Sana Biotechnology, Inc.

Previous wording

We currently focus our efforts across three areas and have three ongoing clinical trials across multiple disease types and therapeutic areas, including type 1 diabetes (T1D), B-cell mediated autoimmune diseases, and B-cell malignancies.

Current wording

We currently focus our efforts across three areas and have three ongoing clinical trials across multiple disease types and therapeutic areas, including type 1 diabetes (T1D), B-cell mediated autoimmune diseases, and B-cell malignancies. We retain worldwide rights to each of the product candidates described below.

Previous wording

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 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 investigator-sponsored first-in-human study (IST) evaluating UP421, an allogeneic, primary islet cell therapy engineered with our HIP technology, in patients with T1D. We expect to share additional data from the IST in 2025 and file an investigational new drug application (IND) for SC451 as early as 2026.

Current wording

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. We expect to share additional data from the IST in 2025 and file an investigational new drug application (IND) for SC451 as early as 2026.

Previous wording

Allogeneic CAR T cells: We are developing SC291, our HIP-modified CD19-directed allogeneic CAR T cell product candidate, in patients with B-cell mediated autoimmune diseases. The GLEAM study is a Phase 1 clinical trial evaluating SC291 in patients with lupus nephritis (LN), extrarenal lupus (ERL), and antineutrophil cytoplasmic antibody (ANCA)-associated vasculitis. If successful, SC291 has the potential to benefit patients in a number of additional B-cell mediated autoimmune diseases. We are also developing SC262, our HIP-modified CD22-directed allogeneic CAR T cell product candidate. The VIVID study is a Phase 1 clinical trial evaluating SC262 in patients with relapsed and/or refractory (R/R) B-cell malignancies who have received prior CD19-directed CAR T therapy. We are enrolling patients in both the GLEAM and VIVID trials and expect to share data from each study in 2025.

Current wording

Allogeneic CAR T cells: We are developing SC291, our HIP-modified CD19-directed allogeneic CAR T cell product candidate, in patients with B-cell mediated autoimmune diseases. The GLEAM study is a Phase 1 clinical trial evaluating SC291 in patients with lupus nephritis (LN), extrarenal lupus (ERL), and antineutrophil cytoplasmic antibody (ANCA)-associated vasculitis. We are also preclinically developing SC291 for other B-cell mediated autoimmune diseases. If the GLEAM study is successful, SC291 has the potential to benefit patients in various B-cell mediated autoimmune diseases. We are also developing SC262, our HIP-modified CD22-directed allogeneic CAR T cell product candidate. The VIVID study is a Phase 1 clinical trial evaluating SC262 in patients with relapsed and/or refractory (R/R) B-cell malignancies who have received prior CD19-directed CAR T therapy. We are enrolling patients in both the GLEAM and VIVID trials and expect to share data from each study in 2025.

Previous wording

In vivo CAR T cells: Using our fusogen platform, which allows for cell-specific, in vivo delivery of various payloads, we are developing our SG299 product candidate, which 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 and gonadal tissue. We plan to develop SG299 in a range of B-cell cancers and B-cell mediated autoimmune diseases and expect to file an IND for SG299 as early as 2026.

Current wording

In vivo CAR T cells: Using our fusogen platform, which allows for cell-specific, in vivo delivery of various payloads, we are preclinically developing our SG299 product candidate, which 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 and gonadal tissue. We plan to develop SG299 in a range of B-cell cancers and B-cell mediated autoimmune diseases and expect to file an IND for SG299 as early as 2026.

Previous wording

We believe the time is right to develop engineered cell therapies across a broad range of 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 platforms – our hypoimmune allogeneic CAR T cell platform and our stem-cell derived platform that also leverages our HIP technology – and ourin vivo cell engineering platform. We are in the early stages of development across a broad pipeline of product candidates, which are summarized below:

Current wording

We believe the time is right to develop engineered cell therapies across a broad range of 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 platforms – our hypoimmune allogeneic CAR T cell platform and our stem-cell derived platform that also leverages our HIP technology – and ourin vivo cell engineering platform.

Previous wording

We announced positive four- and 12-week results from the UP421 IST demonstrating that all primary and secondary endpoints were met. Results of the study through 12 weeks 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. Magnetic resonance imaging scanning also demonstrates a sustained signal at the site of transplanted cells over time, which is consistent with graft survival. 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. We and our collaborators at Uppsala University Hospital expect to report additional data from this study, including longer-term follow-up, as the year progresses at scientific conferences and/or in a peer-reviewed publication.

Current wording

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, as the year progresses. In addition, we continue preclinical development of SC451, and a recent FDA INTERACT meeting increases our confidence in moving forward with our HIP-edited master cell bank for good manufacturing practices (GMP) manufacturing and our non-clinical testing plan.

Previous wording

In November 2024, we announced a portfolio prioritization to prioritize clinical and preclinical development in T1D, B-cell mediated autoimmune diseases, refractory B-cell malignancies, and the fusogen platform for generatingin vivo CAR T cells. We suspended development of SC291, our HIP-modified CD19 allogeneic CAR T therapy, in oncology, and SC379, our glial progenitor cell program, as we seek partnerships for these programs. As part of these efforts, we are winding down the ARDENT Phase 1 clinical trial evaluating SC291 in B-cell malignancies, including non-Hodgkin’s lymphoma and chronic lymphoblastic leukemia. In connection with the portfolio prioritization, we incurred approximately $5.8 million of cash-based expenses related to employee severance, benefits, and related costs. This portfolio update and associated workforce reduction are substantially complete.

Current wording

In November 2024, we announced a portfolio prioritization to prioritize clinical and preclinical development in T1D, B-cell mediated autoimmune diseases, refractory B-cell malignancies, and the fusogen platform for generatingin vivo CAR T cells. We suspended development of SC291, our HIP-modified CD19 allogeneic CAR T therapy, in oncology, and SC379, our glial progenitor cell program, as we seek partnerships for these programs. As part of these efforts, we are winding down the ARDENT Phase 1 clinical trial evaluating SC291 in B-cell malignancies, including non-Hodgkin’s lymphoma and chronic lymphoblastic leukemia. In connection with the portfolio prioritization, we incurred approximately $5.8 million of cash-based expenses related to employee severance, benefits, and related costs. This portfolio update and associated workforce reduction is fully complete.

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 three months ended March 31, 2025 and 2024 were $49.4 million and $107.5 million, respectively. As of March 31, 2025, we had an accumulated deficit of $1.7 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 six months ended June 30, 2025 and 2024 were $143.2 million and $157.8 million, respectively. As of June 30, 2025, we had an accumulated deficit of $1.7 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). Concurrently with entering into the Sales Agreement, we terminated our prior sales agreement with TD Cowen (as successor to Cowen and Company, LLC) entered into in August 2022 (the Prior Sales Agreement). As of March 31, 2025, we sold an aggregate of 4.9 million shares of our common stock under the Prior Sales Agreement for net proceeds of $28.5 million, after deducting commissions and expenses.

Current 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). Concurrently with entering into the Sales Agreement, we terminated our prior sales agreement with TD Cowen (as successor to Cowen and Company, LLC) entered into in August 2022 (the Prior Sales Agreement). As of June 30, 2025, we had sold an aggregate of 0.2 million shares of our common stock under the Sales Agreement. We received gross proceeds of $0.5 million for sales of common stock under the Sales Agreement during the quarter ended June 30, 2025, and did not sell any common stock under the Prior Sales Agreement during the quarter ended June 30, 2025. From July 1, 2025 through the date of this Quarterly Report, we raised $28.6 million in net proceeds under the Sales Agreement.

Previous wording

As of March 31, 2025, we had cash, cash equivalents, and marketable securities of $104.7 million. We will need to raise additional financing within the next 12 months and in the future to fund our operations, including 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 June 30, 2025, we had cash, cash equivalents, and marketable securities of $72.7 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 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 expect our operating losses and expenses to decrease in 2025 compared to 2024 as a result of our portfolio prioritization announced in November 2024. Operating expenses may increase over the longer term if our clinical trials are successful and if we expand our research and development efforts. Cost increases would be driven in large part by commencing and advancing our current and future product candidates through clinical trials; identifying additional product candidates; continuing to establish our manufacturing capabilities, including through third-party contract development and manufacturing organizations (CDMOs) and our internal manufacturing capabilities; initiating and advancing preclinical development of our current and future product candidates; advancing and expanding the capabilities of our ex 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; engaging in commercialization activities for any of our product candidates for which we obtain marketing approval; increasing our personnel, including those required to support our research, clinical and preclinical development, manufacturing, and potential future commercialization efforts; expanding our operational, financial, and management systems; continuing to develop, prosecute, and defend our intellectual property portfolio; and continuing to incur legal, accounting, or other expenses to operate our business, including the costs associated with being a public company.

Current wording

Excluding one-time items, we expect our operating losses and expenses to decrease in 2025 compared to 2024 as a result of our portfolio prioritization announced in November 2024. Operating expenses may increase over the longer term if our clinical trials are successful and if we expand our research and development efforts. Cost increases would be driven in large part by commencing and advancing our current and future product candidates through clinical trials; identifying additional product candidates; continuing to establish our manufacturing capabilities, including through third-party contract development and manufacturing organizations (CDMOs); initiating and advancing preclinical development of our current and future product candidates; advancing and expanding the capabilities of our ex 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; engaging in commercialization activities for any of our product candidates for which we obtain marketing approval; increasing our personnel, including those required to support our research, clinical and preclinical development, manufacturing, and potential future commercialization efforts; expanding our operational, financial, and management systems; continuing to develop, prosecute, and defend our intellectual property portfolio; and continuing to incur legal, accounting, or other expenses to operate our business, including the costs associated with being a public company.

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 expect our research and development expenses to decrease in 2025 compared to 2024. 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 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 third-party CDMOs and our internal manufacturing capabilities; 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. As a result of our portfolio prioritization and associated workforce reduction announced in November 2024, we expect our research and development expenses to decrease in 2025 compared to 2024, excluding one-time items. 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 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.

Previous wording

Comparison of the three months ended March 31, 2025 and 2024

Current wording

Comparison of the three and six months ended June 30, 2025 and 2024

Previous wording

Research and development expense was $37.2 million and $56.4 million for the three months ended March 31, 2025 and 2024, respectively. The decrease of $19.3 million was primarily due to:

Current wording

Research and development expense was $29.8 million and $60.9 million for the three months ended June 30, 2025 and 2024, respectively. The decrease of $31.1 million was primarily due to:

Previous wording

a decrease of $3.6 million in clinical development costs primarily related to the suspension of the ARDENT trial in November 2024 and clinical development milestones recorded in the first quarter of 2024 that did not recur in 2025; and

Current wording

a decrease of $12.1 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 in November 2024, and clinical development milestones recorded in the second quarter of 2024 that did not recur in 2025;

Previous wording

a decrease of $8.1 million in personnel-related expenses due to lower research and development headcount related to the portfolio prioritization announced in November 2024;

Current wording

a decrease of $10.3 million in personnel-related expenses, including non-cash stock-based compensation, due to lower research and development headcount related to the portfolio prioritization announced in November 2024;

Previous wording

a decrease of $3.0 million in facility and other allocated costs primarily due to the portfolio prioritization announced in November 2024.

Current wording

a decrease of $4.7 million in facility and other allocated costs primarily due to the portfolio prioritization announced in November 2024; and

Previous wording

These decreases were partially offset by an increase of $1.2 million in third-party manufacturing costs.

Current wording

a decrease in third-party manufacturing costs of $2.3 million.

Previous wording

The expense related to the change in the estimated fair value of our Cobalt Success Payment was $0.1 million for the three months ended March 31, 2025, compared to $27.9 million for the same period in 2024. The changes in value were due to changes in our market capitalization during the relevant periods. The gain related to the change in the estimated fair value of our Harvard Success Payments was immaterial for the three months ended March 31, 2025, compared to an expense of $4.7 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 expense related to the change in the estimated fair value of our Cobalt Contingent Consideration was $1.9 million compared to $5.4 million for the three months ended March 31, 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 expense related to the change in the estimated fair value of our Cobalt Success Payment was $3.6 million for the three months ended June 30, 2025, compared to a gain of $20.7 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 $0.4 million for the three months ended June 30, 2025, compared to a gain of $3.9 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 expense related to the change in the estimated fair value of our Cobalt Contingent Consideration was $6.3 million compared to a gain of $3.4 million for the three months ended June 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.

Previous wording

General and administrative expenses were $11.5 million and $16.3 million for the three months ended March 31, 2025 and 2024, respectively. The decrease of $4.8 million was primarily due to lower personnel-related costs, including non-cash stock-based compensation of $2.3 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 $1.5 million and $0.7 million, respectively.

Current wording

The decrease of $6.1 million for the three months ended June 30, 2025 was primarily due to lower personnel-related costs, including non-cash stock-based compensation of $3.7 million due to a decrease in headcount as a result of our portfolio prioritization announced in November 2024, and a decrease in consulting and legal fees of $1.0 million and $0.7 million, respectively.

Previous wording

Interest income, net, was $1.0 million and $3.0 million for the three months ended March 31, 2025 and 2024, respectively, and consisted primarily of interest earned on our cash and marketable securities balances.

Current wording

Interest income, net, was $0.6 million and $1.6 million for the three and six months ended June 30, 2025, respectively, compared to $3.2 million and $6.2 million for the same periods in 2024, respectively, and consisted primarily of interest earned on our cash and marketable securities balances.

Previous wording

As of March 31, 2025, we had $104.7 million in cash, cash equivalents, and marketable securities. To date we have raised an aggregate of approximately $1.5 billion in net proceeds from sales of common stock and private placements of our convertible preferred stock.

Current wording

As of June 30, 2025, we had $72.7 million in cash, cash equivalents, and marketable securities. Since inception through June 30, 2025, we have raised an aggregate of approximately $1.5 billion in net proceeds from sales of common stock and private placements of our convertible preferred stock.

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 internal and 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 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.

Previous wording

the cost, timing, and scope of our manufacturing capabilities, as well as costs associated with the manufacturing of clinical and commercial supplies of our current and future product candidates;

Current wording

the cost, timing, and scope of our manufacturing capabilities and our uses of our existing facilities, as well as costs associated with the manufacturing of clinical and commercial supplies of our current and future product candidates;

Previous wording

Until such time, if ever, as we can generate significant revenue from product sales, 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. In the event that additional financing is required, we may not be able to raise it on terms that are acceptable to us or at all. Our ability to raise additional financing may be adversely impacted by potential worsening global economic conditions and the recent disruptions to, and volatility in, the credit and financial markets in the United States and worldwide resulting from public health crises, the conflict in Ukraine and the Middle East, or other regions, changes in inflation, interest rate uncertainty, disruptions in global trade caused by political tensions and conflicts between countries, and other factors creating market risk. Bank failures have also caused increased concerns about liquidity in the broader financial services industry, and our business, business partners, or industry as a whole may be adversely impacted in ways that we cannot predict at this time. If we raise additional funds through the issuance of equity or convertible debt securities, existing stockholders’ ownership interests will be diluted, and the terms of these securities may include liquidation or other preferences that adversely affect the rights of our stockholders. Debt financing, if available, may result in increased fixed payment obligations, and the existence of securities with rights that may be senior to those of our common stock, and involve agreements that include covenants limiting or restricting our ability to take specific actions, such as incurring additional debt, making capital expenditures, declaring dividends, or acquiring, selling, or licensing intellectual property rights or assets, which could adversely impact our ability to conduct our business. If we raise funds through strategic collaborations or licensing or other arrangements, we may have to relinquish significant rights or grant licenses on terms that are not favorable to us. Our ability to raise additional funds may be adversely impacted by potential worsening global economic conditions and the recent disruptions to, and volatility in, the credit and financial markets in the United States and worldwide resulting from various factors beyond our control. If we are unable to raise additional capital when desired, our business, results of operations, and financial condition would be adversely affected.

Current wording

Until such time, if ever, as we can generate significant revenue from product sales, 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. In the event that additional financing is required, we may not be able to raise it on terms that are acceptable to us or at all. Our ability to raise additional financing may be adversely impacted by potential worsening global economic conditions and the recent disruptions to, and volatility in, the credit and financial markets in the United States and worldwide resulting from public health crises, the conflicts in Ukraine and the Middle East, or other regions, changes in inflation, interest rate uncertainty, disruptions in global trade caused by political tensions and conflicts between countries, and other factors creating market risk. Bank failures have also caused increased concerns about liquidity in the broader financial services industry, and our business, business partners, or industry as a whole may be adversely impacted in ways that we cannot predict at this time. If we raise additional funds through the issuance of equity or convertible debt securities, existing stockholders’ ownership interests will be diluted, and the terms of these securities may include liquidation or other preferences that adversely affect the rights of our stockholders. Debt financing, if available, may result in increased fixed payment obligations, and the existence of securities with rights that may be senior to those of our common stock, and involve agreements that include covenants limiting or restricting our ability to take specific actions, such as incurring additional debt, making capital expenditures, declaring dividends, or acquiring, selling, or licensing intellectual property rights or assets, which could adversely impact our ability to conduct our business. If we raise funds through strategic collaborations or licensing or other arrangements, we may have to relinquish significant rights or grant licenses on terms that are not favorable to us. Our ability to raise additional funds may be adversely impacted by potential worsening global economic conditions and the recent disruptions to, and volatility in, the credit and financial markets in the United States and worldwide resulting from various factors beyond our control. If we are unable to raise additional capital when desired, our business, results of operations, and financial condition would be adversely affected.

Previous 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 revaluation of our success payment liabilities and contingent consideration, respectively, partially offset by other non-cash adjustments of $1.0 million.

Current wording

During the six months ended June 30, 2025, net cash used in operating activities was $81.8 million, consisting primarily of net loss of $143.2 million and the change in net operating assets and liabilities of $14.2 million, offset by non-cash adjustments of $75.6 million. The non-cash adjustments of $75.6 million consisted of $44.6 million for impairment of long-lived assets, $13.7 million of non-cash stock-based compensation, expenses of $8.2 million and $4.1 million for revaluation of our contingent consideration and success payment liabilities, respectively, and depreciation expense of $6.5 million, partially offset by other non-cash adjustments of $1.5 million.

Previous wording

During the three months ended March 31, 2024, net cash used in operating activities was $65.6 million, consisting primarily of net loss of $107.5 million and the change in net operating assets and liabilities of $7.4 million, offset by non-cash adjustments of $49.3 million. The non-cash adjustments of $49.3 million consisted of $9.1 million of non-cash stock-based compensation, expenses of $32.6 million and $5.4 million for revaluation of our success payment liabilities and contingent consideration, respectively, and depreciation expense of $3.7 million, offset by other non-cash adjustments of $1.5 million.

Current wording

During the six months ended June 30, 2024, net cash used in operating activities was $124.2 million, consisting primarily of net loss of $157.8 million and the change in net operating assets and liabilities of $5.1 million, offset by non-cash adjustments of $38.7 million. The non-cash adjustments of $38.7 million consisted of $20.5 million of non-cash stock-based compensation, expenses of $8.0 million and $2.0 million for revaluation of our success payment liabilities and contingent consideration, respectively, and depreciation expense of $7.6 million, offset by other non-cash adjustments of $0.6 million.

Previous wording

Cash provided by investing activities was $16.6 million during the three months ended March 31, 2025, and cash used in investing activities was $77.2 million during the three months ended March 31, 2024. 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. For the three months ended March 31, 2024, this consisted of net purchases and maturities of marketable securities of $61.4 million and purchases of property and equipment of $15.8 million.

Current wording

Cash provided by investing activities was $24.3 million during the six months ended June 30, 2025, and cash used in investing activities was $71.4 million during the six months ended June 30, 2024. For the six months ended June 30, 2025, this consisted of net purchases and maturities of marketable securities of $23.7 million and net sales of property and equipment of $0.6 million. For the six months ended June 30, 2024, this consisted of net purchases and maturities of marketable securities of $42.5 million and purchases of property and equipment of $28.9 million.

Previous wording

During the three months ended March 31, 2025 and 2024, cash provided by financing activities was $1.0 million and $186.4 million, respectively, consisting primarily of net proceeds from issuance of common stock.

Current wording

During the six months ended June 30, 2025 and 2024, cash provided by financing activities was $1.5 million and $197.0 million, respectively, consisting 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 March 31, 2025 and for the three months ended March 31, 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 June 30, 2025 and for the three and six months ended June 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.