The decrease of $14.7 million for the nine months ended September 30, 2025 was primarily due to lower personnel-related costs, including non-cash stock-based compensation of $9.3 million due to a decrease in headcount as a result of our portfolio prioritization announced in November 2024, and a decrease in legal and consulting fees of $2.7 million and $1.5 million, respectively.

Previous report

Impairment of long-lived assets was $44.6 million for the nine months ended September 30, 2025. See Note 11, Impairment of long-lived assets to our condensed consolidated financial statements included elsewhere in this Quarterly Report for additional information.

Previous report

Other income (expense), net

Previous report

Other income, net, was $0.4 million and $1.2 million for the three and nine months ended September 30, 2025, respectively, compared to other expense, net of $0.7 million and $4.6 million for the three and nine months ended September 30, 2024, respectively. The increases of $1.1 million and $5.8 million for the three and nine months ended September 30, 2025, respectively, were due to other-than-temporary impairments of other assets recorded in the second and third quarters of 2024.

Previous report

In February 2024, we completed an underwritten public offering pursuant to which we sold 21.8 million shares of our common stock, including 4.5 million shares pursuant to the full exercise of the underwriters' option to purchase additional shares, and pre-funded warrants to purchase 12.7 million shares of our common stock for net proceeds of approximately $180.0 million, after deducting underwriting discounts and commissions and offering expenses.

Previous report

Based on our current operating plan, we believe that our existing cash, cash equivalents, and marketable securities as of the date of this Quarterly Report, including the net proceeds received from the Offering and the ATM facility, will be sufficient to meet our working capital and capital expenditure needs for at least one year from the filing of this Quarterly Report. However, we will need to raise additional financing in the future to fund our operations, including the commercialization of any approved product candidates. We are subject to the risks typically related to the development of new products, and we may encounter unforeseen expenses, difficulties, complications, delays, and other unknown factors that may adversely affect our business.
Reworded paragraphs (28)

Previous wording

We were founded on the belief that engineered cells will be one of the most important transformations in medicine over the next several decades. The burden of diseases that can be addressed at their root cause through engineered cells is significant. We view engineered cells as having the potential to be as therapeutically disruptive as biologic drugs to clinical practice, enabling us to repair cells in the body when possible and replace them when needed. We are developingex vivo andin vivo cell engineering platforms to revolutionize treatment of various diseases with unmet treatment needs, including type 1 diabetes, B-cell cancers, and B-cell mediated autoimmune diseases.

Current wording

We were founded on the belief that engineered cells will be one of the most important transformations in medicine over the next several decades. The burden of diseases that can be addressed at their root cause through engineered cells is significant. We view engineered cells as having the potential to be as therapeutically disruptive as biologic drugs to clinical practice, enabling us to repair cells in the body when possible and replace them when needed. We have developedex vivo andin vivo cell engineering platforms to revolutionize treatment across a broad array of therapeutic areas with unmet treatment needs, including type 1 diabetes, oncology, and B-cell mediated autoimmune diseases.

Previous wording

For ourex vivo platform, we have made focused investments in our hypoimmune platform technology, which we refer to as our HIP technology, with the twin goals of engineering allogeneic cells that can "hide" from the patient's immune system to overcome the fundamental challenge of immune rejection and cell persistence, and that we can manufacture at scale. A successful therapeutic requires cells that can engraft, function, and persist in the body, and we believe our approach can unlock a wave of disruptive therapeutics. Forin vivo therapies that aim to repair and control genes in the body, a successful product candidate requires both gene modification andin vivo delivery of the therapeutic payload. Of these, we view effectivein vivo delivery as the greatest current limitation to dramatically expanding the impact of this class of therapeutics. To this end, our initial focus is on cell-specific delivery of genetic payloads that integrate into the genome of the target cells.

Current wording

For ourex vivo platform, we have made focused investments in our hypoimmune platform technology, which we refer to as our HIP technology, with the twin goals of engineering allogeneic cells that can "hide" from the patient's immune system to overcome the fundamental challenge of immune rejection and cell persistence, and that we can manufacture at scale. A successful therapeutic requires cells that can engraft, function, and persist in the body, and we believe our approach can unlock a wave of disruptive therapeutics, starting in type 1 diabetes. Forin vivo therapies that aim to repair or control genes in the body, a successful product candidate requires both gene modification andin vivo delivery of the therapeutic payload. Our initial focus is on cell-specific delivery of genetic payloads, known as chimeric antigen receptors (CARs), to a patient’s T cells, resulting in the generation and proliferation of CAR T cells, which have been shown to deplete a patient’s disease-causing B cells.

Previous wording

Hypoimmune Platform – Type 1 Diabetes: Approximately nine million people suffer from T1D worldwide, and there have been no major novel medicines for the disease since insulin. We are preclinically developing SC451, a HIP-modified, stem cell-derived pancreatic islet cell therapy, for the treatment of T1D. The goal of this therapy is euglycemia, or normal blood glucose, without the need for exogenous insulin injections or immunosuppression. We currently have an ongoing Phase 1 investigator-sponsored first-in-human study (IST) evaluating UP421, an allogeneic, primary islet cell therapy engineered with our HIP technology addressing T1D, for which we have disclosed positive six-month results and expect to share additional data as the study progresses. We expect to file an investigational new drug application (IND) and begin our Phase 1 clinical trial for SC451 as early as 2026.

Current wording

Type 1 Diabetes: Almost ten million people suffer from type 1 diabetes (T1D) worldwide, and there has been limited progress in treatments for this disease since the advent of insulin injections over 100 years ago. We are developing SC451, a HIP-modified, stem cell-derived pancreatic islet cell therapy, for the treatment of T1D. The goal of this therapy is euglycemia, or normal blood glucose, without the need for exogenous insulin injections or immunosuppression. Through a first-in-human investigator-sponsored study (IST), we have shown that UP421, an allogeneic, primary islet cell therapy engineered with our HIP technology, can survive and function for 14 months post-transplant in a patient with T1D without the need for immunosuppression. We have incorporated this HIP technology into a more scalable manufacturing platform with SC451 and expect to file an investigational new drug application (IND) as well as begin a Phase 1 clinical trial for this therapy as early as this year.

Previous wording

In November 2025, we announced that, in order to prioritize our resources and follow promising data in the SC451 and fusogen programs, we plan to prioritize further development of our SC451 and SG293 programs, and have suspended development of and any further internal investment in our two allogeneic cell therapy CAR T programs – SC291 in B-cell mediated autoimmune diseases and SC262 in oncology. As part of these efforts, we have begun winding down the GLEAM Phase 1 clinical trial evaluating SC291 in B-cell mediated autoimmune diseases and the VIVID Phase 1 clinical trial evaluating SC262 in oncology.

Current wording

In November 2025, in order to prioritize our resources and pursue promising data in the SC451 and fusogen programs, we announced our prioritization of further development of our SC451 and SG293 programs, and suspended development of our two allogeneic cell therapy CAR T programs – SC291 in B-cell mediated autoimmune diseases and SC262 in oncology. As part of these efforts, we are winding down the GLEAM Phase 1 clinical trial evaluating SC291 in B-cell mediated autoimmune diseases and the VIVID Phase 1 clinical trial evaluating SC262 in oncology.

Previous wording

We believe the time is right to develop engineered cell therapies in various therapeutic areas. Substantial progress in the understanding of genetics, gene editing, protein engineering, stem cell biology, immunology, process analytics, and computational biology have converged to create an opportunity to markedly increase the breadth and depth of the potential impact of cellular medicines. We continue to make progress developing ourex vivo cell engineering platform that leverages our HIP technology and ourin vivo cell engineering platform. Each of our programs provides the potential for meaningful standalone value while also supporting our potential ability to further exploit our platforms in a manner that leads to the development of broadly applicable medicines.

Current wording

We believe the time is right to develop engineered cell therapies in various therapeutic areas. Substantial progress in the understanding of genetics, gene editing, protein engineering, stem cell biology, immunology, process analytics, and computational biology have converged to create an opportunity to markedly increase the breadth and depth of the potential impact of cellular medicines. We continue to make progress developing ourex vivo cell engineering platform that leverages our HIP technology and ourin vivo cell engineering platform that leverages our fusogen technology. Each of our programs provides the potential for meaningful standalone value while also supporting our potential ability to further exploit our platforms in a manner that leads to the development of broadly applicable medicines.

Previous wording

We continue to make progress on advancing our research- and preclinical-stage product candidates into and through preclinical development and toward potential IND submissions. As certain of our product candidates advance toward potential IND submissions, we are conducting good laboratory practices toxicology studies and establishing necessary scale-up for our manufacturing processes.

Current wording

We continue to make progress on advancing our product candidates into and through preclinical development and toward potential IND submissions. As our product candidates advance toward potential IND submissions, we are conducting good laboratory practices toxicology studies and establishing necessary scale-up for our manufacturing processes.

Previous wording

Given the depth and breadth of our portfolio, we expect to continue to assess and prioritize our programs on an ongoing basis based on various factors, including internal and external opportunities and constraints, which may result in our decision to advance certain programs ahead or instead of others or suspend, discontinue, or divest certain programs that represent our current development focus.

Current wording

We expect to continue to assess and prioritize our programs on an ongoing basis based on various factors, including internal and external opportunities and constraints, which may result in our decision to advance certain programs ahead or instead of others or suspend, discontinue, or divest certain programs that represent our current development focus. For details regarding our product candidates, see the section titled “Business—Overview” in Part I, Item 1 included in our 2025 Annual Report.

Previous wording

Our operations to date have included developing ourex vivo andin vivo cell engineering platforms, identifying and developing potential product candidates, executing preclinical studies, establishing manufacturing capabilities, conducting clinical trials of our product candidates, supporting clinical trials of product candidates developed using our technologies, acquiring technologies, staffing the company, business planning, establishing and maintaining our intellectual property portfolio, raising capital, and providing general and administrative support for these operations. All of our programs are currently in the development stage, and we do not have any products approved for sale. We have incurred net losses each year since our inception. Our net losses for the nine months ended September 30, 2025 and 2024 were $185.3 million and $217.7 million, respectively. As of September 30, 2025, we had an accumulated deficit of $1.8 billion. Our net losses resulted primarily from our research and development programs, and, to a lesser extent, general and administrative costs associated with our operations.

Current wording

Our operations to date have included developing ourex vivo andin vivo cell engineering platforms, identifying and developing potential product candidates, executing preclinical studies, establishing manufacturing capabilities, conducting clinical trials of our product candidates, supporting clinical trials of product candidates developed using our technologies, acquiring technologies, staffing the company, business planning, establishing and maintaining our intellectual property portfolio, raising capital, and providing general and administrative support for these operations. All of our programs are currently in the development stage, and we do not have any products approved for sale. We have incurred net losses each year since our inception. Our net losses for the three months ended March 31, 2026 and 2025 were $47.2 million and $49.4 million, respectively. As of March 31, 2026, we had an accumulated deficit of $1.9 billion. Our net losses resulted primarily from our research and development programs, and, to a lesser extent, general and administrative costs associated with our operations.

Previous wording

In May 2025, we entered into a sales agreement (the Sales Agreement) with TD Securities (USA) LLC (TD Cowen), acting as sales agent, pursuant to which we may offer and sell through TD Cowen up to $119.0 million of shares of our common stock from time to time in a series of one or more at the market equity offerings (collectively, the ATM facility). During the quarter ended September 30, 2025, we sold an aggregate of 7.3 million shares of our common stock under the Sales Agreement, for net proceeds of $28.6 million, after deducting commissions and expenses.

Current wording

In March 2026, we entered into an amended and restated sales agreement (the Sales Agreement) with TD Securities (USA) LLC (TD Cowen), acting as sales agent, pursuant to which we may offer and sell through TD Cowen shares of our common stock from time to time in a series of one or more at the market equity offerings, and filed a prospectus supplement with the SEC pursuant to which we may offer and sell up to $150.0 million of shares of our common stock pursuant to the Sales Agreement (collectively, the ATM facility). The Sales Agreement amends and restates our prior sales agreement with TD Cowen entered into in May 2025 (the Prior Sales Agreement). During the quarter ended March 31, 2026, we did not sell any shares of our common stock under the Prior Sales Agreement or the Sales Agreement.

Previous wording

As of September 30, 2025, we had cash, cash equivalents, and marketable securities of $153.1 million. Based on our current operating plan, we believe that our existing cash, cash equivalents, and marketable securities as of the date of this Quarterly Report, including the net proceeds received from the Offering and the ATM facility, will be sufficient to fund our planned operations for at least one year from the filing of this Quarterly Report. However, we will need to raise additional financing in the future to fund our operations, including the conduct of clinical trials and the commercialization of any approved product candidates. Until such time, if ever, as we can generate substantial product revenue, we expect to finance our operations with our existing cash, cash equivalents, and marketable securities, proceeds from any future equity or debt financings, and milestone, royalty, and other payments received under any future licenses, collaborations, or other arrangements. Additional capital may not be available on terms that are reasonable or acceptable to us, if at all. If we are unable to raise capital when needed or on attractive terms, our business, results of operations, and financial condition would be adversely affected.

Current wording

As of March 31, 2026, we had cash, cash equivalents, and marketable securities of $101.1 million. We will need to raise additional financing within the next 12 months and in the future to fund our operations, including conducting clinical trials and the commercialization of any approved product candidates. Until such time, if ever, as we can generate substantial product revenue, we expect to finance our operations with our existing cash, cash equivalents, and marketable securities, proceeds from any future equity or debt financings, and milestone, royalty, and other payments received under any future licenses, collaborations, or other arrangements. Additional capital may not be available on terms that are reasonable or acceptable to us, if at all. If we are unable to raise capital when needed or on attractive terms, our business, results of operations, and financial condition would be adversely affected.

Previous wording

We have completed various acquisitions since inception. For details regarding our acquisitions, see the section titled “Business—Key Intellectual Property Agreements” included in our 2024 Annual Report, and Note 4, Acquisitions to our condensed consolidated financial statements included elsewhere in this Quarterly Report.

Current wording

We have completed various acquisitions since inception. For details regarding acquisitions involving technologies that we are currently developing, see the section titled “Business—Key Intellectual Property Agreements” included in our 2025 Annual Report, and Note 4, Acquisitions to our condensed consolidated financial statements included elsewhere in this Quarterly Report.

Previous wording

To date, research and development expenses have related primarily to discovery and development of our platform technologies and product candidates. Research and development expenses are recognized as incurred, and payments made prior to the receipt of goods or services to be used in research and development are recorded as prepaid expenses, until the goods or services are received.

Current wording

To date, research and development expenses have been related primarily to the discovery and development of our platform technologies and product candidates. Research and development expenses are recognized as incurred, and payments made prior to the receipt of goods or services to be used in research and development are recorded as prepaid expenses, until the goods or services are received.

Previous wording

Research and development activities account for a significant portion of our operating expenses. As a result of our portfolio prioritization and associated workforce reduction announced in November 2024, we have decreased our research and development expenses. However, research and development expenses may increase over the longer term (or our expected decreases may be less than anticipated) due to a variety of factors, including if our future clinical trials are successful and if we expand our research and development efforts. Cost increases, if they occur, would be driven in large part by advancing our current and future product candidates into and through clinical trials; identifying additional product candidates; continuing to establish our manufacturing capabilities, including through CDMOs, initiating and advancing preclinical development of our current and future product candidates; advancing and expanding the capabilities of ourex vivo andin vivo cell engineering platforms; acquiring and licensing technologies aligned with ourex vivo andin vivo cell engineering platforms, or modifying the terms of existing acquisition or license arrangements; seeking regulatory approval of our current and future product candidates; and increasing our workforce to support our expanded research, clinical, and preclinical development efforts. A change in the outcome of any of these factors could result in a significant change in the costs and timing associated with the development of our product candidates. In addition, recent and potential future developments in international trade, including tariffs imposed on imports from other countries, could cause unanticipated increases in our research and development costs, primarily through increased CDMO costs and costs of our laboratory supplies, and we may not be able to accurately forecast their impacts on our business.

Current wording

Research and development activities account for a significant portion of our operating expenses. Excluding any one-time items, we expect our research and development expenses to be materially flat or slightly lower in 2026 compared to 2025. Research and development expenses may increase over the longer term due to a variety of factors, including if our future clinical trials are successful and if we expand our research and development efforts. Cost increases, if they occur, would be driven in large part by advancing our current and future product candidates into and through clinical trials; identifying additional product candidates; continuing to establish our manufacturing capabilities, including through CDMOs, initiating and advancing preclinical development of our current and future product candidates; advancing and expanding the capabilities of ourex vivo andin vivo cell engineering platforms; acquiring and licensing technologies aligned with ourex vivo andin vivo cell engineering platforms, or modifying the terms of existing acquisition or license arrangements; seeking regulatory approval of our current and future product candidates; and increasing our workforce to support our expanded research, clinical, and preclinical development efforts. A change in the outcome of any of these factors could result in a significant change in the costs and timing associated with the development of our product candidates. In addition, recent and potential future developments in international trade, including tariffs imposed on imports from other countries, could cause unanticipated increases in our research and development costs, primarily through increased CDMO costs and costs of our laboratory and manufacturing supplies, and we may not be able to accurately forecast their impacts on our business.

Previous wording

As a result of our portfolio prioritization and associated workforce reduction announced in November 2024, our general and administrative expenses have decreased in 2025 compared to 2024. General and administrative expenses may increase over the longer term to support potential expanded research and development activities.

Current wording

Excluding any one-time items, we expect our general and administrative expenses to be materially flat in 2026 compared to 2025. General and administrative expenses may increase over the longer term to support potential expanded research and development activities.

Previous wording

Comparison of the three and nine months ended September 30, 2025 and 2024

Current wording

Comparison of the three months ended March 31, 2026 and 2025

Previous wording

Research and development expense was $30.1 million and $53.2 million for the three months ended September 30, 2025 and 2024, respectively. The decrease of $23.1 million was primarily due to:

Current wording

Research and development expenses were $28.7 million and $37.2 million for the three months ended March 31, 2026 and 2025, respectively. The decrease of $8.5 million was primarily due to:

Previous wording

a decrease of $10.7 million in personnel-related expenses, including non-cash stock-based compensation, due to lower research and development headcount primarily related to the portfolio prioritization announced in November 2024;

Current wording

a decrease of $4.7 million in personnel-related expenses, including non-cash stock-based compensation, due to lower research and development headcount;

Previous wording

a decrease of $4.1 million in facility and other allocated costs primarily due to the portfolio prioritization announced in November 2024.

Current wording

a decrease of $2.1 million in facility and other allocated costs primarily related to depreciation, allocated personnel, and other costs.

Previous wording

The expense related to the change in the estimated fair value of our Cobalt Success Payment was $4.8 million for the three months ended September 30, 2025, compared to a gain of $4.9 million for the same period in 2024. The changes in value were due to changes in our market capitalization during the relevant periods. The expense related to the change in the estimated fair value of our Harvard Success Payments was $0.3 million for the three months ended September 30, 2025, compared to a gain of $0.8 million for the same period in 2024. The changes in value were primarily due to changes in our common stock price during the relevant periods. The gain related to the change in the estimated fair value of our Cobalt Contingent Consideration was $2.0 million compared to an expense of $0.2 million for the three months ended September 30, 2025 and 2024, respectively. The changes in value were due primarily to changes in the timing and probability of the achievement of milestones during the relevant periods.

Current wording

The gain related to the change in the estimated fair value of our Cobalt Success Payment was $1.8 million for the three months ended March 31, 2026, compared to an expense of $0.1 million for the same period in 2025. The changes in value were primarily due to changes in our market capitalization during the relevant periods. The gain related to the change in the estimated fair value of our Harvard Success Payments was $0.5 million for the three months ended March 31, 2026, compared to an immaterial gain for the same period in 2025. The changes in value were primarily due to changes in our common stock price during the relevant periods. The expense related to the change in the estimated fair value of our Cobalt Contingent Consideration was $10.7 million for the three months ended March 31, 2026 compared to $1.9 million for the same period in 2025, respectively. The changes in value were due primarily to changes in the timing and probability of the achievement of milestones during the relevant periods.

Previous wording

Interest income, net, was $1.0 million and $2.6 million for the three and nine months ended September 30, 2025, respectively, compared to $2.6 million and $8.8 million for the same periods in 2024, respectively, and consisted primarily of interest earned on our cash and marketable securities balances.

Current wording

Interest income, net, was $1.0 million for the three months ended March 31, 2026, unchanged compared to the three months ended March 31, 2025, and consisted primarily of interest earned on our cash and marketable securities balances.

Previous wording

As of September 30, 2025, we had $153.1 million in cash, cash equivalents, and marketable securities. Since inception through September 30, 2025, we have raised an aggregate of approximately $1.6 billion in net proceeds from sales of our equity securities.

Current wording

As of March 31, 2026, we had $101.1 million in cash, cash equivalents, and marketable securities. Since inception through March 31, 2026, we have raised an aggregate of approximately $1.7 billion in net proceeds from sales of our equity securities.

Previous wording

In May 2025, we entered into the Sales Agreement, pursuant to which we may offer and sell up to $119.0 million of shares of our common stock from time to time under the ATM facility. During the quarter ended September 30, 2025, we sold an aggregate of 7.3 million shares of our common stock under the Sales Agreement, for net proceeds of $28.6 million, after deducting commissions and expenses.

Current wording

In March 2026, we entered into the Sales Agreement with TD Cowen, acting as sales agent, and filed a prospectus supplement with the SEC, pursuant to which we may offer and sell up to $150.0 million of shares of our common stock from time to time under the ATM facility. The Sales Agreement amends and restates the Prior Sales Agreement. During the quarter ended March 31, 2026, we did not sell any shares of our common stock under the Prior Sales Agreement or the Sales Agreement.

Previous wording

We expect to incur additional losses for the foreseeable future as we conduct our research and development efforts, including conducting clinical trials and preclinical studies, developing new product candidates, continuing to establish our external manufacturing capabilities, and funding our operations generally. We are subject to the risks typically related to the development of new products, and we may encounter unforeseen expenses, difficulties, complications, delays, and other unknown factors that may adversely affect our business.

Current wording

We expect to incur additional losses for the foreseeable future as we conduct our research and development efforts, including conducting preclinical studies and clinical trials, developing new product candidates, continuing to establish our external manufacturing capabilities, and funding our operations generally. We are subject to the risks typically related to the development of new products, and we may encounter unforeseen expenses, difficulties, complications, delays, and other unknown factors that may adversely affect our business.

Previous wording

During the nine months ended September 30, 2025, net cash used in operating activities was $111.2 million, consisting primarily of net loss of $185.3 million and the change in net operating assets and liabilities of $13.6 million, offset by non-cash adjustments of $87.7 million. The non-cash adjustments of $87.7 million consisted of $44.6 million for impairment of long-lived assets, $19.1 million of non-cash stock-based compensation, expenses of $9.2 million and $6.2 million for revaluation of our success payment liabilities and contingent consideration, respectively, and depreciation expense of $9.7 million, partially offset by other non-cash adjustments of $1.1 million.

Current wording

During the three months ended March 31, 2026, net cash used in operating activities was $37.4 million, consisting primarily of net loss of $47.2 million and the change in net operating assets and liabilities of $6.5 million, offset by non-cash adjustments of $16.3 million. The non-cash adjustments of $16.3 million consisted of an expense of $10.7 million for revaluation of our contingent consideration, $5.7 million of non-cash stock-based compensation, and depreciation expense of $2.4 million, partially offset by a gain of $2.3 million for revaluation of our success payment liabilities, and other non-cash adjustments of $0.2 million.

Previous wording

During the nine months ended September 30, 2024, net cash used in operating activities was $176.0 million, consisting primarily of net loss of $217.7 million and the change in net operating assets and liabilities of $5.5 million, offset by non-cash adjustments of $47.2 million. The non-cash adjustments of $47.2 million consisted of $31.2 million of non-cash stock-based compensation, depreciation expense of $11.7 million, and expenses of $2.3 million for revaluation of each of our success payment liabilities and contingent consideration, offset by other non-cash adjustments of $0.3 million.

Current wording

During the three months ended March 31, 2025, net cash used in operating activities was $48.7 million, consisting primarily of net loss of $49.4 million and the change in net operating assets and liabilities of $10.9 million, offset by non-cash adjustments of $11.6 million. The non-cash adjustments of $11.6 million consisted of $7.0 million of non-cash stock-based compensation, depreciation expense of $3.6 million, and expenses of $0.1 million and $1.9 million for the revaluation of our success payment liabilities and contingent consideration, respectively, partially offset by other non-cash adjustments of $1.0 million.

Previous wording

Cash used in investing activities was $23.7 million during the nine months ended September 30, 2025, compared to $29.6 million during the nine months ended September 30, 2024. For the nine months ended September 30, 2025, this consisted of net purchases and maturities of marketable securities of $24.4 million and net sales of property and equipment of $0.7 million. For the nine months ended September 30, 2024, this consisted of purchases of property and equipment of $33.0 million, partially offset by net maturities of marketable securities of $3.4 million.

Current wording

Cash provided by investing activities was $49.4 million during the three months ended March 31, 2026, and $16.6 million during the three months ended March 31, 2025. For the three months ended March 31, 2026, this consisted primarily of net purchases and maturities of marketable securities of $49.5 million. For the three months ended March 31, 2025, this consisted of net purchases and maturities of marketable securities of $16.5 million and net sales of property and equipment of $0.1 million.

Previous wording

During the nine months ended September 30, 2025 and 2024, cash provided by financing activities was $111.1 million and $199.1 million, respectively, consisting primarily of net proceeds from issuance of common stock.

Current wording

During the three months ended March 31, 2026 and 2025, cash used in financing activities was $0.1 million and cash provided by financing activities was $1.0 million, respectively. During the three months ended March 31, 2025, financing activities consisted primarily of net proceeds from issuance of common stock.

Previous wording

Our condensed consolidated financial statements are prepared in accordance with generally accepted accounting principles in the United States. The preparation of these financial statements requires us to make estimates and assumptions that affect the amounts reported in the condensed consolidated financial statements and accompanying notes. Our estimates are based on our historical experience and on various other factors that we believe are reasonable under the circumstances, the results of which form the basis for making judgments about the carrying value of assets and liabilities that are not readily apparent from other sources. Actual results may differ from these estimates under different assumptions or conditions. Our significant accounting policies are described in more detail in the notes to our condensed consolidated financial statements as of September 30, 2025 and for the three and nine months ended September 30, 2025 and 2024, and are consistent with those discussed in Part II, Item 7. Management’s Discussion and Analysis of Financial Condition and Results of Operations “—Critical accounting policies and significant judgments and estimates” included in our 2024 Annual Report.

Current wording

Our condensed consolidated financial statements are prepared in accordance with generally accepted accounting principles in the United States. The preparation of these financial statements requires us to make estimates and assumptions that affect the amounts reported in the condensed consolidated financial statements and accompanying notes. Our estimates are based on our historical experience and on various other factors that we believe are reasonable under the circumstances, the results of which form the basis for making judgments about the carrying value of assets and liabilities that are not readily apparent from other sources. Actual results may differ from these estimates under different assumptions or conditions. Our significant accounting policies are described in more detail in the notes to our condensed consolidated financial statements as of March 31, 2026 and for the three months ended March 31, 2026 and 2025, and are consistent with those discussed in Part II, Item 7. Management’s Discussion and Analysis of Financial Condition and Results of Operations “—Critical accounting policies and significant judgments and estimates” included in our 2025 Annual Report.
Rearranged previous paragraphs (4)

Previous report — wording carried elsewhere

The following table summarizes the components of our research and development expenses for the periods presented:

Previous report — wording carried elsewhere

a decrease of $29.1 million in personnel-related expenses, including non-cash stock-based compensation, due to lower research and development headcount primarily related to the portfolio prioritization announced in November 2024;

Previous report — wording carried elsewhere

The following table summarizes the expenses associated with research and development related success payments and contingent consideration for the periods presented:

Previous report — wording carried elsewhere

The expense related to the change in the estimated fair value of our Cobalt Success Payment was $8.5 million for the nine months ended September 30, 2025, compared to $2.3 million for the same period in 2024. The changes in value were due to changes in our market capitalization during the relevant periods. The expense related to the change in the estimated fair value of our Harvard Success Payments was $0.7 million for the nine months ended September 30, 2025, compared to an immaterial gain for the same period in 2024. The changes in value were primarily due to changes in our common stock price during the relevant periods. The expense related to the change in the estimated fair value of our Cobalt Contingent Consideration was $6.2 million compared to $2.3 million for the nine months ended September 30, 2025 and 2024, respectively. The changes in value were due primarily to changes in the timing and probability of the achievement of milestones during the relevant periods.